Document:

Unassociated Document

     

    Exhibit
10.1

     

    
      ADDENDUM
TO THE DEVELOPMENT AND MANUFACTURING AGREEMENT

      BETWEEN
MEDTRONIC, INC. AND NEUROLOGIX, INC.

      

      This
Addendum is effective August 1, 2008, and amends the Development and
Manufacturing Agreement first effective April 27, 2005 (the “Agreement”) between
Medtronic, Inc. (“Medtronic”) and Neurologix, Inc.
(“Neurologix”).  Capitalized terms not defined in this Addendum have
the meaning given to such terms in the Agreement.

      

      RECITALS

      

      
        	
                A.

              	
                Medtronic
      and Neurologix were parties to the Agreement along with Neurologix
      Research, Inc., a wholly owned subsidiary of Neurologix that was merged
      with and into Neurologix and no longer exists;
  and

              

      

      

      
        	
                B.

              	
                The
      Parties desire to complete preparation for the Phase II clinical trial
      entitled: Safety and
      Efficacy Study Evaluating Glutamic Acid Decarboxylase Gene Transfer to the
      Subthalamic Nuclei in Subjects with Advanced Parkinson’s Disease
      (the “PD Clinical Study”); and

              

      

      

      
        	
                C.

              	
                The
      Parties desire to set forth additional terms to the original Agreement;
      and

              

      

      

      
        	
                D.

              	
                The
      Parties agree as follows.

              

      

      

      AGREEMENT

      

      
        	
                1.

              	
                General.

              

      

      

      
        	
                1.1

              	
                Confirmation of
      Specification.  The Parties hereby agree and confirm that
      the PD Application Work Plan identified as Product
      Specification—Neurologix Acute Delivery System, Document Number A27432,
      Revision B, a copy of which is attached hereto as Exhibit A (the
      “Specification”), is the PD Application Work Plan under Article 2.1 of the
      Agreement.  Unless otherwise agreed by the Parties through an
      amendment to the Agreement, Medtronic shall manufacture the Products in
      accordance with such Specification.  The Product used in the
      cadaver study by Dr. Michael Kaplitt in Memphis on May 21, 2007 was
      manufactured in accordance with this
  Specification.

              

      

      

      
        	
                1.2

              	
                Modified Informed
      Consent.  Neurologix shall modify the template informed
      consent for the PD Clinical Study with the language set forth in the
      document attached as Exhibit B and assure that all sites include the
      confidentiality language in substantially the same wording as shown in
      Exhibit C.  Neurologix shall provide Medtronic a copy of the
      Institutional Review Board’s (IRB) approved final version of each informed
      consent that includes this amended language (and separate HIPAA
      authorization, if applicable) for each PD Clinical Study site within
      thirty (30) days of the approval by each site’s IRB or at an earlier date
      if Neurologix requires Product to be shipped to that site, as stated in
      Section 4.1 of this Addendum.

              

      

      

      
        	
                1.3

              	
                Changes to the
      Protocol.  Neurologix shall modify the protocol for the
      PD Clinical Study with the language set forth in the document attached as
      Exhibit D.  Neurologix shall provide Medtronic a copy of the
      final version of the PD Clinical Study protocol that includes this amended
      language after submission to the FDA and resolution of any questions, if
      they arise.  Neurologix further acknowledges the receipt of
      additional suggestions for the PD Clinical Study protocol made by
      Medtronic in a letter dated May 30, 2008.  Notwithstanding these
      provisions, Neurologix acknowledges that it remains solely responsible for
      the PD Study protocol.

              

      

       

      
        
          
          

        

        
          Page
1

          
            

          

        

        
          
          

        

      

       

      
        	
                1.4

              	
                Adverse Event
      Reporting.  Neurologix shall send serious adverse device
      events (as such term is defined in the PD Clinical Study protocol)
      information to Medtronic, including any supporting documentation, as soon
      as possible after the information is received by Neurologix, and in no
      case later than 2 days after receipt of the information by
      Neurologix.  Neurologix shall send all other adverse events and
      technical observations information to Medtronic, including any supporting
      documentation, on the same schedule it sends such information to its Data
      Management Committee.  Neurologix shall work with Medtronic to
      assure all reports and other correspondence to be submitted to the FDA for
      serious adverse device events is accurately stated.  Neurologix
      will provide an electronic copy of its clinical database (in a
      standardized data transfer format, e.g. SAS) with all adverse device
      events and technical observations to Medtronic on a calendar quarterly
      basis.  The data sent on a quarterly basis does not need to be
      monitored.  Neurologix will send a copy of its draft clinical
      report to Medtronic and collaborate with Medtronic on the reporting of all
      adverse device events and device accountability records for reporting to
      the FDA.  Neurologix will also send a copy of its final clinical
      report and final database of adverse events and technical observations to
      Medtronic with monitored data at the conclusion of the
    study.

