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Exhibit 10.15
EXECUTION COPY
RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
BETWEEN
PREDIX PHARMACEUTICALS HOLDINGS, INC.
AND
CYSTIC FIBROSIS FOUNDATION THERAPEUTICS INCORPORATED
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
<PAGE>
Research, Development and Commercialization Agreement
TABLE OF CONTENTS
<TABLE>
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Page
<S> <C>
ARTICLE I -
DEFINITIONS...........................................................................
2
ARTICLE II - RESEARCH
PROGRAM.....................................................................
8
2.1 Commencement;
Objective...............................................................
8
2.2
Term..................................................................................
9
2.3 Research
Diligence....................................................................
9
2.4 Research
Plan.........................................................................
9
2.5 Joint Research
Committee..............................................................
10
2.6 Exchange of
Information...............................................................
11
ARTICLE III -
PAYMENTS............................................................................
12
3.1 Staffing and Research Support
Payments................................................ 12
3.2
Payments..............................................................................
15
3.3
Records...............................................................................
16
ARTICLE IV - COMMERCIALIZATION;
ROYALTIES.........................................................
17
4.1 Discovery and Commercialization of a CFTR Corrector-Based
Product;
Commercialization of P2(Y)2
Product............................................................
17
4.2 Due
Diligence.........................................................................
18
4.3
Royalties.............................................................................
18
4.4 Sales
Reports.........................................................................
18
ARTICLE V -
CONFIDENTIALITY.......................................................................
20
5.1
Undertaking...........................................................................
21
5.2
Exceptions............................................................................
22
5.3
Publicity.............................................................................
23
ARTICLE VI -
PUBLICATION..........................................................................
24
ARTICLE VII -
INDEMNIFICATION.....................................................................
26
7.1 Indemnification by
Predix.............................................................
26
7.2 Claims
Procedures.....................................................................
26
ARTICLE VIII - PATENTABLE
INVENTIONS..............................................................
28
8.1
Ownership.............................................................................
28
8.2
Preparation...........................................................................
28
8.3
Costs.................................................................................
29
ARTICLE IX - TERM AND
TERMINATION.................................................................
29
9.1
Term..................................................................................
29
9.2 Termination of the Research Programs Without
Cause.................................... 29
9.3 Termination of the Research Program by CFFT for
Cause................................. 29
9.4 Termination of the Research Program by Predix for
Cause............................... 30
9.5 General Effect of
Termination.........................................................
31
</TABLE>
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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<PAGE>
<TABLE>
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9.6 Consequences of an
Interruption.......................................................
31
ARTICLE X - REPRESENTATIONS AND
WARRANTIES........................................................
32
10.1 Representations and Warranties of
Predix.............................................. 32
10.2 Representations and Warranties of
CFFT................................................ 32
ARTICLE XI - MISCELLANEOUS
PROVISIONS.............................................................
33
11.1 Governing Law, and
Jurisdiction.......................................................
33
11.2
Waiver................................................................................
33
11.3 Force
Majeure.........................................................................
33
11.4
Severability..........................................................................
34
11.5 Government
Acts.......................................................................
34
11.6
Assignment............................................................................
34
11.7
Counterparts..........................................................................
35
11.8 No
Agency.............................................................................
36
11.9
Notice................................................................................
36
11.10
Headings..............................................................................
37
11.11
Authority.............................................................................
37
11.12 Entire
Agreement......................................................................
38
11.13 Notice of Pharmaceutical
Side-Effects.................................................
38
</TABLE>
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
- ii -
<PAGE>
RESEARCH, DEVELOPMENT AND COMMECIALIZATION AGREEMENT
This Agreement (this "Agreement") is made on this 7th day of
March, 2005
(the "Effective Date"), between Predix Pharmaceuticals Holdings,
Inc.
("Predix"), a Delaware corporation with principal offices at 10K
Gill Street,
Woburn, MA 01801, and Cystic Fibrosis Foundation Therapeutics
Incorporated, a
Delaware corporation with its principal offices at 6931
Arlington Road,
Bethesda, Maryland 20814 ("CFFT"). Collectively, Predix and CFFT
shall be
referred to hereinafter as the "Parties".
