Document:

EXHIBIT 10.1
                                                                    ------------

                          (NGM Group, Inc. Letterhead)

                                                         September 3, 2004

Mr. Jerry Mahoney iVoice, Inc. 750 Route 34 Matawan, NJ 07747

Re: Letter of Intent to Acquire Intellectual Property

Dear Mr. Mahoney:

     I am pleased to provide you with this letter of intent which sets forth our
understanding with respect to the proposed terms and conditions under which NGM
TEC, Inc. (hereinafter "NGM") will acquire all rights, title, and interests in
that certain intellectual property (hereinafter, the "IP") detailed in Paragraph
C herein from iVoice, Inc. ("iVoice"). This letter of intent is subject to the
completion of our due diligence and the preparation and execution of definitive
documents

     The covenants in paragraphs E, G, H, I, J and N are binding upon the
parties whether or not the parties reach a definitive agreement with respect to
the sale of the IP.

     While the terms and conditions of this letter of intent are non-binding as
to the parties hereto (except where otherwise noted), the parties agree to act
in good faith towards negotiating and executing a binding purchase and sale
agreement substantially incorporates the terms and conditions enunciated herein.

     This letter of intent describes a proposed transaction involving the sale
and purchase of the IP as follows:

A. Consideration                        The purchase price of the IP shall be
                                        $6,250,000, payable as follows:

                                        (i) $500,000 in cash at closing, and an
                                        additional $500,000 in cash no later

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                                        than sixty days from the date of
                                        closing. A promissory note to this
                                        effect, secured by the IP, shall be
                                        executed by and between the parties.

                                        NGM shall issue to iVoice those number
                                        of shares of NGM's s fully paid and
                                        non-assessable Common Stock equal to
                                        $2,250,000. The price per share utilized
                                        to determine the number of shares
                                        tendered shall be equal to the lowest
                                        price per share paid by outside
                                        investors for NGM stock at any time in
                                        the sixty (60) days prior to the closing
                                        of the transaction contemplated herein.
                                        For the purposes of this paragraph, any
                                        shares issued pursuant to the exercise
                                        of currently outstanding warrants or
                                        options of NGM shall not count towards
                                        the computation of lowest price paid by
                                        outside investors. Only shares newly
                                        issued pursuant to a private placement
                                        or some other financing in the sixty
                                        (60) day time period shall count towards
                                        determining the lowest price paid. ..

                                        NGM will file with the Securities and
                                        Exchange Commission a Registration
                                        Statement, on Form S-1, SB-2, S-3 or
                                        such other suitable form, registering
                                        the stock tendered by NGM pursuant to
                                        paragraph A (ii) above, no later than
                                        five (5) business days from the date of
                                        closing.

                                        Upon receipt of notification from the
                                        Securities and Exchange Commission that
                                        the registration has been declared
                                        effective, iVoice will distribute, in
                                        the form of a dividend, all of such
                                        shares to its shareholders.

                                        iii) NGM shall issue to IVoice
                                        $2,900,000 of NGM Convertible Preferred
                                        Stock. NGM will register the shares

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                                        underlying the Convertible Preferred
                                        Stock in the registration statement with
                                        the SEC. Once NGM's Common Stock has
                                        commenced trading on the Principal
                                        Market, iVoice will be entitled, at its
                                        option, to convert, and sell on the same
                                        day, at any time and from time to time,
                                        until redemption in full of this
                                        Preferred Stock, all or any part of the
                                        face amount of the Preferred Stock, into
                                        shares of NGM's common stock, at the
                                        price per share equal to an amount equal
                                        to eighty percent (80%) of the lowest
                                        closing bid price of NGM's Common Stock,
                                        as quoted by Bloomberg, LP (the "Closing
                                        Bid Price"), for the five (5) trading
                                        days immediately preceding the
                                        Conversion Date. NGM shall further have
                                        the right to redeem the Preferred Stock,
                                        in whole or in part, at any time, in an
                                        amount equal to one hundred twenty
                                        percent (120%) of the face amount of the
                                        Preferred Stock to be redeemed.

                                        iv) NGM will issue to iVoice a $100,000
                                        5% 2 year secured convertible note. NGM
                                        will register the shares underlying the
                                        convertible note in the registration
                                        statement with the SEC. Once NGM's
                                        Common Stock has commenced trading on
                                        the Principal Market, iVoice will be
                                        entitled, at its option, to convert, and
                                        sell on the same day, at any time and
                                        from time to time, until payment in full
                                        of this Debenture, all or any part of
                                        the principal amount of the Debenture,
                                        plus accrued interest, into shares of
                                        the NGM's common stock, at the price per
                                        share equal to eighty percent (80%) of
                                        the lowest closing bid price of the
                                        Company's Common Stock, as quoted by
                                        Bloomberg, LP (the "Closing Bid Price"),
                                        for the five (5) trading days
                                        immediately preceding the Conversion
                                        Date. The note shall be secured by all

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                                        assets conveyed by iVoice to NGM in the
                                        transaction contemplated herein. Failure
                                        to go effective with the SEC as per
                                        A(ii) or, alternatively, failure to
                                        acquire a public shell per A (v), shall
                                        constitute an event of default on the
                                        note, and shall provide iVoice with the
                                        opportunity to foreclose on the
                                        collateral. The note shall be secured by
                                        all assets conveyed by iVoice to NGM in
                                        the transaction contemplated herein. .
                                        NGM shall not have the right to pre-pay
                                        or retire the Convertible Note until
                                        such time that the Convertible Preferred
                                        Stock, as described in Paragraph A (iii)
                                        above, has been either converted in full
                                        to Common Stock or redeemed in full.

                                        v) In the event that the SEC fails to
                                        declare NGM's registration statement
                                        effective on or before February 1, 2005,
                                        NGM will acquire, no later than March
                                        31, 2005, a reporting bulletin board
                                        shell, and shall reverse merge its
                                        business operations into such shell. NGM
                                        will then again file a registration
                                        statement to register iVoice's shares in
                                        accordance with paragraphs (ii), (ii),
                                        and (iv) above. Failure to go effective
                                        with the SEC as per this paragraph, or,
                                        alternatively, failure to acquire a
                                        public shell in accordance with this
                                        paragraph, shall constitute an event of
                                        default on the Convetible Note described
                                        in Paragraph A (iv) herein, and shall
                                        provide iVoice with the right to
                                        foreclose on the collateral.

B. Intellectual Property                NGM shall acquire all right, title, and
                                        interest from iVoice in the following
                                        assets: i) The source code and all
                                        documentation relating to iVoice's
                                        speech engine;

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                                        ii) Patent No. 6,563,911 , which covers
                                        speech enabled, automatic telephone
                                        dialer using names, including seamless
                                        interface with computer-based address
                                        book programs.

                                        Patent No. 6,671,354, which covers
                                        speech enabled, automatic telephone
                                        dialer using names, including seamless
                                        interface with computer-based address
                                        book programs without the use of a PBX.

                                        980.010 Patent/Application Serial No.
                                        10/055,854 , which is a patent pending
                                        Entitled: "Telephone Application
                                        Programming Interfaced-Based, Speech
                                        Enabled Automatic Telephone Dialer Using
                                        Names"

                                        iii) The source code and documentation
                                        relating to iVoice's suite of speech
                                        applications, including Auto Attendant.

