Exhibit 10.2
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
AMENDED AND RESTATED
RESEARCH AND DEVELOPMENT AGREEMENT
among
LEXICON PHARMACEUTICALS, INC.
SYMPHONY ICON HOLDINGS LLC
and
SYMPHONY ICON, INC.
Dated as of June 15, 2007
1
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
TABLE OF CONTENTS
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1.
Assignment
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2. Overview of
Development
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3. Development
Committee
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4. Development
Plan and Development Budget
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4.1
Generally
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4.2
Amendments
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4.3 Lexicon Funded
Research
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5. Regulatory
Matters
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5.1 FDA
Sponsor
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5.2
Correspondence
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5.3 Inspections
and Meetings
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5.4 Transfer of
FDA Sponsorship
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6. Lexicon’s
Obligations
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6.1
Generally
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6.2
Subcontracting
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6.3 Reports and
Correspondence
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6.4 Staffing
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6.5 QA Audit
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6.6 Financial
Audit
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6.7
Insurance
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7. Symphony
Icon’s Obligations
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7.1
Generally
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7.2
Subcontracting
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7.3
Insurance
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7.4 Staffing
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7.5 Inspection and
Audit
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8. Funding and
Payments
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8.1 Use of
Proceeds
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8.2
Reimbursement
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8.3 Budget
Allocation and Deviations
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8.4 Employee
Benefits
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9. Covenants
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9.1 Mutual
Covenants
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10.
Confidentiality
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11.
Discontinuation Option
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12.
Representations and Warranties
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12.1 Lexicon
Representations and Warranties
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12.2 Symphony Icon
Representations and Warranties
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13. Relationship
Between Lexicon and Symphony Icon
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14. Change of
Control
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15. No
Restrictions; Indemnification
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15.1 No
Restrictions
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15.2
Indemnification
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16. Limitation of
Liabilities
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16.1 Between the
Parties
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16.2 Pursuant to
the RRD Services Agreement
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17. Term and
Termination
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17.1 Term
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17.2 Termination
for Lexicon’s Breach
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17.3 Termination
for Symphony Icon’s or Holdings’ Breach
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17.4 Termination
of License Agreement
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17.5
Survival
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18.
Miscellaneous
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18.1 No
Petition
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18.2 Notices
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18.3 Governing
Law; Consent to Jurisdiction and Service of Process
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18.4 Waiver of
Jury Trial
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18.5 Entire
Agreement
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18.6 Amendment;
Successors; Assignment; Counterparts
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18.7
Severability
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18.8 Third Party
Beneficiary
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Annex A
— Certain Definitions
Annex B — Development Committee Charter
Annex C — Initial Development Plan and Initial Development
Budget
Annex D — [Intentionally Omitted.]
Annex E — Payment Terms
Schedule 6.2 — Subcontracting Agreements
Schedule 6.4 — Lexicon Key Personnel
Schedule 12.1(f) — Material Disclosed Contracts
ii
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
AMENDED AND RESTATED
RESEARCH AND
DEVELOPMENT AGREEMENT
This AMENDED AND RESTATED RESEARCH
AND DEVELOPMENT AGREEMENT (this “ Agreement ”)
is entered into as of June 15, 2007 (the “ Closing
Date ”) by and among LEXICON PHARMACEUTICALS, INC., a
Delaware corporation (“ Lexicon ”), SYMPHONY
ICON, INC., a Delaware corporation (“ Symphony Icon
”) (each of Lexicon and Symphony Icon being a “
Party ,” and collectively, the “ Parties
”), and SYMPHONY ICON HOLDINGS LLC, a Delaware limited
liability company (“ Holdings ”). Capitalized
terms used herein and not defined herein shall have the meanings
assigned to such terms in Annex A attached hereto.
PRELIMINARY STATEMENT
Lexicon and Holdings have entered
into that certain Research and Development Agreement, dated as of
June 15, 2007 (the “ Research and Development
Agreement ”). Pursuant to this Agreement, Holdings
desires to assign all of its rights and delegate its obligations
under the Research and Development Agreement to Symphony Icon, and
Lexicon and Symphony Icon desire to amend and restate the terms and
conditions of the Research and Development Agreement.
In the Novated and Restated
Technology License Agreement, Lexicon grants Symphony Icon an
exclusive license to develop and commercialize the Products.
Symphony Icon wishes for Lexicon to continue to develop such
Products. Symphony Icon and Lexicon desire to establish, and agree
on the responsibilities of, a Development Committee to oversee such
development. Lexicon and Symphony Icon further desire to comply
with and perform certain agreements and obligations related
thereto.
The Parties hereto agree as
follows:
1. Assignment . The
Parties agree that from and after the Closing Date, all of the
rights and obligations of Holdings under the Research and
Development Agreement will be assigned and transferred to, and
assumed by, Symphony Icon.
2. Overview of
Development .
(a) The
Parties shall develop the Programs in a collaborative and efficient
manner as set forth in this Article 2 . Representatives
of the Parties shall engage in joint decision-making for the
Programs as set forth in Articles 3 and 4 hereof.
Symphony Icon shall have overall responsibility for all matters set
forth in the Development Plan (pursuant to Article 7
hereof), and shall engage Lexicon (pursuant to
Article 6 hereof), RRD (pursuant to the RRD Services
Agreement), and such independent contractors and agents as Lexicon
may retain on Symphony Icon’s behalf or as it may retain with
RRD’s assistance (which contractors include entities retained
by Lexicon prior to the Closing Date pursuant to the Subcontracting
Agreements set forth on
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
Schedule 6.2 ), to act on behalf of Symphony Icon and
carry out the duties set forth therein and herein.
(b) With
respect to the LG617 Program and the LG103 Program, Lexicon shall
be responsible for the execution of all pre-clinical and clinical
development, all scientific and technical services associated with
such development, and all patent work, including all related
matters set forth in the Development Plan for such Programs.
(c) Nothing
in Section 2(b) shall in any way limit the authority of
the Development Committee (as defined below) or the Symphony Icon
Board hereunder, and the engagements and delegations set forth
therein shall be subject to the terms and conditions of this
Agreement and the RRD Services Agreement, and the satisfactory
performance by RRD and Lexicon of their obligations pursuant hereto
and thereto. The allocations of responsibility described in this
Article 2 shall remain subject to further modification
in accordance with the terms and conditions of this Agreement and
the RRD Services Agreement.
