Medtronic development agreement


Exhibit 10.8

 



MATERIAL
IN THIS DOCUMENT

HAS BEEN
OMITTED PURSUANT

TO A
CONFIDENTIAL TREATMENT REQUEST







DEVELOPMENT
AND MANUFACTURING AGREEMENT

 

THIS
DEVELOPMENT AND MANUFACTURING AGREEMENT (this "Agreement") is
made and entered into as of April 27, 2005 ("Effective
Date"), by
and among Neurologix, Inc., a Delaware corporation and Neurologix Research,
Inc., a Delaware corporation (collectively "Neurologix") and
Medtronic, Inc., a Minnesota corporation ("Medtronic"). Each
of the above is sometimes referred to herein individually as a "Party" and
collectively as the "Parties."

 

RECITALS:

 

WHEREAS,
Medtronic has expertise and technology relating to delivery systems for delivery
of biologic and pharmaceutical compositions;

 

WHEREAS,
Neurologix has expertise and technology relating to biologics for the treatment
of Parkinson's Disease and temporal lobe epilepsy;

 

WHEREAS,
the Parties wish to collaborate on a project under which Medtronic will develop
a delivery system for delivering biologics; and

 

WHEREAS,
Neurologix desires to sell, and Medtronic (or one of Medtronic's Affiliates)
desires to purchase, shares of Neurologix pursuant to a stock purchase agreement
and the closing of certain transactions contemplated by the Stock Purchase
Agreement are conditional upon the execution and delivery of this
Agreement.

 

AGREEMENT

 

In
consideration of the mutual covenants contained in this Agreement and the Stock
Purchase Agreement, and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereto each agree to
the terms and conditions in this Agreement intending to be legally bound by
them.

 

ARTICLE
1

 

DEFINITIONS

 

Specific
Definitions. As used
in this Agreement, the following terms shall have the meanings set forth or as
referenced below:

 

"AAV
Vector" means a
vector derived from an adeno-associated virus.

 

"Affiliate" means a
Person, corporation or other entity that directly, or indirectly through one or
more intermediaries, controls, or is controlled by, or is under common control
with, the Party specified. "Control" for purposes of this definition means
ownership, either directly or indirectly through intermediaries, of more than
50% of the shares of stock entitled to vote for the election of directors in the
case of a corporation, and more than 50% of the voting power in the case of a
business entity other than a corporation.

 

 







1












 

"Agreement" means
this Agreement and all Exhibits and Schedules hereto.

 

"Biologic" means a
Neurologix product consisting of an AAV Vector containing: (i) a GAD Gene for PD
Application; or (ii) Neurologix's first product for TLE
Application.

 

"Biologic-Related
Neurologix Intellectual Property" means
Intellectual Property created or conceived by Neurologix employees, contractors,
or consultants or otherwise Controlled by Neurologix that relates solely to the
Biologic.

 

"Biologic-Related
Program Intellectual Property" means
Intellectual Property created or conceived during the period commencing on the
Effective Date of this Agreement and ending upon FDA Regulatory Approval of the
Product by Medtronic employees, contractors, or consultants engaged in the
development of the Product that relates solely to the Biologic and which arises
from or relates to the development of the Product.

 

"Commission-Free
Practitioner" means
(a) any medical practitioner (e.g., Martin J. Kaplitt, M.D.) who is also a 5% or
greater investor, principal, director, officer, employee, agent or consultant of
Neurologix, or (b) any partner or associate surgeon in medical practice with any
person covered by part (a) of this definition, but with respect to such partner
or associate surgeon, only for such time as they are engaged in a medical
practice with the person covered by part (a) of this definition.

 

"Confidential
Information" means
any information or compilation of information of one of the Parties (the
"disclosing Party") which becomes known to the other Party (the "receiving
Party") in connection with the Development Program that is not generally known
to the public, including trade secrets and know-how, whether disclosed before or
during the Term, excluding information which:

 

(a) was
already in the possession of the receiving Party prior to the receiving Party's
receipt from the disclosing Party (provided that the receiving Party is able to
provide the disclosing Party with reasonable documentary proof thereof and, if
received from a Third Party, that such information was acquired without any
Party's breach of a confidentiality or non-disclosure obligation to the
disclosing Party related to such information);

 

(b) is or
becomes part of the public domain by reason of acts not attributable to the
receiving Party;

 

(c) is or
becomes available to the receiving Party from a source other than the disclosing
Party which source has rightfully obtained such information and has no
obligation of non-disclosure or confidentiality (directly or indirectly) to the
disclosing Party with respect thereto; or

 

(d) has been
independently developed by the receiving Party without breach of this Agreement
or use of any Confidential Information of the disclosing Party (provided that
the receiving Party is able to provide the disclosing Party with reasonable
documentary proof thereof).

 

 







2












 

Confidential
Information includes any information that by reason of its nature, source, use,
or other sensitivity ought reasonably to be understood to be confidential or
proprietary. All information identified as being "confidential," "trade secret"
or labeled with words of similar import shall be presumed to be Confidential
Information. Confidential Information includes information being held in
confidence by a disclosing Party for the benefit of a Third Party. The Parties
agree that the terms of this Agreement shall be considered Confidential
Information.

 

"Control" or
"Controlled" means
the ability of a Party to grant access to an Invention, or a license or
sublicense under Intellectual Property Rights, without violating the terms of
any agreement or other arrangement with any Third Party existing at the time
such Party would be required hereunder to grant the other Party such access or
license or sublicense.

 

[CONFIDENTIAL]

 

"Development
Program" means
the activities of each Party and the effort by Medtronic to design and develop a
Product in accordance with the Work Plan and the terms and conditions of this
Agreement.

 

"Device" means
any Product that, in the country of its sale, is covered by a Valid Claim of any
patent that is included within Patent Rights Controlled by Medtronic or
Neurologix or any of their Affiliates, where such Valid Claim: (i) arose from
Medtronic activities under the Development Program, or (ii) incorporates any
Product-Related Intellectual Property that is transferred to Medtronic by
Neurologix under the terms of this Agreement and that is the subject of written
documentation existing as of the Effective Date and provided by Neurologix to
Medtronic prior to or within sixty (60) days after the Effective
Date.

 

"Effective
Date" means
the date that appears in the introductory paragraph of this
Agreement.

 

"Expired" means,
with respect to a particular patent, the patent's expiration, abandonment,
cancellation, disclaimer, award to a Third Party other than a licensor of a
Party or its Affiliates in an interference proceeding, or declaration of
invalidity or unenforceability by a court or other authority of competent
jurisdiction (including final rejection in a re-examination or re-issue
proceeding).

 

"FDA" means
the United States Food and Drug Administration.

 

"Force
Majeure" means
any event or condition, not existing as of the Effective Date, not reasonably
within the control of either Party, which prevents in whole or in material part
the performance by one of the Parties of its obligations hereunder, such as an
act of government, war or related actions, terrorism, civil insurrection, riot,
sabotage, and similar events.

 

 







3












 

"Fully
Allocated Cost of Goods" with
respect to Products supplied to Neurologix by Medtronic for use in clinical and
preclinical trials means (a) the variable costs and fixed costs incurred by
Medtronic associated with the manufacture (inclusive of finishing processes
including filling, packaging, labeling and/or other preparation) quality
assurance, quality control and other testing, storage and shipping of batches of
such Products or (b) if components of Products are not manufactured by
Medtronic, the amounts paid to the vendor plus costs associated with acquisition
from such vendor. For purposes of this definition, "variable costs" means the
cost of labor, raw materials, scrap, obsolescence, supplies and other resources
directly consumed in the manufacture, quality assurance, quality control and
other testing, storage and shipping of batches of such Products. For purposes of
this definition, "fixed costs" means the cost of facilities, utilities,
insurance (including any product liability insurance or accrual for
self-insurance), facility and equipment depreciation and other fixed costs
directly related to the manufacture, quality assurance, quality control and
other testing, storage and shipping of batches of such Product, as well as
amounts paid to Third Parties under an agreement with a Third Party as a result
of the manufacture, use or sale of such Products. Fixed costs shall be allocated
to such Product based upon the proportion of such costs directly attributable to
support of the manufacturing, quality assurance, quality control and other
testing, storage and shipping processes for such Product. If a facility is used
to manufacture Products and has the capacity to manufacture products for other
programs of Medtronic, fixed costs shall be allocated in proportion to the
actual use of such facility for the manufacture of Products and the capacity to
manufacture products for such other programs. For the avoidance of doubt: (i) no
idle capacity of a manufacturing facility, or a proportionate use thereof, shall
be included in Fully Allocated Cost of Goods except, in the case of a facility
dedicated solely to the manufacture of Products, and (ii) none of the
development costs and expenses actually paid for pursuant to Section 4.2 shall
be included in Fully Allocated Cost of Goods. Except as otherwise provided in
this Agreement, all cost determinations made hereunder shall be made in
accordance with GAAP.

 

"GAAP" means
the then-current United States generally accepted accounting principles,
consistently applied.

 

[CONFIDENTIAL]

 

"GAD
Gene" means a
nucleotide sequence that encodes a GAD.

 

"Intellectual
Property" means
all forms of legally protected intellectual property (excluding trademarks) in
any jurisdiction and under any law, whether now or hereafter existing,
including: (a) Patent Rights; (b) Know-How; (c) Inventions; (d) copyrights,
whether or not registered, and any non-registered copyright to any writings and
other copyrightable works of authorship, including source code, object code,
documentation (whether or not released), and databases; (e) integrated circuit
topographies and mask works; (f) moral rights; (g) features of shape,
configuration, pattern or ornament; and (h) registrations of, and applications
to register, any of the foregoing with any governmental entity and any renewals
or extensions thereof and all other rights to any of the foregoing.

 

"Invention" means
any idea, invention, discovery, know-how, data, information, improvement,
technology, process or concept, whether or not patentable, copyrightable or
protectable as a trade secret, and whether or not reduced to practice or
memorialized in writing.

 

"Jointly
Owned Intellectual Property" means
Uncategorized Intellectual Property conceived or created jointly by employees,
consultants or contractors of Neurologix and Medtronic whether or not in
conjunction with employees, consultants or contractors of one or more Third
Parties, during the course of, and in furtherance of, the Development
Program.

 

 







4












 

"Know-How" means
trade secrets and other confidential or non-public business information,
including ideas, formulas, compositions, inventor's notes, discoveries,
improvements, concepts, know-how, manufacturing and production processes and
techniques, testing information, research and development information, data
resulting or derived form research activities, inventions, invention
disclosures, unpatented blue prints, drawings, specifications, designs, plans,
proposals and technical data, business and marketing plans, market surveys,
market know-how and customer lists and related information.