                                        iv) iVoice's customer list

                                        v) iVoice's agreements with resellers

C. Sales Commission Agreement           NGM will enter into a sales commission
                                        agreement with iVoice, Inc. to provide
                                        guidance and counsel relating to the
                                        sales and marketing of the IP. The terms
                                        of such agreement shall be mutually
                                        agreed upon prior to closing. In
                                        addition to a sales commission
                                        structure, the agreement will provide
                                        for a mutually agreed upon number of
                                        hours of consulting for iVoice to
                                        provide NGM during the first forty five
                                        (45) days following the date of closing
                                        on a no-cost basis. After that initial
                                        forty five (45) day period, iVoice will
                                        provide NGM with consulting services, on
                                        an as requested basis, at the rate of
                                        $150 per hour, plus reimbursement of any
                                        and all expenses which have been
                                        pre-approved by NGM prior to the time
                                        that such expenses were incurred.

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D. Omitted Intentionally

E. Expenses                             The parties hereto shall each be
                                        responsible for any and all of their own
                                        expenses associated with the transaction
                                        contemplated herein. NGM acknowledges
                                        that no banker, broker or finder is due
                                        or entitled to any fee or compensation
                                        as a result of the transaction
                                        contemplated herein. iVoice shall be
                                        responsible for fees due and owing
                                        Bristol Townsend & Co., Inc.

F. Pre-Closing Covenants                The parties will use their best efforts
                                        to obtain all necessary third party and
                                        government consents (including all
                                        certificates, permits, approvals, and
                                        assignments required in connection with
                                        the merger).

G. Best Efforts                         The parties agree to negotiate in good
                                        faith, and to use their best efforts to
                                        (a) to execute a definitive agreement
                                        with respect to the purchase and sale of
                                        the IP as expeditiously as possible, on
                                        or before October 1, 2004, and (b) close
                                        the transaction on the date of execution
                                        of the definitive agreement.

H. Conditions to Obligation             Neither NGM nor iVoice will be obligated
                                        to consummate the transaction
                                        contemplated hereby unless and until the
                                        parties have reached a definitive
                                        agreement as to all the terms and
                                        conditions of the acquisition.

I. Due Diligence                        iVoice agrees to cooperate with NGM's
                                        due diligence investigation of the IP
                                        and to provide NGM and its
                                        representatives with prompt access to
                                        all books, records, contracts, and other
                                        information pertaining to the IP (the
                                        "Due Diligence Information").

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<PAGE>

J. Confidentiality                      NGM will use the Due Diligence
                                        Information solely for the purpose of
                                        its due diligence investigation of the
                                        IP, and unless and until the parties
                                        consummate the transaction contemplated
                                        herein, NGM, its affiliates, directors,
                                        officers, employees, advisors and agents
                                        will keep the Due Diligence Information
                                        strictly confidential.

K. Closing                              It is the intention of the parties
                                        hereto to close this transaction on or
                                        about October 1, 2004.

L. Term of Letter of Intent             This letter of intent shall become
                                        effective only upon receipt of an
                                        executed copy of this letter by iVoice
                                        from NGM.

M. License To Speech Engine             NGM acknowledges that iVoice will be
                                        entering into a license agreement with
                                        one of its subsidiaries relating to the
                                        use of the speech engine with it's IVR
                                        product. NGM will assume this license as
                                        part of the IP acquisition. The license
                                        shall provide for a license fee of $1000
                                        for the software development kit
                                        ("SDK"), and an additional payment of
                                        $400 per port

N.                                      NGM acknowledges and agrees that iVoice
                                        will be filing a Form 8-K with the
                                        Securities and Exchange Commission
                                        relating to the execution of the letter
                                        of intent between our companies, and
                                        that iVoice will furthermore issue a
                                        press release announcing the execution
                                        of the letter of intent.

O.                                      iVoice acknowledges that NGM is in the
                                        process of discussing a potential merger
                                        with a third company. In the event that

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                                        NGM merges with such company prior to
                                        the consummation of the transaction
                                        contemplated herein, the parties
                                        acknowledge that all securities due to
                                        be issued to iVoice as consideration for
                                        the sale of the IP may be in securities
                                        of this third company, and that the same
                                        pricing formulas as detailed in
                                        Paragraph A herein shall continue to
                                        control the issuance of such shares..

           If you are in agreement with the terms of this letter of intent,
please sign where indicated below. Upon receipt of the signed copy, we will
proceed with our plans for consummating the transaction in a timely manner.

                                                 Sincerely,

                                                 ---------------------
                                                 President

AGREED TO AND ACCEPTED BY:
iVoice, Inc.

---------------------------
BY:  Jerry Mahoney
TITLE:  Chief Executive Officer

                                        8Exhibit 10.68

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (the
“Agreement”) is entered into and made effective as of March 29, 2002 (the
“Effective Date”), between INTERMUNE, INC.,
(“InterMune”); MARNAC, INC.,
(“Marnac”); KDL, INC. and KDL GMBH (collectively, “KDL”); DR. SOLOMON MARGOLIN (“Margolin”); and DR.  SHITOTOMO
YAMAUCHI (“Yamauchi”).   Each
party to this agreement may be referred to herein each as a “Party” and all
parties may be referred to jointly as the “Parties.”

 

RECITALS

 

WHEREAS,
InterMune is involved in the research, development and
commercialization of products potentially useful in the prevention, mitigation
and treatment of fibrotic and other diseases;

 

WHEREAS, Marnac and
KDL hold all ownership rights in that certain U.S. Patent No. [*]; and corresponding foreign
patents, including any and all divisions, re-issues, continuations and
substitutes in whole or in part of such patents in the Territory (as defined
below) with respect to the anti-fibrotic uses of Pirfenidone; and directly
related Information; and

 

WHEREAS, InterMune
desires to obtain from Marnac and KDL, and Marnac and KDL desire to grant to
InterMune, the exclusive, sublicensable right to make, have made, use, market,
distribute, sell, import, have imported, export, have exported or otherwise
exploit Pirfenidone in the Territory for the anti-fibrotic uses of Licensed
Product.

 

NOW, THEREFORE, in
consideration of the foregoing recitals and the mutual covenants and agreements
contained herein, the Parties hereby agree as follows:

 

1.             DEFINITIONS

 

1.1          “Acceptance” as used in this
Agreement, shall mean acceptance by the appropriate governing authority as
being filed in correct form, rather than as signifying regulatory approval.

 

1.2          “Affiliate” means any company or
entity controlled by, controlling or under common control with a Party.  As used in this Section 1.1, “control” means
(a) that an entity or company owns, directly or indirectly, more than fifty
percent (50%) of the voting stock of another entity, or (b) that an entity,
person or group has the actual ability to control and direct the management of
the entity, whether by contract or otherwise.

 

1.3          “Best Efforts” means every
necessary and prudent effort of a Party applied in a prompt, commercially
reasonable manner.

 

1.4          “Commercially Reasonable Business Practice”
means making efforts and devoting resources that a similarly situated
biopharmaceutical company would typically devote to a product of similar market
potential, profit potential or strategic value, based on conditions then
prevailing.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

1.5          “Information” means information,
results and data of any type whatsoever, in any tangible or intangible form,
including without limitation inventions, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill, experience,
trade secrets, test data (including pharmacological, biological, chemical,
biochemical, toxicological and clinical test data), analytical and quality
control data, stability data, studies and procedures, all filings made to
Regulatory Agencies, and patent and other legal information or descriptions,
and all intellectual property rights therein, all limited to the anti-fibrotic
application of Pirfenidone.

 

1.6          “First Sale” means the first
commercial sale of Licensed Product.

 

1.7          “IND” shall have the
meaning given in Section 6.2.

