AMENDED AND RESTATED RESEARCH AND DEVELOPMENT AGREEMENT among OXiGENE, INC. SYMPHONY ViDA HOLDINGS LLC and SYMPHONY ViDA, INC. Dated as of October 1, 2008
Exhibit 10.58
EXECUTION COPY
AMENDED AND RESTATED
among
OXiGENE, INC.
SYMPHONY ViDA HOLDINGS LLC
and
SYMPHONY ViDA, INC.
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.
TABLE OF CONTENTS
Page | ||||
1. Assignment |
1 | |||
2. Overview of Development |
1 | |||
3. Development Committee |
2 | |||
4. Development Plan and Development Budget |
3 | |||
4.1 Generally |
3 | |||
4.2 Amendments |
4 | |||
5. Regulatory Matters |
5 | |||
5.1 FDA Sponsor |
5 | |||
5.2 Correspondence |
5 | |||
5.3 Inspections and Meetings |
6 | |||
6. The Company’s Obligations |
7 | |||
6.1 Generally |
7 | |||
6.2 Subcontracting |
7 | |||
6.3 Reports and Correspondence |
8 | |||
6.4 Staffing |
9 | |||
6.5 QA Audit |
9 | |||
6.6 Financial Audit |
10 | |||
6.7 Insurance |
10 | |||
7. The Symphony Collaboration’s Obligations |
11 | |||
7.1 Generally |
11 | |||
7.2 Subcontracting |
11 | |||
7.3 Insurance |
11 | |||
7.4 Staffing |
11 | |||
7.5 Inspection and Audit |
12 | |||
8. Funding and Payments |
12 | |||
8.1 Use of Proceeds |
12 | |||
8.2 Reimbursement |
13 | |||
8.3 Budget Allocation and Deviations |
14 | |||
8.4 Employee Benefits |
14 | |||
9. Covenants |
15 | |||
9.1 Mutual Covenants |
15 | |||
10. Confidentiality |
16 |
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
Page | ||||
11. Discontinuation Option |
16 | |||
12. Representations and Warranties |
17 | |||
12.1 Company Representations and Warranties |
17 | |||
12.2 The Symphony Collaboration Representations and Warranties |
19 | |||
13. Relationship Between the Company and the Symphony Collaboration |
21 | |||
14. Change of Control |
21 | |||
15. No Restrictions; Indemnification |
21 | |||
15.1 No Restrictions |
21 | |||
15.2 Indemnification |
21 | |||
16. Limitation of Liabilities |
25 | |||
16.1 Between the Parties |
25 | |||
16.2 Pursuant to the RRD Services Agreement |
26 | |||
17. Term and Termination |
26 | |||
17.1 Term |
26 | |||
17.2 Termination for Company’s Breach |
26 | |||
17.3 Termination for the Symphony Collaboration’s or Holdings’ Breach |
27 | |||
17.4 Termination of License Agreement |
27 | |||
17.5 Survival |
27 | |||
17.6 Transition following Expiration or Termination of Purchase Option |
28 | |||
18. Miscellaneous |
29 | |||
18.1 No Petition |
29 | |||
18.2 Notices |
29 | |||
18.3 Governing Law; Consent to Jurisdiction and Service of Process |
30 | |||
18.4 Waiver of Jury Trial |
31 | |||
18.5 Entire Agreement |
31 | |||
18.6 Amendment; Successors; Assignment; Counterparts |
31 | |||
18.7 Severability |
32 | |||
18.8 Third Party Beneficiary |
32 |
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
AMENDED AND RESTATED
RESEARCH AND DEVELOPMENT AGREEMENT
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.
PRELIMINARY STATEMENT
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.
4.1 Generally.
(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.
4.2 Amendments.
(a) All amendments of, and all material deviations from, the Development Plan and Development
Budget (including amendments or deviations made at the request of 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. Regulatory Matters.
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.
6.1 Generally.
(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.
8.1 Use of Proceeds.
(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. Covenants.
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.
15.2 Indemnification.
(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 Subcontractors) in connection with the Company’s performance of its
obligations under this Agreement (including the Development Plan), (E) any action
undertaken or 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 the Symphony Collaboration being the Indemnifying Party, (A) any
breach of any representation or warranty made by the Symphony Collaboration herein or in
any other Operative Document, (B) any breach of any covenant, agreement or obligation of
the Symphony Collaboration 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 the Symphony
Collaboration (and not that of its direct subcontractors) in connection with the Symphony
Collaboration’s 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
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.
22
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
the Symphony Collaboration 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 the Symphony Collaboration 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 the Symphony Collaboration may
be duplicated by any other undertaking by the Company or the Symphony Collaboration 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).
(b) Notice of Claims. Any Indemnified Party that proposes to assert a right to be
indemnified under this Section 15.2 shall notify the Company or the Symphony Collaboration,
as applicable (the “Indemnifying Party”), promptly after receipt of notice of commencement
of any action, suit or proceeding against such Indemnified Party (an “Indemnified
Proceeding”) in respect of which a claim is to be made under this Section 15.2, or the
incurrence or realization of any Loss in respect of which a claim is to be made under this
Section 15.2, of the commencement of such Indemnified Proceeding or of such incurrence or
realization, enclosing a copy of all relevant documents, including all papers served and claims
made, but the omission so to notify the applicable Indemnifying Party promptly of any such
Indemnified Proceeding or incurrence or realization shall not relieve (x) such Indemnifying Party
from any liability that it may have to such Indemnified Party under this Section 15.2 or
otherwise, except, as to such Indemnifying Party’s liability under this Section 15.2, to
the extent, but only to the extent, that such Indemnifying Party shall have been prejudiced by such
omission, or (y) any other indemnitor from liability that it may have to any Indemnified Party
under the Operative Documents.
(c) Defense of Proceedings. In case any Indemnified Proceeding shall be brought
against any Indemnified Party, it shall notify the applicable Indemnifying Party of the
commencement thereof as provided in Section 15.2(b), and such Indemnifying Party shall be
entitled to participate in, and provided such Indemnified Proceeding involves a claim
solely for money damages and does not seek an injunction 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.
23
other equitable relief against the Indemnified Party and is not a criminal or regulatory
action, to assume the defense of, such Indemnified Proceeding with counsel reasonably satisfactory
to such Indemnified Party. After notice from such Indemnifying Party to such Indemnified Party of
such Indemnifying Party’s election so to assume the defense thereof and the failure by such
Indemnified Party to object to such counsel within [ * ] ([ * ]) Business Days following its
receipt of such notice, such Indemnifying Party shall not be liable to such Indemnified Party for
legal or other expenses related to such Indemnified Proceedings incurred after such notice of
election to assume such defense except as provided below and except for the reasonable costs of
investigating, monitoring or cooperating in such defense subsequently incurred by such Indemnified
Party reasonably necessary in connection with the defense thereof. Such Indemnified Party shall
have the right to employ its counsel in any such Indemnified Proceeding, but the fees and expenses
of such counsel shall be at the expense of such Indemnified Party unless:
(i) the employment of counsel by such Indemnified Party at the expense of the
applicable Indemnifying Party has been authorized in writing by such Indemnifying Party;
(ii) such Indemnified Party shall have reasonably concluded in its good faith (which
conclusion shall be determinative unless a court determines that such conclusion was not
reached reasonably and in good faith) that there is or may be a conflict of interest
between the applicable Indemnifying Party and such Indemnified Party in the conduct of the
defense of such Indemnified Proceeding or that there are or may be one or more different or
additional defenses, claims, counterclaims, or causes of action available to such
Indemnified Party (it being agreed that in any case referred to in this
clause (ii) such Indemnifying Party shall not have the right to direct the defense
of such Indemnified Proceeding on behalf of the Indemnified Party);
(iii) the applicable Indemnifying Party shall not have employed counsel reasonably
acceptable to the Indemnified Party to assume the defense of such Indemnified Proceeding
within a reasonable time after notice of the commencement thereof; provided,
however, that (A) this clause (iii) shall not be deemed to constitute a
waiver of any conflict of interest that may arise with respect to any such counsel, and
(B) an Indemnified Party may not invoke this clause (iii) if such Indemnified Party
failed to timely object to such counsel pursuant to the first paragraph of this
Section 15.2(c) above (it being agreed that in any case referred to in this
clause (iii) such Indemnifying Party shall not have the right to direct the defense
of such Indemnified Proceeding on behalf of the Indemnified Party); or
(iv) any counsel employed by the applicable Indemnifying Party shall fail to timely
commence or reasonably conduct the defense of such Indemnified Proceeding and such failure
has prejudiced (or is in
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.
24
immediate danger of prejudicing) the outcome of such Indemnified Proceeding (it being
agreed that in any case referred to in this clause (iv) such Indemnifying Party
shall not have the right to direct the defense of such Indemnified Proceeding on behalf of
the Indemnified Party);
in each of which cases the fees and expenses of counsel for such Indemnified Party shall be at the
expense of such Indemnifying Party. Only one counsel shall be retained by all Indemnified Parties
with respect to any Indemnified Proceeding, unless counsel for any Indemnified Party reasonably
concludes in good faith (which conclusion shall be determinative unless a court determines that
such conclusion was not reached reasonably and in good faith) that there is or may be a conflict of
interest between such Indemnified Party and one or more other Indemnified Parties in the conduct of
the defense of such Indemnified Proceeding or that there are or may be one or more different or
additional defenses, claims, counterclaims, or causes or action available to such Indemnified
Party.
(d) Settlement. Without the prior written consent of such Indemnified Party, such
Indemnifying Party shall not settle or compromise, or consent to the entry of any judgment in, any
pending or threatened Indemnified Proceeding, unless such settlement, compromise, consent or
related judgment (i) includes an unconditional release of such Indemnified Party from all liability
for Losses arising out of such claim, action, investigation, suit or other legal proceeding,
(ii) provides for the payment of money damages as the sole relief for the claimant (whether at law
or in equity), (iii) involves no admission of fact adverse to the Indemnified Party or finding or
admission of any violation of law or the rights of any Person by the Indemnified Party, and (iv) is
not in the nature of a criminal or regulatory action. No Indemnified Party shall settle or
compromise, or consent to the entry of any judgment in, any pending or threatened Indemnified
Proceeding (A) in respect of which any payment would result hereunder or under any other Operative
Document, (B) which includes an injunction that will adversely affect any Indemnifying Party,
(C) which involves an admission of fact adverse to the Indemnifying Party or a finding or admission
of any violation of law or the rights of any Person by the Indemnifying Party, or (D) which is in
the nature of a criminal or regulatory action, without the prior written consent of the
Indemnifying Party, such consent not to be unreasonably conditioned, withheld or delayed.
