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S-1/A - S-1/A - Rules-Based Medicine Incd70440a2sv1za.htm
EX-3.3 - EX-3.3 - Rules-Based Medicine Incd70440a2exv3w3.htm
EX-3.2 - EX-3.2 - Rules-Based Medicine Incd70440a2exv3w2.htm
EX-2.1 - EX-2.1 - Rules-Based Medicine Incd70440a2exv2w1.htm
EX-23.1 - EX-23.1 - Rules-Based Medicine Incd70440a2exv23w1.htm
EX-10.5 - EX-10.5 - Rules-Based Medicine Incd70440a2exv10w5.htm
EX-10.5.1 - EX-10.5.1 - Rules-Based Medicine Incd70440a2exv10w5w1.htm
EX-10.9.1 - EX-10.9.1 - Rules-Based Medicine Incd70440a2exv10w9w1.htm
Exhibit 10.6.1
VARIATION AGREEMENT
TO CO-DEVELOPMENT

AND COMMERCIALIZATION AGREEMENT
     THIS VARIATION AGREEMENT (“Variation Agreement”) is made and entered into as of the 19 day of December, 2009 by and among Rules-Based Medicine, Inc., a Delaware corporation (“RBM”); and Psynova Neurotech Limited, a company incorporated in England and Wales (“Psynova”).
W I T N E S S E T H:
     WHEREAS, RBM and Psynova are parties to that certain Co-Development and Commercialization Agreement dated September 5, 2008 (as amended and varied, the “Agreement”) whereby, among other things, Psynova granted certain rights to RBM under Section 9.3 of the Agreement (the “Schizophrenia IP Rights”);
     WHEREAS, the Schizophrenia IP Rights include rights under any Psynova Background IP (as defined in the Agreement), which includes Intellectual Property (as defined in the Agreement”) that is related to a Schizophrenia Product (as defined in this Agreement) that is subject to the Framework Agreement between The Chancellor, Masters and Scholars of the University of Cambridge, Cambridge Enterprise Limited, and Psynova (the “Framework Agreement”); and
     WHEREAS, Psynova has certain rights to the intellectual property set forth in Schedule 1, which is subject to the Framework Agreement and the parties desire to amend the Agreement to memorialize the inclusion of said intellectual property within the Schizophrenia IP rights granted to RBM under the Agreement.
     NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
     1. Definitions. Capitalized terms used but not defined herein shall have the meaning given in the Agreement.
     2. Amendments to Agreement.
     (a) Psynova Background IP. The definition of Psynova Background IP is hereby deleted in its entirety and replaced with the following:
“Psynova Background IP” means (a) any Intellectual Property owned, licensed to or developed by Psynova independently of the R&D Project and this Agreement, which relates to any Schizophrenia Product, and (b) the Intellectual Property identified in Schedule 1 hereto, which relates to any Schizophrenia Product.
     (b) Inventions. The definition of Invention is hereby deleted in its entirety and replaced with the following:

 


 

“Invention” means (a) an invention conceived by one or more employee or agent of either Psynova or RBM or the parties jointly, which invention arises from the R&D Project or otherwise under the terms of this Agreement, and includes without limitation all New Biomarkers and New Assays and (b) an invention owned, licensed to or developed by Psynova independently of the R&D Project and this Agreement, which relates to any Schizophrenia Product (such as Intellectual Property licensed to Psynova as contemplated by the Framework Agreement), and includes without limitation, the Inventions identified in Schedule 2.
     3. Confirmation
The parties agree and declare that the Agreement shall (save as amended by this Variation Agreement) continue in full force and effect and this Variation Agreement shall be read as one with, and shall be supplemental to, the Agreement. Where there is any inconsistency or ambiguity between the terms of the Agreement and this Variation Agreement, the terms of this Variation Agreement shall prevail.
     4. Miscellaneous Provisions
  a.   The provisions of clauses 22 and 23.11 of the Agreement shall apply mutatis mutandis.
 
  b.   This Variation Agreement is not intended to confer any legally enforceable rights on any person other than the parties, their successors in title and assignees, whether pursuant to the Contracts (Rights of Third Parties) Act 1999 applicable to England and Wales or otherwise.
 
  c.   Each party acknowledges to the others (and shall execute this Variation Agreement in reliance on such acknowledgement) that it has not been induced to enter into this Variation Agreement by, nor relied on, any representation or warranty.
 
  d.   This Variation Agreement may be executed in any number of counterparts and by the different parties hereto in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Delivery of an executed counterpart of a signature page to this Variation Agreement by fax or email shall be effective as delivery of a manually executed counterpart of this Variation Agreement.

 


 

     IN WITNESS WHEREOF, the parties hereto have executed this Variation Agreement as of the date first set forth above.
         
  RULES-BASED MEDICINE, INC.
 
