EXHIBIT 10.32
START UP LETTER OF AGREEMENT
START-UP AGREEMENT
FOR CLINICAL RESEARCH AND RELATED SERVICES
This Start-up Agreement ("Agreement") is effective as of September 11, 2006
("Effective Date") and is by and between ImaRx Therapeutics, Inc., 0000 X. 00xx
Xxxxxx, Xxxxxx, XX 00000-0000 ("ImaRx") and INC RESEARCH(R), Inc., together with
its subsidiaries and legal affiliates, 0000 Xxxxx xx Xxxxx Xxxx, Xxxxx 000,
Xxxxxxx, XX 00000 ("INC")
WHEREAS, the parties hereby enter to this Agreement for Clinical Research and
Related Services, including its related exhibit ("Exhibit") detailing the full
scope of work, the study budget and payment schedule, and each parties
responsibilities regarding the execution of the ImaRx study entitled "A phase
I-II, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the
Safety, Tolerability, and Activity of Ascending Single Doses of MRX-815 with
Continuous Ultrasound Administration in Subjects with Acute Ischemic Stroke
Receiving Treatment with Intravenous Tissue Plasminogen Activator" ("Study").
NOW, THEREFORE, in consideration of the mutual promises and undertakings herein
set forth, the parties hereto agree as follows:
1. SERVICES
INC will perform only those services designated in the Budget and Detailed Unit
Pricing Grid presented in and attached hereto as ATTACHMENT A.
2. FEES
Upon signature of this Agreement, ImaRx shall pay INC $200,000 US dollars as an
advance payment ("Advance"), This amount includes Service fees, Pass-Through
Expenses (defined as all actual, necessary and reasonable travel-related
expenses, courier shipments, translations, printing, Investigator meeting
expenses including third-party meeting planners, and other non-labor related
expenses incurred by INC in performing the Services), and Investigator Grants.
This Advance will be applied against the total amount due to INC under the
Agreement executed by the parties as follows:
o Direct Costs - $ 150,000
o Indirect Costs - $25,000
o Investigator Grants - $25,000
These amounts will be credited against the Advance based on the actual work
performed by INC and calculated based on the detailed unit pricing grid
contained in Attachment A, and actual Pass-Through Expenses and Investigator
Grant expenses incurred. ImaRx will be invoiced for any amounts which exceed
those specified in each costing category of the Advance. In no event will INC
perform Services and/or invoice ImaRx in excess of the total amount in
Attachment A without ImaRx's express authorization.
INC agrees to provide ImaRx Therapeutics with copies of actual receipts for all
Pass-Through Expenses in excess of $100 USD incurred in performing the
Services.
All Service fees and Pass-through Expenses shall be paid by ImaRx net thirty
(30) days from receipt of INC's invoice (except for the Advance, which is
payable immediately upon execution), and shall be subject to VAT where
applicable.
If any portion of an invoice is disputed, then ImaRx shall timely pay the
undisputed amounts, and the parties shall use good faith efforts to reconcile
the disputed amount as soon as practicable ImaRx shall pay INC interest in an
amount equal to one and one-half percent (1 1/2%) (or such maximum lesser amount
allowed by applicable law) per month with regard to all undisputed amounts past
due and payable.
START UP LETTER OF AGREEMENT
ImaRx shall remit all payments to:
US Check Remittance Address: Wire Remittance:
---------------------------- ----------------
(within US use ABA; for International use SWIFT):
For Payments (Via Mail): Silicon Valley Bank
INC RESEARCH(R), Inc. Tasman Drive
Dept. CH 10711 Xxxxx Xxxxx, XX 00000
Xxxxxxxx, XX 00000 ABA (routing) number: 000000000
Beneficiary name: INC RESEARCH, Inc.
For Payments (Via Overnight Beneficiary account #: 3300248471
Courier): Federal Tax ID No.: 00-0000000
INC RESEARCH(R), Inc.
Chicago Lockbox
0000 Xxxxx Xxxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Box# 10711
Federal Tax ID No.: 00-0000000
The parties shall submit all invoices and communications to the addresses listed
below:
Xxxxx Xxxxxxx, Clinical Operations Manager
ImaRx Therapeutics, Inc.