WHEREAS, Predix has expertise in 3D technology and the discovery
and
development of small molecule compounds addressing a variety of
diseases; and
WHEREAS, CFFT is significantly focused on the discovery and
development of
methods of treatment of cystic fibrosis, to which CFFT and its
Affiliates bring
significant scientific and human resources and financial
support; and
WHEREAS, CFFT wishes to support the Research Programs
specified
hereinafter to be undertaken by Predix;
NOW, THEREFORE, in consideration of the mutual covenants set
forth in this
Agreement, and other good and valuable consideration, the
Parties agree as
follows:
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DENOTES
OMISSIONS.
<PAGE>
ARTICLE I - DEFINITIONS
For purposes of this Agreement, the terms defined in this
Article 1 shall
have the following meanings whether used in their singular or
plural forms. Use
of the singular shall include the plural and vice versa, unless
the context
requires otherwise:
1.1 "Affiliate" shall mean, with respect to any Person, any
other Person
who directly or indirectly, by itself or through one or more
intermediaries,
controls, or is controlled by, or is under direct or indirect
common control
with, such Person. The term "control" means the possession,
direct or indirect,
of the power to direct or cause the direction of the management
and policies of
a Person, whether through the ownership of voting securities, by
contract or
otherwise. Control will be presumed if one Person owns, either
of record or
beneficially, more than fifty percent (50%) of the voting stock
of any other
Person. For the avoidance of any doubt, the Cystic Fibrosis
Foundation and CFFT
are considered to be Affiliates.
1.2 "Agreement" means this agreement, together with all
appendices,
exhibits and schedules hereto, and as the same may be amended or
supplemented
from time to time hereafter by a written agreement duly executed
by authorized
representatives of each party hereto.
1.3 "Budget" shall mean the total amount to be paid by CFFT to
Predix for
each of Research Program I and Research Program II as specified
in Article III.
1.4 "CF" means the disease known as Cystic Fibrosis.
1.5 "CF Field" means the treatment of humans diagnosed with
CF.
1.6 "CFTR" shall mean a CF transmembrane conductance regulator
protein
which has the biological effect of transporting molecules across
human cellular
membranes.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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1.7 "[*******************] Efforts" shall have the definition
set forth in
Section 4.2.
1.8 "Controlled" (except in the context of Section 1.1) shall
mean the
legal authority or right of a party hereto to grant a license or
sublicense of
intellectual property rights to another party hereto, or to
otherwise disclose
proprietary or trade secret information to such other party,
without breaching
the terms of any agreement with a Third Party, infringing upon
the intellectual
property rights of a Third Party, or misappropriating the
proprietary or trade
secret information of a Third Party.
1.9 "Corrector" shall mean a compound which, as its principal
mode of
therapeutic action, modulates the biological effect of CFTR by
increasing the
amount of functional AF508 CFTR present at the apical cell
membrane.
1.10 "Effective Date" shall mean the date specified in the first
paragraph
of this Agreement.
1.11 "Field" shall mean the treatment of conditions or diseases
in the CF
Field and the Pulmonary Field.
1.12 "First Commercial Sale" shall mean the first sale of a
P2(Y)2 Product
by Predix or an Affiliate, licensee or sublicensee of Predix in
a country in the
Territory following Regulatory Approval of the P2(Y)2 Product in
that country
or, if no such Regulatory Approval or similar marketing approval
is required,
the date upon which the P2(Y)2 Product is first commercially
launched in that
country.
1.13 "FTE" shall mean the equivalent of the work of one Predix
scientist
or other project managerial professional, full time for one
year, on or directly
related to the Research
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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Program. Activities included in calculating FTE's shall
[***********************
*******************************************************************************
**********************************].
1.14 "Hit" shall have the meaning ascribed to it in Section
3.1.2 of this
Agreement.
1.15 "Interruption" shall occur (i) if at any time before the
First
Commercial Sale of a P2(Y)2 Product, Predix, its Affiliates and
sublicensees,
all cease to conduct, or have conducted, research activities
associated with the
development of such Product for a period of
[*******************************];
and (ii) as specified in Section 4.1.1.
1.16 "Joint Research Committee" or "JRC" shall have the meaning
ascribed
to it in Section 2.5 of Agreement.