 

1.8          “Licensed Patents” means that
certain U.S. Patent No. [*]; and all
corresponding foreign patent applications and patents throughout the Territory,
including any and all divisions, re-issues, re-examinations, renewals,
continuations and substitutes in whole or in part of such patents and patent
applications in the Territory with respect to the anti-fibrotic uses of
Pirfenidone; and all Patents (as defined in 1.13).  The Licensed Patents shall specifically exclude [*]

 

1.9          “Licensed Product” means a product
that [*]  a Valid Claim for the
therapeutic treatment of a specific fibrotic human disease, which product has
been approved after the Effective Date for the therapeutic treatment of such
specific fibrotic human disease by the United States Food and Drug
Administration (“FDA”) and/or any Regulatory Agencies through the granting of a
New Drug Application (“NDA”) or equivalent foreign approval document.

 

1.10        “Net Sales” means, with respect to
any Licensed Product, the gross invoiced sales of such Licensed Product by
InterMune, its Affiliates and its sublicensees to Third Party purchasers, less
the following deductions:

 

(a)           discounts,
credits, rebates, allowances, adjustments, rejections and recalls for which the
customer has been credited the original sales price and returns;

 

(b)           trade,
quantity, or cash discounts or rebates customary to the industry and actually
allowed, given or accrued (including, but not limited to, cash, governmental
and managed care rebates, and hospitals or other buying group chargebacks);

 

(c)           sales,
excise, turnover, inventory, value-added, and similar taxes assessed on the
sale of such Licensed Product;

 

(d)           [*];

 

(e)           costs
[*]  for transportation, importation,
insurance and other handling expenses; and

 

(f)            [*].

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2

 

A sale of a Licensed Product shall be deemed
to occur upon the [*] by [*] for
such Licensed Product from a Third-Party purchaser.

 

1.11        “Ongoing Clinical Trials” shall
have the meaning given in Section 6.2.

 

1.12        “Orphan Drug Status” is an
exclusive approval to market a therapeutic for the treatment of a human
fibrotic disease based upon orphan drug status under the Orphan Drug Act of
1983 in the United States (Pub.L. 97-414, Jan.4, 1983, 96 Stat. 2049) or any
corresponding or similar non-U.S. statutes, granted by the U.S. Food and Drug
Administration (“FDA”), the Committee on Proprietary Medicinal Products
(“CPMP”) or other Regulatory Agencies in the Territory to InterMune for the
anti-fibrotic uses of Pirfenidone for such disease.

 

1.13        “Patents” means all of Marnac’s,
KDL’s, Margolin’s and Yamauchi’s (a) [*]
patent applications heretofore or hereafter filed or having legal force
in any country including without limitation divisionals, continuations,
continuation-in-part and provisional applications; (b)  issued, unexpired [*]  patents in any country,
including utility, model and design patents and certificates of invention; and
(c) substitutions, extensions, reissues, renewals, and supplementary protection
certificates with respect to any such issued patents.  For clarity, such patent applications and patents shall include
those owned, as well as those controlled with the right to grant licenses, by
any of Marnac, KDL, Margolin and Yamauchi. 
The Patents shall not include patent applications and patents to the
extent claiming [*]  other than for [*]  uses, nor [*]  for [*]  applications other than [*].

 

1.14        “Permitted Seller” means InterMune
and its Affiliates and any permitted assignee, licensee or sublicensee having
the right to sell Product hereunder.

 

1.15        “Pirfenidone” shall mean [*].

 

1.16        “Regulatory Agencies” means the
FDA, the CPMP, and other governmental agencies having similar jurisdiction over
the development, manufacturing, and marketing of pharmaceuticals.

 

1.17        “Territory” means worldwide
(excluding Japan, Taiwan and Korea).

 

1.18        “Third Party” means any party
other than InterMune and Marnac and their respective Affiliates, and other than
KDL, Margolin and Yamauchi.

 

1.19        “Valid Claim” means a claim of an
issued and unexpired Licensed Patent in a country which claim:  (i) but for this Agreement, would preclude
the [*]  of Pirfenidone [*]  by InterMune or another seller,
(ii) has not been revoked or held unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and (iii) has not been
abandoned, disclaimed or admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3

 

2.             GRANT OF LICENSE

 

2.1          Grant to InterMune.  Subject to Section 2.2, Marnac and KDL
hereby grant to InterMune an exclusive (even as to Marnac, KDL, Margolin and
Yamauchi), royalty-bearing (as set forth in Section 3.3), freely sublicenseable
license in the Territory under the Licensed Patents and Information for all
purposes, including without limitation, to develop, use, make, have made,
import, have imported, export, have exported, offer for sale, have sold and sell
Licensed Products.

 

2.2          Research and Clinical Development.  [*]
may conduct [*]  relating to the
anti-fibrotic uses of Pirfenidone, but shall not, under any conditions, conduct
[*]  relating to the anti-fibrotic
uses of Pirfenidone without the prior written consent of InterMune.

 

3.             CONSIDERATION

 

3.1          Initial Payment.  Within five (5) business days after the
Effective Date, InterMune shall pay to Marnac Eighteen Million Seven Hundred
and Fifty Thousand Dollars ($18,750,000) in cash.

 

3.2          Milestone Payments.  InterMune shall make the following milestone
payments to Marnac, within [*]  days of achieving
these milestones:

 

(a)           [*] on grant of [*] in the [*]  for use of Pirfenidone for the
treatment of [*];

 

(b)           [*] on [*]  from the [*]
of its [*] of the [*] for Pirfenidone for an
anti-fibrotic indication;

 

(c)           [*] on [*]
from the [*] of its [*] for
Pirfenidone for a [*] anti-fibrotic
indication;

 

(d)           [*] on [*]  from the [*]
of its [*] of the [*]  filing for Pirfenidone for an
anti-fibrotic indication [*]; and

 

(e)           [*] on [*]  from the [*]
of its [*] of
[*]  for Pirfenidone for a new anti-fibrotic
indication [*].

 

No milestone
payments shall be owed or paid for regulatory filings or approvals in the [*]
for [*].

 

3.3          Royalties.

 

(a)           InterMune
shall pay to Marnac a royalty of [*]
on Net Sales of all Licensed Products in the Territory calculated by U.S.
generally accepted accounting principles (“GAAP”).

 

(b)           If
InterMune [*] of a Licensed Product in a
country in the Territory in which [*]
of a Licensed Product are not covered by a Valid Claim, InterMune shall pay a
royalty to Marnac at the rate of [*]
of Net Sales on such sales for the [*]
in such country.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

4

 

(c)           InterMune’s
obligations pursuant to this Section 3.3 to pay royalties shall expire with
respect to Net Sales for Licensed Products approved for particular indications
with the expiration of this Agreement with respect thereto as set forth in
Section 10.1.

 

3.4          Payments to Marnac and KDL.  With respect to any dollar amounts that
InterMune is required to pay in dollars hereunder pursuant to Section 3.1, 3.2
or 3.3, InterMune shall make such payment [*];
provided that Marnac notifies
InterMune no later than [*]  business days
before such payment is due in writing as to [*].  If Marnac does not provide written direction
by [*]  business days before any such
payment is due hereunder, then InterMune shall [*].

 

3.5          Payment of Royalties.  Following the First Sale of a Licensed
Product and during the term of the Agreement, InterMune shall furnish to Marnac
a quarterly written report for each calendar quarter showing the sales of all
Licensed Products subject to royalty payments hereunder during the reporting
period and the royalties payable under this Agreement.  Reports shall be due within [*] days following the close of each
calendar quarter.  Royalties that have
accrued in a particular calendar quarter shall be due and payable on the date
such royalty report is due. InterMune shall keep complete and accurate records
in sufficient detail to enable the royalties payable hereunder to be
determined.