Attention: Accounts Payable
0000 00xx Xxxxxx
Xxxxxx, XX 00000-00
Xxxxxxxx X. Xxxxx
Vice President, Proposals and Contracts Department
0000 Xxxxx xx Xxxxx Xxxx
Xxxxx 000
Xxxxxxx, Xxxxx Xxxxxxxx 00000-0000
Tel: (000)000-0000
Fax: (000) 000-0000
Prior to or upon execution of this Agreement, ImaRx shall provide INC with a
copy of ImaRx's effective Certificate of Insurance or such other documented
evidence offering that it has adequate coverage consistent with industry
standards. If requested by ImaRx to contract with any entities, ImaRx hereby
authorizes INC to provide its contractors with a copy of ImaRx's Certificate of
Insurance.
3. CONFIDENTIALITY
Each party agrees (i) to maintain in confidence and not to disclose the
disclosing party's proprietary and/or confidential information ("Confidential
Information") and (ii) not to use the disclosing party's Confidential
Information for any purpose except the purpose for which the Confidential
Information is disclosed, The recipient may disclose the discloser's
Confidential Information only to the recipient's affiliates and its and their
respective employees and independent contractors, and/or ImaRx's designees who
have a need to know such Confidential Information. Confidential Information will
not include information that (i) is or becomes part of the public domain through
no fault of the recipient; (ii) was in the recipient's rightful possession prior
to disclosure by discloser; (iii) is rightfully disclosed to the recipient by a
third party with the right to disclose the information; or (iv) is independently
developed by the recipient without use of the discloser's Confidential
Information. Nothing in this section will be construed to prohibit disclosure of
the other party's Confidential Information to the extent such disclosure is
required by law or valid order of a court or other governmental authority
("Required Disclosure"); provided that, the party responding to the Required
Disclosure will promptly notify the other party of such Required Disclosure.
START UP LETTER OF AGREEMENT
4. MUTUAL INDEMNIFICATION
ImaRx will defend, indemnify and hold harmless INC and its affiliates and their
respective directors, officers, employees, independent contractors and agents
("INC Indemnitees") from and against all damages, liabilities, judgments,
settlements, penalties, losses and costs and expenses (including without
limitation, reasonable fees and disbursements of counsel and costs and expenses
associated with document production and testimony) as incurred by INC
Indemnitees, even in advance of judgment, arising out of or in connection with
any (including without limitation, government agencies) claims, suits, actions,
proceedings, investigations and demands ("Third Party Claims") arising out of or
in connection with this Agreement, including without limitation, the protocol,
ImaRx's product and ImaRx's negligence and willful misconduct. ImaRx will have
no obligation to indemnify INC's Indemnitees to the extent that any Third Party
Claims are based on INC's negligence of willful misconduct, and INC shall
defend, indemnify and hold harmless ImaRx, to the extent that any Third Party
Claims are based on INC's negligence or willful misconduct. Notwithstanding the
above, for the sake of clarity and for the purposes of this Agreement, INC shall
not be responsible for the actions or inaction of and shall not be required to
indemnify any subcontractors or independent contractors required by ImaRx to be
obtained in accordance with a Study, including but not limited to
Institution(s), Investigator(s) and Study-related vendor(s). INC shall not be
responsible for the authenticity of the Study drug. The party seeking
indemnification shall promptly notify the indemnifying party of any such claim
and shall cooperate with the indemnifying party in the defense of such claim.
The indemnified party shall not settle any such claim without the other's prior
written approval, which approval shall not be unreasonably withheld or delayed.
Upon reasonable request by ImaRx-approved vendors or
hospitals/facilities/institutions utilized in connection with this Agreement,
ImaRx shall execute and provide a separate letter of indemnification with such
vendors or hospitals/facilities/institutions mutually acceptable to all parties.
If requested by ImaRx and at ImaRx's expense, INC will assist administratively
with the tasks related to this Section 4 herein.
5. PERFORMANCE AND DISCLAIMERS
ImaRx and INC each warrant that they shall comply with all applicable laws,
rules and regulations in the performance of this Agreement. ImaRx shall provide
INC with all information and materials necessary for INC's performance of
Services.
INC shall perform the Services in a professional and workmanlike manner
commensurate with generally accepted standards within the applicable industry.