16. Limitation of Liabilities.
16.1 Between the Parties. TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, NEITHER
PARTY NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, MEMBERS, MANAGERS, EMPLOYEES, INDEPENDENT
CONTRACTORS OR AGENTS (INCLUDING RRD AND ITS MEMBERS, MANAGERS, EMPLOYEES, INDEPENDENT CONTRACTORS
AND AGENTS) SHALL HAVE ANY LIABILITY OF ANY TYPE (INCLUDING, BUT NOT LIMITED TO, CLAIMS IN
CONTRACT, NEGLIGENCE AND TORT LIABILITY) FOR ANY SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE 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.
25
CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, THE LOSS OF OPPORTUNITY, LOSS OF USE OR
LOSS OF REVENUE OR PROFIT IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT OR THE SERVICES
PERFORMED HEREUNDER, EVEN IF SUCH DAMAGES MAY HAVE BEEN FORESEEABLE. THE FOREGOING SHALL NOT LIMIT
EITHER PARTY’S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTION 15.2 AND SHALL NOT APPLY TO
BREACHES OF ITS CONFIDENTIALITY OBLIGATIONS PURSUANT TO ARTICLE 10.
16.2 Pursuant to the RRD Services Agreement. Each Party hereby acknowledges and
agrees that, pursuant to Sections 9(f) and (g) of the RRD Services Agreement, RRD
has expressly disclaimed all liability for (a) any claim arising out of, or allegedly arising out
of the activities carried out by (or within the authority of) the Company (and such Company
Subcontractors and vendors it may retain) hereunder, or for any liability arising under the Novated
and Restated Technology License Agreement with respect to any license or sublicense thereunder in
relation to the activities carried out by (or within the authority of) the Company (and such
Company Subcontractors and vendors it may retain) hereunder, and (b) supervising, compensating or
discharging, or any other liability to or with respect to, any vendor retained by the Company (or,
in the case of a vendor engaged by both RRD and the Company, to and for such vendor to the extent
that such vendor performs services for the Company), except that RRD shall make payments from the
Symphony Collaboration’s funds to reimburse the Company, in accordance with Article 8 and
Annex C of this Agreement, for costs and expenses incurred by the Company in connection
with the engagement of such vendors by the Company for the performance of services contemplated
under the Development Plan. Each Party acknowledges that RRD has certain rights in respect of such
disclaimers pursuant to the RRD Services Agreement.
17. Term and Termination.
17.1 Term. This Agreement shall be effective as of the Closing Date and shall expire
on the last day of the Term, unless the Agreement is earlier terminated as specified in this
Article 17.
17.2 Termination for Company’s Breach.
(a) The Symphony Collaboration may terminate this Agreement at any time upon written notice to
the Company if the Company is in material default or breach of this Agreement, and such material
default or breach continues unremedied for a period of [ * ] ([ * ]) days after written notice
thereof is delivered to the Company. Such cure period may be extended if (i) the Company
reasonably believes such breach can be cured within [ * ] ([ * ]) days of the Company’s receipt of
the Symphony Collaboration’s written notice of such breach (and notifies the Symphony Collaboration
in writing of such belief and the basis for such belief), and (ii) the
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.
26
Symphony Collaboration, acting reasonably, agrees. If the Company fails to remedy the default
or breach within the applicable cure period, the Symphony Collaboration may by final notice of
termination to the Company terminate this Agreement.
(b) In the event that the Symphony Collaboration terminates this Agreement pursuant to
Section 17.2(a) above, the Company may exercise its Purchase Option (which shall, in
addition, include the costs associated with the Company’s material default or breach to the extent
not previously paid by the Symphony Collaboration), pursuant to Section 1(c)(iv) of the
Purchase Option Agreement, within [ * ] ([ * ]) Business Days of receiving such notice of
termination from the Symphony Collaboration; provided, that if such termination occurs
after a Change of Control with respect to the Company due to the Surviving Entity’s material
default or breach of this Agreement, and if the Surviving Entity does not exercise such Purchase
Option, then Holdings may exercise its Put Option pursuant to Section 2A of the Purchase
Option Agreement.
17.3 Termination for the Symphony Collaboration’s or Holdings’ Breach. The Company
may terminate this Agreement at any time upon written notice to the Symphony Collaboration and
Holdings if the Symphony Collaboration or Holdings is in material default or breach of this
Agreement, and such material default or breach continues unremedied for a period of [ * ] ([ * ])
days after written notice thereof is delivered to the Symphony Collaboration and Holdings. Such
cure period may be extended if (i) the Symphony Collaboration or Holdings reasonably believes such
breach can be cured within [ * ] ([ * ]) days of the Symphony Collaboration’s and Holdings’ receipt
of the Company’s written notice of such breach (and notifies the Company in writing of such belief
and the basis for such belief), and (ii) the Company, acting reasonably, agrees. If the Symphony
Collaboration or Holdings fails to remedy the default or breach within the applicable cure period,
the Company may by final notice of termination to the Symphony Collaboration and Holdings terminate
this Agreement.
17.4 Termination of License Agreement. This Agreement shall automatically terminate
upon the termination of the Novated and Restated Technology License Agreement.
17.5 Survival.
(a) The agreements and covenants of the Parties set forth in Articles 10, 11,
15, 16 and 18, and Sections 4.1(b), 6.7 and 17.5
shall survive the expiration or termination of this Agreement. In addition, Section 8.2
shall, to the extent that the costs and expenses reimbursable thereunder have been incurred or
become uncancellable prior to such termination, also survive such expiration.
(b) If the Company does not exercise the Purchase Option, in addition to the provisions
specified in Section 17.5(a), Section 17.6 shall also survive such unexercised
expiration.
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.
27
17.6 Transition following Expiration or Termination of Purchase Option.
(a) On or prior to the [ * ] ([ * ]) day after the unexercised expiration or termination of
the Purchase Option, the Company shall cease to act as the FDA Sponsor for the Programs for which
the Company has not exercised a Discontinuation Option, and the Company and the Symphony
Collaboration shall, at the Symphony Collaboration’s expense, take all actions necessary to effect
the transfer of (x) the Regulatory Files (subject to the Symphony Collaboration’s rights under
Section 2.7 of the Novated and Restated Technology License Agreement) related to such
Programs to the Symphony Collaboration or its designee in accordance with Section 2.7 of
the Novated and Restated Technology License Agreement, and (y) any and all materials necessary for
the Symphony Collaboration to practice or exploit the license granted to it under the Novated and
Restated Technology License Agreement, by such date; provided, however, that if the Ophthalmology
Program is subject to this Section 17.6(a), any materials that are useful in both the Ophthalmology
Program and any other program of the Company shall be reasonably allocated between the Company and
the Symphony Collaboration. In conjunction with such transfer, the Company shall assign to the
Symphony Collaboration or its designee, at the Symphony Collaboration’s expense and as of the date
specified in the first sentence of this Section 17.6(a), all of the material Subcontracting
Agreements to which the Company is a party and that are assignable to the Symphony Collaboration or
its designee without consent from the other party to the agreement; provided, however, that if the
Ophthalmology Program is subject to this Section 17.6(a), the Company shall not be required to
assign to the Symphony Collaboration any contract for the manufacture of both Ophthalmology
Products (or any component thereof) and products (or any component thereof) for any other program
of the Company, and shall instead use commercially reasonable efforts to cause the manufacturer
under any such contract to agree to provide such Ophthalmology Products (or component thereof) to
the Symphony Collaboration on the same terms as they are being supplied to the Company. Except as
set forth in the proviso to the preceding sentence, the Company shall use commercially reasonable
efforts to cause the assignment of any non-assignable material Subcontracting Agreement or portion
thereof relating to the Programs. If it is not successful in causing such assignment, the Company
shall act as the Symphony Collaboration’s agent, at the Symphony Collaboration’s reasonable request
and expense, in procuring all goods and services under such agreements until such time as the
Symphony Collaboration enters into alternative arrangements to procure such services,
provided that the Symphony Collaboration uses commercially reasonable efforts to enter into
such alternative arrangements as soon as possible. The Company shall provide copies of all such
Subcontracting Agreements to the Symphony Collaboration, at the Symphony Collaboration’s expense,
in connection with such transfer. The Company agrees to take such commercially reasonable actions
as the Symphony Collaboration may request in furtherance of the foregoing, at the expense of the
Symphony Collaboration. Such efforts shall not include any obligation for the Company to incur any
out-of-pocket costs.
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.
28
(b) Except as provided in the Amended and Restated Technology License Agreement, upon the
discontinuation of any of the Programs pursuant to Section 4.2(c), the Company shall have
no further obligations with respect to such Programs under the Operative Documents. If such
Program is transferred or licensed to a third party in accordance with Section 11 (such
third party, the “Transferee”), then the Company shall cooperate with the Symphony
Collaboration and the Transferee to effect the assignment to the Transferee of the sponsorship to
the Regulatory Files (subject to the Symphony Collaboration’s rights under Section 2.7 of
the Novated and Restated Technology License Agreement) that are related to such Program. The
assignment of such Regulatory Files to the Transferee does not include an assignment of any
Licensed Intellectual Property.
18. Miscellaneous.
18.1 No Petition. The Company covenants and agrees that, prior to the date which is [
* ] ([ * ]) and [ * ] ([ * ]) after the expiration of the Term, the Company will not institute or
join in the institution of any bankruptcy, insolvency, reorganization or similar proceeding against
the Symphony Collaboration. The provisions of this Section 18.1 shall survive the
termination of this Agreement.
18.2 Notices. Any notice, request, demand, waiver, consent, approval or other
communication which is required or permitted to be given to any party shall be in writing addressed
to the party at its address set forth below and shall be deemed given (i) when delivered to the
party personally, (ii) if sent to the party by facsimile transmission (promptly followed by a
hard-copy delivered in accordance with this Section 18.2), when the transmitting party
obtains written proof of transmission and receipt; provided, however, that
notwithstanding the foregoing, any communication sent by facsimile transmission after 5:00 PM
(receiving party’s time) or not on a Business Day shall not be deemed received until the next
Business Day, (iii) when delivered by next Business Day delivery by a nationally recognized courier
service, or (iv) if sent by registered or certified mail when received, provided postage
and registration or certification fees are prepaid and delivery is confirmed by a return receipt:
The Company:
OXiGENE, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: (000) 000-0000
000 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: (000) 000-0000
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.
29
The Symphony Collaboration:
Symphony ViDA, Inc.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxxx X. Xxxx, Ph.D.
Facsimile: (000) 000-0000
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxxx X. Xxxx, Ph.D.
Facsimile: (000) 000-0000
Holdings:
Symphony ViDA Holdings LLC
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Xx.
Facsimile: (000) 000-0000
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Xx.
Facsimile: (000) 000-0000
with copies to:
Symphony Capital Partners, L.P.
