RESEARCH AND DEVELOPMENT AGREEMENT between OXiGENE, INC. and SYMPHONY ViDA HOLDINGS LLC Dated as of October 1, 2008
Exhibit 10.57
EXECUTION COPY
between
OXiGENE, INC.
and
SYMPHONY ViDA HOLDINGS LLC
Dated as of October 1, 2008
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
TABLE OF CONTENTS
Page | ||||
1. [Intentionally Omitted] |
1 | |||
2. Overview of Development |
1 | |||
3. Development Committee |
2 | |||
4. Development Plan and Development Budget |
2 | |||
4.1 Generally |
2 | |||
4.2 Amendments |
3 | |||
5. Regulatory Matters |
4 | |||
5.1 FDA Sponsor |
4 | |||
5.2 Correspondence |
4 | |||
5.3 Inspections and Meetings |
5 | |||
6. The Company’s Obligations |
5 | |||
6.1 Generally |
5 | |||
6.2 Subcontracting |
6 | |||
6.3 Reports and Correspondence |
7 | |||
6.4 Staffing |
8 | |||
6.5 QA Audit |
8 | |||
6.6 Financial Audit |
8 | |||
6.7 Insurance |
9 | |||
7. Holdings’ Obligations |
9 | |||
7.1 Generally |
9 | |||
7.2 Subcontracting |
9 | |||
7.3 Insurance |
10 | |||
7.4 Staffing |
10 | |||
7.5 Inspection and Audit |
10 | |||
8. Funding and Payments |
10 | |||
8.1 Use of Proceeds |
10 | |||
8.2 Reimbursement |
10 | |||
8.3 Budget Allocation and Deviations |
11 | |||
8.4 Employee Benefits |
11 | |||
9. Covenants |
12 | |||
9.1 Mutual Covenants |
12 | |||
10. Confidentiality |
13 |
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 |
13 | |||
12. Representations and Warranties |
14 | |||
12.1 Company Representations and Warranties |
14 | |||
12.2 Holdings Representations and Warranties |
16 | |||
13. Relationship Between the Company and Holdings |
17 | |||
14. Change of Control |
18 | |||
15. No Restrictions; Indemnification |
18 | |||
15.1 No Restrictions |
18 | |||
15.2 Indemnification |
18 | |||
16. Limitation of Liabilities |
22 | |||
16.1 Between the Parties |
22 | |||
17. Term and Termination |
22 | |||
17.1 Term |
22 | |||
17.2 Termination for Company’s Breach |
22 | |||
17.3 Termination for Holdings’ Breach |
23 | |||
17.4 Termination of License Agreement |
23 | |||
17.5 Survival |
23 | |||
18. Miscellaneous |
23 | |||
18.1 No Petition |
23 | |||
18.2 Notices |
24 | |||
18.3 Governing Law; Consent to Jurisdiction and Service of Process |
25 | |||
18.4 Waiver of Jury Trial |
25 | |||
18.5 Entire Agreement |
26 | |||
18.6 Amendment; Successors; Assignment; Counterparts |
26 | |||
18.7 Severability |
26 |
Annex A — Certain Definitions
Annex B — Development Committee Charter
Annex C — Payment Terms
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
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
This RESEARCH AND DEVELOPMENT AGREEMENT (this “Agreement”) is entered into as of
October 1, 2008 (the “Closing Date”) by and between OXiGENE, INC., a Delaware corporation
(the “Company”) and SYMPHONY ViDA HOLDINGS LLC, a Delaware limited liability company
(“Holdings”) (each of the Company and Holdings being a “Party,” and collectively,
the “Parties”). Capitalized terms used herein and not defined herein shall have the
meanings assigned to such terms in Annex A attached hereto.
PRELIMINARY STATEMENT
In the Technology License Agreement, the Company grants Holdings an exclusive license to the
Programs. Holdings wishes for the Company to continue to develop such Programs. Holdings and the
Company desire to establish, and agree on the responsibilities of, a Development Committee to
oversee such development. The Company and Holdings further desire to comply with and perform
certain agreements and obligations related thereto.
The Parties hereto agree as follows:
1. [Intentionally Omitted].
2. Overview of Development.
(a) The Parties shall develop the Programs in a collaborative and efficient manner as set
forth in this Article 2. Representatives of the Parties shall engage in joint
decision-making for the Programs as set forth in Articles 3 and 4 hereof. Holdings
shall have overall responsibility for all matters set forth in the Development Plan (pursuant to
Article 7 hereof), and shall engage the Company (pursuant to Article 6 hereof), and
such independent contractors and agents as the Company may retain (which contractors include
entities retained by the Company prior to the Closing Date pursuant to the Subcontracting
Agreements set forth on Schedule 6.2), to act on behalf of Holdings and carry out the
duties set forth therein and herein.
(b) With respect to the Programs, the Company shall be responsible for the execution of all
non-clinical and clinical development, all regulatory activities, all scientific and technical
services associated with such development (including manufacturing), and all patent work, including
all related matters set forth in the Development Plan for such Programs.
(c) Nothing in Section 2(b) shall in any way limit the authority of the Development
Committee (as defined below) or the Holdings’ managing member (the “Manager”) hereunder,
and the engagements and delegations set forth
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
therein shall be subject to the terms and conditions
of this Agreement, and the satisfactory performance by the Company of its obligations pursuant
hereto and thereto. The allocations of responsibility described in this Article 2 shall
remain subject to further modification in accordance with the terms and conditions of this
Agreement.
3. Development Committee. The Parties shall establish and maintain a committee (the “Development Committee”)
to oversee the development of the Programs (including the continued development and refinement of
the Development Plan and the Development Budget). The Development Committee shall be established,
operated and governed in accordance with the policies and procedures set forth in Annex B
hereto (the “Development Committee Charter”). The Development Committee Charter may be
amended only with the unanimous approval of the Development Committee Members and the consent of
Holdings and the Company. In no event shall the Development Committee have the power to amend the
terms of any Operative Document.
4. Development Plan and Development Budget.
4.1 Generally.
(a) The Parties shall agree to a Development Plan and a Development Budget following the
Closing Date, and which shall be further developed and refined from time to time in accordance
herewith. The Development Plan shall consist of detailed provisions governing all research,
non-clinical, clinical, development, manufacturing, scientific, technical, regulatory and patent
work to be performed under the Operative Documents. Following the Closing Date, the Development
Committee shall, on an ongoing basis, develop the Development Plan to include, without limitation,
(i) an outline of the plan for the clinical development of each Program; and (ii) outlines of
non-clinical activities, key regulatory and quality activities, and CMC activities for each
Program. The Development Budget shall consist of two (2) components: (x) a development budget for
each Program covered by the Development Plan (the “Program Specific Budget Component”), and
(y) a budget for the cross program management and administrative functions of Holdings (the
“Cross Program Budget Component”). The development budgets for each Program in the Program
Specific Budget Component covered by the Development Plan shall be further divided into budget
spreadsheets summarizing (1) anticipated costs of engaging third party service providers and the
scope of work to be performed by such third parties; and (2) the number of FTEs to be dedicated to
the Programs (by function and work responsibilities, on a Program-by-Program basis).
