RESEARCH AND DEVELOPMENT
AGREEMENT
SYMPHONY ViDA HOLDINGS
LLC
Dated as of October 1,
2008
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 24b-2
of the Securities Exchange Act of 1934, as amended.
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1
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2. Overview of Development
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4. Development Plan and Development
Budget
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5
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5
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5
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5.3 Inspections and Meetings
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6. The Company’s Obligations
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6.3 Reports and Correspondence
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7. The Symphony Collaboration’s
Obligations
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8.3 Budget Allocation and Deviations
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15
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16
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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 24b-2
of the Securities Exchange Act of 1934, as amended.
i
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Page
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11. Discontinuation Option
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12. Representations and Warranties
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12.1 Company Representations and
Warranties
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12.2 The Symphony Collaboration Representations
and Warranties
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13. Relationship Between the Company and the
Symphony Collaboration
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15. No Restrictions; Indemnification
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16. Limitation of Liabilities
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25
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16.2 Pursuant to the RRD Services
Agreement
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17.2 Termination for Company’s
Breach
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17.3 Termination for the Symphony
Collaboration’s or Holdings’ Breach
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17.4 Termination of License Agreement
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17.6 Transition following Expiration or
Termination of Purchase Option
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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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18.6 Amendment; Successors; Assignment;
Counterparts
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32
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18.8 Third Party Beneficiary
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Annex A — Certain
Definitions
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Annex B — Development Committee
Charter
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Schedule 6.2 — Subcontracting
Agreements
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Schedule 6.4 — Key
Personnel
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Schedule 12.1(f) — Material Disclosed
Contracts
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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 24b-2
of the Securities Exchange Act of 1934, as amended.
ii
AMENDED AND RESTATED
RESEARCH AND DEVELOPMENT AGREEMENT
This
AMENDED AND RESTATED RESEARCH AND DEVELOPMENT AGREEMENT (this
“ Agreement ”) is entered into as of
October 1, 2008 (the “ Closing Date ”) by
and among OXiGENE, INC., a Delaware corporation (the “
Company ”), SYMPHONY ViDA, INC., a Delaware
corporation (the “ Symphony Collaboration ”)
(each of the Company and the Symphony Collaboration being a “
Party ,” and collectively, the “ Parties
”), and SYMPHONY ViDA 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.
The
Company and Holdings have entered into that certain Research and
Development Agreement, dated as of October 1, 2008 (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 the Symphony Collaboration, and the
Company and the Symphony Collaboration desire to amend and restate
the terms and conditions of the Research and Development
Agreement.
In
the Novated and Restated Technology License Agreement, the Company
grants the Symphony Collaboration an exclusive license to the
Programs. The Symphony Collaboration wishes for the Company to
continue to develop such Programs. The Symphony Collaboration and
the Company desire to establish, and agree on the responsibilities
of, a Development Committee to oversee such development. The
Company and the Symphony Collaboration 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, the Symphony
Collaboration.
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. The
Symphony Collaboration shall have overall responsibility for
all
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 24b-2
of the Securities Exchange Act of 1934, as amended.
matters set
forth in the Development Plan (pursuant to Article 7
hereof), and shall engage the Company (pursuant to
Article 6 hereof), RRD (pursuant to the RRD Services
Agreement), and such independent contractors and agents as the
Company may retain on the Symphony Collaboration’s behalf or
as it may retain with RRD’s assistance (which contractors
include entities retained by the Company prior to the Closing Date
pursuant to the Subcontracting Agreements set forth on
Schedule 6.2 ), to act on behalf of the Symphony
Collaboration and carry out the duties set forth therein and
herein.
(b) With
respect to the Programs, the Company shall be responsible for the
execution of all non-clinical and clinical development, all
regulatory activities, all scientific and technical services
associated with such development (including manufacturing), 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
Collaboration 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 the Company and RRD 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) The
Company hereby acknowledges and agrees to the Symphony
Collaboration’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
Collaboration Board, (ii) the management and administration of
the Symphony Collaboration, (iii) monitoring the
Company’s implementation of the Programs, and
(iv) subject to Section 6.1(a) and without
limiting the Company’s role thereunder, such other
development-related work as the Symphony Collaboration may
reasonably delegate to RRD in accordance with the Development
Plan.
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 Committee Members and the consent of the
Symphony Collaboration Board, Holdings and the Company. In no event
shall the Development Committee have the power to amend the terms
of any Operative Document.
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 24b-2
of the Securities Exchange Act of 1934, as amended.
2
4.
Development Plan and Development Budget .