 

3.6          Records and Audit.  InterMune shall maintain the records used to
calculate all royalties payable under Section 3.3(a) and 3.3(b), including,
without limitation, all records which support the calculation of each component
of the equation for Net Sales.  Such
records shall be maintained for at least [*]
years following the end of the calendar year to which they pertain.  Such records will be open for audit during
such [*] year period by an independent certified
public accountant selected by Marnac and KDL and reasonably acceptable to
InterMune for the purpose of verifying InterMune’s royalty and Net Sales
calculations.  Such audits may be made
no more than once each calendar year, at reasonable times mutually agreed by
InterMune, Marnac and KDL.  Marnac and
KDL shall bear the costs and expenses of audits conducted under this Section
3.6 unless a variation or error producing an underpayment in royalties payable
exceeding [*] of the amount payable for the time
period inspected is established in the course of any such audit, whereupon all
costs relating to the audit and any unpaid amounts that are discovered will be
paid by InterMune, together with interest on such unpaid amounts equal to the
lesser of prime rate [*] per year, or the
maximum rate permitted by law.  Should
the inspection prove overpayment by InterMune, such overpayment shall be
deducted from the next royalty or other payment due from InterMune hereunder,
without any interest due by Marnac and KDL. 
If InterMune [*] such records
available for audit as set forth in this Section 3.6, then the Parties agree
that [*] that could have been [*] shall be [*].

 

All
information obtained during and resulting from such audits conducted according
to this Section 3.6 are hereby deemed Confidential Information as such term is
defined in Section 8.1 and shall be kept confidential pursuant to Section 8.1.

 

3.6          Income Tax Withholding.  If laws, rules or regulations require
withholding of income taxes or other taxes imposed upon payments set forth in
this Section 3, InterMune shall

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5

 

make such withholding payments
as required and subtract such withholding payments from the payments set forth
in this Section 3.  InterMune shall submit
appropriate proof of payment of the withholding taxes to Marnac or KDL, as
appropriate, within a reasonable period of time.

 

4.             MANUFACTURING AND SUPPLY.

 

4.1          [*]           Marnac shall assist
InterMune in making contact with [*]
and other [*], including but not limited to
the [*], associated with the [*] (collectively [*]).  Marnac shall grant permission to all [*] to use Marnac’s and their own
Information to [*] Licensed Product
for InterMune.  InterMune shall be
responsible for negotiating and executing [*] with [*], or such other [*] that InterMune elects to use to [*]  Licensed Product.

 

4.2          Marnac Supply.

 

(a)           Marnac
shall provide InterMune with sufficient quantities  of Licensed Product (in the form of [*]  that is currently being used in
the Ongoing Clinical Trials) to supply (i) the Ongoing Clinical Trials through
to their completion in accordance with their protocols and (ii) those patients
that as of the Effective Date have  [*]
to Pirfenidone through Marnac and any additional patients to which
InterMune elects to provide  [*]  to Pirfenidone, on
a timetable adequate to permit InterMune to timely supply the parties
conducting such clinical trials and such patients with [*], for which supply InterMune
shall reimburse Marnac within  [*]
days of receipt of such quantity of Pirfenidone, an amount equal to [*].  Marnac shall provide to InterMune, prior to its delivery of
Licensed Product, with verification of  [*]
of such quantity of Licensed Product. 
Marnac’s duties to provide InterMune with
[*]
shall expire  [*]  after the [*].

 

(b)           Marnac
agrees to provide InterMune with sufficient quantities of  [*]  to use to conduct clinical
trials (other than the Ongoing Clinical Trials) and other customary research
and/or business practices at  [*]
of such quantities until the later of (a)
[*] or (b) [*] after the Effective Date.  InterMune agrees to reimburse Marnac for its  [*]  of such [*], as well as any  [*]  costs actually incurred to
deliver such Pirfenidone to InterMune.

 

(c)           Along
with each delivery of Pirfenidone delivered hereunder, Marnac shall provide to
InterMune a certificate of analysis  [*]
for the Pirfenidone being delivered.

 

5.             INTERMUNE DEVELOPMENT AND COMMERCIALIZATION
OBLIGATIONS.

 

5.1          [*].  InterMune shall use its Best Efforts to
apply for  [*]  for the treatment of IPF within  [*]  of the Effective Date.

 

5.2          Development and Commercialization.

 

(a)           InterMune
shall, within  [*]  from the Effective
Date, file an NDA with the FDA in at least one  [*]
human disease, assuming that the clinical data from a pivotal clinical
trial performed to support such a filing is sufficiently positive to support
the filing of an NDA based on  [*]
 In the event that InterMune does
not perform a pivotal clinical trial or the data from a pivotal clinical trial
is sufficiently positive, based on [*],
and InterMune does not file an NDA by

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

6

 

the expiration of  [*]  from the Effective Date,
InterMune will pay to Marnac  [*] for the [*] and [*] for the [*], in lieu of the milestone
payments set forth in Sections 3.2(b) and 3.2(d) in the [*].

 

(b)           InterMune
shall also, within  [*]  from the Effective
Date, complete a  [*]  clinical study,
designed to show proof-of-concept in a  [*]
human disease.  In the event that
InterMune does not complete a  [*]
study in  [*]  human disease by the
expiration of  [*]  from the Effective
Date, InterMune will pay to Marnac  [*] for the [*] and [*] for the [*],
in lieu of the milestone payments set forth in Sections 3.2(c) and 3.2(e) for
the [*].

 

(c)           For
purposes of Sections 5.2(a) and 5.2(b),  [*]
shall not qualify as a  [*]
human disease in the context of those paragraphs.

 

6.             Marnac and Margolin
Obligations

 

6.1          Information.  Marnac and Margolin shall deliver to
InterMune, within  [*]  of the Effective
Date, all Information in Marnac’s or in Margolin’s possession, including but
not limited to:  a list of Licensed
Patents; any Information relating to the Licensed Patents, the anti-fibrotic
uses of Pirfenidone, and/or the clinical development and manufacturing of Licensed
Product; provided that, if Marnac or Margolin are aware of any Information not
in their possession, they shall inform InterMune within the  [*]  of the Information and shall use
all reasonable efforts to [*].   InterMune acknowledges that the  [*]  may be in possession of
Information regarding the manufacture of Pirfenidone that they have not
disclosed to Marnac or Margolin.  With
respect to such manufacturing Information that the  [*]  have not disclosed to Marnac or
Margolin, the Parties agree that while  [*]
shall not be required to obtain such Information for [*], [*]
shall reasonably cooperate with  [*]
to the extent reasonably requested by  [*]
in relation to any efforts that  [*]
makes to request the  [*]  to disclose such
Information to [*].

