Exhibit 10.1


 


LICENSE AND OPTION AGREEMENT





 


 


BETWEEN


 


 


VALENTIS, INC.


 


 


AND


 


 


SCHERING AG


 


CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS,

HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION

PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.




 





 

















 


INDEX


 


	
  Background

  
	
   

  
	
  Part I:  

  	
  Definitions

  
	
   

  
	
   

  	
  ARTICLE 1  DEFINITIONS

  
	
   

  	
   

  
	
  Part II: 
  

  	
  License for [***]

  
	
   

  
	
   

  	
  ARTICLE 2  LICENSE GRANT

  
	
   

  	
  2.1  Grant

  
	
   

  	
  2.2  Limitations

  
	
   

  	
  2.3  Exclusivity

  
	
   

  	
   

  
	
   

  	
  ARTICLE 3  DEVELOPMENT

  
	
   

  	
  3.1 
  Development by Schering

  
	
   

  	
  3.2 
  Diligence

  
	
   

  	
   

  
	
   

  	
  ARTICLE 4  SUPPLY OF ELECTROPORATION DEVICES

  
	
   

  	
   

  
	
   

  	
  ARTICLE 5 
  CONSIDERATION LICENSE [***]

  
	
   

  	
  5.1  License Fee

  
	
   

  	
  5.2  Milestone Payments

  
	
   

  	
  5.3  Royalty Payments

  
	
   

  	
  5.4  Third Party Royalties

  
	
   

  	
   

  
	
  Part III: 
  

  	
  Option Gene X

  
	
   

  	
   

  
	
   

  	
  ARTICLE 6  OPTION GRANT GENE X

  
	
   

  	
  6.1  Grant

  
	
   

  	
  6.2  Exercise of the Option; naming of Gene X

  
	
   

  	
  6.3 
  Option Fee

  
	
   

  	
  6.4  Research License

  
	
   

  	
  6.5  Exclusivity

  
	
   

  	
   

  
	
  Part IV:  

  	
  Option [***]

  
	
   

  	
   

  
	
   

  	
  ARTICLE 7  OPTION GRANT [***]

  
	
   

  	
  7.1  Grant

  
	
   

  	
  7.2  Exercise of the Option

  



 


2

















 


	
   

  	
  7.3 
  Option Fee

  
	
   

  	
  7.4  Research License

  
	
   

  	
   

  
	
   

  	
  ARTICLE 8  DEVELOPMENT

  
	
   

  	
   

  
	
   

  	
  ARTICLE 9  CONSIDERATION LICENSE [***]

  
	
   

  	
  9.1 
  License Fee

  
	
   

  	
  9.2  Milestone Payments

  
	
   

  	
  9.3  Royalty Payments

  
	
   

  	
  9.4  Third Party Royalties

  
	
   

  	
   

  
	
  Part V: 
    

  	
  General Provisions

  
	
   

  	
   

  
	
   

  	
  ARTICLE 10 
  TECHNOLOGY TRANSFER

  
	
   

  	
  10.1  Transfer of Technical Information and
  Supplies

  
	
   

  	
  10.2  Technical Assistance

  
	
   

  	
  10.3  Restricted Use

  
	
   

  	
   

  
	
   

  	
  ARTICLE 11  GRANTBACK LICENSE

  
	
   

  	
  11.1 
  Grant

  
	
   

  	
  11.2  Sublicenses

  
	
   

  	
  11.3  Improvement Patents

  
	
   

  	
   

  
	
   

  	
  ARTICLE 12  IMPROVEMENTS; INFORMATION EXCHANGE

  
	
   

  	
  12.1 
  Principle

  
	
   

  	
  12.2  Annual updates

  
	
   

  	
  12.3  Ad hoc notifications

  
	
   

  	
  12.4  Valentis Improvements

  
	
   

  	
  12.5 
  Schering Information and Data

  
	
   

  	
  12.6  Adverse Drug Reactions

  
	
   

  	
   

  
	
   

  	
  ARTICLE 13 
  SUBSTITUTION OF GENES

  
	
   

  	
  13.1 
  Substitution by Backup Genes

  
	
   

  	
  13.2  Election of Backup Genes

  
	
   

  	
  13.3 
  [***]

  
	
   

  	
   

  
	
   

  	
  ARTICLE 14  SUB-LICENSES

  
	
   

  	
   

  
	
   

  	
  ARTICLE 15 
  REPORTS AND PAYMENT PROVISIONS

  
	
   

  	
  15.1  Reports and Payments

  
	
   

  	
  15.2  Mode of Payment

  
	
   

  	
  15.3  Late Payments

  
	
   

  	
  15.4  Taxes

  
	
   

  	
  15.5  Records of Revenues and Expenses; Audits

  



 


3

















 


	
   

  	
  ARTICLE 16 
  INTELLECTUAL PROPERTY

  
	
   

  	
  16.1  Patent Enforcement

  
	
   

  	
  16.2  Infringement of Third Party Rights

  
	
   

  	
  16.3 
  Trademarks and Domain Names

  
	
   

  	
   

  
	
   

  	
  ARTICLE 17  REPRESENTATIONS, WARRANTIES AND COVENANTS

  
	
   

  	
  17.1 
  Representations and Warranties

  
	
   

  	
  17.2 
  Performance by Affiliates

  
	
   

  	
  17.3  Governmental Compliance

  
	
   

  	
   

  
	
   

  	
  ARTICLE 18  INDEMNITY

  
	
   

  	
  18.1  Indemnification for Breach of
  Representations and Warranties

  
	
   

  	
  18.2  Indemnification with respect to Products

  
	
   

  	
  18.3  Notification of Claim; Conditions to
  Indemnification Obligations

  
	
   

  	
  18.4 
  Insurance

  
	
   

  	
   

  
	
   

  	
  ARTICLE 19 
  TERM AND TERMINATION

  
	
   

  	
  19.1  Term

  
	
   

  	
  19.2  Termination at Will

  
	
   

  	
  19.3  Termination for Cause

  
	
   

  	
  19.4 
  Termination for Insolvency

  
	
   

  	
  19.5  Effect of Expiration or Termination

  
	
   

  	
  19.6 
  Survival

  
	
   

  	
   

  
	
   

  	
  ARTICLE 20  CONFIDENTIALITY

  
	
   

  	
  20.1 
  Confidentiality and Non-Use

  
	
   

  	
  20.2  Authorized Disclosure

  
	
   

  	
  20.3  Identity of Genes

  
	
   

  	
  20.4 
  Use of Names

  
	
   

  	
  20.5  Termination of Prior Agreements

  
	
   

  	
  20.6  Terms of Agreement

  
	
   

  	
  20.7  Termination

  
	
   

  	
   

  
	
   

  	
  ARTICLE 21  MISCELLANEOUS

  
	
   

  	
  21.1  Further Assurances

  
	
   

  	
  21.2  No Implied Rights

  
	
   

  	
  21.3  Limitation of Liability

  
	
   

  	
  21.4  Governing Law

  
	
   

  	
  21.5  Force Majeure

  
	
   

  	
  21.6  Independent Contractors

  
	
   

  	
  21.7 
  Assignment

  
	
   

  	
  21.8 
  Notices

  
	
   

  	
  21.9  Severability

  
	
   

  	
  21.10  Modification; Waiver

  
	
   

  	
  21.11  Entire Agreement

  



 


4

















 


	
   

  	
  21.12 
  Headings

  
	
   

  	
  21.13  Counterparts

  
	
   

  	
  21.14  Ambiguities

  



 


APPENDICES


 


	
  Appendix 1.20

  	
   

  	
  Patents relating
  to Electroporation

  
	
   

  	
   

  	
   

  
	
  Appendix 1.30

  	
   

  	
  GeneSwitch
  Patents

  
	
   

  	
   

  	
   

  
	
  Appendix 1.62

  	
   

  	
  PINC Patents

  
	
   

  	
   

  	
   

  
	
  Appendix 1.70

  	
   

  	
  Supplies and
  Technical Information

  
	
   

  	
   

  	
   

  
	
  Appendix 2.2

  	
   

  	
  Valentis Third
  Party Licenses

  
	
   

  	
   

  	
   

  
	
  Appendix 4

  	
   

  	
  Terms for Supply
  of Electroporation Devices

  
	
   

  	
   

  	
   

  
	
  Appendix 5.3.1

  	
   

  	
  Calculation of
  Royalties

  



 


5

















 


LICENSE AND OPTION AGREEMENT


 


THIS LICENSE AND OPTION AGREEMENT
(“Agreement”) effective as of December 19, 2002 (“Effective Date”), is made and
entered into by and between VALENTIS, INC.,
a Delaware corporation, having its principal place of business at 863A Mitten
Road, Burlingame, CA 94010, USA (“Valentis”) and SCHERING AG, a German corporation having its principal place
of business at Müllerstrasse 178, 13353 Berlin, Germany (“Schering”).  Valentis and Schering each may be referred
to herein individually as a “Party,” or collectively as the “Parties.”


 


BACKGROUND


 


A.            Valentis
owns or otherwise controls certain intellectual property and other rights in
and to technologies relating to the delivery and expression of genes, that may
have substantial commercial value; and


 


B.            Schering
desires to obtain from Valentis a license and options to use such delivery
technologies to do research on, develop, make, have made, use and sell
pharmaceutical products; and


 


C.            Valentis
is willing to grant such license and options to Schering on the terms and
conditions hereinafter set forth.


 


NOW, THEREFORE, in
consideration of the mutual covenants and obligations set forth herein,
Valentis and Schering hereby agree as follows:


 


PART I -
DEFINITIONS


 


1              DEFINITIONS


 


As used in this Agreement, the following
terms shall have the meanings indicated:


 


1.1                                 “Affiliate”
means any person, corporation, partnership, firm, joint venture or other entity
that, directly or indirectly, through one or more intermediaries, controls, is
controlled by or is under common control with, Valentis or Schering, as the
case may be.  As used in this definition
(but not elsewhere in this Agreement), “control” means the possession of the
power to direct or cause the direction of the management and policies of an
entity, whether through the ownership of the outstanding voting securities or
by contract or otherwise.


 


1.2                                 “Audit Disagreement”   shall have the
meaning set forth in Section 15.5.2.


 


6

















 


1.3                                 “Average Royalty
Percentage” shall have the meaning set forth in Section 5.3.1
and 9.3.1.


 


1.4                                 “Backup Gene”
shall be a gene substituted for one of the Genes
pursuant to Section 13.


 


1.5                                 “Backup License”  shall have the meaning set forth in Section 13.2.


 


1.6                                 “Bankruptcy Event”  shall have the meaning set forth in
Section 19.4.


 


1.7                                 “Business Day”  means any day that is not a Saturday, a
Sunday or other day on which banks are required or authorized by law to be
closed in California, US, or Berlin. Germany.


 


1.8                                 “Clinical Development”   means the conduct of studies of a Product in humans to assess the
dosing, safety and/or efficacy of such Product, including, but not limited to,
Phase I Clinical Trials, Phase II Clinical Trials and Phase III Clinical
Trials.


 


1.9                                 “CMC/Manufacturing”  shall mean the development of one or more
processes for the manufacture and packaging of the Product for Preclinical
Development, Clinical Development and Commercialization, and shall include,
without limitation, formulation, production, fill/finish, sourcing of components,
raw materials and packaging supplies, development of regulatory methods and
controls, including assays, quality control and quality assurance methodology
and stability protocols.


 


1.10                           “Commercialization”and
“Commercialize”  shall
refer to all activities undertaken relating to the manufacture for commercial
sale, pre-marketing, marketing, distribution and sale of a Product, and the
process of Commercialization, respectively.


 


1.11                           “Confidential Information”  shall have the meaning assigned to it in
Section 20.1.


 


1.12                           “Control” or  “Controlled”
shall mean possession of the ability to grant a license or sublicense of patent
rights, know-how, Technical Information or other intangible rights as provided
for herein without violating the terms of any agreement or other arrangement
with any Third Party.


