Contract
Exhibit 10.29
[ * ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
AMENDED AND RESTATED
RESEARCH AND DEVELOPMENT AGREEMENT
RESEARCH AND DEVELOPMENT AGREEMENT
among
ALEXZA PHARMACEUTICALS, INC.,
SYMPHONY ALLEGRO HOLDINGS LLC
and
SYMPHONY ALLEGRO, INC.
Dated as of December 1, 2006
Table of Contents
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1. | ASSIGNMENT |
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 | |||||||
4.3 Alexza’s Independent Staccato Technology Research |
4 | |||||||
5. | REGULATORY MATTERS |
5 | ||||||
5.1 FDA Sponsor |
5 | |||||||
5.2 Correspondence |
6 | |||||||
5.3 Inspections and Meetings |
6 | |||||||
5.4 Transfer of FDA Sponsorship |
7 | |||||||
6. | ALEXZA’S OBLIGATIONS |
8 | ||||||
6.1 Generally |
8 | |||||||
6.2 Subcontracting |
9 | |||||||
6.3 Reports and Correspondence |
11 | |||||||
6.4 Manufacturing |
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6.5 Staffing |
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6.6 QA Audit |
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6.7 Financial Audit |
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6.8 Insurance |
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7. | SYMPHONY ALLEGRO’S OBLIGATIONS |
14 | ||||||
7.1 Generally |
14 | |||||||
7.2 Subcontracting |
14 | |||||||
7.3 Reports |
14 | |||||||
7.4 Insurance |
14 | |||||||
7.5 Staffing |
15 |
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Table of Contents
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7.6 Audit |
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8. | FUNDING AND PAYMENTS |
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8.1 Use of Proceeds |
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8.2 Reimbursement |
16 | |||||||
8.3 Budget Allocation and Deviations |
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8.4 Employee Benefits |
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9. | COVENANTS |
17 | ||||||
9.1 Mutual Covenants |
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10. | CONFIDENTIALITY |
18 | ||||||
11. | DISCONTINUATION OPTION |
18 | ||||||
12. | REPRESENTATIONS AND WARRANTIES |
19 | ||||||
12.1 Alexza Representations and Warranties |
19 | |||||||
12.2 Symphony Allegro Representations and Warranties |
21 | |||||||
13. | RELATIONSHIP BETWEEN ALEXZA AND SYMPHONY ALLEGRO |
22 | ||||||
14. | CHANGE OF CONTROL |
22 | ||||||
15. | NO RESTRICTIONS; INDEMNIFICATION |
22 | ||||||
15.1 No Restrictions |
22 | |||||||
15.2 Indemnification |
22 | |||||||
16. | LIMITATION OF LIABILITIES |
25 | ||||||
16.1 Between the Parties |
25 | |||||||
16.2 Pursuant to the RRD Services Agreement |
26 | |||||||
17. | TERM AND TERMINATION |
26 | ||||||
17.1 Term |
26 | |||||||
17.2 Termination for Alexza’s Breach |
26 | |||||||
17.3 Termination for Symphony Allegro’s or Holdings’ Breach |
27 | |||||||
17.4 Termination of License Agreement |
27 | |||||||
17.5 Survival |
27 | |||||||
18. | MISCELLANEOUS |
27 | ||||||
18.1 No Petition |
27 |
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Table of Contents
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18.2 Notices |
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18.3 Governing Law; Consent to Jurisdiction and Service of Process |
29 | |||||||
18.4 WAIVER OF JURY TRIAL |
29 | |||||||
18.5 Entire Agreement |
29 | |||||||
18.6 Amendment; Successors; Assignment; Counterparts |
30 | |||||||
18.7 Severability |
30 | |||||||
18.8 Third Party Beneficiary |
30 |
Annex A — Certain Definitions
Annex B — Development Committee Charter
Annex C — Initial Development Plan and Initial Development Budget
Annex D — {Intentionally Omitted.}
Annex E — Payment Terms
Annex B — Development Committee Charter
Annex C — Initial Development Plan and Initial Development Budget
Annex D — {Intentionally Omitted.}
Annex E — Payment Terms
Schedule 6.2 — Subcontracting Agreements
Schedule 6.5 — Alexza Key Personnel
Schedule 12.1(f) — Material Disclosed Contracts
Schedule 6.5 — Alexza Key Personnel
Schedule 12.1(f) — Material Disclosed Contracts
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
AMENDED AND RESTATED
This Amended And Restated Research And Development Agreement (this “Agreement”) is
entered into as of December 1, 2006 (the “Closing Date”) by and among Alexza Pharmaceuticals,
Inc., a Delaware corporation (“Alexza”), Symphony Allegro, Inc., a Delaware
corporation (“Symphony Allegro”) (each of Alexza and Symphony Allegro being a “Party,” and
collectively, the “Parties”), and Symphony Allegro Holdings LLC, a Delaware limited
liability company (“Holdings”). Capitalized terms used herein and not defined herein shall have
the meanings assigned to such terms in Annex A attached hereto.
PRELIMINARY STATEMENT
Alexza and Holdings have entered into that certain Research and Development Agreement, dated
as of December 1, 2006 (the “Research and Development Agreement”). Pursuant to this Agreement,
Holdings desires to assign all of its rights and delegate its obligations under the Research and
Development Agreement to Symphony Allegro, and Alexza and Symphony Allegro desire to amend and
restate the terms and conditions of the Research and Development Agreement.
In the Novated and Restated Technology License Agreement, Alexza grants Symphony Allegro an
exclusive license to develop and commercialize the Products. Symphony Allegro wishes for Alexza to
continue to develop such Products. Symphony Allegro and Alexza desire to establish, and agree on
the responsibilities of, a Development Committee to oversee such development. Alexza and Symphony
Allegro further desire to comply with and perform certain agreements and obligations related
thereto.
The Parties hereto agree as follows:
1. Assignment. The Parties agree that from and after the Closing Date, all of the
rights and obligations of Holdings under the Research and Development Agreement will be assigned
and transferred to, and assumed by, Symphony Allegro.
2. Overview of Development.
(a) The Parties shall develop the Programs in a collaborative and efficient manner as set
forth in this Article 2. Representatives of the Parties shall engage in joint decision-making for
the Programs as set forth in Articles 3 and 4 hereof. Symphony Allegro shall have overall
responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof),
and shall engage Alexza (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services
Agreement), and such independent contractors and agents as it may retain with RRD’s assistance or
as Alexza may retain on Symphony Allegro’s behalf (which contractors include entities retained by
Alexza prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule
6.2), to act on behalf of Symphony Allegro and carry out the duties set forth therein and herein,
including management, supervisory and accounting functions,
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
1.
pre-clinical and clinical development, manufacturing, scientific and technical services
associated with such development, and patent work under the Programs.
(b) Alexza hereby acknowledges and agrees to Symphony Allegro’s engagement of RRD to act on
its behalf and to carry out the duties assigned to RRD herein and in the RRD Services Agreement,
including, but not limited to (i) providing personnel and support to the Development Committee and
the Symphony Allegro Board, (ii) the management and administration of Symphony Allegro, (iii)
supervising and monitoring Alexza’s implementation of the Programs, and (iv) subject to Section
6.1(a) and without limiting Alexza’s role thereunder, such other development-related work as
Symphony Allegro may reasonably delegate to RRD in accordance with the Development Plan.
(c) With respect to the AZ-002 Program and the AZ-004 Program, Alexza shall be responsible for
the execution of all pre-clinical and clinical development, all scientific and technical services
associated with such development, and all patent work, including all related matters set forth in
the Development Plan for such Programs.
(d) Nothing in Section 2(c) shall in any way limit the authority of the Development Committee
(as defined below) or the Symphony Allegro Board hereunder, and the engagements and delegations set
forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services
Agreement, and the satisfactory performance by RRD and Alexza of their obligations pursuant hereto
and thereto. The allocations of responsibility described in this Article 2 shall remain subject to
further modification in accordance with the terms and conditions of this Agreement and the RRD
Services Agreement.
3. Development Committee. The Parties shall establish and maintain a committee (the
“Development Committee”) to oversee the development of the Programs (including the continued
development and refinement of the Development Plan and the Development Budget). The Development
Committee shall be established, operated and governed in accordance with the policies and
procedures set forth in Annex B hereto (the “Development Committee Charter”). The Development
Committee Charter may be amended only with the unanimous approval of the Development Committee
Members and the consent of the Symphony Allegro Board, Holdings and Alexza. In no event shall the
Development Committee have the power to amend the terms of any Operative Document.
4. Development Plan and Development Budget.
4.1 Generally. The Parties have agreed, as of the Closing Date, to an Initial Development
Plan and an Initial Development Budget, which are attached hereto and incorporated herein as Annex
C, and which shall be further developed and refined from time to time in accordance herewith. The
Initial Development Plan consists (and the Development Plan shall consist) of detailed provisions
governing all research, pre-clinical, clinical, development, manufacturing, scientific, technical,
regulatory and patent work to be performed under the Operative Documents. Following the Closing
Date, the Development Committee shall, on an ongoing basis, further develop the Development Plan to
include, without limitation, (i) an outline of the plan for the development of each Program; (ii)
outlines of non-clinical activities, key regulatory and quality activities, and CMC activities for
each Program; and (iii) a forecast for
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
2.
amounts of Clinical Trial Materials required for each Program and a timeline for manufacturing
such Clinical Trial Materials. The Initial Development Budget consists (and the Development Budget
shall consist) of two (2) components: (x) a budget for the Development Plan (the “Clinical Budget
Component”), and (y) a budget for the management and administrative functions of Symphony Allegro,
as set forth in Section 1(a) of the RRD Services Agreement. The Clinical Budget Component shall be
further divided into separate budgets for each Program, and, following the Closing Date, the
Development Committee shall further develop and refine the Clinical Budget Component to include,
without limitation, (1) budget spreadsheets summarizing anticipated costs of engaging third party
service providers and the scope of work to be performed by such third parties; and (2) the number
of FTEs to be dedicated to the Programs (by function and work responsibilities, on a
Program-by-Program basis). All presently anticipated or actual expenditures of Symphony Allegro,
including, without limitation, compensation of members of the Symphony Allegro Board and
compensation to RRD, are included in the Initial Development Budget attached hereto, and will
continue to be included in any amendments thereof. The Development Committee shall, at the request
of the Symphony Allegro Board, submit the Development Plan and the Development Budget (as each
shall have been developed and refined up to such point) to the Symphony Allegro Board for its
review at the first meeting of the Symphony Allegro Board. Following the Symphony Allegro Board’s
review, the Development Committee shall work diligently to incorporate any comments generated by
the Symphony Allegro Board’s review and update the Development Plan and the Development Budget as
soon as practicable, and submit the updated Development Plan and the updated Development Budget to
the Symphony Allegro Board for further review.
4.2 Amendments.
(a) All amendments of, and all material deviations from, the Development Plan and Development
Budget (including amendments or deviations made at the request of Alexza or RRD, in accordance with
Section 8.3 hereof or Section 2(b) of the RRD Services Agreement, respectively) shall be made in
accordance with the procedures described in this Article 4 and in the Development Committee
Charter, including obtaining the approval of the Symphony Allegro Board, as may be required by the
Development Committee Charter. No amendment of the Development Plan that alters the forecast for
the amounts of Clinical Trial Materials provided by Alexza and required for either Program within
six (6) months after the amendment effective date shall be made without (i) amending the
Development Budget to compensate Alexza for costs associated with accommodating such alteration and
(ii) receiving written confirmation from Alexza that it can complete delivery of the revised
forecasts within the applicable time periods specified in such amendment to the Development Plan.
Any proposed amendment of the Development Budget which increases the Management Fee or the
Development Fee shall require the written consent of Alexza, not to be unreasonably withheld. Any
proposed amendment of the Development Budget which has the effect of increasing, in aggregate, by
$50,000 or more for a given contract year, those aggregate Cross Program Expenses set forth in line
items 7 through 12 of page 2 of the Development Budget attached hereto shall require Alexza’s prior
consent (such consent not to be unreasonably withheld). The Development Committee shall approve
all amendments to the Development Plan and Development Budget that are proposed by Alexza to
implement changes to the Product configurations or specifications to make them consistent with
other Staccato Technology-
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
3.
employing products being manufactured by or on behalf of Alexza unless such amendments,
individually or in the aggregate, have or could reasonably be expected to have a materially adverse
impact on timelines within the Development Plan or on manufacturing or other costs set forth in the
Development Budget.
(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 Alexza and RRD to
the Development Committee.