(a) The
Parties have agreed to agree upon a Development Plan and a
Development Budget within [ * ] ([ * ]) days of the Closing Date,
and which shall be further developed and refined from time to time
in accordance herewith. The Development Plan shall consist of
detailed provisions governing all research, non-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, 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 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 the
Symphony Collaboration, as set forth in 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 the Symphony Collaboration
shall be included in the Development Budget, and will continue to
be included in any amendments thereof. The Development Committee
shall, at the request of the Symphony Collaboration Board, submit
the Development Plan and the Development Budget (as each shall have
been developed and refined up to such point) to the Symphony
Collaboration Board for its review at the first meeting of the
Symphony Collaboration Board. Following the Symphony Collaboration
Board’s review, the Development Committee shall work
diligently to incorporate any comments generated by the Symphony
Collaboration 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 Collaboration Board for further review.
(b) Prior
to the initiation of any Activity pursuant to the Development Plan,
funds sufficient to pay all of the estimated costs and expenses for
work to be performed in relation to such Activity until completion
of such Activity, must be available, either as committed by the
Symphony Collaboration or committed by the Company. If such funds
are committed by the Company, the Company shall (i) make such
commitment in writing; and (ii) be obligated to provide such
committed funds until completion of the related Activity, and such
obligation shall survive beyond the expiration or termination of
the Purchase Option or any of the Operative Documents;
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 24b-2
of the Securities Exchange Act of 1934, as amended.
3
provided , that following the expiration or termination
of the Purchase Option or any of the Operative Documents, if any
changes in the scope or nature of the related Activity increase the
cost of the completion of such Activity, the Company shall not be
obligated to make additional funds available.
(a) All
amendments of, and all material deviations from, the Development
Plan and Development Budget (including amendments or deviations
made at the request of the Company or RRD, in accordance with
Section 8.3 hereof or Section 2(b) of the
RRD Services Agreement, respectively) shall be made in accordance
with the procedures described in this Article 4 and in
the Development Committee Charter, including obtaining the approval
of the Symphony Collaboration Board, as may be required by the
Development Committee Charter.
(b) The
Development Committee shall review the Development Plan and
Development Budget in their entirety on a semi-annual basis 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 the Company 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 the likelihood of success for a particular Program or Product
is not sufficient to warrant further development (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
Collaboration Board resolves to discontinue such Program or
Product, with the number of members of the Symphony Collaboration
Board required to approve such resolution being one less than the
entire number of members of the Symphony Collaboration Board at
that time; provided , that notwithstanding the foregoing,
the Symphony Collaboration 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 and
Development Budget to reflect such discontinuation.
(d) The
Development Plan shall never be amended in any manner that would
require the Company or the Symphony Collaboration (or any Person
acting on behalf of the Company or the Symphony Collaboration
(including RRD and its RRD Personnel)) to perform any assignments
or tasks in a manner that would
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 24b-2
of the Securities Exchange Act of 1934, as amended.
4
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 the Company or the
Symphony Collaboration (or any Person acting on behalf of the
Company or the Symphony Collaboration (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.
5.1
FDA Sponsor . Notwithstanding any governance provision
contained herein or in any Operative Document, the Parties agree
that, until the expiration or termination of the Purchase Option
without the Company’s exercise of the Purchase Option, the
Company shall be the FDA sponsor, and shall serve the equivalent
role with respect to any 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 the
Company (the “ FDA Sponsor ”). As the FDA
Sponsor, the Company shall have the responsibility and the
authority to act as the sponsor and make those decisions and take
all actions reasonably necessary to assure compliance with all
regulatory requirements. The Company 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 foreign Regulatory
Authority related to the Company’s role as the FDA Sponsor.
Notwithstanding anything to the contrary in Article 4
or the Development Committee Charter, the Company, in its capacity
as FDA Sponsor, may discontinue or modify any Program without the
approval of the Development Committee or the Symphony Collaboration
Board in the event such actions are: (a) attributable to an
event that is reportable to the FDA or corresponding 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, the Company 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 Collaboration
Board.
5.2
Correspondence . Each Party hereto acknowledges that the
Company, in its capacity as FDA Sponsor, shall be the Party
responding to any regulatory correspondence or inquiry regarding,
or which would reasonably be expected to affect, any of the
Programs. The Company shall, within [ * ] ([ * ]) hours:
(a) notify at least one (1) Development Committee Member
designated by Holdings of any FDA or other governmental or
regulatory correspondence, inspection or inquiry regarding or
reasonably expected to impact any of the Programs; and
(b) forward to the Development Committee copies of any
correspondence sent to or received from any regulatory or
governmental agency, including, but not limited to, Form FD-483
notices and FDA
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 24b-2
of the Securities Exchange Act of 1934, as amended.
