EXHIBIT 10.20
MASTER AGREEMENT FOR SERVICES
This Master Services Agreement ("Master Agreement") is made this 10th day of May
2004 ("Effective Date") by and between Synteract, Inc., a California corporation
with offices at 0000 Xxxxx Xx, Xxxxx 000, Xxxxxxxx, XX 00000 ("Synteract"), and
Somaxon Pharmaceuticals, with offices at 00000 Xxxx Xxxxx Xxxxx, Xxxxx 000, Xxx
Xxxxx, XX 00000 ("Client").
WHEREAS, Client would like to retain the services of Synteract from time to time
to conduct certain services ("Services"), as more fully set forth in various
specific project agreements to be attached to this Master Agreement and
incorporated herein by reference (each individually a "Project Agreement"); and
WHEREAS, Synteract is engaged in the business of providing such services and
would like to provide the services to Client on the terms and conditions
contained in this Master Agreement and in each Project Agreement.
NOW, THEREFORE, for good and valuable consideration, and intending to be legally
bound, the parties agree as follows:
1. PROJECT AGREEMENTS
In the event that the parties hereto shall reach agreement with respect to
particular Services (as hereinafter defined in Section 2.1), a Project
Agreement for said Services shall be attached to this Master Agreement and
the two shall collectively, independent from other Project Agreements,
constitute the entire agreement for the specific Services. No Project
Agreement shall be attached to this Master Agreement without first being
executed by the parties hereto. To the extent any terms set forth in a
Project Agreement or any other agreement to which both Synteract and
Somaxon are parties shall conflict with the terms set forth in this Master
Agreement, the terms of this Master Agreement shall control unless
specifically set forth otherwise in the Project Agreement or other
agreements to which both Synteract and Somaxon are parties.
2. SERVICES
2.1 Synteract hereby agrees to provide to Client the services described in the
"services" section of each Project Agreement attached to this Master
Agreement. Each Project Agreement shall define certain terms and
conditions, including, but not limited to, the scope and nature of the
Services requested and the start and completion date of the services, all
fees and pass through expenses for the Services and description of how
such amounts are determined and when they are payable, and a transfer of
regulatory obligations from Client to Synteract under the Federal Food,
Drug and Cosmetic Act and its regulations. The personnel provided by
Synteract, whether employees or independent
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contractors that are assigned to the Client to perform the services
subject to a Project Agreement shall be referred to, hereinafter, as the
"Consultant."
2.2 Consultant shall complete the Services in accordance with the requirements
of this Master Agreement, the applicable Project Agreement, Client's
formats and specifications, the standards and practices that are generally
accepted in the industry and exercised by other persons engaged in
performing similar services, and all applicable local, state and federal
laws, rules, regulations and guidances, including, but not limited to, the
U.S. Food and Drug Administration's Good Clinical Practice ("GCP")
regulations.
2.3 The Client shall provide, at no charge, Consultant with all of the
materials identified in the applicable Project Agreement that are
necessary to complete the Services. Consultant shall use such materials
only in strict accordance with the applicable Project Agreement and for no
other purpose without the prior written consent of Client. The Client
shall act in good faith to provide reasonable reviews of Consultants' work
in accordance with the Project Agreement as agreed to by both parties.
3. COMPENSATION AND PAYMENT
Synteract's compensation and payment for the Services provided hereunder
shall be set forth in the applicable Project Agreement. All invoices will
be submitted in accordance with the payment schedule in the applicable
Project Agreement. In the event that Synteract or Consultant is requested
or required to perform services beyond that which are specifically set
forth in a Project Agreement, any such additional services and a
compensation schedule thereto must be mutually agreed upon by the parties
in writing prior to the provision of said services. Said mutually agreed
upon writing shall be an amendment to the pertinent Project Agreement and
the services set forth therein shall be deemed to be Services as the term
is used in this Agreement. Synteract shall invoice the Client on a monthly
basis for the incremental Services provided. Unless subject to a valid
dispute, payments are due within thirty (30) days of the date of invoice.
Interest on unpaid invoices will be charged at the rate of 1% per month on
invoices which remain unpaid after thirty (30) days from receipt by
Client.