(c) A Program may only be discontinued in the event that either (i) the Parties mutually agree
to discontinue such Program 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 is not enough to warrant further development (a
“Scientific Discontinuation Event”) that arises in the course of developing such Program; or (ii)
upon recommendation of the Development Committee, the Symphony Allegro Board resolves to
discontinue such Program by (A) if the Symphony Allegro Board shall have less than five (5)
members, the unanimous consent of all the members of the Symphony Allegro Board, or (B) if the
Symphony Allegro Board shall have five (5) members, an affirmative vote of at least four-fifths
(4/5ths) of the members of the Symphony Allegro Board; provided, that notwithstanding the
foregoing, the Symphony Allegro Board may at any time, by the applicable vote described in this
clause (ii), discontinue a Program upon a Medical Discontinuation Event without a prior
recommendation of the Development Committee. The Development Committee shall promptly thereafter
amend the Development Plan to reflect such discontinuation and amend the Development Budget to
reallocate to any or all of the remaining Programs some or all of the funds previously allocated to
the discontinued Program (with any funds not then allocated to be held for reallocation by the
Development Committee).
(d) The Development Plan shall never be amended in any manner that would require Alexza or
Symphony Allegro (or any Person acting on behalf of Alexza or Symphony Allegro (including RRD and
its RRD Personnel)) to perform any assignments or tasks in a manner that would violate any
applicable law or regulation. In the event of a change in any applicable law or regulation, the
Development Committee shall consider amending the Development Plan to enable Alexza or Symphony
Allegro (or any Person acting on behalf of Alexza or Symphony Allegro (including RRD and its RRD
Personnel)), as the case may be, to comply fully with such law or regulation. If such amendment is
not approved, the affected Party shall be excused from performing any activity specified herein or
in the Development Plan that would violate or result in a violation of any applicable law or
regulation.
4.3 Alexza’s Independent Staccato Technology Research.
(a) Symphony Allegro and Holdings acknowledge that Alexza may perform work on the Staccato
Technology that is outside the scope of the Development Plan and may use Alprazolam and Loxapine in
the course of such work, including performing tests
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
4.
designed to evaluate the technical and commercial feasibility and other characteristics of
potential new Product configurations that employ improvements to the Staccato Technology; provided
however, that Alexza cannot directly or indirectly conduct any clinical trials with respect to
Alprazolam or Loxapine in the course of performing such independent work.
(b) If the Development Committee is interested in pursuing any such Staccato Technology
improvement in one or both Programs, the Development Committee shall give notice thereof to Alexza
and Alexza shall provide such Staccato Technology improvement to Symphony Allegro and the
Development Plan shall be amended to reflect the work to be performed on such alternate Product
configuration(s), and the Development Budget shall be amended (i) to reimburse Alexza for a
reasonable proportion of the costs previously incurred by Alexza but not otherwise reimbursed by
Symphony Allegro with respect to the development and testing of such Staccato Technology
improvement, with such proportion (the “Past Staccato Technology Proportion”) to be negotiated in
good faith by Symphony Allegro and Alexza and determined based upon commercially reasonable terms
no less favorable than those terms offered by Alexza to third parties; provided that if the parties
are unable to agree on such proportion within [ * ], it shall be determined in accordance with
clause (c) below, and (ii) to cover a proportion of future costs associated with such alternate
Product configurations and the manufacture and quality assurance thereof, including any capital
improvements made to facilitate such manufacture and quality assurance, such proportion (the
“Future Staccato Technology Proportion”) negotiated in good faith by Symphony Allegro and Alexza
and determined based upon commercially reasonable terms no less favorable than those terms offered
by Alexza to third parties; provided that if the parties are unable to agree on such proportion
within [ * ], it shall be determined in accordance with clause (c) below.
(c) If Alexza and Symphony Allegro cannot agree on the Past Staccato Technology Proportion or
the Future Staccato Technology Proportion (each such non-agreed proportion, the “Disputed Staccato
Technology Proportion”), then such parties shall jointly select an independent nationally
recognized expert to resolve any disagreements regarding the Disputed Staccato Technology
Proportion(s). The Parties shall use commercially reasonable efforts to cause such expert to make
its determination of the Disputed Staccato Technology Proportion(s) within [ * ] of accepting its
selection. The expert’s determination of the Disputed Staccato Technology Proportion(s) shall,
absent manifest error, be final, binding and conclusive and Alexza shall provide to Symphony
Allegro such Staccato Technology improvement in accordance with the terms thereof. All costs and
expenses of the expert shall be shared equally between Alexza and Symphony Allegro.
Notwithstanding the foregoing, in any case, each Party shall be responsible for the payment of its
respective costs and expenses, including any attorneys’ fees.
5. Regulatory Matters.
5.1 FDA Sponsor. Notwithstanding any governance provision contained herein or in any
Operative Document, the Parties agree that, until the termination or unexercised expiration of the
Purchase Option, Alexza shall be the FDA sponsor, and shall serve the equivalent role with respect
to any corresponding recognized regulatory authority outside of the United States, for the
Programs, except any Programs which were the subject of a Discontinuation Option that was not
exercised by Alexza (the “FDA Sponsor”). As the FDA
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
5.
Sponsor, Alexza shall have the responsibility and the authority to act as the sponsor and make
those decisions and take all actions necessary to assure compliance with all regulatory
requirements. Alexza agrees to be bound by, and perform all obligations set forth in, 21 C.F.R. §
312 and any and all similar obligations imposed by a recognized foreign regulatory authority
related to Alexza’s role as the FDA Sponsor. Notwithstanding anything to the contrary in Article 4
or the Development Committee Charter, Alexza, in its capacity as FDA Sponsor, may discontinue or
modify any Program without the approval of the Development Committee or the Symphony Allegro Board
in the event such actions are: (a) attributable to an event that is reportable to the FDA or
corresponding recognized regulatory authority outside of the United States; and (b) reasonably
necessary to avoid the imposition of criminal or civil liability; provided, however, that to the
extent commercially reasonable, Alexza shall (i) pursuant to Section 5.2, advise and consult with
the Development Committee prior to taking such action and (ii) forward a copy of all regulatory
correspondence relevant to such discontinuation or modification to the members of the Symphony
Allegro Board.
5.2 Correspondence. Each Party hereto acknowledges that Alexza, in its capacity as FDA
Sponsor, shall be the Party responding to any regulatory correspondence or inquiry regarding one or
both Programs. Alexza shall: (a) notify at least one (1) Development Committee Member designated
by Holdings within twenty-four (24) hours of any FDA or other governmental or regulatory inspection
or inquiry concerning any study or project under the Programs, including, but not limited to,
inspections of investigational sites or laboratories; and (b) forward to the Development Committee
copies of any correspondence from any regulatory or governmental agency relating to such a study or
project, including, but not limited to, Form FD-483 notices and FDA refusal to file, action or
warning letters, even if they do not specifically mention Symphony Allegro. Subject to the
following sentence, Symphony Allegro shall not have any right to initiate any regulatory
correspondence with respect to the Programs. In the event that Symphony Allegro receives a request
or notification from a Governmental Authority with respect to the Programs, Symphony Allegro shall:
(i) notify Alexza within twenty-four (24) hours of receipt of such request or communication and
(ii) to the extent practicable, submit any proposed response to Alexza for review and approval;
provided, that such approval shall not be unreasonably withheld and shall not prevent Symphony
Allegro from complying with any legal requirements. Furthermore, Alexza shall be the Party
responsible for responding to or handling any FDA or regulatory inspection with respect to one or
both Programs; provided, that Alexza shall notify at least one (1) of the Development Committee
Members designated by Holdings (i) within twenty-four (24) hours of receiving notice of the
commencement of a clinical hold for any Protocol, and (ii) concurrently with its submission to the
FDA of any IND safety reports for the Programs.
5.3 Inspections and Meetings. Each Party agrees that, during an inspection by the FDA or
other Regulatory Authority concerning any study or project under the Programs, it will not disclose
to such agency any information and materials (including but not limited to (x) financial data and
pricing data including, but not limited to, budget and payment schedules, (y) sales data (other
than shipment data), and (z) personnel data (other than data as to qualification of technical and
professional persons performing functions subject to regulatory requirements)) that are not
required to be disclosed to such agency without first obtaining the consent of the other Party,
which consent shall not be unreasonably withheld or delayed, except to the extent
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
6.
that such Party may be required by law to disclose such information and materials. Alexza
shall be the Party responsible for arranging and participating in any meetings with any Regulatory
Authority concerning one or both Programs. To the extent practicable, Alexza 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 Symphony Allegro, 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, Alexza
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 twenty-four (24) hours
of such meeting and a written summary of that portion within five (5) Business Days of such
meeting.
5.4 Transfer of FDA Sponsorship.
(a) On or prior to the thirtieth (30th) day after the unexercised expiration or termination of
the Purchase Option, Alexza shall cease to act as the FDA Sponsor for the Programs for which Alexza
has not exercised the Discontinuation Option, and Alexza and Symphony Allegro shall, at Symphony
Allegro’s expense, take all actions necessary to effect the transfer of (x) the Regulatory Files
(excluding Drug Master Files, but subject to Symphony Allegro’s rights under Section 2.7 of the
Novated and Restated Technology License Agreement) related to such Programs to Symphony Allegro or
its designee in accordance with Section 2.7 of the Novated and Restated Technology License
Agreement, and (y) any and all materials necessary for Symphony Allegro to practice or exploit the
license granted to it under the Novated and Restated Technology License Agreement, by such date.
In conjunction with such transfer, Alexza shall assign to Symphony Allegro or its designee, at
Symphony Allegro’s expense and as of the date specified in the first sentence of this Section
5.4(a), all of the material Development Subcontracting Agreements to which Alexza is a party and
that: (i) are solely related to such Programs or are directly but not solely related to such
Programs to the extent the rights related to or used in connection with such Programs are severable
or otherwise separately assignable; (ii) provide Alexza with preclinical or clinical services from
third party suppliers and subcontractors; (iii) are not related to the manufacture of a Product or
the improvement of the Staccato Technology; and (iv) are assignable to Symphony Allegro or its
designee without consent from the other party to the agreement. The Parties shall negotiate in
good faith regarding the assignment, or other mechanism, of providing Symphony Allegro with the
rights, benefits and obligations of other Development Subcontracting Agreements to the extent
related to or used in connection with the Programs and that meet the criteria set forth in (i),
(ii), (iii) and (iv) above; provided that Alexza shall use commercially reasonable efforts to cause
the assignment of any non-assignable material Development Subcontracting Agreement or portion
thereof that meet the criteria set forth in (i), (ii) and (iii) above. If it is not successful in
causing such assignment, Alexza shall act as Symphony Allegro’s agent, at Symphony Allegro’s
reasonable request and expense, in procuring all goods and services under such agreements until
such time as Symphony Allegro enters into alternative arrangements to procure such services,
provided that Symphony Allegro uses commercially reasonable efforts to enter into such alternative
arrangements as soon as possible. Alexza agrees to take such commercially reasonable actions as
Symphony Allegro
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
7.
may request in furtherance of the foregoing, at the expense of Symphony Allegro. Such efforts
shall not include any obligation for Alexza to incur any out-of-pocket costs. Alexza shall provide
copies of all such Development Subcontracting Agreements to Symphony Allegro, at Symphony Allegro’s
expense, in connection with such transfer. For clarity, Alexza shall not have any obligation
pursuant to this Section 5.4(a) to: (A) transfer to Symphony Allegro or its designee any Drug
Master File or equivalent thereof for the manufacture of any Product, (B) assign to Symphony
Allegro or its designee any material agreement that pertains to the manufacture of any Product or
to any product that is not a Product except in accordance with this Section 5.4(a), (C) deliver to
Symphony Allegro or its designee any units of finished Product that Symphony Allegro did not pay
for prior to the expiration or termination of the unexercised Purchase Option, other than units of
finished Product for which an order is outstanding (and payment is made) as of the expiration or
termination of the unexercised Purchase Option, or (D) deliver to Symphony Allegro or its designee
any components (including bulk Alprazolam and Loxapine) of the Products or any partially assembled
or partially finished Products.
(b) Except as provided in the Amended and Restated Technology License Agreement, upon the
discontinuation of any of the Programs pursuant to Section 4.2(c), Alexza shall have no further
obligations with respect to such Programs under the Operative Documents. If such Program is
transferred or licensed to a third party in accordance with Section 11 (such third party, the
“Transferee”), then Alexza shall cooperate with Symphony Allegro and the Transferee to effect the
assignment to the Transferee of the sponsorship to the Regulatory Files (excluding Drug Master
Files, but subject to Symphony Allegro’s rights under Section 2.7(a)(i) of the Novated and Restated
Technology License Agreement) that are solely related to such Program; provided, however, that
Alexza shall not be obligated to take any action pursuant to this Section 5.4(b) for which it will
not receive full reimbursement from Symphony Allegro or another party. The assignment of such
Regulatory Files to the Transferee does not include an assignment of any Licensed Intellectual
Property.