5
refusal to
file, action or warning letters, even if they do not specifically
mention the Symphony Collaboration. To the extent practicable, the
Company shall consult with the Development Committee prior to
responding to any such regulatory correspondence or inquiry, but
the Company shall not be obligated to do so if such action would
require a delay beyond any time period permitted by applicable law
or regulations. During the Company’s consultation with the
Development Committee, the Company and the Development Committee
shall discuss and agree upon issues including, but not limited to,
overall regulatory strategy and goals and objectives. Subject to
the following sentence, the Symphony Collaboration shall not have
any right to initiate any regulatory correspondence with respect to
the Programs. In the event that the Symphony Collaboration receives
a request or notification from a Governmental Authority with
respect to the Programs, the Symphony Collaboration shall:
(i) notify the Company within [ * ] ([ * ]) hours of receipt
of such request or communication and (ii) to the extent
practicable, submit any proposed response to the Company for review
and approval; provided , that such approval shall not be
unreasonably withheld and shall not prevent the Symphony
Collaboration from complying with any legal requirements or acting
to avoid any civil or criminal liability.
5.3
Inspections and Meetings . Each Party agrees that, during an
inspection by the FDA or other Regulatory Authority concerning the
Programs, it will not disclose to such agency any information and
materials that are not, in the reasonable judgment of the
disclosing Party, 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. The Company shall be the Party
responsible for arranging and participating in any meetings with
any Regulatory Authority concerning any of the Programs. To the
extent practicable, the Company 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
the Company’s consultation with the Development Committee,
the Company 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. The Company shall provide prompt and reasonable prior
notice of any such meetings to at least one (1) of the
Development Committee Members designated by Holdings, and shall,
upon a request from the Symphony Collaboration, and to the extent
reasonably possible, facilitate the attendance of at least one
(1) of the Development Committee Members designated by
Holdings at any such meeting reasonably anticipated to pertain in a
material way to a Program. Following any meeting that pertains to a
Program, but that was not attended for any reason by at least one
(1) of the Development Committee Members designated by
Holdings, the Company shall provide at least one (1) of the
Development Committee Members designated by Holdings with an oral
summary of that portion of the meeting relevant to such Program
within [ * ] ([ * ]) hours of such meeting and a written summary of
that portion within [ * ] ([ * ]) Business Days of such
meeting.
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 24b-2
of the Securities Exchange Act of 1934, as amended.
6
6.
The Company’s Obligations .
(a) The
Company shall have primary responsibility for the implementation of
the Development Plan. Without limiting the foregoing, the Company
shall specifically be responsible for (i) performing all
non-clinical and clinical development for the Programs in
accordance with the Development Plan, (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 the Company by the Symphony
Collaboration pursuant to the Development Plan (collectively, the
“ Company Obligations ”).
(b) The
Company agrees that it will work diligently and use commercially
reasonable efforts to discharge the Company 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 the Company and
third parties (including without limitation clinical research
organizations and contract manufacturers) for such third parties to
perform any Company Obligations (each such third party, a “
Company Subcontractor ” and each such agreement, a
“ Subcontracting Agreement ”) entered into by
the Company 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, the Company 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. The Development
Committee may, in its discretion, approve standard forms of
Subcontracting Agreements with respect to which the Company may
enter into pursuant to such standing authority granted by the
Development Committee from time to time, as such authority may be
modified or terminated by the Development Committee in its
discretion. The Company shall provide the Development Committee
with a copy of each draft Subcontracting Agreement (other than
those using standard forms and entered into in accordance with the
preceding sentence). The Development Committee, or its designee(s),
shall have [ * ] ([ * ]) Business Days to approve or reject the
terms of such draft Subcontracting Agreement; provided that
during such [ * ] ([ * ]) Business Day period the Company 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
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 24b-2
of the Securities Exchange Act of 1934, as amended.
7
member thereof.
Only approval of the terms of such draft Subcontracting Agreement
by the Development Committee will entitle the Company to
reimbursement by the Symphony Collaboration 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 [ * ] ([ * ]) Business Day
period. The terms of any such Subcontracting Agreements shall be
deemed the Confidential Information of the Company and be subject
to the rights and obligations set forth in the Confidentiality
Agreement. The Company shall monitor the performance of its Company
Subcontractors and shall promptly notify the Development Committee
with respect to any Company Subcontractor performance issues that
may have a material adverse effect on the Programs. The Company
shall deliver a copy of each Subcontracting Agreement within [ * ]
([ * ]) Business Days after it is executed by all parties thereto.