(b) Prior to the initiation of any Activity pursuant to the Development Plan, funds sufficient
to pay all of the estimated costs and expenses for work to be performed in relation to such
Activity until completion of such Activity, must be available, either as committed by Holdings or
committed by the Company. If such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
2
funds are committed by the Company, the Company shall (i) make
such commitment in writing; and (ii) be obligated to provide such committed funds until completion
of the related Activity, and such obligation shall survive beyond the expiration or termination of
the Purchase Option or any of the Operative Documents; provided, that following the
expiration or termination of the Purchase Option or any of the Operative Documents, if any changes
in the scope or nature of the related Activity increase the cost of the completion of such
Activity, the Company shall not be obligated to make additional funds available.
4.2 Amendments.
(a) All amendments of, and all material deviations from, the Development Plan and Development
Budget shall be made in accordance with the procedures described in this Article 4 and in
the Development Committee Charter, including obtaining the approval of Holdings, as may be required
by the Development Committee Charter.
(b) The Development Committee shall review the Development Plan and Development Budget in
their entirety on a semi-annual basis to determine whether any changes are required, and shall
comply with all procedures required to amend the Development Plan or Development Budget to
implement such changes. Furthermore, following the Closing Date, the Development Committee shall,
on an ongoing basis, continue to develop the Development Plan, including, without limitation, as
set forth in Section 4.1 and in response to requests, proposals or reports from the Company
to the Development Committee.
(c) A Program, or a Product within a Program, may only be discontinued in the event that
either (i) the Parties mutually agree to discontinue such Program or Product based on (A) a Medical
Discontinuation Event, or (B) scientific evidence (regardless of whether such evidence is generated
by a Party or a third party) that the likelihood of success for a particular Program or Product is
not sufficient to warrant further development (a “Scientific Discontinuation Event”) that
arises in the course of developing such Program or Product; or (ii) Holdings resolves to
discontinue such Program or Product. The Development Committee shall promptly thereafter amend the
Development Plan and Development Budget to reflect such discontinuation.
(d) The Development Plan shall never be amended in any manner that would require the Company
or Holdings to perform any assignments or tasks in a manner that would violate any applicable law
or regulation. In the event of a change in any applicable law or regulation, the Development
Committee shall consider amending the Development Plan to enable the Company or Holdings (or any
Person
acting on behalf of the Company or Holdings), as the case may be, to comply fully with such
law or regulation. If such amendment is not approved, the affected Party shall be excused from
performing any activity specified herein or in the Development Plan that would violate or result in
a violation of any applicable law or regulation.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
3
5. Regulatory Matters.
5.1 FDA Sponsor. Notwithstanding any governance provision contained herein or in any Operative Document, the
Parties agree that, unless and until the expiration or termination of the purchase option (the
“Purchase Option”) to be granted to the Company pursuant to an agreement among Holdings,
the Company and such other party as may be required, the term of which has been agreed between the
Parties, and which agreement shall provide for the Company to purchase the rights to the Programs
from Holdings (the “Purchase Option Agreement”) without the Company’s exercise of the
Purchase Option, the Company shall be the FDA sponsor, and shall serve the equivalent role with
respect to any Regulatory Authority outside of the United States, for the Programs, except any
Programs which were the subject of a Discontinuation Option that was not exercised by the Company
(the “FDA Sponsor”). As the FDA Sponsor, the Company shall have the responsibility and the
authority to act as the sponsor and make those decisions and take all actions reasonably necessary
to assure compliance with all regulatory requirements. The Company agrees to be bound by, and
perform all obligations set forth in, 21 C.F.R. § 312 and any and all similar obligations imposed
by a foreign Regulatory Authority related to the Company’s role as the FDA Sponsor.
Notwithstanding anything to the contrary in Article 4 or the Development Committee Charter,
the Company, in its capacity as FDA Sponsor, may discontinue or modify any Program without the
approval of the Development Committee or Holdings in the event such actions are: (a) attributable
to an event that is reportable to the FDA or corresponding Regulatory Authority outside of the
United States; and (b) reasonably necessary to avoid the imposition of criminal or civil liability;
provided, however, that to the extent commercially reasonable, the Company shall
(i) pursuant to Section 5.2, advise and consult with the Development Committee prior to
taking such action and (ii) forward a copy of all regulatory correspondence relevant to such
discontinuation or modification to the Manager.
5.2 Correspondence. Each Party hereto acknowledges that the Company, in its capacity as FDA Sponsor, shall be
the Party responding to any regulatory correspondence or inquiry regarding, or which would
reasonably be expected to affect, any of the Programs. The Company shall, within [ * ] ([ * ])
hours: (a) notify at least one (1) Development Committee Member designated by Holdings of any FDA
or other governmental or regulatory correspondence, inspection or inquiry regarding or reasonably
expected to impact any of the Programs; and (b) forward to the Development Committee copies of any
correspondence sent to or received from any regulatory or governmental agency,
including, but not limited to, Form FD-483 notices and FDA refusal to file, action or warning
letters, even if they do not specifically mention Holdings. To the extent practicable, the Company
shall consult with the Development Committee prior to responding to any such regulatory
correspondence or inquiry, but the Company shall not be obligated to do so if such action would
require a delay beyond any time period permitted by applicable law or regulations. During the
Company’s consultation with the Development Committee, the Company and the Development
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
4
Committee
shall discuss and agree upon issues including, but not limited to, overall regulatory strategy and
goals and objectives. Subject to the following sentence, Holdings shall not have any right to
initiate any regulatory correspondence with respect to the Programs. In the event that Holdings
receives a request or notification from a Governmental Authority with respect to the Programs,
Holdings shall: (i) notify the Company within [ * ] ([ * ]) hours of receipt of such request or
communication and (ii) to the extent practicable, submit any proposed response to the Company for
review and approval; provided, that such approval shall not be unreasonably withheld and
shall not prevent the Holdings from complying with any legal requirements or acting to avoid any
civil or criminal liability.