4. TERMS AND TERMINATION
4.1 This Master Agreement will commence on the Effective Date and will remain
effective until terminated under this Section 4. Each Project Agreement
will commence on the date of the Project Agreement's complete execution by
the parties and, unless terminated earlier under this Section 4, each
Project Agreement will terminate upon either the termination of this
Master Agreement or the completion of Services required under such Project
Agreement. Termination of the Master Agreement under this Section 4 shall
result in the automatic and concurrent termination of all Project
Agreements.
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4.2 Client and Synteract, by mutual written agreement, may terminate this
Master Agreement or any Project Agreement at any time.
4.3 Client may terminate this Master Agreement or any Project Agreement at any
time upon thirty (30) days prior written notice for good cause. Good cause
shall include, without limitation: (i) unsatisfactory completion of the
Services by Synteract or Consultant; (ii) non-compliance with any
applicable local, state or federal law, rule or regulation; or (iii) any
material breach by Synteract of any of its obligations under this Master
Agreement or any Project Agreement.
4.4 Synteract may terminate this Master Agreement or any Project Agreement at
any time upon thirty (30) days prior written notice for good cause. Good
cause shall include, without limitation, any material breach by Client of
any of its obligations under this Master Agreement or any Project
Agreement.
4.5 If Client terminates this Master Agreement and/or any Project Agreement,
Client shall reimburse Synteract for Synteract's actual costs for all
Services performed through the effective termination date and all
uncancellable obligations as of such date, provided that such costs and
uncancellable obligations are in accordance with the Master Agreement and
all applicable Project Agreements and Synteract provides Client with an
accounting of any such costs and uncancellable obligations in writing
within thirty (30) days of termination.
4.6 In the event of the termination of this Master Agreement or any Project
Agreement, Synteract will promptly provide to the Client all original
records and reports related to all terminated projects, and shall promptly
surrender and deliver to Client all documents and materials of any nature
provided to Synteract or Consultant by Client and any other documents or
materials of any nature from any source pertaining to or arising out of
Synteract's performance of the Services. Upon such termination, and in
full compliance with this Master Agreement, all applicable Project
Agreements, and all applicable local, state and federal laws, rules,
regulations and guidances, Synteract shall complete all activities, and
provide reasonable assistance as may be requested by the Client, necessary
for the orderly and timely close of the Services rendered up to the date
of such termination.
5. INDEPENDENT CONTRACTOR RELATIONSHIP
Synteract is an independent contractor of Client and nothing contained in
this Master Agreement shall be construed to place the parties hereto in
the relationship of partners, principal and agent, employer/employee or
joint venturer. Both parties agree that neither shall have power or right
to bind or obligate the other, nor shall either hold itself out as having
such authority.
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6. PERSONNEL
Synteract shall be obligated at all times to provide a sufficient number
of trained personnel to meet the requirements of the Services. During the
term of this Agreement, Synteract may contract for work with competitors
of the Client or other groups, and Consultant may be assigned to other
projects for other customers of Synteract, however, Synteract affirms that
they do not have and shall not enter into any agreement, which would
restrict its ability to fulfill this Agreement. Synteract agrees that in
fulfilling contracts with others, it shall not use or disclose any
confidential or proprietary information as set forth in Section 8 of this
Agreement and, in assigning its employees and agents to perform under this
Agreement, Synteract will establish appropriate internal controls to
prevent such disclosure, including reasonably limiting those employees or
agents that possess confidential or proprietary information under Section
8 from work with competitors of Client.
7. EMPLOYMENT
During the term of this Agreement and for six (6) months after the
termination of this Agreement, the Client agrees that it will not solicit
to hire or retain as an independent contractor any employees of Synteract
without the prior written consent of Synteract, and Synteract agrees that
it will not solicit to hire or retain as an independent contractor any
employees of the Client without the prior written consent of Client.
8. CONFIDENTIALITY
8.1 During the course of a Project Agreement, it may be necessary for Client
to disclose confidential information ("Confidential Information") of
Client to Synteract. Confidential Information" shall refer to all
commercial, scientific, medical and technical information and data
relating to Client or a Project Agreement. Confidential Information shall
not refer to information that:
(a) is now in the public domain or subsequently enters the public domain
through no fault of Synteract;
(b) does not consist of computer programming or statistical methods of
analysis developed by Consultant in completing the Services;
(c) Synteract receives from any third party not under any obligation to
the Client to keep such information confidential; or
(d) is required to be disclosed by law, provided that Synteract shall
give Client prior notice of any such intended disclosure and shall
cooperate with any attempt by Client to seek a mutually satisfactory
way to disclose such Confidential
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Information as necessary for this limited purpose and with all
protections of confidentiality permitted by law.