The Development Committee shall have the authority to direct the
Company to terminate any Subcontracting Agreement pursuant to the
terms thereof.
6.3
Reports and Correspondence .
(a) The
Company 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 Development Committee, or according to a schedule
agreed to by the Development Committee, the Company shall, to the
extent reasonably required by the Development Committee, provide a
summary of the Company’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) patient enrollment, adverse
events or serious adverse events (to the extent the Company has
been notified of such adverse events), any added or terminated
clinical trial sites, any significant Protocol deviations, the
results of any interim analyses, statistical reports, updated
Investigator Brochures or final clinical study reports or any new
Protocols, Protocol amendments or studies synopses being drafted,
all to the extent relating to the Development Plan; and
(B) CMC status, non-clinical program status, regulatory and
quality program status, communications with regulatory agencies,
results of meetings of the Company’s standing or ad hoc
clinical advisors, safety monitoring boards or other similar
oversight bodies (if and when formed) for a particular Program, and
results of meetings with consultants for the Programs, all to the
extent related to the Company Obligations; (ii) a copy of each
standard clinical study progress report for the Programs received
by the Company during the preceding period from any of the clinical
research organizations engaged by the Company 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) copies of all Subcontracting Agreements
executed since the previous Development Committee Meeting; and
(v) such other information as the Development
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 24b-2
of the Securities Exchange Act of 1934, as amended.
8
Committee may
reasonably request. The Company shall notify at least one
(1) of the Development Committee Members designated by
Holdings as soon as possible, but no later than within [ * ] ([ *
]) hours of the occurrence of any event that has, or could
reasonably be expected to have, in the Company’s judgment in
light of the circumstances existing at the time, a material 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.
(b) The
Symphony Collaboration Board member designated by the Company (the
“ Company Board Member ”) and the Chairman of
the Symphony Collaboration Board (the “ Symphony
Chairman ”) shall from time to time agree on the
strategic goals and general business terms (the
“Parameters”) upon which third parties will be
approached for the development or commercialization of any of the
Programs (“Strategic Relationships”), including without
limitation, material economic and business terms. The Company shall
be primarily responsible for negotiating (within the Parameters at
the time) the Strategic Relationships. The Company Board Member
shall notify the Symphony Chairman upon the commencement of any
formal discussions with any third party concerning a potential
Strategic Relationship with such third party. The Company Board
Member shall report to and consult with the Symphony Chairman on
any matters relating to such potential Strategic Relationship that
may be reasonably requested by the Symphony Chairman and take the
Symphony Chairman’s comments into account in negotiating such
Strategic Relationships. For the avoidance of doubt, the Company
can engage in business development activities not constituting
Strategic Relationships, including disclosure of confidential
information (subject to the terms of the Confidentiality
Agreement), without obtaining prior consent of the Symphony
Collaboration.
6.4
Staffing . The Company 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, the Company) that have
the skill and expertise necessary to perform the Company
Obligations. The Company shall notify the Symphony Collaboration 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, the Company will permit the
Symphony Collaboration’s representatives (such
representatives (i) to be identified by the Symphony
Collaboration in advance and reasonably acceptable to the Company
and (ii) to enter into a confidentiality agreement with the
Company) to examine and audit, during regular business hours, the
work performed by the Company hereunder and the Company facilities
at which such work is conducted to determine that the Company
Obligations are being conducted in accordance with the terms of the
Agreement, the Development Plan and the Development Budget (“
QA Audits ”). The Symphony Collaboration shall give
the Company reasonable advance notice of such QA Audits
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 24b-2
of the Securities Exchange Act of 1934, as amended.
9
specifying the
scope of the audit. If a particular QA Audit reveals a material
deficiency in the Company’s quality assurance procedures,
then the Company will be responsible for all costs of such QA
Audit, including the Symphony Collaboration’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. The Symphony Collaboration and the Company 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. The
Company shall make commercially reasonable efforts to reconcile all
such deficiencies found by the Symphony Collaboration during such
QA Audit.
6.6
Financial Audit . During the Term, the Company will permit
the Symphony Collaboration’s representatives (such
representatives (i) to be identified by the Symphony
Collaboration in advance and reasonably acceptable to the Company
and (ii) to enter into a confidentiality agreement with the
Company), to verify the Company’s invoices, other receipts,
and FTE records that are related to the Company’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. The Symphony Collaboration
shall give the Company reasonable advance notice of such Financial
Audits specifying the scope of the audit, which shall not include
work that has previously undergone Financial Audits. The Symphony
Collaboration shall reimburse the Company 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 the Company to the
Symphony Collaboration for reimbursement purposes during the period
covered by such Financial Audit that exceeds [ * ]% in the
aggregate, then the Company will be responsible for all costs of
such Financial Audit, including the Symphony Collaboration’s
reasonable costs associated therewith. The Symphony Collaboration
and the Company 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. The Company shall make
commercially reasonable efforts to reconcile all such discrepancies
found by the Symphony Collaboration during such Financial Audit. In
addition, the Company shall, during regular business hours,
cooperate with, and promptly respond to, inquiries from the
Symphony Collaboration Auditors, if the Symphony Collaboration
Auditors shall reasonably conclude that they require additional
information or clarification regarding any invoices, other receipts
or FTE records submitted by the Company.