(d) Lexicon
hereby acknowledges and agrees to Symphony Icon’s engagement
of RRD to act on its behalf and to carry out the duties assigned to
RRD herein and in the RRD Services Agreement, including, but not
limited to (i) providing personnel and support to the
Development Committee and the Symphony Icon Board, (ii) the
management and administration of Symphony Icon,
(iii) monitoring Lexicon’s implementation of the
Programs, and (iv) subject to Section 6.1(a) and
without limiting Lexicon’s role thereunder, such other
development-related work as Symphony Icon may reasonably delegate
to RRD in accordance with the Development Plan.
(e) The
Parties acknowledge that, subject to the rights of Symphony Icon
under the Operative Documents, Lexicon may enter into arrangements
with one or more third parties with respect to the development and
commercialization of one or more Programs or Products; provided
that such arrangements are consistent with Lexicon’s
potential reversionary interest in the Programs and/or Products. In
the event Lexicon enters into any such arrangement, subject to the
rights of Symphony Icon under the Operative Documents, Symphony
Icon will use reasonable efforts to accommodate requests by Lexicon
with respect to the participation of such third party in
development activities hereunder relating to such Program or
Product, including without limitation, participation or observation
rights for Development Committee meetings and activities; provided
such participation shall be limited to the applicable Programs or
Products.
3. Development Committee
. The Parties shall establish and maintain a committee (the “
Development Committee ”) to oversee the development of
the Programs (including the continued development and refinement of
the Development Plan and the Development Budget). The Development
Committee shall be established, operated and governed in accordance
with the policies and procedures set forth in Annex B hereto
(the “ Development Committee Charter ”). The
Development Committee Charter may be amended only with the
unanimous approval of the Development
2
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
Committee Members and the consent of the Symphony Icon Board,
Holdings and Lexicon. In no event shall the Development Committee
have the power to amend the terms of any Operative Document.
4. Development Plan and
Development Budget .
4.1
Generally . The Parties have agreed, as of the Closing Date,
to an Initial Development Plan and an Initial Development Budget,
which are attached hereto and incorporated herein as Annex C
, and which shall be further developed and refined from time to
time in accordance herewith. The Initial Development Plan consists
(and the Development Plan shall consist) of detailed provisions
governing all research, pre-clinical, clinical, development,
manufacturing, scientific, technical, regulatory and patent work to
be performed under the Operative Documents. Following the Closing
Date, the Development Committee shall, on an ongoing basis, further
develop the Development Plan to include, without limitation,
(i) an outline of the plan for the clinical development of
each Program; and (ii) outlines of non-clinical activities,
key regulatory and quality activities, and CMC activities for each
Program. The Initial Development Budget consists (and the
Development Budget shall consist) of two (2) components: (x) a
development budget for each Program covered by the Development Plan
(the “ Program Specific Budget Component ”), and
(y) a budget for the cross program management and
administrative functions of Symphony Icon, as set forth in
Section 1(a) of the RRD Services Agreement (the “
Cross Program Budget Component ”). The development
budgets for each Program in the Program Specific Budget Component
covered by the Development Plan shall be further divided into
budget spreadsheets summarizing (1) anticipated costs of
engaging third party service providers and the scope of work to be
performed by such third parties; and (2) the number of FTEs to
be dedicated to the Programs (by function and work
responsibilities, on a Program-by-Program basis). All presently
anticipated or actual expenditures of Symphony Icon, [**] , are
included in the Initial Development Budget attached hereto, and
will continue to be included in any amendments thereof. The
Development Committee shall, at the request of the Symphony Icon
Board, submit the Development Plan and the Development Budget (as
each shall have been developed and refined up to such point) to the
Symphony Icon Board for its review at the first meeting of the
Symphony Icon Board. Following the Symphony Icon Board’s
review, the Development Committee shall work diligently to
incorporate any comments generated by the Symphony Icon
Board’s review and update the Development Plan and the
Development Budget as soon as practicable, and submit the updated
Development Plan and the updated Development Budget to the Symphony
Icon Board for further review.
4.2
Amendments .
(a) All
amendments of, and all material deviations from, the Development
Plan and Development Budget (including amendments or deviations
made at the request of Lexicon or RRD, in accordance with
Section 8.3 hereof or Section 2(b) of the
RRD Services Agreement, respectively) shall be made in
3
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
accordance with the procedures described in this
Article 4 and in the Development Committee Charter,
including obtaining the approval of the Symphony Icon Board, as may
be required by the Development Committee Charter.
(b) The
Development Committee shall review the Development Plan and
Development Budget [**] to determine whether any changes are
required, and shall comply with all procedures required to amend
the Development Plan or Development Budget to implement such
changes. Furthermore, following the Closing Date, the Development
Committee shall, on an ongoing basis, continue to develop the
Development Plan, including, without limitation, as set forth in
Section 4.1 and in response to requests, proposals or
reports from Lexicon and RRD to the Development Committee.
(c) A
Program, or a Product within a Program, may only be discontinued in
the event that either (i) the Parties mutually agree to
discontinue such Program or Product based on (A) a Medical
Discontinuation Event, or (B) scientific evidence (regardless
of whether such evidence is generated by a Party or a third party)
that [**] (a “ Scientific Discontinuation Event
”) that arises in the course of developing such Program or
Product; or (ii) upon recommendation of the Development
Committee, the Symphony Icon Board resolves to discontinue such
Program or Product by (A) [**], or (B) [**] ; provided ,
that notwithstanding the foregoing, the Symphony Icon Board may at
any time, by the applicable vote described in this clause
(ii) , discontinue a Program or Product upon a Medical
Discontinuation Event without a prior recommendation of the
Development Committee. The Development Committee shall promptly
thereafter amend the Development Plan to reflect such
discontinuation and amend the Development Budget to reallocate to
any or all of the remaining Programs some or all of the funds
previously allocated to the discontinued Program or Product (with
any funds not then allocated to be held for reallocation by the
Development Committee).
(d) The
Development Plan shall never be amended in any manner that would
require Lexicon or Symphony Icon (or any Person acting on behalf of
Lexicon or Symphony Icon (including RRD and its RRD Personnel)) to
perform any assignments or tasks in a manner that would violate any
applicable law or regulation. In the event of a change in any
applicable law or regulation, the Development Committee shall
consider amending the Development Plan to enable Lexicon or
Symphony Icon (or any Person acting on behalf of Lexicon or
Symphony Icon (including RRD and its RRD Personnel)), as the case
may be, to comply fully with such law or regulation. If such
amendment is not approved, the affected Party shall be excused from
performing any activity specified herein or in the Development Plan
that would violate or result in a violation of any applicable law
or regulation.