 

"Medtronic
Uncategorized Intellectual Property" means
Uncategorized Intellectual Property that is solely conceived or created by
Medtronic employees or for Medtronic by consultants or contractors.

 

"Net
Sales" means
gross invoiced sales by Medtronic or its Affiliates, or Neurologix or its
Affiliates, as the case may be, less:

 


	 	
      (a)
	
      non-commercial
      sales, such as transactions among Affiliates of either Party, or sales for
      pre-clinical or clinical trials or other
testing;




 


	 	
      (b)
	
      sales
      by Medtronic to Commission-Free Practitioners or hospitals or clinics at
      which a Commission-Free Practitioner has privileges to implant
      Devices;




 


	 	
      (c)
	
      sales,
      use, value added, occupation or excise taxes, and other taxes based or
      imposed on the transfer of a product from one party to another or the
      provision of a service;




 


	 	
      (d)
	
      freight,
      duty or insurance; and




 


	 	
      (e)
	
      rebates,
      refunds, exchanges, discounts and allowances and credits for the foregoing
      and net of amounts written off by either of Medtronic or Neurologix as
      uncollectible.




 

"Neurologix
Uncategorized Intellectual Property" means
Uncategorized Intellectual Property that is solely conceived or created by
Neurologix employees or for Neurologix by consultants or
contractors.

 

"Patent
Rights" means
all patent applications, patents (including letters patent, industrial designs,
design patents, and inventor's certificates), design registrations, invention
disclosures, and applications to register industrial designs, and any and all
rights to any of the foregoing anywhere in the world, including any
provisionals, substitutions, extensions, supplementary patent certificates,
reissues, re-exams, renewals, divisions, continuations, continuations in part,
continued prosecution applications, term extensions (under applicable patent law
or regulation or other government law or regulation), and other similar filings
or notices provided for under the laws of the United States, or of any other
country.

 

"PD
Application" means
Parkinson's Disease therapy.

 

 







5












 

"Person" means
any individual, partnership, joint venture, corporation, trust, unincorporated
organization or government or any department or agency thereof.

 

"Phase
III Clinical Trial" means a
controlled study to confirm with statistical significance the efficacy and
safety of the Biologic performed to obtain FDA Regulatory Approval.

 

"Product" means a
Delivery System developed by Medtronic pursuant to the Development
Program.

 

"Product-Related
Confidential Information" means
Confidential Information related solely to the Product and its design, use and
manufacture.

 

"Product-Related
Intellectual Property" means
Intellectual Property (i) conceived or created by or for Neurologix and
Controlled by Neurologix prior to the Effective Date that relates solely to the
Product or methods of use or manufacture thereof and (ii) conceived or created
by or for either Party during the period commencing on the Effective Date and
ending upon FDA Regulatory Approval of the Product that relates solely to the
Product or methods of use or manufacture thereof and that arises from or relates
to development of the Product.

 

"Proposed
Transaction"
means:

 

(a) a bona
fide offer, letter of intent, term sheet or similar proposal submitted to, and
not rejected by, Neurologix by a Person other than Medtronic or an Affiliate of
Medtronic regarding any distribution or commercialization of any gene therapy
for any PD Application or TLE Application; or

 

(b) the
determination by Neurologix that it wishes to explore the possibility of
entering into an agreement or the like pertaining to any distribution or
commercialization of any gene therapy for any PD Application or TLE Application
(including, without limitation, a determination to seek indications of interest
with respect to such a transaction).

 

"Regulatory
Approval" means
the approval of the applicable Regulatory Authority necessary for the marketing
and sale of a Product for a particular indication in a country, excluding
separate pricing and/or reimbursement approvals that may be
required.

 

"Regulatory
Authority" means a
federal, national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity with authority over the testing,
manufacture, use, storage, import, promotion, marketing or sale of a Product in
a country or territory.

 

"Stock
Purchase Agreement" means
the Stock Purchase agreement between Neurologix and Medtronic of even date
herewith.

 

"Third
Party" means
any Person other than Medtronic and its Affiliates and Neurologix and its
Affiliates.

 

"TLE
Application" means
temporal lobe epilepsy therapy.

 

 







6












 

"Uncategorized
Intellectual Property" means
Intellectual Property created or conceived by employees, consultants, or
contractors of Medtronic or Neurologix arising out of Development Program
activities relating to the development of the Product that cannot reasonably be
categorized either: (i) as Biologic-Related Program Intellectual Property or
Biologic-Related Neurologix Intellectual Property, or (ii) as Product-Related
Intellectual Property.

 

"Unexpired" means a
patent that has not Expired.

 

"Valid
Claim" means a
claim of an issued, Unexpired patent, which has not been: (i) held invalid,
unpatentable or unenforceable by a final decision, which was not appealed or is
unappealable, of a court of competent jurisdiction, an administrative agency
having authority over patents, or (ii) admitted to be invalid, unpatentable or
unenforceable by the holder by reissue, disclaimer or otherwise.

 

"Work
Plan" means a
work plan describing the activities to be undertaken during the Development
Program, as adopted, updated or amended pursuant to Section 2.1 with respect to
PD Application, or as adopted, updated or amended pursuant to Section 2.2 with
respect to TLE Application.

 

Definitional
Provisions.

 

(a) The words
"hereof," "herein," and "hereunder" and words of similar import, when used in
this Agreement, shall refer to this Agreement as a whole and not to any
particular provisions of this Agreement.

 

(b) Terms
defined in the singular shall have a comparable meaning when used in the plural,
and vice versa.

 

(c) References
to an "Exhibit" or to a "Schedule" are, unless otherwise specified, to one of
the Exhibits or Schedules attached to or referenced in this Agreement, and
references to an "Article" or a "Section" are, unless otherwise specified, to
one of the Articles or Sections of this Agreement.

 

(d) The term
"person" includes any individual, partnership, joint venture, corporation,
trust, unincorporated organization or government or any department or agency
thereof.

 

Other
Terms. Each of
the following terms shall have the respective meaning ascribed to such term in
the Section of this Agreement set forth opposite such term below:




	
      Definition
	
      Section

	
      "Actions"
	
      5.7.2

	
      "Agreement"
	
      Preamble

	
      "Clinical
      Trials"
	
      2.5.1

	
      "Corporate
      Event"
	
      11.1

	
      "Effective
      Date"
	
      Preamble

	
      "Enforcement
      Action"
	
      5.3.2.3

	
      "Indemnifiable
      Losses"
	
      9.1.1

	
      "Infringement
      Notice"
	
      5.3.2.3

	
      "Invalidity
      Claim"
	
      5.7.3

	
      "Licensed
      Product"
	
      5.6.4

	
      "Losses"
	
      5.6.5.1

	
      "Medtronic"
	
      Preamble

	
      "Negotiation
      Period"
	
      3.2.3

	
      "Neurologix"
	
      Preamble

	
      "PD
      Application Work Plan"
	
      2.1

	
      "Term"
	
      8.1

	
      "Third
      Party Infringement Claim"
	
      5.7.1

	
      "TLE
      Application Work Plan"
	
      2.2

	
      "Transaction
      Notice"
	
      3.2.2







 

 







7












 

ARTICLE
2

 

DEVELOPMENT
OF PRODUCT

 

2.1 Work
Plan.   As soon
as practicable after the Effective Date, Medtronic will provide a Work Plan in
substantial accordance with the terms set forth in Exhibit
A
("PD
Application Work Plan") and
any updates or amendments thereto to Neurologix, and Neurologix will have two
(2) weeks from its receipt thereof to propose written modifications to the PD
Application Work Plan or to accept the PD Application Work Plan. In the event
Neurologix proposes modifications to Medtronic's proposed PD Application Work
Plan, the Parties agree to negotiate in good faith the final provisions. The PD
Application Work Plan shall be approved when signed by both Parties. If within
one month of the delivery of the PD Application Work Plan to Neurologix or at
the end of the ninety (90) day period following the Effective Date, whichever is
later, the Parties have failed to reach agreement on the Work Plan, the Parties
agree that the issues that remain in dispute will be resolved in accordance with
the issue resolution procedures set forth in Section 2.6. Reasonably promptly
following approval of the Work Plan by both Parties, Medtronic shall commence
the specific Development Program activities for PD Application in accordance
with the Work Plan. Medtronic may reasonably update or amend the PD Application
Work Plan upon providing Neurologix at least fifteen (15) days prior written
notice.

 

2.2 [CONFIDENTIAL]

 

2.3 Assistance.
Due to the relationship between the Biologic and the Product, Medtronic may
freely request reasonable technical assistance of Neurologix for its Development
Program activities and Neurologix shall cooperate to obtain and provide such
assistance in a timely manner at its own expense.

 

2.4 Subcontractors. 
Medtronic
may subcontract or delegate to a Third Party sub-components of work associated
with the Development Program.

 

 







8












 

2.5 Regulatory
Approvals.

 

2.5.1 Unless
otherwise specified in the Work Plan, Neurologix shall be responsible at its
sole cost for obtaining all necessary regulatory approvals for the commercial
sale of the Biologic with reference to the Product for the PD Application and
TLE Application, including the preparation of the clinical study protocols,
selection of investigational sites, preparation of the investigator's brochures,
instruction and training of clinical investigators, monitoring the performance
of clinical trials, data collection and analysis, reporting of adverse events,
preparation and prosecution of regulatory submissions, and post approval
clinical studies ("Clinical
Trials").
Medtronic shall: (i) allow Neurologix to access and cross reference necessary
regulatory filings related to the Biologic and Product, and (ii) provide other
assistance to Neurologix, in each of the foregoing cases (i) and (ii) as may be
reasonably necessary to gain approval of the Biologic with reference to the
Product.

 

2.5.2 Notwithstanding
the foregoing, Medtronic shall be responsible at its sole cost for obtaining all
necessary Regulatory Approvals for the commercial sale of the Product without
reference to the Biologic, if a decision is made in Medtronic's sole discretion
to seek such regulatory approval, including the preparation of the clinical
study protocols, selection of investigational sites, preparation of the
investigator's brochures, instruction and training of clinical investigators,
monitoring the performance of clinical trials, data collection and analysis,
reporting of adverse events, preparation and prosecution of regulatory
submissions, and post approval clinical studies. Neurologix shall: (i) allow
Medtronic to access and cross reference necessary regulatory filings related to
the Biologic and Product, and (ii) provide other assistance to Medtronic, in
each of the foregoing cases (i) and (ii) as may be reasonably necessary to gain
approval of the Product.