6.7
Insurance . The Company shall carry and maintain throughout
the Term (i) clinical trial liability insurance (including
errors and omissions coverage and product coverage), at the
Company’s sole expense, with limits of at least $[ * ] per
occurrence, and (ii) property and casualty insurance covering
Products and other Company assets used in executing the Development
Plan in amounts customarily carried by business entities with a
size and risk profile similar to the Company, at the
Company’s
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 24b-2
of the Securities Exchange Act of 1934, as amended.
10
sole expense,
with limits of at least $[ * ]. The Symphony Collaboration and RRD
shall be named as additional insureds on all clinical trial
liability insurance. Upon the Symphony Collaboration’s
request, the Company shall instruct its insurance carrier(s) to
promptly furnish to the Symphony Collaboration certificates
reflecting such coverage and a representation indicating that such
coverage shall not be canceled or otherwise terminated during the
Term without [ * ] ([ * ]) days’ prior written notice to the
Symphony Collaboration. Notwithstanding anything to the contrary
herein, this Section 6.7 shall survive for a period of
[ * ] ([ * ]) years following termination or expiration of this
Agreement.
7.
The Symphony Collaboration’s Obligations .
7.1
Generally . The Symphony Collaboration 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. The Symphony Collaboration 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 . The Symphony Collaboration is
subcontracting, and will in the future subcontract, certain of its
responsibilities under the Development Plan to the Company
(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 the Symphony Collaboration shall
remain responsible for the performance of its obligations hereunder
notwithstanding any such arrangement. Each subcontracting agreement
entered into by the Symphony Collaboration (except for the RRD
Services Agreement) shall include a provision permitting assignment
at any time of the subcontracting agreement from the Symphony
Collaboration to the Company without the subcontractor’s
consent; provided that the Symphony Collaboration may not
assign its obligations under any such subcontracting agreement to
the Company without the Company’s prior written
consent.
7.3
Insurance . The Symphony Collaboration 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 . The Symphony Collaboration 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 the Symphony Collaboration’s
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 24b-2
of the Securities Exchange Act of 1934, as amended.
11
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. The Symphony Collaboration shall notify the Company 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 . The Symphony Collaboration shall
permit each of the Company, Holdings, Investors and each Symphony
Fund and their duly authorized representatives at all reasonable
business hours to inspect and audit (1) the Symphony
Collaboration’s books, records and other reasonably requested
materials and (2) any and all properties of the Symphony
Collaboration, and it shall provide to each of the Company,
Holdings, Investors and each Symphony Fund all books, records and
other materials related to any meeting of the Symphony
Collaboration Board or the Symphony Collaboration Shareholders and
to permit the Company, 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. The Symphony
Collaboration 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. The Symphony Collaboration shall make commercially
reasonable efforts to reconcile all such discrepancies found by the
Company, Holdings, Investors or any Symphony Fund during such
inspection or audit.
8.
Funding and Payments .
(a) The
Symphony Collaboration shall use any and all (i) proceeds
received by the Symphony Collaboration as a result of the
Financing, (ii) indemnity payments received by the Symphony
Collaboration, and (iii) payments received by the Symphony
Collaboration pursuant to first and third party covered insurance
claims, for the development of the Programs and general corporate
purposes of the Symphony Collaboration, 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 the Symphony Collaboration under the
Operative Documents and
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 24b-2
of the Securities Exchange Act of 1934, as amended.
12
agreements with
third party contractors. Notwithstanding the foregoing, the
Symphony Collaboration agrees that any agreement under which the
Symphony Collaboration indemnifies any Person shall contain
appropriate provisions to cause such Person who receives payments
from the Symphony Collaboration as a result of the Symphony
Collaboration’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 the Symphony
Collaboration, to then reimburse the Symphony Collaboration the
amounts paid to such Person by the Symphony Collaboration to the
extent of the insurance proceeds. The Symphony Collaboration
further agrees to use all commercially reasonable means to enforce
such provisions.