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
and
Symphony Strategic Partners, LLC
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
or to such other address as such party may from time to time specify by notice given in the manner
provided herein to each other party entitled to receive notice hereunder.
18.3 Governing Law; Consent to Jurisdiction and Service of Process.
(a) This Agreement shall be governed by, and construed in accordance with, the laws of the
State of New York; except to the extent that this Agreement pertains to the internal governance of
the Symphony Collaboration or Holdings, and to such extent this Agreement shall be governed and
construed in accordance with the laws of the State of Delaware.
(b) Each of the Parties hereby irrevocably and unconditionally submits, for itself and its
property, to the nonexclusive jurisdiction of 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.
30
New York State court or federal court of the United States of America sitting in County of New
York in the State of New York, and any appellate court from any jurisdiction thereof, in any action
or proceeding arising out of or relating to this Agreement, or for recognition or enforcement of
any judgment, and each of the Parties hereby irrevocably and unconditionally agrees that all claims
in respect of any such action or proceeding may be heard and determined in any such New York State
court or, to the fullest extent permitted by law, in such federal court. Each of the Parties
agrees that a final judgment in any such action or proceeding shall be conclusive and may be
enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.
Nothing in this Agreement shall affect any right that any Party may otherwise have to bring any
action or proceeding relating to this Agreement.
(c) Each of the Parties irrevocably and unconditionally waives, to the fullest extent it may
legally and effectively do so, any objection that it may now or hereafter have to the laying of
venue of any suit, action or proceeding arising out of or relating to this Agreement in any
New York State or federal court. Each of the Parties irrevocably waives, to the fullest extent
permitted by law, the defense of an inconvenient forum to the maintenance of such action or
proceeding in any such court.
18.4 Waiver of Jury Trial. EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ALL RIGHT TO
TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR
OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT.
18.5 Entire Agreement. This Agreement (including any Annexes, Schedules, Exhibits or
other attachments hereto) constitutes the entire agreement between the Parties with respect to the
matters covered hereby, and no oral or written statement may be used to interpret or vary the
meaning of the terms and conditions hereof. This Agreement supersedes all prior and
contemporaneous agreements, correspondence, discussion and understanding with respect to such
matters between the Parties, including the Research and Development Agreement, but excluding the
Operative Documents.
18.6 Amendment; Successors; Assignment; Counterparts.
(a) The terms of this Agreement shall not be altered, modified, amended, waived or
supplemented in any manner whatsoever except by a written instrument signed by each of the Parties
and Holdings.
(b) Nothing expressed or implied herein is intended or shall be construed to confer upon or to
give to any Person, other than the Parties (and, to the extent of Section 18.8, RRD), any
right, remedy or claim under or by reason of this Agreement or of any term, covenant or condition
hereof, and all the terms, covenants, conditions, promises and agreements contained herein shall be
for the sole and exclusive
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.
31
benefit of the Parties (and, to the extent of Section 18.8, RRD) and their successors
and permitted assigns.
(c) This Agreement may not be assigned by either Party hereto without the prior written
consent of the other Party; provided that, in the event the Company undergoes a Change of
Control in compliance with Article 14 hereof, the Company may assign this Agreement to its
Surviving Entity.
(d) This Agreement may be executed in one or more counterparts, each of which, when executed,
shall be deemed an original but all of which taken together shall constitute one and the same
Agreement.
18.7 Severability. If any term or other provision of this Agreement is invalid,
illegal or incapable of being enforced by any rule of law or public policy, all other conditions
and provisions of this Agreement shall nevertheless remain in full force and effect so long as the
economic or legal substance of the transactions contemplated hereby is not affected in a manner
materially adverse to either party. Upon such determination that any term or other provision is
invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good faith
to modify this Agreement so as to effect the original intent of the parties as closely as possible
in an acceptable manner to the end that the transactions contemplated hereby are fulfilled to the
extent possible.
18.8 Third Party Beneficiary. Each of the Parties agrees that RRD shall be a third
party beneficiary of Articles 2, 8 and 16, and Sections 4.1,
4.2(a), 4.2(b), 6.7, 7.1, 7.3, 9.1(f), 15.2
and 18.6(b) of this Agreement.
[SIGNATURES FOLLOW ON NEXT PAGE]
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.
32
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the day
and year above written.
SYMPHONY ViDA HOLDINGS LLC | ||||||
By: | Symphony Capital Partners, L.P., its Manager | |||||
By: | Symphony Capital GP, L.P., its general partner | |||||
By: | Symphony GP, LLC, its general partner |
|||||
By: | /s/ Xxxx Xxxxxx | |||||
Title: Managing Member | ||||||
SYMPHONY ViDA, INC. | ||||||
By: | /s/ Xxxx Xxxxxx | |||||
Title: Chairman of the Board | ||||||
OXiGENE, INC. | ||||||
By: | /s/ Xxxx X. Xxxxxxx | |||||
Title: Chief Operating Officer |
[Signature Page to Amended and Restated Research and Development Agreement.]
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.
ANNEX A
CERTAIN DEFINITIONS
“$” means United States dollars.
“33 Act Legend” has the meaning set forth in Section 2(f) of the Purchase
Option Agreement.
“Accredited Investor” has the meaning set forth in Rule 501(a) of Regulation D
promulgated under the Securities Act of 1933, as amended.
“Act” means the Delaware Limited Liability Company Act, 6 Del. C. § 18-101 et seq.
“Activity” means:
(a) in the case of goods or services procured from third party vendors, the resources applied
(and the costs incurred therefor) on one clinical study or protocol under a single contract with a
vendor, said contract consisting of either a purchase order or a stand alone contract, if for a
one-time purchase, or any work order under a master contract or master services agreement, if for
multiple purchases of similar goods or services from the same vendor; and
(b) in the case of internally provided goods or services, the resources applied, allocated or
reallocated (and the costs associated therewith) under a single budgetary line item for any
Program.
“Ad Hoc Meeting” has the meaning set forth in Paragraph 6 of Annex B of (i)
the Amended and Restated Research and Development Agreement, with respect to the Operative
Documents, and (ii) the Advisory Agreement, with respect to the Zybrestat Operative Documents.
“Additional Closing Date” has the meaning set forth in Section 2(c) of the
Additional Funding Agreement.
“Additional Funding Agreement” means the Additional Funding Agreement, dated as of the
Closing Date, among the Company, Holdings, Investors and the Symphony Collaboration.
“Additional Holdings Funding” has the meaning set forth in the Preliminary Statement
of the Additional Funding Agreement.
“Additional Holdings Funding Commitment” has the meaning set forth in the Preliminary
Statement of the Additional Funding Agreement.
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.
Annex A – 1
“Additional Holdings Payment Amount” has the meaning set forth in Section 3(a)
of the Additional Funding Agreement.
“Additional Investment Shares” has the meaning set forth in the Preliminary Statement
of the Additional Funding Agreement.
“Additional Investment Warrant” has the meaning set forth in Section 5(b) of
the Additional Funding Agreement.
“Additional Party” has the meaning set forth in Section 14 of the
Confidentiality Agreement or the Zybrestat Confidentiality Agreement, as the case may be.
“Additional Regulatory Filings” means such Governmental Approvals as required to be
made under any law applicable to the purchase of the Symphony Collaboration Equity Securities under
the Purchase Option Agreement.
“Adjusted Capital Account Deficit” has the meaning set forth in Section 1.01
of the Holdings LLC Agreement.
“Advisory Agreement” means the Zybrestat Advisory Agreement, dated as of the Closing
Date, between Holdings and the Company.
“Advisory Committee” has the meaning set forth in Article 3 of the Advisory
Agreement.
“Advisory Committee Charter” has the meaning set forth in Article 3 of the
Advisory Agreement.
“Advisory Services” has the meaning set forth in Section 1(a) of the RRD
Zybrestat Services Agreement.
“Affected Member” has the meaning set forth in Section 26 of the Investors LLC
Agreement.
“Affiliate” means, with respect to any Person (i) any Person directly or indirectly
controlling, controlled by or under common control with such Person, (ii) any officer, director,
general partner, member or trustee of such Person, or (iii) any Person who is an officer, director,
general partner, member or trustee of any Person described in clauses (i) or (ii)
of this sentence. For purposes of this definition, the terms “controlling,” “controlled by” or
“under common control with” shall mean the possession, direct or indirect, of the power to direct
or cause the direction of the management and policies of a Person or entity, whether through the
ownership of voting securities, by contract or otherwise, or the power to elect at least 50% of the
directors, managers, general partners, or persons exercising similar authority with respect to such
Person or entities.
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.
Annex A – 2
“Amended and Restated Research and Development Agreement” means the Amended and
Restated Research and Development Agreement dated as of the Closing Date, among the Company,
Holdings and the Symphony Collaboration.
“Angiogene License Agreement” has the meaning set forth in Schedule 2.2 of the Novated
and Restated Technology License Agreement.
“Approved Amount” has the meaning set forth in Section 2(b) of the Additional
Funding Agreement.
“ASU License Agreement” has the meaning set forth in Schedule 2.2 of the Novated and
Restated Technology License Agreement.
“Asset Value” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Auditors” means an independent certified public accounting firm of recognized
national standing.
“Balance Sheet Deficiency” has the meaning set forth in Section 1(c)(iii) of
the Purchase Option Agreement.
“Balance Sheet Deficiency Date” has the meaning set forth in Section 1(c)(iii)
of the Purchase Option Agreement.
“Balance Sheet Deficiency Threshold” shall be equal to $[ * ].
“Bankruptcy Code” means the United States Bankruptcy Code.
“Bankruptcy Event” means, with respect to a Person, the occurrence of either of the
following:
(a) a case or other proceeding shall be commenced, without the application or consent of such
Person, in any court, seeking the liquidation, reorganization, debt arrangement, dissolution,
winding up, or composition or readjustment of debts of such Person, the appointment of a trustee,
receiver, custodian, liquidator, assignee, sequestrator or the like for such Person of all or
substantially all of its assets, or any similar action with respect to such Person under any Law
relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of
debts, and such case or proceeding shall continue undismissed, or unstayed and in effect, for a
period of [ * ] consecutive days; or an order for relief in respect of such Person shall be entered
in an involuntary case under the federal bankruptcy Laws or other similar Laws now or hereafter in
effect; or
(b) such Person shall generally not pay its debts as such debts become due or shall admit in
writing its inability to pay its debts generally or such Person shall commence a voluntary case or
other proceeding under any applicable bankruptcy,
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.