              

      

      

      
        	
                1.5

              	
                Device
      Accountability.  Neurologix shall provide device
      accountability records (as described in the protocol) to Medtronic on a
      calendar quarter basis, beginning during the quarter in which the first PD
      Clinical Study procedure is performed.    The data
      sent on a quarterly basis does not need to be
  monitored.

              

      

      

      
        	
                1.6

              	
                FDA Confirmation of
      Neurologix Study Sponsorship.  Neurologix shall deliver
      to Medtronic a copy of the FDA confirmation that Neurologix holds the
      Investigational New Drug Application (IND) for the PD Clinical Study
      within thirty (30) days of Neurologix’s receipt
  thereof.

              

      

      

      
        	
                1.7

              	
                Amendment to Section
      5.6.4 to the Agreement.  The following sentence shall be
      added at the end of Section 5.6.4 of the
  Agreement:

              

      

      

      “For
clarity, Medtronic’s provision of technical assistance to Neurologix shall
include providing access to Neurologix to relevant Know-How documentation within
sixty (60) days from the granting of the license.”

      

      Except
for this clarification, Section 5.6.4 of the Agreement shall remain in full
force and effect unchanged.

       

      

      
        	
                2.

              	
                Services,
      Invoicing, and Payment.

              

      

      

      
        	
                2.1

              	
                Services.  Medtronic
      shall provide the technical and clinical support services for the PD
      Clinical Study listed in the attached Exhibit E (the
      “Services”).  All such Services shall be provided in a
      workmanlike manner in accordance with Medtronic’s ordinary
      practices.  Any additional Services requested beyond those
      enumerated in Exhibit E must be agreed upon in writing and signed by both
      Parties.  All Services will be billed to Neurologix at the
      hourly rate set forth in Exhibit E.  In addition, Neurologix
      shall reimburse Medtronic for all reasonable travel and lodging expenses
      incurred in connection with Medtronic’s provision of
    Services.

              

      

      

      
        	
                2.2

              	
                Services
      Invoicing.  Medtronic shall invoice Neurologix on a
      monthly basis for Services provided during the previous calendar
      month.  Each invoice shall include a brief description of the
      Services provided, the number of hours spent and the corresponding amount
      due.  Neurologix shall pay all such invoices within thirty (30)
      days of its receipt thereof.

              

      

       

      
        
          
          

        

        
          Page
2

          
            

          

        

        
          
          

        

      

       

      
        	
                3.

              	
                Product
      Pricing, Orders, Invoicing, and
Payment.

              

      

      

      
        	
                3.1

              	
                Product Pricing and
      Quantities.  Subject to (i) Medtronic’s completion of the
      activities referred to in Exhibit F; and (ii) Neurologix’s completion of
      the activities referred to in Exhibit F (in each case, as
      more fully described in the Addendum section number referred to in such
      Exhibit F), Medtronic shall sell to Neurologix up to the number of
      Products and external infusion pumps listed below for use by Neurologix in
      the PD Clinical Study only.  The prices listed below reflect
      Medtronic’s current ######## and, in the case of the
      ########.  Further, the Parties acknowledge that the prices set
      forth below reflect only the calculations of the ######## being sold
      hereunder, and shall in no way bind the Parties to purchase and sell the
      Products at those prices in any future clinical trials or for commercial
      use.

              

      

      
      

      

      
        
          	
                  Device
      Description

                	
                  Maximum
      Number to be Supplied

                	
                  Price

                  (each)

                
	
                  Product:  ########

                	
                  ########

                	
                  $########

                
	
                  Product:  ########

                	
                  ########

                	
                  $########

                
	
                  Product:  ########

                	
                  ########

                	
                  $########

                
	
                  ########

                	
                  ########

                	
                  $########

                
	
                  **########

                

        

      

       

      
        	
                 
      

              	
                Note:
      the above pricing information constitutes Medtronic confidential
      information.