6. Alexza’s Obligations.
6.1 Generally.
(a) Alexza shall have primary responsibility for and “prime contractor” status with respect to
the implementation of the Programs. Without limiting the foregoing, Alexza shall specifically be
responsible for (i) performing all pre-clinical and clinical development for the AZ-002 Program and
the AZ-004 Program in accordance with the Development Plan, (ii) manufacturing of Clinical Trial
Materials for the Programs, and carrying out the quality assurance therefor, in each case in
accordance with the Development Plan, (iii) making improvements to the Staccato Technology for
potential incorporation into the Products and testing such improvements with Alprazolam and/or
Loxapine, as applicable, and implementing changes to manufacturing processes and facilities to
enable manufacture of new Product conformations incorporating such improvements, in each case in
accordance with the Development Plan, and (iv) executing all other matters set forth in the
Development Plan that are delegated to Alexza by Symphony Allegro pursuant to the Development Plan
(collectively, the “Alexza Obligations”).
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8.
(b) On account of Alexza’s prime contractor status, the Development Committee shall first
offer Alexza the opportunity to perform any activity included in the Development Plan (other than
those types and categories of activities allocated to a party other than Alexza in the Initial
Development Plan) and shall only allocate such activity to RRD (other than activities set forth in
the RRD Services Agreement) or a third party if Alexza is not willing or able to perform such
activity or lacks the resources to perform such activity in accordance with industry standards and
on commercially reasonable terms as determined by the Development Committee. Alexza agrees that it
will work diligently and use commercially reasonable efforts to discharge the Alexza Obligations in
a manner consistent with the standards customary in the biopharmaceutical industry for comparable
high quality services and in accordance with the Development Plan, the Development Budget, and the
terms of this Agreement. In the event that either Party is concerned that Alexza may be unable to
execute any of the aforementioned development activities which comprise the Alexza Obligations,
such Party shall bring such concern to the attention of the Development Committee. The Development
Committee shall evaluate the concern and consider in good faith commercially reasonable amendments
to the Development Plan and Development Budget that would facilitate Alexza’s ability to perform
such Alexza Obligations and shall explore the feasibility and expense of Alexza engaging a new
subcontractor to perform such Alexza Obligations in lieu of Alexza or its current subcontractor.
If the Development Committee (A) decides by majority vote that the concern is valid and compelling
but is unable to agree upon a solution that addresses such concern, or (B) is unable to decide by
at least a majority as to whether such concern is valid and compelling, then, in each case, the
Parties will follow the dispute resolution procedures set forth in Paragraph 11 of the Development
Committee Charter. If such procedures do not result in a solution that resolves such concern, then
the Symphony Allegro Board shall have the power to instruct the Development Committee to re-assign
such development activities in a manner to be determined by the Development Committee, and Alexza
shall, at the reasonable request of the Development Committee and at the expense of Symphony
Allegro, transfer and deliver to Symphony Allegro (or RRD on behalf of Symphony Allegro) copies of
any and all consents, materials, documents, files and other information (excluding Drug Master
Files, but subject to Symphony Allegro’s rights under Section 2.7(a)(i) of the Novated and Restated
Technology License Agreement) that relate to such development activities and that are necessary for
another entity to perform such development activities; provided, that Alexza shall be permitted to
retain the originals of such transferred materials, documents, files and other information relating
to such development activities as necessary in order to comply with any requirements of a
Governmental Authority or to use such items for purposes other than the relevant Program.
6.2 Subcontracting.
(a) Alexza agrees that it will not enter into any non-written Subcontracting Agreements. Each
and every Subcontracting Agreement in effect as of the Closing Date (other than certain stand-alone
purchase orders to be reviewed by the Development Committee after the Closing Date) is disclosed on
Schedule 6.2 hereto. Other than the Subcontracting Agreements set forth on Schedule 6.2, there are
no other written or oral agreements, contracts, understandings, arrangements or other commitments
in effect as of the Closing Date that are related to the performance of the Alexza Obligations by
third parties (other than certain stand-alone purchase orders to be reviewed by the Development
Committee after the
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
9.
Closing Date). The Subcontracting Agreements set forth on Schedule 6.2 shall be deemed to be
acceptable to the Parties in all respects.
(b) Following the Closing Date, if Alexza wishes to enter into a work order, change order,
purchase order or the like (collectively, a “Work Order”) for the performance of Alexza Obligations
(other than manufacturing-related obligations) pursuant to a master services agreement entered into
prior to the Closing Date and set forth on Schedule 6.2, Alexza shall provide the Development
Committee with a copy of such draft Work Order, shall consider in good faith all comments with
respect to such draft Work Order received from Development Committee Members within five (5)
Business days and shall obtain the Development Committee’s approval of the final Work Order before
entering into the Work Order. Such final Work Order shall be deemed a “Development Subcontracting
Agreement” at the time of entry but the corresponding master services agreement shall not be
subject to further review as a Development Subcontracting Agreement.
(c) Following the Closing Date, Alexza shall provide the Development Committee, for its review
and approval, a copy of Alexza’s template agreements for clinical sites, principal investigators
and other third parties that routinely accept other companies’ forms and the template agreements of
any other third party contractors. When negotiating the terms of a Development Subcontracting
Agreement with such a third party, Alexza shall use commercially reasonable efforts to obtain the
terms set forth in the relevant Development Committee-approved template agreement. Alexza may
enter into a Development Subcontracting Agreement based on a Development Committee-approved
template without obtaining the prior approval of the Development Committee provided that the terms
of such agreement are not materially different from or less favorable to Alexza or Symphony Allegro
than the terms of the applicable template.
(d) Following the Closing Date, Alexza shall obtain the approval of the Development Committee
prior to: (i) entering into any Development Subcontracting Agreement not addressed in Section
6.2(b) or (c) or (ii) amending or terminating any Development Subcontracting Agreement, in each
case such approval is not to be unreasonably withheld and shall be deemed given if not objected to
by any Development Committee Member within five (5) Business Days of the Development Committee’s
receipt of a final copy of such agreement; provided that during such five (5) Business Day period
Alexza 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.
(e) At each meeting of the Development Committee, or at such other time as may be agreed among
the Parties, Alexza shall update the Development Committee on the status of any negotiations or
discussions with respect to any material Subcontracting Agreements and, if requested, provide draft
copies of any such material Subcontracting Agreement.
(f) Subject to the foregoing, Alexza shall have full discretion to enter into Manufacturing
Subcontracting Agreements after the Closing Date; provided that Alexza
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10.
shall give prior notice to the Development Committee of any such material Manufacturing
Subcontracting Agreements.
(g) The terms of all Subcontracting Agreements shall be deemed the Confidential Information of
Alexza and be subject to the rights and obligations set forth in the Confidentiality Agreement.
Alexza shall monitor the performance of its Alexza Subcontractors and shall promptly notify the
Development Committee with respect to any Alexza Subcontractor performance issues that may have a
material adverse effect on the Programs.
(h) The Development Committee shall have the authority to direct Alexza to terminate any
Development Subcontracting Agreement (i) that Alexza has the right to terminate, pursuant to the
terms thereof, without cost or other obligation, and (ii) any other Development Subcontracting
Agreement, provided that the Development Budget shall be amended to cover all costs or other
obligations associated with or arising from such termination.
6.3 Reports and Correspondence. Alexza 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, Alexza shall, to the extent reasonably
required by the Development Committee, provide the Development Committee with a summary of Alexza’s
activities and developments with respect to the Programs for the period following the most recent
preceding Scheduled Meeting. Such summary shall include: (i) updates regarding (A) patient
enrollment, any adverse events (to the extent Alexza has been notified of such adverse events) or
serious adverse events, any added or terminated clinical trial sites, any significant Protocol
deviation, 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 clinical trials under the Development Plan; and (B) CMC status,
non-clinical program status, regulatory and quality program status, communications with regulatory
agencies, results of meetings of Alexza’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 Alexza Obligations;
(ii) a copy of each standard clinical study progress report for the Programs received by Alexza
during the preceding month from any of the clinical research organizations engaged by Alexza
pursuant to any Subcontracting Agreements and a copy of any final preclinical study reports for
such Programs; (iii) a financial report, in a format agreed upon by the Development Committee,
itemizing actual spending under the Development Plan as well as any variation from planned
spending; (iv) if the portion of the Development Budget related to a particular Program is altered
to the extent that available funding for such Program no longer appears to be adequate to complete
the Program, an updated budget forecast; and (v) such other information as the Development
Committee may reasonably request. Alexza shall notify at least one (1) of the Development
Committee Members designated by Holdings within twenty-four (24) hours of the occurrence of any
event that has, or could reasonably be expected to have, a material adverse effect on the
Development Plan or the Development Budget and shall keep the Development Committee regularly
updated and informed with respect to any such event.
6.4 Manufacturing.
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11.
(a) Subject to Section 6.4(d), if Clinical Trial Materials manufactured by or on behalf of
Alexza for a Program do not conform with the applicable specifications, then Alexza shall use
commercially reasonable efforts to replace such Clinical Trial Materials at Alexza’s sole expense.
(b) Subject to Section 6.4(d), if Alexza foresees or experiences difficulty in supplying
Clinical Trial Materials for the Programs, it shall notify Symphony Allegro and confer with the
Development Committee regarding the source of the problem and Alexza’s plans to address such
problem.
(c) Subject to Section 6.4(d), if on two (2) separate occasions during the Term Alexza
materially breaches its Clinical Trial Materials supply obligation hereunder by failing to supply
at least [ * ] of the amount ordered or failing to replace non-conforming Clinical Trial Material
on time and fails to cure such breach within [ * ] of Symphony Allegro’s written notice thereof,
then upon Symphony Allegro’s written notice that Alexza has materially breached for a third (3rd)
time, its Clinical Trial Materials supply obligation hereunder by failing to supply at least [ * ]
of the amount ordered or failing to replace non-conforming Clinical Trial Material on time, the
Parties shall negotiate in good faith to agree upon a mechanism for Symphony Allegro to obtain an
alternate source of Clinical Trial Material supply (including seeking to validate an alternate
manufacturing source and granting such licenses as may be required). In the event that, despite
such good faith negotiations, Symphony Allegro and Alexza fail to reach an agreement regarding an
alternate source within [ * ] after Symphony Allegro’s notice regarding such third (3rd) breach,
then upon Symphony Allegro’s request, the Parties shall amend the Novated and Restated Technology
License Agreement to expand the license granted to Symphony Allegro pursuant to Section 2.2 thereof
to include the non-exclusive right to manufacture, or have manufactured, the Product(s) affected by
such breach.
(d) If a force majeure event causes Alexza to materially default on or breach its obligations
hereunder to manufacture Clinical Trial Materials for the Program, Alexza shall promptly notify
Symphony Allegro of such force majeure event and shall keep Symphony Allegro apprised of the status
of its efforts to eliminate the effects of such force majeure event or otherwise regain its ability
to fulfill its Clinical Trial Material manufacturing obligation. If such a force majeure event
persists for six (6) months or more, then upon Symphony Allegro’s request, the Parties shall amend
the Novated and Restated Technology License Agreement to expand the license granted to Symphony
Allegro pursuant to Section 2.2 thereof to include the non-exclusive right to manufacture, or have
manufactured, the Product(s) affected by such force majeure.
(e) In the event that the Parties amend the Novated and Restated Technology License Agreement
pursuant to Section 6.4(c) or 6.4(d), Alexza shall, at the reasonable request of the Development
Committee and at the expense of Symphony Allegro, transfer and deliver to Symphony Allegro (or RRD
on behalf of Symphony Allegro) copies of any and all consents, materials, documents, files and
other information (excluding Drug Master Files, but subject to Symphony Allegro’s rights under
Section 2.7(a)(i) of the Novated and Restated Technology License Agreement) that are necessary for
another entity to manufacture such Product(s); provided, that Alexza shall be permitted to retain
the originals of such
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
12.
transferred materials, documents, files and other information relating to such development
activities and to use such originals for all purposes.
6.5 Staffing. Alexza shall provide such sufficient and competent staff and Personnel
(including, without limitation, such employees or agents of, or independent contractors retained
by, Alexza) that have the skill and expertise necessary to perform the Alexza Obligations. Alexza
shall notify Symphony Allegro in advance, if practicable, and in any event promptly thereafter, of
any change in Key Personnel involved in the Programs.
6.6 QA Audit. During the Term, Alexza will permit Symphony Allegro’s representatives (such
representatives to be identified by Symphony Allegro in advance and reasonably acceptable to Alexza
and to enter into a confidentiality agreement with Alexza) to examine and audit, during regular
business hours, the work performed by Alexza hereunder and the Alexza facilities at which such work
is conducted to determine that the project assignment is being conducted in accordance with the
agreed upon services (“QA Audits”). Symphony Allegro shall give Alexza reasonable advance notice
of such QA Audits specifying the scope of the audit. Symphony Allegro shall reimburse Alexza for
its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a
material deficiency in Alexza’s quality assurance procedures, then Alexza will be responsible for
all costs of such QA Audit, including Symphony Allegro’s reasonable costs associated with such QA
Audit, the work to be re-performed and the costs or expenses associated with curing such material
deficiencies. Symphony Allegro and Alexza 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. Alexza shall make commercially
reasonable efforts to reconcile all such deficiencies found by Symphony Allegro during such QA
Audit.