Annex A – 3
insolvency, reorganization, debt arrangement, dissolution or other similar Law now or
hereafter in effect, or shall consent to the appointment of or taking possession by a receiver,
liquidator, assignee, trustee (other than a trustee under a deed of trust, indenture or similar
instrument), custodian, sequestrator (or other similar official) for, such Person or for any
substantial part of its property, or shall make any general assignment for the benefit of
creditors, or shall be adjudicated insolvent, or admit in writing its inability to pay its debts
generally as they become due, or, if a corporation or similar entity, its board of directors shall
vote to implement any of the foregoing.
“Baylor License Agreement” has the meaning set forth in Schedule 2.2 of the Novated
and Restated Technology License Agreement.
“Bio-Reductive Trigger” means a [ * ] on a [ * ] that [ * ] such [ * ] but which such
[ * ] a [ * ] or other [ * ] under [ * ] to [ * ] the [ * ], including (a) a [ * ] or (b) a [ * ].
“BMS License Agreement” has the meaning set forth in Schedule 2.2 of the Novated and
Restated Technology License Agreement.
“Business Day” means any day other than Saturday, Sunday or any other day on which
commercial banks in the City of New York are authorized or required by law to remain closed.
“Capital Contributions” has the meaning set forth in Section 1.01 of the
Holdings LLC Agreement.
“Capitalized Leases” means all leases that have been or should be, in accordance with
GAAP, recorded as capitalized leases.
“Cash Available for Distribution” has the meaning set forth in Section 1.01 of
the Holdings LLC Agreement.
“Chair” has the meaning set forth in Paragraph 4 of Annex B to the Amended and
Restated Research and Development Agreement.
“Change of Control” means and includes the occurrence of any of the following events,
but specifically excludes (i) acquisitions of capital stock directly from the Company for cash,
whether in a public or private offering, (ii) sales of capital stock by stockholders of the
Company, and (iii) acquisitions of capital stock by or from any employee benefit plan or related
trust:
(a) the merger, reorganization or consolidation of the Company into or with another
corporation or legal entity in which the Company’s stockholders holding the right to vote with
respect to matters generally immediately preceding such merger, reorganization or consolidation,
own less than fifty percent (50%) of the voting securities of the surviving entity; 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.
Annex A – 4
(b) the sale of all or substantially all of the Company’s assets or business.
“Change of Control Put Option” has the meaning set forth in Section 2A(b) of
the Purchase Option Agreement.
“Change of Control Put Option Exercise Notice” has the meaning set forth in
Section 2A(c) of the Purchase Option Agreement.
“Class A Member” means a holder of a Class A Membership Interest.
“Class A Membership Interest” means a Class A Membership Interest in Holdings.
“Class B Member” means a holder of a Class B Membership Interest.
“Class B Membership Interest” means a Class B Membership Interest in Holdings.
“Class C Member” means a holder of a Class C Membership Interest.
“Class C Membership Interest” means a Class C Membership Interest in Holdings.
“Class D Member” means a holder of a Class D Membership Interest.
“Class D Membership Interest” means a Class D Membership Interest in Holdings.
“Client Schedules” has the meaning set forth in Section 5(b)(i) of the RRD
Services Agreement.
“Clinical Trial Material” means Product and placebo for administration to animals for
non-clinical testing or to humans for clinical testing, and Product for non-clinical testing.
“Closing Date” means October 1, 2008.
“Closing Market Price” means, depending on when an Operative Document is entered into,
either (i) the previous trading day’s closing bid price of Company Common Stock if such Operative
Document is entered into during market hours before the close of the regular session of the NASDAQ
Global Market or (ii) that day’s closing bid price of Company Common Stock if such Operative
Document is entered into after the close of the regular session.
“CMC” means the chemistry, manufacturing and controls documentation as required for
filings with a Regulatory Authority relating to the manufacturing, production and testing of drug
products.
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.
Annex A – 5
“Code” means the Internal Revenue Code of 1986, as amended from time to time.
“Combretastatin” mean [ * ] of the [ * ] that [ * ] either a [ * ] or [ * ], in which
at least one of the [ * ] is [ * ] with [ * ] or [ * ] or [ * ], including but not limited to [ * ]
and [ * ].
“Common Stock” means the common stock, par value $0.01 per share, of the Symphony
Collaboration.
“Company” means OXiGENE, Inc., a Delaware corporation.
“Company Accounting Advisor” means Ernst & Young LLP.
“Company Board” has the meaning set forth in Section 3.02 (e) of the Stock and
Warrant Purchase Agreement.
“Company Common Stock” means the common stock, par value $0.01 per share, of the
Company.
“Company Common Stock Valuation” has the meaning set forth in Section 2(e) of
the Purchase Option Agreement.
“Company Obligations” has the meaning set forth in Section 6.1(a) of the
Amended and Restated Research and Development Agreement.
“Company Payment Amount” has the meaning set forth in Section 4(a) of the
Additional Funding Agreement.
“Company Payment Commitment” has the meaning set forth in the Preliminary Statement of
the Additional Funding Agreement.
“Company Payment Date” has the meaning set forth in Section 4(b) of the
Additional Funding Agreement.
“Company Personnel” has the meaning set forth in Section 8.4 of the Amended
and Restated Research and Development Agreement.
“Company Public Filings” means all publicly available filings made by the Company with
the SEC.
“Company Securities” has the meaning set forth Section 3.02(b) of the Stock
and Warrant Purchase Agreement.
“Company Shares” has the meaning set forth in Section 2.02 of the Holdings LLC
Agreement.
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.
Annex A – 6
“Company Warrants” has the meaning set forth in Section 2.02 of the Holdings
LLC Agreement.
“Company Subcontractor” means a third party that has entered into a Subcontracting
Agreement with the Company.
“Confidential Information” has the meaning set forth in Section 2 of the
Confidentiality Agreement or the Zybrestat Confidentiality Agreement, as the case may be.
“Confidentiality Agreement” means the Confidentiality Agreement, dated as of the
Closing Date, among the Symphony Collaboration, Holdings, the Company, SCP, SSP, Investors,
Symphony Capital and RRD, as such agreement may be amended or amended and restated from time to
time.
“Conflict Transaction” has the meaning set forth in Article X of the Symphony
Collaboration Charter.
“Control” means, with respect to any material, information or intellectual property
right, that a Party owns or has a license to such item or right, and has the ability to grant the
other Party access, a license or a sublicense (as applicable) in or to such item or right as
provided in the Operative Documents or Zybrestat Operative Documents, as applicable, without
violating the terms of any agreement or other arrangement with any third party.
“Cross Program Budget Component” has the meaning set forth in Section 4.1 of
the Amended and Restated Research and Development Agreement.
“Debt” of any Person means, without duplication:
(a) all indebtedness of such Person for borrowed money,
(b) all obligations of such Person for the deferred purchase price of property or services
(other than any portion of any trade payable obligation that shall not have remained unpaid for [ *
] days or more from the later of (A) the original due date of such portion and (B) the customary
payment date in the industry and relevant market for such portion),
(c) all obligations of such Person evidenced by bonds, notes, debentures or other similar
instruments,
(d) all obligations of such Person created or arising under any conditional sale or other
title retention agreement with respect to property acquired by such Person (whether or not the
rights and remedies of the seller or lender under such agreement in an event of default are limited
to repossession or sale of such property),
(e) all Capitalized Leases to which such Person is a party,
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.
Annex A – 7
(f) all obligations, contingent or otherwise, of such Person under acceptance, letter of
credit or similar facilities,
(g) all obligations of such Person to purchase, redeem, retire, defease or otherwise acquire
for value any Equity Securities of such Person,
(h) the net amount of all financial obligations of such Person in respect of Hedge Agreements,
(i) the net amount of all other financial obligations of such Person under any contract or
other agreement to which such Person is a party,
(j) all Debt of other Persons of the type described in clauses (a) through (i)
above guaranteed, directly or indirectly, in any manner by such Person, or in effect guaranteed,
directly or indirectly, by such Person through an agreement (A) to pay or purchase such Debt or to
advance or supply funds for the payment or purchase of such Debt, (B) to purchase, sell or lease
(as lessee or lessor) property, or to purchase or sell services, primarily for the purpose of
enabling the debtor to make payment of such Debt or to assure the holder of such Debt against loss,
(C) to supply funds to or in any other manner invest in the debtor (including any agreement to pay
for property or services irrespective of whether such property is received or such services are
rendered) or (D) otherwise to assure a creditor against loss, and
(k) all Debt of the type described in clauses (a) through (i) above secured by (or for which
the holder of such Debt has an existing right, contingent or otherwise, to be secured by) any
Encumbrance on property (including accounts and contract rights) owned or held or used under lease
or license by such Person, even though such Person has not assumed or become liable for payment of
such Debt.
“Declaration Period” has the meaning set forth in Section 2(a)(ii) of the
Purchase Option Agreement.
“Development Budget” means (i) the budget (comprised of the Program Specific Budget
Component with components for each Program and the Cross Program Budget Component) for the
implementation of the Development Plan, as may be further developed and revised from time to time
in accordance with the Development Committee Charter and the Amended and Restated Research and
Development Agreement, or (ii) the budget for the implementation of the Development Plan, as may be
further developed and revised from time to time in accordance with the Advisory Committee Charter
and the Advisory Agreement, as the case may be.
“Development Committee” has the meaning set forth in Article 3 of the Amended
and Restated Research and Development Agreement.
“Development Committee Charter” has the meaning set forth in Article 3 of the
Amended and Restated Research and Development Agreement.
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.
Annex A – 8
“Development Committee Indemnification Agreement” means the Indemnification Agreement
among the Symphony Collaboration and the members of the Development Committee named therein, dated
as of the Closing Date, as such agreement may be amended and restated from time to time.
“Development Committee Member” has the meaning set forth in Paragraph 1 of
Annex B to the Amended and Restated Research and Development Agreement.
“Development Plan” means (i) with respect to the Operative Documents, the development
plan covering all the Programs with components for each Program, as may be further developed and
revised from time to time in accordance with the Development Committee Charter and the Amended and
Restated Research and Development Agreement, or (ii) with respect to the Zybrestat Operative
Documents, the development plan covering the Zybrestat Program, as may be further developed and
revised from time to time in accordance with the Advisory Committee Charter and the Advisory
Agreement, as the case may be.
“Development Product” means a Product that is administered in a clinical trial
performed pursuant to the Development Plan.
“Development Services” has the meaning set forth in Section 1(b) of the RRD
Services Agreement.
“DGCL” means Delaware General Corporate Law, as amended from time to time.
“Direct Investment Shares” has the meaning set forth in the Preliminary Statement of
the Purchase Option Agreement.
“Direct Investment Warrant” has the meaning set forth in the Preliminary Statement of
the Purchase Option Agreement.
“Director(s)” means the Persons identified as such in the Preliminary Statement of the
Indemnification Agreement (including such Persons as may become parties thereto after the date
hereof).