 

2.6 Issue
Resolution.  Any issue
in dispute between the Parties related to provisions of or performance of work
under a Work Plan, which has not been resolved by good faith negotiation of the
Parties during the time period specified, the Parties agree that the respective
project manager level employees of Medtronic and Neurologix responsible for the
technical group most directly impacted by resolution of the issues in dispute
will meet and engage in good faith negotiations to resolve the dispute. In the
event that the project managers fail to reach an agreement within five (5)
business days of written submission to them, the Parties agree that the disputed
issues shall be submitted to the General Managers of the respective businesses
who shall meet and negotiate in good faith. In the absence of any agreement
between the Parties with respect to the approval of a Work Plan, either Party
may terminate the Agreement pursuant to 8.2.5. Without limiting the foregoing,
the Parties agree that participation in the issue resolution process set forth
in this Section shall not be construed as a waiver of either Party's rights or
remedies at law and equity.

 

 

ARTICLE
3

 

SUPPLY

 

3.1 Clinical
Trials for Biologic.  [CONFIDENTIAL].
Upon completion of the design and manufacturing qualifications and
specifications for the Product as set forth in the PD Application Work Plan and
satisfaction of appropriate regulatory requirements (e.g., Investigational
Device Exemption), Medtronic shall manufacture and supply in accordance with
such design and manufacturing specifications, sufficient quantities of the
Product to enable Neurologix to perform Clinical Trials necessary for Regulatory
Approval at the Fully Allocated Cost of Goods of Products so manufactured and
supplied.

 

 







9












 

3.2 Right
of First Offer.

 

3.2.1 Neurologix
shall not proceed with any Proposed Transaction without first giving the
Transaction Notice (as defined below) to Medtronic with respect thereto and
complying with the terms of this Section.

 

3.2.2 Within
ten (10) days after receipt of an offer or a determination referenced in the
definition of a Proposed Transaction, Neurologix shall deliver to Medtronic
written notice of such offer or such determination (the "Transaction
Notice"). The
Transaction Notice shall set forth, as applicable, the name of the offeror and
the material terms and provisions of such offer or, in the case of a
determination, the material terms and provisions upon which Neurologix would be
willing to enter into any such transaction.

 

3.2.3 During
the sixty (60) days following Medtronic's receipt of the Transaction Notice with
respect to any Proposed Transaction (the "Negotiation
Period"),
Neurologix shall negotiate in good faith exclusively with and provide
information exclusively to Medtronic regarding the terms for entering into the
Proposed Transaction with Medtronic. During the Negotiation Period, Neurologix
shall not solicit offers from, negotiate with, provide information to or enter
into any agreement with any Third Party regarding the Proposed Transaction.
Without limiting the generality of the foregoing, during the Negotiation Period,
Neurologix may not take any action to impair Neurologix's ability to consummate
a Proposed Transaction with Medtronic.

 

3.2.4 If
Medtronic and Neurologix fail to reach a mutual agreement upon the terms and
provisions of a Proposed Transaction during the Negotiation Period, then
Neurologix shall have one hundred twenty (120) days from the expiration of the
Negotiation Period in which to negotiate and enter into definitive agreements
for the Proposed Transaction with the Person whose bona fide offer was described
in Neurologix Transaction Notice (with respect to a Proposed Transaction offer)
or with any Third Party (with respect to a Proposed Transaction determination);
provided, that
Neurologix shall not enter into any such definitive agreements unless
Neurologix's board of directors has determined conclusively in good faith that
the terms and conditions of such definitive agreements are (i) more favorable to
Neurologix than the terms and conditions, if any, proposed by Medtronic during
the Negotiation Period and (ii) no less favorable to Neurologix than the terms
and conditions set forth in the Transaction Notice. If Neurologix fails to enter
into such definitive agreements with respect to such Proposed Transaction within
such 120-day period, then Medtronic's rights under this Section shall be
reinstated and Neurologix shall not enter into such Proposed Transaction without
first giving Medtronic a new Transaction Notice and complying with the terms of
this Section.

 

 







10












 

ARTICLE
4

 

FINANCIAL
PROVISIONS

 

4.1 Equity
Investments.  The
Parties shall enter into a Stock Purchase Agreement simultaneously with, and as
a condition to, entering into this Agreement, Medtronic and Neurologix pursuant
to which Medtronic will make an equity investment in Neurologix.

 

4.2 Development
Costs.  Subject
to Section 2.2, Neurologix shall make payments to Medtronic totaling eight
hundred fifty thousand dollars ($850,000) for the development of the Product.
[CONFIDENTIAL].

 

4.3 Revenue
Sharing.  In
consideration of Neurologix payments under Section 4.2 and its use of
Medtronic's Delivery Systems in clinical trials, following Regulatory Approval
of the Device by Medtronic, Medtronic shall pay to Neurologix a commission of
[CONFIDENTIAL] of its and its Affiliates' Net Sales of Devices, subject to an
aggregate cap [CONFIDENTIAL]. Upon payment by Medtronic pursuant to this Section
4.3 of a cumulative [CONFIDENTIAL], no further payments of any kind shall be due
to Neurologix relating to the sale or commercialization of any
Product.

 

4.3.1 Revenue
Payable Only Once.
Medtronic's obligation to share revenue under Section 4.3 is imposed only once
with respect to the same unit of Devices, including by reason of such Device
being covered by more than one Valid Claim of a patent with Patent Rights
Controlled by Medtronic or Neurologix.

 

4.3.2 System
or Kit Sales. For
Devices sold as part of a system or kit for a total system or kit price, the
commission will be paid on the average sales price of the Device (rather than
the entire system or kit) for the country (or comparable country) in which the
sale took place. If the Device is not sold separately in that country (or
comparable country), the commission will be based on an allocated percentage of
the system or kit's manufacturing cost. As used herein "average sales price"
means Net Sales in the relevant country of a product model divided by the
corresponding number of units, as calculated for each Medtronic fiscal year, in
good faith by Medtronic in the ordinary course of business.

 

4.3.3 Adjustments
to Revenue-Sharing.

 

4.3.3.1 Credits
Against Future Payments. If the
validity of a Valid Claim of an issued patent is the subject of administrative
or legal action and is later revoked or held unenforceable or invalid by a
decision of a court or governmental agency of competent jurisdiction or is
disclaimed or admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise, and such claim was the sole basis for a payment by
Medtronic pursuant to Section 4.3, Medtronic shall be entitled to credit the
amount of such payment, from the date such claim became the subject of such
action to the date of the final unappealable decision, against any future
payments to be made with respect to the commercialization of the Device. If such
claim is the last claim of any Patent Right upon which a payment would be owed,
Medtronic shall be entitled, from the date any action challenging the validity
or unenforceability of such claim until the final decision, to escrow payments
due to Neurologix under this Section 4.3 and if such claim is declared invalid
or unenforceable retain such payments.

 

 







11












 

4.3.3.2 Title
Claims. If any
Third Party with which an employee, consultant or contractor of Neurologix is or
was affiliated alleges that it has ownership rights in any Product-Related
Intellectual Property assigned to Medtronic pursuant to this Agreement: (i)
Neurologix, in its discretion, shall have the first right to respond to, settle
or otherwise resolve such allegation for a period of one hundred twenty (120)
days after receiving notice of such allegation and (ii) if Neurologix is unable
to settle or otherwise resolve such allegation within such one hundred twenty
(120) day period, Medtronic shall be entitled, in its discretion, to respond to,
settle, or defend against such allegation. Neurologix agrees to cooperate with
Medtronic. Furthermore, Medtronic shall have the right, without limiting any of
its other rights or remedies, to set off against any amounts which are then owed
or thereafter become owed by Medtronic to Neurologix any damages, liabilities,
interest and penalties, costs and expenses (including, without limitation,
reasonable legal fees and disbursements incurred in connection therewith) and
any amounts or expenses required to be paid by Medtronic resulting from such
allegation.

 

4.3.4 Reports;
Payments.
Medtronic shall, within sixty (60) days after the end of each quarter of
Medtronic's fiscal year following the first commercial sale of a Device by
Medtronic, deliver to Neurologix a reasonably detailed written accountings of
Net Sales of Devices that are subject to payments under Section 4.3 due to
Neurologix for such quarter, and deliver all payments due under Section 4.3 to
Neurologix for the preceding quarter of Medtronic's fiscal year. As used herein,
"fiscal year" means the fiscal year used by Medtronic in the ordinary course of
business, which, as of the Effective Date, ends on the last Friday of April.
Such accountings shall be Confidential Information of Medtronic unless otherwise
excluded. Such annual reports shall indicate (i) Net Sales on a
country-by-country basis, (ii) deductions taken in calculating Net Sales and
(iii) the calculation of payments from such Net Sales.

 

4.3.5 Audits.
Medtronic shall keep, and shall require its Affiliates to keep, complete and
accurate records of the latest three (3) years relating to Net Sales. For the
sole purpose of verifying amounts payable to Neurologix, Neurologix shall have
the right annually to retain an independent certified public accountant selected
by Neurologix and reasonably acceptable to Medtronic, to review such records in
the location(s) where such records are maintained by Medtronic or its Affiliates
upon reasonable notice and during regular business hours. Such representatives
shall execute a suitable confidentiality agreement reasonably acceptable to
Medtronic prior to conducting such audit. Such representatives shall disclose to
Neurologix only their conclusions regarding the accuracy of payments and of
records related thereto. The right to audit any report shall extend for three
(3) years from the end of the calendar year in which the report was delivered.
Each report shall be subject only to one such audit. Medtronic shall pay to
Neurologix the amount of any underpayment revealed by such audit. Neurologix
will pay for the audit unless it discloses an underpayment of more than seven
percent (7%) from the amount of the payments due under this Agreement for the
period examined, in which event Medtronic will reimburse Neurologix for the
audit.

 

 







12












 

ARTICLE
5

 

INTELLECTUAL
PROPERTY OWNERSHIP,

 

PROTECTION
AND RELATED MATTERS

 

5.1 Ownership
of Inventions.

 

5.1.1 Non-Development
Program Intellectual Property. Any
Intellectual Property conceived, created or developed by Medtronic prior to or
outside the Development Program shall remain the sole property of
Medtronic.

 

5.1.2 Product-Related
Intellectual Property.
Medtronic shall exclusively own all Product-Related Intellectual Property,
including such Product-Related Intellectual Property conceived or created by or
for Neurologix prior to, during, or outside the Development Program, and
Neurologix agrees to assign for no additional consideration, and hereby assigns,
to Medtronic all its right, title and interest in and to all such
Product-Related Intellectual Property. After the Effective Date, Medtronic shall
be solely responsible at its sole cost and in its sole discretion for the
preparing, filing, prosecution and maintenance of Patent Rights within
Product-Related Intellectual Property.