 


1.13                           “Device”
shall mean, individually or collectively, as the case may be, the
electroporation generator used for the electrically assisted delivery of
Products and/or the disposable applicator.


 


1.14                           “Disease Class”
means a disease category being the subject of a separate Section of the Merck
Manual of Diagnosis and Therapy, 17th Edition, 1999.


 


1.15                           “Drug Approval Application”
means an application for Regulatory Approval required to be approved before
commercial sale or use of a Product as a drug in a regulatory jurisdiction,
including, for purposes of Regulatory Approval in the US, a New Drug
Application or a Biological License Application and all supplements filed
pursuant to the requirements of the FDA (including all documents, data and
other information concerning a Product that are necessary for, or included in,
FDA approval to market a Product) and,


 


7

















 


for the
purposes of Regulatory Approval in the EU, all applications for Regulatory
Approval to EMEA or any other applicable national regulatory authority.


 


1.16                           “Effective Date”
shall have the meaning set forth at the head of this Agreement.


 


1.17                           “Electroporation”
means a certain delivery technology licensed by Valentis from Genetronics,
Inc., relating to electrically-assisted plasmid delivery to muscle for
therapeutic or prophylactic applications, excluding DNA vaccines.


 


1.18                           “Electroporation Intellectual Property” means Electroporation Know-How and
Electroporation Patents.


 


1.19                           “Electroporation Know-How”
means all information currently existing, whether or not patentable, that is
Controlled by Valentis or its Affiliates and that relates to Electroporation,
and Improvements to Electroporation coming within the ownership or Control of
Valentis or its Affiliates during the term of this Agreement.


 


1.20                           “Electroporation Patents”
means any Patents relating to Electroporation, owned or Controlled by Valentis
or its Affiliates.  A list of
Electroporation Patents existing as of the Effective Date is attached hereto as
Appendix 1.20.  “Electroporation Patents” shall also
include any Patent on any Improvement to Electroporation coming within the
ownership or Control of Valentis during the term of this Agreement.


 


1.21                           “EMEA”
means the European Medicines Evaluation Agency, or any successor agency.


 


1.22                           “EU”
means the countries of the European Union, at any given point in time.


 


1.23                           “FDA”
means the United States Food and Drug Administration of the Department of
Health and Human Services, or any successor agency with responsibility for
regulating the development, manufacture and sale of human pharmaceutical
products.


 


1.24                           “Field”
means all preventive, therapeutic or diagnostic applications in humans.


 


1.25                           “First Commercial Sale”
means the date Schering or an Affiliate or a sublicensee of Schering first
sells commercially, pursuant to a Regulatory Approval, a Product to a Third
Party in any country of the Territory. 
A sale of a Product by Schering to an Affiliate or sublicensee under
this Agreement shall not constitute a First Commercial Sale.


 


1.26                           “Follow-on Product”
shall have the meaning as set forth in Section 5.2.2.


 


1.27                           “Gene(s)”
shall mean Gene X, [***] and [***], or each of them.


 


1.28                           “GeneSwitch Intellectual Property” means GeneSwitch Know-How and GeneSwitch Patents.


 


1.29                           “GeneSwitch Know-How”
means all information currently existing, whether or not patentable that is
Controlled by Valentis or its Affiliates and that relates to GeneSwitch


 


8

















 


Technology, and Improvements to the
GeneSwitch Technology coming within the ownership or Control of Valentis or its
Affiliates during the term of this Agreement.


 


1.30                           “GeneSwitch Patents”
means any Patents relating to the GeneSwitch Technology, owned or Controlled by
Valentis or its Affiliates.  A list of
GeneSwitch Patents existing as of the Effective Date is attached hereto as Appendix
1.30.  “GeneSwitch Patents” shall also include any Patent covering any
Improvement to the GeneSwitch Technology coming within the ownership or Control
of Valentis during the term of this Agreement.


 


 


1.31                           “GeneSwitch Technology”
means the mutated steroid hormone-based expression system for regulating
transgene expression licensed by Valentis from Baylor College of Medicine.


 


1.32                           “Gene X”
means the gene to be named by Schering pursuant to Section 6.2.


 


1.33                           “Gene X Evaluation”
shall have the meaning as set forth in Section 6.4.


 


1.34                           “Gene X License”
means the license granted by Valentis to Schering upon exercise of Option I.


 


1.35                           “Gene X Product”
means any product containing Gene X and one or more of the Valentis Delivery
Technologies.


 


1.36                           “Grantback License”
shall have the meaning as set forth in Section 11.


 


1.37                           [***] means the [***].


 


1.38                           [***] License” means the license granted by
Valentis to Schering pursuant Part II of this Agreement.


 


1.39                           [***] Product” means any product containing [***] and one or
more of the Valentis Delivery Technologies.


 


1.40                           “Improvement(s)”
means all advancements, modifications, revisions, changes, developments and
alterations to the Valentis Delivery Technologies developed by or coming into
the Control of either Party during the term of this Agreement.


 


1.41                           “Infringement”
shall have the meaning as set forth in Section 16.1.1.


 


1.42                           “Initial Clinical Trial”
shall mean in respect of a particular Product the first of (i) a Phase I
Clinical Trial and (ii) a Phase II Clinical Trial.


 


1.43                           “License(s)”
means the [***]
License, the Gene X License and the [***] License, or each of them.


 


1.44                           “Ligand”
means a [***].


 


9

















 


1.45                           “Major European Country(ies)”
means (each of) [***]
and [***].


 


1.46                           “Net Sales”
means the amount invoiced by Schering, its Affiliates or its sublicensees on
account of sales of a Product to Third Parties in the Territory, less the
following deductions applicable to the Product for: (a) transportation charges
and insurance relating thereto paid by Schering, its Affiliates or its
sublicensees, (b) sales and excise taxes or customs duties paid by Schering,
its Affiliates or its sublicensees and any other governmental charges imposed
upon the sale of a Product and paid by Schering, its Affiliates or
sublicensees; (c) fees paid to distributors, consignees or agents in connection
with the sale of the Product; (d) rebates or allowances granted, allowed
or incurred in connection with the sale of a Product; (e) quantity discounts,
cash discounts or chargebacks granted, allowed or incurred in connection with the
sale of a Product; (f) allowances or credits to customers in connection with
the sale of a Product on account of governmental requirements, rejection,
outdating, recalls or return of such Product; (g) provisions for price
reductions actually granted; (h) free goods in amounts reasonably consistent
with accepted trading practice in the pharmaceutical industry; (i) costs of
customer programs such as cost effectiveness or patient or physician assistance
studies or programs designed to aid in patient compliance with medication
schedules in connection with sale of the Product; and (j) reasonable allowances
for bad debts.


 


For the purpose of calculating Net Sales of
Schering, its Affiliates or sublicensees, the Parties recognize that: (i)
Schering’s customers may include persons in the chain of commerce who enter
into agreements with Schering as to price even though title to Product does not
pass directly from Schering to such customers, even though payment for such
Product is not made by such customers directly to Schering, and (ii) in such
cases, chargebacks paid by Schering to or through a Third Party (such as a
wholesaler) can be deducted by Schering from gross revenue in order to
calculate a Product’s Net Sales.  Any deductions
listed above which involve a payment by Schering shall be taken as a deduction
against aggregate sales for the period in which the payment or deduction is
made.  Sales of Products solely for
research or clinical testing purpose shall be excluded from the computation of
Net Sales.  The same stipulations shall
apply also to Net Sales of Affiliates and sublicensees of Schering.


 


In the event that Products are sold in a
bundle with other products, any discount applied to the Products to determine
the Net Sales shall not be greater than the average discount of the entire
bundle.


 


If a Product is sold as part of a Combination
Product, as defined below, the Net Sales from the Combination Product, for the
purpose of determining the royalty amount payable by Schering to Valentis,
shall be determined by multiplying the Net Sales of the Combination Product
during the applicable accounting period by the fraction A/A+B where A is the
average sales price of the Product when sold separately in finished form and B
is the average sales price of the other therapeutically active product(s)
included in the Combination Product, when sold separately in finished form, in
each case during the applicable reporting period or, if sales of both the
Product and the other product(s) did not occur in such period, then in the most
recent royalty reporting period in which sales of


 


10

















 


both occurred.  If, on a country-by-country basis, the other therapeutically
active product(s) included in the Combination Product are not sold separately
in that country, Net Sales shall be calculated by multiplying actual Net
Sales of such Combination Product by the fraction A/C where A is the average
puce of the Combination Product when sold separately, and C is the average
price of the Combination Product.  If,
on a country-by-country basis, neither the Product nor the therapeutically
active product(s) included in the Combination Product is sold separately in
said country, then Schering shall calculate in good faith a hypothetical market
price with respect to the Product within such Combination Product,
allocating the same proportions of costs, overhead and profit as are then
allocated to all similar substances or products then being made and marketed
and having an ascertainable market price. 
As used above, the term “Combination
Product” means any product which comprises a Product and one or more
other ingredients or compounds that has biologic activity as a therapeutic
agent when present alone.


 


1.47                           [***] means
Schering’s [***].


 


1.48                           [***] Evaluation” shall have the meaning
set forth in Section 7.4.


 


1.49                           [***] License” means the license granted
by Valentis to Schering upon exercise of Option II.


 


1.50                           [***] Product” means any product
containing [***]
the PINC Technology.


 


1.51                           “Option I” shall have the meaning
set forth in Section 6.1.


 


1.52                           “Option II” shall have the meaning
set forth in Section 7.1.


 


1.53                           “Option Period I” shall have the
meaning set forth in Section 6.1.


 


1.54                           “Option Period II” shall have the
meaning set forth in Section 7.1.


 


1.55                           “Part(s)” shall mean (each of) the [***] License as
set forth in Part II, the Option I as set forth in Part III and the Option II
as set forth in Part IV of this Agreement.


 


1.56                           “Patent” means: (i) all issued and
existing letters patent, including any extensions, supplemental protection
certificates, registrations, confirmations, reissues, reexaminations or
renewals thereof, and (ii) all pending applications, including any provisional
applications, converted provisional applications, continuing prosecution
applications and continuation, divisional, or continuation-in-part applications
thereof for any of the foregoing.


 


1.57                           “Phase I Clinical Trials” has the
meaning described in the ICH Harmonized Tripartite Guideline entitled “General Considerations for Clinical
Trials”, as amended, and such other studies as the FDA, EMEA or other
regulatory authority may require prior to the initiation of Phase II Clinical
Trials.


 


11

















 


1.58                           “Phase II Clinical Trials” has the
meaning described in the ICH Harmonized Tripartite Guideline entitled “General Considerations for Clinical Trials”, as amended.


 


1.59                           “Phase III Clinical Trials” has the
meaning described in the ICH Harmonized Tripartite Guideline entitled “General Considerations for Clinical
Trials”, as amended.


 


1.60                           “PINC Intellectual Property” means
PINC Know-How and PINC Patents.


 


1.61                           “PINC Know-How” means all
information, whether currently existing or developed during the term of this
Agreement and whether or not patentable that is now Controlled or hereinafter
becomes Controlled by Valentis or its Affiliates and that relates to the PINC
Technology.


 


1.62                           “PINC Patents” means any Patents
relating to PINC Technology owned or Controlled by Valentis or its Affiliates.  A list of PINC Patents existing as of the
Effective Date is attached hereto as Appendix 1.62.  “PINC Patents” shall also include any Patent
covering Improvements to the PINC Technology coming within the ownership or
Control of Valentis during the term of this Agreement.


 


1.63                           “PINC Technology” means Valentis’
proprietary polymeric transfection facilitating agents which, when formulated
with nucleic acids, do not condense the nucleic acids.