“Disclosing Party” has the meaning set forth in Section 4 of the
Confidentiality Agreement or the Zybrestat Confidentiality Agreement, as the case may be.
“Discontinuation Option” has the meaning set forth in Section 11(a) of the
Amended and Restated Research and Development Agreement.
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.
Annex A – 9
“Discontinuation Option Closing Date” means the date of expiration of the
Discontinuation Option pursuant to Section 11(a) of the Amended and Restated Research and
Development Agreement.
“Discontinuation Price” has the meaning set forth in Section 11(a) of the
Amended and Restated Research and Development Agreement.
“Discontinued Funds” has the meaning set forth in Section 8.1(b) of the
Amended and Restated Research and Development Agreement.
“Discontinued Program” has the meaning set forth in Section 2.10 of the
Novated and Restated Technology License Agreement.
“Disinterested Directors” has the meaning set forth in Article X of the
Symphony Collaboration Charter.
“Disposition” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Distribution” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“DMF” means a Regulatory File relating to the manufacture of a Product, including any
drug master file or similar file.
“Effective Registration Date” has the meaning set forth in Section 1 of the
Registration Rights Agreement.
“Encumbrance” means (i) any security interest, pledge, mortgage, lien (statutory or
other), charge or option to purchase, lease or otherwise acquire any interest, (ii) any adverse
claim, restriction, covenant, title defect, hypothecation, assignment, deposit arrangement, license
or other encumbrance of any kind, preference or priority, or (iii) any other security agreement or
preferential arrangement of any kind or nature whatsoever (including, without limitation, any
conditional sale or other title retention agreement).
“Equity Securities” means, with respect to any Person, shares of capital stock of (or
other ownership or profit interests in) such Person, warrants, options or other rights for the
purchase or other acquisition from such Person of shares of capital stock of (or other ownership or
profit interests in) such Person, securities convertible into or exchangeable for shares of capital
stock of (or other ownership or profit interests in) such Person or warrants, rights or options for
the purchase or other acquisition from such Person of such shares (or such other interests), and
other ownership or profit interests in such Person (including, without limitation, partnership,
member or trust interests therein), whether voting or nonvoting, and whether or not such shares,
warrants, options, rights or other interests are authorized or otherwise existing on any date of
determination.
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.
Annex A – 10
“ERISA” means the United States Employee Retirement Income Security Act of 1974, as
amended.
“Excepted Debt” has the meaning set forth in Section 5(c)(iii) of the Purchase
Option Agreement.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules
and regulations promulgated thereunder.
“Existing Confidentiality Agreement” has the meaning set forth in Section 2(a)
of the Confidentiality Agreement.
“FDA” means the United States Food and Drug Administration or its successor agency in
the United States.
“FDA Sponsor” has the meaning set forth in Section 5.1 of the Amended and
Restated Research and Development Agreement.
“Final Termination Date” has the meaning set forth in Section 1(c)(iii) of the
Purchase Option Agreement.
“Financial Audits” has the meaning set forth in Section 6.6 of the Amended and
Restated Research and Development Agreement.
“Financing” has the meaning set forth in the Preliminary Statement of the Purchase
Option Agreement.
“Fiscal Year” has the meaning set forth in each Operative Document in which it
appears.
“FTE” means the time and effort of one or more qualified scientists, technicians,
project managers, preclinical or clinical research personnel, regulatory personnel, or patent
professionals that is equivalent to [ * ] hours per year.
“Funds Termination Date” has the meaning set forth in Section 1(c)(iii) of the
Purchase Option Agreement.
“Funds Termination Notice” has the meaning set forth in Section 1(c)(iii) of
the Purchase Option Agreement.
“GAAP” means generally accepted accounting principles in effect in the United States
of America from time to time.
“Governmental Approvals” means authorizations, consents, orders, declarations or
approvals of, or filings with, or terminations or expirations of waiting periods imposed by any
Governmental Authority.
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.
Annex A - 11
“Governmental Authority” means any United States or non-United States federal,
national, supranational, state, provincial, local, or similar government, governmental, regulatory
or administrative authority, agency or commission or any court, tribunal, or judicial or arbitral
body.
“Governmental Order” means any order, writ, judgment, injunction, decree, stipulation,
determination or award entered by or with any Governmental Authority.
“Hedge Agreement” means any interest rate swap, cap or collar agreement, interest rate
future or option contract, currency swap agreement, currency future or option contract or other
similar hedging agreement.
“Holdings” means Symphony ViDA Holdings LLC, a Delaware limited liability company.
“Holdings Expenses” has the meaning set forth in Section 5.09 of the Holdings
LLC Agreement.
“Holdings LLC Agreement” means the Amended and Restated Limited Liability Company
Agreement of Holdings dated as of the Closing Date.
“Holdings Property” has the meaning set forth in Section 1.01 of the Holdings
LLC Agreement.
“HSR Filings” means the pre-merger notification and report forms required under the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended.
“IND” means an Investigational New Drug Application, as described in 21 U.S.C.
§ 355(i)(1) and 21 C.F.R. § 312 in the regulations promulgated by the United States Food and Drug
Administration, or any foreign equivalent thereof.
“Indemnification Agreement” means the Indemnification Agreement among the Symphony
Collaboration and the Directors named therein, dated as of the Closing Date, as such agreement may
be amended or amended and restated from time to time.
“Indemnified Party” has the meaning set forth in each Operative Document or Zybrestat
Operative Document in which it appears.
“Indemnified Proceeding” has the meaning set forth in each Operative Document or
Zybrestat Operative Document in which it appears.
“Indemnifying Party” has the meaning set forth in each Operative Document or Zybrestat
Operative Document in which it appears.
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.
Annex A - 12
“Initial Holdings LLC Agreement” means the Agreement of Limited Liability Company of
Holdings, dated July 31, 2008.
“Initial Investors Funding” means the initial $15,000,000 contribution to the Symphony
Collaboration by the Investors through Holdings.
“Initial Investors LLC Agreement” means the Agreement of Limited Liability Company of
Investors, dated July 31, 2008.
“Initial LLC Member” has the meaning set forth in Section 1.01 of the Holdings
LLC Agreement.
“Interest Certificate” has the meaning set forth in Section 1.01 of the
Holdings LLC Agreement.
“Investment Company Act” means the Investment Company Act of 1940, as amended.
“Investment Policy” has the meaning set forth in Section 1(a)(vi) of the RRD
Services Agreement.
“Investors” means Symphony ViDA Investors LLC.
“Investors LLC Agreement” means the Amended and Restated Agreement of Limited
Liability Company of Investors dated as of the Closing Date.
“IRS” means the U.S. Internal Revenue Service.
“IV Commercialization Activities” means submitting an application for, or obtaining
regulatory approval of, or the promotion of any IV Ophthalmology Product.
“IV Ophthalmology Product” means [ * ] comprising [ * ] and [ * ] or other[ * ]. [ *
] do not include products that are [ * ] or other [ * ].
“Key Personnel” means those Company Personnel listed on Schedule 6.4 to the
Amended and Restated Research and Development Agreement or the Advisory Agreement, as applicable,
as such schedule may be updated from time to time by mutual agreement of the parties to the Amended
and Restated Research and Development Agreement or the Advisory Agreement, as applicable.
“Know-How” means any and all proprietary technology, including without limitation,
manufacturing processes or protocols, know-how, writings, documentation, data, technical
information, techniques, results of experimentation and testing, diagnostic and prognostic assays,
specifications, databases, any and all laboratory, research, pharmacological, toxicological,
analytical, quality control, non-clinical and clinical data, and other information and materials,
whether or not patentable.
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.
Annex A - 13
“Knowledge” of the Company, the Symphony Collaboration or Holdings, as the case may
be, means, as of any relevant date, the actual (and not imputed) knowledge of the executive
officers or managing member of such Person holding such office at such time, without the duty of
inquiry or investigation.
“Law” means any law, statute, treaty, constitution, regulation, rule, ordinance, order
or Governmental Approval, or other governmental restriction, requirement or determination, of or by
any Governmental Authority.
“License” has the meaning set forth in the Preliminary Statement of the Purchase
Option Agreement.
“Licensed Intellectual Property” means the Licensed Patent Rights and the Licensed
Know-How.
“Licensed Know-How” means any and all Know-How that is Controlled by Licensor or its
Affiliates on or after the Closing Date and prior to the expiration or termination of the Purchase
Option without Licensor’s exercise of the Purchase Option that relates to, or is exploitable in
connection with, the Licensed Patent Rights, Regulatory Files, Products or the Programs.
“Licensed Patent Rights” means:
(a) [ * ] and [ * ] and [ * ] prior to the expiration or termination of the [ * ] without [ *
] relating to, or exploitable in connection with, any [ * ] and/or any [ * ];
(b) [ * ] and [ * ] or [ * ] of the [ * ] or [ * ] described in (a) filed prior to the [ * ]
without [ * ]; and
(c) [ * ] and [ * ] of the [ * ] or [ * ] described in (a) or (b) filed after [ * ] but solely
to the extent the subject matter in any such [ * ].
Licensed Patent Rights include (i) [ * ] and (ii) [ * ].
“Licensor” means the Company.
“Licensor Regulatory Files” means any IND, NDA, DMF or any other correspondence or
filings filed with or received from any Regulatory Authority Controlled by Licensor or its
Affiliates at any time subsequent to the expiration or termination of the Purchase Option without
Licensor’s exercise of the Purchase Option relating to, or exploitable in connection with,
Zybrestat Compounds.
“Licensor Zybrestat Patents” means, other than the [ * ], any and all other patents,
patent applications and invention disclosures [ * ].
“Lien” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
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.
Annex A - 14
“Liquidating Event” has the meaning set forth in Section 8.01 of the Holdings
LLC Agreement.
“LLC Agreements” means the Initial Holdings LLC Agreement, the Holdings LLC Agreement,
the Initial Investors LLC Agreement and the Investors LLC Agreement.
“Loss” has the meaning set forth in each Operative Document in which it appears.
“Management Fee” has the meaning set forth in Section 6(a) of the RRD Services
Agreement.
“Management Services” has the meaning set forth in Section 1(a) of the RRD
Services Agreement.
“Manager” means (i) for each LLC Agreement in which it appears, the meaning set forth
in such LLC Agreement, and (ii) for each other Operative Document in which it appears, RRD in its
capacity as the provider of Management Services on behalf of the Symphony Collaboration pursuant to
the RRD Services Agreement.
“Manager Event” has the meaning set forth in Section 3.01(g) of the Holdings
LLC Agreement.