5.3 Inspections and Meetings. Each Party agrees that, during an inspection by the FDA or other Regulatory Authority
concerning the Programs, it will not disclose to such agency any information and materials that are
not, in the reasonable judgment of the disclosing Party, required to be disclosed to such agency
without first obtaining the consent of the other Party, which consent shall not be unreasonably
withheld or delayed, except to the extent that such Party may be required by law to
disclose such information and materials. The Company shall be the Party responsible for arranging
and participating in any meetings with any Regulatory Authority concerning any of the Programs. To
the extent practicable, the Company shall consult with the Development Committee prior to any such
meetings and provide to the Development Committee for review all relevant correspondence to date.
During the Company’s consultation with the Development Committee, the Company and the Development
Committee shall discuss and agree upon issues including, but not limited to, overall regulatory
strategy, proposed agendas, goals and objectives, preparation and attendees. The Company shall
provide prompt and reasonable prior notice of any such meetings to at least one (1) of the
Development Committee Members designated by Holdings, and shall, upon a request from Holdings, and
to the extent reasonably possible, facilitate the attendance of at least one (1) of the Development
Committee Members designated by Holdings at any such meeting reasonably anticipated to pertain in a
material way to a Program. Following any meeting that pertains to a Program, but that was not
attended for any reason by at least one (1) of the Development Committee Members designated by
Holdings, the Company shall provide at least one (1) of the Development Committee Members
designated by Holdings with an oral summary of that portion of the meeting relevant to such Program
within [ * ] ([ * ]) hours of such meeting and a written summary of that portion within [ * ] ([ *
]) Business Days of such meeting.
6. The Company’s Obligations.
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
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
5
development for the Programs in accordance with the
Development Plan, (ii) manufacturing of, or arranging for third parties to manufacture, Clinical
Trial Materials for the Programs, and carrying out the quality assurance therefor, in each case in
accordance with the Development Plan, and (iii) executing all other matters set forth in the
Development Plan that are delegated to the Company by Holdings pursuant to the Development Plan
(collectively, the “Company Obligations”).
(b) The Company agrees that it will work diligently and use commercially reasonable efforts to
discharge the Company Obligations in a good scientific manner and in accordance with the
Development Plan, the Development Budget, and the terms of this Agreement.
6.2 Subcontracting. All agreements between the Company and third parties (including without limitation clinical
research organizations and contract manufacturers) for such third parties to perform any Company
Obligations (each such third party, a “Company Subcontractor” and each such agreement, a
“Subcontracting Agreement”) entered into by the Company prior to the Closing Date (except
for those master service agreements executed prior to the Closing Date that, only through the
subsequent addition of a new work order, change order, project or the like after the Closing Date,
become Subcontracting Agreements) and listed on Schedule 6.2 hereto, shall be deemed to be
acceptable to the Parties in all respects. Following the Closing Date, the Company shall obtain
approval of the Development Committee prior to entering into any Subcontracting Agreement, issuing
new work orders against existing Subcontracting Agreements, or amending or terminating any
Subcontracting Agreement, which approval shall not unreasonably be withheld. The Development
Committee may, in its discretion, approve standard forms of Subcontracting Agreements with respect
to which the Company may enter into pursuant to such standing authority granted by the Development
Committee from time to time, as such authority may be modified or terminated by the Development
Committee in its discretion. The Company shall provide the Development Committee with a copy of
each draft Subcontracting Agreement (other than those using standard forms and entered into in
accordance with the preceding sentence). The Development Committee, or its designee(s), shall have
[ * ] ([ * ]) Business Days to approve or reject the terms of such draft Subcontracting Agreement;
provided that during such [ * ] ([ * ]) Business Day period the Company shall make
appropriate representatives available to the
Development Committee to discuss such Subcontracting Agreement in good faith and reasonable
detail and shall provide any information as may be reasonably requested by the Development
Committee or any member thereof. Only approval of the terms of such draft Subcontracting Agreement
by the Development Committee will entitle the Company to reimbursement by Holdings for such
Subcontracting Agreement. The terms of such draft Subcontracting Agreement shall be deemed to have
been approved if not objected to by any Development Committee Member within the [ * ] ([ * ])
Business Day period. The terms of any such Subcontracting Agreements shall be deemed the
Confidential Information of the Company and be subject to the rights and obligations set forth in
the Confidentiality
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
6
Agreement. The Company shall monitor the performance of its Company
Subcontractors and shall promptly notify the Development Committee with respect to any Company
Subcontractor performance issues that may have a material adverse effect on the Programs. The
Company shall deliver a copy of each Subcontracting Agreement within [ * ] Business Days after it
is executed by all parties thereto. The Development Committee shall have the authority to direct
the Company to terminate any Subcontracting Agreement pursuant to the terms thereof.
6.3 Reports and Correspondence. The Company shall keep the Development Committee informed of its activities under the
Development Plan through regular reports, as set forth in this Section 6.3. At each
Scheduled Meeting of the Development Committee, or according to a schedule agreed to by the
Development Committee, the Company shall, to the extent reasonably required by the Development
Committee, provide a summary of the Company’s activities and developments with respect to the
Programs for the period following the most recent preceding scheduled summary report. Such summary
report shall include the following types of information in a format and frequency as determined by
the Development Committee: (i) updates regarding (A) patient enrollment, adverse events or serious
adverse events (to the extent the Company has been notified of such adverse events), any added or
terminated clinical trial sites, any significant Protocol deviations, the results of any interim
analyses, statistical reports, updated Investigator Brochures or final clinical study reports or
any new Protocols, Protocol amendments or studies synopses being drafted, all to the extent
relating to the Development Plan; and (B) CMC status, non-clinical program status, regulatory and
quality program status, communications with regulatory agencies, results of meetings of the
Company’s standing or ad hoc clinical advisors, safety monitoring boards or other similar oversight
bodies (if and when formed) for a particular Program, and results of meetings with consultants for
the Programs, all to the extent related to the Company Obligations; (ii) a copy of each standard
clinical study progress report for the Programs received by the Company during the preceding period
from any of the clinical research organizations engaged by the Company pursuant to any
Subcontracting Agreements and a copy of any final preclinical study reports for such Programs;
(iii) a financial report, in a format agreed upon by the Development Committee, itemizing actual
spending under the Development Plan as well as any variation from planned spending; (iv) copies of
all Subcontracting Agreements executed since the previous Development Committee Meeting; and
(v) such other information as the Development Committee may reasonably request. The Company shall
notify at least one (1) of the Development Committee Members designated by Holdings as soon as
possible, but no later than within [ * ] ([ * ]) hours of the occurrence of any event that has, or
could reasonably be expected to have, in the Company’s judgment in light of the circumstances
existing at the time, a material effect on the Development Plan or the Development Budget and shall
keep the Development Committee regularly updated and informed with respect to any such event.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
7
6.4 Staffing. The Company shall use commercially reasonable efforts to provide such sufficient and
competent staff and Personnel (including, without limitation, such employees or agents of, or
independent contractors retained by, the Company) that have the skill and expertise necessary to
perform the Company Obligations. The Company shall notify Holdings in advance, if practicable, and
in any event promptly thereafter, of any change in Key Personnel involved in the Programs.