 

6.2          Clinical and Regulatory Transition Assistance.

 

(a)           Marnac
represents that Exhibit B contains lists of (i) all Investigational New Drug
Applications (each, an “IND”) relating to Pirfenidone for anti-fibrotic uses—or
any regulatory filing having a similar effect in a country of the Territory
other than the U.S.—filed in Marnac’s name or with their cooperation (the
“Marnac INDs”) as of the Effective Date, and (ii) all ongoing clinical trials
of Pirfenidone for any anti-fibrotic indication pursuant to the Marnac INDs or
with Marnac’s, Margolin’s, KDL’s or Yamauchi’s sponsorship as of the Effective
Date anywhere in the Territory (the “Ongoing Clinical Trials”).  Within thirty (30) days after the Effective
Date, Marnac shall make inquiry with KDL and Yamauchi as to any INDs or other
regulatory filing having a similar effect in any country of the Territory for
the anti-fibrotic use of Pirfenidone and any clinical trials sponsored by
either of them relating to such use of Pirfenidone in the Territory, and report
back to InterMune KDL’s and Yamauchi’s responses.  During the period commencing on the Effective Date and ending  [*]  thereafter, Marnac and Margolin
shall provide: (i) reasonable assistance in granting InterMune such
authorizations, letter of access and other access to any of the Marnac INDs
(which relate to anti-fibrotic uses) as may be reasonably required to assist
InterMune in filing INDs relating to Pirfenidone in InterMune’s own name and/or
to incorporate information from the Marnac INDs into InterMune’s INDs for
Pirfenidone;

 

 

CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

7

 

(ii) reasonable assistance in
transferring management of the Ongoing Clinical Trials (which are for
anti-fibrotic uses) of Pirfenidone to InterMune; (iii) access, during normal
business hours and upon reasonable advance notice, to Margolin and appropriate
Marnac personnel to consult on current and future clinical trials; and (iv)
reasonable assistance in other aspects of InterMune’s assumption of
responsibility for the development of Licensed Product.  Such assistance set forth in (ii) in the
foregoing sentence shall include, without limitation, that Marnac shall permit
InterMune to review Marnac’s agreements with each party conducting an Ongoing
Clinical Trial and shall assign any such contract that InterMune requests to
InterMune to the extent permitted under the contract, which shall include
seeking consent to such an assignment from the party conducting the relevant
Ongoing Clinical Trial if required for assignment.

 

(b)           InterMune
shall be entitled, to every extent possible, to assume Marnac’s role in
connection with management of Ongoing Clinical Trials (which are for
anti-fibrotic uses).  InterMune shall be
responsible for payment of all sums accruing to be paid in connection with the
Ongoing Clinical Trials subsequently to the Effective Date to the extent that
InterMune accepts assignment of the contracts governing such trials, and shall
indemnify, defend and hold Marnac and KDL harmless from any such sums due to
any Third Party for the conduct from and after the Effective Date of such
Ongoing Clinical Trials for which InterMune has accepted an assignment of the
governing contract.  In the event that
InterMune elects not to continue with any particular Ongoing Clinical Trial for
which InterMune has accepted an assignment, InterMune shall defend, indemnify
and hold Marnac and KDL harmless from any claims or damages resulting from such
cessation of the study.  With respect to
the Ongoing Clinical Trials, Marnac shall defend, indemnify and hold harmless
InterMune (and its directors, officers, employees and agents) from any claims
or damages arising out of events occurring in such Ongoing Clinical Trials
(other than to the extent resulting from an election by InterMune not to
continue a clinical trial) prior to  [*]
after the Effective Date.

 

6.3          Publication.  Marnac, Margolin, KDL or Yamauchi shall
obtain InterMune’s prior written consent, which consent shall not be
unreasonably withheld, for any oral or written presentation, or written
submission for publication relating to the anti-fibrotic uses of Pirfenidone.  The Parties recognize that for the Ongoing
Clinical Trials, for investigator-sponsored clinical trials of Pirfenidone for
anti-fibrotic uses that are already underway as of the Effective Date, and
certain pre- and other non-clinical research regarding Pirfenidone for
anti-fibrotic uses that is ongoing as of the Effective Date (collectively, such
clinical trials and pre- and non-clinical research, the “Other Trials”) Marnac
has obligations  [*]  regarding the
conduct of the Other Trials.  To the extent
that Marnac has the right to review, pre-approve or otherwise control any
publication relating to any Other Trial, Marnac shall afford InterMune the
right to exercise such right or shall act on behalf of InterMune to exercise
such right in accordance with InterMune’s instructions.  The Parties recognize the  [*]  of one or more of the papers so
generated regarding an Other Trial, and InterMune consents to this arrangement,
subject only to InterMune’s rights with respect to such publications as set
forth in this Section 6.2.  Marnac
represents that the list included as Exhibit C to this Agreement is a complete
list of the Other Trials, as defined above in this Section 6.3.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

8

 

6.4          [*].   The Parties recognize that a number of
patients receive Pirfenidone on a  [*]
basis.   Marnac shall provide
InterMune with a list of all such patients. 
InterMune shall  [*]  to provide these
patients with Pirfenidone powder on the same basis the basis upon which those
patients are now provided Pirfenidone; provided that InterMune may elect to  [*]  providing Pirfenidone to such
patients as warranted [*].  InterMune shall have the right in its sole
discretion to determine whether and which additional patients in the future
shall be granted  [*]  to Pirfenidone.  Marnac may refer any inquiries regarding  [*]  to Pirfenidone for
anti-fibrotics to InterMune.

 

7.             Intellectual Property Matters; Patents.

 

7.1          Ownership.  InterMune shall solely own any Information
invented or developed in connection with any Licensed Product and all
intellectual property rights therein, including without limitation any patents
claiming such Information.

 

7.2          Control and Prosecution.  InterMune shall be responsible for and
control all patent filings, and prosecute and maintain any patents, divisions,
continuations with respect to the Licensed Patents in the Territory; provided,
however, that InterMune shall provide Marnac with prior notice and opportunity
to review and comment on any action taken by InterMune in controlling such
Licensed Patents.  Marnac and KDL on the
one hand, and InterMune on the other hand, shall
[*]
the cost of patent prosecution and maintenance [*].  Marnac and KDL shall be  [*] for [*] of such costs.

 

7.3          Cooperation.  Each Party agrees to cooperate with the
other and take all reasonable additional actions as may be reasonably required
to achieve the intent of this Section 7, including, without limitation, the
execution of necessary and appropriate instruments and documents.

 

7.4          Infringement of Third Party Patents.  In the event that a Third Party files an
action against a Party alleging that such Party’s activities under this
Agreement infringe such Third Party’s patent rights, such Party shall give
written notice to the other Party, and the Parties will consult and cooperate
on the best course of action.  The Party
that was sued shall have the right to defend itself against such action, and
the other Party shall provide all reasonable assistance in such defense.

 

7.5          Infringement of Licensed Patents.  If any Party becomes aware that a Third
Party is infringing any rights in the Licensed Patents, such Party shall give
written notice to the other Party describing in detail the nature of such
infringement.  InterMune shall have the
initial right to enforce the Licensed Patents against such Third Party
infringer.  Marnac and KDL agree to
provide InterMune all reasonable assistance  [*]
in such enforcement, including without limitation being joined as a party to
the suit where appropriate.  In the
event that InterMune fails to institute an infringement suit or take other
reasonable action in response to such infringement within  [*]  after its receipt of notice of
such infringement, Marnac shall have the right, but not the obligation, to
institute such suit or take other appropriate action in its own name to enforce
the Licensed Patents.  Any damages or
other recovery, whether by settlement or otherwise, from an

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9

 

action hereunder to enforce the
Licensed Patents shall first be applied to pay the costs and expenses of
participating in such action, and any remaining amount shall be shared by the
Parties as follows: (i) if InterMune institutes the infringement suit,  [*]  shall be paid to Marnac and the
remainder shall be paid to InterMune, and (ii) if Marnac or KDL institutes the
infringement suit because InterMune fails to institute an infringement suit or
take other reasonable action in response to such infringement,  [*]  shall be paid to Marnac and the
remainder shall be paid to InterMune.