1.17 "Net Sales" with respect to any product shall mean the
gross amount
invoiced by the selling party and its Affiliates, licensees or
sublicensees for
products sold in bona fide, arms-length transactions to Third
Parties for use in
the Field, less (i) quantity and/or cash discounts from the
gross invoice price
which are actually allowed or taken; (ii) freight, postage and
insurance
included in the invoice price; (iii) amounts repaid or credited
by reasons of
rejections or return of goods or because of retroactive price
reductions
specifically identifiable to such product; (iv) amounts payable
resulting from
government (or agency thereof) mandated rebate programs; (v)
third-party rebates
or charge-backs to the extent actually allowed; (vi) invoiced
customs duties and
sales taxes (excluding income, value-added and similar taxes),
if any, actually
paid and directly related to the sale that are not reimbursed by
the buyer; and
(vii) any other specifically identifiable amounts included in
the product's
gross invoice price that should be credited for reasons
substantially equivalent
to those listed above; all as determined in
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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accordance with the selling party's usual and customary
accounting methods,
which are in accordance with generally accepted accounting
principles.
In the case of any sale or other disposal of a product between
or
among the selling party and its Affiliates, licensees and
sublicensees, for
resale, Net Sales shall be calculated as above
[********************************
**********************************************];
In the case of any sale which is not invoiced or is delivered
before
invoice, Net Sales shall be calculated at the time of shipment
or when the
product is paid for, if paid for before shipment or invoice;
In the case of any sale or other disposal for value, such as
barter
or counter-trade, of any product, or part thereof, other than in
an arm's length
transaction exclusively for money, Net Sales shall be calculated
as above on the
value of the consideration received;
In the event the product is sold in a finished dosage form
containing the product in combination with one or more other
active ingredients
(a "Combination Product"), the Net Sales of the product, for the
purposes of
determining royalty payments, shall be determined
[*****************************
********************************************************************************
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********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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<PAGE>
********************************************************************************
*****************************************************************************].
1.18 "Patents" means all existing patents and patent
applications and all
patent applications hereafter filed, including any
continuation,
continuation-in-part, division, provisional or any substitute
applications, any
patent issued with respect to any such patent applications, any
reissue,
reexamination, renewal or extension (including any supplementary
protection
certificate) of any such patent, and any confirmation patent or
registration
patent or patent of addition based on any such patent, and all
foreign
counterparts of any of the foregoing.
1.19 "Person" means any individual, corporation, partnership,
association,
joint-stock company, trust, unincorporated organization or
government or
political subdivision thereof.
1.20 "Predix CF Technology" shall mean all data, technical
information,
know-how, inventions (whether or not patented) trade secrets,
processes and
methods discovered or developed, and Controlled by Predix or its
Affiliates, in
the performance of the Research Program under this Agreement,
including without
limitation, the
[***************************************************];
provided,
however, that notwithstanding the foregoing, the term "Predix CF
Technology"
shall not include any data, technical information, know-how,
inventions (whether
or not patented) trade secrets, processes or methods owned or
Controlled by
Predix prior to, or outside of, Predix's performance of the
Research Program
under this Agreement, including without limitation, Predix's
general receptor
and ion channel modeling technology, or computational drug
discovery, drug
optimization and drug design technology, or any enhancements or
improvements to
any of the foregoing.
1.21 "Predix Patents" shall mean any Patents Controlled by
Predix or its
Affiliates claiming Predix CF Technology.
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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<PAGE>
1.22 "Prime Rate" shall mean
[******************************************
***************************].
1.23 "Pulmonary Field" shall mean the treatment of diseases of
the human
pulmonary tract or lungs, other than CF.
1.24 "P2Y(2) Product" shall have the meaning set forth in
Section 2.1.
1.25 "Regulatory Approval" shall mean, with respect to any
country, all
authorizations by the appropriate governmental entity or
entities necessary for
commercial sale of a pharmaceutical product in that country
including, without
limitation and where applicable, approval of labeling, price,
reimbursement and
manufacturing. "Regulatory Approval" in the United States shall
mean final
approval of a new drug application pursuant to 21 CFR Section
314, permitting
marketing of the P2(Y)2 Product in interstate commerce in the
United States.
"Regulatory Approval" in the European Union shall mean final
approval of a
Marketing Authorization Application, or equivalent.