 


1.64                           “Pivotal Clinical Trial” shall mean
a Phase III Clinical Trial of a Product, unless a Phase II Clinical Trial is
intended to serve as the basis for a filing for Regulatory Approval for a
Product, in which case, such Phase II Clinical Trial shall be deemed a Pivotal
Clinical Trial.


 


1.65                           “Preclinical Development” means all
activities relating to the planning and execution of non-human studies
conducted in relevant in vivo animal models or in vitro directed toward
obtaining Regulatory Approval of a Product in each regulatory jurisdiction in
the Territory.


 


1.66                           “Product(s)” means (each of) [***] Product(s),
Gene X Product(s) and/or [***] Product(s).


 


1.67                           “Regulatory Approval” means any
approvals, product and/or establishment licenses, registrations or
authorizations of any federal, state or local regulatory agency, department,
bureau or other governmental entity, necessary for the commercial manufacture,
use, storage, import, export, transport, Commercialization or sale of a Product
in a regulatory jurisdiction.


 


1.68                           “Royalty Term” means, with respect
to each Product, on a country-by-country basis, the time period extending from
the date of First Commercial Sale until the later to occur of: (i) the
expiration of the last Valid Claim within the Valentis Delivery Technology(ies)
used with such Product and covering the manufacture, use or sale of such
Product, and (ii) [***].


 


1.69                           “Schering Trademark(s)” shall have
the meaning set forth in Section 16.3.1.


 


12

















 


1.70                           “Supplies” means any materials,
including but not limited to constructs, reagents and assays necessary for the
successful testing of the Delivery Technologies, in the possession of Valentis
at the Effective Date or coming in Valentis’ possession during the term of this
Agreement that are useful or needed for the research on, development,
utilization, manufacture, use, importation, sale or offer for sale of the
Valentis Delivery Technologies or the Products.  A list of currently existing Supplies to be transferred to
Schering is attached hereto as Appendix 1.70.


 


1.71                           “Technical Information” means
published and unpublished research and development information, unpatented
inventions, know-how, trade secrets, methods, instructions and technical data
in the possession of Valentis at the Effective Date or coming in Valentis’
possession during the term of this Agreement that are useful or needed for the
research on, development, utilization, manufacture, use, importation, sale or
offer for sale of the Valentis Delivery Technologies or the Products.  A list of currently existing documents
containing Technical Information to be transferred to Schering is attached
hereto as Appendix 1.70.


 


1.72                           “Territory” shall mean the world.


 


1.73                           “Third Party” means any entity other
than Schering, Valentis and their respective Affiliates.


 


1.74                           “USA” means the United States of
America, its territories and possessions.


 


1.75                           “Valentis Delivery Technologies”
means GeneSwitch Technology, PINC Technology, and Electroporation, GeneSwitch
Technology, PINC Technology and Electroporation being each a Valentis Delivery
Technology.


 


1.76                           “Valentis Intellectual Property”
means Valentis Know-How and Valentis Patents.


 


1.77                           “Valentis Know-How” means all
unpublished Technical Information relating to the Valentis Delivery
Technologies, whether currently existing or developed during the term of this
Agreement and whether or not patentable that is now Controlled or hereinafter
becomes Controlled by Valentis or its Affiliates.  Notwithstanding anything herein to the contrary, Valentis
Know-How shall exclude Valentis Patents.


 


1.78                           “Valentis Patents” means,
collectively, the GeneSwitch Patents, the PINC Patents, and the Electroporation
Patents.


 


1.79                           “Valentis Trademark(s)” shall have
the meaning set forth in Section 16.3.5.


 


1.80                           “Valid Claim” means a claim of an
issued and unexpired Patent, which Patent has not lapsed or been abandoned or
withdrawn or disclaimed, and which claim has not been canceled or declared
invalid or unenforceable by an unreversed and unappealable decision or judgment
of a court or other appropriate body of competent jurisdiction, and which has
not been admitted to be invalid or unenforceable through reissue or disclaimer.


 


13

















 


PART II - LICENSE
FOR [***]


 


2              LICENSE GRANT


 


2.1          Grant.  Subject to the terms and conditions of this
Agreement, Valentis hereby grants to Schering an exclusive (even as to
Valentis) worldwide, sub-licensable license under the Valentis Intellectual
Property.  to do or have done research
on use, develop, have developed, make and have made, sell, offer for sale,
import and distribute [***] Products in the Field.


 


2.2          Limitations.  Schering recognizes that certain rights
granted hereunder are sublicenses of rights licensed by Valentis from Third
Parties.  A list of all such Third Party
licenses existing as of the Effective Date is attached hereto as Appendix
2.2, and Valentis confirms that, to the extent allowed under such license,
true, correct and complete copies of these licenses have been provided to
Schering prior to the Effective Date. 
As such, any sublicenses granted to Schering hereunder shall be subject
to the terms and conditions of such Third Party licenses and Schering agrees to
be bound to the extent required of it as a sublicensee.


 


2.3          Exclusivity.  During the term of the [***]
License Valentis shall not grant any other 

licenses to Third Parties under the Valentis Intellectual Property in the field
of [***] nor shall it develop itself any products containing one or
more of the Valentis Delivery Technologies and intended for the use in [***].


 


3              DEVELOPMENT


 


3.1          Development
by Schering. Schering shall have the sole responsibility for development
and Commercialization of the [***] Products and will bear all costs of such
development.  All Drug Approval Applications
will be submitted in the name of Schering, its Affiliates or sub-licensees, and
all Regulatory Approvals will belong to Schering, its Affiliates or
sub-licensees.  If Schering requests any
development activities to be performed by Valentis, and Valentis has the
capacity to do so, Valentis will perform such tasks and the costs of such
activities will be funded by Schering [***].


 


3.2          Diligence.
Schering shall utilize [***] diligence to develop one [***]
Product in an indication of its choice. 
In order to satisfy this diligence requirement, Schering must [***]
research, development and/or Commercialization activities with respect to an [***]
Product, provided, however, that Schering shall not be required to expend
greater efforts than would correspond [***] taking into account for example the
establishment of the [***] Product in the marketplace, the
competitiveness of alternative products, the likely proprietary position of the
[***] Product, the likelihood of regulatory approval for the [***]
Product, considerations of safety and efficacy, the potential profitability of
the [***] Product and Schering’s resources available.  If during the term of the [***]
License, Schering (or its Affiliates or sub-licensees as the case may be) fails
to utilize [***] diligence to develop at least one [***]
Product and fails to cure the breach [***] upon


 


14

















 


written notice from Valentis, then Valentis
may terminate the [***] License, being understood, however, that [***]
this Section 3.2.


 


4              SUPPLY OF ELECTROPORATION DEVICES


 


If Schering wishes to make use of
Electroporation for the development and Commercialization of a [***]
Product, the Parties shall negotiate in good faith, upon Schering’s request, a
supply agreement for Devices to be supplied to Schering by Valentis on the
terms set out in Appendix 4.


 


5              CONSIDERATION
LICENSE [***]


 


5.1          License
Fee.  Schering shall pay Valentis
a license fee of [***] within fifteen (15) Business Days of
receipt of a signed fax copy of this Agreement by Schering.


 


5.2          Milestone
Payments.


 


5.2.1          [***]
Product.  Schering shall make
the following milestone payments to Valentis within thirty (30) days after the
first achievement by the [***] Product of each of the following
milestones.  For the avoidance of doubt,
it is hereby expressly agreed and declared that, [***].


 


15

















 


	
  Milestone Event

  	
   

  	
  Payment

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
  US$[***]

  



 


5.2.2          Follow-on Products.  If Schering develops [***],
or seeks approval of [***] and such additional [***]
then for such Product (“Follow-on Product”) the following milestones shall
apply, the milestone payments otherwise to be made under the terms and
conditions set forth in Section 5.2.1. 
Valentis shall be entitled [***].


 


	
  Milestone Event

  	
   

  	
  Payment

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
  US$[***]

  



 


5.2.3          Reduction of Milestone Payments.  The milestone payments set forth in Section
5.2.1 and Section 5.2.2 above shall each be reduced by [***].


 


5.3          Royalty Payments.


 


5.3.1            Royalties. 
In further consideration of the rights and licenses granted to Schering
under Article 2 of this Agreement, Schering shall pay to Valentis royalties at
the rates set out below on Net Sales of [***] Products in the Territory payable on a
country-by-country basis from the First Commercial Sale until the later of (i) [***]
or (ii) the expiry of the last Valid Claim of a Patent within the Valentis
Delivery Technology(ies) used with this [***] Product that covers the manufacture, use
or sale of the respective [***] Product. 
The applicable royalty rate shall be 


 


16

















 


determined on a
Product-by-Product basis for each calendar quarter as follows.  In determining the royalty rate for
each Product, all Net Sales of such Product in the Territory in the respective
calendar quarter and previous calendar quarters of the same calendar year shall
be taken into account and it shall be determined an average royalty percentage
for the respective calendar quarter (the “Average Royalty Percentage”) by
applying the different royalty percentages set out in the table below on
an incremental basis.  After
determination of the Average Royalty Percentage for such Product for such
calendar quarter, such Average Royalty Percentage, modified as set forth
below in this Section 5.3, shall be applied to the Net Sales for each country
of the Territory on a country-by-country basis to determine the royalty
owed by Schering to Valentis with regard to Net Sales in such country.  An example of the royalty calculation
according to this Section 5.3 is attached as Appendix 5.3.1.


 


	
  Net Sales

  	
   

  	
  Royalty
  Percentage

  
	
  For aggregate Net Sales of less than [***]
  in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  but less than [***] in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  but less than [***] in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  in a calendar year

  	
   

  	
  [***]

  



 


5.3.2          No Valid Claim.  For countries in which the manufacture, use or sale of the
applicable [***] Product is not covered by a Valid Claim
within the Valentis Delivery Technology(ies) used with this [***]
Product, and in countries where the expiration of the last Valid Claim within
the respective Valentis Delivery Technology(ies) covering the manufacture, use
or sale of the respective [***] Product is less than [***]
the Average Royalty Percentage determined as set forth in Section 5.3.1 shall
be reduced by [***] (as shown in the example in Appendix
5.3.1) for the sales of the respective [***] Product in
that country for the applicable time period.


 


5.4          Third Party Royalties.


 


5.4.1          Royalties to be borne by Valentis.  [***].


 


5.4.2          Royalties to be borne by Schering.  [***].


 


5.4.3          Royalties to be shared by the Parties.  [***].


 


17

















 


PART III - OPTION GENE X


 


6              OPTION
GRANT GENE X


 


6.1          Grant.  For a period of [***] from the
Effective Date (“Option Period I”), Schering shall have an option (“Option I”)
to obtain an exclusive (even as to Valentis) worldwide, sub-licensable license
under the Valentis Intellectual Property, to do or have done research on, use,
develop, have developed, make and have made, sell, offer for sale, import and
distribute Gene X Products in the Field.


 


6.2          Exercise
of the Option; naming of Gene X.


 


6.2.1          During Option
Period I, Schering shall have the right to exercise Option I by delivery of a
notice in writing to Valentis specifying the gene that shall be Gene X.  [***], the proposed gene shall be Gene X and
the Parties shall be deemed, upon exercise of Option I, to have entered a
license agreement with respect to Gene X Products (“Gene X License”) on
the same terms and conditions as those set out in Part II of this
Agreement, whereby the License Fee pursuant to Section 5.1 shall be due
within ten (10) Business Days from notification from Valentis that the
proposed gene is available for an exclusive license.  The exclusivity pursuant to Section 2.3
shall however not apply.


 


6.2.2          [***].


 


6.2.3          Schering may
also name Gene X prior to exercise of Option I by delivery of a notice in
writing to Valentis specifying the gene that shall be Gene X.  [***], the proposed gene shall be deemed to be
Gene X and Option I shall then be exclusive as of receipt of Schering’s
notice.  [***]


 


6.3          Option fee.  In consideration
of the grant of Option I, Schering shall pay to Valentis an option fee of [***]
payable within fifteen (15) Business Days from receipt of a signed fax copy of
this Agreement by Schering.