 

7.6          New Inventions.  New  [*]
patent applications and patents obtained by InterMune shall be subject
to  [*]  should this Agreement terminate
prior to the term set forth in Section 9.1. 
Marnac, KDL, Margolin and Yamauchi shall not seek or obtain new Patents
without the prior written consent of InterMune.  Nothing in this paragraph shall affect, limit, or restrict in any
way Marnac’s or KDL’s right to seek new applications of Pirfenidone which are
not  [*]  nor affect Marnac or KDL’s right
to make new inventions [*].

 

8.             CONFIDENTIALITY

 

8.1          The
Parties incorporate into this Agreement the Mutual Confidential Disclosure
Terms, attached as Exhibit A (the “CDA”), and “Confidential Information” has
the meaning given therein.

 

8.2          InterMune will issue
a press release concerning the Parties’ entry into this Agreement, with the
contents of such release to be approved in writing in advance by Marnac, which
approval shall not be unreasonably withheld. 
Except as required by law, none of the Parties shall publicly disclose
the terms and conditions of this Agreement unless expressly authorized in
writing to do so by the other Party, which authorization shall not be
unreasonably withheld.

 

9.             Representations and
Warranties

 

9.1          Mutual Representations and Warranties.  Each Party hereby represents and warrants to
each other Party that:

 

(a)           it
has full corporate or personal power and authority under the laws of the state
or country of its incorporation to enter into this Agreement and to carry out
the provisions hereunder;

 

(b)           this
Agreement is a legal and valid obligation binding upon it and is enforceable in
accordance with its terms;

 

(c)           the
execution, delivery and performance of this Agreement by it does not materially
conflict with any agreement, oral or written, to which it is a party or by
which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it;
and

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

10

 

(d)           [*].

 

9.2          Additional Representations and Warranties.  Marnac, KDL, Margolin and Yamauchi each
hereby represents and warrants to InterMune that:

 

(a)           Marnac
owns or has the right to represent all the owners of the Licensed Product;

 

(b)           None of the claims
in the Licensed Patents have been misappropriated from any Third Party nor are
the result of any misuse of any Third Party’s intellectual property;

 

(b)           All
inventors of the Licensed Patents have irrevocably assigned all right, title
and interest in the Licensed Patents to Marnac and/or KDL;

 

(c)           InterMune’s
practice of the claims under the Licensed Patents will not infringe the rights
of any Third Party;

 

(d)           No
claim, whether or not embodied in an action past or present, of any
infringement, of any conflict with, or of any violation of any patent, trade
secret or other intellectual property right or similar right of any Third
Party, has been made or is pending or threatened with respect to the Licensed
Patents; and

 

(e)           This
Agreement does not conflict with any other agreement to which Marnac, KDL,
Margolin or Yamauchi is a party, and none of them shall enter into an agreement
during the term of this Agreement that is in conflict with this Agreement.

 

9.3          Additional Representation and Warranty.   [*] further represents and warrants
that to the best of its knowledge, the written Information provided by  [*]  to [*], as well as the written
Information provided  [*]  to [*], were true and correct copies of
the materials reflected therein, and that to the best of their knowledge, any
material express representations that  [*]
made in such written materials  [*]
were and are true and correct. 
Nothing in the representation and warranty in the preceding sentence is
intended to warrant the [*].   Rather such warranty and representation is
limited to a warranty and representation that, to the best of  [*]  knowledge, the material
statements contained in the documents provided by  [*]  to [*], were and are true and correct,
and, to the best of  [*]  knowledge, the
document copies provided were true and correct copies.

 

9.4          Disclaimer.  Aside from the representations and
warranties made by the Parties expressly in this Agreement, EACH PARTY HEREBY
DISCLAIMS ANY IMPLIED WARRANTY AS TO THE LEGAL EFFECT OF THE LICENSED PATENTS,
THE FITNESS OF THE LICENSED PATENTS FOR THEIR INTENDED PURPOSE, THE
MERCHANTABILITY OF THE LICENSED PATENTS, AND ALL OTHER WARRANTIES WHICH MAY BE
IMPLIED AT LAW.  THE LICENSED PATENTS
ARE LICENSED “AS IS” WITHOUT WARRANTY OTHER THAN WARRANTIES OF TITLE AND WARRANTIES
EXPRESSLY SET OUT IN THIS AGREEMENT.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

11

 

This
disclaimer of warranty, however, shall not disclaim: (i) the implied
contractual covenant of good faith and fair dealing, which the Parties hereby
expressly recognize as applicable to this Agreement; (ii) the express and
implied duties of the Parties to perform as set forth herein; and (iii) any
warranty which may not be disclaimed as a matter of patent or other existing
law.

 

9.5          Indemnity. Each Party to this
Agreement shall defend, indemnify and hold harmless the other Parties (and
their directors, officers, employees and agents) against any liability or
damages from any claims of any Third Party to the extent that such claims arise
from a material breach by the indemnifying Party(ies) of any of his or its representations
or warranties contained herein.

 

10.          TERM AND TERMINATION.

 

10.1        Term. The term of this Agreement
shall commence on the Effective Date and expire upon the later of (a) the
expiration of U.S. Patent [*]; and (b) on a
disease-by-disease and country-by-country basis (as determined by reference to
the indications for which Pirfenidone is approved in such country), the later
of (i) in the event that Orphan Drug Status is granted, the expiration of
market exclusivity that results from the Orphan Drug Status for such disease in
such country, and (ii) the expiration of the last Valid Claim claiming the use
of Pirfenidone to treat such disease in such country, after which expiration of
this Agreement, InterMune shall have a fully paid-up, royalty-free, perpetual,
irrevocable, sublicenseable license to the Licensed Patents and Information.

 

10.2        Termination by InterMune.  InterMune may terminate this Agreement upon
thirty (30) days’ written notice to Marnac.

 

10.3        Termination for Material Breach.  If a Party materially breaches this
Agreement, and within sixty (60) days of written notice of breach from the
non-breaching Party, the breaching Party has not (i) cured the breach or (ii)
initiated good faith efforts to cure such breach to the reasonable satisfaction
of the non-breaching Party, then the non-breaching Party may terminate this
Agreement in writing promptly after expiration of such sixty (60) day period.

 

10.4        Effect of Termination.

 

(a)           In
the event that InterMune terminates this Agreement pursuant to Section 10.2, or
Marnac terminates this Agreement pursuant to Section 10.3, the license granted
to InterMune pursuant to Section 2.1 shall immediately terminate.

 

(b)           In the event that
Marnac or KDL materially breach this Agreement, InterMune shall have the right
to seek specific performance of this Agreement, in lieu of termination.  The Parties agree that InterMune may not
have an adequate remedy at law in the event of any material breach that
interferes with InterMune’s ability to commercially develop those rights
licensed in this Agreement.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

12

 

10.5        Bankruptcy Rights.  In the event that this Agreement is
terminated or rejected by a Party or its receiver or trustee under applicable
bankruptcy laws due to such Party’s bankruptcy, then all rights and licenses
granted under or pursuant to this Agreement by such Party to the other Party
are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code and any similar law or regulation in any other country,
licenses of rights to “intellectual property” as defined under Section 101(52)
of the Bankruptcy Code.  The Parties
agree that all intellectual property rights licensed hereunder, including
without limitation any patents or patent applications of a Party in any country
covered by the license grants under this Agreement, are part of the
“intellectual property” as defined under Section 101(52) of the Bankruptcy Code
subject to the protections afforded the non-terminating Party under Section
365(n) of the Bankruptcy Code, and any similar law or regulation in any other
country.

