Contract
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
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A.
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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
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B.
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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 Xxxxxxxxx’x Disease
(the “PD Clinical Study”); and
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C.
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The
Parties desire to set forth additional terms to the original Agreement;
and
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D.
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The
Parties agree as follows.
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AGREEMENT
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1.
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General.
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1.1
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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 Xx. Xxxxxxx Xxxxxxx in Memphis on May 21, 2007 was
manufactured in accordance with this
Specification.
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1.2
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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.
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1.3
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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.
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Page
1
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1.4
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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.
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1.5
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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.
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1.6
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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.
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1.7
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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:
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“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.
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2.
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Services,
Invoicing, and Payment.
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2.1
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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.
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2.2
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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.
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2
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3.
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Product
Pricing, Orders, Invoicing, and
Payment.
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3.1
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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.
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Device
Description
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Maximum
Number to be Supplied
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Price
(each)
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Product: ########
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########
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$########
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Product: ########
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########
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$########
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Product: ########
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########
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$########
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########
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########
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$########
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**########
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Note:
the above pricing information constitutes Medtronic confidential
information.
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3.2
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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:
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Xxxxxxx
Xxxxxx
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Medtronic,
Inc.
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0000
Xxxxxxx Xxxxxx X.X.
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Xxxxxxxxxxx,
XX 00000
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(000)
000-0000
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xxxxxxx.x.xxxxxx@xxxxxxxxx.xxx
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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.
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3.3
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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.
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3.4
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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.
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########
= 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.
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3
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4.
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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.
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5.
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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.
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6.
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Limitation
of Liability.
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6.1
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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.
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6.2
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Neurologix
acknowledges that Medtronic assumes no responsibility or liability with
respect to modifications made to the Product after delivery by
Medtronic.
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6.3
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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.
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6.4
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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.
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6.5
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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.
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Except to
the extent provided above, the remaining terms and conditions of the Agreement
remain in full force and effect.
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MEDTRONIC,
INC.
By
/s/ Xxxxxx Xxxxxx VP Research +
BD
Date Aug 5 -
2008
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NEUROLOGIX,
INC.
By /s/ Xxxx X. Xxxxxxx
(print
name) Xxxx X. Xxxxxxx
Title President & CEO
By /s/ Xxxx Xxxxxx
(print
name) Xxxx Xxxxxx
Title Chief Financial
Officer
Date 8/12/08
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