              

      

      

      
        	
                3.2

              	
                Product
      Orders.  Products and the external infusion pump for the
      PD Clinical Study will be ordered by contacting Medtronic at the address
      below to the Medtronic-Neurologix project manager, with a copy to a
      Medtronic clinical employee designated by such project manager in
      writing:

              

      

      

      
        	
                 
      

              	
                Charles
      Graves

              

      

      
        	
                 
      

              	
                Medtronic,
      Inc.

              

      

      
        	
                 
      

              	
                7000
      Central Avenue N.E.

              

      

      
        	
                 
      

              	
                Minneapolis,
      MN  55432

              

      

      
        	
                 
      

              	
                (763)
      526-8042

              

      

      
        	
                 
      

              	
                charles.t.graves@medtronic.com

              

      

      

      Within
ten (10) days of activation of each Study site and receipt by Medtronic of a
copy of the site’s IRB approval letter, Medtronic will ship four (4) external
infusion pumps and two (2) Medtronic 8765 Accessory Kits to the
site.  Thereafter, Neurologix can order additional product by
notifying Medtronic at least ten (10) days prior to a study subject’s implant as
described in this Section 3.2.  Neurologix shall send an order to the
Medtronic contact person identified above with the following information: the
Product(s) or pump(s) description, the quantities of each Product or pump, the
date of implant, shipping instructions, and the shipping address of the Study
site. Orders may be submitted via mail, fax or email.

      

      
        	
                3.3

              	
                Acceptance, Terms, and
      Packaging.  Orders will be deemed accepted upon receipt
      unless Medtronic provides notice of rejection to Neurologix within five
      (5) business days.  The terms and conditions of this Addendum
      and the Agreement shall govern and supersede any additional or contrary
      pre-printed terms set forth in Neurologix’s written
      documentation.  Medtronic will pack the Product and the external
      infusion pump for shipment in compliance with industry
      standards.

              

      

      

      
        	
                3.4

              	
                Additional Costs,
      Invoicing, and Payment.  Neurologix shall be responsible
      for the freight, insurance, taxes, and other costs, if any, associated
      with the purchase and shipment of the Products and internal infusion pumps
      sold hereunder.  Such amounts shall be in addition to the prices
      stated in Section 3 and shall be included in the
      invoice.  Medtronic will invoice Neurologix monthly for shipment
      of the Products and pumps and Neurologix shall pay such invoices within
      thirty (30) days of its receipt
thereof.

              

      

       

       

      
        ########
= Material omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission on the date of filing of this Form
8-K.

      

       

      
        
          
          

        

        
          Page
3

          
            

          

        

        
          
          

        

      

       

      
        	
                4.

              	
                Right
      to Observe Procedures.  Subject to site approval,
      Neurologix shall allow designated Medtronic personnel access to observe
      the implant procedures at the PD Clinical Study sites that have a surgical
      observation room or equivalent.  Moreover, Neurologix agrees to
      facilitate designated Medtronic personnel access for the sole purpose of
      observing the implanting surgeon’s technical use of the
      Product.  Medtronic will not be responsible for, nor interfere
      with, the conduct of the procedures.  Medtronic will assume all
      of the costs related to its designated personnel observing the implant
      procedures, except for travel related expenses when travel is associated
      with work covered under Exhibit D.

              

      

      

      
        	
                5.

              	
                Intellectual
      Property.  For clarity, Intellectual Property ownership
      arising from the Services or any other activity under this Amendment shall
      be governed by Article 5 of the
Agreement.

              

      

      

      
        	
                6.

              	
                Limitation
      of Liability.