 

5.1.3 Biologic-Related
Program Intellectual Property.
Neurologix shall exclusively own all Biologic-Related Neurologix Intellectual
Property and Biologic-Related Program Intellectual Property, and Medtronic
agrees to assign, without any additional consideration, and hereby assigns, to
Neurologix all of Medtronic's right, title and interest in and to all
Biologic-Related Program Intellectual Property. After the Effective Date,
Neurologix shall be solely responsible at its sole cost and in its sole
discretion for the preparing, filing, prosecution and maintenance of Patent
Rights within Biologic-Related Program Intellectual Property or Biologic-Related
Neurologix Intellectual Property.

 

5.1.4 Medtronic
Uncategorized Intellectual Property.
Medtronic shall exclusively own all Medtronic Uncategorized Intellectual
Property and shall be solely responsible at its sole cost and in its sole
discretion for the preparing, filing, prosecution and maintenance of Patent
Rights within Medtronic Uncategorized Intellectual Property.

 

5.1.5 Neurologix
Uncategorized Intellectual Property.
Neurologix shall exclusively own all Neurologix Uncategorized Intellectual
Property and shall be solely responsible at its sole cost and in its sole
discretion for the preparing, filing, prosecution and maintenance of Patent
Rights within Neurologix Uncategorized Intellectual Property.

 

5.1.6 Jointly
Owned Intellectual Property.
Neurologix and Medtronic shall jointly own all right, title and interest in and
to any Jointly Owned Intellectual Property. Notwithstanding the previous
sentence, Medtronic shall be solely responsible for the preparing, filing,
prosecution and maintenance of Patent Rights arising from Jointly Owned
Intellectual Property. Neurologix at its option will reimburse Medtronic for
fifty percent (50%) of all costs incurred by Medtronic as a result of the
preparation, filing, prosecution and maintenance of such Patent Rights;
provided, however, that if Neurologix does not pay such share of costs with
respect to a particular patent application or patent that is included in the
Jointly Owned Intellectual Property with respect to a particular country,
Neurologix will, upon written notice from Medtronic, assign to Medtronic all of
Neurologix's right, title and interest in and to such patent application or
patent with respect to such country to Medtronic. The Parties acknowledge and
agree that any such patent application and any resulting patents will be
included in the Medtronic Uncategorized Intellectual Property, including, but
not limited to, for the purposes of Section 5.6.1 below.

 

 







13












 

5.1.7 Data
Ownership; Right of Reference and Other Use. All
preclinical and clinical data generated with respect to the Product and Biologic
in the course of the Development Program shall be jointly owned by the Parties
and the Parties shall have equal access to such data ("Jointly-Owned Data").
Each Party shall be entitled to access, reference, disclose to investors,
lendors, acquirors, licensees, contractors and prospective investors, lendors,
acquirors, licensees and contractors, and otherwise use all Jointly-Owned Data
without the other Party's consent and without any duty to account to the other
Party for such access, reference disclosure and other use. Notwithstanding
anything to the contrary, for a period of five (5) years following creation of
any Jointly-Owned Data: (i) Medtronic may not, without the prior, written
consent of Neurologix, disclose Jointly-Owned Data relating solely to the
Biologic except: (a) to the extent necessary to obtain Regulatory Approval for
the Product or (b) by making generalized references to matters included in such
Jointly-Owned Data in connection with the commercialization of the Product, and
(ii) Neurologix may not, without the prior, written consent of Medtronic,
disclose Jointly-Owned Data relating solely to the Product except: (a) to the
extent necessary to obtain Regulatory Approval for the Biologic with reference
to the Product or (b) by making generalized references to matters included in
such Jointly-Owned Data in connection with the commercialization of the
Biologic.

 

5.1.8 Further
Actions and Assignments. Each
Party shall take all further actions and execute all assignments requested by
the other Party and reasonably necessary or desirable to vest in the other Party
the ownership rights set forth in this Section 5.1. Neurologix agrees to assign
its rights to Medtronic in Product-Related Intellectual Property and to obtain
assignments from Neurologix's employees, consultants and contractors of their
rights in Product-Related Intellectual Property in substantially the form
attached hereto as Exhibit B.

 

5.2 Cooperation. 
Each of
Medtronic and Neurologix shall make available to the other (or to the other's
authorized attorneys, agents or representatives) its employees, agents or
consultants to the extent necessary or appropriate to enable the appropriate
Party to file, prosecute and maintain patent applications and resulting patents
with respect to Inventions owned by a Party and for periods of time sufficient
for such Party to obtain the assistance it needs from such
personnel.

 

5.3 Third
Party Infringement.

 

5.3.1 Notice. Each
Party shall promptly report in writing to the other Party during the term of
this Agreement any (i) known or suspected infringement of Product Related
Intellectual Property, Biologic-Related Program Intellectual Property or Jointly
Owned Intellectual Property; and (ii) known or suspected unauthorized use or
misappropriation of Product-Related Intellectual Property, Biologic-Related
Program Intellectual Property or Jointly Owned Intellectual Property related to
the unauthorized manufacture, use, offer for sale, sale or importation of the
Product in the PD Application or TLE Application, of which such Party becomes
aware, and shall provide the other Party with all available evidence supporting
such infringement, suspected infringement, unauthorized use or misappropriation
or suspected unauthorized use or misappropriation.

 

 







14












 

5.3.2 Infringement
Action.

 

5.3.2.1 Neurologix
shall have the sole and exclusive right, but not the obligation, to initiate a
suit or take other appropriate action that it believes is required to protect
the Biologic-Related Program Intellectual Property. To the extent that any such
suit or actions pertains to Products, Neurologix shall give Medtronic advance
notice of its intent to file any such suit or take any such action and the
reasons therefor, and shall provide Medtronic with an opportunity to make
suggestions and comments regarding such suit or action. Thereafter, Neurologix
shall keep Medtronic promptly informed, and shall from time to time consult with
Medtronic regarding the status of any such suit or action and shall provide
Medtronic with copies of all material documents (e.g., complaints, answers,
counterclaims, material motions, orders of the court, memoranda of law and legal
briefs, interrogatory responses, depositions, material pre-trial filings, expert
reports, affidavits filed in court, transcripts of hearings and trial testimony,
trial exhibits and notices of appeal) filed in, or otherwise relating to, such
suit or action. For the avoidance of doubt, Medtronic shall have no right to
enforce any solely owned intellectual property rights of
Neurologix.

 

5.3.2.2 Medtronic
shall have the sole and exclusive right, but not the obligation, to initiate a
suit or take other appropriate action that it believes is required to protect
Product-Related Intellectual Property. To the extent that any such suit or
actions pertains to Biologics, Medtronic shall give Neurologix advance notice of
its intent to file any such suit or take any such action and the reasons
therefor, and shall provide Neurologix with an opportunity to make suggestions
and comments regarding such suit or action. Thereafter, Medtronic shall keep
Neurologix promptly informed, and shall from time to time consult with
Neurologix regarding the status of any such suit or action and shall provide
Neurologix with copies of all material documents (e.g., complaints, answers,
counterclaims, material motions, orders of the court, memoranda of law and legal
briefs, interrogatory responses, depositions, material pre-trial filings, expert
reports, affidavits filed in court, transcripts of hearings and trial testimony,
trial exhibits and notices of appeal) filed in, or otherwise relating to, such
suit or action. For the avoidance of doubt, Neurologix shall have no right to
enforce any solely owned intellectual property rights of Medtronic.

 

5.3.2.3 Each
Party will as promptly as practicable notify the other in writing upon learning
of any infringement of any patent or other Intellectual Property included in the
Jointly Owned Intellectual Property (the "Infringement Notice"). Medtronic shall
have the initial right to initiate a suit or take other appropriate action that
it believes is reasonably required to protect Jointly Owned Intellectual
Property (an "Enforcement
Action"). If
within one hundred twenty (120) days after receiving the applicable Infringement
Notice from Neurologix, Medtronic does not either persuade the alleged infringer
to desist its alleged infringing activity or commence an Enforcement Action,
Neurologic will have the right to commence, prosecute and control an Enforcement
Action, but only against an alleged infringer that is making or selling a
biologic related to the alleged infringement.

 

 







15












 

5.3.3 Conduct
of Action; Costs. The
Party initiating suit shall have the sole and exclusive right to select counsel
for any suit initiated by it under this Section 5.3. If required under
applicable law in order for such Party to initiate and/or maintain such suit,
the other Party shall join as a party to the suit. If requested by the Party
initiating suit, the other Party shall provide reasonable assistance to the
Party initiating suit in connection therewith at no charge to such Party except
for reimbursement of reasonable out-of-pocket expenses incurred in rendering
such assistance. The Party initiating suit shall assume and pay all of its own
out-of-pocket costs incurred in connection with any litigation or proceedings
described in this Section 5.3, including the fees and expenses of the counsel
selected by it. The other Party shall have the right to participate and be
represented in any such suit by its own counsel at its own expense.

 

5.3.4 Recoveries. To the
extent that any such suit or action pertains to Biologics or Products, any
recovery obtained as a result of any proceeding described in this Section 5.3 or
from any counterclaim or similar claim asserted in a proceeding described in
Section 5.4, by settlement or otherwise, shall be applied in the following order
of priority:

 

(i) first,
the Party initiating the suit or action shall be reimbursed for all costs in
connection with such proceeding paid by such Party;

 

(ii) second,
the other Party shall be reimbursed for all costs in connection with such
proceeding paid by the other Party; and

 

(iii) third,
any remainder shall be paid one hundred percent (100%) to the Party initiating
the suit or action.

 

5.4 Claimed
Infringement; Claimed Invalidity.

 

5.4.1 Notice. In the
event that a Third Party at any time provides written notice of a claim to, or
brings an action, suit or proceeding against a Party, or any of its Affiliates
or sublicensees, claiming infringement of such Third Party's Patent Rights or
unauthorized use or misappropriation of such Third Party's Know-How, based upon
an assertion or claim arising out of the research, development, manufacture, use
or sale of Products or Biologics for the PD Application or the TLE Application
by such Party (a "Third
Party Infringement Claim"), such
Party shall promptly notify the other Party of the claim or the commencement of
such action, suit or proceeding, enclosing a copy of the claim and/or all papers
served.

 

 







16












 

5.4.2 Defense
of Third Party Infringement Claims. If the
manufacture, production, sale or use of any Product or Biologic for the PD
Application or the TLE Application pursuant to this Agreement results in a
claim, suit or proceeding (collectively, "Actions")
alleging infringement of an intellectual property right of a Third Party against
Medtronic or Neurologix (or their respective Affiliates), such Party shall
promptly notify the other Parties hereto in writing, and the Party or Parties
against whom the Action is brought shall defend and control the defense of such
Action. Except as agreed in writing by Medtronic and Neurologix, neither Party
shall enter into any settlement relating to a Product or Biologic, if such
settlement admits the invalidity or unenforceability of any Patent Rights
Controlled by the other Party. Each Party agrees to keep the other Party hereto
reasonably informed of all material developments in connection with any such
Action.