It is understood and agreed that the Services may include advice and
recommendations, but all decisions in connection with the implementation of such
advice and recommendations shall be the sole responsibility of, and made solely
by, ImaRx. There can be no assurance by INC that the Services described herein
will result in favorable regulatory action by any regulatory agency, and final
regulatory responsibility remains with ImaRx.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, INC MAKES NO OTHER WARRANTIES,
REPRESENTATIONS, OR COVENANTS OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY,
INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF TITLE,
NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
6. LIMITATION OF LIABILITY
INC'S AGGREGATE LIABILITY, REGARDLESS OF THE THEORY OF LIABILITY, FOR ALL
CLAIMS, BREACH OR DEFAULT UNDER THIS AGREEMENT, SHALL BE LIMITED TO PROVEN,
DIRECT DAMAGES AWARDED TO COMPANY, NOT TO EXCEED THE FEES RECEIVED BY INC FROM
COMPANY IN CONNECTION WITH THE PARTICULAR SERVICE(S) PERFORMED HEREUNDER GIVING
RISE TO THE CLAIM, EXCLUSIVE OF PASS THROUGH EXPENSES. IN NO EVENT SHALL EITHER
PARTY BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL
DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST PROFITS, REGARDLESS OF WHETHER A
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
7. TERM AND TERMINATION
Upon signature by both parties, this Agreement shall commence as of the
Effective Date and shall continue until December 1, 2006, or terminated as
provided herein. This Agreement may be superceded by a subsequent agreement
governing the remaining scope of work.
Either party may terminate this Agreement upon thirty (30) days written notice
to the other party; provided, however, that all terms and conditions expressly
surviving said Agreement shall remain in full force and effect, including
payment terms.
START UP LETTER OF AGREEMENT
Upon termination of this Agreement or the Services, ImaRx shall pay INC for all
Services performed and Pass-through Expenses either incurred or uncancelable
through the effective date of termination, including the closeout or winding
down period. In the event of early termination, INC shall either apply excess
payment as a credit against other amounts due and payable or promptly refund
such excess if there are no outstanding payments owed INC. Any payment due and
payable under this Section 7 shall be made within thirty (30) days after
termination and in accordance with Section 2 herein.
8. RIGHT TO AUDIT
At ImaRx's expense, INC will permit ImaRx-designated representatives (unless
such representatives are competitors of INC) to examine, at a reasonable time
and during normal business hours, raw Study data and other relevant information,
which ImaRx may reasonably require in order to confirm that the Study is being
conducted in conformance with the Protocol and in compliance with applicable
laws and regulations. Such audit shall be limited to one audit per twelve-month
period at no-cost to ImaRx, unless such audit finds that INC has breached this
Agreement or applicable law or regulation, audits in excess of this shall be at
ImaRx's expense. ImaRx will provide INC with a minimum of thirty (30) business
days advance notice of its intention to conduct such audit in order for INC to
facilitate the availability of appropriate staff. INC will notify ImaRx
immediately if any regulatory authority requests an inspection or commences an
unscheduled inspection. In the event of a regulatory audit, ImaRx agrees to pay
upon invoice supporting the audit for INC's reasonable costs incurred.
Notwithstanding the above, INC reserves the right to conduct its own internal
and external audits and generate reports as a result of such audits. Any such
reports or documentation shall be deemed INC's work product that is confidential
and proprietary information.
9. MISCELLANEOUS
a. Force Majeure
The performance of this Agreement by either party, in part or in full, is
subject to events or occurrences beyond its control such as, but not limited to,
the following: acts of God, war, threat of war, government retaliation against
foreign enemies, government regulation or advisory, disasters, fire,
earthquakes, accidents or other casualty, strikes or threats of strikes
(exception: neither party may terminate or suspend this Agreement for strikes,
labor disputes, or work stoppages involving its respective employees or agents),
civil disorder, terrorist acts and/or threats of terrorism, acts of foreign
enemies, or curtailment of transportation services making it illegal,
impossible, or commercially impracticable to perform its obligations under this
Agreement.
Either party may terminate, suspend, or partially perform its obligations under
this Agreement, without liability or further obligation, by written notice to
the other party if such obligations are delayed, prevented, or frustrated by any
of the above events, or similar events or occurrences, to the extent such events
or occurrences are beyond the reasonable control of the party whose reasonable
performance is prevented, made impracticable, or partially curtailed; provided,
however, that ImaRx must perform its obligations to pay for all INC's
uncancelable expenses incurred as a result the above events or similar
intervening causes. ImaRx also agrees to pay all reasonable expenses incurred in
connection with ImaRx-directed meetings whereby any of the above actions or
threats of actions prevent the attendees from attending or delay the departure
of attendees from a designated meeting facility.
b. Data Protection
Each party represents and warrants that procedures compatible with the relevant
directives, data protection laws and regulations will be employed so that
processing and transfer of relative personal data and identifiers, relating to
all data subjects or protected information will not be impeded.
c. Choice of Law
The laws of the state of Delaware shall govern this Agreement. INC is an
independent contractor and nothing in this Agreement shall be construed to
create a partnership, or joint venture relationship between the parties. This
Agreement, which may only be amended in a writing signed by both parties, is the
complete agreement between the parties with respect to the Services described
herein and supersedes all prior agreements, understandings or representations,
whether written or oral. The provisions of this Agreement that would by their
nature survive the expiration or termination of this Agreement, shall survive
any expiration or termination of this Agreement. Neither party shall have the
right to assign this Agreement or any of the rights or obligations hereunder
without the prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed.
