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. [Intentionally Omitted]
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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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5.3 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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8.3 Budget Allocation and Deviations
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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.
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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 Holdings Representations and
Warranties
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13. Relationship Between the Company and
Holdings
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15. No Restrictions; Indemnification
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16. Limitation of Liabilities
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17.2 Termination for Company’s
Breach
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17.3 Termination for Holdings’
Breach
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17.4 Termination of License Agreement
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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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Annex A
— Certain Definitions
Annex B — Development Committee Charter
Annex C — Payment Terms
Schedule 6.2 — Subcontracting
Agreements
Schedule 6.4 — Key Personnel
Schedule 12.1(f) — Material Disclosed
Contracts
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
RESEARCH AND DEVELOPMENT
AGREEMENT
This RESEARCH AND
DEVELOPMENT AGREEMENT (this “ Agreement ”) is
entered into as of October 1, 2008 (the “ Closing
Date ”) by and between OXiGENE, INC., a Delaware
corporation (the “ Company ”) and SYMPHONY ViDA
HOLDINGS LLC, a Delaware limited liability company (“
Holdings ”) (each of the Company and Holdings being a
“ Party ,” and collectively, the “
Parties ”). Capitalized terms used herein and not
defined herein shall have the meanings assigned to such terms in
Annex A attached hereto.
In the Technology
License Agreement, the Company grants Holdings an exclusive license
to the Programs. Holdings wishes for the Company to continue to
develop such Programs. Holdings and the Company desire to
establish, and agree on the responsibilities of, a Development
Committee to oversee such development. The Company and Holdings
further desire to comply with and perform certain agreements and
obligations related thereto.
The Parties hereto
agree as follows:
1.
[Intentionally Omitted] .
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.
Holdings shall have overall responsibility for all matters set
forth in the Development Plan (pursuant to Article 7
hereof), and shall engage the Company (pursuant to
Article 6 hereof), and such independent contractors and
agents as the Company may retain (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 Holdings 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 Holdings’
managing member (the “ Manager ”) hereunder, and
the engagements and delegations set forth
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.
therein shall
be subject to the terms and conditions of this Agreement, and the
satisfactory performance by the Company of its 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.
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 Holdings
and the Company. In no event shall the Development Committee have
the power to amend the terms of any Operative Document.
4.
Development Plan and Development Budget .
(a) The
Parties shall agree to a Development Plan and a Development Budget
following 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 Holdings (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).
(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
Holdings or committed by the Company. If such
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
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;
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 shall be made in accordance with the
procedures described in this Article 4 and in the
Development Committee Charter, including obtaining the approval of
Holdings, 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 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) Holdings
resolves to discontinue such Program or Product. 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 Holdings 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 the Company or Holdings (or any Person acting on behalf
of the Company or Holdings), 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.
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
5.1
FDA Sponsor . Notwithstanding any governance provision
contained herein or in any Operative Document, the Parties agree
that, unless and until the expiration or termination of the
purchase option (the “ Purchase Option ”) to be
granted to the Company pursuant to an agreement among Holdings, the
Company and such other party as may be required, the term of which
has been agreed between the Parties, and which agreement shall
provide for the Company to purchase the rights to the Programs from
Holdings (the “ Purchase Option Agreement ”)
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 Holdings 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 Manager.
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 refusal to file, action or warning letters, even if
they do not specifically mention Holdings. 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
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
Committee shall
discuss and agree upon issues including, but not limited to,
overall regulatory strategy and goals and objectives. Subject to
the following sentence, Holdings shall not have any right to
initiate any regulatory correspondence with respect to the
Programs. In the event that Holdings receives a request or
notification from a Governmental Authority with respect to the
Programs, Holdings 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 Holdings 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 Holdings, 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.
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
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
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 Holdings 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 member
thereof. Only approval of the terms of such draft Subcontracting
Agreement by the Development Committee will entitle the Company to
reimbursement by Holdings 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
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
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 . 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 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.
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
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 Holdings 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
Holdings’ representatives (such representatives (i) to
be identified by Holdings 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 ”). Holdings shall give the
Company reasonable advance notice of such QA Audits 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 Holdings’ reasonable costs associated with
such QA Audit, the work to be re-performed and the costs or
expenses associated with curing such material deficiencies.
Holdings 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 Holdings during such QA Audit.
6.6
Financial Audit . During the Term, the Company will permit
Holdings’ representatives (such representatives (i) to
be identified by Holdings 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. Holdings 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. Holdings 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 Holdings 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
Holdings’ reasonable costs associated therewith. Holdings 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
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
discrepancies
found by Holdings during such Financial Audit. In addition, the
Company shall, during regular business hours, cooperate with, and
promptly respond to, inquiries from Holdings Auditors, if Holdings
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 sole expense, with limits of at least $[ * ].