 


6.4          Research License. 
Valentis hereby grants to Schering, for the Option Period I, a
non-exclusive, royalty–free license under the Valentis Intellectual
Property solely to carry out or have 


 


18

















 


carried out research to
evaluate the Valentis Intellectual Property for use with Gene X (the “Gene X
Evaluation”).  This license shall be [***].  For the avoidance of doubt, Schering and its
Affiliates shall [***].


 


6.5          Exclusivity. 
During the Option Period I, if Option I has become exclusive pursuant to
Section 6.2.3, Valentis shall not cooperate with nor grant any
licenses to any Third Party with regard to the research on and development of
products containing the Valentis Delivery Technologies and Gene X.


 


PART IV - OPTION [***]


 


7              OPTION GRANT [***]


 


7.1          Grant.  For a period of [***] from the
Effective Date (“Option Period II”), Schering shall have an option (“Option
II”) to obtain a non-exclusive, worldwide, sub-licensable license under the
PINC Intellectual Property, to do or have done research on, use, develop, have
developed, make and have made, sell, offer for sale, import and distribute [***]
Products in the Field.


 


7.2          Exercise of the Option. 
During Option Period II, Schering shall have the right to exercise
Option II by delivery of a notice in writing to
Valentis.  Upon exercise of Option II,
the Parties shall be deemed to have entered a license agreement with respect to
[***] Products (“[***] License”) on the terms and conditions set
out below in Articles 8 and 9.


 


7.3          Option Fee. 
In consideration of the grant of Option II, Schering shall pay to
Valentis an option fee of [***] payable within fifteen (15) Business Days
from receipt of a signed fax copy of this Agreement by Schering.


 


7.4          Research License.  Valentis hereby grants to Schering, for the
Option Period II, a non-exclusive, royalty-free license under the PINC
Intellectual Property solely to carry out or to have carried out research to
evaluate the PINC Intellectual Property for use with [***] (the “[***]
Evaluation”).  This license shall be [***]
for the avoidance of doubt, Schering and its Affiliate [***].


 


8              DEVELOPMENT


 


Schering shall have the sole responsibility
for development and Commercialization of the [***] Products and will bear all costs of such
development.  All Drug Approval
Applications will be submitted in the name of Schering, its Affiliates or
sub-licensees, and all Regulatory Approvals will belong to Schering, its
Affiliates or sub-licensees.  If
Schering requests any development activities to be performed by Valentis, and
Valentis has the capacity to do so, Valentis will perform such tasks and the
costs of such activities will be funded by Schering [***].


 


19

















 


9              CONSIDERATION
LICENSE [***]


 


9.1          License Fee. 
Schering shall pay Valentis a license fee of [***] within ten
(10) Business Days from exercise of Option II.


 


9.2          Milestone Payments.


 


9.2.1          [***]
Product.  Schering shall make
the following milestone payments to Valentis within thirty (30) days after the
first achievement by the [***] Product of each of the following
milestones.  For the avoidance of doubt,
it is hereby expressly agreed and declared that, [***].


 


	
  Milestone Event

  	
   

  	
  Payment

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
  US$[***]

  



 


9.2.2          Follow-on Products.  If Schering develops [***]
or seeks approval of [***] then for such Follow-on Product the
following milestones shall apply, the milestone payments otherwise to be made
under the terms and conditions set forth in Section 9.2.1.  Valentis shall be entitled [***].


 


	
  Milestone Event

  	
   

  	
  Payment

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
  [***]

  	
   

  	
  US$[***]

  
	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
  US$[***]

  



 


20

















 


9.2.3          Reduction of Milestone Payments.  The milestone payments set forth in Section
9.2.1 and Section 9.2.2 above shall each be reduced by [***].


 


9.3          Royalty Payments.


 


9.3.1          Royalties.  In further consideration
of the rights and licenses granted to Schering under Part IV of this Agreement,
Schering shall pay to Valentis royalties at the rates set out below on Net
Sales of [***] Products in the Territory payable from [***]
or (ii) the expiry of the last Valid Claim of a Patent within the PINC
Intellectual Property covering the manufacture, use or sale of the respective [***]
Product.  The applicable royalty rate
shall be determined on a Product-by-Product basis for each calendar quarter as
follows.  In determining the royalty
rate for each Product, all Net Sales of such Product in the Territory in the
respective calendar quarter and previous calendar quarters of the same calendar
year shall be taken into account and it shall be determined an average royalty
percentage for the respective calendar quarter (the “Average Royalty
Percentage”) by applying the different royalty percentages set out in the table
below on an incremental basis.  After
determination of the Average Royalty Percentage for such Product for such
calendar quarter, such Average Royalty Percentage, modified as set forth below
in this Section 9.3, shall be applied to the Net Sales for each country of the
Territory on a country-by-country basis to determine the royalty owed by
Schering to Valentis with regard to Net Sales in such country.  An example of the royalty calculation according
to this Section 9.3 is attached as Appendix 5.3.1.


 


	
  Net Sales

  	
   

  	
  Royalty
  Percentage

  
	
  For
  aggregate Net Sales of less than [***] in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  but less than [***] in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  but less than [***] in a calendar year

  	
   

  	
  [***]

  
	
  For
  incremental aggregate Net Sales equal to or exceeding [***]
  in a calendar year

  	
   

  	
  [***]

  



 


9.3.2          No Valid Claim.  For countries in which the manufacture, use or sale of the
respective [***] Product is not covered by a Valid Claim
within the PINC Patents, and in countries where the expiration of the last
Valid Claim within the PINC Patents covering the manufacture, use or sale of
the respective [***] Product is less than [***]
the Average Royalty Percentage determined as set forth in Section 9.3.1 shall
be reduced by [***] (as shown in the example set out in Appendix
5.3.1 for the sales of the respective [***] Product in that country for the
applicable time period.


 


21

















 


9.4          Third Party Royalties.


 


9.4.1          Royalties to be borne by Schering.  [***].


 


9.4.2          Royalties to be shared by the Parties.  [***].


 


PART V - GENERAL PROVISIONS


 


10           TECHNOLOGY
TRANSFER


 


10.1        Transfer of Technical Information and
Supplies. 
Valentis shall within thirty (30) days from the Effective Date make
available to Schering for its use the Technical Information and the Supplies
listed in Appendix 1.70.  In case
of any Technical Information or Supplies coming into Valentis’ possession after
the Effective Date, Valentis shall provide these to Schering subject to the
provisions in Article 12.


 


10.2        Technical Assistance. 
At Schering’s request, to the extent Valentis is able to do so, Valentis
shall provide Schering, its Affiliates and sub-licensees, as the case may be,
during the term of this Agreement, with such assistance that Schering, its
Affiliates or its sub-licensees may reasonably need in order to do or have done
research on, use, develop, have developed, make and have made, sell, offer for
sale, import and distribute Products. 
In particular, Valentis will, at Schering’s request, send to the
facilities of Schering, its Affiliates or sub-licensees available members of Valentis’
staff to assist Schering, its Affiliates or sub-licensees, as the case may be,
in the use of the Technical Information. 
Schering shall [***].


 


10.3        Restricted Use.  Schering shall not practice, develop or
utilize the Valentis Delivery Technologies outside of the licenses granted
herein.  Schering shall use the
Technical Information and the Supplies only for the development, manufacture
and Commercialization of Products, and shall not transfer to any Third Party
any portion of any Technical Information or Supplies, [***],
except to its’ Affiliates, contract partners and sub-licensees for the purposes
of developing, seeking and obtaining Regulatory Approval of and for
Commercializing Products.


 


11           GRANTBACK
LICENSE


 


11.1        Grant.  Schering hereby grants to Valentis, subject
to the provisions of Article 12, a nonexclusive worldwide, irrevocable,
royalty-free license under any Improvements made by Schering, its Affiliates or
sublicensees to the Valentis Delivery Technologies [***] to do or
have done research on, use, develop, have developed, make and have made, sell,
offer for sale, import and distribute products [***] (“Grantback
License”).  For the avoidance of doubt,
it is hereby expressly agreed that no rights shall be granted by Schering to
Valentis to [***].


 


11.2        Sublicenses. The Grantback License includes the
right to [***] and shall


 


22

















 


not be [***], except with the prior written consent of
Schering.


 


11.3        Improvement Patents.  Schering is under no obligation to file,
prosecute, maintain, defend or enforce any Patent that is subject of the
Grantback License.


 


12           IMPROVEMENTS; INFORMATION EXCHANGE


 


12.1        Principle.  During the term of this Agreement Schering
and Valentis shall disclose and make available to each other [***]
any Improvements Schering shall however not be obliged to disclose to Valentis [***].


 


12.2        Annual updates.  The Parties shall provide each other on an
annual basis written reports containing information on Improvements and
updating the other Party on research, development and commercialization
activities relating to the Valentis Delivery Technologies.  At the request of either Party the Parties
may also meet instead of providing a written report.


 


12.3        Ad hoc notifications.  The Parties intend to [***]
to disclose Improvements to one another as and when such Improvement arises or
is acquired.  [***].


 


12.4        Valentis Improvements.  Any Valentis Know-How and Valentis Patents
acquired or Controlled by Valentis after the Effective Date shall, on
acquisition of Control, become part of the Licenses unless Schering informs
Valentis within sixty (60) days of notification of the said acquisition that it
does not wish such Valentis Know-How or Valentis Patent(s) to become part of
this Agreement.  On such notification of
Schering the respective Valentis Know-How or Valentis Patent(s) shall cease to
be part of this Agreement and shall be deemed never to have been part of it.


 


12.5        Schering Information and Data.


 


12.5.1       Any information
and data disclosed to Valentis by Schering in connection with the disclosure of
any Improvements, [***] may be used by Valentis only upon
Schering’s prior written consent, which shall not be unreasonably
withheld.  Notwithstanding the
foregoing, Schering may withhold consent, at its absolute discretion, [***].


 


12.5.2       From time to
time Schering will disclose to Valentis, at Schering’s sole discretion, [***].  Notwithstanding Section 20.1 Valentis may
use these information and data [***] provided that Schering must give its
written consent, which shall not


be unreasonably withheld, before the [***]
such information and data. 
Notwithstanding the foregoing, [***].


 


12.6        Adverse Drug Reactions


 


12.6.1       Both Parties
agree to promptly exchange all information that relates to the safety of the
Valentis Delivery Technologies and especially all adverse reactions relating to
them.


 


23

















 


12.6.2       Before
enrollment of the first patient in a Phase I Clinical Trial relating to a
Product, the Parties will adopt a standard operating procedure to govern the
investigation of and action to be taken with regard to adverse drug experience
reports related to the Valentis Delivery Technologies (from both clinical
studies and marketing experience), such that each Party can comply with its
legal obligations worldwide.  The
standard operating procedure will: (i) define responsibilities for adverse
experience handling for initial, follow-up and/or periodic submission to
government agencies of significant information on the product from pre clinical
laboratory, animal toxicology and pharmacology studies and pre clinical
Development and (ii) include arrangements for the exchange of serious and
non-serious cases including formats and timelines, periodic safety update
reports, periodic reports and answers to safety-related queries by regulatory
authorities; and (iii) be promptly amended as changes in legal obligations
require or as otherwise agreed to by the Parties.


 


13           SUBSTITUTION
OF GENES


 


13.1        Substitution by Backup Genes. 
Schering shall be entitled to substitute each of the Genes by another
gene of its choice (“Backup Gene”) within [***] of (i) the Effective Date for [***]
and (ii) [***].