 

5.4.3 Patent
Invalidity Claim. If a
Third Party at any time asserts a claim that any Patent Right of the Neurologix
Product-Related Intellectual Property or Delivery System Related Intellectual
Property or Jointly Owned Intellectual Property covering a Product is invalid or
otherwise unenforceable (an "Invalidity
Claim"),
whether as a defense in an infringement action brought by Medtronic pursuant to
Section 5.4, in a declaratory judgment action or in a Third Party Infringement
Claim brought against Medtronic or Neurologix, the Parties shall cooperate with
each other in preparing and formulating a response to such Invalidity Claim.
Neither Medtronic nor Neurologix shall settle or compromise any Invalidity Claim
involving Patent Rights Controlled by the other Party without the consent of the
other Party. If Medtronic incurs expenses to respond to Invalidity Claims
involving Jointly Owned Intellectual Property Patent Rights and pertaining to
use of a Device for the PD Application or the TLE Application, Medtronic shall
be entitled to deduct fifty percent (50%) of the reasonable and documented
amount of such expenses from the payments that Medtronic pays to Neurologix with
respect to such Device pursuant to Section 4.3.2. For clarity, in no event shall
Neurologix be required to reimburse Medtronic for any such
expenses.

 

5.5 Other
Obligations.

 

5.5.1 Subject
to Section 5.5.2, if Medtronic decides, other than for termination reasons set
forth in Sections 8.2.1, 8.2.2, or 8.2.5, in its sole discretion after
completion of design validation of the Product in accordance with the PD
Application Work Plan that it does not wish to move forward with manufacturing
and supplying Products to Neurologix for preclinical and clinical trials,
Medtronic shall notify Neurologix in writing of its intent. Within thirty (30)
days of Neurologix receipt of such notice from Medtronic, it may request that
Medtronic grant it a license pursuant to Section 5.6.4.

 

5.5.2 [CONFIDENTIAL].

 

 







17












 

5.6 License
Grants.

 

5.6.1 Medtronic
Grant.
Medtronic agrees to grant and hereby grants to Neurologix a non-exclusive,
perpetual, irrevocable, royalty-free, fully paid-up, worldwide license under
Medtronic Uncategorized Intellectual Property to manufacture, have manufactured,
use, sell or have sold, import or have imported and otherwise commercialize
biologics. The foregoing license does not grant any right to manufacture, have
manufactured, use, sell or have sold, import or have imported and otherwise
commercialize devices, such as the Delivery System.

 

5.6.2 Neurologix
Grant.
Neurologix agrees to grant and hereby grants to Medtronic a non-exclusive,
perpetual, irrevocable, royalty-free, fully paid-up, worldwide license under
Neurologix Uncategorized Intellectual Property to manufacture, have
manufactured, use, sell or have sold, import or have imported and otherwise
commercialize products, such as the Delivery System. The foregoing license does
not grant any right to manufacture, have manufactured, use, sell or have sold,
import or have imported and otherwise commercialize biologics, such as the
Biologic.

 

5.6.3 Jointly
Owned Intellectual Property. Each
Party shall have full right to use all Jointly Owned Intellectual Property
without accounting or payment to the other Party. Without the prior written
consent of Neurologix, Medtronic will not grant to any Third Party a license to
manufacture, have manufactured, use, sell or have sold, import or have imported
and otherwise commercialize biologics, such as the Biologic, under such Jointly
Owned Intellectual Property. Without the prior written consent of Medtronic,
Neurologix will not grant to any Third Party a license to manufacture, have
manufactured, use, sell or have sold, import or have imported and otherwise
commercialize devices, such as the Product, under such Jointly Owned
Intellectual Property.

 

5.6.4 License
Grant to Neurologix. If
pursuant to Section 5.5.1 or Section 8.3.4, Medtronic decides not manufacture
Products for Neurologix, Medtronic agrees to grant to Neurologix, at
Neurologix's request, a royalty-bearing, worldwide, nonexclusive license under
Product-Related Intellectual Property. The grant of this license is subject
Neurologix's obtaining product liability insurance for product liability claims
arising from its exercise of such license or the sale of products covered by the
license in accordance with the terms of Section 5.6.5. Medtronic further agrees
that for a three (3) year period following Medtronic's grant of such license,
not to grant any Third Party a license under Product-Related Intellectual
Property for use in the field of delivery of the Biologic, except to Affiliates
of Medtronic or patent licensees of licenses granted as part of resolution of
disputes with Third Parties. Medtronic shall also provide technical assistance
to Neurologix or its designee related to Know-How related to the Product arising
from the Development Program. As consideration for such license and assistance
Neurologix shall pay Medtronic a royalty of: (i) five percent (5%) of its Net
Sales of Products if Medtronic terminates the Agreement or discontinues
manufacturing and supplying Products to Neurologix on or after design validation
as set forth in the Work Plan, (ii) four percent (4%) of its Net Sales of
Products if Medtronic terminates the Agreement or discontinues developing the
Product on or after design verification and/or lot qualification as set forth in
the Work Plan but before design validation, or (iii) three (3%) of its Net Sales
of Products if Medtronic terminates the Agreement or discontinues developing the
Product on or after delivery of a design as set forth in the Work Plan but
before design verification and/or lot qualification, subject to a cumulative cap
of twenty five million dollars ($25,000,000).

 

 







18












 

5.6.4.1 Reports;
Payments.
Neurologix shall, within sixty (60) days after the end of each quarter of
Neurologix's fiscal year following the first commercial sale of a product
covered by the license in Section 5.6.4 (a "Licensed Product") by Neurologix or
its Affiliates, deliver to Medtronic a reasonably detailed written accountings
of Net Sales of Licensed Product that are subject to payments under Section
5.6.4 due to Medtronic for such quarter, and deliver all payments due under
Section 5.6.4 to Medtronic for the preceding quarter of Neurologix's fiscal
year. Such accountings shall be Confidential Information of Neurologix unless
otherwise excluded. Such annual reports shall indicate (i) Net Sales on a
country by-country basis (ii) deductions taken in calculating Net Sales and
(iii) the calculation of payments from such Net Sales.

 

5.6.4.2 Audits.
Neurologix shall keep, and shall require its Affiliates to keep, complete and
accurate records of the latest three (3) years relating to Net Sales. For the
sole purpose of verifying amounts payable to Medtronic, Medtronic shall have the
right annually to retain an independent certified public accountant selected by
Medtronic and reasonably acceptable to Neurologix, to review such records in the
location(s) where such records are maintained by Neurologix or its Affiliates
upon reasonable notice and during regular business hours. Such representatives
shall execute a suitable confidentiality agreement reasonably acceptable to
Neurologix prior to conducting such audit. Such representatives shall disclose
to Medtronic only their conclusions regarding the accuracy of payments and of
records related thereto. The right to audit any report shall extend for three
(3) years from the end of the calendar year in which the report was delivered.
Each report shall be subject only to one such audit. Neurologix shall pay to
Medtronic the amount of any underpayment revealed by such audit. Medtronic will
pay for the audit unless it discloses an underpayment of more than seven percent
(7%) from the amount of the payments due under this Agreement for the period
examined, in which event Neurologix will reimburse Medtronic for the
audit.

 

5.6.5 Indemnification
and Product Liability Insurance.

 

5.6.5.1 Neurologix's
agrees that the grant of the license pursuant to Section 5.6.4 is subject to
Neurologix's indemnification of Medtronic and its Affiliates, and their
respective officers, directors, employees, shareholders, agents and
representatives, from and against and in respect of any and all demands, claims,
actions or causes of action, assessments, losses, damages, liabilities, interest
and penalties, costs and expenses (including, without limitation, reasonable
legal fees and disbursements incurred in connection therewith and in seeking
indemnification therefor, and any amounts or expenses required to be paid or
incurred in connection with any action, suit, proceeding, claim, appeal, demand,
assessment or judgment), to the extent involving a Third Party claim, ("Losses")
resulting from, arising out of, or imposed upon or incurred by any person to be
indemnified hereunder by reason of: (a) manufacture of products covered by
patents within Patent Rights covering Product-Related Intellectual Property; and
(b) personal injury and property damages, and costs and expenses related thereto
that occur during production (i.e. the formulation, fabrication, or
manufacturing) of a Product by or for Neurologix, and (c) any personal injury or
product damage resulting from the failure of a product to meet any specification
or due to a defect in materials or workmanship of such product.

 

 







19












 

5.6.5.2 Neurologix
agrees that prior to its first sale of a product covered by the license grant in
Section 5.6.5, that it shall, at its sole cost and expense, obtain and at all
times during the term of this Agreement maintain products liability insurance
with policy limits equal to the greater of (i) such amounts as ordinary good
business practice for its type of business would make advisable; (ii) such
amount as Neurologix carries for its products, generally; and (iii) Ten Million
Dollars ($10,000,000) per occurrence and One Hundred Million Dollars
($100,000,000) in the aggregate. Such products liability insurance shall name
Medtronic, Inc. as a named insured thereunder, it being understood that
Medtronic shall have the right to seek recovery under said products liability
insurance for any claims for damages, liabilities, costs (including but not
limited to attorneys' fees), settlements or judgments which may be made against
Medtronic on account of bodily injury, property damage, medical expense, or
personal injury to any person caused by or arising from defects in materials,
design, workmanship, or manufacture of products and Medtronic agrees to seek
recovery for any such claims directly from Neurologix's products liability
insurance carrier. Neurologix's products liability insurance coverage shall: (i)
provide for thirty (30) days advance written notice to Medtronic before any
cancellation or modification of such coverage; and (ii) provide that the
coverages will be primary and will not participate with nor be excess over, any
insurance or program of self-insurance carried or maintained by Medtronic; and
(iii) provide that Medtronic's right to payment under such coverage is separate
from and in addition to any right to payment of Neurologix (iv) with respect to
recovery by Medtronic as described above, not be subject to any deductible or
self-insured retention. Neurologix shall obtain and deliver to Medtronic a true
and accurate certificate of insurance setting forth the amount of products
liability insurance maintained by Neurologix prior to its exercise of the
license set forth in Section 5.5.4 and thereafter within thirty (30) days after
the beginning of each twelve (12) month period following Neurologix's acceptance
of a license while products covered by the license are being sold by or on
behalf of Neurologix or its Affiliate.