4.3
Lexicon Funded Research . Lexicon and Symphony Icon hereby
agree that, until the end of the Term, Lexicon, upon request to the
Development Committee, using commercially reasonable methods, may
expend its own funds to extend, increase, or otherwise modify,
outside the scope of the Development Plan, the trials and
development activities run by Lexicon, subject to the prior
approval of the
4
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
Development Committee. The Development Committee shall consider any
such request in good faith taking into account the fact that
Symphony Icon will receive the benefits, if any, of such additional
activities, without any cost to Symphony Icon as well as taking
into account the risks, if any, of such activities to the relevant
Program. Such additional Lexicon-supplied funds shall not be
included in the calculations used to determine the Discontinuation
Price (pursuant to Section 11(a) hereof) or the
Purchase Price (pursuant to Section 2(b) of the Purchase Option
Agreement). Lexicon agrees that the results of such research and
development shall immediately become part of the Licensed
Intellectual Property and shall thereafter be subject to the terms
of the Operative Documents. Lexicon’s rights pursuant to this
Section 4.3 are in addition to, and separate from, its
rights pursuant to Section 8.3 hereof.
5. Regulatory Matters
.
5.1
FDA Sponsor . Notwithstanding any governance provision
contained herein or in any Operative Document, the Parties agree
that, until the termination or unexercised expiration of the
Purchase Option, Lexicon shall be the FDA sponsor, and shall serve
the equivalent role with respect to any corresponding recognized
regulatory authority outside of the United States, for the
Programs, except any Programs which were the subject of a
Discontinuation Option that was not exercised by Lexicon (the
“ FDA Sponsor ”). As the FDA Sponsor, Lexicon
shall have the responsibility and the authority to act as the
sponsor and make those decisions and take all actions necessary to
assure compliance with all regulatory requirements. Lexicon agrees
to be bound by, and perform all obligations set forth in, 21 C.F.R.
§ 312 and any and all similar obligations imposed by a
recognized foreign regulatory authority related to Lexicon’s
role as the FDA Sponsor. Notwithstanding anything to the contrary
in Article 4 or the Development Committee Charter,
Lexicon, in its capacity as FDA Sponsor, may discontinue or modify
any Program without the approval of the Development Committee or
the Symphony Icon Board in the event such actions are:
(a) attributable to an event that is reportable to the FDA or
corresponding recognized regulatory authority outside of the United
States; and (b) reasonably necessary to avoid the imposition
of criminal or civil liability; provided , however ,
that to the extent commercially reasonable, Lexicon shall
(i) pursuant to Section 5.2 , advise and consult
with the Development Committee prior to taking such action and
(ii) forward a copy of all regulatory correspondence relevant
to such discontinuation or modification to the members of the
Symphony Icon Board.
5.2
Correspondence . Each Party hereto acknowledges that
Lexicon, in its capacity as FDA Sponsor, shall be the Party
responding to any regulatory correspondence or inquiry regarding
one or both Programs. Lexicon shall: (a) notify at least one
(1) Development Committee Member designated by Holdings within
[**] of any FDA or other governmental or regulatory inspection or
inquiry concerning any study or project under the Programs,
including, but not limited to, inspections of investigational sites
or laboratories; and (b) forward to the Development Committee
copies of any correspondence from any regulatory or governmental
agency relating to such a study or project, including, but not
limited to, Form FD-483 notices and FDA refusal to file,
5
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
action
or warning letters, even if they do not specifically mention
Symphony Icon. Subject to the following sentence, Symphony Icon
shall not have any right to initiate any regulatory correspondence
with respect to the Programs. In the event that Symphony Icon
receives a request or notification from a Governmental Authority
with respect to the Programs, Symphony Icon shall: (i) notify
Lexicon within [**] of receipt of such request or communication and
(ii) to the extent practicable, submit any proposed response
to Lexicon for review and approval; provided , that such
approval shall not be unreasonably withheld and shall not prevent
Symphony Icon from complying with any legal requirements.
Furthermore, Lexicon shall be the Party responsible for responding
to or handling any FDA or regulatory inspection with respect to one
or both Programs; provided , that Lexicon shall notify at
least one (1) of the Development Committee Members designated
by Holdings (i) within [**] of receiving notice of the
commencement of a clinical hold for any Protocol, and
(ii) concurrently with its submission to the FDA of any IND
safety reports for the Programs.
5.3
Inspections and Meetings . Each Party agrees that, during an
inspection by the FDA or other Regulatory Authority concerning any
study or project under the Programs, it will not disclose to such
agency any information and materials (including but not limited to
(x) financial data and pricing data including, but not limited
to, budget and payment schedules, (y) sales data (other than
shipment data), and (z) personnel data (other than data as to
qualification of technical and professional persons performing
functions subject to regulatory requirements)) that are not
required to be disclosed to such agency without first obtaining the
consent of the other Party, which consent shall not be unreasonably
withheld or delayed, except to the extent that such Party
may be required by law to disclose such information and materials.
Lexicon shall be the Party responsible for arranging and
participating in any meetings with any Regulatory Authority
concerning one or both Programs. To the extent practicable, Lexicon
shall consult with the Development Committee prior to any such
meetings and provide to the Development Committee for review all
relevant correspondence to date. During Lexicon’s
consultation with the Development Committee, Lexicon and the
Development Committee shall discuss and agree upon issues including
but not limited to overall regulatory strategy, proposed agendas,
goals and objectives, preparation and attendees. Following any
meeting that pertains to a Program, but that was not attended by at
least one (1) of the Development Committee Members designated
by Holdings, Lexicon shall provide at least one (1) of the
Development Committee Members designated by Holdings with an oral
summary of that meeting within [**] of such meeting and a written
summary of that meeting within [**] of such meeting.
5.4
Transfer of FDA Sponsorship .