 


13.2        Election of Backup Genes. 
If Schering wishes to substitute a Gene it shall deliver to Valentis a
written notification specifying the Gene and the gene it wishes to nominate as
Backup Gene.  Provided that Valentis is
not prohibited from granting a license for the suggested gene with the same
scope as the license for the respective Gene by any rights granted to a Third
Party, the suggested gene shall become a Backup Gene and the Parties shall be
deemed to have entered as of receipt of Schering’s notification by Valentis a
license agreement for the Backup Gene (“Backup License”) under the same terms
and conditions as for the respective Gene. 
[***].


 


If Valentis is prohibited from granting a
license for the suggested Backup Gene with the same scope as the license for
the respective Gene by any rights granted to a Third Party, it shall inform
Schering in writing and submit sufficient evidence thereof within ten (10)
Business Days.  Schering shall then be
entitled to nominate [***] another gene as Backup Gene.  This Section 13.2 shall apply accordingly.


 


13.3        [***].  The substitution of a Gene by a Backup Gene [***].


 


14           SUB-LICENSES


 


Schering shall notify any sublicensee under
any of the Licenses of all rights and obligations of Schering under this
License that are sublicensed to such sublicensee and shall, within thirty (30)
days of the grant of any sublicense hereunder, notify Valentis of such
sublicense and provide a redacted copy of such sublicense to Valentis;
provided, however, that no information relevant to Valentis’ rights hereunder
shall be redacted.


 


24

















15           REPORTS AND PAYMENT PROVISIONS


 


15.1        Reports and Payments.  Schering shall make royalty payments to
Valentis within sixty (60) days after the end of each calendar quarter in which
Net Sales occurred.  A report summarizing
the Net Sales of each Product during the relevant quarter on a
country-by-country basis shall be delivered to Valentis within sixty (60) days
following the end of each calendar quarter for which royalties are due.


 


15.2        Mode of Payment. 
All payments made pursuant to this Agreement shall be due on such date
as specified in this Agreement and, in the event such date is not a Business
Day, then the next succeeding Business Day. 
Payments shall be made by direct wire transfer of United States Dollars
in immediately available funds in the requisite amount to an account at a
commercial bank designated by Valentis in writing at least ten (10) Business
Days before the payment is due.  The
calculation of royalty payments within Schering is based upon Euro.  Therefore, where payments are based on Net
Sales in countries other than the member states of the European Monetary Union,
the amount of such Net Sales expressed in the currency of each country shall be
converted into Euro at the Euro Foreign Exchange Reference Rates published by
the European Central Bank in Frankfurt / Main, Germany on the last Business Day
of the applicable calendar quarter.  The
resulting Euro amount will be converted into US dollars at the Euro Foreign
Exchange Reference Rates published by the European Central Bank in Frankfurt /
Main, Germany on the last Business Day of the applicable calendar quarter.  These Euro Foreign Exchange Reference Rates
are, as of the Effective Date, published on Reuters screen <ECB37>.  If no Euro Foreign Exchange Reference Rate
is determined for the relevant currency, the Parties shall agree upon another
appropriate reference rate.


 


15.3        Late Payments. 
Any payments due under this Agreement shall be due on such date as
specified in the Agreement and, in the event that such date is not a Business
Day, then the next succeeding Business Day. 
Any failure by Schering to make a payment within ten (10) days after the
date when due shall obligate Schering to pay computed interest, the interest
period commencing on the due date and ending on the payment day, to the
receiving Party at a rate per annum equal to the Prime Rate as quoted by the
Bank of America on REUTERS screen


 


25

















 


<USPRIME1> plus a premium
of 2%, or the highest rate allowed by law, whichever is lower.  The interest calculation shall be based on
the act / 360 computation method.  The
interest rate shall be adjusted whenever there is a change in the Prime Rate
quotation on REUTERS screen <USPRIME1> mentioned above.  Interest shall be compounded annually in
arrears.  Such interest shall be due and
payable on the tender of the underlying principal payment.


 


15.4        Taxes.  The Party receiving
payments shall pay any and all taxes levied on account of payments it receives
under this Agreement.  If laws or
regulations require that taxes be withheld, the selling Party will (i) deduct
those taxes from the remittable payment, (ii) timely pay the taxes to the
proper taxing authority, and (iii) send proof of payment to the other Party
within thirty (30) days of receipt of confirmation of payment from the relevant
taxing authority.  The selling Party
agrees to make all lawful and reasonable efforts to minimize such taxes to the
other Party.


 


15.5        Records of Revenues and Expenses;
Audits.


 


15.5.1       Records.  Schering will maintain complete and accurate
records which are relevant to revenues, costs, expenses and payments on a
country-by-country basis under this Agreement and such records shall be open
during reasonable business hours for a period of three (3) years from creation
of individual records for examination at Valentis’ expense from time to time by
an independent certified public accounting firm selected by Valentis, or
Valentis’ internal accountants unless Schering objects to the use of such
internal accountants, for the sole purpose of verifying for Valentis the
correctness of calculations and classifications of such revenues, costs,
expenses or payments made under this Agreement.  Each Party shall bear its own costs related to such audit;
provided that, for any underpayments greater than five (5) percent by Schering,
Schering shall pay Valentis the amount of underpayment, interest as provided
for in Section 15.3 from the time the amount was due and Valentis’
out-of-pocket expenses.  For any
underpayments less than five (5) percent by Schering found under this Section,
Schering shall pay Valentis the amount of underpayment plus interest.  Any overpayments by Schering will be
refunded to Schering or credited to future royalties, at Schering’s
election.  Any records or accounting
information received from the other Party shall be Confidential Information for
the purposes of Article 20.  Results of
any audit shall be provided to both Parties and shall be Confidential
Information for the purposes of Article 20.


 


15.5.2       Audit
Disagreement. If there is a dispute between the
Parties following any audit performed pursuant to Section 15.5.1, either Party
may refer the issue (an “Audit Disagreement”) to an independent certified
public accountant for resolution.  In
the event an Audit Disagreement is submitted for resolution by either party,
the Parties shall comply with the following procedures:  (i) The Party submitting the Audit
Disagreement for resolution shall provide written notice to the other Party
that it is invoking the procedures of this Section 15.5.2.  (ii) Within thirty (30) Business Days of the
giving of such notice, the Parties shall jointly select a recognized
international accounting firm to act as an independent expert to resolve such
Audit Disagreement.  (iii) The Audit
Disagreement submitted for resolution shall be described by the Parties to the
independent expert, which description may be in written or oral form, within
ten (10) Business Days of the selection of such independent expert.  (iv) The independent expert shall render a
decision on the matter as soon as practicable. 
(v) The decision of the independent expert shall be final and binding
unless such Audit Disagreement involves alleged fraud, breach


 


26

















 


of this Agreement or
construction or interpretation of any of the terms and conditions thereof.  (vi) All fees and expenses of the
independent expert, including any Third Party support staff or other costs
incurred with respect to carrying out the procedures specified at the direction
of the independent expert in connection with such Audit Disagreement, shall be
borne by each Party in inverse proportion to the disputed amounts awarded to
the Party by the independent expert through such decision (e.g. Valentis
disputes $100, the independent expert awards Valentis $60, then Valentis pays
forty (40%) percent and Schering pays sixty (60%) percent of the independent
expert’s costs.)


 


16           INTELLECTUAL PROPERTY


 


16.1        Patent Enforcement.


 


16.1.1       Notice.  If any Patent within the Valentis
Intellectual Property is or might reasonably be infringed by a Third Party
through the manufacture, use, sale, offer for sale or importation of a Product
(an “Infringement”), the Party first having knowledge of such Infringement shall
promptly notify the other Party in writing. 
Such notice shall set forth the facts of the Infringement in reasonable
detail.


 


16.1.2       Enforcement.  Schering shall have the right, but not the
obligation, to institute, prosecute and control at its own expense any action
or proceeding with respect to Infringement of any Patents within the Valentis
Intellectual Property covering the manufacture, use, importation, sale or offer
for sale of Products, by counsel of its own choice.  Valentis shall have the right, at its own expense, to be
represented in any action by counsel of its own choice.  In the event that Schering fails to
institute an action or proceeding or otherwise to take appropriate action to
abate such Infringement within a period of [***] after notice by Valentis to Schering
requesting action, Valentis shall have the right, but not the obligation, to
institute and/or prosecute and control an action or proceeding in its name with
respect to such an Infringement by counsel of Valentis’ choice, and Schering
shall have the right to be represented in any such action by counsel of its own
choice and at its own expense.  If one
Party brings any such action or proceeding, the other Party agrees to be joined
as a party plaintiff if necessary to prosecute the action or proceeding and to
give the first Party commercially reasonable assistance and authority to file
and prosecute the suit.


 


All damages or
other monetary awards recovered pursuant to this Section 16.1.2 shall be paid
and applied as follows: (i) first, to reimburse the costs and expenses
(including reasonable attorneys’ fees and costs) of the Party bringing suit,
then to the costs and expenses, if any, of the other Party; [***].


 


27

















 


Notwithstanding
anything to the contrary herein, this Section 16.1.2 shall not apply to the
extent it is inconsistent with any license agreement between Valentis and a
Third Party, which license rights are sublicensed to Schering under this
Agreement.


 


Except as
specified in this Section 16.1.2 as to enforcement with respect to an
Infringement on account of the manufacture, use, importation, sale or offer for
sale of Products, Valentis shall have the sole right, in its sole discretion,
to enforce any and all Patents within the Valentis Intellectual Property, and
to institute, prosecute and control any action or proceeding related thereto,
and shall retain any and all monies recovered therefrom, through judgment,
settlement or otherwise.  Schering
agrees to be joined as a party plaintiff if necessary to prosecute the action
or proceeding.


 


16.1.3       Settlement
with a Third Party.  The Party that controls the prosecution of a given action shall
also have the right to control settlement of such action; provided, however,
that if one Party controls, no settlement shall be entered into without the
written consent of the other party (which consent shall not be unreasonably
withheld) if such settlement would materially and adversely affect the
interests of such other Party.  Any
amounts received in settlement of any action shall be [***].


 


16.2        Infringement of Third Party Rights.


 


16.2.1       Principle.  If the sale of any Product is alleged to
infringe, or if Schering or its Affiliates or sublicensees receive notice of or
is sued for infringement of, a patent owned or licensed by a Third Party, which
infringement is alleged based on Schering or its Affiliates or sublicensees
practice or intended practice of the Valentis Intellectual Property, Schering
may request a meeting with Valentis to discuss what action should be taken and
if requested, Valentis will cooperate fully with Schering in defending such
action.  [***].  Schering will be solely responsible for the
defense or settlement of any such patent infringement claim or lawsuit,
including all expenses and amounts payable as damages or in settlement,
provided that [***] and further provided that [***].


16.2.2       [***]. 
In case of infringement or alleged infringement of the [***]
arising from or occurring as a result of the use, testing, operation, sale,
manufacture, distribution or Commercialization of Products by Schering, its
Affiliates or sub-licensees, as the case may be, [***].


 


28

















 


16.3        Trademarks and Domain Names


 


16.3.1       Schering
Trademarks. 
Subject to Section 16.3.5, Schering shall be responsible for the
selection, registration and maintenance of all trademarks which it employs in
connection with the marketing, sale or distribution of the Products (the
“Schering Trademarks”).  Schering shall own
and control such Schering Trademarks and pay all relevant costs thereto.


 


16.3.2       Valentis
recognizes the exclusive ownership by Schering of any proprietary Schering
name, logotype or Schering Trademarks. 
Valentis shall not, either while this 

Agreement is in effect, or at any time thereafter, register, use or challenge
or assist others to challenge the Schering Trademarks nor shall Valentis
attempt to obtain any right in or to any name, logotype or trademark
confusingly similar for the marketing, sale or distribution of any goods or
products, notwithstanding whether such goods or products have a different use
or are dissimilar to the Products.