              

      

      

      
        	
                6.1

              	
                EXCEPT
      AS EXPRESSLY PROVIDED IN THIS AMENDMENT, MEDTRONIC MAKES NO WARRANTY AS TO
      THE SERVICES PROVIDED HEREUNDER.  PRODUCTS SOLD UNDER THIS
      AMENDMENT AND THE AGREEMENT ARE PROVIDED WITH THE WARRANTY SET FORTH IN
      THE AGREEMENT AND ARE SUBJECT TO ALL THE LIMITATIONS SET FORTH
      THEREIN.  MEDTRONIC'S SOLE AND EXCLUSIVE WARRANTY WITH RESPECT
      TO THE EXTERNAL INFUSION PUMP SOLD UNDER THIS AMENDMENT ARE SET FORTH IN
      THE STANDARD WARRANTY DOCUMENT PROVIDED WITH THE EXTERNAL INFUSION PUMPS
      AND ARE SUBJECT TO THE LIMITATIONS SET FORTH THEREIN.  IN
      ADDITION TO THE LIMITATION OF LIABILITY SET FORTH IN ARTICLE 7.9 OF THE
      AGREEMENT, AND EXCEPT AS EXPRESSLY PROVIDED HEREUNDER, MEDTRONIC MAKES NO
      WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY
      ARISING FROM STATUTE, COMMON LAW, CUSTOM OR
      OTHERWISE.  MEDTRONIC IS NOT AUTHORIZING ANY PERSON, INCLUDING
      WITHOUT LIMITATION NEUROLOGIX, TO BIND MEDTRONIC OR OTHERWISE TO MAKE ANY
      REPRESENTATION OR WARRANTY ON BEHALF OF MEDTRONIC WITH RESPECT TO THE
      SERVICES, THE PRODUCTS, OR THE EXTERNAL INFUSION
  PUMPS.

              

      

      

      
        	
                6.2

              	
                Neurologix
      acknowledges that Medtronic assumes no responsibility or liability with
      respect to modifications made to the Product after delivery by
      Medtronic.

              

      

      

      
        	
                6.3

              	
                In
      addition to any indemnification obligation of Neurologix set forth in the
      Agreement, Neurologix shall indemnify, defend and hold harmless Medtronic
      and each of its Affiliates, and their respective officers, directors,
      members, employees and agents from and against and in respect of any and
      all Indemnifiable Losses resulting from, arising out of, or imposed upon
      or incurred by any person to be indemnified hereunder by reason of any
      Services provided hereunder or any modifications of the Product or use of
      the Product with any equipment other than that for which the Product is
      designed to work with per its Specification, whether or not known by
      Medtronic.

              

      

      

      
        	
                6.4

              	
                Neurologix
      will purchase and maintain, through an appropriate, reputable insurance
      provider, insurance coverage in the amount of US$5 million for each claim
      and US$5 million in the aggregate, adequate to cover claims against
      Medtronic in connection with the implant procedures of the PD Clinical
      Study, including any indemnification obligations arising from Neurologix’s
      activities or obligations under the Agreement or this
      Addendum.  Neurologix shall provide to Medtronic a copy of a
      certificate of insurance that complies with the foregoing requirements and
      names Medtronic as an additional insured within 15 days of execution of
      this Amendment and at any other time as reasonably requested by
      Medtronic.

              

      

      

      
        	
                6.5

              	
                The
      exclusions and limitations set out above are not intended to, and should
      not be construed to, contravene mandatory provisions of applicable
      law.  If any part or term of this disclaimer of warranty is held
      to be illegal, unenforceable or in conflict with applicable law by a court
      or competent jurisdiction, the validity of the remaining portions of this
      disclaimer of warranty shall not be affected, and all rights and
      disclaimer of warranty shall not be affected, and all rights and
      obligations shall be construed and enforced as if this disclaimer of
      warranty did not contain the particular part of term held to be
      invalid.

              

      

       

      
        
          
          

        

        
          Page
4

          
            

          

        

        
          
          

        

      

       

      Except to
the extent provided above, the remaining terms and conditions of the Agreement
remain in full force and effect.

      

      
        	
                MEDTRONIC,
      INC.     

                 

                By
      /s/ Lothar Krinke VP Research +
      BD

                 

                Date Aug 5 -
2008

              	 	
                NEUROLOGIX,
      INC.

                 

                By /s/ John E. Mordock

                (print
      name) John E. Mordock

                Title President & CEO

                 

                By /s/ Marc Panoff

                (print
      name) Marc Panoff

                Title Chief Financial
      Officer

                Date 8/12/08fs1a1ex10ii_ea2universal.htm

    

     

    The
Nash Group

    704
Black Pearl Cove

    Rocky
Mount, NC 27804

    Telephone:
252-973-0780 - Fax: 252-454-0783

     

    August
13, 2008

     

    Lanny M.
Roof, CPA (Retired) 

    CEO &
Treasurer

    Universal
Holdings, Inc.