 

11.          MISCELLANEOUS

 

11.1        Entire Agreement; Amendment.  This Agreement and the CDA set forth the
complete, final and exclusive agreement between the Parties with respect to the
subject matter hereof, and all of the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties
hereto with respect to such subject matter, and supersedes and terminates all
prior agreements and understandings between the Parties with respect to such
subject matter.  There are no covenants,
promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties with respect to
such subject matter other than as are set forth herein and therein.  No subsequent alteration, amendment, change
or addition to this Agreement shall be binding upon the Parties unless reduced
to writing and signed by the Party, if an individual, or an authorized officer
of each Party.

 

11.2        Force Majeure.  The Parties shall be excused from the
performance of their obligations under this Agreement to the extent that such
performance is prevented by force majeure and the non-performing Party promptly
provides notice of the prevention to the other Party.  Such excuse shall be continued so long as the condition
constituting force majeure continues and the non-performing Party takes
reasonable efforts to remove the condition. 
For purposes of this Agreement, “force majeure” shall include conditions
beyond the control of the Parties, including without limitation, an act of God,
voluntary or involuntary compliance with any regulation, law or order of any
government, war, civil commotion, labor strike or lock-out, epidemic, failure
or default of public utilities or common carriers, destruction of production
facilities or materials by fire, earthquake, storm or similar catastrophe.

 

11.3        Notices.  Any notice required or permitted to be given under this Agreement
shall be in writing, shall specifically refer to this Agreement and shall be
deemed to have been sufficiently given for all purposes if mailed by first
class certified or registered mail, postage prepaid, express delivery service
or personally delivered, or if sent by facsimile and confirmed through one of
the foregoing methods.  Unless otherwise
specified in writing, the mailing addresses of the Parties shall be as
described below.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13

 

	
  For InterMune:

  	
   

  	
  InterMune, Inc.

  
	
   

  	
   

  	
  3280 Bayshore Boulevard

  
	
   

  	
   

  	
  Brisbane, CA 94005

  
	
   

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: General Counsel

  
	
   

  	
   

  	
   

  
	
  For Marnac:

  	
   

  	
  Marnac, Inc.

  
	
   

  	
   

  	
  9400 N.
  Central Expressway, Suite 305

  
	
   

  	
   

  	
  Dallas, TX 75231

  
	
   

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: Solomon B. Margolin

  
	
   

  	
   

  	
   

  
	
  For Margolin:

  	
   

  	
  Marnac, Inc.

  
	
   

  	
   

  	
  9400 N.
  Central Expressway, Suite 305

  
	
   

  	
   

  	
  Dallas, TX 75231

  
	
   

  	
   

  	
  [*]

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: Solomon B. Margolin

  
	
   

  	
   

  	
   

  
	
  For KDL:

  	
   

  	
  KDL GmbH

  
	
   

  	
   

  	
  Bahnhof
  Strasse 11

  
	
   

  	
   

  	
  CH-6301 Zug

  
	
   

  	
   

  	
  Switzerland

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention:  [*]

  
	
   

  	
   

  	
   

  
	
  For Yamauchi:

  	
   

  	
  KDL GmbH

  
	
   

  	
   

  	
  Bahnhof
  Strasse 11

  
	
   

  	
   

  	
  CH-6301 Zug

  
	
   

  	
   

  	
  Switzerland

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention:  [*]

  
	
   

  	
   

  	
   

  
	
  With a copy to:

  	
   

  	
  [*]

  
	
   

  	
   

  	
  Wisener*Nunnally, LLP

  
	
   

  	
   

  	
  620 West Main Street

  
	
   

  	
   

  	
  Garland, Texas 75040

  
	
   

  	
   

  	
  [*]

  

 

11.4        Independent Contractors.  The status of the Parties under this
Agreement shall be that of independent contractors.  Neither Party shall have the right to enter into any agreements
on behalf of the other Party, nor shall it represent to any person that it has
any such right or authority.  Nothing in
this Agreement shall be construed as establishing a partnership or joint venture
relationship between the Parties.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

14

 

11.5        Maintenance of Records.  Each Party shall keep and maintain all
records required by law or regulation with respect to the Product and shall
make copies of such records available to the other Party upon request.

 

11.6        United States Dollars.  References in this Agreement to “Dollars” or
“$” shall mean the legal tender of the United States of America.

 

11.7        No Strict Construction.  This Agreement has been prepared jointly and
shall not be strictly construed against any Party.   This Agreement shall be construed liberally to accomplish the
Parties’ objectives set forth in this Agreement.

 

11.8        Assignment.  Neither Party may assign or transfer this
Agreement or any rights or obligations hereunder without the prior written
consent of the other; provided however, a Party may make such an assignment
without the other Party’s consent to a successor-in-interest to substantially
all of the business assets of such Party to which this Agreement relates,
whether in a merger, sale of stock, sale of assets or other transaction.  Any permitted successor or assignee of
rights and/or obligations hereunder shall, in a writing to the other Party,
expressly assume performance of such rights and/or obligations. This Agreement
shall be binding upon and shall inure to the benefit of each Party’s
successors-in-interest and permitted assigns. 
Any assignment or attempted assignment by either Party in violation of
the terms of this Section 10 shall be null and void and of no legal effect.

 

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

 

11.10      Further Actions.  Each Party agrees to execute, acknowledge
and deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.

 

11.11      Severability.  If any one or more of the provisions of this
Agreement is held to be invalid or unenforceable, the provision shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof.  The
Parties shall make a good faith effort to replace any invalid or unenforceable
provision with a valid and enforceable one such that the objectives
contemplated by the Parties when entering this Agreement may be realized.

 

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

 

11.13      Headings.  The headings for each article and section in
this Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular article or section.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

15

 

11.14      No Waiver.  Any delay in enforcing a Party’s rights
under this Agreement or any waiver as to a particular default or other matter
shall not constitute a waiver of such Party’s rights to the future enforcement
of its rights under this Agreement, excepting only as to an express written and
signed waiver as to a particular matter for a particular period of time.

 

11.15      Choice of Law; Jurisdiction; Venue.  This Agreement will be governed and
construed in accordance with the laws of the State of Colorado as applied to
transactions taking place wholly within Colorado between Colorado residents.
For any legal action arising from or related to this Agreement, the Parties
hereby: (i) consent and submit solely to jurisdiction and venue of the state
and federal courts located in Denver, Colorado, (ii) agree that such courts
shall be the sole courts utilized and (iii) hereby waive any jurisdictional or
venue objections to such courts, including without limitation, forum non conveniens.

 

11.16      Litigation Costs.  If any dispute arises between the Parties
with respect to the matters covered by this Agreement which leads to a proceeding
to resolve such dispute, the prevailing Party in such proceeding shall, upon a
finding by the Court that the non-prevailing Party’s position lacked
substantial merit, be entitled to receive its reasonable attorneys’ fees,
expert witness fees and out-of-pocket costs incurred in connection with such
proceeding, in addition to any other relief it may be awarded.

 

11.17      Injunctive Relief.  A breach of any of the promises or
agreements contained in Section 8 of this Agreement may result in irreparable
and continuing damage to a Party for which there may be no adequate remedy at
law, and each Party is therefore entitled to seek injunctive relief as well as
such other and further relief as may be appropriate.  The obligations provided under Section 8 of this Agreement are
acknowledged as necessary and reasonable in order to protect each Party and its
business, and each Party expressly agrees that monetary damages would be
inadequate to compensate the other Party for the breach thereof.  Accordingly, each Party agrees and
acknowledges that any such violation or threatened violation will cause
irreparable injury to the other Party and that, in addition to any other
remedies that may be available, in law, in equity or otherwise, each Party
shall be entitled to obtain injunctive relief against the breach or threatened
breach by the other Party of Section 8 of this Agreement, without the necessity of proving actual
damages.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

16

 

IN WITNESS WHEREOF,
the Parties have executed this Agreement in by their proper officers as of the
date and year first above written.