 


16.3.3       Only Schering
will be authorized to initiate at its own discretion legal proceedings against
any infringement or threatened infringement of a Schering Trademark


 


16.3.4       Schering shall
be responsible for the registration, hosting, maintenance and defense of the
Schering Trademarks as domain names. 
Schering may at its sole and absolute discretion register in its own
name or in name of others, host on its own servers or on Third Party servers,
maintain and defend such domain names and use them for websites.


 


16.3.5       Valentis
Trademarks. 
Schering recognizes the exclusive ownership by Valentis of the PINCTM and
GeneSwitch® trademarks (the “Valentis Trademarks”).  Valentis hereby grants to the Schering a non-exclusive,
sublicensable license to use the Valentis Trademarks solely in connection with
Products developed and Commercialized by Schering pursuant to this
Agreement.  Title to and ownership of
the Valentis Trademarks shall remain with Valentis.  Schering shall not take any action inconsistent with Valentis’
ownership of the Valentis Trademarks, and any benefits accruing from use of
such mark shall automatically vest in Valentis.  Schering shall not create any combination marks with the Valentis
Trademarks.  Valentis may terminate the
foregoing license to use the Valentis Trademarks if, in its reasonable
discretion, Schering’s use of the Valentis Trademarks tarnishes, blurs or
dilutes the quality associated with the Valentis Trademarks or the associated
goodwill and such use is not discontinued within ten (10) days of Schering’ s
receipt of notice to such effect from Valentis.


 


16.3.6       Infringement
of Valentis Trademarks.  Only Valentis will be authorised to initiate
at its own discretion, legal proceedings against any infringement or threatened
infringement of a Valentis Trademark.


 


29

















 


17           REPRESENTATIONS, WARRANTIES AND COVENANTS


 


17.1        Representations and Warranties.


 


17.1.1       Each of the
Parties hereby represents and warrants to the other Party that (i) it is a
corporation duly organized validly existing under the laws of Delaware (in the
case of Valentis) or under the laws of Germany (in the case of Schering); and
(ii) the execution, delivery and performance of this Agreement have been duly
authorized by all necessary corporate action on its part.


 


17.1.2       Valentis hereby
represents and warrants to Schering as follows:


 


(1)           Valentis
has not granted, and during the term of the Agreement will not grant, any right
to any Third Party relating to the Valentis Intellectual Property which would
conflict with the rights granted to Schering hereunder.


 


(2)           As
of the Effective Date, the information provided by Valentis to Schering is
fair, accurate and representative of all the information in its possession
concerning efficacy, side effects, injury, toxicity or sensitivity, reaction
and incidents of severity thereof, associated with any clinical use, studies,
investigation or tests with the Valentis Delivery Technologies, whether or not
determined to be attributable to the Valentis Delivery Technologies.


 


(3)           As
of the Effective Date, except as it may have previously disclosed to Schering
in writing, Valentis has not received any notices of infringement or any
written communications relating in any way to a possible infringement with
respect to the Valentis Delivery Technologies and any potential Products, and
that Valentis is not aware that the manufacture, use or sale of the Products
infringe any valid Third Party patent rights.


 


(4)           As
of the Effective Date, Valentis is not aware of any prior act or any fact which
causes it to conclude that any Valentis Patent is invalid or unenforceable.


 


(5)           Valentis
has complied in all material respects with the terms of each Third Party
license listed on Appendix 2.2 hereto relating to the Products, and
during the term hereof will comply in all material respects, and use all
reasonable efforts to keep in full force and effect each such license for such
time as the applicable sublicense to Schering under this Agreement remains in
effect.  [***].


 


(6)           Valentis
has obtained all right, title and interest in and to all rights to the Valentis
Delivery Technologies and the Valentis Intellectual Property, or licenses
thereto as the case may be, free and clear of any liens, encumbrances or rights
to repurchase;


 


30

















 


(7)           During
the term hereof, Valentis will not grant a lien on this Agreement or on any of
Valentis’ rights or obligations hereunder or on the Valentis Intellectual
Property.


 


(8)           With
respect to any Patents listed on Appendix 1.30  [***],
Valentis is the exclusive licensee of such Patent rights, and has the ability
to grant exclusive sublicenses to Schering as contemplated under Parts II and
III of this Agreement.


 


(9)           Valentis
has [***].


 


17.2        Performance by Affiliates.  The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through Affiliates,
provided however, that each Party shall remain responsible for and be a
guarantor of the performance by its Affiliates and shall cause its Affiliates
to comply with the provisions of this Agreement in connection with such
performance.


 


17.3        Governmental Compliance.  Schering shall at all times during the term of this Agreement,
and for so long as it shall sell Products, comply and cause its sublicensees to
comply with all local, state, federal and foreign formalities, laws, orders,
rules decrees or regulations that may control the import, export, manufacture,
use or sale of Products or any other activity undertaken pursuant to this Agreement.


 


18           INDEMNITY


 


18.1        Indemnification for Breach of
Representations and Warranties.  Each Party hereby agrees to save, defend and
hold the other Party and its directors, officers, agents and employees (each an
“Indemnitee”) harmless from and against any and all liabilities, damages,
costs, expenses and/or losses, including reasonable legal expenses and
attorneys’ fees (collectively “Losses”) resulting from a claim, suit or
proceeding made or brought by a Third Party against an Indemnitee, arising from
or occurring directly or indirectly as a result of the breach of any
representation or warranty made by such Party hereunder.


 


18.2        Indemnification with respect to
Products.  With respect to Products, Schering agrees to
save, defend and hold Valentis and its directors, officers, agents and
employees (each a “Valentis Indemnitee”) harmless from and against any and all
Losses resulting from a claim, suit or proceeding made or brought by a Third
Party against a Valentis Indemnitee, arising from or occurring as a result of
the use, testing, operation, sale, manufacture, distribution or
Commercialization of Products, except to the extent that such Losses result
from the negligence or willful misconduct of Valentis or a breach by Valentis
of any warranty, covenant or obligation under Article 17, in which case
Valentis hereby agrees to save, defend and hold Schering and its directors,
officers, agents and employees harmless from any and all such Losses.


 


18.3        Notification of Claim; Conditions to
Indemnification Obligations.  As a condition to a Party’s right to receive
indemnification under this Article 18, such Party shall: (i) promptly notify
the other Party as soon as the Party seeking indemnity becomes aware of a claim
or action for which indemnification may be sought pursuant hereto; (ii)
cooperate with the indemnifying 


 


31

















 


Party in the defense of such
claim or suit, at the expense of the indemnifying Party; and (iii) permit the
indemnifying Party to control the defense of such claim or suit, including,
without limitation, the right to select defense counsel.  In no event, however, shall the indemnifying
Party compromise or settle any claim or suit in a manner which admits fault or
negligence on the part of the indemnified Party, or that otherwise materially
affects the indemnified Party’s rights under this Agreement, without the prior
written consent of the indemnified Party. 
The indemnifying Party will have no liability under this Article 18 with
respect to claims or suits settled or compromised without its prior written
consent.


 


18.4        Insurance. 
Schering and Valentis each represents and warrants that it is covered
and will continue to be covered, and will require its Affiliates and, for
Schering, its sublicensees, to be covered, by a comprehensive general liability
insurance program which covers all activities and obligations of Schering or
Valentis, as the case may be, and its Affiliates and sublicensees,
hereunder.  Each Party shall provide the
other with written notice at least fifteen (15) days prior to any cancellation
or material change in such insurance programs to the extent that any such
change or cancellation would affect its ability to meet its obligations under
this Section 18.4.  Each Party shall
maintain, and shall require its Affiliates and sublicensees hereunder to
maintain, such insurance programs, or other programs with comparable coverage,
beyond the expiration or termination of this Agreement during (i) the period
that any Product is being commercially distributed or sold by Schering, its
Affiliates or a sublicensee, and (ii) a commercially reasonable period
thereafter.


 


19           TERM AND TERMINATION


 


19.1        Term.  The term of this Agreement shall commence on
the Effective Date and, unless sooner terminated as provided herein, shall
continue in full force and effect until the expiration of the last of the
Royalty Terms.


 


19.2        Termination at Will.  Notwithstanding any other term of provision hereof expressly or
impliedly to the contrary, Schering may terminate (i) this Agreement in its
entirety, (ii) only one or several Parts of it or (iii) each License on a
country-by-country and/or Product-by-Product basis, and be fully released from
any corresponding obligations hereunder (except as expressly provided for
herein) at any time, upon ninety (90) days’ advance written notice to Valentis.


 


19.3        Termination for Cause.  If either Party commits a material breach of this Agreement, the
other Party may notify the breaching Party in writing of such breach, setting forth
the nature of the breach in reasonable detail. 
If the breaching Party fails to cure such breach within thirty (30) days
(in the case of a payment due on this Agreement) or one hundred twenty (120)
days (in the case of any other breach) of the receipt of the foregoing notice
from the non-breaching Party, then, subject to the terms of this Section 19.3,
the non-breaching Party may terminate (i) the respective Part of this Agreement
or (ii) if the breach is of a general nature having a material


 


32

















 


impact on all Parts, the entire
Agreement effective immediately upon a second written notice to the breaching
Party, provided, however, that [***]. 
The right of either Party to terminate this Agreement as hereinabove
provided shall not be affected in any way by its waiver of, or failure to take
action with respect to any previous default.


 


19.4        Termination for Insolvency.  To the extent permitted by applicable law,
in the event that one of the Parties hereto shall go into liquidation, a
receiver or a trustee be appointed for the property or estate of that party and
said receiver or trustee is not removed within sixty (60) days, or the Party
makes an assignment for the benefit of creditors other than in the normal
course of business (each a “Bankruptcy Event”), and whether any of the
aforesaid events be the outcome of the voluntary act of that Party, or
otherwise, the other Party shall be entitled to terminate this Agreement (or in
the event that Valentis suffers such a Bankruptcy Event, Schering may effect
its rights described in Section 19.5.3 forthwith by giving written notice to
Valentis).


 


19.5        Effect of Expiration or Termination.


 


19.5.1       In the event
that this Agreement is terminated by Schering in one or more countries or for
one or more Products or for one or more Parts or Licenses or in its entirety
pursuant to Section 19.2 above, or by Valentis pursuant to Sections 19.3 or
19.4 above, Schering will, with respect to each License, country or Product
(except where a Product containing the same Gene and using the same Valentis
Delivery Technology is still under development or being Commercialized in the
relevant country), as the case may be, (i) deliver to Valentis the Valentis
Know-How, in either case relating solely to the License, country or to the
Product, as the case may be, that is the subject of the termination; (ii) not
use the Valentis Know-How as long as it has to be kept confidential pursuant to
Section 20.7 hereof in such country or with respect to such License or Product,
as the case may be; (iii) not infringe any of the Valentis Patents in such
country or with respect to such License or Product, as the case may be; and
(iv) make all payments accrued under this Agreement with respect to such
License, country or such Product, as the case may be.  In the event that this Agreement is terminated by Valentis
pursuant to Sections 19.3 or 19.4 above, all rights and licenses granted to
Schering hereunder shall terminate immediately.


 


19.5.2       Confidential
Information. 
In the event of expiration or termination of this Agreement, each Party
shall promptly return, or at the other Party’s request destroy, any
Confidential Information of the other Party in such Party’s possession or
control at the time of termination, provided that each party may retain one
copy of the other party’s Confidential Information in its legal files for the
purposes of monitoring its ongoing obligations under this Agreement.


 


19.5.3       In the event of
a Bankruptcy Event described in Section 19.4 by Valentis Schering may elect in
lieu of terminating this Agreement to declare the licenses granted pursuant to
this Agreement to be irrevocable.  From
the date of receipt of notice of such election, Valentis shall have no further
rights or obligations under this Agreement, except that Valentis may enforce
any financial obligations of Schering.


 


33

















 


19.6        Survival.  Articles 17, 18,
19.5, 20 and 21.3 shall survive expiration or termination of this Agreement for
any reason.