6.5 QA Audit. During the Term, the Company will permit Holdings’ representatives (such representatives
(i) to be identified by Holdings in advance and reasonably acceptable to the Company and (ii) to
enter into a confidentiality agreement with the Company) to examine and audit, during regular
business hours, the work performed by the Company hereunder and the Company facilities at which
such work is conducted to determine that the Company Obligations are being conducted in accordance
with the terms of the Agreement, the Development Plan and the Development Budget (“QA
Audits”). Holdings shall give the Company reasonable advance notice of such QA Audits
specifying the scope of the audit. If a particular QA Audit reveals a material deficiency in the
Company’s quality assurance procedures, then the Company will be responsible for all costs of such
QA Audit, including Holdings’ reasonable costs associated with such QA Audit, the work to be
re-performed and the costs or expenses associated with curing such material deficiencies. Holdings
and the Company shall meet to discuss the results of the QA Audit and, if required, jointly agree
upon any actions that will be required as a result of such QA Audit including defining material
deficiencies to be addressed. The Company shall make commercially reasonable efforts to reconcile
all such deficiencies found by Holdings during such QA Audit.
6.6 Financial Audit. During the Term, the Company will permit Holdings’ representatives (such representatives
(i) to be identified by Holdings in advance and reasonably acceptable to the Company and (ii) to
enter into a confidentiality agreement with the Company), to verify the Company’s invoices, other
receipts, and FTE records that are related to the Company’s performance of the work under the
Programs (“Financial Audits”), which review shall be conducted during regular business
hours and will take place no more than once per year, unless otherwise agreed to by the Parties.
Holdings shall give the Company reasonable advance notice of such Financial Audits specifying the
scope of the audit, which shall not include work that has previously undergone
Financial Audits. Holdings shall reimburse the Company for its time associated with Financial
Audits; provided, however, that should a particular Financial Audit reveal an
overstatement of costs and expenses in the reports submitted by the Company to Holdings for
reimbursement purposes during the period covered by such Financial Audit that exceeds [ * ]% in the
aggregate, then the Company will be responsible for all costs of such Financial Audit, including
Holdings’ reasonable costs associated therewith. Holdings and the Company shall meet to discuss
the results of the Financial Audit and, if required, jointly agree upon any actions that will be
required as a result of such Financial Audit including defining material discrepancies to be
addressed. The Company shall make commercially reasonable efforts to reconcile all such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
8
discrepancies found by Holdings during such Financial Audit. In addition, the Company shall,
during regular business hours, cooperate with, and promptly respond to, inquiries from Holdings
Auditors, if Holdings Auditors shall reasonably conclude that they require additional information
or clarification regarding any invoices, other receipts or FTE records submitted by the Company.
6.7 Insurance. The Company shall carry and maintain throughout the Term (i) clinical trial liability
insurance (including errors and omissions coverage and product coverage), at the Company’s sole
expense, with limits of at least $[ * ] per occurrence, and (ii) property and casualty insurance
covering Products and other Company assets used in executing the Development Plan in amounts
customarily carried by business entities with a size and risk profile similar to the Company, at
the Company’s sole expense, with limits of at least $[ * ]. Holdings shall be named as an
additional insured on all clinical trial liability insurance. Upon Holdings’ request, the Company
shall instruct its insurance carrier(s) to promptly furnish to Holdings certificates reflecting
such coverage and a representation indicating that such coverage shall not be canceled or otherwise
terminated during the Term without [ * ] ([ * ]) days’ prior written notice to Holdings.
Notwithstanding anything to the contrary herein, this Section 6.7 shall survive for a
period of [ * ] ([ * ]) years following termination or expiration of this Agreement.
7. Holdings’ Obligations.
7.1 Generally. Holdings shall have overall responsibility for all matters set forth in the Development
Plan, and shall be responsible for (i) executing or delegating its management and administration
responsibilities; and (ii) executing or delegating the development activities set forth in the
Development Plan. Holdings shall, and shall instruct all Persons whom it engages pursuant to
Article 2 hereof to, perform its obligations hereunder and under the Development Plan in
good faith and in accordance with the applicable provisions of the Development Plan and the
Development Budget, and the terms of this Agreement.
7.2 Subcontracting. Holdings is subcontracting, and will in the future subcontract, certain of its
responsibilities under the Development Plan to the Company (pursuant hereto), and to other vendors
and service providers (pursuant to subcontracting agreements to be approved by the Development
Committee); provided, that Holdings shall remain responsible for the performance of its
obligations hereunder notwithstanding any such arrangement. Each subcontracting agreement entered
into by Holdings shall include a provision permitting assignment at any time of the subcontracting
agreement from Holdings to the Company without the subcontractor’s consent; provided that
Holdings may not assign its obligations under any such subcontracting agreement to the Company
without the Company’s prior written consent.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
9
7.3 Insurance. Holdings shall maintain insurance with creditworthy insurance companies against such risks
and in such amounts as are usually maintained or insured against by other companies of established
repute engaged in the same or a similar business.
7.4 Staffing. Holdings shall use commercially reasonable efforts to provide, or cause to be provided on
its behalf, sufficient and competent staff and Personnel that have the skill and expertise
necessary to perform Holdings’ obligations under this Agreement, the Development Plan and the
Development Budget, including, but not limited to, carrying out its clinical development duties in
accordance with this Agreement, the Development Plan and the Development Budget.
7.5 Inspection and Audit. Holdings shall permit each of the Company, Investors and each Symphony Fund and their duly
authorized representatives at all reasonable business hours to inspect and audit (1) Holdings’
books, records and other reasonably requested materials and (2) any and all properties of Holdings,
and it shall provide to each of the Company, Investors and each Symphony Fund all books, records
and other materials related to any meeting of Manager or Shareholders and to permit the Company,
Investors and each Symphony Fund to make copies or extracts therefrom; provided, that each
aforementioned party may conduct one such inspection or audit in each calendar year without cost to
such party, and that any party conducting additional inspections or audits shall reimburse the
Manager for its reasonable costs and expenses in facilitating such additional inspections or audits
unless such additional inspections or audits were performed to determine whether previously
identified material deficiencies have been addressed. Holdings and the party conducting such
inspection or audit, or such party’s representative, shall meet to discuss the results of such
inspection or audit and, if required, jointly agree upon any actions that will be required as a
result of such inspection or audit including defining material discrepancies to be addressed.