 

5.7 Maintain
Licenses in Force.  Neurologix
shall promptly notify Medtronic if any Third Party with which Neurologix has
entered into a license agreement material to the manufacture, use or sale of any
Biologic alleges any breach, default, or event that with the passage of time or
giving of notice could become a default, by Neurologix of any such license
agreement. Medtronic shall be entitled, but not obligated, to cure any alleged
breach or default by Neurologix of a payment obligation under any such license
agreement and set-off the cost of such cure against amounts otherwise owed to
Neurologix hereunder. Neurologix agrees that, prior to modifying, waiving,
amending or letting lapse any provision of any such license agreement in a
manner material to any Biologic, Neurologix shall notify Medtronic of such
prospective modification, waiver, amendment or lapse and provide Medtronic with
a reasonable opportunity to provide Neurologix with input regarding such
prospective modification, waiver, amendment or lapse. Neurologix shall use
reasonable efforts, consistent with the exercise of reasonable business
judgment, not to modify, waive, amend or let lapse any such license agreement,
and not to take any action or omit to take any action with respect to any such
license agreement, an effect of which would be to adversely affect Medtronic's
rights or obligations hereunder in any material respect.

 

 







20












 

ARTICLE
6

 

CONFIDENTIALITY

 

6.1 Confidential
Information.  With
respect to any Confidential Information of a Party disclosed by it or its
Affiliates to the other Party, such receiving Party agrees: (a) not to use any
Confidential Information in connection with activities other than those
contemplated by this Agreement, (b) that any Confidential Information shall not
be used in conjunction with any Third Party who is not a consultant of, or an
advisor to, the receiving Party or its Affiliates without the prior written
consent of the disclosing Party, (c) that such Confidential Information shall be
maintained in confidence by the receiving Party and its Affiliates, and (d) that
such Confidential Information shall not be disclosed by the receiving Party or
its Affiliates to any Third Party who is not a consultant of, or an advisor to,
the receiving Party or its Affiliates without the prior written consent of the
disclosing Party. Notwithstanding the foregoing provisions of this Section 6.1,
either Party may disclose Confidential Information of the other Party or the
terms of this Agreement if such Party reasonably determines, based on advice
from its counsel, that it is required to make such disclosure by applicable law,
regulation or legal process, including by the rules or regulations of the United
States Securities and Exchange Commission (the "SEC") or similar regulatory
agency in a country other than the United States or of any stock exchange or
NASDAQ, in which event such Party shall provide prior notice of such intended
disclosure to such other Party sufficiently in advance to enable the other Party
to seek confidential treatment or other protection for the Confidential
Information subject to such requirement unless the disclosing Party is prevented
by law or regulation from providing such advance notice, shall disclose only
such Confidential Information of such other Party as such disclosing Party
reasonably determines is required to be disclosed, and shall seek confidential
treatment of any terms of this Agreement that such other Party considers
particularly sensitive, including the royalty rate terms of this Agreement, from
the SEC, similar regulatory agencies in countries other than the United States,
any stock exchange or NASDAQ.

 

6.2 Disclosures
to Employees, Consultants, Contractors and Advisors. 
Each
Party agrees that it and its Affiliates shall provide Confidential Information
received from the other Party only to the receiving Party's respective
employees, consultants and advisors, and to the employees, consultants and
advisors of the receiving Party's Affiliates, who have a need to know such
Confidential Information to assist the receiving Party in fulfilling its
obligations under this Agreement, provided that each Party shall remain
responsible for any failure by its and its Affiliates' respective employees,
consultants and advisors to treat such information and materials as required
under Section 6.1.

 

 







21












 

6.3 Term. 
All
obligations imposed under this Article 6 shall expire, with respect to any
Confidential Information of the other Party obtained pursuant to this Agreement,
for a period of five (5) years from the date on which such Confidential
Information was disclosed to the receiving Party as a result of disclosure under
this Agreement.

 

6.4 Publications. 
The
Parties agree to use commercially reasonable efforts to control public
scientific disclosures of the results of the Development Program to prevent any
potential adverse effect of any premature public disclosure of such results. The
Parties shall establish a procedure for publication review and each Party shall
first submit to the other Party an early draft of all such publications, whether
they are to be presented orally or in written form, at least thirty (30) days
prior to submission for publication. Each Party shall review such proposed
publication in order to avoid the unauthorized disclosure of a Party's
Confidential Information and to preserve the patentability of Intellectual
Property. If, as soon as reasonably possible, but no longer than thirty (30)
days following receipt of an advance copy of a Party's proposed publication, the
other Party informs such Party that its proposed publication contains
Confidential Information of the other Party, then such Party shall delete such
Confidential Information from its proposed publication. In addition, if at any
time during such thirty (30) day period, the other Party informs such Party that
its proposed publication discloses Inventions made by either that have not yet
been protected through the filing of a patent application, or the public
disclosure of such proposed publication could be expected to have a material
adverse effect on any Patent Rights or Know-How of such other Party, then such
Party shall either delay such proposed publication, for up to ninety (90) days
from the date the other Party informed such Party of its objection to the
proposed publication, to permit the timely preparation and first filing of
patent application(s) on the information involved or remove the identified
disclosures prior to publication.

 

6.5 Use
of Information.  Neurologix
agrees that it will not share with Medtronic any Confidential Information
related to medical devices (including the design, manufacture, or use thereof)
other than Product-Related Confidential Information and any other Confidential
Information related to medical devices shared by Neurologix with Medtronic shall
not be considered to be Confidential Information of Neurologix. Medtronic may
use any Confidential Information related to medical devices shared with it by
Neurologix for any purpose, including, but not limited to, filing patent
applications.

 

ARTICLE
7

 

REPRESENTATIONS
AND WARRANTIES

 

7.1 Representations
of Authority.  Medtronic
represents and warrants to Neurologix that it has the full corporate right,
power and authority to enter into this Agreement and to perform its respective
obligations under this Agreement. Neurologix represents and warrants to
Medtronic that it has the full corporate right, power and authority to enter
into this Agreement and to perform its respective obligations under this
Agreement.

 

7.2 Consents. 
Medtronic
represents and warrants to Neurologix that all necessary consents, approvals and
authorizations of all government authorities and other Persons required to be
obtained by Medtronic as of the Effective Date in connection with the execution,
delivery and performance of this Agreement have been or shall be obtained by the
Effective Date. Neurologix represents and warrants to Medtronic that all
necessary consents, approvals and authorizations of all government authorities
and other Persons required to be obtained by it as of the Effective Date in
connection with the execution, delivery and performance of this Agreement have
been or shall be obtained by the Effective Date.

 







22












 

7.3 No
Conflict.  Medtronic
represents and warrants to Neurologix that, notwithstanding anything to the
contrary in this Agreement, the execution and delivery of this Agreement, the
performance of any of Medtronic's obligations in the conduct of the Development
Program and the assignments to be granted pursuant to this Agreement (a) do not
and will not conflict with or violate any requirement of applicable laws or
regulations existing as of the Effective Date and (b) do not and will not
conflict with, violate, breach or constitute a default under any contractual
obligations of Medtronic or any of its Affiliates existing as of the Effective
Date. Neurologix represents and warrants to Medtronic that, notwithstanding
anything to the contrary in this Agreement, the execution and delivery of this
Agreement, the performance of any of Neurologix's obligations in the conduct of
the Development Program and the assignments to be granted pursuant to this
Agreement (a) do not and will not conflict with or violate any requirement of
applicable laws or regulations existing as of the Effective Date and (b) do not
and will not conflict with, violate, breach or constitute a default under any
contractual obligations of such Party or any of its Affiliates existing as of
the Effective Date.

 

7.4 Enforceability. 
Medtronic
represents and warrants to Neurologix that this Agreement is a legal and valid
obligation binding upon it and is enforceable in accordance with its terms.
Neurologix represents and warrants to Medtronic that this Agreement is a legal
and valid obligation binding upon it and is enforceable in accordance with its
terms.

 

7.5 Employee
Obligations.  Medtronic
represents and warrants that all of its employees, officers, consultants and
advisors who are or will be involved in the Development Program have executed or
will have executed agreements or have existing obligations under law requiring
assignment to Medtronic of all Intellectual Property made during the course of
and as the result of their association with Medtronic, and obligating the
individual to maintain confidential information, to the extent required to
support Medtronic's obligations under this Agreement. Medtronic represents and
warrants that, to its knowledge, none of its employees who are or will be
involved in the Development Program are, as a result of the nature of such
Development Program to be conducted by the Parties, in violation of any covenant
in any contract with a Third Party relating to non-disclosure of proprietary
information, non-competition or non-solicitation. Neurologix represents and
warrants that all of its employees, officers, consultants and advisors who are
or will be involved in the Development Program have executed or will have
executed agreements or have existing obligations under law requiring assignment
to it all Intellectual Property made during the course of and as the result of
their association with Neurologix, and obligating the individual to maintain
confidential information, to the extent required to support Neurologix's
obligations under this Agreement. Neurologix represents and warrants that, to
its knowledge, none of its employees who are or will be involved in the
Development Program are, as a result of the nature of such Development Program
to be conducted by the Parties, in violation of any covenant in any contract
with a Third Party relating to non-disclosure of proprietary information,
non-competition or non-solicitation.

 







23












 

7.6 Intellectual
Property

 

 

    7.6.1 Medtronic
and Neurologix each represent and warrant to the other Party that, to such
Party's knowledge, the performance by any Party of its obligations under a Work
Plan will not result in the infringement of any Intellectual Property rights or
the use of misappropriated trade secrets of any Third Party.

 

7.6.2 Neurologix
represents and warrants to Medtronic that as of the Effective Date, Neurologix
exclusively owns, all of the Product-Related Intellectual Property assigned to
Medtronic by Neurologix, subject to no lien, charge, security interest,
mortgage, pledge, restriction, adverse claim or any other encumbrance whatsoever
(and without any obligation to any person or entity for royalties, fees or
commissions). No current or former stockholder, employee or consultant of
Neurologix has any rights in or to the Neurologix Product-Related Intellectual
Property. To the best of Neurologix's knowledge, no person or entity nor such
person's or entity's business or products has infringed, misused,
misappropriated or conflicted with the Neurologix Product-Related Intellectual
Property or currently is infringing, misusing, misappropriating or conflicting
with the Neurologix Product-Related Intellectual Property.

 

7.6.3 Neurologix
represents and warrants to Medtronic that it has disclosed to Medtronic any
Intellectual Property Controlled by Third Parties of which Neurologix has
knowledge that may affect Neurologix's right to commercialize the Biologic.
Neurologix further represents and warrants that it has disclosed to Medtronic
any and all changes to the manufacturing process currently being used to produce
the Biologic or in the Biologic contemplated by Neurologix in whole or in part
as a result of the scope of protection of such Third Party Intellectual
Property. Neurologix also represents and warrants to Medtronic that the
preclinical toxicity tests were conducted using just AAV Vectors containing
GAD65 and just AAV Vectors containing GAD67.