    PO Box
8851

    Rocky
Mount, NC 27804

     

    RE: Turn
Key Tool Manufacturing Agreement with Advance Thermo Control, Ltd.

     

    Dear Mr.
Roof:

     

    In
response to your request that I
clarify our earlier discussion concerning the agreement with Advance
Thermo Control, Ltd. (ATC) for the manufacturing of the Turn Key Tool product,
the following information is provided.

     

    Universal
Products Marketing, Inc. (UPM) was an earlier product development firm
incorporated in 2002. The original UPM acquired both the Turn Key patent and the
original inventory of product. The product was purchased from Advance Thermo
Control, Ltd. The manufacturer of this product was found by a product
acquisition consultant The WestWord Group LLC.

     

    In 2006
the original Universal Products Marketing, Inc. was in serious financial
difficulty and was not able to pursue their business plan. The Nash Group
entered into negotiations to acquire all remaining product and inventory from
UPM in return for taking on the company debt of $125,000. This transaction
occurred in November of 2006. Following this the original Universal Products
Marketing, Inc. folded and no longer exists.

     

    In 2007
when you approached The Nash Group about re-organization of the manufacturing
and distribution of the Turn Key product we indicated that we were happy to sell
you the patent and our remaining inventory. We also made it clear that we no
longer had any rights to the name Universal Products Marketing and were happy to
have you use it as the name of your new company. We then sold you the patent on
March 17, 2008 and inventory on June 13, 2008.

     

    The Nash
Group no longer has any claim to the patent or the inventory for the Turn Key
product .

     

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

     

    I am
attaching to this letter the original agreement between ATC and The WestWord
Group as well as the original invoice for material. Please let me know if you
request any further information on this matter.

     

    Sincerely,

    

     

    /s/  Carlton
Harlow

    Carlton
Harlow Managing Partner The Nash Group

    

     

     

     

     

     

     

     

     

     

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
 

     

    Advance
Thermo Control, Ltd.

    19°
Floor Million Fortune Industrial Centre

    34-36
Chai Wan Kok Street, Tsuen Wan, N.T. Hong Kong

    Phone:
852-2498-7465 Fax: 852-2413-3080

    U.S.
Representative

    Advance Technical Components Inc.

    630
Pratt Avenue North

    Schaumburg,
IL 60193

    (847)
985-8383 (Fax) 985-1323

     

    Stuart
Schantz

    Westward
Group

    8024
Glenwood Avenue Suite 205

    Raleigh,
NC 27612

    April 16,
2003

    Re:Turn-Key
program

     

    Dear
Stuart,

     

    In
follow-up to our conversations I would like to offer this letter to you and the
Westward Group in order to establish our working principles , and guidelines for
the Turn-Key program initiation.

     

    As an
independent entrepreneurial group we understand the start up processes necessary
to establish your sales, marketing, and distribution channels for your new
product. We are keenly enthused with the product focus and believe that you have
a keen opportunity to fulfill a niche market requirement that offers a great
growth opportunity.

     

    In order
to validate the quotation of this product the annual volume of up to 25,000
units in the first year is offered with the understanding to allow for your
initial smaller volume production releases necessary as you establish this new
product line.

     

    We
understand that based upon a pilot production of 100 pieces subsequent releases
at a minimum of 1,000 units will be issued and increased as your marketplace is
established.

     

    Our
strategic supplier alliance plan is allow the Westward Group the ability to
establish your marketplace while providing the volume flexibility to maintain
your working capital inline with actual sales growth.

     

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

     

     

     

    I have
enclosed the Aluminum 'professional' unit tooling cost which had been over
looked in Michaels earlier fax quotation.

     

    Once we
have received the initial 50% tooling deposit our engineering team will provide
you with a GANT chart outlining tooling completion and production start-up
schedule dates for your product introduction preparations.

     

    We would
also offer an open invitation for your visitation to Our China facilities during
the initial production pilot run.

     

    Thank you
for the opportunity to service your requirements. Please feel free to contact
myself our Michael directly if you should have any questions or require further
assistance.

     

    Sincerely,

     

    /s/  Bill
Irwin

     

    Bill
Irwin

    Director

    Cc:
Michael Irwin, A.J. Horner, John Elliasen, Carlton
Harlow

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