Holdings shall be named as an additional insured on all clinical
trial liability insurance. Upon Holdings’ request, the
Company shall instruct its insurance carrier(s) to promptly furnish
to Holdings 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 Holdings. 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.
Holdings’ Obligations .
7.1
Generally . Holdings 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. Holdings 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 . Holdings is subcontracting, and will in the
future subcontract, certain of its responsibilities under the
Development Plan to the Company (pursuant hereto), and to other
vendors and service providers (pursuant to subcontracting
agreements to be approved by the Development Committee);
provided , that Holdings shall remain responsible for the
performance of its obligations hereunder notwithstanding any such
arrangement. Each subcontracting agreement entered into by Holdings
shall include a provision permitting assignment at any time of the
subcontracting agreement from Holdings to the Company without the
subcontractor’s consent; provided that Holdings may
not assign its obligations under any such subcontracting agreement
to the Company without the Company’s prior written
consent.
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
7.3
Insurance . Holdings 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 . Holdings shall use commercially reasonable
efforts to provide, or cause to be provided on its behalf,
sufficient and competent staff and Personnel that have the skill
and expertise necessary to perform Holdings’ obligations
under this Agreement, the Development Plan and the Development
Budget, including, but not limited to, carrying out its clinical
development duties in accordance with this Agreement, the
Development Plan and the Development Budget.
7.5
Inspection and Audit . Holdings shall permit each of the
Company, Investors and each Symphony Fund and their duly authorized
representatives at all reasonable business hours to inspect and
audit (1) Holdings’ books, records and other reasonably
requested materials and (2) any and all properties of
Holdings, and it shall provide to each of the Company, Investors
and each Symphony Fund all books, records and other materials
related to any meeting of Manager or Shareholders and to permit the
Company, 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. Holdings 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. Holdings shall make commercially
reasonable efforts to reconcile all such discrepancies found by the
Company, Investors or any Symphony Fund during such inspection or
audit.
8.
Funding and Payments .
8.1
Use of Proceeds . Holdings shall use any and all proceeds
received by Holdings from Investors and the Symphony Funds for the
development of the Programs.
8.2
Reimbursement . Holdings 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 to be agreed between the Parties (the “
Payment Terms ”) attached hereto as
Annex C , the terms of which are hereby adopted and
incorporated herein; provided that the Company 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.
10
directly
responsible for compensation and reimbursement of the Company
Subcontractors, it being understood that the cost shall be passed
through to Holdings. 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.
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 Manager 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 . Holdings 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, Holdings 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 Holdings 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
Holdings acknowledges that the FTE rates used as the basis for
reimbursing the Company for the services of Company Personnel
include 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.
11
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 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 Holdings
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
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
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 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 Holdings
to enable Holdings to fulfill its obligations to the Company under
Section 5(d) of the Purchase Option
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) Holdings 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 Holdings of such
discontinuation, to buy back all rights of Holdings 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 Holdings) 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 Holdings 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
extended by the time needed
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
for such
determination so that the Company has at least [ * ] ([ * ]) days
after such determination to decide whether it wishes to exercise a
Discontinuation Option.
(b) If
the Company and Holdings cannot agree on the Discontinuation Price
within [ * ] ([ * ]) days after receipt of such written notice from
Holdings of such discontinuation, then at the Company’s
request, the Chief Executive Officer of the Company and the Manager
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 the Manager 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
Holdings. 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 Holdings following exercise of a Discontinuation
Option..
12.
Representations and Warranties .
12.1
Company Representations and Warranties . The Company hereby
represents and warrants to 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 under this Agreement and the Technology License
Agreement and to consummate the transactions contemplated thereby.
The execution, delivery and performance by the Company of this
Agreement and the 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 Technology License
Agreement or for the Company to perform its obligations under this
Agreement or the Technology License Agreement. This Agreement and
the Technology
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
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 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 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 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
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
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
Holdings under the Technology License Agreement), including
contractors, manufacturers or suppliers, used with or otherwise
necessary for the Programs, and all such contracts are assignable
to Holdings. Except as disclosed on Schedule 12.1(f)
hereto, each such contract is assignable to Holdings 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 Holdings 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
Holdings’ rights under the 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
Holdings Representations and Warranties . Holdings hereby
represents and warrants to the Company that, as of the Closing
Date:
(a)
Organization . Holdings is a limited liability company, duly
organized, validly existing and in good standing under the laws of
the State of Delaware.