“Material Adverse Effect” means, with respect to any Person, a material adverse effect
on (i) the business, assets, property or condition (financial or otherwise) of such Person or,
(ii) its ability to comply with and satisfy its respective agreements and obligations under the
Operative Documents or the Zybrestat Operative Documents, as applicable, or, (iii) the
enforceability of the obligations of such Person under any of the Operative Documents or the
Zybrestat Operative Documents, as applicable, to which it is a party.
“Maximum Premium” has the meaning set forth in Section 4.03(d) of the Stock
and Warrant Purchase Agreement.
“Medical Discontinuation Event” means a series of adverse events, side effects or
other undesirable outcomes that, when collected in a Program, would cause a reasonable FDA Sponsor
to discontinue such Program.
“Membership Interest” means (i) for each LLC Agreement in which it appears, the
meaning set forth in such LLC Agreement, and (ii) for each other Operative Document in which it
appears, the meaning set forth in the Holdings LLC Agreement.
“NASDAQ Rules” means the rules and regulations promulgated by the NASDAQ Stock Market,
including, without limitation, Rules 4350(i)(1)(B) and 4350(i)(1)(D).
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.
Annex A - 15
“NDA” means a New Drug Application, as defined in the regulations promulgated by the
FDA, or any foreign equivalent thereof.
“Non-IV Closing Date” means the date, chosen by Holdings, at which the Non-IV Shares
and/or Non-IV Warrant are issued and purchased by Holdings; provided that Holdings must select a
date within one year after the Company delivers the Non-IV Notice.
“Non-IV Notice” means a notice from the Company stating that that the Company believes
in good faith that the licensing and/or commercialization of a Zybrestat Compound for use in any
oncology indication will be benefited by prohibiting the Symphony Collaboration from conducting IV
Commercialization Activities and stating that the Symphony Collaboration shall be prohibited from
conducting any future IV Commercialization Activities.
“Non-IV Shares” means (a) 4,000,000 (four million) shares of Company Common Stock if
the Symphony Collaboration has both (x) completed sufficient clinical trials to enable the conduct
of a pivotal trial (as determined by the Development Committee and as approved by the Symphony
Collaboration Board) and (y) given the Company written notice that the Symphony Collaboration
intends to commence a pivotal trial of an IV VDA Ophthalmology Product or (b) if the Symphony
Collaboration has not both (x) completed sufficient clinical trials to enable the conduct of a
pivotal trial (as determined by the Development Committee and as approved by the Symphony
Collaboration Board) and (y) given the Company written notice that the Symphony Collaboration
intends to commence a pivotal trial of an IV VDA Product, 2,000,000 (two million) shares of Company
Common Stock.
“Non-IV Warrant” has the meaning set forth in Section 2.06 of the Stock and
Warrant Purchase Agreement.
“Non-Pivotal Requirements” means that with respect to the applicable contemplated
clinical study: (a) the primary purpose for conducting such study, as reasonably determined by the
Symphony Collaboration, is to subsequently enable initiation of a pivotal study as the next
clinical study with an IV Ophthalmology Product; (b) the primary purpose of such study is not, as
reasonably determined by the Symphony Collaboration, to materially benefit or further the
development of a product other than an IV Ophthalmology Product; and (c) the Symphony Collaboration
has previously completed at least one clinical study with an IV Ophthalmology Product.
“Novated and Restated Technology License Agreement” means the Novated and Restated
Technology License Agreement, dated as of the Closing Date, among the Company, the Symphony
Collaboration and Holdings.
“Operative Documents” means, collectively, the Indemnification Agreement, the
Development Committee Indemnification Agreement, the Holdings LLC Agreement, the Purchase Option
Agreement, the Stock and Warrant Purchase
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.
Annex A - 16
Agreement, the Subscription Agreement, the Additional Funding Agreement, the Registration
Rights Agreement, the Technology License Agreement, the Novated and Restated Technology License
Agreement, the RRD Services Agreement, the Research and Development Agreement, the Amended and
Restated Research and Development Agreement, the Confidentiality Agreement, the OXiGENE Directors
Indemnification Agreement, and each other certificate and agreement executed in connection with any
of the foregoing documents.
“Ophthalmology Product” means any [ * ] or [ * ] comprising a [ * ] for use in the [ *
].
“Ophthalmology Program” means the identification, development, manufacture and/or use
of any Ophthalmology Product.
“Option Premium Shares” has the meaning set forth in the Preliminary Statement of the
Purchase Option Agreement.
“Optional Company Funding” has the meaning set forth in Section 2(c) of the
Additional Funding Agreement.
“Optional Company Funding Amount” has the meaning set forth in the Preliminary
Statement of the Additional Funding Agreement.
“OQP” means any [ * ] that contains at least one [ * ] derived from, or that may be
converted to, [ * ], including but not limited to [ * ].
“Organizational Documents” means any certificates or articles of incorporation or
formation, partnership agreements, trust instruments, bylaws or other governing documents.
“Original Agreement” has the meaning set forth in each Operative Document in which it
appears.
“OXi4503” means [ * ] which has the following chemical structure:
[ * ]
“OXi4503 Compounds” means [ * ], which has the [ * ] and the following chemical
structure:
[ * ]
[ * ].
“OXiGENE Directors Indemnification Agreement” means the Indemnification Agreement
among the Company and the Directors named therein, dated
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.
Annex A - 17
as of the Closing Date, as such agreement may be amended or amended and restated from time to
time.
“Partial Stock Payment” has the meaning set forth in Section 3(a)(iii) of the
Purchase Option Agreement.
“Party(ies)” means, for each Operative Document, Zybrestat Operative Document or other
agreement in which it appears, the parties to such Operative Document, Zybrestat Operative Document
or other agreement, as set forth therein. With respect to any agreement in which a provision is
included therein by reference to a provision in another agreement, the term “Party” shall
be read to refer to the parties to the document at hand, not the agreement that is referenced.
“Payment Terms” has the meaning set forth in Section 8.2 of the Amended and
Restated Research and Development Agreement.
“Percentage” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Permitted Investments” has the meaning set forth in Section 1.01 of the
Holdings LLC Agreement.
“Permitted Lien” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Person” means any individual, partnership (whether general or limited), limited
liability company, corporation, trust, estate, association, nominee or other entity.
“Personnel” of a Party means such Party, its employees, subcontractors, consultants,
representatives and agents.
“Prime Rate” means the quoted “Prime Rate” at JPMorgan Chase Bank or, if such bank
ceases to exist or is not quoting a base rate, prime rate reference rate or similar rate for United
States dollar loans, such other major money center commercial bank in New York City selected by the
Manager.
“Products” means Ophthalmology Products and/or Second Generation OQP Products.
“Profit” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Program Specific Budget Component” has the meaning set forth in Section 4.1
of the Amended and Restated Research and Development Agreement.
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.
Annex A - 18
“Program-Specific Claim” means any claim in a patent or patent application in the
Licensed Patent Rights that is directed exclusively to the composition of matter, formulations or
use of any Product.
“Program-Specific Patents” means any and all Licensed Patent Rights that contain at
least one Program-Specific Claim.
“Program” or “Programs” means the Ophthalmology Program and/or the Second
Generation OQP Program, with respect to the Operative Documents.
“Protocol” means a written protocol that meets the substantive requirements of
Section 6 of the ICH Guideline for Good Clinical Practice as adopted by the FDA, effective
May 9, 1997, and is included within the Development Plan or later modified or added to the
Development Plan pursuant to the Amended and Restated Research and Development Agreement or the
Advisory Agreement, as the case may be.
“Public Companies” has the meaning set forth in Section 5(e) of the Purchase
Option Agreement.
“Purchase Option” has the meaning set forth in Section 1(a) of the Purchase
Option Agreement.
“Purchase Option Agreement” means the Purchase Option Agreement dated as of the
Closing Date, among the Company, Holdings and the Symphony Collaboration.
“Purchase Option Closing” has the meaning set forth in Section 2(a) of the
Purchase Option Agreement.
“Purchase Option Closing Date” has the meaning set forth in Section 2(a) of
the Purchase Option Agreement.
“Purchase Option Commencement Date” has the meaning set forth in
Section 1(c)(iii) of the Purchase Option Agreement.
“Purchase Option Exercise Date” has the meaning set forth in Section 2(a) of
the Purchase Option Agreement.
“Purchase Option Exercise Notice” has the meaning set forth in Section 2(a) of
the Purchase Option Agreement.
“Purchase Option Period” has the meaning set forth in Section 1(c)(iii) of the
Purchase Option Agreement.
“Purchase Option Shares” has the meaning set forth in the recitals to the Registration
Rights Agreement.
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.
Annex A - 19
“Purchase Price” has the meaning set forth in Section 2(b) of the Purchase
Option Agreement.
“QA Audits” has the meaning set forth in Section 6.5 of the Amended and
Restated Research and Development Agreement.
“Regulatory Allocation” has the meaning set forth in Section 3.06 of the
Holdings LLC Agreement.
“Regulatory Authority” means the United States Food and Drug Administration, or any
successor agency in the United States, or any health regulatory authority(ies) in any other country
that is a counterpart to the FDA and has responsibility for granting registrations or other
regulatory approval for the marketing, manufacture, storage, sale or use of drugs in such other
country.
“Regulatory Files” means any IND, NDA, DMF or any other correspondence or filings
filed with or received from any Regulatory Authority with respect to the Programs.
“Representative” of any Person means such Person’s shareholders, principals,
directors, officers, employees, members, managers and/or partners.
“Research and Development Agreement” means the Research and Development Agreement,
dated as of the Closing Date, between the Company and Holdings.
“RRD” means RRD International, LLC, a Delaware limited liability company.
“RRD Indemnified Party” has the meaning set forth in Section 10(a) of the RRD
Services Agreement.
“RRD Loss” has the meaning set forth in Section 10(a) of the RRD Services
Agreement.
“RRD Personnel” has the meaning set forth in Section 1(a)(ii) of the RRD
Services Agreement.
“RRD Services Agreement” means the RRD Services Agreement, between the Symphony
Collaboration and RRD, dated as of the Closing Date.
“RRD Zybrestat Services Agreement” means the RRD Zybrestat Services Agreement, between
Holdings, the Company and RRD, dated as of the Closing Date.
“Schedule K-1” has the meaning set forth in Section 9.02(a) of the Holdings
LLC Agreement.
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.
Annex A - 20
“Scheduled Meeting” has the meaning set forth in Paragraph 6 of
Annex B of the Amended and Restated Research and Development Agreement.
“Scientific Discontinuation Event” has the meaning set forth in Section 4.2(c)
of the Amended and Restated Research and Development Agreement.
“SCP” means Symphony Capital Partners, L.P., a Delaware limited partnership.
“Second Generation OQP Products” means any pharmaceutical composition or method
comprising an OQP.
“Second Generation OQP Program” means the identification, development, manufacture
and/or use of any Second Generation OQP Product.