(a) On
or prior to the thirtieth (30th) day after the unexercised
expiration or termination of the Purchase Option, Lexicon shall
cease to act as the FDA Sponsor for the Programs for which Lexicon
has not exercised a Discontinuation Option, and Lexicon and
Symphony Icon shall, at Symphony Icon’s expense, take all
actions necessary to effect the transfer of (x) the Regulatory
Files
6
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
(subject
to Symphony Icon’s rights under Section 2.7 of
the Novated and Restated Technology License Agreement) related to
such Programs to Symphony Icon or its designee in accordance with
Section 2.7 of the Novated and Restated Technology
License Agreement, and (y) any and all materials necessary for
Symphony Icon to practice or exploit the license granted to it
under the Novated and Restated Technology License Agreement, by
such date. In conjunction with such transfer, Lexicon shall assign
to Symphony Icon or its designee, at Symphony Icon’s expense
and as of the date specified in the first sentence of this
Section 5.4(a) , all of the material Development
Subcontracting Agreements to which Lexicon is a party and that are
assignable to Symphony Icon or its designee without consent from
the other party to the agreement. Lexicon shall use commercially
reasonable efforts to cause the assignment of any non-assignable
material Development Subcontracting Agreement or portion thereof
relating to the Programs. If it is not successful in causing such
assignment, Lexicon shall act as Symphony Icon’s agent, at
Symphony Icon’s reasonable request and expense, in procuring
all goods and services under such agreements until such time as
Symphony Icon enters into alternative arrangements to procure such
services, provided that Symphony Icon uses commercially
reasonable efforts to enter into such alternative arrangements as
soon as possible. Lexicon agrees to take such commercially
reasonable actions as Symphony Icon may request in furtherance of
the foregoing, at the expense of Symphony Icon. Such efforts shall
not include any obligation for Lexicon to incur any out-of-pocket
costs. Lexicon shall provide copies of all such Development
Subcontracting Agreements to Symphony Icon, at Symphony
Icon’s expense, in connection with such transfer.
(b) Except
as provided in the Amended and Restated Technology License
Agreement, upon the discontinuation of any of the Programs pursuant
to Section 4.2(c) , Lexicon shall have no further
obligations with respect to such Programs under the Operative
Documents. If such Program is transferred or licensed to a third
party in accordance with Section 11 (such third party,
the “ Transferee ”), then Lexicon shall
cooperate with Symphony Icon and the Transferee to effect the
assignment to the Transferee of the sponsorship to the Regulatory
Files (subject to Symphony Icon’s rights under
Section 2.7 of the Novated and Restated Technology
License Agreement) that are related to such Program;
provided , however , that Lexicon shall not be
obligated to take any action pursuant to this
Section 5.4(b) for which it will not receive full
reimbursement from Symphony Icon or another party. The assignment
of such Regulatory Files to the Transferee does not include an
assignment of any Licensed Intellectual Property.
6. Lexicon’s
Obligations .
6.1
Generally .
(a) Lexicon
shall have primary responsibility for the implementation of the
Programs. Without limiting the foregoing, Lexicon shall
specifically be responsible for (i) performing all
pre-clinical and clinical development for the LG617 Program and the
LG103 Program in accordance with the Development Plan,
7
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
(ii) manufacturing of, or arranging for third parties to
manufacture, Clinical Trial Materials for the Programs, and
carrying out the quality assurance therefor, in each case in
accordance with the Development Plan, and (iii) executing all
other matters set forth in the Development Plan that are delegated
to Lexicon by Symphony Icon pursuant to the Development Plan
(collectively, the “ Lexicon Obligations
”).
(b) Lexicon
agrees that it will work diligently and use commercially reasonable
efforts to discharge the Lexicon Obligations in a good scientific
manner and in accordance with the Development Plan, the Development
Budget, and the terms of this Agreement.
6.2
Subcontracting . All agreements between Lexicon and third
parties (including without limitation clinical research
organizations and contract manufacturers) for such third parties to
perform any Lexicon Obligations (each such third party, a “
Lexicon Subcontractor ” and each such agreement, a
“ Subcontracting Agreement ”) entered into by
Lexicon prior to the Closing Date (except for those master service
agreements executed prior to the Closing Date that, only through
the subsequent addition of a new work order, change order, project
or the like after the Closing Date, become Subcontracting
Agreements) and listed on Schedule 6.2 hereto, shall be deemed
to be acceptable to the Parties in all respects. Following the
Closing Date, Lexicon shall obtain approval of the Development
Committee prior to entering into any Subcontracting Agreement,
issuing new work orders against existing Subcontracting Agreements,
or amending or terminating any Subcontracting Agreement, which
approval shall not unreasonably be withheld. Lexicon shall provide
the Development Committee with a copy of each draft Subcontracting
Agreement. The Development Committee, or its designee(s), shall
have [**] to approve or reject the terms of such draft
Subcontracting Agreement; provided that during such [**]
period Lexicon shall make appropriate representatives available to
the Development Committee to discuss such Subcontracting Agreement
in good faith and reasonable detail and shall provide any
information as may be reasonably requested by the Development
Committee or any member thereof. Only approval of the terms of such
draft Subcontracting Agreement will entitle Lexicon to
reimbursement by Symphony Icon for such Subcontracting Agreement.
The terms of such draft Subcontracting Agreement shall be deemed to
have been approved if not objected to by any Development Committee
Member within the [**] period. The terms of any such Subcontracting
Agreements shall be deemed the Confidential Information of Lexicon
and be subject to the rights and obligations set forth in the
Confidentiality Agreement. Lexicon shall monitor the performance of
its Lexicon Subcontractors and shall promptly notify the
Development Committee with respect to any Lexicon Subcontractor
performance issues that may have a material adverse effect on the
Programs. The Development Committee shall have the authority to
direct Lexicon to terminate any Subcontracting Agreement pursuant
to the terms thereof.
6.3
Reports and Correspondence . Lexicon shall keep the
Development Committee informed of its activities under the
Development Plan through regular reports, as set forth in this
Section 6.3 . At each Scheduled Meeting of the
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omissions.
Development
Committee, or according to a schedule agreed to by the Development
Committee, Lexicon shall, to the extent reasonably required by the
Development Committee, provide a summary of Lexicon’s
activities and developments with respect to the Programs for the
period following the most recent preceding scheduled summary
report. Such summary report shall include the following types of
information in a format and frequency as determined by the
Development Committee: (i) updates regarding (A) [**]; and (B)
[**]; (ii) a copy of each standard clinical study progress
report for the Programs received by Lexicon during the preceding
period from any of the clinical research organizations engaged by
Lexicon pursuant to any Subcontracting Agreements and a copy of any
final preclinical study reports for such Programs; (iii) a
financial report, in a format agreed upon by the Development
Committee, itemizing actual spending under the Development Plan as
well as any variation from planned spending; (iv) if the
portion of the Development Budget related to a particular Program
is altered to the extent that available funding for such Program no
longer appears to be adequate to complete the Program, an updated
budget forecast; (v) copies of all Subcontracting Agreements
executed since the previous Development Committee Meeting; and
(vi) such other information as the Development Committee may
reasonably request. Lexicon shall notify at least one (1) of
the Development Committee Members designated by Holdings as soon as
possible, but no later than within [**] of the occurrence of any
event that has, or could reasonably be expected to have, in
Lexicon’s judgment in light of the circumstances existing at
the time, a material adverse effect on the Development Plan or the
Development Budget and shall keep the Development Committee
regularly updated and informed with respect to any such
event.