6.7 Financial Audit. During the Term, Alexza will permit Symphony Allegro’s representatives
(such representatives to be identified by Symphony Allegro in advance and reasonably acceptable to
Alexza and to enter into a confidentiality agreement with Alexza), to verify Alexza’s invoices,
other receipts, and FTE records that are related to Alexza’s performance of the work under the
Programs (“Financial Audits”), which review shall be conducted during regular business hours and
will take place no more than once per year, unless otherwise agreed to by the Parties. Symphony
Allegro shall give Alexza reasonable advance notice of such Financial Audits specifying the scope
of the audit, which shall not include work that has previously undergone Financial Audits.
Symphony Allegro shall reimburse Alexza for its time associated with Financial Audits; provided,
however, that should a particular Financial Audit reveal an aggregate variance of more than [ * ]
between such financial records and the reports submitted by Alexza to Symphony Allegro for
reimbursement purposes during the period covered by such Financial Audit, then Alexza will be
responsible for all costs of such Financial Audit, including Symphony Allegro’s reasonable costs
associated therewith. Symphony Allegro and Alexza 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. Alexza shall
make commercially reasonable efforts to reconcile all such discrepancies found by Symphony Allegro
during such Financial Audit. In addition, Alexza shall, during regular business hours, cooperate
with, and promptly respond to, inquiries from the Symphony Allegro Auditors, if the Symphony
Allegro Auditors shall
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13.
reasonably conclude that they require additional information or clarification regarding any
invoices, other receipts or FTE records submitted by Alexza.
6.8 Insurance. Alexza shall carry and maintain throughout the Term clinical trial liability
insurance (including errors and omissions coverage and product coverage), at Alexza’s sole expense,
with limits of at least $10,000,000 per occurrence, and property insurance covering Products, at
Alexza’s sole expense, with limits of at least $1,000,000. Upon Symphony Allegro’s request, Alexza
shall instruct its insurance carrier(s) to promptly furnish to Symphony Allegro certificates
reflecting such coverage and a representation indicating that such coverage shall not be canceled
or otherwise terminated during the Term without thirty (30) days’ prior written notice to Symphony
Allegro. Notwithstanding anything to the contrary herein, this Section 6.8 shall survive for a
period of two (2) years following termination or expiration of this Agreement.
7. Symphony Allegro’s Obligations.
7.1 Generally. Symphony Allegro 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 clinical development and
manufacturing activities set forth in the Development Plan. Symphony Allegro shall, and shall
instruct all Persons whom it engages pursuant to Article 2 hereof to, perform its obligations
hereunder and under the Development Plan in good faith and in accordance with the applicable
provisions of the Development Plan and the Development Budget, and the terms of this Agreement.
7.2 Subcontracting. Symphony Allegro is subcontracting, and will in the future subcontract,
certain of its responsibilities under the Development Plan to Alexza (pursuant hereto), to RRD
(pursuant to the RRD Services Agreement) and to other vendors and service providers (pursuant to
subcontracting agreements to be approved by the Development Committee); provided, that Symphony
Allegro shall remain responsible for the performance of its obligations hereunder notwithstanding
any such arrangement. Each subcontracting agreement entered into by Symphony Allegro (except for
the RRD Services Agreement) shall include a provision permitting assignment at any time of the
subcontracting agreement from Symphony Allegro to Alexza without the subcontractor’s consent;
provided that Symphony Allegro may not assign its obligations under any such subcontracting
agreement to Alexza without Alexza’s prior written consent.
7.3 Reports. Symphony Allegro shall keep the Development Committee informed of its activities
under the Development Plan that are subcontracted to RRD or any Person other than Alexza, through
regular reports as set forth in this Section 7.3. At each Scheduled Meeting of the Development
Committee, Symphony Allegro shall, to the extent reasonably required by the Development Committee,
provide the Development Committee with a summary of such subcontractors’ activities and
developments with respect to the Programs for the period following the most recent preceding
Scheduled Meeting. Such summary shall include such information as the Development Committee may
reasonably request. Symphony Allegro shall notify at least one (1) Development Committee Member
nominated by Alexza within twenty-four (24) hours of the occurrence of any event that has, or could
reasonably be expected
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
14.
to have, a material adverse effect on the Development Plan or the Development Budget and shall
keep the Development Committee regularly updated and informed with respect to any such event.
7.4 Insurance. Symphony Allegro 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.
7.5 Staffing. Symphony Allegro shall use commercially reasonable efforts to provide, or cause
to be provided on its behalf (including Personnel retained by RRD), sufficient and competent staff
and Personnel that have the skill and expertise necessary to perform Symphony Allegro’s obligations
under this Agreement, the RRD Services Agreement, the Development Plan and the Development Budget,
including, but not limited to, (i) carrying out its management and administrative functions
pursuant to the RRD Services Agreement, and (ii) carrying out its clinical development duties in
accordance with this Agreement, the Development Plan and the Development Budget. Symphony Allegro
shall notify Alexza in advance, if practicable, and in any event promptly thereafter, of any change
in the key RRD Personnel involved in the Programs.
7.6 Audit. Symphony Allegro shall permit each of Alexza, Holdings, Investors and each
Symphony Fund and their duly authorized representatives at all reasonable business hours to inspect
(1) Symphony Allegro’s books, records and other reasonably requested materials and (2) any and all
properties of Symphony Allegro, and it shall provide to each of Alexza, Holdings, Investors and
each Symphony Fund all books, records and other materials related to any meeting of the Symphony
Allegro Board or Shareholders and to permit Holdings, Investors and each Symphony Fund to make
copies or extracts therefrom; provided, that each aforementioned party may conduct one such
inspection in each calendar year without cost to such party, and that any party conducting
additional inspections shall reimburse the Manager for its reasonable costs and expenses in
facilitating such additional inspections unless such additional inspections were performed to
determine whether previously identified material deficiencies have been addressed. Symphony
Allegro and Alexza shall meet to discuss the results of the audit and, if required, jointly agree
upon any actions that will be required as a result of such audit including defining material
discrepancies to be addressed. Symphony Allegro shall make commercially reasonable efforts to
reconcile all such discrepancies found by Alexza, Holdings, Investors or any Symphony Fund during
such audit.
8. Funding and Payments.
8.1 Use of Proceeds. Symphony Allegro shall use any and all (x) proceeds received by Symphony
Allegro as a result of the Financing, (y) indemnity payments received by Symphony Allegro, and (z)
payments received by Symphony Allegro pursuant to first and third party covered insurance claims,
for the development of the Programs and general corporate purposes of Symphony Allegro, including
the payment of all fees and expenses in accordance with the Development Plan and the Development
Budget, as may be modified from time to time pursuant to Section 4.2, and the payment of any
indemnification obligations of Symphony Allegro under the Operative Documents and agreements with
third party contractors.
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Notwithstanding the foregoing, Symphony Allegro agrees that any agreement under which Symphony
Allegro indemnifies any Person shall contain appropriate provisions to cause such Person who
receives payments from Symphony Allegro as a result of Symphony Allegro’s indemnification
obligations under the Operative Documents, and who is subsequently reimbursed from insurance
proceeds with respect to such losses, costs, interest, awards, judgments, fees, liabilities,
damages and expenses for which such Person received the indemnity payments from Symphony Allegro,
to then reimburse Symphony Allegro the amounts paid to such Person by Symphony Allegro to the
extent of the insurance proceeds. Symphony Allegro further agrees to use all commercially
reasonable means to enforce such provisions.
8.2 Reimbursement.
(a) Symphony Allegro shall compensate Alexza 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 Alexza in accordance with this Agreement. Such
compensation shall be made in accordance with the provisions of this Article 8 and the payment
terms attached hereto as Annex E (the “Payment Terms”), the terms of which are hereby adopted and
incorporated herein; provided that Alexza shall be directly responsible for compensation and
reimbursement of third parties with respect to all development activities and services performed by
third parties on Alexza’s behalf in accordance with the Development Plan and all expenses incurred
by third parties in connection with such development activities and services, it being understood
that the cost shall be passed through to Symphony Allegro. With respect to costs for travel,
unless the Development Committee provides Alexza with prior approval, all Alexza personnel shall
adhere to Alexza’s travel policy.
(b) To the extent included in the Development Plan and Development Budget as such Development
Plan and Development Budget may be modified upon approval of the Development Committee,
reimbursement for Alexza’s manufacturing services shall include compensation for Alexza’s fully
burdened costs for all materials and services supporting pre-clinical testing, clinical trial
requirements and regulatory submissions, including, without limitation, costs associated with
procurement of Alprazolam, Loxapine, and Product components, Product manufacture, testing,
packaging, storage, transportation and insurance, allowed overage, percent retention, quality
assurance, CMC compliance, and stability programs.
8.3 Budget Allocation and Deviations. Alexza 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 Alexza reasonably anticipates that the actual cost for any
particular activity will exceed that portion of the Development Budget allocated over any twelve
(12) month period for such activity by $50,000 or more (or such greater amount as the Symphony
Allegro Board may subsequently determine), then Alexza 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. Alexza 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 such amounts (x) are set forth in the Development Budget and do not exceed the amounts set
forth in the Development Budget by the criteria set forth in this Section 8.3, or (y) are otherwise
approved in advance by
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16.
the Development Committee. Without the prior approval of the Development Committee, Alexza
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 Alexza pursuant to this Section 8.3 to amend the Development
Budget, then Alexza shall no longer be obligated to perform such incremental activity that is
expected to give rise to such additional expenditures.
8.4 Employee Benefits. Symphony Allegro 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 Alexza or to any employees of Alexza or any persons retained or
used by Alexza to perform activities pursuant to the Development Plan, including independent
contractors, Subcontractors and agents (collectively, “Alexza Personnel”). As to Alexza or any
Alexza Personnel, Symphony Allegro 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. Alexza agrees that, as between Symphony Allegro and Alexza, Alexza is and will continue
to be solely responsible for: (i) all matters relating to the payment of compensation and
provision of benefits to Alexza Personnel; and (ii) compliance with all applicable laws, rules and
regulations governing Alexza’s employees. Alexza acknowledges that Alexza is not entitled for
reimbursement with respect to any amounts related to the services of Alexza Personnel in excess of
the fully burdened FTE rates in accordance with Annex E attached hereto and Symphony Allegro
acknowledges that the FTE rates used as the basis for reimbursing Alexza for the services of Alexza
Personnel include Alexza’s costs associated with providing such benefits and fulfilling such
responsibilities.
9. Covenants.
9.1 Mutual Covenants. Each of Alexza and Symphony Allegro 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
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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 any breach by it of any representation, warranty, covenant
or any other term or condition of this Agreement or acquiring Knowledge of a material event or
development that is, or is reasonably expected to be, adverse to the other Party with respect to
any Program or the transactions contemplated hereby, such Party shall promptly notify the other
Party in writing within three (3) 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, material event or development and that notice under this
Section 9.1(e) shall not in itself constitute notice of any breach of any of the Operative
Documents, unless explicitly stated in such notice; 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
Alexza’s obligations to provide financial and other necessary information in respect of such
Programs to Symphony Allegro and RRD to enable Symphony Allegro to fulfill its obligations to
Alexza under Section 5(d) of the Purchase Option Agreement, and to enable RRD to fulfill its
obligations to Symphony Allegro and Alexza under Sections 5(a) and 5(b) of the RRD Services
Agreement.
10. Confidentiality. It is understood that during the course of this Agreement each
of the Parties shall be bound by the terms of the Confidentiality Agreement.
11. Discontinuation Option.
(a) A Program may only be discontinued in accordance with Section 4.2(c). In the event of
such a Program discontinuation during the Term, (i) Symphony Allegro shall so notify Alexza
promptly and in writing of such discontinuation, and (ii) Alexza shall have the right and option (a
“Discontinuation Option”), exercisable for [ * ] after receipt of such written notice from Symphony
Allegro of such discontinuation, to buy back the Licensed Intellectual Property related to such
discontinued Program for a price (payable by wire transfer to Symphony Allegro) that is 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 [ * ] after receipt of such
written notice from Symphony Allegro of such discontinuation,
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
18.
to be determined in accordance with Section 11(b) hereof. If the Discontinuation Price is
determined in accordance with Section 11(b), then the [ * ] period for Alexza’s exercise of the
Discontinuation Option shall be extended by the time needed for such determination so that Alexza
has at least [ * ] after such determination to decide whether it wishes to exercise the
Discontinuation Option. Following the unexercised expiration of the Discontinuation Option,
Symphony Allegro may transfer or license its rights to such Program to a third party at any time
prior to the expiration of the Term. Under no circumstances may Symphony Allegro or Alexza (unless
Alexza has exercised its Discontinuation Option for such Program) reinitiate work on a discontinued
Program prior to the expiration or termination of the Purchase Option. Any Discontinuation Price
paid to Symphony Allegro by Alexza and subsequently divided or otherwise distributed to Holdings
shall reduce the Purchase Price in the amount of such dividends or other distributions.