(b) The
Symphony Collaboration shall use any and all (i) payments
received by the Symphony Collaboration from the Company 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, and
(ii) any remaining funds (the “ Discontinued
Funds ”) previously allocated to the discontinued Program
or Product in the manner as determined by the Development
Committee. If the Development Committee determines such payments
from the Company or a third party or such Discontinued Funds are
not necessary for the development of the Programs, general
corporate purposes of the Symphony Collaboration, or payment of any
indemnification obligations of the Symphony Collaboration, the
Development Committee shall so notify the Symphony Collaboration
Board the amount thereof and that such amount is released to the
Symphony Collaboration for application as determined by the
Symphony Collaboration Board. After the Additional Closing Date,
the Symphony Collaboration 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 . The Symphony Collaboration shall compensate
the Company 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
the Company 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 C (the “ Payment Terms ”), the
terms of which are hereby adopted and incorporated herein;
provided that the Company shall be directly responsible for
compensation and reimbursement of the Company Subcontractors, it
being understood that the cost shall be passed through to the
Symphony Collaboration. With respect to costs for travel, unless
the Development Committee provides the Company with prior approval,
all the Company personnel shall adhere to the Company’s
travel policy.
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 24b-2
of the Securities Exchange Act of 1934, as amended.
13
8.3
Budget Allocation and Deviations . The Company 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 the Company reasonably
anticipates that the actual cost for any particular Activity will
cause that portion of the Development Budget allocated over any [ *
] ([ * ]) month period to be exceeded by $[ * ] or more (or such
greater amount as the Symphony Collaboration Board may subsequently
determine), then the Company 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. The Company 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, the Company 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 the Company pursuant to this
Section 8.3 to amend the Development Budget, then the
Company shall no longer be obligated to perform such incremental
activity that is expected to give rise to such additional
expenditures.
8.4
Employee Benefits . The Symphony Collaboration 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 the Company or to any
employees of the Company or any persons retained or used by the
Company to perform activities pursuant to the Development Plan,
including independent contractors, Subcontractors and agents
(collectively, “ Company Personnel ”). As to the
Company or any Company Personnel, the Symphony Collaboration 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. The Company agrees that, as between the Symphony
Collaboration and the Company, the Company is and will continue to
be responsible for: (i) all matters relating to the payment of
compensation and provision of benefits to Company Personnel; and
(ii) compliance with all applicable laws, rules and
regulations governing the Company’s employees. The Company
acknowledges that the Company is not entitled to reimbursement with
respect to any amounts related to the services of Company Personnel
in excess of the fully burdened FTE rates in accordance with
Annex C attached hereto, and the Symphony Collaboration
acknowledges that the FTE rates used as the basis for reimbursing
the Company for the services of Company Personnel include the
Company’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
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 24b-2
of the Securities Exchange Act of 1934, as amended.
14
an employee;
all payroll related taxes and costs; all fringe benefits and
perquisites; all overhead and support provided by the Company 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 the Company or multiple departments,
projects or employees within the Company.
9.1
Mutual Covenants . Each of the Company and the Symphony
Collaboration 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 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 [ * ] ([ *
]) Business Days 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
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 24b-2
of the Securities Exchange Act of 1934, as amended.
15
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 the Company’s obligations to provide financial and
other necessary information in respect of such Programs to the
Symphony Collaboration and RRD to enable the Symphony Collaboration
to fulfill its obligations to the Company under
Section 5(d) of the Purchase Option Agreement, and to
enable RRD to fulfill its obligations to the Symphony Collaboration
and the Company 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) the Symphony
Collaboration shall so notify the Company promptly and in writing
of such discontinuation, and (ii) the Company shall have the
right and option (a “ Discontinuation Option ”),
exercisable for [ * ] ([ * ]) days after receipt of such written
notice from the Symphony Collaboration of such discontinuation, to
buy back all rights of the Symphony Collaboration to such
discontinued Program, the Products being developed in such
discontinued Program, and the Licensed Intellectual Property
related to such discontinued Program for a price (payable by wire
transfer to the Symphony Collaboration) that is [ * ]% of the sum
of (x) the funds expended on such discontinued Program and
(y) a share of all non-Program-specific expenditures that is
in the same proportion to the total of all non-Program-specific
expenditures as the amount in clause (x) of this sentence is
to the aggregate of all Program-specific expenditures (such sum,
the “ Discontinuation Price ”), to be reasonably
determined between the Parties, or, if the Parties are unable to
come to a resolution within [ * ] ([ * ]) days after receipt of
such written notice from the Symphony Collaboration of such
discontinuation, to be determined in accordance with
Section 11(b) hereof; provided , that if the
Ophthalmology Program is discontinued, the Discontinuation Price
with respect to such Program shall be reduced by [ * ]% of the
purchase price paid by Holdings in consideration for the purchase
of all Non-IV Shares pursuant to the Stock and Warrant Purchase
Agreement. If the Discontinuation Price is determined in accordance
with Section 11(b) , then the [ * ] ([ * ]) day period
for the Company’s exercise of a Discontinuation Option shall
be
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 24b-2
of the Securities Exchange Act of 1934, as amended.