 


20           CONFIDENTIALITY


 


20.1        Confidentiality and Non-Use.  Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing, the Parties agree that the
receiving Party shall keep confidential and shall not publish or otherwise
disclose or use for any purpose other than as provided for in this Agreement
any proprietary information, materials and technical and business information,
including but not limited to the Valentis Delivery Technologies, Technical
Information, data related to the Genes and the Products, disclosed to it by the
other Party (collectively “Confidential Information”), except to the extent
that it can be established by the receiving Party that such Confidential
Information:


 


(a)  was in the receiving Party’s or its Affiliates’ possession, other
than under an obligation of confidentiality, prior to receipt from the
disclosing Party; (b) is or becomes, through no fault of the receiving Party or
its Affiliates or sublicensees hereunder, publicly known; (c) is furnished to
the receiving Party by a Third Party without breach of a duty to the disclosing
Party; or (d) is independently developed by the receiving Party or its
Affiliates without use of, application of or access to the disclosing Party’s
Confidential information, as documented in its corporate records.


 


20.2        Authorized Disclosure.  Each Party may disclose Confidential Information of the other 

Party hereunder to the extent such disclosure is reasonably necessary in filing
or prosecuting patent applications, prosecuting or defending litigation, filing
or updating any Drug Approval Application, complying with applicable
governmental regulations or conducting Preclinical Development or Clinical
Development or CMC/Manufacturing of any Product, provided that if a Party is
required by law or regulation to make any such disclosures of the other Party’s
Confidential Information it will, except where impracticable for disclosures
required by law or exigent circumstances, for example in the event of a medical
emergency, give reasonable advance notice to the other Party of such disclosure
requirement and, except to the extent inappropriate in the case of patent
applications, will use its reasonable efforts to secure confidential treatment
of such Confidential Information required to be disclosed.  In addition, each Party shall be entitled to
disclose, under a binder of confidentiality, Confidential Information of the
other Party to any Third Party for the purpose of carrying out the purposes of
this Agreement.  Without prejudice to
the generality of the foregoing, Schering, its Affiliates, contract partners
and sub-licensees shall be authorized to use all Confidential Information for
the purposes of developing, seeking and obtaining Regulatory Approval of and
for Commercializing Products.


 


20.3        Identity of Genes. 
The Parties agree that the identity of the Genes shall be treated as 

Confidential Information of Schering under this Article 20, provided, however,
that Valentis 

shall be entitled to [***].


 


20.4        Use of Names 
Neither Party shall use the name of the other Party in relation to this
transaction in any public announcement, press release or other public document
without the 


 


34

















 


written consent of such other Party,
which consent shall not be unreasonably withheld or delayed: provided, however,
that either Party may use the name of the other Party in any document filed
with any regulatory agency or authority to comply with legal or regulatory
requirements, including the FDA, the EMEA and the Securities and Exchange
Commission, in which case Schering shall be referred to as “Schering AG,
Germany”.


 


20.5        Termination of Prior Agreements.  This Agreement supersedes any prior
Confidentiality Agreements entered into between the Parties, provided that all
non-public information that was exchanged under such previous agreements shall
be treated as Confidential Information of the disclosing Party under this
Article 20.


 


20.6        Terms of Agreement. 
The terms of this Agreement shall be Confidential Information of both
Parties, and subject to the terms of this Article 20.  Notwithstanding the foregoing, either Party may make a disclosure
of terms of this Agreement if, but only to the extent, such disclosure is
required by applicable law, in which case it will, however, notify the other
Party before the disclosure is made. 
Subject to the foregoing, the Parties will agree on the wording of a
mutually acceptable press release regarding the Agreement, which will however
not be issued without the other Party’s prior written consent.


 


20.7        Termination. 
All obligations of confidentiality and non-use imposed under this
Article 20 shall expire ten (10) years after the date of expiration or
termination of this Agreement.


 


21           MISCELLANEOUS


 


21.1        Further Assurances.  From time to time during the term of this Agreement, each Party
shall at the reasonable request of the other Party (a) deliver to such other
Party such records, data or other documents consistent with the provisions of
this Agreement, and (b) take or cause to be taken all such other actions, as
such other Party may reasonably deem necessary or desirable in order for such
Party to obtain the full benefits of this Agreement, including but not limited
to the recordal of any License granted hereunder, and the transactions
contemplated thereby.


 


21.2        No Implied Rights. 
Only the rights 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.


 


21.3        Limitation of Liability.  EXCEPT AS ARISE IN CONNECTION WITH A PARTY’S 

OBLIGATIONS OF INDEMNIFICATION PURSUANT TO ARTICLE 18, IN NO EVENT SHALL EITHER
PARTY BE LIABLE FOR INCIDENTAL, CONSEQUENTLY, INDIRECT, PUNITIVE OR SPECIAL
DAMAGES OF THE OTHER PARTY ARISING OUT OF OR RELATED TO THIS AGREEMENT, HOWEVER
CAUSED, UNDER ANY THEORY OF LIABILITY.


 


35

















 


21.4        Governing Law. 
This Agreement shall be governed by, and construed and interpreted, in
accordance with the internal laws of the state of New York without giving
effect to any choice of law rule that would cause the application of the laws
of any jurisdiction other than the internal laws of the state of New York to
the rights and duties of the Parties.


 


21.5        Force Majeure. 
Except for the payment of money, neither Party shall be held responsible
for any delay or failure in performance hereunder caused by strikes, embargoes,
unexpected government requirements, civil or military authorities, acts of God,
earthquake, or by the public enemy or other causes reasonably beyond such
Party’s control and without such Party’s fault or negligence; provided that the
affected Party notifies the unaffected Party as soon as reasonably possible,
and resumes performance hereunder as soon as reasonably possible following
cessation of such force majeure event.


 


21.6        Independent Contractors.  The relationship of Valentis and Schering established by this 

Agreement is that of independent contractors. 
Nothing in this Agreement shall be construed to create any other
relationship between Valentis and Schering. 
Neither Party shall have any right, power or authority to bind the other
or assume, create or incur any expense, liability or obligation, express or
implied, on behalf of the other.


 


21.7        Assignment. 
Schering may assign any of its rights or obligations under this
Agreement in any country to any of its Affiliates, provided however that such
assignment shall not relieve Schering of its responsibilities for performance
of its obligations under this Agreement. 
Either Party may transfer or assign its rights and obligations under
this Agreement, without consent, to a successor to all or substantially all of
its business or assets relating to this Agreement, whether by sale, merger,
operation of law or otherwise, provided that, in the event of such sale or
merger, [***]. 
Except as provided herein, the Parties agree that their rights and
obligations under this Agreement may not be transferred or assigned without the
prior written consent of the other Party hereto, which consent may be withheld
in such other Party’s sole discretion. 
Any assignment not in accordance with this Agreement shall be void.


 


21.8        Notices  Any notice, report,
communication or consent required or permitted by this Agreement shall be in
writing and shall be sent (a) by prepaid registered or certified mail, return
receipt requested, (b) by express delivery service by an internationally
recognized courier, or (c) via confirmed facsimile or telecopy, followed within
five (5) days by a copy mailed in the preceding manner, addressed to the other
Party at the address shown below or at such other address for which such Party
gives notice hereunder.  Such notice
will be deemed to have been given when delivered or, if delivery is not
accomplished by some fault of the addressee, when tendered.


 


If to Valentis:                                        Valentis,
Inc.


                                                                863A Mitten Road


                                                                Burlingame, California 94010, USA


                                                                Attn: Chief Executive Officer


                                                                Facsimile: +1 (650) 652-1990


 


36

















 


If to Schering:                                       Schering
AG


                                                                Mülerstr. 178


                                                                13353 Berlin, Germany


                                                                Attn: Legal Department


                                                                Facsimile: +49-30-46814086


 


                                                                With a copy to:


                                                                Berlex Biosciences


                                                                2600 Hilltop Drive


                                                                Richmond, CA 94806, USA


                                                                Attn: Legal Department


                                                                Facsimile: +1 (510) 669-4350


 


21.9        Severability 
In the event that any provisions of this Agreement are determined to be
invalid or unenforceable by a court of competent jurisdiction, the remainder of
the Agreement shall remain in full force and effect without said
provision.  In such event the Parties
shall, in good faith, negotiate a substitute clause for any provision declared
invalid or unenforceable, which shall most nearly approximate the intent of the
Parties entering this Agreement.


 


21.10      Modification; Waiver.  This Agreement may not be altered, amended or modified in any way
except by a writing signed by both Parties. 
The failure of a Party to enforce any rights or provisions of the
Agreement shall not be construed to be a waiver of such rights or provisions,
or a waiver by such Party to thereafter enforce such rights or provision or any
other rights or provisions hereunder. 
No waiver shall be effective unless made in writing and signed by the
waiving Party.


 


21.11      Entire Agreement. 
The Parties hereto acknowledge that this Agreement, together with the
Appendices attached hereto, set forth the entire agreement and understanding of
the Parties hereto as to the subject matter hereof, and supersedes all prior
and contemporaneous discussions, agreements and writings in respect hereto.


 


21.12      Headings.  The article, section
and paragraph headings contained herein are for the purposes of convenience
only and are not intended to define or limit the contents of the articles,
sections or paragraphs to which such headings apply.


 


21.13      Counterparts. 
This Agreement may be executed in two or more counterparts (and by
facsimile), each of which shall be deemed an original and all of which together
shall constitute one instrument.


 


37

















 


21.14      Ambiguities. 
Ambiguities, if any, in this Agreement shall not be construed against
either Party, irrespective of which Party may be deemed to have authored the
ambiguous provision.


 


IN WITNESS WHEREOF, Valentis
and Schering have executed this Agreement by their respective duly authorized
representatives.


 


	
  VALENTIS, INC.

  	
  SCHERING AG

  
	
  (“Valentis”)

  	
  (“Schering”)

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  19 Dec 02

  	
   

  	
  Date:

  	
  19 Dec 02

  	
   

  
	
  By:

  	
  /s/ Benjamin F. McGraw, III

  	
   

  	
  By:

  	
  /s/ Björn Wallmark

  	
   

  
	
  Name:

  	
  Benjamin F. McGraw, III

  	
   

  	
  Name:

  	
  Prof. Dr.
  Björn Wallmark

  	
   

  
	
  Title:

  	
  Chairman, President & CEO

  	
   

  	
  Title:

  	
  Head of
  Corporate Research

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Date:

  	
  19 Dec 02

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Barbara Putz

  	
   

  
	
   

  	
   

  	
  Name:

  	
  Dr. Barbara
  Putz

  
	
   

  	
   

  	
  Title:

  	
  Head of
  Corporate Clinical Development

  Specialized Therapeutics Europe

  
																



 


38

















 


Appendix 1.20


 


Patents relating to Electroporation


 


	
  family

  	
   

  	
  Patent No. or Application Serial No.