 
  By:   /s/ Samuel T. LaBrie    
  Title:  Vice President — Corporate Development   
       
  PSYNOVA NEUROTECH LIMITED
 
 
  By:   /s/ Paul Rodgers    
  Title:  Director   
       
 

 


 

SCHEDULE 1 TO CO-DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Assigned to Cambridge and Subject to Framework Agreement with Psynova
                 
Country     Application Number   Filing Date   Description
 
PCT
    PCT/GB2006/050034   2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
Australia
    2006212041     2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
Canada
    2594405     2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
China
    200680004894.5     2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
Japan
    2007553715     2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
Europe
    06710158     2/14/2006   Bah-1253-01-Biomarkers and targets-psychiatric disorders/related disorders of CNS
PCT
    PCT/GB2007/003090   8/15/2007   Bah-1677-06 – Diagnosing, monitoring, screening for major depressive order
Australia
    2007285632     2/4/2009 (National Entry Date)   Bah-1677-06 – Diagnosing, monitoring, screening for major depressive order
Europe
    EP20070789213   8/15/2007   Bah-1677-06 – Diagnosing, monitoring, screening for major depressive order
Japan
    2009524229     8/15/2007   Bah-1677-06 – Diagnosing, monitoring, screening for major depressive order
GB
    GB0521098.4   10/18/2005   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
PCT
    PCT/GB2006/003870   10/18/2006   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
Australia
    2006303026     11/4/2008 (National Entry)   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
Canada
    2626490     4/17/2008 (National Entry)   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
European
    2006794812     10/18/2006   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
US
    12/090,530     2/22/2009   Bah-1487-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
PCT
    PCT/GB2006/004509   4/12/2006   Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
Australia
    2006321389     06/02/2008 (National Entry Date)   Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
Canada
    2640846     05/29/2008 (National Entry Date)   Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
China
    200680051802.9         Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
Europe
    2006820395         Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
Japan
    2008542840         Bah-1546-05 and Bah-1737-06 – biomarkers for psychotic disorders
PCT
    PCT/GB2006/004433   11/28/2006    
Australia
    2006318912     06/20/2008    
Canada
    2632052     05/27/2008 (National Entry)    
China
    200680051583.4     07/22/2008    
Europe
    2006808694     05/30/2008    
Japan
    2008541830     05/27/2008    
US
    12095146     10/27/2008    
GB
    GB0720548   10/19/2007    
GB
    GB07200545   10/19/2007    
GB
    GB0707001   4/11/2007    
PCT
    PCT/GB2004/002503   06/14/2004   Bah-812-01 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
Europe
    2004736765     09/01/2006   Bah-812-01 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
US
    10560279     10/03/2006   Bah-812-01 – Biomarkers and targets-psychiatric disorders/related disorders of CNS


 

                 
Country   Application Number   Filing Date   Description
 
PCT
  PCT/GB2007/000193   1/22/2007    
GB
  GB0511302.2       Bah-1360-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
GB
  GB05241110.4       Bah-1510-05 – Biomarkers and targets-psychiatric disorders/related disorders of CNS
GB
  GB0704515.6       Bah-1901-07 – Diagnosis, Monitor, Screening for psychotic disorders
PCT
  PCT/GB2008/00831       Bah-1901-07 – Diagnosis, Monitor, Screening for psychotic disorders
PCT
  PCT/GB2006/050140   6/5/2006    
             
Country   Application Number   Filing Date   Description
 
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
GB
  GB0724735.6   12/19/2007    
US
  11/912,029   6/5/2006    
GB
  GB701626   12/01/2007   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders
PCT
  PCT/GB2008/000199   1/21/2008   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders
EPO
  EP8701876.8   1/21/2008   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders
CA
  Canada-2676091   1/21/2008   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders
AU
  AU2008208717   1/21/2008   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders
JP
  JP2009546000   1/21/2008   Methods and Biomarkers for Diagnosing and Monitoring Psychotic Disorders


 

SCHEDULE 2 TO CO-DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Assigned to Cambridge and Subject to Framework Agreement with Psynova
             
Country   Application Number   Filing Date   Description
 
Great Britian
  GB0818658.7   10/10/2008   Bah-2194-08 – Diag. and monitor. of schizophrenia and other pyschotic disorders
Great Britian
  GB0818660.3   10/10/2008   Bah-2205-08 – Diag. and monitor. of schizophrenia and other pyschotic disorders
 
           
Great Britian
  GB0915736.3   9/9/2009   Bah-2310-09 – Diag. and monitor of schizophrenia and other psychotic disorders
 
           
 
          PSY022 (Bah-2310-09)
 
           
 
          PSY024 (Bah-2318-09)
 
          PSY025 (Bah-2329-09)
 
          PSY026 (Bah-2338-09)
 
  PSY027 (Bah-2351-09)        
PSY028 (Bah-2360-09)        
PSY029 (Bah-2361-09)