 

7.6.4 Neurologix
represents and warrants that, except as set forth on Schedule 7.6.4 attached
hereto, it owns or possesses licenses or other rights to use all Intellectual
Property necessary for or used in the conduct of its business as conducted and
as proposed to be conducted by it, free and clear of any liens of any kind. No
claim is pending or, to Neurologix's knowledge, threatened to the effect that
the operations of Neurologix infringe upon or conflict with the rights of any
Third Party under any Intellectual Property and, to the knowledge of Neurologix,
there is no basis for any such claim. Biologic-Related Neurologix Intellectual
Property owned or licensed by Neurologix is, to the knowledge of Neurologix,
valid and enforceable and has not been challenged in any judicial or
administrative proceeding. No claim is pending or, to Neurologix's knowledge,
threatened to the effect that any Biologic-Related Neurologix Intellectual
Property is invalid or unenforceable by Neurologix and, to Neurologix's
knowledge, there is no basis for any such claim. Neurologix has made all
statutorily required filings to record its interests and taken reasonable
actions to protect its rights in Biologic-Related Neurologix Intellectual
Property.

 

7.6.5 To each
Party's knowledge, no Third Party with which such Party has entered into any
license agreement under which Patent Rights or Know-How material to this
Agreement are licensed from such Third Party intends to cancel or terminate such
license agreement.

 

 







24












 

7.6.6 Neurologix
represents and warrants that any consultant or contractor who provides or will
provide services in connection with Neurologix's performance of development
activities related to the Product pursuant to the Development Program, will not
use any time, materials, equipment or facilities of any Third Party (e.g.,
academic institution) in the performance of such activities, unless such
development activities are performed pursuant to a specific agreement among
Neurologix, Medtronic and the Third Party or between either Neurologix or
Medtronic and the Third Party with the approval of the agreement by the other of
Neurologix and Medtronic and where such agreement includes provisions regarding
ownership of Intellectual Property.

 

7.7 Development
Program.  Medtronic
will perform the work under the Development Program in a workmanlike manner in
accordance with Medtronic's ordinary practices used by Medtronic in developing
products of this type.

 

7.8 No
Warranties.  EXCEPT AS
OTHERWISE EXPRESSLY SET FORTH HEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY
REPRESENTATIONS OR WARRANTIES AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR NONINFRINGEMENT.

 

7.9 Limitation
of Liability.  THE
PARTIES AGREE THAT NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY FOR ANY SPECIAL,
CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED
REVENUES OR NET PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING
TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING
NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS
ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. NOTWITHSTANDING THE FOREGOING,
NO DAMAGES ACTUALLY PAID TO A THIRD PARTY AS DAMAGES THAT ARE SUBJECT TO
INDEMNIFICATION HEREUNDER SHALL BE CONSIDERED SPECIAL, CONSEQUENTIAL, EXEMPLARY
OR INCIDENTAL DAMAGES UNDER THIS SECTION.

 

ARTICLE
8

 

TERM
AND TERMINATION

 

8.1 Term. 
This
Agreement shall become effective upon the Effective Date and, unless earlier
terminated in accordance with its terms, shall continue until the second
anniversary of the Effective Date, and shall automatically renew for successive
one-year periods unless either Party gives the other Party written notice of
non-renewal at least sixty (60) days prior to the next renewal date (the
"Term").
Nothing contained in this Agreement will be interpreted as requiring Medtronic
to renew or extend the Term beyond the initial term or any renewal term
hereof.

 

8.2 Termination. 
This
Agreement may be terminated in accordance with the following
provisions:

 

8.2.1 Medtronic
or Neurologix may terminate this Agreement by giving notice in writing to the
other Party if the other Party is in breach of any material representation,
warranty or covenant of this Agreement and, except as otherwise provided herein,
shall have failed to cure such breach within sixty (60) days after receipt of
written notice thereof from the first Party.

 







25












8.2.2 Medtronic
may terminate this Agreement at any time by giving notice in writing to
Neurologix, which notice shall be effective upon dispatch, should one of the
Neurologix Parties become insolvent, make an assignment for the benefit of
creditors, go into liquidation or receivership. Neurologix may terminate this
Agreement at any time by giving notice in writing to Medtronic, which notice
shall be effective upon dispatch, should Medtronic become insolvent, make an
assignment for the benefit of creditors, go into liquidation or
receivership.

 

8.2.3 Medtronic
may terminate this Agreement at any time prior to the completion of the design
verification and validation of the Product as set forth in the Work Plan by
giving notice in writing to Neurologix.

 

8.2.4 Neurologix
may terminate this Agreement at any time prior to the completion of the design
verification and validation of the Product as set forth in the Work Plan by
giving notice in writing to Medtronic.

 

8.2.5 Medtronic
or Neurologix may terminate this Agreement in the event the Parties fail to
agree on the terms, amendments, or modifications to the PD Application Work Plan
pursuant to Section 2.6.

 

8.3 Rights
and Obligations on Termination.  In the
event of termination of this Agreement for any reason, the Parties shall have
the following rights and obligations:

 

8.3.1 Termination
of this Agreement shall not release Medtronic or Neurologix from the obligation
to make payment of all amounts previously due and payable. For clarity, except
as expressly provided in Section 8.3.5, Neurologix shall have no obligation to
make any payments pursuant to Section 4.2 that are associated with milestones
that have not occurred as of termination.

 

8.3.2 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release Medtronic or Neurologix from any obligation that matured prior to the
effective date of such termination.

 

8.3.3 Upon any
termination of this Agreement, the Parties will return and deliver to the other
Party all of such Party's records, materials and documents acquired or developed
during the performance of this Agreement provided that a Party may retain one
copy of such materials and documents for legal purposes.

 

8.3.4 If
Medtronic terminates the Agreement pursuant to Section 8.2.3, or if Neurologix
terminates the Agreement pursuant to Section 8.2.1, Medtronic shall grant to
Neurologix a non-exclusive license pursuant to Section 5.5.4.

 

8.3.5 If
Neurologix terminates the Agreement pursuant to Section 8.2.4 Neurologix shall
promptly reimburse Medtronic for all of Medtronic's costs and expenses relating
to the Development Program up to eight hundred fifty thousand dollars
($850,000).

 







26












 

8.3.6 Upon any
termination or expiration of this Agreement prior to the completion of the
design verification and validation of the Product as set forth in the Work Plan,
Medtronic shall refund to Neurologix any amounts paid pursuant to Section 4.2
that are in excess of Medtronic's costs and expenses relating to the Development
Program.

 

ARTICLE
9

 

INDEMNIFICATION

 

9.1 Indemnification

 

9.1.1 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 demands, claims, actions or causes of
action, assessments, losses, damages, liabilities, interest and penalties,
costs, and expenses (including, without limitation, reasonable legal fees and
disbursements incurred in connection therewith and in seeking indemnification
therefor, and any amounts or expenses required to be paid or incurred in
connection with any action, suit, proceeding, claim, appeal, demand, assessment
or judgment), resulting from a Third Party claim, ("Indemnifiable
Losses")
resulting from, arising out of, or imposed upon or incurred by any person to be
indemnified hereunder by reason of: (a) any breach of any representation,
warranty, covenant or agreement by Neurologix contained in this Agreement or any
agreement, certificate or document executed and delivered by Neurologix pursuant
hereto or in connection with any of the transactions contemplated by this
Agreement; (b) any product liability relating to the Biologic (c) patent
infringement claims related solely to the Biologic arising from Medtronic's
sales of the Device (or the Biologic, if applicable) and (d) any claim of
misappropriation of Confidential Information relating to Intellectual Property
transferred from Neurologix to Medtronic.

 

9.1.2 Medtronic
shall indemnify, defend, and hold harmless Neurologix and each of its
Affiliates, and their respective officers, directors, members, employees and
agents from and against and in respect of any and all demands, claims, actions
or causes of action, assessments, losses, damages, liabilities, interest and
penalties, costs, and expenses (including, without limitation, reasonable legal
fees and disbursements incurred in connection therewith and in seeking
indemnification therefor, and any amounts or expenses required to be paid or
incurred in connection with any action, suit, proceeding, claim, appeal, demand,
assessment or judgment), resulting from a Third Party claim, resulting from,
arising out of, or imposed upon or incurred by any person to be indemnified
hereunder by reason of: (a) any breach of any representation, warranty, covenant
or agreement by Medtronic contained in this Agreement or any agreement,
certificate or document executed and delivered by Neurologix pursuant hereto or
in connection with any of the transactions contemplated by this Agreement; (b)
any product liability relating to Products sold by or on behalf of Medtronic or
one or more of its Affiliates; (c) patent infringement claims related solely to
the Product arising from Medtronic's sales of the Device, and (d) any claim of
misappropriation of Confidential Information relating to Intellectual Property
transferred from Medtronic to Neurologix

 

 







27












 

9.2 Third-Party
Claims.  If a
claim by a Third Party is made against an indemnified Party and if such Party
intends to seek indemnity with respect thereto under this Article 9, such Party
shall promptly notify the indemnifying Party of such claim; provided, however,
that failure to give timely notice shall not affect the rights of the
indemnified Party so long as the failure to give timely notice does not
adversely affect the indemnifying Party's ability to defend such claim against a
Third Party. The indemnifying Party shall be entitled to settle or assume the
defense of such claim, including the employment of counsel reasonably
satisfactory to the indemnified Party. If the indemnifying Party elect(s) to
settle or defend such claim, the indemnifying Party shall notify the indemnified
Party within thirty (30) days (but in no event less than 20 days before any
pleading, filing or response on behalf of the indemnified Party is due) of the
its intent to do so. If the indemnifying Party that has agreed to indemnify the
indemnified Party elects not to settle or defend such claim or fail(s) to notify
the indemnified Party of the election within thirty (30) days (or such shorter
period provided above) after receipt of its notice of a claim of indemnity
hereunder, the indemnified Party shall have the right to contest, settle or
compromise the claim without prejudice to any rights to indemnification
hereunder. Regardless of which Party is controlling the settlement or defense of
any claim, (a) the indemnified Party and the indemnifying Party shall act in
good faith, (b) the indemnifying Party shall not thereby permit to exist any
lien, encumbrance or other adverse charge upon any asset of the indemnified
Party or any of its Affiliates, (c) the indemnifying Party shall permit the
indemnified Party to participate in such settlement or defense through counsel
chosen by the indemnified Party, with all fees, costs, and expenses of such
counsel borne by the indemnified Party, provided however, that the indemnifying
Party shall not assume the defense for matters as to which there is a conflict
of interest or separate and different defenses; in which case the indemnified
Party's costs of defense, including reasonable fees of separate legal counsel,
shall be borne by the indemnifying Party, (d) no entry of judgment or settlement
of a claim may be agreed to without the written consent of the indemnified
Party, and (e) the indemnifying Party shall promptly reimburse the indemnified
Party for the full amount of such claim and the related expenses as incurred by
the indemnified Party pursuant to this Article 9. So long as the indemnifying
Party is reasonably contesting any such Third Party claim in good faith and the
foregoing clause (b) is being complied with, the indemnified Party shall not pay
or settle any such claim. The controlling Party shall upon request deliver, or
cause to be delivered, to the other Party or Parties copies of all
correspondence, pleadings, motions, briefs, appeals or other written statements
relating to or submitted in connection with the settlement or defense of any
such claim, and timely notices of any hearing or other court proceeding relating
to such claim.