Holdings shall make
commercially reasonable efforts to reconcile all such discrepancies found by the Company,
Investors or any Symphony Fund during such inspection or audit.
8. Funding and Payments.
8.1 Use of Proceeds. Holdings shall use any and all proceeds received by Holdings from Investors and the
Symphony Funds for the development of the Programs.
8.2 Reimbursement. Holdings shall compensate the Company for its Development Plan-associated activities and
services, including, without limitation, its research, clinical and manufacturing services and any
other activities delegated to and by the Company in accordance with this Agreement. Such
compensation shall be made in accordance with the provisions of this Article 8 and the
payment terms to be agreed between the Parties (the “Payment Terms”) attached hereto as
Annex C, the terms of which are hereby adopted and incorporated herein; provided
that the Company shall be
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
10
directly responsible for compensation and reimbursement of the Company
Subcontractors, it being understood that the cost shall be passed through to Holdings. With
respect to costs for travel, unless the Development Committee provides the Company with prior
approval, all the Company personnel shall adhere to the Company’s travel policy.
8.3 Budget Allocation and Deviations. The Company shall have the discretion to incur out-of-pocket fees, expenses and costs and
allocate its resources in a manner consistent with the Development Plan and the Development Budget.
If the Company reasonably anticipates that the actual cost for any particular Activity will cause
that portion of the Development Budget allocated over any [ * ] ([ * ]) month period to be exceeded
by $[ * ] or more (or such greater amount as Manager may subsequently determine), then the Company
may request that the Development Committee amend the Development Budget, either at its next
Scheduled Meeting or at an Ad Hoc Meeting, to reflect such cost increase. The Company shall be
fully reimbursed, pursuant to Section 8.2, for all out-of-pocket amounts incurred with
respect to an Activity performed pursuant to the Development Plan, as such Development Plan may be
modified upon approval of the Development Committee, provided that, without the approval of
the Development Committee, the Company shall not be reimbursed for expenditures that exceed the
amounts set forth in the Development Budget by the criteria set forth in the second sentence of
this Section 8.3. If the Development Committee denies a request made by the Company
pursuant to this Section 8.3 to amend the Development Budget, then the Company shall no
longer be obligated to perform such incremental activity that is expected to give rise to such
additional expenditures.
8.4 Employee Benefits. Holdings shall not be responsible for providing or paying any benefits (including, but not
limited to, unemployment, disability, insurance, or medical, and any pension or profit sharing
plans) to the Company or to any employees of the Company or any persons retained or used by the
Company to perform activities pursuant to the Development Plan, including independent contractors,
Subcontractors and agents (collectively, “Company Personnel”). As to the Company or any
Company Personnel, Holdings shall not be responsible for: (a) any federal, state or local income
tax withholding; (b) Federal Insurance Contributions Act contributions; (c) contributions to state
disability funds or liability funds or similar withholdings; (d) payment of any overtime wages;
(e) workers’ compensation; or (f) compliance with any laws, rules or regulations governing
employees. The Company agrees that, as between Holdings and the Company, the Company is and will
continue to be responsible for: (i) all matters relating to the payment of compensation and
provision of benefits to Company Personnel; and (ii) compliance with all applicable laws, rules and
regulations governing the Company’s employees. The Company acknowledges that the Company is not
entitled to reimbursement with respect to any amounts related to the services of Company Personnel
in excess of the fully burdened FTE rates in accordance with Annex C attached hereto, and
Holdings acknowledges that the FTE rates used as the basis for reimbursing the Company for the
services of Company Personnel include the Company’s
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
11
costs associated with providing such benefits
and fulfilling such responsibilities. Such FTE rates also cover all direct and indirect, cash and
non-cash compensation paid to or on behalf of said employee or other individual performing duties
customarily performed by an employee; all payroll related taxes and costs; all fringe benefits and
perquisites; all overhead and support provided by the Company for said employee, including but not
limited to facility, office, laboratory and equipment costs, training and education, and general
corporate management, supervision, executive and administrative functions and activities; and
quality assurance and other functions and activities benefiting the Company or multiple
departments, projects or employees within the Company.
9. Covenants.
9.1 Mutual Covenants. Each of the Company and Holdings covenants and agrees that, with respect to the Programs
and any other rights and obligations set forth in the Operative Documents, it shall:
(a) perform all of its obligations pursuant to this Agreement in material compliance with:
(i) all applicable federal and state laws, statutes, rules, regulations and orders (including all
applicable approval and qualification requirements thereunder), including, without limitation, the
Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto; (ii) all
applicable good
clinical practices and guidelines; (iii) all applicable standard operating procedures;
(iv) all applicable Protocols; and (v) the provisions of this Agreement;
(b) keep complete, proper and separate books of record and account, including a record of all
costs and expenses incurred, all charges made, all credits made and received, and all income
derived in connection with the operation of its business, all in accordance with GAAP;
(c) not employ (or, to the best of its Knowledge, shall not use any contractor or consultant
who is or that employs) any individual or entity debarred by the FDA (or subject to a similar
sanction of any other Regulatory Authority), or, to the best of its Knowledge, any individual who
or entity which is the subject of an FDA debarment investigation or proceeding (or similar
proceeding of any other Regulatory Authority), in the conduct of the Programs;
(d) promptly deliver to the other, upon receipt thereof, notice of all actions, suits,
investigations, litigation and proceedings before any Governmental Authority, which would
reasonably be expected to affect such Party’s ability to perform its obligations under this
Agreement;
(e) upon its acquiring Knowledge of (i) any breach by it of any representation, warranty,
covenant or any other term or condition of this Agreement or (ii) any other event or development,
in each case that is, or is reasonably expected to be, materially adverse to the other Party with
respect to any Program, such
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
12
Party shall promptly notify the other Party in writing within [ * ] ([
* ]) Business Days of acquiring such Knowledge; provided, that the failure to provide such
notice shall not impair or otherwise be deemed a waiver of any rights any Party may have arising
from such breach, event or development and that notice under this Section 9.1(e) shall not
be deemed an admission by the Party providing such notice of any breach of any of the Operative
Documents; and
(f) with reasonable promptness, deliver to the other Party such data and information relating
to the ability of such Party to perform its obligations hereunder as from time to time may be
reasonably requested by the other Party (subject to the maintenance of the confidentiality of any
such information by the receiving Party). For the avoidance of doubt, this Section 9.1(f)
includes the Company’s obligations to provide financial and other necessary information in respect
of such Programs to Holdings to enable Holdings to fulfill its obligations to the Company under
Section 5(d) of the Purchase Option Agreement.