“SEC” means the United States Securities and Exchange Commission.
“Securities Act” means the Securities Act of 1933, as amended.
“Share Date” has the meaning set forth in Section 2.02 of the Stock and
Warrant Purchase Agreement.
“Solvent” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“SSP” means Symphony Strategic Partners, LLC, a Delaware limited liability company.
“Stock and Warrant Purchase Agreement” means that certain Stock and Warrant Purchase
Agreement, dated as of the Closing Date, by and between the Company and Holdings.
“Stock Payment Date” has the meaning set forth in Section 2 of the
Subscription Agreement.
“Stock Purchase Price” has the meaning set forth in Section 2 of the
Subscription Agreement.
“Stockholder Approval” means the approval required to be obtained by the Company from
its stockholders in accordance with the DGCL, the NASDAQ Rules, the Securities Act, Exchange Act
and other applicable Laws to approve the transactions contemplated by the Operative Documents,
including, without limitation, the issuance of the Company Securities.
“Subcontracting Agreement” means (a) any written agreement between the Company and a
third party pursuant to which the third party performs any Company Obligations or (b) any work
order, change order, purchase order or the like entered into
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.
Annex A - 21
pursuant to Section 6.2 of the Amended and Restated Research and Development Agreement
or Section 6.2 of the Advisory Agreement, as the case may be.
“Sublicense Obligations” has the meaning set forth in Section 3.2 of the
Novated and Restated Technology License Agreement.
“Sublicensed Intellectual Property” has the meaning set forth in Section 3.2
of the Novated and Restated Technology License Agreement.
“Subscription Agreement” means the Subscription Agreement between the Symphony
Collaboration and Holdings, dated as the Closing Date.
“Subsidiary” of any Person means any corporation, partnership, joint venture, limited
liability company, trust or estate of which (or in which) more than 50% of (a) the issued and
outstanding capital stock having ordinary voting power to elect a majority of the board of
directors of such corporation (irrespective of whether at the time capital stock of any other class
or classes of such corporation shall or might have voting power upon the occurrence of any
contingency); (b) the interest in the capital or profits of such partnership, joint venture or
limited liability company; or (c) the beneficial interest in such trust or estate is at the time
directly or indirectly owned or controlled by such Person, by such Person and one or more of its
other Subsidiaries or by one or more of such Person’s other Subsidiaries.
“Surviving Entity” means the surviving legal entity which survives the Company after
giving effect to a Change of Control.
“Symphony Capital” means Symphony Capital LLC, a Delaware limited liability company.
“Symphony Collaboration” means Symphony ViDA, Inc., a Delaware corporation.
“Symphony Collaboration Auditors” has the meaning set forth in Section 5(b) of
the RRD Services Agreement.
“Symphony Collaboration Board” means the board of directors of the Symphony
Collaboration.
“Symphony Collaboration By-laws” means the By-laws of the Symphony Collaboration, as
adopted by resolution of the Symphony Collaboration Board on the Closing Date.
“Symphony Collaboration Charter” means the Amended and Restated Certificate of
Incorporation of the Symphony Collaboration, dated as of the Closing Date.
“Symphony Collaboration Director Event” has the meaning set forth in
Section 3.01(h)(i) of the Holdings LLC Agreement.
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.
Annex A - 22
“Symphony Collaboration Enhancements” means [ * ] (including [ * ]), that is made by
or on behalf of [ * ], including [ * ] and including [ * ], together with [ * ].
“Symphony Collaboration Equity Securities” means the Common Stock and any other stock
or shares issued by the Symphony Collaboration.
“Symphony Collaboration Loss” has the meaning set forth in Section 10(b) of
the RRD Services Agreement.
“Symphony Collaboration Relevant Infringement” means an infringement,
misappropriation, illegal use or misuse of the Licensed Patent Rights or other Licensed
Intellectual Property due to the manufacture, use, sale or importation of any of the Products for
which the Company has not exercised a Discontinuation Option.
“Symphony Collaboration Shareholder” means any Person who owns any Symphony
Collaboration Shares.
“Symphony Collaboration Shares” has the meaning set forth in Section 2.02 of
the Holdings LLC Agreement.
“Symphony Fund(s)” means Symphony Capital Partners, L.P., a Delaware limited
partnership, and Symphony Strategic Partners, LLC, a Delaware limited liability company.
“Symphony Regulatory Files” means any IND, NDA, DMF or any other correspondence or
filings filed with or received from any Regulatory Authority Controlled by the Symphony
Collaboration or its Affiliates at any time subsequent to either (i) the expiration or termination
of the Purchase Option without Licensor’s exercise of the Purchase Option; or (ii) the expiration
of the Discontinuation Option relating to the Ophthalmology Program without exercise thereof, in
either case, relating to, or exploitable in connection with, Zybrestat Compounds.
“Symphony Zybrestat Patents” means any and all patents, patent applications and
invention disclosures Controlled by the Symphony Collaboration or its Affiliates at any time
subsequent to the expiration or termination of the Purchase Option without Licensor’s exercise of
the Purchase Option relating to, or exploitable in connection with, Zybrestat Compounds.
“Tangible Materials” means [ * ], that embodies or relates to [ * ], including [ * ];
provided, however, that Tangible Materials shall not include [ * ].
“Tax Amount” has the meaning set forth in Section 4.02 of the Holdings LLC
Agreement.
“Technology License Agreement” means the Technology License Agreement, dated as of the
Closing Date, between the Company and Holdings.
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.
Annex A - 23
“Term” has the meaning set forth in Section 4(b)(iv) of the Purchase Option
Agreement, unless otherwise stated in the applicable Operative Document.
“Territory” means the world.
“Third Party IP” has the meaning set forth in Section 2.9 of the Novated and
Restated Technology License Agreement.
“Third Party License Agreement” means any agreement between the Company or its
Affiliates and a third party pursuant to which any element of the Licensed Intellectual Property is
licensed to the Company or its Affiliates. Third Party License Agreements include the ASU License
Agreement, the Baylor License Agreement, the BMS License Agreement and the Angiogene License
Agreement.
“Third Party Licensor” means a third party from which the Company has received a
license or sublicense to Licensed Intellectual Property.
“Transaction Event” means a merger, acquisition or similar change of control event
involving the Company.
“Transfer” has for each Operative Document in which it appears the meaning set forth
in such Operative Document.
“Transferee” has, for each Operative Document in which it appears, the meaning set
forth in such Operative Document.
“Treasury Regulations” means the rules, regulations and orders, and interpretations
thereof, adopted by the IRS under the Code, as in effect from time to time.
“Vascular Disrupting Agent” means an agent that selectively disrupts abnormal blood
vessels or a radioisomer, salt, solvate, polymorph, isomer, metabolite or prodrug thereof,
including, but not limited to, Combretastatins; provided, however, that Vascular
Disrupting Agents shall not include any such agent that includes a Bio-Reductive Trigger.
“Voluntary Bankruptcy” has the meaning set forth in Section 1.01 of the
Holdings LLC Agreement.
“Warrant Shares” has the meaning set forth in the Preliminary Statement of the
Purchase Option Agreement.
“Zybrestat” means [ * ], which has the following chemical structure:
[ * ]
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.
Annex A - 24
“Zybrestat Compounds” means [ * ] and the following chemical structure:
[ * ]
[ * ].
“Zybrestat Confidentiality Agreement” means the Confidentiality Agreement, dated as of
the Closing Date, among the Symphony Collaboration, Holdings, the Company, SCP, SSP, Investors,
Symphony Capital and RRD, as such agreement may be amended or amended and restated from time to
time.
“Zybrestat Indemnification Agreement” means the Advisory Committee Indemnification
Agreement, dated as of the Closing Date, among the Company and the members of the Advisory
Committee named therein, as such agreement may be amended and restated from time to time.
“Zybrestat Operative Documents” means, collectively, the Advisory Agreement, the RRD
Zybrestat Services Agreement, the Advisory Committee Indemnification Agreement and the Zybrestat
Confidentiality Agreement.
“Zybrestat Product” or “Zybrestat Product” has the meaning set forth in the
Preliminary Statement of the Advisory Agreement.
“Zybrestat Program” has the meaning set forth in the Preliminary Statement of the
Advisory Agreement.
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.
Annex A - 25
ANNEX B
SYMPHONY ViDA, INC.
DEVELOPMENT COMMITTEE CHARTER
Purpose
The Development Committee (the “Development Committee”) is established by SYMPHONY
ViDA, INC. (the “Symphony Collaboration”) to oversee a clinical development plan (the
“Development Plan”) and a development budget (the “Development Budget”) for the
Programs (each as defined in that certain Novated and Restated Technology License Agreement
(“TLA”), dated as of October 1, 2008, among the Symphony Collaboration, OXiGENE, INC. (the
“Company”) and SYMPHONY ViDA HOLDINGS LLC (“Holdings”, and together with the
Company, the “Parties” and each a “Party”), and to develop the Ophthalmology
Program and the Second Generation OQP Program (each as defined in the TLA). Capitalized terms used
herein and not defined herein shall have the meanings assigned to such terms in Annex A to
the Amended and Restated Research and Development Agreement, dated as of October 1, 2008, among the
Symphony Collaboration, Holdings and the Company.
Composition
1. The Development Committee shall initially have six (6) members, and shall at all times have
an even number of members and consist of an equal number of members designated by each Party (the
“Development Committee Members”). Each Party may bring additional employees or
representatives to each meeting as non-voting observers, but only if such employees or
representatives are bound by confidentiality obligations at least as stringent as those described
in the Confidentiality Agreement. The size and composition of the Development Committee provided
herein may not be changed without the consent of both Holdings and the Company.
2. One-half (1/2) of the Development Committee Members shall be designated by the Company and
one-half (1/2) shall be designated by Holdings.
3. Each Development Committee Member shall have the requisite background, experience and
training to carry out the duties and obligations of the Development Committee. Development
Committee Members need not be directors of the Symphony Collaboration, Holdings or the Company.
4. The chair of the Development Committee shall be, initially, Xxxxxxxx X. Xxxxxxx, M.D.,
Ph.D., the Vice President and Chief Medical Officer of the Company, and any succeeding chair shall
be such person as may be appointed to the position of Vice President and Chief Medical Officer of
the Company (or an equivalent
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.
Annex B - 1
successor position) (the “Chair”). If the Company wishes to appoint a Chair other
than the then-current Vice President and Chief Medical Officer of the Company (or the holder of an
equivalent successor position), then such appointment shall require the consent of the Symphony
Collaboration Board; provided, that (x) if the Symphony Collaboration Board shall have less
than five (5) members, an affirmative vote of at least three members of the Symphony Collaboration
Board shall be required; or (y) if the Symphony Collaboration Board shall have five (5) members, an
affirmative vote of at least three-fifths (3/5ths) of the members of the Symphony Collaboration
Board shall be required.