1.26 "Research Plan" shall have the meaning set forth in Section
2.4
hereof.
1.27 "Research Program I" shall have the meaning set forth in
Section 2.1.
1.28 "Research Program II" shall have the meaning set forth in
Section
2.1.
1.29 "Research Programs" shall mean collectively all research
activities
undertaken under this Agreement relating to Research Program I
and Research
Program II.
1.30 "Research Termination Date" shall mean the date which
is
[***************] following the Effective Date for Research
Program I and the
date which is [**********
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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*******] following the Effective Date for Research Program II,
in both cases
subject to extension as provided in Section 2.2.
1.31 "Territory" shall mean worldwide.
1.32 "Third Party" shall mean any person or entity which is not
a party or
an Affiliate of any party to this Agreement.
ARTICLE II - RESEARCH PROGRAM
2.1 COMMENCEMENT; OBJECTIVE.
Predix will be responsible for the conduct of the Research
Programs as set
forth herein. CFFT will provide the financial support
hereinafter specified, and
consultation and advice as provided herein through its
participation on the JRC
as provided below. The Research Program will consist of two sets
of separate
activities, as set forth in the Research Plan, and generally
described as
follows: (i) Predix will use its 3D technology and modeling
expertise to model
the 3D structure of the CFTR (such activities are the "Research
Program I") and
(ii) Predix will use its 3D GPCR technology to discover a
small-molecule P2Y(2)
agonist that once optimized will be a novel compound for the
treatment of CF
(such activities are "Research Program II" and any product
containing a
small-molecule P2Y(2) agonist discovered during the performance
of Research
Program II, whether or not the molecule has been further
optimized, is a "P2Y(2)
Product").
Following the successful completion of Research Program I (or
prior to its
completion if the Parties so desire), the Parties agree to
negotiate in good
faith towards an agreement pursuant to which a molecule that
will act as a CFTR
Corrector will be discovered, optimized, developed
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DENOTES
OMISSIONS.
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and commercialized, all as more fully set forth in Section 4.1.
Subject to
CFFT's rights in the event of an Interruption pursuant to
Section 9.6 of this
Agreement, Predix shall have exclusive rights to further develop
and
commercialize all P2Y(2) Products.
2.2 TERM.
The Research Programs shall commence on the Effective Date and
will
conclude on the Research Termination Date, unless extended by
agreement of the
Parties, or unless earlier terminated in accordance with the
provisions of
Article IX hereof. The Parties may discuss at any time whether,
and upon what
basis, the Research Program might be extended beyond the initial
Research
Termination Date.
2.3 RESEARCH DILIGENCE.
Predix will
[***********************************************************
*******], to accomplish the goals of the Research Programs.
Predix will dedicate
to the Research Programs at least that level of staffing
referenced in Section
3.1 hereof, and expects to employ an appropriate combination of
experience and
training in the CF Field.
2.4 RESEARCH PLAN.
Predix and CFFT have agreed upon an overall research plan for
the
Research Programs, a copy of which is attached to this Agreement
as Exhibit 2.4.
The JRC will review and evaluate the Research Plan, taking into
consideration
ongoing research outcomes and other scientific and commercial
developments, at
each meeting of the JRC after the Effective Date, and any
resulting
modifications will be incorporated into the Research Plan (the
original plan,
and any such modifications are referred to herein as the
"Research Plan").
Modifications to the Research Plan may be proposed by either
Predix or CFFT and
must be approved by [*******]
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DENOTES
OMISSIONS.
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before being adopted. Any modification to the Research Plan
proposed by [******]
that would
[********************************************************************
*****************************************************************************],
shall not be adopted without the approval of [*****], which will
act
expeditiously on any such proposal.
2.5 JOINT RESEARCH COMMITTEE.
2.5.1 Composition and Purposes. Predix and CFFT shall establish
a
Joint Research Committee ("JRC") consisting of at least six (6)
representatives
(as may be increased or decreased by the JRC), half of whom
shall be designated
from time to time by each party. Each party shall choose a
Program Coordinator
who may be changed from time to time by designation of each
party. The Program
Coordinator for Predix shall be [*********]. The Program
Coordinator for CFFT
shall be [******************]. If the JRC chooses to designate a
Committee
Chair, the Chair will be [******************]. The JRC shall
meet formally no
less frequently than once in each three (3) month period during
the Research
Program, and at such time and location, as may be established by
the Committee.