10. Confidentiality. It is understood that during the course of this Agreement each of the Parties shall be
bound by the terms of the Confidentiality Agreement.
11. Discontinuation Option.
(a) A Program may only be discontinued in accordance with Section 4.2(c). In the
event of such a Program discontinuation during the Term, (i) Holdings shall so notify the Company
promptly and in writing of such discontinuation, and (ii) the Company shall have the right and
option (a “Discontinuation Option”), exercisable for [ * ] ([ * ]) days after receipt of
such written notice from Holdings of such discontinuation, to buy back all rights of Holdings to
such discontinued Program, the Products being developed in such discontinued Program, and the
Licensed Intellectual Property related to such discontinued Program for a price (payable by wire
transfer to Holdings) that is [ * ]% of the sum of (x) the funds expended on such discontinued
Program and (y) a share of all non-Program-specific expenditures that is in the same proportion to
the total of all non-Program-specific expenditures as the amount in clause (x) of this
sentence is to the aggregate of all Program-specific expenditures (such sum, the
“Discontinuation Price”), to be reasonably determined between the Parties, or, if the
Parties are unable to come to a resolution within [ * ] ([ * ]) days after receipt of such written
notice from Holdings of such discontinuation, to be determined in accordance with
Section 11(b) hereof; provided, that if the Ophthalmology Program is discontinued,
the Discontinuation Price with respect to such Program shall be reduced by [ * ]% of the purchase
price paid by Holdings in consideration for the purchase of all Non-IV Shares pursuant to the Stock
and Warrant Purchase Agreement. If the Discontinuation Price is determined in accordance with
Section 11(b), then the [ * ] ([ * ]) day period for the Company’s exercise of a
Discontinuation Option shall be extended by the time needed
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
13
for such determination so that the
Company has at least [ * ] ([ * ]) days after such determination to decide whether it wishes to
exercise a Discontinuation Option.
(b) If the Company and Holdings cannot agree on the Discontinuation Price within [ * ] ([ * ])
days after receipt of such written notice from Holdings of such discontinuation, then at the
Company’s request, the Chief Executive Officer of the Company and the Manager shall make good faith
efforts to resolve the disagreement(s) regarding the calculation of the Discontinuation Price. If
the Chief Executive Officer of the Company and the Manager do not agree on the Discontinuation
Price within [ * ] ([ * ]) days after the Company’s request, then the Parties shall jointly select
a nationally recognized expert to resolve any remaining disagreements regarding calculation of the
Discontinuation Price. The Parties shall use their respective commercially reasonable efforts to
cause such expert to make its determination of the Discontinuation Price within [ * ] ([ * ]) days
of accepting its selection. The expert’s determination of the Discontinuation Price shall, absent
manifest error, be (i) binding and conclusive and (ii) the Discontinuation Price at which a
Discontinuation Option may be exercised by the Company. All costs and expenses of the expert shall
be shared equally between the Company and Holdings. Notwithstanding the foregoing, in any case,
each Party shall be responsible for the payment of its respective costs and expenses, including any
attorneys’ fees.
(c) Upon the exercise of a Discontinuation Option for a Program, such Program shall no longer
be a Program and the Products being developed in such Program shall no longer be Products for
purposes of the Operative Documents, except to the extent the Operative Documents deal with the
rights of the Company and the obligations of Holdings following exercise of a Discontinuation
Option..
12. Representations and Warranties.
12.1 Company Representations and Warranties. The Company hereby represents and warrants to Holdings that, as of the Closing Date:
(a) Organization. The Company is a corporation, duly organized, validly existing and
in good standing under the laws of the State of Delaware.
(b) Authority and Validity. The Company has all requisite corporate power and
authority to execute, deliver and perform its obligations under this Agreement and the Technology
License Agreement and to consummate the transactions contemplated thereby. The execution, delivery
and performance by the Company of this Agreement and the Technology License Agreement and the
consummation of the transactions contemplated thereby have been duly and validly authorized by all
necessary action required on the part of the Company, and no other proceedings on the part of the
Company are necessary to authorize this Agreement or the Technology License Agreement or for the
Company to perform its obligations under this Agreement or the Technology License Agreement. This
Agreement and the Technology
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
14
License Agreement constitute the lawful, valid and legally binding
obligations of the Company, enforceable in accordance with their terms, except as the same may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting
the enforcement of creditors’ rights generally and general equitable principles regardless of
whether such enforceability is considered in a proceeding at law or in equity.
(c) No Violation or Conflict. The execution, delivery and performance of this
Agreement and the Technology License Agreement and the transactions contemplated thereby do not and
will not (i) violate, conflict with or result in the breach of any provision of the Organizational
Documents of the Company, (ii) conflict with or violate any law or Governmental Order applicable to
the Company or any of its assets, properties or businesses, or (iii) conflict with, result in any
breach of, constitute a default (or event that with the giving of notice or lapse of time, or both,
would become a default) under, require any consent under, or give to others any rights of
termination, amendment, acceleration, suspension, revocation or cancellation of, or result in the
creation of any Encumbrance on any of the assets or properties of the Company, pursuant to, any
note, bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise
or other instrument or arrangement to which the Company is a
party except, in the case of clauses (ii) and (iii), to the extent that such
conflicts, breaches, defaults or other matters would not, individually or in the aggregate,
reasonably be expected to have a Material Adverse Effect on the Company or a material adverse
effect on the Programs.
(d) Governmental Consents and Approvals. The execution, delivery and performance of
this Agreement and the Technology License Agreement by the Company do not, and the consummation of
the transactions contemplated thereby do not and will not, require any Governmental Approval which
has not already been obtained, effected or provided, except with respect to which the failure to so
obtain, effect or provide would not, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect on the Company or a material adverse effect on the Programs.
(e) Litigation. Except as disclosed on the most recently filed Form 10-K filing of
the Company, there are no actions by or against the Company pending before any Governmental
Authority or, to the Knowledge of the Company, threatened to be brought by or before any
Governmental Authority, that would, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect on the Company. There are no pending or, to the Knowledge of the
Company, threatened actions, to which the Company is a party (or is threatened to be named as a
party) to set aside, restrain, enjoin or prevent the execution, delivery or performance of this
Agreement or the Operative Documents or the consummation of the transactions contemplated hereby or
thereby by any party hereto or thereto. The Company is not subject to any Governmental Order (nor,
to the Knowledge of the Company, is there any
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
15
such Governmental Order threatened to be imposed by
any Governmental Authority) that would, individually or in the aggregate, reasonably be expected to
have a Material Adverse Effect on the Company or a material adverse effect on the Programs.