  	
   

  	
  Title

  	
   

  	
  Inventor(s)

  	
   

  	
  Issue Date or Filing Date

  
	
  1

  	
   

  	
  US 5,273,525

  	
   

  	
  Injection and Electroporation Apparatus for Drug and Gene Delivery

  	
   

  	
  Hofmann

  	
   

  	
  Dec. 28, 1993

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  US 5,439,440

  	
   

  	
  Electroporation System with Voltage Control Feedback for Clinical
  Applications

  	
   

  	
  Hofmann

  	
   

  	
  Aug. 8, 1995

  
	
   

  	
   

  	
  US 5,702,359

  	
   

  	
  Needle Electrodes for Mediated Delivery of Drugs and Genes

  	
   

  	
  Hofmann, Gilbert, Hayakawa, Heller and Jaroszeski

  	
   

  	
  Dec. 30, 1997

  
	
   

  	
   

  	
  PCT/US96/07470

  	
   

  	
  (WO96/39226)

  	
   

  	
   

  	
   

  	
  5/22/96

  
	
   

  	
   

  	
  *EP 0874663
  B1

  	
   

  	
  Apparatus For Treatment Using Electroporation-Mediated Delivery of
  Drugs and Genes

  	
   

  	
  Dev, Hofmann, Gilbert, Hayakawa, Heller and Jaroszeski

  	
   

  	
  Sep. 29,
  1999

  
	
   

  	
   

  	
  *BE, DE, DK,
  CH, NL, SE, MC, LU, ES, FI, FR, GB, GR, FE, IT, PT

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  9/29/99

  
	
   

  	
   

  	
  *AT2,182,083

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  9/29/99

  
	
   

  	
   

  	
  *AU 702,054

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  *CA
  2,218,255

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Nov. 20,
  2001

  
	
   

  	
   

  	
  *KR 260,238

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  April 4,
  2000

  
	
   

  	
   

  	
  *RUS

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  allowed

  
	
   

  	
   

  	
  *CN, *JP,
  *MX

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  PENDING

  
	
   

  	
   

  	
  US 5,993,434

  	
   

  	
  Method of Treatment Using Electroporation Mediated Delivery of Drugs
  and Genes

  	
   

  	
  Dev and Hofmann

  	
   

  	
  Nov. 30, 1999

  
	
   

  	
   

  	
  US 6,451,002

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Sep. 17, 2002

  
	
   

  	
   

  	
  US 6,428,341

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  July 9, 2002

  
	
   

  	
   

  	
  *10/053,861

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  1/17/02

  
	
   

  	
   

  	
  *10/177,560

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  6/21/02

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  US5,869,326

  	
   

  	
  Electroporation Employing User-Configured Pulsing Scheme

  	
   

  	
   

  	
   

  	
  Feb. 9, 1999

  
	
   

  	
   

  	
  US6,096,020
(DIV)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Aug. 1, 2000

  
	
   

  	
   

  	
  PCT/US97/01088

  	
   

  	
  (WO98/10510)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  *EP, DE, FR,
  GB, IT, ES, SE

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Apr. 10,2002

  
	
   

  	
   

  	
  *KR, *JP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  US 6,055,453

  	
   

  	
  Method and Apparatus For Using Electroporation-Mediated Delivery of
  Drugs and Genes

  	
   

  	
  Hofmann et al.

  	
   

  	
  Apr. 25, 2000

  
	
   

  	
   

  	
  US 6,233,482
(Divisional)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  May 15, 2001

  
	
   

  	
   

  	
  US 6,068,650
(Divisional)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  May 30, 2000

  
	
   

  	
   

  	
  US
  09/189,064

  (Divisional)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  
	
   

  	
   

  	
  US 6,216,034
(Divisional)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  April 10,  2001

  
	
   

  	
   

  	
  US 6,014,584
(Divisional)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jan. 11, 2000

  
	
   

  	
   

  	
  PCT/US98/16101

  	
   

  	
  (WO99/06101)

  	
   

  	
   

  	
   

  	
  7/31/98

  
	
   

  	
   

  	
  *AR
  P980104103

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  
	
   

  	
   

  	
  *AU 734,343

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  *BR
  P19806069-4

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *CA
  2,268,026

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *CN
  98801461.0

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *EP
  98938256.9

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *JP
  11-511309

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *KR
  101999700278

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *MX 99 3016

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *RU 99109111

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  allowed

  
	
   

  	
   

  	
  *SG
  9901969-7

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  allowed

  
	
   

  	
   

  	
  *TW 118,054

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Nov. 28, 2000

  
	
   

  	
   

  	
  *WO 98/16042

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Jul. 31,
  1998

  
	
   

  	
   

  	
  *ZA 98/7596

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Aug. 31, 1999

  
	
   

  	
   

  	
  *SA 98/7596

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Aug. 31,
  1999

  
	
   

  	
   

  	
  US 6,241,701
(CIP)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  June 5, 2001

  
	
   

  	
   

  	
  PCT/US99/24787

  	
   

  	
  (WO
  00/23143)

  	
   

  	
   

  	
   

  	
  10/21/99

  
	
   

  	
   

  	
  *AR, AU, CA,
  EP, HK, TW

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  *09/861,016

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  allowed

  
	
   

  	
   

  	
  *09/900,601

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  7/5/01

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  US 6,027,488

  	
   

  	
  Flow-through Electroporation System for Ex Vivo Gene Therapy

  	
   

  	
  Hofmann, Rabussay

  	
   

  	
  Feb. 22, 2000

  
	
   

  	
   

  	
  PCT/US99/12136

  	
   

  	
  (WO99/62592)

  	
   

  	
   

  	
   

  	
  6/1/99

  
	
   

  	
   

  	
  *AU746,484

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  allowed

  
	
   

  	
   

  	
  *CA, *EP,
  *JP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  *09/470,567

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  12/22/99

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6

  	
   

  	
  *US
  09/352,809

  	
   

  	
  Skin and Muscle-Targeted Gene Therapy By Pulsed Electrical Field

  	
   

  	
  Dev, Hofmann, Nolan, Rabussay, Tonnessen, Widera, Zhang

  	
   

  	
  July 13,
  1998

  
	
   

  	
   

  	
  PCT/US99/15755

  	
   

  	
  (WO
  00/02621)

  	
   

  	
   

  	
   

  	
  July 13,
  1999

  
	
   

  	
   

  	
  *EP, *AU,
  *CA, *JP

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  *09/567,404

  	
   

  	
  Method of Electroporation Enhanced Molecule Delivery

  	
   

  	
  Dev at al.

  	
   

  	
  Allowed

  
	
   

  	
   

  	
  PCT/US00/12657

  	
   

  	
  (WO
  00/67837)

  	
   

  	
   

  	
   

  	
   

  



 


39

















 


Appendix 1.30


 


GeneSwitchÒ Patents


 


	
  Serial
  Number

  	
   

  	
  Title

  	
   

  	
  Status

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  US 5,364,791

  	
   

  	
  Progesterone Receptor Having C Terminal Hormone Binding Domain
  Truncations (Assigned
  to Baylor College of Medicine and exclusively licensed to Valentis via
  GeneMedicine)

  	
   

  	
  issued
  11/15/94 on Serial No. /882771 (original priority 05/14/92)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  WO93/23431

  	
   

  	
  Mutated
  Steroid Hormone Receptors, Methods for Their Use and Molecular Switch for
  Gene Therapy

  	
   

  	
  filed
  5/11/93 as PCT/US93/04399; evolved

  
	
   

  	
   

  	
  AU 685054

  	
   

  	
   

  	
   

  	
  issued

  
	
   

  	
   

  	
  AU 724598

  	
   

  	
   

  	
   

  	
  issued

  
	
   

  	
   

  	
  EPC
  93911198.5

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  CA 2,135,644

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  JP 503676

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  US 5,874,534

  	
   

  	
  Mutated Steroid Hormone Receptors, Methods for Their Use and
  Molecular Switch for Gene Therapy

  	
   

  	
  CIP issued
  2/23/99 on 08/479846 filed 6/6/95

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  US 5,935,934

  	
   

  	
  Same as above

  	
   

  	
  issued
  8/10/99 on 08/454,418 filed 5/30/95

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  09/465,133

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  US 6,416,998

  	
   

  	
  Modified Steroid Hormones for Gene Therapy and Methods for Their Use

  	
   

  	
  CIP, issued
  7/9/2002 on 08/479,913 filed 6/7/95

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  WO9818925

  	
   

  	
  Modified
  Glucocorticoid Receptors, Glucocorticoid Receptors/Progesterone Receptors
  Hybrids

  	
   

  	
  filed
  10/28/97 as PCT/US97/19607; evolved

  
	
   

  	
   

  	
  AU 69089

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  JP 520723

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  CA 2,269,642

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  EPC
  97949348.3

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  10/124,741

  	
   

  	
  CIP w/priority to 5/14/92

  	
   

  	
  filed
  4/16/02, pending

  
	
   

  	
   

  	
  10/124,739

  	
   

  	
  CIP w/priority to 6/6/95

  	
   

  	
  filed
  4/16/02, pending

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  WO/0224899

  	
   

  	
  Improved System for Regulation of Transgene Expression (Assigned to Valentis)

  	
   

  	
  filed as
  PCT/US01/30305 on 09/25/01, priority to 09/25/00

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TRADEMARK/SERVICEMARK

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Serial
  Number

  	
   

  	
  Mark

  	
   

  	
  Status/Notes

  
	
  1.

  	
   

  	
  US 75/189340

  	
   

  	
  GeneSwitchÒ

  	
   

  	
  Filed 10/29/96, Reg. 10/09/01 as 2,496,464

  



 


40

















 


Appendix 1.62


 


PINC Patents


 


	
  Serial
  Number

  	
   

  	
  Title

  	
   

  	
  Status

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  US 6,040,295

  	
   

  	
  Formulated Nucleic Acid Compositions and Methods of Administering the
  Same for Gene Therapy (Polymer formulations for gene delivery to muscle; PVP, PVA, PEG, PG;
  assigned to Valentis)

  	
   

  	
  issued from
  US 08/372,213, filed 01/13/95

  
	
   

  	
   

  	
  WO9621470

  	
   

  	
  (~PCT/US95/017038)

  	
   

  	
  evolved

  
	
   

  	
   

  	
  EP95944270.8

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  AU 703419

  	
   

  	
   

  	
   

  	
  granted

  
	
   

  	
   

  	
  AU 744010

  	
   

  	
   

  	
   

  	
  granted

  
	
   

  	
   

  	
  CA 2210132

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  JP 521697

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  US
  08/798,974

  	
   

  	
   

  	
   

  	
  CIP, allowed

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  WO 01/65911

  	
   

  	
  Improved Poloxamer Compositions for Nucleic Acid Delivery (select poloxamer and poloxamine formulations for
  gene delivery; assigned to Valentis)

  	
   

  	
  filed as
  PCT/US01/06831  on 03/03/01 w/
  priority  from 03/03/00; evolved

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  US

  	
   

  	
  National
  stages entered 9/3/02

  	
   

  	
  CIP filed
  from PCT, 9/3/02

  
	
   

  	
   

  	
  EP

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  JP

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  CA

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  AU

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  BR

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  WO/0166149

  	
   

  	
  Nucleic Acid Compositions and Methods of Administration for Gene
  Therapy (polyanionic
  formulations including poly-L—glutamate formulations with electroporation;
  assigned to Valentis)

  	
   

  	
  filed as
  PCT/US01/06953 on 03/03/01 w/priority from 03/03/00; evolved

  
	
   

  	
   

  	
  US

  	
   

  	
  National
  stages entered 9/3/02

  	
   

  	
  pending

  
	
   

  	
   

  	
  EP

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  JP

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  CA

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  AU

  	
   

  	
   

  	
   

  	
  pending

  
	
   

  	
   

  	
  BR

  	
   

  	
   

  	
   

  	
  pending

  



 


41

















 


Appendix 1.70


 


SUPPLIES AND TECHNICAL INFORMATION


 


PINC


 


Supplies


[***]


 


 


Technical
Information


[***]


 


[***]


 


 


GENESWITCH


 


Supplies


 


[***]


 


Technical
Information


 


[***]


 


42

















 


[***]


 


 


ELECTROPORATION


 


Supplies


[***]


 


Technical
Information


[***]


 


43

















 


Appendix 2.2


 


Valentis Third Party Licenses


 


 


[***]


 


44

















 


Appendix 4


 


Terms and Supply of Electroporation Devices


 


 


•                    Valentis
to supply to Schering [***].


 


•                    If
the Devices are obtained from [***], the supply price for Devices [***].  If the Devices are obtained from [***],
the supply price for the Devices [***].


 


•                    The
supply price for Devices for [***].


 


•                    The
supply agreement shall contain appropriate quality assurance provisions,
including for compliance with specifications, and [***].


 


45

















 


Appendix 5.3.1


 


Calculation of Royalties


 


	
   

  	
   

  	
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46