16
extended by the
time needed for such determination so that the Company has at least
[ * ] ([ * ]) days after such determination to decide whether it
wishes to exercise a Discontinuation Option. Following the
unexercised expiration of a Discontinuation Option, the Symphony
Collaboration may transfer or license its rights to such Program to
a third party at any time. Any Discontinuation Price paid to the
Symphony Collaboration by the Company and subsequently dividended
or otherwise distributed to Holdings shall reduce the Purchase
Price in the amount of such dividends or other
distributions.
(b) If
the Company and the Symphony Collaboration cannot agree on the
Discontinuation Price within [ * ] ([ * ]) days after receipt of
such written notice from the Symphony Collaboration of such
discontinuation, then at the Company’s request, the Chief
Executive Officer of the Company and the Symphony Chairman shall
make good faith efforts to resolve the disagreement(s) regarding
the calculation of the Discontinuation Price. If the Chief
Executive Officer of the Company and Symphony Chairman do not agree
on the Discontinuation Price within [ * ] ([ * ]) days after the
Company’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 [ * ] ([ * ]) days 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 may be exercised by the Company. All costs and expenses of
the expert shall be shared equally between the Company and the
Symphony Collaboration. Notwithstanding the foregoing, in any case,
each Party shall be responsible for the payment of its respective
costs and expenses, including any attorneys’ fees.
(c) Upon
the exercise of a Discontinuation Option for a Program, such
Program shall no longer be a Program and the Products being
developed in such Program shall no longer be Products for purposes
of the Operative Documents, except to the extent the Operative
Documents deal with the rights of the Company and the obligations
of the Symphony Collaboration following exercise of a
Discontinuation Option.
12.
Representations and Warranties .
12.1
Company Representations and Warranties . The Company hereby
represents and warrants to the Symphony Collaboration and Holdings
that, as of the Closing Date:
(a)
Organization . The Company is a corporation, duly organized,
validly existing and in good standing under the laws of the State
of Delaware.
(b)
Authority and Validity . The Company has all requisite
corporate power and authority to execute, deliver and perform its
obligations
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 24b-2
of the Securities Exchange Act of 1934, as amended.
17
under this
Agreement and the Novated and Restated Technology License Agreement
and to consummate the transactions contemplated thereby. The
execution, delivery and performance by the Company 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 the Company, and no other proceedings on the part of
the Company are necessary to authorize this Agreement or the
Novated and Restated Technology License Agreement or for the
Company 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 the
Company, 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 the Company, (ii) conflict with or violate any
law or Governmental Order applicable to the Company 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 the Company,
pursuant to, any note, bond, mortgage or indenture, contract,
agreement, lease, sublease, license, permit, franchise or other
instrument or arrangement to which the Company 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 the Company 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 the Company 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 the Company or a material adverse effect
on the Programs.
(e)
Litigation . Except as disclosed on the most recently filed
Form 10-K filing of the Company, there are no actions by or against
the Company
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 24b-2
of the Securities Exchange Act of 1934, as amended.
18
pending before
any Governmental Authority or, to the Knowledge of the Company,
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 the Company. There
are no pending or, to the Knowledge of the Company, threatened
actions, to which the Company is a party (or is threatened to be
named as a party) to set aside, restrain, enjoin or prevent 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. The
Company is not subject to any Governmental Order (nor, to the
Knowledge of the Company, 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 the Company 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 the Company and any third party (other than
licenses of intellectual property that are in turn licensed to the
Symphony Collaboration 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 the Symphony Collaboration.
Except as disclosed on Schedule 12.1(f) hereto, each
such contract is assignable to the Symphony Collaboration 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 the Symphony Collaboration 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 the Symphony Collaboration’s rights under the
Novated and Restated Technology License Agreement.
(g)
Information . All information provided or otherwise made
available by the Company or its representatives in connection with
the Programs and the underlying intellectual property, this
Agreement, the Operative Documents and the transactions
contemplated thereby, when taken as a whole, is complete and
correct in all material respects and does not contain any untrue
statement of material fact or omit to state a material fact
necessary to make the statements contained therein, in light of the
circumstances under which such statements are made, not
misleading.
12.2
The Symphony Collaboration Representations and Warranties .