(f) No Contracts. Except as disclosed on Schedule 12.1(f) hereto, there are
no material contracts between the Company and any third party (other than licenses of intellectual
property that are in turn licensed to Holdings under the Technology License Agreement), including
contractors, manufacturers or suppliers, used with or otherwise necessary for the Programs, and all
such contracts are assignable to Holdings. Except as disclosed on Schedule 12.1(f) hereto,
each such contract is assignable to Holdings without the prior consent of the applicable third
party, or the absence of such contract (due to the inability or impracticability of assigning such
contract to Holdings following a termination of this Agreement without the exercise of the Purchase
Option) would not have a material adverse effect on any of the Programs or on Holdings’ rights
under the Technology License Agreement.
(g) Information. All information provided or otherwise made available by the Company
or its representatives in connection with the Programs and the underlying intellectual property,
this Agreement, the Operative Documents and the transactions contemplated thereby, when taken as a
whole, is complete and correct in all material respects and does not contain any untrue statement
of material fact or omit to
state a material fact necessary to make the statements contained therein, in light of the
circumstances under which such statements are made, not misleading.
12.2 Holdings Representations and Warranties. Holdings hereby represents and warrants to the Company that, as of the Closing Date:
(a) Organization. Holdings is a limited liability company, duly organized, validly
existing and in good standing under the laws of the State of Delaware.
(b) Authority and Validity. Holdings has all requisite limited liability company
power and authority to execute, deliver and perform its obligations under this Agreement and the
Technology License Agreement and to consummate the transactions contemplated thereby. The
execution, delivery and performance by Holdings of this Agreement and the Technology License
Agreement and the consummation of the transactions contemplated thereby have been duly and validly
authorized by all necessary action required on the part of Holdings, and no other proceedings on
the part of Holdings are necessary to authorize this Agreement or the Technology License Agreement
or for Holdings to perform its obligations under this Agreement or the Technology License
Agreement. This Agreement and the Technology License Agreement constitute the lawful, valid and
legally binding obligations of Holdings, enforceable in accordance with its terms, except as the
same may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar
laws affecting
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
16
the enforcement of creditors’ rights generally and general equitable principles
regardless of whether such enforceability is considered in a proceeding at law or in equity.
(c) No Violation or Conflict. The execution, delivery and performance of this
Agreement and the Technology License Agreement and the transactions contemplated thereby do not and
will not (i) violate, conflict with or result in the breach of any provision of the Organizational
Documents of Holdings, (ii) conflict with or violate any law or Governmental Order applicable to
Holdings or any of its assets, properties or businesses, or (iii) conflict with, result in any
breach of, constitute a default (or event that with the giving of notice or lapse of time, or both,
would become a default) under, require any consent under, or give to others any rights of
termination, amendment, acceleration, suspension, revocation or cancellation of, or result in the
creation of any Encumbrance on any of the assets or properties of Holdings, pursuant to any note,
bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or
other instrument or arrangement to which Holdings is a party except, in the case of clauses
(ii) and (iii), to the extent that such conflicts, breaches, defaults or other matters
would not, individually or in the aggregate, reasonably be expected to have a Material Adverse
Effect on Holdings.
(d) Governmental Consents and Approvals. The execution, delivery and performance of
this Agreement and the Technology License Agreement by Holdings do not, and the consummation of the
transactions contemplated
thereby do not and will not, require any Governmental Approval which has not already been
obtained, effected or provided, except with respect to which the failure to so obtain, effect or
provide would not, individually or in the aggregate, reasonably be expected to have a Material
Adverse Effect on Holdings.
(e) Litigation. There are no actions by or against Holdings pending before any
Governmental Authority or, to the Knowledge of Holdings, threatened to be brought, by or before any
Governmental Authority that would, individually or in the aggregate, reasonably be expected to have
a Material Adverse Effect on Holdings. There are no pending or, to the Knowledge of Holdings,
threatened actions to which Holdings is a party (or is threatened to be named as a party) to set
aside, restrain, enjoin or prevent the execution, delivery or performance of this Agreement or the
consummation of the transactions contemplated hereby by any party hereto. Holdings is not subject
to any Governmental Order (nor, to the knowledge of Holdings, is there any such Governmental Order
threatened to be imposed by any Governmental Authority) that would, individually or in the
aggregate, reasonably be expected to have a Material Adverse Effect on Holdings or a material
adverse effect on the Programs.
13. Relationship Between the Company and Holdings. Nothing contained in this Agreement or any acts or omissions hereunder shall constitute or
be construed so as to create any joint venture or partnership relationship between the Company and
Holdings, and the Parties acknowledge and agree that the Company is
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
17
acting as an independent
contractor in the performance of its obligations under this Agreement.
14. Change of Control. Holdings has the Change of Control Put Option described in Section 2A of the
Purchase Option Agreement following a Change of Control with respect to the Company.
15. No Restrictions; Indemnification.
15.1 No Restrictions. Nothing in this Agreement shall limit or restrict the right of any director, officer or
employee of the Company or any director, officer, or employee of any of its subsidiaries or its
Affiliates to engage in any other business or to devote his or her time and attention to the
management or other aspects of any other business, whether of a similar or dissimilar nature, nor
limit or restrict the right of the Company or any of its affiliates to engage in any other business
or to render services of any kind to any other Person.