 

9.3 Cooperation
as to Indemnified Liability.  Each
Party hereto shall cooperate fully with the other Parties with respect to access
to books, records, or other documentation within such Party's control, if deemed
reasonably necessary or appropriate by any Party in the defense of any claim
that may give rise to indemnification hereunder.

 

9.4 Set-off. 
Medtronic
shall be entitled, in its discretion and without limitation of any other rights
or remedies, to set off against any amounts which are then owed or thereafter
become owed by Medtronic to Neurologix all or any part of an Indemnifiable Loss
incurred by Medtronic. Medtronic shall be entitled to set off Indemnifiable
Losses when actually incurred. If Medtronic defers payment of any amount to
Neurologix past the scheduled payment date because there exists a pending
indemnification claim by Medtronic pursuant to this Article which has not then
been finally determined, the excess, if any, of such deferred amount over the
finally determined amount of the indemnification claim shall be promptly paid
upon such final determination, together with interest on such excess accrued
from the originally scheduled payment date for such deferred
amount.

 







28












ARTICLE
10

 

FORCE
MAJEURE

 

10.1 Notice
of Force Majeure. Upon
giving notice to Medtronic or Neurologix, as the case may be, a Party affected
by an event of Force Majeure shall be released without any liability on its part
from the performance of its obligations under this Agreement, except for the
obligation to pay any amounts due and owing hereunder, but only to the extent
and only for the period that its performance of such obligations is prevented by
the event of Force Majeure.

 

10.2 Suspension
of Performance. During
the period that the performance by one of the Parties of its obligations under
this Agreement has been suspended by reason of an event of Force Majeure, the
other Party or Parties may likewise suspend the performance of all or part of
its or their obligations hereunder (except for the obligation to pay any amounts
due and owing hereunder) to the extent that such suspension is commercially
reasonable.

 

ARTICLE
11

 

MISCELLANEOUS

 

11.1 Assignment. Neurologix
shall not have the right to assign or otherwise transfer its rights and
obligations under this Agreement (whether by merger, share exchange, combination
or consolidation of any type, operation of law, purchase or otherwise
(collectively, a "Corporate Event")) except with the prior written consent of
Medtronic; provided,
however, that in
the event Medtronic does not provide its written consent to an assignment as a
part of a Corporate Event of Neurologix within ten (10) business days of
Neurologix's request for such consent, Neurologix may nonetheless undergo such
Corporate Event without obtaining Medtronic's consent provided that Neurologix
forfeits to Medtronic all licenses and other rights relating to the Medtronic
Uncategorized Intellectual Property, the Jointly Owned Intellectual Property and
the Product-Related Intellectual Property (but in no event shall such forfeiture
affect the right to receive payment pursuant to Section 4.3). Medtronic shall
not have the right to assign or otherwise transfer its rights and obligations
under this Agreement (whether by merger, share exchange, combination or
consolidation of any type, operation of law, purchase or otherwise) except with
the prior written consent of Neurologix, provided that Medtronic may assign its
rights pursuant to this Agreement to any Affiliate. Any prohibited assignment
shall be null and void.

 

11.2 Further
Assurances. At
such time and from time to time on and after the date hereof, upon request by
Medtronic, Neurologix will execute, acknowledge and deliver, or will cause to be
done, executed, acknowledged and delivered, all such further acts, certificates
and assurances that may be reasonably required for the better conveying,
transferring, assigning, delivering, assuring and confirming to Medtronic, or to
its respective successors and assigns, to otherwise carry out the purposes of
this Agreement and the agreements, documents and instruments contemplated
hereby.

 







29











 


11.3 Complete
Agreement.   The
Schedules and Exhibits to this Agreement shall be construed as an integral part
of this Agreement to the same extent as if they had been set forth verbatim
herein. This Agreement and the Schedules and Exhibits hereto constitute the
entire agreement between the Parties hereto with respect to the subject matters
hereof and thereof and supersede all prior agreements whether written or oral
relating hereto.

 

11.4 Survival.
 All
representations and warranties made in this Agreement, all obligations pursuant
to Sections 3.2, 4.3 and 8.3, Articles 5, 6, 7, 9, 10 and 11 hereof, and all
other terms and provisions hereof intended by the Parties to be observed and
performed after the termination or expiration hereof, shall survive such
termination or expiration and continue thereafter in full force and
effect.

 

11.5 Waiver,
Discharge, Amendment, Etc.  The
failure of either Party to enforce at any time any of the provisions of this
Agreement shall in no way be construed to be a waiver of any such provision, nor
in any way to affect the validity of this Agreement or any part of it or the
right of either Party after any such failure to enforce each and every such
provision. No waiver of any breach of this Agreement shall be held to be a
waiver of any other or subsequent breach. Any amendment to or waiver of any
portion of this Agreement shall be in writing and signed by Neurologix and
Medtronic.

 

11.6 Notices.
 All
notices or other communications to a Party required or permitted hereunder shall
be in writing and shall be delivered personally or by telecopy (receipt
confirmed) to such Party as follows or shall be sent by a reputable express
delivery service or by certified mail, postage prepaid with return receipt
requested, addressed as follows:

 

if to
Medtronic, to:

 

Medtronic,
Inc.

World
Headquarters

710
Medtronic Parkway NE

Minneapolis,
MN 55432-5604

Attention:
General Counsel 

FAX:
(763) 572-5459




with
separate copies thereof addressed to

 

Medtronic,
Inc.

World
Headquarters

710
Medtronic Parkway NE

Minneapolis,
MN 55432-5604

Attention:
Vice President and Chief Development Officer 

FAX:
(763) 505-2542

 







30













 

if to
Neurologix to:

 

Neurologix,
Inc.

One
Bridge Plaza

Fort Lee,
New Jersey

Attention:
Michael Sorell, M.D. 

Telephone
No.: 201-592-6451 

Telecopy
No.: 201-585-9798




with a
copy to:

 

Lowenstein
Sandler PC

65
Livingston Avenue

Roseland,
NJ 07068

Attention:
Stephen R. Buckingham 

Phone:
(973) 597-2326

Fax:
(973) 597-2327




Any Party
may change the above-specified recipient and/or mailing address by notice to all
other Parties given in the manner herein prescribed. All notices shall be deemed
given on the day when actually delivered as provided above (if delivered
personally or by telecopy) or on the day shown on the return receipt (if
delivered by mail or delivery service).

 

11.7 Use
of Name; Public Announcement. Neither
Party shall, except with the written consent of the other Party or as required
by applicable securities laws or regulation or exchange rules, publicly use the
other Party's name in any external advertising, publicity, press release,
endorsement, or promotional communication without the express written approval
of that Party, not to be unreasonably withheld, or disclose the Parties'
relationship. Except as required by applicable securities law or regulation or
exchange rules, in the event Neurologix proposes to issue any press release or
public announcement concerning any provisions of this Agreement, the Stock
Purchase Agreement or the transactions contemplated hereby, Neurologix shall so
advise Medtronic and submit such press release or public announcement to
Medtronic for review at least thirty (30) days prior to submittal for
publication (including re-publication abstracts or summaries), and the Parties
shall thereafter use their best efforts to cause a mutually agreeable release or
announcement to be issued. Neither Party will publicly disclose or divulge any
provisions of this Agreement or the transactions contemplated hereby without the
other Party's written consent, except as may be required by applicable law or
stock exchange regulation, and except for communications to employees. However,
Neurologix may disclose the existence of this Agreement and the existence of an
ownership interest by Medtronic in Neurologix as may be necessary in connection
with disclosures made to, or due diligence performed by parties investigating or
transacting other business with Neurologix, as long as any such parties to whom
such disclosure is made are subject to an appropriate confidentiality agreement
with Neurologix.

 

 







31












 

11.8 Expenses. Neurologix
and Medtronic shall each pay their own expenses incident to this Agreement and
the preparation for, and consummation of, the transactions provided for
herein.

 

11.9 Governing
Law.  The
formation, legality, validity, enforceability and interpretation of this
Agreement shall be governed by the laws of the State of Minnesota, without
giving effect to the principles of conflict of laws.

 

11.10 Titles
and Headings; Construction.  The
titles and headings to the Articles and Sections herein are inserted for the
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement. This Agreement shall be
construed without regard to any presumption or other rule requiring construction
hereof against the Party causing this Agreement to be drafted.

 

11.11 Benefit.
 Nothing
in this Agreement, expressed or implied, is intended to confer on any person
other than the Parties to this Agreement and Medtronic, or their respective
successors or assigns, any rights, remedies, obligations or liabilities under or
by reason of this Agreement.

 

11.12 Counterparts.
 This
Agreement may be executed in any number of counterparts, each of which shall be
deemed as original and all of which together shall constitute one instrument,
and may be delivered in person or by facsimile transmission.

 

11.13 Severability.
. If any
provision of this Agreement is held invalid by a court of competent
jurisdiction, the remaining provisions shall nonetheless be enforceable
according to their terms. Further, if any provision is held to be overbroad as
written, such provision shall be deemed amended to narrow its application to the
extent necessary to make the provision enforceable according to applicable law
and shall be enforced as amended.

 

11.14 Parties
in Interest.  All
representations, covenants, and agreements contained in this Agreement by or on
behalf of any of the Parties hereto shall bind and inure to the benefit of the
respective successors and assigns of the Parties hereto, whether so expressed or
not.

 

IN
WITNESS WHEREOF, each of the Parties has caused this Development and
Manufacturing Agreement to be executed in the manner appropriate for each, and
to be dated as of the date first above written.

 

NEUROLOGIX,
INC.







By:  /s/
Michael Sorell     

Name:
Michael Sorell

Title:
President and CEO







NEUROLOGIX
RESEARCH, INC. 




By:  /s/
Michael Sorell 

Name:
Michael Sorell

Title:
President







MEDTRONIC,
INC.

 

By:
/s/Michael D. Ellwein    

Name: 
Michael D. Ellwein

Title:
Vice President and CDO












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