8.2 Synteract agrees to keep in strict confidence all Confidential Information
and to disclose said Confidential Information to the Consultant and its
other employees on a strict need to know basis only, and to its
independent contractors, vendors and agents under a confidentiality
agreement. Synteract agrees that the Confidential Information shall be
used for the purpose of providing the Services for Client and for no other
purpose without the prior written consent of Client.
8.3. The terms in this Section 8 shall continue in full force and effect for a
period of five (5) years from the termination or expiration of this Master
Agreement.
9. OWNERSHIP
9.1 All of (i) Client's Confidential Information (including, without
limitation, all original records and reports related to a project) and
(ii) unused materials provided by Client pursuant to a Project Agreement
shall be the exclusive property of the Client. All information generated
by Synteract under this Master Agreement shall be delivered to the Client
at the termination or expiration this Master Agreement, provided, however,
that Synteract may retain one copy of Client's Confidential Information in
its files for archival purposes, as a means of determining any continuing
obligations under this Master Agreement (including the Project
Agreements).
9.2 All inventions, improvements in know-how, new uses, processes and
compounds involving the Services under this Master Agreement and/or the
Project Agreements that are conceived or reduced to practice as a direct
result of a project ("Inventions") shall be and remain the sole property
of Client. Synteract shall cooperate fully with Client in obtaining, at
Client's sole cost and expense, any patent protection as may be available
for the Inventions, and shall execute all documents reasonably deemed
necessary by Client for purposes of procuring such patent protection.
Synteract agrees that it shall endeavor to ensure contractually the prompt
disclosure to Client by the Consultant or any other employee or other
individual retained by Synteract for a Project of any Inventions, as well
as the cooperation of such persons in securing patent protection as set
forth herein.
9.3 Notwithstanding the foregoing, Client acknowledges that Synteract and its
professional staff currently possess certain inventions, processes,
know-how, trade secrets, methods, approaches, analyses, improvements,
other intellectual properties and other assets including, but not limited
to, clinical trial management analyses, analytical methods, procedures and
techniques, computer technical expertise and proprietary software, and
technical and conceptual expertise in the area of conducting clinical
trials, all of which have been developed independently by Synteract
without the benefit of any information provided by Client (collectively,
"Synteract Property"). Client agrees that any Synteract
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Property which is used, improved, modified or developed by Synteract under
or during the term of this Master Agreement shall be and remain the sole
and exclusive property of Synteract.
10. ANNOUNCEMENTS
Synteract shall not make any announcement, oral presentation or
publication relating to any Confidential Information or Services provided
under any Project Agreement without Client's prior written consent (which
consent shall not be unreasonably withheld), except as required by law or
by court or administrative order. Neither party shall employ or use the
name of the other party in any publication or promotional material or in
any form for public distribution, without the prior written consent of the
other party, except as required by law or by court or administrative
order.
11. GOVERNMENT INSPECTION
In the event that Synteract receives a notice of inspection or audit from
the FDA or any comparable federal or state regulatory authority which
relates to the Services provided under any Project Agreement, Synteract
shall notify Client promptly of such notice, keep Client informed of the
progress of the inspection or audit, and provide to Client a copy of any
documents produced to the FDA or such other authority pursuant to the
notice.
12. ACCESS TO FACILITIES
Client's authorized representatives may visit Synteract's site and
facilities at reasonable times and with reasonable frequency during normal
business hours and upon reasonable advance written notice, to observe the
progress of any Services. All such visits shall be subject to Synteract's
restrictions and procedures relating to safety, security and protection of
Confidential Information.
13. INDEMNIFICATION
13.1 Client agrees to indemnify, defend and hold harmless Synteract, its
affiliated entities, officers, directors and employees, and the Consultant
(each, a "Synteract Party") from and against any and all claims, demands,
cost or judgments (each, a "Claim") for any and all liabilities, losses,
damages, penalties, costs or expenses (including but not limited to court
costs, legal fees, awards or settlements) arising out of, in connection
with or related to the Services performed by Synteract under and pursuant
to this Master Agreement and the applicable Project Agreement; provided,
however, that Client's indemnity obligations under this Section 13 shall
not apply to any Claim to the extent arising directly from a negligent,
reckless or willful act or omission of a Synteract Party, a breach by a
Synteract Party of any applicable local, state or federal law, rule,
regulation or guidance, or a breach of the terms of this Master Agreement
or the applicable Project Agreement by a Synteract Party.
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13.2 Synteract agrees to indemnify, defend and hold harmless Client, its
affiliated entities, officers, directors and employees from and against
Claims for any and all liabilities, losses, damages, penalties, costs or
expenses (including but not limited to court costs, legal fees, awards or
settlements) arising out of, in connection with or related to the Services
performed by Synteract under and pursuant to this Master Agreement and the
applicable Project Agreement to the extent arising from a negligent,
reckless or willful act or omission of a Synteract Party, a breach by a
Synteract Party of any applicable local, state or federal law, rule,
regulation or guidance; or a breach of the terms of this Master Agreement
or the applicable Project Agreement by a Synteract Party.
13.3 Each person or entity seeking indemnification under this Section 13 shall,
as a condition thereto, notify the indemnifying party within ten (10) days
after the receipt of notice of the Claim; provided, however, that the
indemnifying party shall not be released from its obligations under this
Section 13 if the failure to notify the indemnifying party within ten (10)
days does not materially prejudice the defense of such Claim. The
indemnifying party shall have the right to select defense counsel and to
direct the defense or, with the consent of the indemnified party (which
consent shall not be unreasonably withheld), settlement of any Claim.
14. ENTIRE AGREEMENT
This Master Agreement, together with all Project Agreements, constitutes
the entire agreement between Client and Synteract with respect to the
subject matter hereof, and replaces and supersedes any and all prior and
contemporaneous agreements and/or understandings, whether oral or written,
between Client and Synteract with respect to the subject matter hereof.
This Master Agreement (including the Project Agreements) may be amended or
modified only by a written instrument executed by a duly authorized
officer of each party.
15. ASSIGNMENT
Neither Client nor Synteract may assign this Master Agreement or any
rights hereunder or delegate the performance of any duties hereunder
without the prior written approval of the other party, which approval
shall not be unreasonably delayed or withheld; provided, however, that
without such consent, either party may assign this Master Agreement in
connection with the transfer or sale of all or substantially all of its
assets, stock or business, or its merger, consolidation or combination
with or into another entity, and provided that, without the written
consent of Client, Synteract may assign the right to payments due to
Synteract under this Master Agreement or applicable Project Agreement to
financial institutions or other lenders of Synteract. Subject to the
foregoing, this Master Agreement shall be binding upon, inure to the
benefit of and be enforceable by the parties and their respective
successors and permitted assigns.
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16. NON-DEBARMENT
16.1 Synteract represents and warrants that Synteract has never been and is not
currently:
(a) an individual who has been debarred by the FDA pursuant to 21 U.S.C.
Section335a (a) or (b) (a "Debarred Individual") from providing
services in any capacity to a person that has an approved or pending
drug product application, or an employer, employee or partner of a
Debarred Individual; or
(b) a corporation, partnership, or association that has been debarred by
the FDA pursuant to 21 U.S.C. Section335a (a) or (b) (a "Debarred
Entity") from submitting or assisting in the submission of a drug
product application, or an employee, partner, shareholder, member,
subsidiary or affiliate of a Debarred Entity.
16.2 Synteract further represents and warrants that Synteract has no knowledge
of any circumstances which may affect the accuracy of the representations
and warranties set forth in Section 16.1 including, but not limited to,
FDA investigations of, or debarment proceedings against, Synteract or any
person or entity performing, or rendering assistance related to, the
Services. Synteract will notify Client promptly upon becoming aware of any
such circumstances during the term of this Master Agreement.
17. INSURANCE
Synteract shall carry insurance including, but not limited to, workers'
compensation and comprehensive general liability insurance, sufficient to
cover its interest or liabilities hereunder, but in no event less than
$1,000,000 per occurrence and $2,000,000 annual aggregate, with a
reputable and financially secure insurance carrier.
18. FORCE MAJEURE
If either party's performance of this Master Agreement or any Project
Agreement is prevented, restricted or delayed (either totally or in part)
by reason of any cause beyond the reasonable control of the parties, such
as acts of God, explosion, disease, weather, war, insurrection, civil
strike, riot or power failure, the party so affected shall, upon giving
prompt notice thereof to the other party, be excused from such performance
to the extent of such prevention, restriction or delay; provided, that the
affected party shall use its commercially reasonable efforts to avoid or
remove such causes of non-performance and shall continue performance with
the utmost dispatch whenever such causes are removed; and provided
further, that nothing herein shall relieve either party from the
obligation to pay promptly in full all payments that may be due to the
other party under this Master Agreement or the Project Agreements.
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19. NO CONFLICT
Each party represents and warrants that it is authorized to enter into
this Master Agreement and that the terms hereof are not inconsistent with
or a violation of any corporate policy, contractual or other legal
obligation to which it is subject.
20. SURVIVAL
Any terms of this Master Agreement, which by their nature extend beyond
its performance, expiration or termination (including, without limitation,
Sections 3, 4, 7, 8, 9, 10, 13, 14, 17, 20, 21, 22 and 23) shall remain in
effect indefinitely until fulfilled in accordance with their terms.
21. CONSTRUCTION OF AGREEMENT
The descriptive headings of the Sections of this Master Agreement are for
convenience only and shall not affect the meaning or construction of any
of the provisions of this Master Agreement. The failure of either party to
enforce any provision of this Master Agreement (including the Project
Agreements) shall not be construed as a waiver or limitation of that
party's subsequent rights to enforce and compel strict compliance with
every provision of this Master Agreement. To the extent any provision of
this Master Agreement or the application thereof is found by a proper
authority to be invalid or unenforceable, it shall be considered deleted
herefrom, and the remainder of this Master Agreement shall continue in
full force and effect. This Master Agreement shall be governed by and
construed in accordance with the laws of the State of California without
regard to provisions of conflicts of law.
22. ARBITRATION
The parties shall attempt, in good faith, to resolve through negotiations
any controversy, claim, or dispute arising out of this Master Agreement,
including, but not limited to, the alleged non-payment of any sum owing to
Synteract. In the event that negotiations are not successful, the
controversy, claim, or dispute shall be submitted to third party mediation
upon terms reasonably acceptable to the parties. If such claim,
controversy or dispute is not resolved through mediation, upon written
demand of either party, the claim, controversy or dispute shall be
submitted to arbitration before three (3) arbitrators. Such arbitration
shall take place in San Diego, California and shall proceed in accordance
with the Commercial Arbitration Rules of the American Arbitration
Association and the laws of the State of California. The decision shall be
enforceable by a court of law, provided that the decision is supported by
substantial fact and is without material error of law. All
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costs of such arbitration, except expert fees and attorneys' fees, shall
be shared equally by the parties. The parties agree that, any provision of
applicable law notwithstanding, they will not request, and the arbitrators
shall have no authority to award, special, indirect, consequential,
incidental, punitive or exemplary damages of any type or kind (including,
without limitation, lost profits) against any party.
23. NOTICES
Any notices, requests or other communications given under this Master
Agreement or a Project Agreement shall be in writing and shall be given by
personal delivery, or sent by (a) facsimile transmission (with message
confirmed during normal business hours); (b) first class mail, postage
prepaid; or (c) Federal Express (or equivalent nationally recognized
overnight delivery service), delivery charges prepaid. All notices shall
be given to a party at its respective address set forth below, or at such
other address as such party from time to time may specify by notice in
accordance with this Section 23. A notice shall be deemed given when
actually received; provided, that if any facsimile notice is received
after 5:00 P.M. local time at the place of receipt, it shall be deemed to
have been given as of the next following business day.
If to Client: Somaxon Pharmaceuticals
00000 Xxxx Xxxxx Xxxxx
Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: Xxxxx Xxxx
Fax: 000.000.0000
If to Synteract: Synteract, Inc.
0000 Xxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000
Attn: Xxxxx Xxxxxx
Fax: 000.000.0000
24. COUNTERPARTS
This Master Agreement may be executed in counterparts, each of which, when
executed and delivered, shall be deemed to be an original, and all of
which, when joined, shall together constitute one and the same agreement.
Any photocopy or facsimile of this Master Agreement, or of any
counterpart, shall be deemed the equivalent of the original.
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IN WITNESS WHEREOF, the parties have caused this Master Agreement to be executed
by duly authorized representatives as of the date first above written.
SYNTERACT, INC. SOMAXON PHARMACEUTICALS
By: /s/ Xxxxx Xxxxxx By: /s/ Xxx X. XxXxxxxx
------------------------ ------------------------
Title: President Title: VP Finance
Date: May 10, 2004 Date: May 12, 2004
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