(b) If Alexza and Symphony Allegro cannot agree on the Discontinuation Price within [ * ]
after receipt of such written notice from Symphony Allegro of such discontinuation, then at
Alexza’s request, the Chief Executive Officer of Alexza and Chairman of the Symphony Allegro Board
shall make good faith efforts to resolve the disagreement(s) regarding the calculation of the
Discontinuation Price. If the Chief Executive Officer of Alexza and Chairman of the Symphony
Allegro Board do not agree on the Discontinuation Price within [ * ] after Alexza’s request, then
the Parties shall jointly select a nationally recognized expert to resolve any remaining
disagreements regarding calculation of the Discontinuation Price. The Parties shall use their
respective commercially reasonable efforts to cause such expert to make its determination of the
Discontinuation Price within [ * ] of accepting its selection. The expert’s determination of the
Discontinuation Price shall, absent manifest error, be (i) binding and conclusive and (ii) the
Discontinuation Price at which the Discontinuation Option shall be exercised by Alexza. All costs
and expenses of the expert shall be shared equally between Alexza and Symphony Allegro.
Notwithstanding the foregoing, in any case, each Party shall be responsible for the payment of its
respective costs and expenses, including any attorneys’ fees.
12. Representations and Warranties.
12.1 Alexza Representations and Warranties. Alexza hereby represents and warrants to Symphony
Allegro and Holdings that, as of the Closing Date:
(a) Organization. Alexza is a corporation, duly organized, validly existing and in good
standing under the laws of the State of Delaware.
(b) Authority and Validity. Alexza has all requisite corporate power and authority to
execute, deliver and perform its obligations under this Agreement and the Novated and Restated
Technology License Agreement and to consummate the transactions contemplated thereby. The
execution, delivery and performance by Alexza of this Agreement and the Novated and Restated
Technology License Agreement and the consummation of the transactions contemplated thereby have
been duly and validly authorized by all necessary action required on the part of Alexza, and no
other proceedings on the part of Alexza are necessary to authorize this Agreement or the Novated
and Restated Technology License Agreement or for Alexza to perform its obligations under this
Agreement or the Novated and Restated Technology
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
19.
License Agreement. This Agreement and the Novated and Restated Technology License Agreement
constitute the lawful, valid and legally binding obligations of Alexza, enforceable in accordance
with their terms, except as the same may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the enforcement of creditors’ rights generally
and general equitable principles regardless of whether such enforceability is considered in a
proceeding at law or in equity.
(c) No Violation or Conflict. The execution, delivery and performance of this Agreement and
the Novated and Restated Technology License Agreement and the transactions contemplated thereby do
not and will not (i) violate, conflict with or result in the breach of any provision of the
Organizational Documents of Alexza, (ii) conflict with or violate any law or Governmental Order
applicable to Alexza 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 Alexza, pursuant to, any note,
bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or
other instrument or arrangement to which Alexza 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
Alexza or a material adverse effect on the Programs.
(d) Governmental Consents and Approvals. The execution, delivery and performance of this
Agreement and the Novated and Restated Technology License Agreement by Alexza 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 Alexza or a material adverse effect on the
Programs.
(e) Litigation. Except as disclosed on the Alexza S 1, there are no actions by or against
Alexza pending before any Governmental Authority or, to the Knowledge of Alexza, 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 Alexza. There are no pending or, to
the Knowledge of Alexza, threatened actions, to which Alexza 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. Alexza is not subject to any Governmental Order
(nor, to the Knowledge of Alexza, 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 Alexza 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 Alexza and any third party other than (i) licenses of intellectual property that
are in turn licensed to Symphony Allegro under the Novated and Restated Technology License
Agreement and (ii) contracts that relate solely to the Staccato
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
20.
Technology and are not related to the Programs or solely to products other than the Products,
used with or otherwise necessary for the Programs, and all such contracts are assignable to
Symphony Allegro. Except as disclosed on Schedule 12.1(f) hereto, each such contract is assignable
to Symphony Allegro without the prior consent of the applicable third party, or the absence of such
contract (due to the inability or impracticability of assigning such contract to Symphony Allegro
following a termination of this Agreement without the exercise of the Purchase Option) would not
have a material adverse effect on any of the Programs or on Symphony Allegro’s rights under the
Novated and Restated Technology License Agreement.
12.2 Symphony Allegro Representations and Warranties. Symphony Allegro hereby represents and
warrants to Alexza that, as of the Closing Date:
(a) Organization. Symphony Allegro is a corporation, duly organized, validly existing and in
good standing under the laws of the State of Delaware.
(b) Authority and Validity. Symphony Allegro has all requisite corporate power and authority
to execute, deliver and perform its obligations under this Agreement and the Novated and Restated
Technology License Agreement and to consummate the transactions contemplated thereby. The
execution, delivery and performance by Symphony Allegro of this Agreement and the Novated and
Restated Technology License Agreement and the consummation of the transactions contemplated thereby
have been duly and validly authorized by all necessary action required on the part of Symphony
Allegro, and no other proceedings on the part of Symphony Allegro are necessary to authorize this
Agreement or the Novated and Restated Technology License Agreement or for Symphony Allegro to
perform its obligations under this Agreement or the Novated and Restated Technology License
Agreement. This Agreement and the Novated and Restated Technology License Agreement constitute the
lawful, valid and legally binding obligations of Symphony Allegro, enforceable in accordance with
its terms, except as the same may be limited by applicable bankruptcy, insolvency, reorganization,
moratorium or similar laws affecting the enforcement of creditors’ rights generally and general
equitable principles regardless of whether such enforceability is considered in a proceeding at law
or in equity.
(c) No Violation or Conflict. The execution, delivery and performance of this Agreement and
the Novated and Restated Technology License Agreement and the transactions contemplated thereby do
not and will not (i) violate, conflict with or result in the breach of any provision of the
Organizational Documents of Symphony Allegro, (ii) conflict with or violate any law or Governmental
Order applicable to Symphony Allegro 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
Symphony Allegro, pursuant to any note, bond, mortgage or indenture, contract, agreement, lease,
sublease, license, permit, franchise or other instrument or arrangement to which Symphony Allegro
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 Symphony Allegro.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
21.
(d) Governmental Consents and Approvals. The execution, delivery and performance of this
Agreement and the Novated and Restated Technology License Agreement by Symphony Allegro 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 Symphony Allegro.
(e) Litigation. There are no actions by or against Symphony Allegro pending before any
Governmental Authority or, to the Knowledge of Symphony Allegro, 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 Symphony Allegro. There are no pending or, to the
Knowledge of Symphony Allegro, threatened actions to which Symphony Allegro 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. Symphony Allegro is not subject to any Governmental Order (nor, to the
knowledge of Symphony Allegro, 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 Symphony Allegro or a material adverse effect on the Programs.
13. Relationship Between Alexza and Symphony Allegro. 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 Alexza and Symphony Allegro, and the Parties
acknowledge and agree that Alexza is acting as an independent contractor in the performance of its
obligations under this Agreement.
14. Change of Control. Holdings has the Change of Control Put Option described in
Section 2A of the Purchase Option Agreement following a Change of Control with respect to Alexza.
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 Alexza 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 Alexza 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, Alexza shall indemnify and hold
harmless Symphony Allegro, Holdings and RRD and each of their respective Affiliates, officers,
directors, employees, agents, members, managers, successors and assigns (each, a “Symphony
Indemnified Party”), and Symphony Allegro shall indemnify and hold harmless Alexza, and its
Affiliates and each of their respective officers, directors, employees,
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
22.
agents (other than Alexza Subcontractors), members, managers, successors and assigns (each, an
“Alexza 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 Alexza 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 Alexza being the Indemnifying Party, (A) any breach of any representation
or warranty made by Alexza herein or in any other Operative Document, (B) any breach of any
covenant, agreement or obligation of Alexza contained herein or in any other Operative Document,
except to the extent such covenant, agreement or obligation relates to Alexza’s performance under
the Development Plan, (C) any gross negligence or willful misconduct of Alexza (and not that of any
Alexza Subcontractors) in connection with Alexza’s performance of its obligations under this
Agreement (including the Development Plan), (D) any action undertaken or performed by or on behalf
of Alexza prior to, and including, the Closing Date that relates to the Programs or the Products,
or (E) in the event Alexza exercises a Discontinuation Option for a Program, any action undertaken
and/or performed by or on behalf of Alexza 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 Alexza 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 Symphony Allegro being the Indemnifying Party, (A) any breach of any
representation or warranty made by Symphony Allegro herein or in any other Operative Document, (B)
any breach of any covenant, agreement or obligation of Symphony Allegro contained herein or in any
other Operative Document, (C) any gross negligence or willful misconduct of Symphony Allegro (and
not that of its direct subcontractors) in connection with Symphony Allegro’s performance of its
obligations under this Agreement, or (D) 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 Alexza’s exercise of the Discontinuation Option, of Products covered under
Section 15.2(a)(i)(E)); in each case, except (1) with respect to Losses for which Symphony Allegro
is entitled to indemnification under this Article 15, or (2) Losses deemed to have arisen from the
breach by Alexza of any covenant, agreement or obligation under this Agreement that relates to
Alexza’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 an Alexza Indemnified Party.
To the extent that the foregoing undertaking by Alexza or Symphony Allegro 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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
23.
(b) Notice of Claims. Any Indemnified Party that proposes to assert a right to be indemnified
under this Section 15.2 shall notify Alexza or Symphony Allegro, 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 ten (10) Business Days following
its receipt of such notice, such Indemnifying Party shall not be liable to such Indemnified Party
for legal or other expenses related to such Indemnified Proceedings incurred after such notice of
election to assume such defense except as provided below and except for the reasonable costs of
investigating, monitoring or cooperating in such defense subsequently incurred by such Indemnified
Party reasonably necessary in connection with the defense thereof. Such Indemnified Party shall
have the right to employ its counsel in any such Indemnified Proceeding, but the fees and expenses
of such counsel shall be at the expense of such Indemnified Party unless:
(i) the employment of counsel by such Indemnified Party at the expense of the applicable
Indemnifying Party has been authorized in writing by such Indemnifying Party;
(ii) such Indemnified Party shall have reasonably concluded in its good faith (which
conclusion shall be determinative unless a court determines that such conclusion was not reached
reasonably and in good faith) that there is or may be a conflict of interest between the applicable
Indemnifying Party and such Indemnified Party in the conduct of the defense of such Indemnified
Proceeding or that there are or may be one or more different or additional defenses, claims,
counterclaims, or causes of action available to such Indemnified Party (it being agreed that in any
case referred to in this clause (ii) such Indemnifying Party shall not have the right to direct the
defense of such Indemnified Proceeding on behalf of the Indemnified Party);
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
24.
(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
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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
25.
16.1 Between the Parties. TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY
NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, MEMBERS, MANAGERS, EMPLOYEES, INDEPENDENT
CONTRACTORS OR AGENTS (INCLUDING RRD AND ITS MEMBERS, MANAGERS, EMPLOYEES, INDEPENDENT CONTRACTORS
AND AGENTS) SHALL HAVE ANY LIABILITY OF ANY TYPE (INCLUDING, BUT NOT LIMITED TO, CLAIMS IN
CONTRACT, NEGLIGENCE AND TORT LIABILITY) FOR ANY SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE OR
CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, THE LOSS OF OPPORTUNITY, LOSS OF USE OR LOSS
OF REVENUE OR PROFIT IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT OR THE SERVICES PERFORMED
HEREUNDER, EVEN IF SUCH DAMAGES MAY HAVE BEEN FORESEEABLE. THE FOREGOING SHALL NOT LIMIT EITHER
PARTY’S INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTION 15.2 AND SHALL NOT APPLY TO BREACHES OF ITS
CONFIDENTIALITY OBLIGATIONS PURSUANT TO ARTICLE 10.
16.2 Pursuant to the RRD Services Agreement. Each Party hereby acknowledges and agrees that,
pursuant to Sections 9(f) and (g) of the RRD Services Agreement, RRD has expressly disclaimed all
liability for (a) any claim arising out of, or allegedly arising out of the activities carried out
by (or within the authority of) Alexza (and such Alexza Subcontractors and vendors it may retain)
hereunder, or for any liability arising under the Novated and Restated Technology License Agreement
with respect to any license or sublicense thereunder in relation to the activities carried out by
(or within the authority of) Alexza (and such Alexza Subcontractors and vendors it may retain)
hereunder, with RRD to receive credit for any such damages to the extent such damages are
disclaimed, and (b) supervising, compensating or discharging, or any other liability to or with
respect to, any vendor retained by Alexza (or, in the case of a vendor engaged by both RRD and
Alexza, to and for such vendor to the extent that such vendor performs services for Alexza), except
that RRD shall make payments from Symphony Allegro’s funds to reimburse Alexza, in accordance with
Article 8 and Annex E of this Agreement, for costs and expenses incurred by Alexza in connection
with the engagement of such vendors by Alexza for the performance of services contemplated under
the Development Plan.