(b)
Authority and Validity . Holdings has all requisite limited
liability company power and authority to execute, deliver and
perform its obligations under this Agreement and the Technology
License Agreement and to consummate the transactions contemplated
thereby. The execution, delivery and performance by Holdings of
this Agreement and the 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 Holdings, and no other proceedings on the part of Holdings
are necessary to authorize this Agreement or the Technology License
Agreement or for Holdings to perform its obligations under this
Agreement or the Technology License Agreement. This Agreement and
the Technology License Agreement constitute the lawful, valid and
legally binding obligations of Holdings, enforceable in accordance
with its terms, except as the same may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws
affecting
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
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 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 Holdings,
(ii) conflict with or violate any law or Governmental Order
applicable to Holdings 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 Holdings, pursuant to any note, bond, mortgage or
indenture, contract, agreement, lease, sublease, license, permit,
franchise or other instrument or arrangement to which Holdings 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 Holdings.
(d)
Governmental Consents and Approvals . The execution,
delivery and performance of this Agreement and the Technology
License Agreement by Holdings 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
Holdings.
(e)
Litigation . There are no actions by or against Holdings
pending before any Governmental Authority or, to the Knowledge of
Holdings, 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 Holdings. There
are no pending or, to the Knowledge of Holdings, threatened actions
to which Holdings 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. Holdings
is not subject to any Governmental Order (nor, to the knowledge of
Holdings, 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 Holdings or a material adverse effect on the
Programs.
13.
Relationship Between the Company and Holdings . 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 Holdings, and
the Parties acknowledge and agree that the Company is
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
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 Holdings and each of its respective
Affiliates, officers, directors, employees, agents, members,
managers, successors and assigns (each, a “ Symphony
Indemnified Party ”), and Holdings 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 “ 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 Subcontractors) in connection with the
Company’s performance of its obligations under this Agreement
(including the Development Plan), (E) any action undertaken
or
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
performed by or
on behalf of the Company prior to, and including, the Closing Date
that relates to the Programs or the Products, (F) any
regulatory matters relating to the Company, its businesses or its
assets, (G) any investigation or claim, including derivative
claims, relating to the Company, its businesses or its assets, or
(H) in the event the Company exercises a Discontinuation
Option for a Program, any action undertaken and/or performed by or
on behalf of the Company after the Discontinuation Option Closing
Date and relating to the Product that was the subject of such
Program (including the development, manufacture, use, handling,
storage, sale or other disposition of such Product); in each case,
except (1) with respect to Losses for which the Company is
entitled to indemnification under this Article 15 or
(2) to the extent such Loss arises from the gross negligence
or willful misconduct of a Symphony Indemnified Party;
and
(ii)
in the case of Holdings being the Indemnifying Party, (A) any
breach of any representation or warranty made by Holdings herein or
in any other Operative Document, (B) any breach of any
covenant, agreement or obligation of Holdings contained herein or
in any other Operative Document, (C) any and all activities
undertaken or performed by or on behalf of the Parties under the
Development Plan during the Term, (D) any gross negligence or
willful misconduct of Holdings (and not that of its direct
subcontractors) in connection with Holdings’ performance of
its obligations under this Agreement, or (E) the development,
manufacture, use, handling, storage, sale or other disposition of
the Products (including in the course of conducting the Programs)
during the Term (except with respect to the development,
manufacture, use, handling, storage, sale or other disposition,
after the Company’s exercise of a Discontinuation Option, of
Products covered under Section 15.2(a)(i)(H)) ; in each
case, except (1) with respect to Losses for which Holdings is
entitled to indemnification under this Article 15 , or
(2) Losses deemed to have arisen from the breach by the
Company of any covenant, agreement or obligation under this
Agreement that relates to the Company’s performance under the
Development Plan, as determined by a court, arbitrator or pursuant
to a settlement agreement, or (3) to the extent such Loss
arises from the gross negligence or willful misconduct of a Company
Indemnified Party.
To the extent that
the foregoing undertaking by the Company or Holdings may be
unenforceable for any reason, such Party shall make the maximum
contribution to the payment and satisfaction of any Loss that is
permissible under applicable law.
To the extent that
the foregoing undertaking by the Company or Holdings may be
duplicated by any other undertaking by the Company or Holdings in
any other Operative Document, the Symphony Indemnified Parties or
the Company Indemnified Parties, as the case may be, shall be
entitled to only one recovery under the Operative Documents for the
relevant Loss (and not entitled to any duplicative recovery for the
same Loss).
Portions of
this Exhibit were omitted and have been filed s
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