START UP LETTER OF AGREEMENT
AGREED TO AND ACCEPTED:
IMARX THERAPEUTICS, INC. INC RESEARCH(R), INC.
By: /s/ XXXXXXXX X. XXXXX By: /s/ XXXXX X. XXXX
------------------------------- -------------------------------
Name: Xxxxxxxx X. Xxxxx Name: Xxxxx X. Xxxx
----------------------------- -----------------------------
Title: COO Title: General Counsel
---------------------------- ----------------------------
Date: 9/11/06 Date: 9/11/06
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START UP LETTER OF AGREEMENT
ATTACHMENT A
START-UP BUDGET AND DETAILED UNIT PRICING GRID
This Attachment A ("Attachment A") is attached and part of the Start-Up
Agreement ("Agreement") effective as of the date of signature of this Agreement
by and between ImaRx Therapeutics, Inc. ("ImaRx") and INC Research, Inc.
("INC"), related to the study entitled "A phase I-II, Randomized,
Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability,
and Activity of Ascending Single Doses of MRX-815 with Continuous Ultrasound
Administration in Subjects with Acute Ischemic Stroke Receiving Treatment with
Intravenous Tissue Plasminogen Activator."
The following start-up budget includes only those start-up services that may be
performed under this Agreement:
UNIT NUMBER OF PER UNIT TOTAL
INC RESEARCH ESTIMATED PROJECT COSTS DESCRIPTION UNITS COST COST
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PROJECT STARTUP/INITIATION
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Protocol Review review 1 $ 5,520.00 $ 5,520
Informed Consent Development ICF 1 $ 6,440.00 $ 6,440
Electronic CRF Design / Development e-CRF page 50 $ 196.76 $ 9,838
Site Identification / Selection site 25 $ 1,245.50 $ 31,138
Site Contract / Grant Negotiation site 25 $ 1,151.00 $ 28,775
Critical Document Collection / Maintenance / QA site 25 $ 1,369.75 $ 34,244
Monitoring Plan/CRA Manual manual 1 $ 7,280.00 $ 7,280
Site Binders / Study Procedures Manual site 25 $ 176.00 $ 4,400
SUB-TOTAL: $ 127,634
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REGULATORY
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Prepare IMPD IMPD 1 $ 22,425.00 $ 22,425
Prepare Xxxxxx XXX XXX 0 $ 2,400.00 $ 2,400
CTA Preparation for Spain, France, and Germany European country 3 $ 2,760.00 $ 8,280
CTA Submission to CA/ Follow-up European country 3 $ 4,275.00 $ 12,825
Central IEC Preparation / Submission / Follow-up central IEC 3 $ 4,735.00 $ 14,205
Local IEC Preparation / Submission / Follow-up
(Germany and Spain) site 5 $ 920.00 $ 4,600
Review / QC of Study Document Translations European country 3 $ 1,495.00 $ 4,485
Trial Insurance (Assist) European country 3 $ 920.00 $ 2,760
Local Warehouse (Manage Vendor) European country 3 $ 2,300.00 $ 6,900
SUB-TOTAL: $ 78,880
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INVESTIGATOR MEETING
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Investigator Meeting Set-up / Coordination meeting 2 $ 9,350.00 $ 18,700
Investigator Meeting Preparation / Attendance meeting 2 $ 26,868.00 $ 53,736
$ 72,436
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CLINICAL MONITORING & SITE MANAGEMENT
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Project Team Training / Familiarization meeting 1 $ 13,584.00 $ 13,584
Site Qualification Visits visit 25 $ 1,668.80 $ 41,720
Site Initiation Visits visit 5 $ 2,384.00 $ 11,920
Clinical Monitoring Oversight (Lead C R A) month 2.50 $ 5,358.26 $ 13,396
Project Kick-Off Meeting meeting 1 $ 4,160.00 $ 4,160
Teleconferences with ImaRx teleconference 10 $ 234.63 $ 2,346
Internal Team Meetings meeting 10 $ 820.89 $ 8,209
SUB-TOTAL: $ 95,335
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MEDICAL MANAGEMENT
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Project Team Training / Familiarization meeting 1 $ 4,080 $ 4,080