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 Alexza’s Breach.
(a) Symphony Allegro may terminate this Agreement at any time upon written notice to Alexza if
Alexza is in material default or breach of this Agreement, and such material default or breach
continues unremedied for a period of [ * ] after written notice thereof is delivered to Alexza.
Such cure period may be extended if (i) Alexza reasonably believes such breach can be cured within
[ * ] of Alexza’s receipt of Symphony Allegro’s written notice of such breach (and notifies
Symphony Allegro in writing of such belief and the basis for such
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
26.
belief), and (ii) Symphony Allegro, acting reasonably, agrees. If Alexza fails to remedy the
default or breach within the applicable cure period, Symphony Allegro may by final notice of
termination to Alexza terminate this Agreement.
(b) In the event that Symphony Allegro terminates this Agreement pursuant to Section 17.2(a)
above, Alexza may exercise its Purchase Option, pursuant to Section 1(c)(v) of the Purchase Option
Agreement, within [ * ] of receiving such notice of termination from Symphony Allegro; provided,
that if such termination occurs after a Change of Control with respect to Alexza 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 Symphony Allegro’s or Holdings’ Breach. Alexza may terminate this
Agreement at any time upon written notice to Symphony Allegro and Holdings if Symphony Allegro or
Holdings is in material default or breach of this Agreement, and such material default or breach
continues unremedied for a period of [ * ] after written notice thereof is delivered to Symphony
Allegro and Holdings. Such cure period may be extended if (i) Symphony Allegro or Holdings
reasonably believes such breach can be cured within [ * ] of Symphony Allegro’s and Holdings’
receipt of Alexza’s written notice of such breach (and notifies Alexza in writing of such belief
and the basis for such belief), and (ii) Alexza, acting reasonably, agrees. If Symphony Allegro or
Holdings fails to remedy the default or breach within the applicable cure period, Alexza may by
final notice of termination to Symphony Allegro and Holdings terminate this Agreement.
17.4 Termination of License Agreement. This Agreement shall automatically terminate upon the
termination of the Novated and Restated Technology License Agreement.
17.5 Survival.
(a) The agreements and covenants of the Parties set forth in Articles 10, 11, 15, 16 and 18,
and Sections 6.8 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 Alexza does not exercise the Purchase Option, in addition to the provisions specified
in Section 17.5(a), Section 5.4 shall also survive such unexercised expiration.
18. Miscellaneous.
18.1 No Petition. Alexza covenants and agrees that, prior to the date which is one (1) year
and one (1) day after the expiration of the Term, Alexza will not institute or join in the
institution of any bankruptcy, insolvency, reorganization or similar proceeding against Symphony
Allegro. The provisions of this Section 18.1 shall survive the termination of this Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
27.
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:
Alexza:
Alexza Pharmaceuticals, Inc.
0000 Xxxx Xxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Attn: August X. Xxxxxxx
Facsimile: (000) 000-0000
0000 Xxxx Xxxxxx Xxxxxx
Xxxx Xxxx, XX 00000
Attn: August X. Xxxxxxx
Facsimile: (000) 000-0000
With a copy to:
Cooley Godward Kronish LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000-0000
Attn: Xxxxxxx X. Xxxxxx, Esq.
Facsimile: (000) 000-0000
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000-0000
Attn: Xxxxxxx X. Xxxxxx, Esq.
Facsimile: (000) 000-0000
Symphony Allegro:
Symphony Allegro, Inc.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxx X. Xxxxxx, Ph.D.
Facsimile: (000) 000-0000
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxx X. Xxxxxx, Ph.D.
Facsimile: (000) 000-0000
Holdings:
Symphony Allegro Holdings LLC
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Xx.
Facsimile: (000) 000-0000
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxx, Xx.
Facsimile: (000) 000-0000
with copies to:
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
28.
Symphony Capital Partners, L.P.
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
and
Symphony Strategic Partners, LLC
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxx Xxxxxx
Facsimile: (000) 000-0000
or to such other address as such party may from time to time specify by notice given in the
manner provided herein to each other party entitled to receive notice hereunder.
18.3 Governing Law; Consent to Jurisdiction and Service of Process.
(a) This Agreement shall be governed by, and construed in accordance with, the laws of the
State of New York.
(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 The City of New York, Borough of Manhattan, 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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
29.
18.5 Entire Agreement. This Agreement (including any Annexes, Schedules, Exhibits or other
attachments hereto) constitutes the entire agreement between the Parties with respect to the
matters covered hereby, and no oral or written statement may be used to interpret or vary the
meaning of the terms and conditions hereof. This Agreement supersedes all prior and
contemporaneous agreements, correspondence, discussion and understanding with respect to such
matters between the Parties, including the Research and Development Agreement, but excluding the
Operative Documents.
18.6 Amendment; Successors; Assignment; Counterparts.
(a) The terms of this Agreement shall not be altered, modified, amended, waived or
supplemented in any manner whatsoever except by a written instrument signed by each of the Parties
and Holdings.
(b) Nothing expressed or implied herein is intended or shall be construed to confer upon or to
give to any Person, other than the Parties (and, to the extent of Section 18.8, RRD), any right,
remedy or claim under or by reason of this Agreement or of any term, covenant or condition hereof,
and all the terms, covenants, conditions, promises and agreements contained herein shall be for the
sole and exclusive benefit of the Parties (and, to the extent of Section 18.8, RRD) and their
successors and permitted assigns.
(c) This Agreement may not be assigned by either Party hereto without the prior written
consent of the other Party; provided that, in the event Alexza undergoes a Change of Control in
compliance with Article 14 hereof, Alexza may assign this Agreement to its Successor Entity.
(d) This Agreement may be executed in one or more counterparts, each of which, when executed,
shall be deemed an original but all of which taken together shall constitute one and the same
Agreement.
18.7 Severability. If any term or other provision of this Agreement is invalid, illegal or
incapable of being enforced by any rule of law or public policy, all other conditions and
provisions of this Agreement shall nevertheless remain in full force and effect so long as the
economic or legal substance of the transactions contemplated hereby is not affected in a manner
materially adverse to either party. Upon such determination that any term or other provision is
invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good faith
to modify this Agreement so as to effect the original intent of the parties as closely as possible
in an acceptable manner to the end that the transactions contemplated hereby are fulfilled to the
extent possible.
18.8 Third Party Beneficiary. Each of the Parties agrees that RRD shall be a third party
beneficiary of Articles 2, 8 and 16, and Sections 4.1, 4.2(a), 4.2(b), 7.1, 7.4, 9.1(f), 15.2 and
18.6(b) of this Agreement.
{SIGNATURES FOLLOW ON NEXT PAGE}
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
30.
In Witness Whereof, the parties hereto have caused this Agreement to be executed as
of the day and year above written.
SYMPHONY ALLEGRO HOLDINGS LLC | ||||||||
By: | Symphony Capital Partners, L.P., its Manager |
|||||||
By: | Symphony Capital GP, L.P., its member |
|||||||
By: | Symphony GP, LLC, its member |
|||||||
By: | /s/ Xxxx Xxxxxx | |||||||
Name: | Xxxx Xxxxxx | |||||||
Title: | Managing Member | |||||||
SYMPHONY ALLEGRO, INC. | ||||||||
By: | /s/ Xxxx X. Xxxxxxx | |||||||
Name: | Xxxx X. Xxxxxxx | |||||||
Title: | Chairman of the Board | |||||||
ALEXZA PHARMACEUTICALS, INC. | ||||||||
By: | /s/ August X. Xxxxxxx | |||||||
Name: | August X. Xxxxxxx | |||||||
Title: | Senior Vice President and | |||||||
Chief Financial Officer |
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
ANNEX A
CERTAIN DEFINITIONS
{See attached.}
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex A-1
CERTAIN DEFINITIONS
“$” means United States dollars.
“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.
“Ad Hoc Meeting” has the meaning set forth in Paragraph 6 of Annex B of the Amended
and Restated Research and Development Agreement.
“Additional Party” has the meaning set forth in Section 14 of the
Confidentiality Agreement.
“Additional Regulatory Filings” means such Governmental Approvals as required to be
made under any law applicable to the purchase of the Symphony Allegro 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.
“Affected Member” has the meaning set forth in Section 27 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.
“Alexza” means Alexza Pharmaceuticals, Inc., a Delaware corporation.
“Alexza Accounting Advisor” means Ernst & Young LLP.
“Alexza Common Stock” means the common stock, par value $0.0001 per share, of Alexza.
“Alexza Common Stock Valuation” has the meaning set forth in Section 2(e) of
the Purchase Option Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex A-1
“Alexza Obligations” has the meaning set forth in Section 6.1(a) of the
Amended and Restated Research and Development Agreement.
“Alexza Personnel” has the meaning set forth in Section 8.4 of the Amended and
Restated Research and Development Agreement.
“Alexza Public Filings” means all publicly available filings made by Alexza with the
SEC.
“Alexza Subcontractor” means a third party that has entered into a Subcontracting
Agreement with Alexza.
“Allegro 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 a pharmaceutical product or device that delivers
Alprazolam (provided that Alexza has not exercised a Discontinuation Option for the AZ-002 Program)
or Loxapine (provided that Alexza has not exercised a Discontinuation Option for the AZ-004
Program), as applicable.
“Alprazolam” means: (a) alprazolam and (b) all salts, metabolites, prodrug and other
physical forms thereof.
“Amended and Restated Research and Development Agreement” means the Amended and
Restated Research and Development Agreement dated as of the Closing Date, among Alexza, Holdings
and Symphony Allegro.
“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.
“AZ-002 Product” means a pharmaceutical product in which Alprazolam is the sole active
ingredient and it is delivered using Staccato Technology.
“AZ-002 Program” means the development, manufacture and/or use of any AZ-002 Product
in accordance with the Development Plan.
“AZ-004 Product” means a pharmaceutical product in which Loxapine is the sole active
ingredient and it is delivered using Staccato Technology.
“AZ-004 Program” means the development, manufacture and/or use of any AZ-004 Product
in accordance with the Development Plan.
“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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
2.
“Balance Sheet Deficiency Threshold” shall have the meaning set forth in Section 2(b)
of the Research Cost Sharing and Extension Agreement.
“Bankruptcy Code” means the United States Bankruptcy Code.
“Business Day” means any day other than Saturday, Sunday or any other day on which
commercial banks in the City of New York or the City of San Francisco 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 Alexza for cash, whether
in a public or private offering, (ii) sales of capital stock by stockholders of Alexza, and (iii)
acquisitions of capital stock by or from any employee benefit plan or related trust:
(a) the merger, reorganization or consolidation of Alexza into or with another corporation or
legal entity in which Alexza’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
(b) the sale of all or substantially all of Alexza’s assets or business.
“Change of Control Put Option” has the meaning set forth in Section 2A of the
Purchase Option Agreement.
“Change of Control Put Option Exercise Notice” has the meaning set forth in
Section 2A 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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
3.
“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) of the RRD
Services Agreement.
“Clinical Budget Component” has the meaning set forth in Section 4.1 of the
Amended and Restated Research and Development Agreement.
“Clinical Trial Material” means Product and placebo for administration to animals for
pre-clinical testing or to humans for clinical testing.
“Closing Date” means any time after the close of business in New York on December 1,
2006.
“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.
“Code” means the Internal Revenue Code of 1986, as amended from time to time.
“Committed Capital” means $50,000,000.00.
“Common Stock” means the common stock, par value $0.01 per share, of Symphony Allegro.
“Company Expenses” has the meaning set forth in Section 5.09 of the Holdings
LLC Agreement.
“Company Property” has the meaning set forth in Section 1.01 of the Holdings
LLC Agreement.
“Confidential Information” has the meaning set forth in Section 2 of the
Confidentiality Agreement.
“Confidentiality Agreement” means the Confidentiality Agreement, dated as of the
Closing Date, among Symphony Allegro, Holdings, Alexza, 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
Allegro 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
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
4.
access, a license or a sublicense (as applicable) in or to such item or right as provided in
the Operative Documents without violating the terms of any agreement or other arrangement with any
third party.
“Cross Program Expenses” are: (i) the Management Fee plus the Development Fee
pursuant to Section 6(a) of the RRD Services Agreement; (ii) actual expenses associated
with RRD carrying out its duties related to creating and maintaining the books of account, records,
financial statements and audit and tax preparation for Symphony Allegro pursuant to Section
5 of the RRD Services Agreement; and (iii) actual expenses for insurance procured for Symphony
Allegro pursuant to Section 1(a)(xi) of the RRD Services Agreement, reasonable legal
expenses incurred on behalf of Symphony Allegro, and travel and miscellaneous out of pocket
expenses of the Symphony Allegro Board, all as and to the extent reimbursable to RRD pursuant to
Section 6(b) of the RRD Services Agreement.