6.4
Staffing . Lexicon shall use commercially reasonable efforts
to provide such sufficient and competent staff and Personnel
(including, without limitation, such employees or agents of, or
independent contractors retained by, Lexicon) that have the skill
and expertise necessary to perform the Lexicon Obligations. Lexicon
shall notify Symphony Icon in advance, if practicable, and in any
event promptly thereafter, of any change in Key Personnel involved
in the Programs.
6.5
QA Audit . During the Term, Lexicon will permit Symphony
Icon’s representatives (such representatives to be identified
by Symphony Icon in advance and reasonably acceptable to Lexicon
and to enter into a confidentiality agreement with Lexicon) to
examine and audit, during regular business hours, the work
performed by Lexicon hereunder and the Lexicon facilities at which
such work is conducted to determine that Lexicon Obligations are
being conducted in accordance with the terms of the Agreement, the
Development Plan and the Development Budget (“ QA
Audits ”). Symphony Icon shall give Lexicon reasonable
advance notice of such QA Audits specifying the scope of the audit.
Symphony Icon shall reimburse Lexicon for its time associated with
QA Audits; provided , however , that should a
particular QA Audit reveal a material deficiency in Lexicon’s
quality assurance procedures, then Lexicon will be responsible for
all costs of such QA Audit, including Symphony Icon’s
reasonable costs associated with such QA Audit, the work to be
re-performed and the costs or expenses associated with curing such
material deficiencies. Symphony Icon and Lexicon
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omissions.
shall
meet to discuss the results of the QA Audit and, if required,
jointly agree upon any actions that will be required as a result of
such QA Audit including defining material deficiencies to be
addressed. Lexicon shall make commercially reasonable efforts to
reconcile all such deficiencies found by Symphony Icon during such
QA Audit.
6.6
Financial Audit . During the Term, Lexicon will permit
Symphony Icon’s representatives (such representatives
(i) to be identified by Symphony Icon in advance and
reasonably acceptable to Lexicon and (ii) to enter into a
confidentiality agreement with Lexicon), to verify Lexicon’s
invoices, other receipts, and FTE records that are related to
Lexicon’s performance of the work under the Programs (“
Financial Audits ”), which review shall be conducted
during regular business hours and will take place no more than once
per year, unless otherwise agreed to by the Parties. Symphony Icon
shall give Lexicon reasonable advance notice of such Financial
Audits specifying the scope of the audit, which shall not include
work that has previously undergone Financial Audits. Symphony Icon
shall reimburse Lexicon for its time associated with Financial
Audits; provided , however , that should a particular
Financial Audit reveal an overstatement of costs and expenses in
the reports submitted by Lexicon to Symphony Icon for reimbursement
purposes during the period covered by such Financial Audit that
exceeds [**] in the aggregate, then Lexicon will be responsible for
all costs of such Financial Audit, including Symphony Icon’s
reasonable costs associated therewith. Symphony Icon and Lexicon
shall meet to discuss the results of the Financial Audit and, if
required, jointly agree upon any actions that will be required as a
result of such Financial Audit including defining material
discrepancies to be addressed. Lexicon shall make commercially
reasonable efforts to reconcile all such discrepancies found by
Symphony Icon during such Financial Audit. In addition, Lexicon
shall, during regular business hours, cooperate with, and promptly
respond to, inquiries from the Symphony Icon Auditors, if the
Symphony Icon Auditors shall reasonably conclude that they require
additional information or clarification regarding any invoices,
other receipts or FTE records submitted by Lexicon.
6.7
Insurance . Lexicon shall carry and maintain throughout the
Term (i) clinical trial liability insurance (including errors
and omissions coverage and product coverage), at Lexicon’s
sole expense, with limits of at least [**], and (ii) property
and casualty insurance covering Products and other Lexicon assets
used in executing the Development Plan in amounts customarily
carried by business entities with a size and risk profile similar
to Lexicon, at Lexicon’s sole expense, with limits of at
least [**]. Symphony Icon and RRD shall be named as additional
insureds on all clinical trial liability insurance. Upon Symphony
Icon’s request, Lexicon shall instruct its insurance
carrier(s) to promptly furnish to Symphony Icon certificates
reflecting such coverage and a representation indicating that such
coverage shall not be canceled or otherwise terminated during the
Term without [**] prior written notice to Symphony Icon.
Notwithstanding anything to the contrary herein, this
Section 6.7 shall survive for a period of [**]
following termination or expiration of this Agreement.
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7. Symphony Icon’s
Obligations .
7.1
Generally . Symphony Icon shall have overall responsibility
for all matters set forth in the Development Plan, and shall be
responsible for (i) executing or delegating its management and
administration responsibilities; and (ii) executing or
delegating the development activities set forth in the Development
Plan. Symphony Icon shall, and shall instruct all Persons whom it
engages pursuant to Article 2 hereof to, perform its
obligations hereunder and under the Development Plan in good faith
and in accordance with the applicable provisions of the Development
Plan and the Development Budget, and the terms of this
Agreement.
7.2
Subcontracting . Symphony Icon is subcontracting, and will
in the future subcontract, certain of its responsibilities under
the Development Plan to Lexicon (pursuant hereto), to RRD (pursuant
to the RRD Services Agreement) and to other vendors and service
providers (pursuant to subcontracting agreements to be approved by
the Development Committee); provided , that Symphony Icon
shall remain responsible for the performance of its obligations
hereunder notwithstanding any such arrangement. Each subcontracting
agreement entered into by Symphony Icon (except for the RRD
Services Agreement) shall include a provision permitting assignment
at any time of the subcontracting agreement from Symphony Icon to
Lexicon without the subcontractor’s consent; provided
that Symphony Icon may not assign its obligations under any such
subcontracting agreement to Lexicon without Lexicon’s prior
written consent.
7.3
Insurance . Symphony Icon shall maintain insurance with
creditworthy insurance companies against such risks and in such
amounts as are usually maintained or insured against by other
companies of established repute engaged in the same or a similar
business.
7.4
Staffing . Symphony Icon shall use commercially reasonable
efforts to provide, or cause to be provided on its behalf
(including Personnel retained by RRD), sufficient and competent
staff and Personnel that have the skill and expertise necessary to
perform Symphony Icon’s obligations under this Agreement, the
RRD Services Agreement, the Development Plan and the Development
Budget, including, but not limited to, (i) carrying out its
management and administrative functions pursuant to the RRD
Services Agreement, and (ii) carrying out its clinical
development duties in accordance with the RRD Services Agreement,
this Agreement, the Development Plan and the Development Budget.