However, the JRC will make its schedule flexible in order to
foster the
successful completion of the Research Programs. The JRC shall
meet for the
following purposes:
(i) to review and discuss the Research Plan and evaluate any
proposed revisions to any of those plans;
(ii) to determine whether milestones have been achieved; and
(iii) to provide guidance to the research team if such
guidance is needed on next steps to implement the Research
Programs.
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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At least [**********] working days prior to each JRC meeting,
Predix
will send a written report to CFFT detailing the progress made
in the respective
Research Programs during the preceding quarter. Within
[**************] days
after the date of each meeting, Predix shall prepare and deliver
minutes of the
meeting to the members of the JRC, setting forth, inter alia,
all decisions of
the JRC, and including as an attachment the report on the
progress of work
performed required by this Section 2.5.1.
2.5.2 MILESTONE DECISION-MAKING. The JRC shall determine whether
or
not milestone events have been achieved. Each of Predix and CFFT
shall have one
vote on such matter, to be exercised by their respective Program
Coordinators.
In the event a deadlock occurs or whether or not a milestone
event has been
successfully completed, the Parties shall mutually select a
Third Party who
shall make such determination. The determination of such party
shall be binding
on the Parties.
Each party shall retain the rights, powers, and discretion
granted
to it under this Agreement, and the JRC shall not be delegated
or vested with
any such rights, powers or discretion except as expressly
provided in this
Agreement. The JRC shall not have the power to amend or modify
this Agreement,
which may only be amended or modified as provided in Section
11.12.
2.6 EXCHANGE OF INFORMATION.
Predix will share information with the JRC when available
and
necessary to facilitate mutual understanding of the status of
the Research
Program and decision-making in connection therewith.
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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ARTICLE III - PAYMENTS
3.1 STAFFING AND RESEARCH SUPPORT PAYMENTS.
CFFT will make the payments to Predix specified below during
the
Term in support of the Research Programs under this
Agreement.
3.1.1 RESEARCH PROGRAM I
<TABLE>
<CAPTION>
FTE Research
Funding (# FTEs
Estimated charged Total
Item in Time at [******* Out-sourced Budgeted
Exhibit 2.4 (Months)* **********] activities Amount
----------- ----------- --------------- -----------
-------------
<S> <C> <C> <C> <C> <C>
a) [******************]: to be paid on the date of execution $
2,000,000
b) Base Research Funding:
[********** [*******] [*******] [*********] [********
[*********]
*********** *********
**** ********
*********** ********
********* ********]
***********
*********
*******
*********]
[*********] [*********] [*********] [*********] [*********]
[*********]
</TABLE>
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
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CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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<TABLE>
<S> <C> <C> <C> <C> <C>
[******** [********
********* ********]
**********
***********
**********
***********
********
***********]
[******** [***] [********] [********] [******** [********]
********* [********]
********** [********]
********
*********
**********]
[******** [***] [********] [********] [******** [********]
********* [********]
********** [********]
********
*********
**********]
c) Milestones:
</TABLE>
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DENOTES
OMISSIONS.
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<TABLE>
<S> <C>
[************************************************************
[********]
****]
[************************************************************
[********]
****]
[************************************************************
[********]
****]
Aggregate Budgeted Amount for Research Program I [********]
</TABLE>
Each milestone shall be due and payable [************] after it
is achieved.
All milestones under Research Program I that are not achieved
prior to the
Research Termination Date will nevertheless be paid by CFFT to
Predix if
achieved within [********] after the Research Termination
Date.
*Periods are estimates. The parties anticipate that particular
aspects of the
Research Programs may take longer than the periods indicated but
that the
Research Programs will likely be completed on or prior to the
Research
Termination Date.
**This payment shall be reduced to [********] if this milestone
is accomplished
before the milestone in subparagraph (c)(2) above ("Milestone
(c)(2)"); and, the
remaining [********] shall be added to the amount specified for
Milestone (c)(2)
and paid to Predix upon the accomplishment of Milestone
(c)(2).
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED
SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S
APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*]
DENOTES
OMISSIONS.
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3.1.2 RESEARC
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