The Symphony Collaboration hereby represents and warrants to the
Company that, as of the Closing Date:
(a)
Organization . The Symphony Collaboration is a corporation,
duly organized, validly existing and in good standing under the
laws of the State of Delaware.
(b)
Authority and Validity . The Symphony Collaboration has all
requisite corporate power and authority to execute, deliver
and
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 24b-2
of the Securities Exchange Act of 1934, as amended.
19
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
the Symphony Collaboration 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 the
Symphony Collaboration, and no other proceedings on the part of the
Symphony Collaboration are necessary to authorize this Agreement or
the Novated and Restated Technology License Agreement or for the
Symphony Collaboration 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 the Symphony Collaboration, 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.
(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 the Symphony Collaboration, (ii) conflict with or
violate any law or Governmental Order applicable to the Symphony
Collaboration 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 the Symphony Collaboration, pursuant to any note,
bond, mortgage or indenture, contract, agreement, lease, sublease,
license, permit, franchise or other instrument or arrangement to
which the Symphony Collaboration 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 the Symphony Collaboration.
(d)
Governmental Consents and Approvals . The execution,
delivery and performance of this Agreement and the Novated and
Restated Technology License Agreement by the Symphony Collaboration
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 the Symphony
Collaboration.
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 24b-2
of the Securities Exchange Act of 1934, as amended.
20
(e)
Litigation . There are no actions by or against the Symphony
Collaboration pending before any Governmental Authority or, to the
Knowledge of the Symphony Collaboration, 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 the Symphony Collaboration. There are no pending or, to
the Knowledge of the Symphony Collaboration, threatened actions to
which the Symphony Collaboration is a party (or is threatened to be
named as a party) to set aside, restrain, enjoin or prevent the
execution, delivery or performance of this Agreement or the
consummation of the transactions contemplated hereby by any party
hereto. The Symphony Collaboration is not subject to any
Governmental Order (nor, to the knowledge of the Symphony
Collaboration, 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 the Symphony Collaboration or a material adverse
effect on the Programs.
13.
Relationship Between the Company and the Symphony
Collaboration . Nothing contained in this Agreement or any acts
or omissions hereunder shall constitute or be construed so as to
create any joint venture or partnership relationship between the
Company and the Symphony Collaboration, and the Parties acknowledge
and agree that the Company is acting as an independent contractor
in the performance of its obligations under this
Agreement.
14.
Change of Control . Holdings has the Change of Control Put
Option described in Section 2A of the Purchase Option
Agreement following a Change of Control with respect to the
Company.
15.
No Restrictions; Indemnification .
15.1
No Restrictions . Nothing in this Agreement shall limit or
restrict the right of any director, officer or employee of the
Company or any director, officer, or employee of any of its
subsidiaries or its Affiliates to engage in any other business or
to devote his or her time and attention to the management or other
aspects of any other business, whether of a similar or dissimilar
nature, nor limit or restrict the right of the Company or any of
its affiliates to engage in any other business or to render
services of any kind to any other Person.
(a) To
the greatest extent permitted by applicable law, the Company shall
indemnify and hold harmless the Symphony Collaboration, Holdings
and RRD and each of their respective Affiliates, officers,
directors, employees, agents, members, managers, successors and
assigns (each, a “ Symphony Indemnified Party
”), and the Symphony Collaboration shall indemnify and hold
harmless the Company, and its Affiliates and each of their
respective officers, directors, employees, agents (other than the
Company Subcontractors), members, managers, successors and assigns
(each, a
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 24b-2
of the Securities Exchange Act of 1934, as amended.
21
“
Company Indemnified Party ”), from and against any and
all claims, losses, costs, interest, awards, judgments, fees
(including reasonable fees for attorneys and other professionals),
court costs, liabilities, damages and expenses incurred by any
Symphony Indemnified Party or Company Indemnified Party
(irrespective of whether any such Indemnified Party is a party to
the action for which indemnification hereunder is sought)
(hereinafter, a “ Loss ”) to the extent
resulting from, arising out of, or relating to any and all third
party suits, claims, actions, proceedings or demands based
upon:
(i)
in the case of the Company being the Indemnifying Party,
(A) any breach of any representation or warranty made by the
Company herein or in any other Operative Document, (B) any
material misrepresentation or omission of facts in the public
information of the Company filed with the SEC, (C) any breach
of any covenant, agreement or obligation of the Company contained
herein or in any other Operative Document, except to the extent
such covenant, agreement or obligation relates to the
Company’s performance under the Development Plan,
(D) any gross negligence or willful misconduct of the Company
(and not that of any Company Subcontracto
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