5. By written notice to the Company, Holdings may remove or replace one or more Development
Committee Members designated by Holdings. By written notice to Holdings, the Company may remove or
replace one or more Development Committee Members designated by the Company.
Operations
6. The Development Committee shall meet once per month during the Term, unless and until the
Development Committee determines that such meetings should occur once per quarter (in either case,
each a “Scheduled Meeting”). Scheduled Meetings may be held in person or by teleconference
when appropriate; provided that each Scheduled Meeting during the first [ * ] months of the
term shall be held in person unless otherwise unanimously agreed by the members of the Development
Committee. In-person Scheduled Meetings shall be held at the Company’s headquarters unless
otherwise unanimously agreed by the members of the Development Committee. Each of the Symphony
Collaboration and the Company shall be solely responsible for the costs associated with its
employees and/or representatives attending and participating in such Scheduled Meetings. In
addition, any Development Committee Member may call for an ad hoc meeting of the Development
Committee to be held by teleconference at any time during regular business hours, by giving the
other members of the Development Committee advance written notice of at least [ * ] ([ * ])
Business Days (each, an “Ad Hoc Meeting”). An Ad Hoc Meeting may be called to address any
time-sensitive matter, including additional expenditure requests pursuant to Section 8.3 of
the Amended and Restated Research and Development Agreement or Section 2 of the RRD
Services Agreement.
7. The Chair shall, in consultation with other Development Committee Members and the
management of the Symphony Collaboration, develop and set the Development Committee’s agenda for
each Scheduled Meeting. The Chair shall include on such agenda each item requested by a
Development Committee member at least two (2) weeks before the applicable Scheduled Meeting. The
agenda and information concerning the business to be conducted at each Scheduled Meeting shall be
communicated in writing to the Development Committee Members at least one (1) week in advance of
such Scheduled Meeting to permit meaningful review. Such an agenda shall not be required for an Ad
Hoc 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.
Annex B - 2
8. Each Party’s Development Committee Members shall collectively have three (3) votes,
regardless of the number of its Development Committee Members participating in any Scheduled
Meeting or Ad Hoc Meeting. No votes shall be taken unless there is at least one (1) Development
Committee Member representing each of the Company and Holdings participating in such Scheduled
Meeting or Ad Hoc Meeting, as the case may be. Each Party may allocate its three (3) votes among
its attending Development Committee Members in any manner, at such Party’s discretion. If only one
(1) Development Committee Member is attending on behalf of a given Party, such Development
Committee Member may cast all the votes allocated to such Party. Unless otherwise specified
herein, all actions taken by the Development Committee as a committee shall be by majority vote.
If the Development Committee Members reach a deadlock on any vote, then such deadlock shall be
resolved in accordance with Paragraph 11 of this Development Committee Charter.
9. Notwithstanding anything herein to the contrary, during the Term, this 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.
10. The Chair, or such person as the Chair may designate, shall prepare, and distribute to all
Development Committee Members, draft committee minutes within a reasonable period of time following
each Scheduled Meeting or Ad Hoc Meeting, but in any case, in sufficient time to be included as
part of the agenda for the next Scheduled Meeting. As part of the agenda of the first Scheduled
Meeting, the Development Committee Members shall agree upon a standard procedure for review and
approval of such draft committee minutes by the Development Committee Members.
11. If the Development Committee is unable to decide by a majority vote on any issue within
the scope of its authority and duties, then the Development Committee shall promptly raise such
issue to the chief executive officer (or equivalent officer) of the Company and the chairman of the
Symphony Collaboration Board. The chief executive officer and chairman shall have [ * ] ([ * ])
Business Days to mutually agree on how to resolve such issue. If such parties are unable to
resolve such issue within the [ * ] ([ * ]) Business Day period, then such issue shall be brought
to the Symphony Collaboration Board, and the Symphony Collaboration Board shall promptly resolve
such issue, which resolution shall be binding on Holdings and the Company.
Authority and Duties
12. The Development Committee shall, within [ * ] ([ * ]) days of the Closing Date of the
Closing Date, work diligently and endeavor to agree upon a Development Plan and Development Budget.
The Development Committee shall continue to develop and refine the Development Plan and
Development Budget, and shall, at the request of the Symphony Collaboration Board, submit each to
the Symphony Collaboration Board at the first meeting of the Symphony Collaboration Board, as
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.
Annex B - 3
provided in Section 4.1 of the Amended and Restated Research and Development
Agreement. Following the Symphony Collaboration Board’s review, the Development Committee shall
work diligently to incorporate the comments generated by such review in order to update the
Development Plan and Development Budget as soon as practicable and shall then submit the updated
Development Plan and Development Budget to the Symphony Collaboration Board for review. The
Development Committee shall thereafter continue to develop and refine the Development Plan and the
Development Budget as needed, and shall conduct a comprehensive review of each on a semi-annual
basis. In addition, the Development Committee shall decide on any other matters relating to the
Development Plan and the Development Budget that may arise, including (i) responding to requests
from RRD or the Company for amendments to the Development Plan and/or the Development Budget, and
(ii) addressing all other matters that are identified in the Operative Documents or the Symphony
Collaboration Charter as requiring the approval of the Development Committee (including, but not
limited to, the approval of any new, or the amendment or termination of any existing,
Subcontracting Agreement). Unless otherwise approved pursuant to Paragraph 11 hereof, or
discontinued or modified pursuant to Sections 4.2(c) or 5.1 of the Amended and
Restated Research and Development Agreement, no material change to the Development Plan or
Development Budget will be adopted by the Symphony Collaboration unless and until the Development
Committee approves such change.
13. The Development Committee shall report at least quarterly to the Symphony Collaboration
Board regarding progress relative to the Development Plan and the Development Budget, and any
changes in the Development Plan and/or Development Budget, and shall respond promptly to any
reasonable requests for additional information made by the Symphony Collaboration Board. The
Development Committee shall also submit its material decisions regarding the Development Plan and
Development Budget to the Symphony Collaboration Board, including regulatory strategies and
discontinuation or modification of the Programs.
14. The Development Committee shall continuously evaluate the funding requirements of the
Programs. On the earlier to occur of the following:
(x) the Development Committee determines that a Balance Sheet Deficiency
has occurred or is reasonably likely to occur within [ * ] days, or
(z) the day [ * ] ([ * ]) days preceding the second anniversary of the
Closing Date;
the Development Committee shall determine the amount, if any, of additional funds that it estimates
will be required to develop the Programs (the “Required Amount”) and report such Required
Amount to the Symphony Collaboration Board and to 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.
Annex B - 4
15. The foregoing list of duties is not exhaustive, and the Development Committee may, in addition,
perform such other functions as may be necessary or appropriate for the performance of its duties
and the furtherance of the development of Programs, including as may be required under any
Operative Document. In no event shall the Development Committee have the power to amend any of the
Operative Documents. The Development Committee shall have the power to delegate its authority and
duties to sub-committees as it deems appropriate; provided, however, that each such
sub-committee shall have at least one (1) Development Committee Member who is designated by
Holdings and at least one
(1) Development Committee Member who is designated by 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.
Annex B - 5
ANNEX C
PAYMENT TERMS
1. | With respect to the development activities and services provided by the Company pursuant to this Agreement, and in accordance with the terms of this Agreement, the Development Plan and the Development Budget, the Company will invoice the Symphony Collaboration, and the Symphony Collaboration will pay the Company, in accordance with this Annex C. |
2. | Out-of-pocket fees, expenses and pass-through costs actually incurred by the Company or Company Personnel in performing the development activities and services pursuant to this Agreement, which fees, expenses and pass-through costs have been estimated in the Development Budget, as such Development Budget may be modified upon approval of the Development Committee, shall be invoiced by the Company to the Symphony Collaboration following the end of the month in which such development activities and services were performed or such out-of-pocket fees, expenses or pass-through costs were incurred. The Symphony Collaboration shall pay the Company the amount of such invoice within [ * ] ([ * ]) days of receipt, provided that the invoice, accompanying documentation and amount invoiced comply with this Annex C and Article 8 of this Agreement. |
3. | The Company’s monthly invoices must include receipts, third party invoices or other reasonable documentation for all fees, expenses and pass-through costs of the Company and Company Personnel. Personnel costs in item 2 shall be reimbursed at an annual fully burdened FTE rate as set forth in Schedule 1 attached hereto. The Company’s invoices not in accordance with the requirements of this section may incur delays in payment. The Company shall not charge any administrative fees to the Symphony Collaboration in connection with any fees, expenses or pass-through costs. |
4. | All fees, expenses and pass-through costs will be payable in US Dollars. If the Symphony Collaboration disputes in good faith any portion of an invoice, then the Symphony Collaboration shall pay the undisputed amounts as set forth in the preceding sentence and the parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. | |
5. | The Company will transmit invoices to the Symphony Collaboration at the following address: |
SYMPHONY ViDA, INC.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Accounts Payable
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Accounts Payable
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.
Annex C - 1
6. | All payments to the Company shall be sent to the Company, as follows: |
If mailed: | OXiGENE, INC. | |||||
000 Xxxxx Xxxxxx | ||||||
Xxxxxxx, XX 00000 | ||||||
If wired: | Name of bank: | [ * ] | ||||
Routing number: | [ * ] | |||||
SWIFT Code: | [ * ] | |||||
The Company account number: [ * ] |
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.
Annex C - 2
SCHEDULE 6.2
SUBCONTRACTING AGREEMENTS
Type | Organization | Effective Date | ||
[ * ]
|
[ * ] | [ * ] |
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.
SCHEDULE 6.4
COMPANY KEY PERSONNEL
Name | Position | |
Xxxxxxxx Xxxxxxx
|
Vice President and CMO | |
Xxxxx Xxxxxxx
|
Vice President and CSO | |
Xxxxxxxxxxx Xxxxx
|
Sr. Director, Project Management | |
Xxxxxxxxxx Xxxxx
|
Sr. Director, Clinical Operations | |
Zelanna Xxxxxxxx
|
Medical Director | |
Xxxx X’Xxxxx
|
Clinical Research Consultant | |
Xxx Xxxxxxx
|
Associate Director, Preclinical Development | |
Bronwyn Siim
|
Director, Research | |
Xxxxx Xxxxxx
|
Director, CMC | |
Xxxxx Xxxxxx
|
Vice President and CFO | |
Xxxx Xxxxxxx
|
COO |
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.
SCHEDULE 12.1(f)
MATERIAL DISCLOSED CONTRACTS
Type | Organization | Effective Date | ||
[ * ]
|
[ * ] | [ * ] |
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.