Symphony Icon shall notify Lexicon in advance, if practicable, and
in any event promptly thereafter, of any change in the key RRD
Personnel involved in the Programs.
7.5
Inspection and Audit . Symphony Icon shall permit each of
Lexicon, Holdings, Investors and each Symphony Fund and their duly
authorized representatives at all reasonable business hours to
inspect and audit (1) Symphony Icon’s books, records and
other reasonably requested materials and (2) any and all
properties of
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omissions.
Symphony
Icon, and it shall provide to each of Lexicon, Holdings, Investors
and each Symphony Fund all books, records and other materials
related to any meeting of the Symphony Icon Board or Symphony Icon
Shareholders and to permit Holdings, Investors and each Symphony
Fund to make copies or extracts therefrom; provided , that
each aforementioned party may conduct one such inspection or audit
in each calendar year without cost to such party, and that any
party conducting additional inspections or audits shall reimburse
the Manager for its reasonable costs and expenses in facilitating
such additional inspections or audits unless such additional
inspections or audits were performed to determine whether
previously identified material deficiencies have been addressed.
Symphony Icon and the party conducting such inspection or audit, or
such party’s representative, shall meet to discuss the
results of such inspection or audit and, if required, jointly agree
upon any actions that will be required as a result of such
inspection or audit including defining material discrepancies to be
addressed. Symphony Icon shall make commercially reasonable efforts
to reconcile all such discrepancies found by Lexicon, Holdings,
Investors or any Symphony Fund during such inspection or
audit.
8. Funding and Payments
.
8.1
Use of Proceeds .
(a) Symphony
Icon shall use any and all (i) proceeds received by Symphony
Icon as a result of the Financing (including proceeds of the
Lexicon Payment Amount), (ii) indemnity payments received by
Symphony Icon, and (iii) payments received by Symphony Icon
pursuant to first and third party covered insurance claims, for the
development of the Programs and general corporate purposes of
Symphony Icon, including the payment of all fees and expenses in
accordance with the Development Plan and the Development Budget, as
may be modified from time to time pursuant to Section 4.2, and
the payment of any indemnification obligations of Symphony Icon
under the Operative Documents and agreements with third party
contractors. Notwithstanding the foregoing, Symphony Icon agrees
that any agreement under which Symphony Icon indemnifies any Person
shall contain appropriate provisions to cause such Person who
receives payments from Symphony Icon as a result of Symphony
Icon’s indemnification obligations under the Operative
Documents, and who is subsequently reimbursed from insurance
proceeds with respect to such losses, costs, interest, awards,
judgments, fees, liabilities, damages and expenses for which such
Person received the indemnity payments from Symphony Icon, to then
reimburse Symphony Icon the amounts paid to such Person by Symphony
Icon to the extent of the insurance proceeds. Symphony Icon further
agrees to use all commercially reasonable means to enforce such
provisions.
(b) Symphony
Icon shall use any and all payments received by Symphony Icon from
Lexicon following the exercise of a Discontinuation Option or from
a third party for the transfer or license of rights to a Program
following the unexercised expiration of a Discontinuation Option,
in the manner as determined by the Development Committee in its
sole discretion. If the Development Committee
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determines such payments from Lexicon or a third party are not
necessary for the development of the Programs, general corporate
purposes of Symphony Icon, or payment of any indemnification
obligations of Symphony Icon, the Development Committee shall so
notify the Symphony Icon Board the amount thereof and that such
amount is released to Symphony Icon for application as determined
by the Symphony Icon Board. The Symphony Icon Board may, in its
sole discretion, declare a dividend or otherwise distribute such
amount to Holdings, and the Purchase Price shall be reduced by the
aggregate amount of such dividends or other distributions.
8.2
Reimbursement . Symphony Icon shall compensate Lexicon for
its Development Plan-associated activities and services, including,
without limitation, its research, clinical and manufacturing
services and any other activities delegated to and by Lexicon in
accordance with this Agreement. Such compensation shall be made in
accordance with the provisions of this Article 8 and the
payment terms attached hereto as Annex E (the “
Payment Terms ”), the terms of which are hereby
adopted and incorporated herein; provided that Lexicon shall
be directly responsible for compensation and reimbursement of
Lexicon Subcontractors, it being understood that the cost shall be
passed through to Symphony Icon. With respect to costs for travel,
unless the Development Committee provides Lexicon with prior
approval, all Lexicon personnel shall adhere to Lexicon’s
travel policy.
8.3
Budget Allocation and Deviations . Lexicon shall have the
discretion to incur out-of-pocket fees, expenses and costs and
allocate its resources in a manner consistent with the Development
Plan and the Development Budget. If Lexicon reasonably anticipates
that the actual cost for any particular Activity will exceed that
portion of the Development Budget allocated for such Activity by
the greater of (a) [**] or more or (b) [**] or more (or such
greater amount as the Symphony Icon Board may subsequently
determine), then Lexicon may request that the Development Committee
amend the Development Budget, either at its next Scheduled Meeting
or at an Ad Hoc Meeting, to reflect such cost increase. Lexicon
shall be fully reimbursed, pursuant to Section 8.2 , for all
out-of-pocket amounts incurred with respect to an Activity
performed pursuant to the Development Plan, as such Development
Plan may be modified upon approval of the Development Committee,
provided that, without the approval of the Development Committee,
Lexicon shall not be reimbursed for expenditures that exceed the
amounts set forth in the Development Budget by the criteria set
forth in the second sentence of this Section 8.3 . If
the Development Committee denies a request made by Lexicon pursuant
to this Section 8.3 to amend the Development Budget,
then Lexicon shall no longer be obligated to perform such
incremental activity that is expected to give rise to such
additional expenditures.