“Current Products” has the meaning set forth in Section 5.1(g) of thef Novated
and Restated Technology License 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 91
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,
(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,
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
5.
(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.
“Development Budget” means the budget (comprised of the Management Budget Component
and the Clinical Budget Component) for the implementation of the Development Plan (the initial form
of which was agreed upon by Alexza and Symphony Allegro as of the Closing Date and attached to the
Amended and Restated Research and Development Agreement as Annex C thereto), 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.
“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.
“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 the development plan covering all the Programs (the initial
form of which was agreed upon by Alexza and Symphony Allegro as of the Closing Date and attached to
the Amended and Restated Research and Development Agreement as Annex C thereto), 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.
“Development Product” means an AZ-002 Product or an AZ-004 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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
6.
“Development Subcontracting Agreement” means a Subcontracting Agreement that is
directly related to one or both of the Programs and is not a Manufacturing Subcontracting
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.
“Discontinuation Option” has the meaning set forth in Section 11(a) of the
Amended and Restated Research and Development Agreement.
“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 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 IX of the
Symphony Allegro Charter.
“Distribution” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Drug Master Files” means all Regulatory Files with respect to the manufacture or
design of a Product, including without limitation drug master files, design history files and
similar files.
“Early Purchase Option Exercise” has the meaning set forth in Section 1(c)(v)
of the Purchase Option Agreement.
“Effective Registration Date” has the meaning set forth in Section 1(b) 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
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
7.
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.
“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.
“Exiting Product” means, with respect to a particular Program, any Development Product
that was administered in a clinical trial pursuant to the Development Plan at any time prior to (a)
the termination of the Discontinuation Option with respect to such Program without exercise by
Licensor or (b) the expiration or termination of the Purchase Option without exercise by Licensor,
whichever comes first.
“Extension Funding” has the meaning set forth in Section 2 of the Research
Cost Sharing and Extension Agreement.
“External Directors” means, at any time, up to two (2) Persons elected to the Symphony
Allegro Board after the Closing Date (who shall be neither employees of Symphony Capital nor of
Alexza) in accordance with the Symphony Allegro Charter, the Symphony Allegro By-laws and
Section 4(b)(iv) of the Purchase Option 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 6.7 of the Amended and
Restated Research and Development Agreement.
“Financing” has the meaning set forth in the Preliminary Statement of the Purchase
Option Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
8.
“Fiscal Year” has the meaning set forth in each Operative Document in which it
appears.
“Form S-3” means the Registration Statement on Form S-3 as defined under the
Securities Act.
“FTE” means the time and effort of one or more qualified scientists working on the
AZ-002 Program or the AZ-004 Program that is equivalent to 1850 hours per year devoted exclusively
to the Programs by one (1) full-time employee. The portion of an FTE year devoted by any one
scientist to the Programs shall be determined by dividing the number of hours during any twelve
(12) month period devoted by such scientist to one or both Programs by 1850 hours, not to exceed
1.0 in any case.
“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.
“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 Allegro Holdings LLC, a Delaware limited liability company.
“Holdings Claims” has the meaning set forth in Section 5.01 of the Warrant
Purchase Agreement.
“Holdings LLC Agreement” means the Amended and Restated Limited Liability Company
Agreement of Holdings dated as of the Closing Date.
“HSR Filings” means the pre-merger notification and report forms required under the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
9.
“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 Symphony Allegro
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 in which it
appears.
“Indemnified Proceeding” has the meaning set forth in each Operative Document in which
it appears.
“Indemnifying Party” has the meaning set forth in each Operative Document in which it
appears.
“IND-Enabling GLP Inhalation Toxicology Studies” means the pharmacokinetic and
toxicology studies required for filing an IND.
“Initial Development Budget” means the initial development budget prepared by
representatives of Symphony Allegro and Alexza prior to the Closing Date, and attached to the
Amended and Restated Research and Development Agreement as Annex C thereto.
“Initial Development Plan” means the initial development plan prepared by
representatives of Symphony Allegro and Alexza prior to the Closing Date, and attached to the
Amended and Restated Research and Development Agreement as Annex C thereto.
“Initial Holdings LLC Agreement” means the Agreement of Limited Liability Company of
Holdings, dated October 24, 2006.
“Initial Investors LLC Agreement” means the Agreement of Limited Liability Company of
Investors, dated October 24, 2006.
“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 Overview” means the investment overview describing the transactions
entered into pursuant to the Operative Documents.
“Investment Policy” has the meaning set forth in Section 1(a)(vi) of the RRD
Services Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
10.
“Investors” means Symphony Allegro 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.
“Key Personnel” means those Alexza Personnel listed on Schedule 6.5 to the
Amended and Restated Research and Development Agreement, 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.
“Know-How” means findings, discoveries, inventions, know-how, information, results and
data of any type whatsoever, including without limitation, technical information, techniques,
results of experimentation and testing, diagnostic and prognostic assays, specifications,
databases, manufacturing processes or protocols, any and all laboratory, research, pharmacological,
toxicological, analytical, quality control, pre-clinical and clinical data.
“Knowledge” of Alexza, Symphony Allegro or Holdings, as the case may be, means the
actual (and not imputed) knowledge of the executive officers or managing member of such Person
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 on or
after the Closing Date and prior to the unexercised expiration or termination of the Purchase
Option that:
(a) is necessary or useful to practice the inventions claimed in the Licensed Patent Rights;
or
(b) is a Symphony Allegro Enhancement;
provided, however, that Licensed Know-How shall not include any Licensed
Patent Rights or any Know-How for the manufacture of a Product, including Know-How associated with
Product quality control or stability testing.
“Licensed Patent Rights” means any and all patents and patent applications Controlled
by Licensor that:
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
11.
(a) are listed on Annex D of the Novated and Restated Technology License Agreement;
(b) are reissues, continuations, divisionals, continuations-in-part, reexaminations, renewals,
substitutes, extensions or foreign counterparts of the patents and patent applications described in
(a) and (i) are filed prior to the unexercised expiration or termination of the Purchase Option or
(ii) are filed after such expiration or termination, but solely to the extent claiming Know-How
conceived and reduced to practice prior to such expiration or termination;
(c) contain a claim that covers an invention disclosed in an invention disclosure listed on
Annex D of the Novated and Restated Technology License Agreement and (i) are filed prior to
the unexercised expiration or termination of the Purchase Option or (ii) are filed after such
expiration or termination, but solely to the extent claiming such invention;
(d) contain a claim that covers a Symphony Allegro Enhancement and (i) are filed prior to the
unexercised expiration or termination of the Purchase Option or (ii) are filed after such
expiration or termination, but solely to the extent claiming such Symphony Allegro Enhancement; or
(e) contain a claim that covers a Development Product or the manufacture or use thereof and
(i) are filed prior to the unexercised expiration or termination of the Purchase Option or (ii) are
filed after such expiration or termination, but solely to the extent claiming Development
Product-related Know-How conceived and reduced to practice prior to such expiration or termination.
“Licensor” means Alexza.
“Lien” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“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.
“Loxapine” means: (a) loxapine and (b) all salts, metabolites, prodrug and other
physical forms thereof.
“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.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
12.
“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 manager of Symphony Allegro.
“Manager Event” has the meaning set forth in Section 3.01(g) of the Holdings
LLC Agreement.
“Manufacturing Subcontracting Agreement” means a Subcontracting Agreement that is
directly related to the manufacture of Product (including procurement of components and development
of improved manufacturing methods) or the improvement of the Staccato Technology.
“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, (iii) the enforceability of the obligations of such Person of any of the
Operative Documents to which it is a party.
“Material Subsidiary” means, at any time, a Subsidiary of Alexza having assets in an
amount equal to at least 5% of the amount of total consolidated assets of Alexza and its
Subsidiaries (determined as of the last day of the most recent reported fiscal quarter of Alexza)
or revenues or net income in an amount equal to at least 5% of the amount of total consolidated
revenues or net income of Alexza and its Subsidiaries for the 12-month period ending on the last
day of the most recent reported fiscal quarter of Alexza.
“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” means the Nasdaq Stock Market, Inc.
“NDA” means a New Drug Application, as defined in the regulations promulgated by the
United States Food and Drug Administration, or any foreign equivalent thereof.
“Non-Alexza Capital Transaction” means any (i) sale or other disposition of all or
part of the Symphony Allegro Shares or all or substantially all of the operating assets of Symphony
Allegro, to a Person other than Alexza or an Affiliate of Alexza or (ii) distribution in kind of
the Symphony Allegro Shares following the unexercised expiration or termination of the Purchase
Option.
“Novated and Restated Technology License Agreement” means the Novated and Restated
Technology License Agreement, dated as of the Closing Date, among Alexza, Symphony Allegro and
Holdings.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
13.
“Operative Documents” means, collectively, the Indemnification Agreement, the Holdings
LLC Agreement, the Purchase Option Agreement, the Warrant Purchase Agreement, the Registration
Rights Agreement, the Subscription Agreement, the Technology License Agreement, the Novated and
Restated Technology License Agreement, the RRD Services Agreement, the Research and Development
Agreement, the Research Cost Sharing and Extension Agreement, the Amended and Restated Research and
Development Agreement, the Confidentiality Agreement, and each other certificate and agreement
executed in connection with any of the foregoing documents.
“Organizational Documents” means any certificates or articles of incorporation or
formation, partnership agreements, trust instruments, bylaws or other governing documents.
“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 or other agreement in which it
appears, the parties to such 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 an AZ-002 Product and/or an AZ-004 Product.
“Profit” has the meaning set forth in Section 1.01 of the Holdings LLC
Agreement.
“Programs” means the AZ-002 Program and/or the AZ-004 Program.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
14.
“Program-Specific Claim” means any claim in a patent or patent application in the
Licensed Patent Rights that is directed exclusively to AZ-002 Products and/or AZ-004 Products.
“Program-Specific Patents” means any and all Licensed Patent Rights that contain at
least one Program-Specific Claim.
“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.
“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 Alexza, Holdings and Symphony Allegro.
“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 Offset Amount” shall mean, following the termination of the Amended
and Restated Research and Development Agreement by Alexza pursuant to Section 17.3 thereof, those
unpaid amounts actually owed to Alexza as a result of the material breach or default of any payment
obligation of Symphony Allegro to Alexza pursuant to the Amended and Restated Research and
Development Agreement by Symphony Allegro or Holdings that was the basis for such termination of
the Amended and Restated Research and Development Agreement by Alexza.
“Purchase Option Period” has the meaning set forth in Section 1(c)(iii) of the
Purchase Option Agreement.
“Purchase Price” has the meaning set forth in Section 2(b) of the Purchase
Option Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
15.
“QA Audits” has the meaning set forth in Section 6.6 of the Amended and
Restated Research and Development Agreement.
“Quarterly Price” has the meaning set forth in Section 2(b)(i) of the Purchase
Option Agreement.
“Registration Rights Agreement” means the Registration Rights Agreement dated as of
the Closing Date, between Alexza and Holdings.
“Registration Statement” has the meaning set forth in Section 1(b) of the
Registration Rights 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 or any other filings filed with 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 Cost Sharing and Extension Agreement” means the Research Cost Sharing and
Extension Agreement dated as of the Closing Date, among Alexza, Holdings and Symphony Allegro.
“Research and Development Agreement” means the Research and Development Agreement
dated as of the Closing Date, between Alexza 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 Symphony Allegro and
RRD, dated as of the Closing Date.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
16.
“Schedule K-1” has the meaning set forth in Section 9.02(a) of the Holdings
LLC Agreement.
“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.
“SEC” means the United States Securities and Exchange Commission.
“Securities Act” means the Securities Act of 1933, as amended.
“Selling Stockholder Questionnaire” has the meaning set forth in Section 4(a)
of the Registration Rights Agreement.
“Shareholder” means any Person who owns any Symphony Allegro Shares.
“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.
“Staccato Technology” means Alexza’s proprietary technology for the vaporization of a
pharmaceutical composition via rapid-heating to form a condensation aerosol that allows rapid
systemic drug delivery to humans through lung inhalation.
“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.
“Subcontracting Agreement” means (a) any written agreement between Alexza and a third
party pursuant to which the third party performs any Alexza Obligations or (b) any work order,
change order, purchase order or the like entered into pursuant to Section 6.2(b) of the Amended and
Restated Research and Development Agreement.
“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 Symphony Allegro and
Holdings, dated as the Closing Date.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
17.
“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 is surviving entity to
Alexza after giving effect to a Change of Control.
“Symphony Allegro” means Symphony Allegro, Inc., a Delaware corporation.
“Symphony Allegro Auditors” has the meaning set forth in Section 5(b) of the
RRD Services Agreement.
“Symphony Allegro Board” means the board of directors of Symphony Allegro.
“Symphony Allegro By-laws” means the By-laws of Symphony Allegro, as adopted by
resolution of the Symphony Allegro Board on the Closing Date.