 

	
  INTERMUNE, INC.

  	
  MARNAC, INC.

  
	
   

  	
   

  
	
  By: 

  	
   /s/
  John J. Wulf

  	
   

  	
  By: 

  	
   /s/
  Solomon B. Margolin

  	
   

  
	
   

  	
   

  
	
  Print Name:  

  	
   John J. Wulf

  	
   

  	
  Print Name:

  	
   Solomon B. Margolin

  	
   

  
	
   

  	
   

  
	
  Title:

  	
   Sr. Vice President of
  Corporate Development

  	
   

  	
  Title:

  	
   President

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  KDL, INC.

  	
  DR. SOLOMON MARGOLIN

  
	
   

  	
   

  
	
  By: Marnac, Inc., its attorney in fact

  	
  /s/ Solomon B. Margolin 

  	
   

  
	
   

  	
   

  
	
  /s/ Solomon B. Margolin

  	
   

  	
   

  
	
   

  	
   

  
	
  Dr. Solomon B. Margolin, President

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  SHITOTOMO YAMAUCHI

  	
  KDL GMBH

  
	
   

  	
   

  
	
  /s/ Solomon B. Margolin

  	
   

  	
  /s/ Solomon B. Margolin 

  	
   

  
	
   

  	
   

  
	
  By:  Marnac, Inc., his
  attorney in fact

  	
  By: Marnac, Inc., its attorney in fact

  
	
   

  	
   

  
	
  Dr. Solomon B. Margolin, President 

  	
  Dr. Solomon B. Margolin, President

  
													

 

 

CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

17

 

Exhibit A—Mutual Confidentiality and Disclosure Agreement

 

The Parties to
the License Agreement are bound by the following further provisions, which are
set out as an exhibit for sake of clarity and convenience:

 

1.             The Parties wish to exchange information
in connection with InterMune’s licensing of Pirfenidone from Marnac through the
License Agreement, which will entail the exchange of certain confidential
information relating to Marnac’s proprietary information, products and/or
business (“Marnac Confidential Information”) and/or InterMune’s proprietary
information, products and/or business (“InterMune Confidential Information”).
(The Marnac Confidential Information and the InterMune Confidential Information
are referred to collectively as “Confidential Information.”)  This Agreement shall govern the disclosure
of the Confidential Information.

 

2.             For purposes of this
Agreement, the party that transmits Confidential Information shall be referred
to as the “Discloser,” and the party to which Confidential Information is
transmitted shall be referred to as the “Recipient.”  Written Confidential Information shall be subject to the terms of
this Agreement [*]   Discloser shall  [*]  proprietary Confidential
Information as [*], within  [*]  days of such  [*]  disclosure.

 

3.             InterMune hereby agrees not to use the
Marnac Confidential Information except as the Parties may agree, and all data
and results from such discussions shall be protected as confidential pursuant
to this Agreement.

 

4.             Marnac hereby agrees not to use the
InterMune Confidential Information except as the Parties may agree, and all
data and results from such discussions shall be protected as confidential
pursuant to this Agreement.

 

5.             Each Party agrees
that, as a Recipient, the Party will use the same degree of care to keep all
Confidential Information confidential as the Party uses with respect to its own
information of similar importance. 
Unless Recipient first obtains the Discloser’s written consent, Recipient
shall not disclose any Confidential Information to others, except to the
licensees, employees or agents of Recipient who reasonably require the
Confidential Information for the purpose of this Agreement and who will use the
Confidential Information only for that purpose.

 

6.             Marnac and KDL
warrant that they will not reveal any InterMune Confidential Information to any
licensee, employee, contactor or agent of Marnac without first informing that
licensee, employee, contractor or agent of the confidential nature of the
InterMune Confidential Information and securing the licensee’s, employee’s,
contractor’s or agent’s agreement to be bound by terms and conditions
substantially equivalent to those in this Agreement as they apply to Marnac.

 

7.             InterMune warrants
that it will not reveal any Marnac Confidential Information to any licensee,
employee, contractor or agent of InterMune without first informing that
licensee, employee, contractor or agent of the confidential nature of the

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

18

 

Marnac Confidential Information
and securing the licensee’s, employee’s, contractor’s or agent’s agreement to
be bound by terms and conditions substantially equivalent to those in this
Agreement as they apply to InterMune.

 

8.             Notwithstanding
anything to the contrary in this Agreement, Recipient shall not be prevented
from using or disclosing Confidential Information that:

 

(a)           Recipient can demonstrate by competent proof
was lawfully known to Recipient before the disclosure by the Discloser and not
obtained or derived directly or indirectly from Discloser;

 

(b)           is now, or becomes in the future, public
knowledge other than by through the act or default of Recipient or its
employees;

 

(c)           Recipient obtains from a source independent
of Discloser who is lawfully in possession of such Confidential Information and
is not subject to an obligation of confidentiality or non-use owed to
Discloser;

 

(d)           Recipient can demonstrate or prove was
independently developed by Recipient without use or knowledge of such
Confidential Information; or

 

(e)           is properly required by law, regulation,
rule, act or order of any governmental authority or agency to be disclosed by
Recipient, provided that
Recipient shall provide Discloser with reasonable advance notice of any such
required disclosure and cooperate with Discloser in minimizing the extent of
any such disclosure and in seeking such protective order(s) or the like as may
be available to protect the confidentiality of the Confidential Information;
and provided further that
Recipient will make such disclosure only to the extent the disclosure is
legally required.

 

Recipient further agrees that,
if any Confidential Information becomes subject to the exceptions set forth in
this Section 8, Recipient will not disclose that such information was received
from and/or is used by Discloser unless such fact also becomes part of the
public domain.

 

Notwithstanding any other
provision in this Agreement, InterMune may use or disclose Marnac Confidential
Information in connection with the filing or publication of any patent or
patent application desired by InterMune to the extent such use or disclosure is
necessary to support the patent or patent application.

 

9.             The receipt of
Confidential Information shall not be deemed an admission by the Recipient of
the novelty or patentability of said subject matter.  Nothing in this Agreement, or in the furnishing of Confidential
Information by the Discloser, shall be construed as giving Recipient any right,
title, interest in or ownership of Confidential

 

 

CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

19

 

Information which is or becomes
covered by any patents, copyrights, trademarks, trade secrets or know-how owned
or held by the Discloser.

 

10.          Each Recipient’s confidentiality and non-use
obligations under this Agreement shall remain in effect for  [*]  years after the expiration or
termination of the License Agreement.

 

11.          If
this Agreement is terminated pursuant to Sections 10.2 or 10.3 of the License
Agreement, then each Party shall return all tangible Confidential Information
(including any samples) to Discloser, except that the Recipient shall have the
right to retain one (1) record copy of such tangible Confidential Information
in its legal files, from which to ascertain Recipient’s continuing obligations
to the Discloser under this Agreement.

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

20

 

EXHIBIT B

 

MARNAC INDS AND

ONGOING CLINICAL TRIALS

(AS EACH IS DEFINED IN SECTION 6.2(A))

 

[*]

 

 

CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

21

 

EXHIBIT C

 

OTHER TRIALS (AS DEFINED IN SECTION 6.3)

 

[*]

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