8.4
Employee Benefits . Symphony Icon shall not be responsible
for providing or paying any benefits (including, but not limited
to, unemployment, disability, insurance, or medical, and any
pension or profit sharing plans) to Lexicon or to any employees of
Lexicon or any persons retained or used by Lexicon to perform
activities pursuant to the Development Plan, including independent
contractors,
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Subcontractors and agents (collectively, “ Lexicon
Personnel ”). As to Lexicon or any Lexicon Personnel,
Symphony Icon shall not be responsible for: (a) any federal,
state or local income tax withholding; (b) Federal Insurance
Contributions Act contributions; (c) contributions to state
disability funds or liability funds or similar withholdings;
(d) payment of any overtime wages; (e) workers’
compensation; or (f) compliance with any laws, rules or
regulations governing employees. Lexicon agrees that, as between
Symphony Icon and Lexicon, Lexicon is and will continue to be
responsible for: (i) all matters relating to the payment of
compensation and provision of benefits to Lexicon Personnel; and
(ii) compliance with all applicable laws, rules and
regulations governing Lexicon’s employees. Lexicon
acknowledges that Lexicon is not entitled to reimbursement with
respect to any amounts related to the services of Lexicon Personnel
in excess of the fully burdened FTE rates in accordance with
Annex E attached hereto and Symphony Icon acknowledges that
the FTE rates used as the basis for reimbursing Lexicon for the
services of Lexicon Personnel include Lexicon’s costs
associated with providing such benefits and fulfilling such
responsibilities. Such FTE rates also cover all direct and
indirect, cash and non-cash compensation paid to or on behalf of
said employee or other individual performing duties customarily
performed by an employee; all payroll related taxes and costs; all
fringe benefits and perquisites; all overhead and support provided
by Lexicon for said employee, including but not limited to
facility, office, laboratory and equipment costs, training and
education, and general corporate management, supervision, executive
and administrative functions and activities; and quality assurance
and other functions and activities benefiting Lexicon or multiple
departments, projects or employees within Lexicon.
9. Covenants .
9.1
Mutual Covenants . Each of Lexicon and Symphony Icon
covenants and agrees that, with respect to the Programs and any
other rights and obligations set forth in the Operative Documents,
it shall:
(a) perform
all of its obligations pursuant to this Agreement in material
compliance with: (i) all applicable federal and state laws,
statutes, rules, regulations and orders (including all applicable
approval and qualification requirements thereunder), including,
without limitation, the Federal Food, Drug and Cosmetic Act and the
regulations promulgated pursuant thereto; (ii) all applicable
good clinical practices and guidelines; (iii) all applicable
standard operating procedures; (iv) all applicable Protocols;
and (v) the provisions of this Agreement;
(b) keep
complete, proper and separate books of record and account,
including a record of all costs and expenses incurred, all charges
made, all credits made and received, and all income derived in
connection with the operation of its business, all in accordance
with GAAP;
(c) not
employ (or, to the best of its Knowledge, shall not use any
contractor or consultant who is or that employs) any individual or
entity
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omissions.
debarred
by the FDA (or subject to a similar sanction of any other
Regulatory Authority), or, to the best of its Knowledge, any
individual who or entity which is the subject of an FDA debarment
investigation or proceeding (or similar proceeding of any other
Regulatory Authority), in the conduct of the Programs;
(d) promptly
deliver to the other, upon receipt thereof, notice of all actions,
suits, investigations, litigation and proceedings before any
Governmental Authority, which would reasonably be expected to
affect such Party’s ability to perform its obligations under
this Agreement;
(e) upon
its acquiring Knowledge of (i) any breach by it of any
representation, warranty, covenant or any other term or condition
of this Agreement or (ii) any other event or development, in
each case that is, or is reasonably expected to be, materially
adverse to the other Party with respect to any Program, such Party
shall promptly notify the other Party in writing within [**] of
acquiring such Knowledge; provided , that the failure to
provide such notice shall not impair or otherwise be deemed a
waiver of any rights any Party may have arising from such breach,
event or development and that notice under this
Section 9.1(e) shall not be deemed an admission by the
Party providing such notice of any breach of any of the Operative
Documents; and
(f) with
reasonable promptness, deliver to the other Party such data and
information relating to the ability of such Party to perform its
obligations hereunder as from time to time may be reasonably
requested by the other Party (subject to the maintenance of the
confidentiality of any such information by the receiving Party).
For the avoidance of doubt, this Section 9.1(f)
includes Lexicon’s obligations to provide financial and other
necessary information in respect of such Programs to Symphony Icon
and RRD to enable Symphony Icon to fulfill its obligations to
Lexicon under Section 5(d) of the Purchase Option
Agreement, and to enable RRD to fulfill its obligations to Symphony
Icon and Lexicon under Sections 5(a) and 5(b) of
the RRD Services Agreement.
10. Confidentiality . It
is understood that during the course of this Agreement each of the
Parties shall be bound by the terms of the Confidentiality
Agreement.
11. Discontinuation
Option .
(a) A
Program may only be discontinued in accordance with
Section 4.2(c) . In the event of such a Program
discontinuation during the Term, (i) Symphony Icon shall so
notify Lexicon promptly and in writing of such discontinuation, and
(ii) Lexicon shall have the right and option (a “
Discontinuation Option ”), exercisable for [**] after
receipt of such written notice from Symphony Icon of such
discontinuation, to buy back the Licensed Intellectual Property
related to such discontinued Program for a price (payable by wire
transfer to Symphony Icon) that is [**] (such sum, the “
Discontinuation Price ”), to be reasonably determined
between the Parties, or, if the Parties are unable to come to a
resolution within [**] after receipt of
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omissions.
such
written notice from Symphony Icon of such discontinuation, to be
determined in accordance with Section 11(b) hereof. If
the Discontinuation Price is determined in accordance with
Section 11(b) , then the [**] period for
Lexicon’s exercise of a Discontinuation Option shall be
extended by the time needed for such determination so that Lexicon
has at least [**] after such determination to decide whether it
wishes to exercise a Discontinuation Option. Following the
unexercised expiration of a Discontinuation Option, Symphony Icon
may transfer or license its rights to such Program to a third party
at any time prior to the expiration of the Term. Under no
circumstances may Symphony Icon or Lexicon (unless Lexicon has
exercised its Discontinuation Option for such Program) reinitiate
work on a discontinued Program prior to the expiration or
termination of the Purchase Option. Any Discontinuation Price paid
to Symphony Icon by Lexicon and subsequently dividended or
otherwise distributed to Holdings shall reduce the Purchase Price
in the amount of such dividends or other distributions.
(b) If
Lexicon and Symphony Icon cannot agree on the Discontinuation Price
within [**] after receipt of such written notice from Symphony Icon
of such discontinuation, then at Lexicon’s request, the Chief
Executive Officer of Lexicon and Chairman of the Symphony Icon
Board shall make good faith efforts to resolve the disagreement(s)
regarding the calculation of the Discontinuation Price. If the
Chief Executive Officer of Lexicon and Chairman of the Symphony
Icon Board do not agree on the Discontinuation Price within [**]
after Lexicon’s request, then the Parties shall jointly
select a nationally recognized expert to resolve any remaining
disagreements regarding calculation of the Discontinuation Price.