“Symphony Allegro Charter” means the Amended and Restated Certificate of Incorporation
of Symphony Allegro, dated as of the Closing Date.
“Symphony Allegro Director Event” has the meaning set forth in Section
3.01(h)(i) of the Holdings LLC Agreement.
“Symphony Allegro Enhancements” means any and all Know-How, whether or not patentable,
that is made by or on behalf of Symphony Allegro during the Term, including Know-How generated or
derived by RRD and assigned to Symphony Allegro pursuant to Section 12 of the RRD Services
Agreement.
“Symphony Allegro Equity Securities” means the Common Stock and any other stock or
shares issued by Symphony Allegro.
“Symphony Allegro Loss” has the meaning set forth in Section 10(b) of the RRD
Services Agreement.
“Symphony Allegro Shares” has the meaning set forth in Section 2.02 of the
Holdings LLC Agreement.
“Symphony Capital” means Symphony Capital LLC, a Delaware limited liability company.
“Symphony Fund(s)” means Symphony Capital Partners, L.P., a Delaware limited
partnership, and Symphony Strategic Partners, LLC, a Delaware limited liability company.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
18.
“Tangible Materials” means any tangible technical, medical, regulatory or marketing
documentation, whether written or electronic, existing as of the Closing Date or made by or on
behalf of Symphony Allegro during the Term, that (a) is Controlled by the Licensor and (b) embodies
or relates solely to the Regulatory Files (other than Drug Master Files), Exiting Products or the
Programs; provided, however, that Tangible Materials shall not include any manufacturing-related
documentation or any documentation related to Licensed Intellectual Property.
“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 Alexza and Holdings.
“Term” has the meaning set forth in Section 4(b)(iii) of the Purchase Option
Agreement, unless otherwise stated in any 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 Licensor” means a third party from which Alexza has received a license or
sublicense to Licensed Intellectual Property.
“Transaction Event” has the meaning set forth in Section 6.05 of the Warrant
Purchase Agreement.
“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.
“Voluntary Bankruptcy” has the meaning set forth in Section 1.01 of the
Holdings LLC Agreement.
“Warrant Closing” has the meaning set forth in Section 2.03 of the Warrant
Purchase Agreement.
“Warrant Date” has the meaning set forth in Section 2.02 of the Warrant
Purchase Agreement.
“Warrant Purchase Agreement” means the Warrant Purchase Agreement, dated as of the
Closing Date, between Alexza and Holdings.
“Warrant Shares” has the meaning set forth in Section 2.01 of the Warrant
Purchase Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
19.
“Warrant Surrender Price” has the meaning set forth in Section 7.08 of the
Warrant Purchase Agreement.
“Warrants” has the meaning set forth in Section 2.01 of the Warrant Purchase
Agreement.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
20.
ANNEX B
SYMPHONY ALLEGRO, INC.
DEVELOPMENT COMMITTEE CHARTER
Purpose
The Development Committee (the “Development Committee”) is established by Symphony Allegro,
Inc. (“Symphony Allegro”) to oversee a clinical development plan (the “Development Plan”) and a
development budget (the “Development Budget”) for the Programs (each as defined in that certain
Novated and Restated Technology License Agreement (“TLA”), dated as of December 1, 2006, among
Symphony Allegro, Alexza Pharmaceuticals, Inc. (“Alexza”) and Symphony Allegro Holdings LLC
(“Holdings”, and together with Alexza, the “Parties” and each a “Party”), and to develop and
commercialize the AZ-002 Product and the AZ-004 Product (each as defined in the TLA). Capitalized
terms used herein and not defined herein shall have the meanings assigned to such terms in Annex A
to the Amended and Restated Research and Development Agreement, dated as of December 1, 2006, among
Symphony Allegro, Holdings and Alexza.
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 Alexza.
2. One-half (1/2) of the Development Committee Members shall be designated by Alexza and
one-half (1/2) shall be designated by Holdings.
3. Each Development Committee Member shall have the requisite background, experience and
training to carry out the duties and obligations of the Development Committee. Development
Committee Members need not be directors of Symphony Allegro, Holdings or Alexza.
4. The chair of the Development Committee shall be, initially, Xxxxx X. Xxxxxxxx, Ph.D., the
Senior Vice President, Research and Development, of Alexza, and any succeeding chair shall be such
person as may be appointed to the position of Senior Vice President, Research and Development, of
Alexza (or an equivalent successor position) (the “Chair”). If Alexza wishes to appoint a Chair
other than the then-current Senior Vice President, Research and Development, of Alexza (or the
holder of an equivalent successor position), then such appointment shall require the consent of the
Symphony Allegro Board; provided, that (x) if the
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex B-1
Symphony Allegro Board shall have less than five (5) members, the unanimous consent of all the
members of the Symphony Allegro Board shall be required, or (y) if the Symphony Allegro Board shall
have five (5) members, an affirmative vote of at least three-fifths (3/5ths) of the members of the
Symphony Allegro Board shall be required.
5. By written notice to Alexza, Holdings may remove or replace one or more Development
Committee Members designated by Holdings. By written notice to Holdings, Alexza may remove or
replace one or more Development Committee Members designated by Alexza.
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. Each of Holdings and Alexza shall be solely responsible for the costs associated with
its employees and/or representatives attending and participating in such Scheduled Meetings. In
addition, any two (2) Development Committee Members may jointly 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 [ * ]
(each, an “Ad Hoc Meeting”). An Ad Hoc Meeting may be called to address any time-sensitive matter,
including additional expenditure requests pursuant to Section 8.3 of the Amended and Restated
Research and Development Agreement or Section 2 of the RRD Services Agreement.
7. The Chair shall, in consultation with other Development Committee Members and the
management of Symphony Allegro, 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 [ * ] 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 [ * ] 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 Alexza and Holdings participating in such Scheduled Meeting
or Ad Hoc Meeting, as the case may be. Each Party may allocate its three (3) votes among its
attending Development Committee Members in any manner, at such Party’s discretion. If only one (1)
Development Committee Member is attending on behalf of a given Party, such Development Committee
Member may cast all the votes allocated to such Party. Unless otherwise specified herein, all
actions taken by the Development Committee as a committee shall be by majority vote. If the
Development Committee Members reach a deadlock
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex B-2
on any vote, then such deadlock shall be resolved in accordance with Paragraph 11 of this
Development Committee Charter.
9. Notwithstanding anything herein to the contrary, during the Term, this Development
Committee Charter may be amended only with the unanimous approval of the Development Committee
Members and the consent of the Symphony Allegro Board, Holdings and Alexza.
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 officer) of Alexza and the chairman of the
Symphony Allegro Board. The chief executive officer and chairman shall have [ * ] to mutually
agree on how to resolve such issue. If such parties are unable to resolve such issue within the [
* ] period, then such issue shall be brought to the Symphony Allegro Board, and the Symphony
Allegro Board shall promptly resolve such issue, which resolution shall be binding on Holdings and
Alexza.
Authority and Duties
12. The Development Committee shall, using the Initial Development Plan and the Initial
Development Budget as a basis, continue to develop and refine the Development Plan and Development
Budget, and shall, at the request of the Symphony Allegro Board, submit each to the Symphony
Allegro Board at the first meeting of the Symphony Allegro Board, as provided in Section 4.1 of the
Amended and Restated Research and Development Agreement. Following the Symphony Allegro Board’s
review, the Development Committee shall work diligently to incorporate the comments generated by
such review in order to update the Development Plan and Development Budget as soon as practicable
and shall then submit the updated Development Plan and Development Budget to the Symphony Allegro
Board for review. The Development Committee shall thereafter continue to develop and refine the
Development Plan and the Development Budget as needed, and shall conduct a comprehensive review of
each on a semi-annual basis. In addition, the Development Committee shall decide on any other
matters relating to the Development Plan and the Development Budget that may arise, including (i)
responding to requests from RRD or Alexza for amendments to the Development Plan and/or the
Development Budget, and (ii) addressing all other matters that are identified in the Operative
Documents or the Symphony Allegro Charter as requiring the approval of the Development Committee
(including, but not limited to, the approval of any new, or the amendment or termination of any
existing, Development Subcontracting Agreement). Unless otherwise approved pursuant to Paragraph
11 hereof, or discontinued or modified pursuant to Sections 4.2(c) or 5.1 of the Amended and
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex B-3
Restated Research and Development Agreement, no material change to the Development Plan or
Development Budget will be adopted by Symphony Allegro unless and until the Development Committee
approves such change.
13. The Development Committee shall report at least quarterly to the Symphony Allegro Board
regarding progress relative to the Development Plan and the Development Budget, and any changes in
the Development Plan and/or Development Budget, and shall respond promptly to any reasonable
requests for additional information made by the Symphony Allegro Board. The Development Committee
shall also submit its material decisions regarding the Development Plan and Development Budget to
the Symphony Allegro Board, including regulatory strategies and discontinuation or modification of
the Programs.
14. The Development Committee shall continuously evaluate the funding requirements of the
Programs, and may, in the event of a shortfall in the funds allocated to one or more Programs, and
subject to the approval of the Symphony Allegro Board, reallocate funds within the Development
Budget to compensate for such shortfall.
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 Alexza.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex B-4
ANNEX C
INITIAL DEVELOPMENT PLAN AND INITIAL DEVELOPMENT BUDGET
{See attached.}
[ * ]
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex C-1
ANNEX D
{Intentionally Omitted}
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex D-1
ANNEX E
PAYMENT TERMS
1. With respect to the development activities and services provided by Alexza pursuant to this
Agreement, and in accordance with the terms of this Agreement, the Development Plan and the
Development Budget, Alexza will invoice Symphony Allegro, and Symphony Allegro will pay Alexza, as
follows:
(a) fees for any development activities or services for which xxxxxxxx and/or payment
provisions are specified within other sections of this Agreement shall be billed and paid in
accordance with such sections of this Agreement,
(b) an annual fee of [ * ], paid in equal monthly installments, for activities and services to
be provided by Alexza Key Personnel in connection with preparation for, and attendance at,
Development Committee meetings, and other activities associated with the oversight and management
of the development activities by Alexza pursuant to this Agreement; provided however, that there
shall be no FTE allocation or reimbursement with respect to activities and services provided by
such Alexza Key Personnel, and
(c) fees for any other development activities and services by non-senior management Alexza
personnel and out-of-pocket fees, associated personnel costs, expenses and pass-through costs
actually incurred by Alexza or Alexza personnel in performing the development activities and
services pursuant to this Agreement, which fees, personnel costs, 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 Alexza to Symphony Allegro following
the end of the month in which such development activities and services were performed or such
out-of-pocket fees, personnel costs, expenses or pass-through costs incurred, and shall be paid by
Symphony Allegro within [ * ] of receipt of a valid invoice from Alexza, and
(d) fees for any manufacturing-related activities shall be:
(i) for Clinical Trial Material and devices produced in Design Verification Testing (DVT), [ *
]; and
(ii) for all other devices (including DVT and DCT production runs), direct cost of all
components plus FTE costs associated with such manufacture, quality testing, etc.
2. Alexza’s monthly invoices must include receipts, third party invoices or
other reasonable documentation for all fees, personnel costs, expenses and pass-through costs of
Alexza and Alexza personnel. Personnel costs in item 1(c) shall be reimbursed at an annual fully
burdened FTE rate of [ * ]. Alexza’s invoices not in accordance with the requirements of this
section may incur delays in payment. Alexza shall not charge any administrative fees to
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex E-1
Symphony Allegro in connection with any fees, personnel costs (other than as set forth in item
1(b) of this Annex E), expenses or pass-through costs.
3. All fees, personnel costs, expenses and pass-through costs will be payable in US Dollars.
If Symphony Allegro disputes in good faith any portion of an invoice, then Symphony Allegro 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.
4. Alexza will transmit invoices to Symphony Allegro at the following address:
Symphony Allegro, Inc.
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Accounts Payable
0000 Xxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attn: Accounts Payable
5. All payments to Alexza shall be sent to Alexza, as follows:
If mailed:
|
Alexza Pharmaceuticals, Inc. | |
0000 Xxxx Xxxxxx Xxxxxx | ||
Xxxx Xxxx, XX 00000 | ||
Attn: Accounts Receivable |
If wired:
|
Name of bank: | [ * ] | ||
Bank number: | [ * ] | |||
Routing number: | [ * ] | |||
Alexza account number: | [ * ] | |||
Bank address: | [ * ] | |||
[ * ] | ||||
[ * ] | ||||
[ * ] |
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
Annex E-2
SCHEDULE 6.2
SUBCONTRACTING AGREEMENTS
1. [ * ]
Development Agreement between Alexza and Autoliv ASP, Inc. dated October 3, 2005.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
SCHEDULE 6.5
ALEXZA KEY PERSONNEL
[ * ]
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
SCHEDULE 12.1(f)
MATERIAL DISCLOSED CONTRACTS
Development Agreement between Alexza and Autoliv ASP, Inc. dated October 3, 2005.
[ * ] = | Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |