Exhibit 10.3
MASTER
CLINICAL DEVELOPMENT AGREEMENT
between
AVANIR PHARMACEUTICALS
San Diego, CA 92121
and
SCIREX CORPORATION
Horsham, PA 19044
MASTER CLINICAL DEVELOPMENT AGREEMENT
THIS AGREEMENT, made as of the date last signed below is by and between
Avanir Pharmaceuticals, a company having its principal place of business at
11388 Sorrento Valley Road, Suite 200, San Diego, CA 92121 ("Avanir"), and
SCIREX Corporation a corporation of the State of Delaware having its principal
place of business at 755 Business Center Drive, Horsham, PA 19044 ("SCIREX").
WITNESSETH:
WHEREAS, Avanir is engaged in the development, manufacture, distribution
and sale of pharmaceutical products and it currently considers from time to time
the evaluation of new drug(s) ("Drug" or "Drugs" as the context requires); and
WHEREAS, SCIREX is in the business of providing services for the
development of experimental new drugs and marketed drugs; and
WHEREAS, Avanir desires to contract with SCIREX from time to time, and
SCIREX desires to be contracted by Avanir, for the purposes of providing such
services to assist Avanir in the execution of clinical development projects
("Project" or "Projects" as the context requires) relating to Drugs as outlined
in the project-specific exhibits to this Agreement ("Exhibit" or "Exhibits" as
the context requires).
NOW, THEREFORE, the parties hereby agree as follows:
1. OBLIGATIONS OF SCIREX
SCIREX hereby agrees to conduct the Projects in accordance with Avanir's
instructions. The details, specifications and obligations of each Project will
be included as an Exhibit. SCIREX will conduct the Projects in accordance with
agreed upon protocols and as outlined in the Exhibits. Projects will be
conducted in accordance with all applicable federal, state and local laws,
statutes, ordinances and regulations.
2. TRANSFER OF RESPONSIBILITIES
For compliance under 21 CFR 312.52, Avanir must identify all
responsibilities which will be transferred to SCIREX. Each Exhibit will contain
a detailed description of transferred obligations. Avanir agrees that the same
description and extent of obligations transferred should be included in form
FDA-1571, Section #13 relating to the specific Drugs under investigation. SCIREX
agrees to carry out diligently all transferred obligations.
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3. CLINICAL SUPPLIES
Unless otherwise specified in an Exhibit, Avanir will supply the clinical
investigators with the Drugs and other clinical drug supplies as are agreed upon
by SCIREX and Avanir for the timely completion of the Projects, and will direct
the shipment of any such supplies to the location indicated by SCIREX, within a
reasonable time after receipt of notification from SCIREX of the need for any
such clinical supplies.
4. STATUS REPORTING
SCIREX will provide status reports on the Projects as agreed to in each
specific Exhibit. The status reports will include, but not be limited to, data
regarding the number of patients entering the Projects, as well as data
regarding the number of patients that either drop out of the Projects or
complete the Projects. Reports of monitoring visits will also be provided on a
timely basis as specified in the Exhibits.
5. CONFIDENTIAL INFORMATION
All information received by SCIREX concerning the implementation of the
Projects is considered to be confidential information to Avanir ("Avanir
Confidential Information"). Avanir Confidential Information will be held in
confidence by SCIREX and not disclosed to third parties; provided however, that
Avanir Confidential Information shall not include, and the obligations of
confidentiality and non-disclosure shall not apply to, disclosed information
that:
A. is or becomes publicly available through no fault of SCIREX;
B. is disclosed to SCIREX by a third party entitled to disclose such
information;
C. is already known to SCIREX as shown by its prior written records; or
D. is required by law to be disclosed.
SCIREX will only use the Avanir Confidential Information for the purpose of
its obligations under this Agreement. Upon the completion or earlier termination
of this Agreement, SCIREX will promptly return to Avanir all written Avanir
Confidential Information, as well as all written material which incorporates any
Avanir Confidential Information, other than such information that is required by
government regulations to be retained by it. Notwithstanding the foregoing,
SCIREX shall have the right to retain one copy of Avanir Confidential
Information for the purposes of demonstrating compliance with GCPs, SOPS, Avanir
written instructions, and all federal, state and local laws and regulations.
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SCIREX will not disclose, without the prior written consent of Avanir, any
Avanir Confidential Information to any third party other than employees who have
a need to know such information, hospital authorities, institutional review
board members, clinical investigators, and others who must be involved the
Projects.
SCIREX will not use any Avanir Confidential Information for its own benefit
or for the benefit of any third party, and will not furnish to any third party
any materials which incorporate any confidential information except as otherwise
provided for herein. All obligations of confidentiality and non-disclosure set
forth in this Agreement will survive, without limitation, the expiration or
earlier termination, for any reason, of this Agreement.
During the term of this Agreement and thereafter (including following any
termination), Avanir, for itself and its employees, agents and independent
contractors, agrees to retain in confidence and not disclose to any third
parties any SCIREX Confidential Information (defined below) without having first
obtained SCIREX' written consent to such disclosure. During the term of this
Agreement, but not thereafter (including following any termination), Avanir may
have access or use SCIREX Confidential Information only in connection with the
Projects; provided, however, that Avanir may not run or have or have access to
SCIREX computer programs or computer code without SCIREX' permission, although
SCIREX will run its computer programs as part of the services provided hereunder
and as and when requested by Avanir during the term of this Agreement. "SCIREX
Confidential Information" shall include but not be limited to confidential and
proprietary know-how, statistical approaches, computer programs, operating
procedures, formulations, methods, processes, specifications and all other
intellectual property of SCIREX that SCIREX considers confidential; provided,
however, that such information shall be to exceptions based on public knowledge,
prior or lawfully obtained Avanir knowledge and requirements of law, rules and
regulations corresponding to the exceptions set forth in A-D above.
6. ACCEPTANCE OF WORK PRODUCT
Avanir agrees to review all work products submitted by SCIREX and to advise
SCIREX promptly of any errors or omissions of which Avanir becomes aware in the
course of its review or thereafter. SCIREX shall, at its expense, correct all
errors that it discovers or which are brought to its attention by Avanir within
ninety (90) days after submission of work product to Avanir. Notwithstanding any
other provision of this Agreement, SCIREX shall not be liable to Avanir, its
affiliates, successors or assigns for errors in work product which are not known
to SCIREX and are not brought to SCIREX attention within the above-stated notice
period. SCIREX' liability within the above-stated notice period shall be limited
to correction of the errors brought to its attention and shall not include
consequential or special damages, including, without limitation, loss of
profits. If errors or omissions are not known to SCIREX or brought to its
attention within
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the above-stated notice period, the work product to which they relate shall
be deemed accepted and approved by Avanir.
7. COMPENSATION
Avanir shall pay to SCIREX the investigator fees and other out-of-pocket
costs and fees set forth in the Exhibits. SCIREX shall complete the transferred
obligations and the Projects by the dates specified in the Exhibits except for
delays caused by Avanir or others, events outside of SCIREX control, or mutual
agreement between SCIREX and Avanir.
The payment schedule for each Project will be contained in the appropriate
Exhibit.
SCIREX will submit invoices to Avanir according to the schedule described
in the Exhibits. All SCIREX invoices are payable within thirty (30) days after
date of invoice.
The total cost of the Projects, individual budget components and time
estimates are based on the specification and assumptions contained in the
Exhibits, and subject to modification only as provided for in Section 7 hereof.
8. CHANGE ORDERS
In the event of a change in the scope of a Project, a change in the nature
or timely execution of the obligations of Avanir or SCIREX, or a change in any
specific Project assumptions which are contained in the Exhibits and outside
SCIREX control, is identified by Avanir or SCIREX, the identifying party will
notify the other party of such change. Within twenty (20) working days from the
receipt by SCIREX of such a notice of changes by Avanir or sending of such a
notice of change by SCIREX, SCIREX shall provide Avanir with an estimate of the
modification to the timeline and costs arising from such change ("Change Order")
whether such a change results in an increase or decrease to the timeline or
costs. Avanir shall have fifteen (15) working days to approve the Change Order.
If Avanir does not approve such Change Order and has not terminated the Project,
both parties will use their best efforts to agree in writing on time and cost
estimates that are mutually acceptable; provided, however, that SCIREX shall not
be obligated to perform increased services due to a change as aforesaid until
such agreement is reached.
During the period over which a Change Order is being prepared and being
assessed, SCIREX shall continue to work on the Project, if possible, but shall
not implement the proposed modification to the project without the approval of
Avanir in writing.
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9. EARLY TERMINATION
Avanir may terminate this Agreement prior to completion of the Projects at
any time for any reasons upon thirty (30) days written notice to SCIREX. In the
event of such termination, SCIREX shall be promptly paid in full for all work
and services performed in connection with the Projects, including all
investigator fees and other out-of-pocket expenses and all SCIREX fees, as of
the date work on such Project is actually concluded. SCIREX shall use all
reasonable efforts to conclude or transfer the Projects as expeditiously as
practicable and in accordance with all applicable laws, rules and regulations.
Further, SCIREX and Avanir shall cooperate with each other during such Project
termination to safeguard patient safety, continuity of patient treatment and to
comply with applicable laws, rules and regulations.
In addition to the costs, expenses and fees specified in this Section 9,
provided that Avanir has not terminated the Projects because of SCIREX' breach
of a material obligation under this Agreement, Avanir shall pay to SCIREX to
cover expected labor costs for three months following the termination. Should
team members transition to other projects during this period, Avanir will not
cover the costs of those team members past the transition. SCIREX shall use its
best efforts to transition team members to other projects as quickly as
possible. Prior to transitioning to other projects, team members are fully
available to Avanir to work on any Avanir project under Avanir direction at no
additional cost.
10. INDEMNITY: CLINICAL INVESTIGATORS
Clinical investigators involved in any Projects, will be indemnified by
Avanir on terms mutually agreed upon by Avanir and such investigators.
11. INDEMNITY: SCIREX/AVANIR
SCIREX shall indemnify Avanir and its officers, directors, employees and
agents from any loss, damage, cost or expense (including reasonable attorney's
fees) (a "Loss") arising from any claim, demand, assessment, action, suit or
proceeding a ("Claim") for personal injury to Project participants or personal
injury to any employee of Avanir or property damage arising or occurring during
the conduct of Projects to the extent of SCIREX' negligence, gross negligence or
intentional misconduct as determined by a court of competent jurisdiction or in
a binding settlement between the parties.
Avanir shall indemnify SCIREX and its officers, directors, employees and
agents from any Claim or Loss arising from or related to (i) personal injury to
a participant in the Projects or personal injury to any employee of SCIREX
directly or indirectly caused by any of the Drugs, (ii) SCIREX' performance of
or involvement with the Projects or its obligations under this Agreement, (iii)
this Agreement, the Projects or any aspect thereof set forth in the Exhibits
that violates any applicable law, rule, regulation or ordinance,
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(iv) the Drug's harmful or otherwise unsafe effect, including without
limitation, a Claim based upon Avanir's or any other person's use, consumption,
sale, distribution or marketing of any substance, including the Drugs, or (v)
the negligence, gross negligence or intentional misconduct of Avanir in the
performance of its obligations under this Agreement or the Exhibits or any
associated protocol related to the Projects; provided that if such Loss or Claim
arises in whole or in part from SCIREX' gross negligence or intentional
misconduct, then the amount of such Loss that Avanir shall indemnify SCIREX for
pursuant to this Section I1 shall be reduced by an amount in proportion to the
percentage of SCIREX' responsibilities for such Loss as determined by a court of
competent jurisdiction or in a binding settlement between the parties.
Upon receipt of notice of any Claim, which may give rise to a right of
indemnity from the other party hereto, the party seeking indemnification (the
"Indemnified Party") shall give written notice thereof to the other party, (the
"Indemnifying Party") of such a Claim for indemnity. Promptly after a Claim is
made for which the Indemnified Party seeks indemnity, the Indemnified Party
shall permit the Indemnifying Party, at its own option and expense, to assume
the complete defense of such Claim.
The Indemnifying Party shall keep the Indemnified Party informed as to the
progress of its defense of any such Claim, and shall not compromise or otherwise
settle any such claim or lawsuit without the Indemnified Party's prior written
consent.
The obligations of the parties under this Section I l shall survive the
termination of the Projects and this Agreement. Further, a breach by the
Indemnified Party of its obligations under this Agreement or any obligations
contained in attached Exhibits shall not relieve the Indemnifying Party of its
obligations under this Section unless such breach was solely responsible for the
Loss or Claim as determined by a court of competent jurisdiction or in a binding
settlement between the parties.
12. LIMITATION ON LIABILITY
Exclusion of Damages. In no event shall either party be liable to the other
party or any other person or entity for any special, exemplary, indirect,
incidental, consequential or punitive damages of any kind or nature whatsoever
(including, without limitation, lost revenues, profits, savings or business,
other than amounts due and payable to SCIREX) or loss of records or data,
whether in an action based on contract, warranty, strict liability, tort
(including, without limitation, negligence) or otherwise, even if such party has
been informed in advance of the possibility of such damages or such damages
could have been reasonably foreseen by such party; provided, however, that
Losses from third party Claims shall be considered direct damages.
Total Liability. Except for any liability of SCIREX under Section I 1
hereof, in no event shall the liability of SCIREX to Avanir arising out of or in
connection with this Agreement or the Projects exceed, in the aggregate, the
total fees paid by Avanir to
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SCIREX for the particular Services or deliverable with respect to which such
liability relates (or in the case of any liability not related to a particular
portion of the Projects, the total fees paid by Avanir to SCIREX under the
applicable Exhibits). In no event shall SCIREX be liable for damages caused by
third parties. SCIREX entire liability under this Agreement or arising from the
Projects shall be subject to the limitations contained in this Section 12.
13. FORCE MAJEURE
No party shall be liable for a delay in performance or failure to perform
this Agreement to the extent such failure to perform is caused by any reason
beyond control, or by reason of any of the following: labor disturbances of any
kind, accidents, failure of any governmental approval, acts of God, energy or
conservation measures, failure of utilities, mechanical breakdown, material
shortages, fire, explosion, war, invasion, government acts, weather or civic
unrest, or disease; provided, however, that the party who is unable to perform
resumes performance as soon as possible following the end of the occurrence
causing delay or failure.
14. PROPERTY OWNERSHIP
All materials, documents, information and suggestions supplied to SCIREX by
Avanir or prepared or developed by SCIREX pursuant to this Agreement ("Avanir
Property"), except for SCIREX Property (defined below) shall be the sole and
exclusive property of Avanir, and Avanir shall have the right to make whatever
use it deems desirable of any such materials, documents and information. Unless
otherwise required by law or by the terms of this Agreement, all Avanir Property
that SCIREX has in its possession shall be maintained by SCIREX for a period of
not less than three (3) years from the date or receipt thereof. After three (3)
years, SCIREX may dispose of Avanir Property in accordance with Avanir's
instructions. If Avanir fails to give said instructions, SCIREX shall so notify
Avanir; and if said instructions are still not forthcoming within thirty (30)
days of said notification, then SCIREX may destroy Avanir Property as it
determines.
Avanir acknowledges that SCIREX possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties and other
assets, including but not limited to analytical methods, procedures and
techniques, procedure manuals, personnel data, financial information, computer
technical expertise and software, which have been independently developed by
SCIREX and which relate to its business operations, and do not rely on Avanir's
property (collectively, "SCIREX Property"). Avanir and SCIREX agree that any
SCIREX Property thereto that is used, improved, modified, developed, or
generated by SCIREX under or during the term of this Agreement is the sole and
exclusive property of SCIREX. Avanir shall treat SCIREX Property as confidential
in accordance with the same terms and conditions SCIREX is obligated to treat
Avanir's Confidential Information under Article 5 of this Agreement.
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15. PATENT RIGHTS
Except for SCIREX Property, SCIREX will disclose promptly to Avanir or its
nominee any and all inventions, discoveries and improvements conceived or made
by SCIREX while providing such services to Avanir pursuant to the Agreement and
relating to such services, and agrees to assign all its interest therein to
Avanir or its nominee whenever requested to do so by Avanir. SCIREX will execute
any and all applications, assignments, or other instruments and give testimony
that Avanir deems necessary to apply for and obtain Letters of Patent of the
United States or of any foreign country or to otherwise protect Avanir's
interests therein, and Avanir shall compensate SCIREX for the time devoted to
said activities and reimburse it for expenses incurred. These obligations shall
continue beyond the termination of this Agreement with respect to inventions,
discoveries and improvements conceived or made by SCIREX, except SCIREX Property
while providing services to Avanir pursuant to this Agreement, and shall be
binding upon SCIREX' assignees, administrators and other legal representatives.
16. MODIFICATIONS
No changes may be made in this Agreement except by written agreement of
both parties. It is anticipated that this Agreement will be modified from
time-to-time by the mutually agreed to addition of specific Exhibits and
associated Change Orders.
17. ENTIRETY
This Agreement, together with attached Exhibits and modifications which may
be added to this Agreement from time to time, is the entire and complete
understanding between the parties in regard to the covered subject matter. With
respect to the attached Exhibits, this document replaces, supersedes and renders
void any and all predecessor agreements between the parties whether written or
oral.
18. INDEPENDENT CONTRACTOR
SCIREX' relationship with Avanir under this Agreement shall be that of an
independent contractor, and nothing in this Agreement or the arrangements for
which it is made shall constitute SCIREX, or anyone furnished or used by SCIREX
in the performance of the services contemplated by this Agreement, as an
employee, joint venturer, partner, or servant of Avanir. All matters of
compensation, benefits and other terns of employment for any employee, agent,
contractor or other personnel used by SCIREX shall be solely a matter between
SCIREX and such individuals or entity.
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19. CONTACT PERSONS
If to SCIREX:
SCIREX Corporation
Attn: David Murcar
Director, Contract
Development 755 Business Center Drive
Horsham, PA 19044
Phone: 215/907-0048, ext. 1055
Fax: 215/907-0068
If to Avanir Pharmaceuticals
Avanir Pharmaceuticals
Attn: James E. Berg
Vice President Clinical & Regulatory Affairs
11388 Sorrento Valley Road, Suite 200
San Diego, CA 92121 Phone: (858) 622-5206 Fax: (858) 658-7448
20. NOTICES
Any notices which either party may be required or shall desire to give
hereunder shall be deemed to be duly given when delivered personally or mailed
by certified or registered mail, postage prepaid, to the party to whom notice is
to be given at the address first given above or such other address or addresses
of which such party shall have given written notice.
21. SEVERABILITY
If any provisions hereof shall be determined to be invalid or
unenforceable, the validity and effect of the other provisions of this Agreement
shall not be affected thereby.
22. GOVERNING LAW
This Agreement is a Pennsylvania contract. It shall be governed and
construed and interpreted in accordance with the laws of Pennsylvania without
regard to choice of law principals.
23. WAIVER
The waiver by either party or the failure by either party to claim a breach
of any provision of this Agreement shall not be deemed to constitute a waiver or
estoppel with respect to any subsequent breach or with respect to any other
provision thereof.
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24. ATTORNEYS' AND COLLECTION FEES
Should any of the fees pursuant to Section 7 be collected at law or in
equity, bankruptcy or other court proceedings, or through binding arbitration,
Avanir agrees to pay, in addition to the fees due, all costs of collection
including, but not limited to, reasonable attorneys' fees and expenses incurred
by SCIREX in collecting.
25. EMPLOYMENT SOLICITATION
During the term of this Agreement and for a one year period thereafter,
Avanir and SCIREX shall not hire, solicit for hire, or otherwise engage any
employee of SCIREX or Avanir for employment (or the provisions of services under
contract) with Avanir or SCIREX, not any person that was employed by SCIREX or
Avanir at any time during the one year period preceding such hiring,
solicitation, or recruitment.
26. CAPTIONS
Any caption used in this Agreement is inserted for convenience and
reference only and is to be ignored in the construction and interpretation of
the provisions hereof.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day
and year written below.
SCIREX Corporation Avanir Pharmaceuticals
BY: /s/ Dave Murcar BY: James E. Berg
TITLE: Director, Contract Dev. TITLE: VP Clinical & Regulatory
DATE: 22 March 2005 DATE: March 16, 2005
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