The Parties shall use their respective commercially reasonable
efforts to cause such expert to make its determination of the
Discontinuation Price within [**] of accepting its selection. The
expert’s determination of the Discontinuation Price shall,
absent manifest error, be (i) binding and conclusive and
(ii) the Discontinuation Price at which a Discontinuation
Option shall be exercised by Lexicon. All costs and expenses of the
expert shall be shared equally between Lexicon and Symphony Icon.
Notwithstanding the foregoing, in any case, each Party shall be
responsible for the payment of its respective costs and expenses,
including any attorneys’ fees.
12. Representations and
Warranties .
12.1
Lexicon Representations and Warranties . Lexicon hereby
represents and warrants to Symphony Icon and Holdings that, as of
the Closing Date:
(a)
Organization . Lexicon is a corporation, duly organized,
validly existing and in good standing under the laws of the State
of Delaware.
(b)
Authority and Validity . Lexicon has all requisite corporate
power and authority to execute, deliver and perform its obligations
under this Agreement and the Novated and Restated Technology
License Agreement and to consummate the transactions contemplated
thereby. The execution, delivery and performance by Lexicon of this
Agreement and the Novated and Restated Technology
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omissions.
License
Agreement and the consummation of the transactions contemplated
thereby have been duly and validly authorized by all necessary
action required on the part of Lexicon, and no other proceedings on
the part of Lexicon are necessary to authorize this Agreement or
the Novated and Restated Technology License Agreement or for
Lexicon to perform its obligations under this Agreement or the
Novated and Restated Technology License Agreement. This Agreement
and the Novated and Restated Technology License Agreement
constitute the lawful, valid and legally binding obligations of
Lexicon, enforceable in accordance with their terms, except as the
same may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the
enforcement of creditors’ rights generally and general
equitable principles regardless of whether such enforceability is
considered in a proceeding at law or in equity.
(c)
No Violation or Conflict . The execution, delivery and
performance of this Agreement and the Novated and Restated
Technology License Agreement and the transactions contemplated
thereby do not and will not (i) violate, conflict with or
result in the breach of any provision of the Organizational
Documents of Lexicon, (ii) conflict with or violate any law or
Governmental Order applicable to Lexicon or any of its assets,
properties or businesses, or (iii) conflict with, result in any
breach of, constitute a default (or event that with the giving of
notice or lapse of time, or both, would become a default) under,
require any consent under, or give to others any rights of
termination, amendment, acceleration, suspension, revocation or
cancellation of, or result in the creation of any Encumbrance on
any of the assets or properties of Lexicon, pursuant to, any note,
bond, mortgage or indenture, contract, agreement, lease, sublease,
license, permit, franchise or other instrument or arrangement to
which Lexicon is a party except, in the case of clauses (ii)
and (iii) , to the extent that such conflicts, breaches,
defaults or other matters would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse Effect
on Lexicon or a material adverse effect on the Programs.
(d)
Governmental Consents and Approvals . The execution,
delivery and performance of this Agreement and the Novated and
Restated Technology License Agreement by Lexicon do not, and the
consummation of the transactions contemplated thereby do not and
will not, require any Governmental Approval which has not already
been obtained, effected or provided, except with respect to which
the failure to so obtain, effect or provide would not, individually
or in the aggregate, reasonably be expected to have a Material
Adverse Effect on Lexicon or a material adverse effect on the
Programs.
(e)
Litigation . Except as disclosed on the most recently filed
Form 10-K filing of Lexicon, there are no actions by or against
Lexicon pending before any Governmental Authority or, to the
Knowledge of Lexicon, threatened to be brought by or before any
Governmental Authority, that would, individually or in the
aggregate, reasonably be expected to have a Material Adverse Effect
on Lexicon. There are no pending or, to the Knowledge of Lexicon,
threatened actions, to which Lexicon is a party (or is threatened
to be named as a party) to set aside, restrain, enjoin or
prevent
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omissions.
the
execution, delivery or performance of this Agreement or the
Operative Documents or the consummation of the transactions
contemplated hereby or thereby by any party hereto or thereto.
Lexicon is not subject to any Governmental Order (nor, to the
Knowledge of Lexicon, is there any such Governmental Order
threatened to be imposed by any Governmental Authority) that would,
individually or in the aggregate, reasonably be expected to have a
Material Adverse Effect on Lexicon or a material adverse effect on
the Programs.
(f)
No Contracts . Except as disclosed on
Schedule 12.1(f) hereto, there are no material
contracts between Lexicon and any third party (other than licenses
of intellectual property that are in turn licensed to Symphony Icon
under the Novated and Restated Technology License Agreement),
including contractors, manufacturers or suppliers, used with or
otherwise necessary for the Programs, and all such contracts are
assignable to Symphony Icon. Except as disclosed on
Schedule 12.1(f) hereto, each such contract is
assignable to Symphony Icon without the prior consent of the
applicable third party, or the absence of such contract (due to the
inability or impracticability of assigning such contract to
Symphony Icon following a termination of this Agreement without the
exercise of the Purchase Option) would not have a material adverse
effect on any of the Programs or on Symphony Icon’s rights
under the Novated and Restated Technology License Agreement.
12.2
Symphony Icon Representations and Warranties . Symphony Icon
hereby represents and warrants to Lexicon that, as of the Closing
Date:
(a)
Organization . Symphony Icon is a corporation, duly
organized, validly existing and in good standing under the laws of
the State of Delaware.
(b)
Authority and Validity . Symphony Icon has all requisite
corporate power and authority to execute, deliver and perform its
obligations under this Agreement and the Novated and Restated
Technology License Agreement and to consummate the transactions
contemplated thereby. The execution, delivery and performance by
Symphony Icon of this Agreement and the Novated and Restated
Technology License Agreement and the consummation of the
transactions contemplated thereby have been duly and validly
authorized by all necessary action required on the part of Symphony
Icon, and no other proceedings on the part of Symphony Icon are
necessary to authorize this Agreement or the Novated and Restated
Technology License Agreement or for Symphony Icon to perform its
obligations under this Agreement or the Novated and Restated
Technology License Agreement. This Agreement and the Novated and
Restated Technology License Agreement constitute the lawful, valid
and legally binding obligations of Symphony Icon, enforceable in
accordance with its terms, except as the same may be limited by
applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting the enforcement of creditors’ rights
generally and general equitable principles regardless of whether
such enforceability is considered in a proceeding at law or in
equity.
18
Confidential materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
(c)
No Violation or Conflict . The execution, delivery and
performance of this Agreement and the Novated and Restated
Technology License Ag
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