15.2 Indemnification.
(a) To the greatest extent permitted by applicable law, the Company shall indemnify and hold
harmless Holdings and each of its respective Affiliates, officers, directors, employees, agents,
members, managers, successors and assigns (each, a “Symphony Indemnified Party”), and
Holdings shall indemnify and hold harmless the Company, and its Affiliates and each of their
respective officers, directors, employees, agents (other than the Company Subcontractors), members,
managers, successors and assigns (each, a “Company Indemnified Party”), from and against
any and all claims, losses, costs, interest, awards, judgments, fees (including reasonable fees for
attorneys and other professionals), court costs, liabilities, damages and expenses incurred by any
Symphony Indemnified Party or Company Indemnified Party (irrespective of whether any such
Indemnified Party is a party to the action for which indemnification hereunder is sought)
(hereinafter, a “Loss”) to the extent resulting from, arising out of, or relating to any
and all third party suits, claims, actions, proceedings or demands based upon:
(i) in the case of the Company being the Indemnifying Party, (A) any breach of any
representation or warranty made by the Company herein or in any other Operative Document,
(B) any material misrepresentation or omission of facts in the public information of the
Company filed with the SEC, (C) any breach of any covenant, agreement or obligation of the
Company contained herein or in any other Operative Document, except to the extent such
covenant, agreement or obligation relates to the Company’s performance under the
Development Plan, (D) any gross negligence or willful misconduct of the Company (and not
that of any Company Subcontractors) in connection with the Company’s performance of its
obligations under this Agreement (including the Development Plan), (E) any action
undertaken or
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
18
performed by or on behalf of the Company prior to, and including, the Closing
Date that relates to the Programs or the Products, (F) any regulatory matters relating to
the Company, its businesses or its assets, (G) any investigation or claim, including
derivative claims, relating to the Company, its businesses or its assets, or (H) in the
event the Company exercises a Discontinuation Option for a Program, any action undertaken
and/or performed by or on behalf of the Company after the Discontinuation Option Closing
Date and relating to the Product that was the subject of such Program (including the
development, manufacture, use, handling, storage, sale or other disposition of such
Product); in each case, except (1) with respect to Losses for which the Company is entitled
to indemnification under this Article 15 or (2) to the extent such Loss arises from
the gross negligence or willful misconduct of a Symphony Indemnified Party; and
(ii) in the case of Holdings being the Indemnifying Party, (A) any breach of any
representation or warranty made by Holdings herein or in any other Operative Document,
(B) any breach of any covenant, agreement or obligation of Holdings contained herein or in
any other
Operative Document, (C) any and all activities undertaken or performed by or on behalf
of the Parties under the Development Plan during the Term, (D) any gross negligence or
willful misconduct of Holdings (and not that of its direct subcontractors) in connection
with Holdings’ performance of its obligations under this Agreement, or (E) the development,
manufacture, use, handling, storage, sale or other disposition of the Products (including
in the course of conducting the Programs) during the Term (except with respect to the
development, manufacture, use, handling, storage, sale or other disposition, after the
Company’s exercise of a Discontinuation Option, of Products covered under
Section 15.2(a)(i)(H)); in each case, except (1) with respect to Losses for which
Holdings is entitled to indemnification under this Article 15, or (2) Losses deemed
to have arisen from the breach by the Company of any covenant, agreement or obligation
under this Agreement that relates to the Company’s performance under the Development Plan,
as determined by a court, arbitrator or pursuant to a settlement agreement, or (3) to the
extent such Loss arises from the gross negligence or willful misconduct of a Company
Indemnified Party.
To the extent that the foregoing undertaking by the Company or Holdings may be unenforceable
for any reason, such Party shall make the maximum contribution to the payment and satisfaction of
any Loss that is permissible under applicable law.
To the extent that the foregoing undertaking by the Company or Holdings may be duplicated by
any other undertaking by the Company or Holdings in any other Operative Document, the Symphony
Indemnified Parties or the Company Indemnified Parties, as the case may be, shall be entitled to
only one recovery under the Operative Documents for the relevant Loss (and not entitled to any
duplicative recovery for the same Loss).
Portions of this Exhibit were omitted and have been filed 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
(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 Holdings, 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 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
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
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
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
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
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
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 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.
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) Holdings 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 Holdings’ written notice
of such breach (and notifies Holdings in writing of such belief and the basis for such belief), 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.
22
(ii) Holdings, acting reasonably, agrees. If the Company fails to remedy the default or breach
within the applicable cure period, Holdings may by final notice of termination to the Company
terminate this Agreement.
(b) In the event that Holdings 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
Holdings), pursuant to Section 1(c)(iv) of the Purchase Option Agreement, within [ * ] ([ *
]) Business Days of receiving such notice of termination from Holdings; 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 Holdings’ Breach. The Company may terminate this Agreement at any time upon written notice to Holdings if
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 Holdings. Such cure period may be extended if (i) Holdings reasonably believes such breach can
be cured within [ * ] ([ * ]) days of 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 Holdings fails to remedy the default or breach
within the applicable cure period, the Company may by final notice of termination to Holdings
terminate this Agreement.
17.4 Termination of License Agreement. This Agreement shall automatically terminate upon the termination of the 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 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.
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,
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
the Company will not institute or join in the
institution of any bankruptcy, insolvency, reorganization or similar proceeding against Holdings.
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 | ||||
Holdings: | ||||
Symphony ViDA Holdings LLC | ||||
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 |
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
and | ||||
Symphony Strategic Partners, LLC | ||||
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
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 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.
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
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 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, 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 benefit of the Parties
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.
[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.
26
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 | |||
Name: Xxxx Xxxxxx Title: Managing Member |
||||
OXiGENE, INC. | ||||
By: | /s/ Xxxx X. Xxxxxxx | |||
Name: Xxxx X. Xxxxxxx Title: Chief Operating Officer |
[Signature Page to 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
DEVELOPMENT COMMITTEE CHARTER
Purpose
The Development Committee (the “Development Committee”) is established by Symphony
ViDA Holdings LLC (“Holdings”) 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 Technology License Agreement (“TLA”), dated as of October 1, 2008,
between OXiGENE, INC. (the “Company”) and Holdings (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 Research
and Development Agreement, dated as of October 1, 2008, between 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.
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 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 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 B - 1
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 Holdings 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 Research and
Development Agreement.
7. The Chair shall, in consultation with other Development Committee Members and the
management of Holdings, 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.
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
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
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 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. 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 manager or officer) of the Company and
Holdings. The chief executive officer and chairman shall have [ * ] ([ * ]) Business Days to
mutually agree on how to resolve such issue.
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 Manager (as defined in the Research and
Development Agreement), submit each to Holdings. Following Holdings’ 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 Holdings 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 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 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 Research and Development Agreement, no material change to the Development Plan or Development
Budget will be adopted by Holdings unless and until the Development Committee approves such change.
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
13. The Development Committee shall report at least quarterly to Holdings 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 Holdings. The Development Committee shall also submit its material
decisions regarding the Development Plan and Development Budget to Holdings, including regulatory
strategies and discontinuation or modification of the Programs.
14. The Development Committee shall continuously evaluate the funding requirements of the
Programs.
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 - 4
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 Holdings, and Holdings 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 Holdings 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. Holdings 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 Holdings 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 Holdings disputes in good faith any portion of an invoice, then Holdings 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 Holdings at the following address: |
SYMPHONY ViDA HOLDINGS LLC
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.