Project Kick-Off Meeting meeting 1 $ 4,400.00 $ 4,400
Teleconferences with ImaRx teleconference 3 $ 275.00 $ 825
Internal Team Meetings meeting 3 $ 275.00 $ 825
SUB-TOTAL: $ 10,130
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PHARMACOVIGILANCE
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Project Team Training / Familiarization meeting 1 $ 2,200.00 $ 2,200
Create SAE Management Plan plan 1 $ 2,400.00 $ 2,400
SAE Hotline Coverage month 1 $ 600.00 $ 600
SAE DATABASE SET-UP database 1 $ 2,784.00 $ 2,784
Project Kick-Off Meeting meeting 1 $ 1,200.00 $ 1,200
Teleconferences with ImaRx teleconference 3 $ 150.00 $ 450
Internal Team Meetings meeting 3 $ 150 $ 450
SUB-TOTAL: $ 10,084
START UP LETTER OF AGREEMENT
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CLINICAL DATA MANAGEMENT (ORACLE CLINICAL REMOTE DATA CAPTURE)
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Project Team Training/Familiarization meeting 1 $ 2,696.00 $ 2,696
Data Management Plan plan 1 $ 7,010.00 $ 7,010
Database Development/Setup/Programming database 1 $ 65,078.00 $ 65,078
EDC Training site 5 $ 465.00 $ 2,325
Prepare/Distribute EDC Packets packet 25 $ 97.84 $ 2,446
Data Management Oversight month 25 $ 925.40 $ 2,314
Project Kick-Off Meeting meeting 1 $ 2,480.00 $ 2,480
Teleconferences with ImaRx teleconference 10 $ 155.00 $ 1,550
Internal Team Meetings meeting 10 $ 223.92 $ 2,239
SUB-TOTAL $ 88,138
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BIOSTATISTICS
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Project Team Training/Familiarization meeting 1 $ 1 280.00 $ 1,280
Randomization Schedule schedule 1 $ 1,280.00 $ 1,280
Statistical Analysis Plan plan 1 $ 10,280.00 $ 10,280
Project Kick-Off Meeting meeting 1 $ 1,280.00 $ 1,280
Teleconferences with ImaRx meeting 3 $ 160.00 $ 480
Internal Team Meetings meeting 3 $ 160.00 $ 480
SUB-TOTAL: $ 15,080
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MEDICAL WRITING
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Project Team Training/Familiarization meeting 1 $ 1,480.00 $ 1,480
Project Kick-Off Meeting meeting 1 $ 1,480.00 $ 1,480
Teleconferences with ImaRx teleconference 10 $ 185.00 $ 1,850
Internal Team Meetings meeting 10 $ 185.00 $ 1,850
SUB-TOTAL: $ 6,660
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SUB-TOTAL: $ --
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PROJECT MANAGEMENT AND ADMINISTRATIVE SUPPORT
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Project Management and Support month 2.50 $ 14,102.67 $ 35,257
Patient Recruitment/Education Strategy strategy 1 $ 9,394.00 $ 9,394
Vendor (3rd-party) Management month 2.50 $ 1,853.33 $ 4,633
Project Kick-Off Meeting meeting 1 $ 4,000.00 $ 4,000
Teleconferences with ImaRx teleconference 10 $ 250.00 $ 2,500
Internal Team Meeting meeting 10 $ 250.00 $ 2,500
SUB-TOTAL: $ 58,284
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TOTAL INC RESEARCH DIRECT COSTS $ 562,661
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PASS-THROUGH EXPENSES
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Investigator Notebook Expenses notebooks 35 $ 100.00 $ 3,500
Investigator Meeting Binder Expenses attendee 62 $ 50.00 $ 3,100
Monitoring Travel Expenses (US) visit 7 $ 800.00 $ 5,600
Monitoring Travel Expenses (Europe) visit 8 $ 600.00 $ 4,800
Telecommunication Expenses month 2.50 $ 2,562.56 $ 6,406
Miscellaneous Shipping Expenses site/month 50 $ 30.00 $ 1,500
Portal Charges for EDC Training attendee 5 $ 100.00 $ 500
Investigator Meeting Expenses attendee 75 $ 2,250.00 $ 168,750
Patient/Site Educational Materials sites 20 $ 692.50 $ 13,850
Central and Local IEC Fees European country 3 $ 8,323.58 $ 24,971
European Regulatory Application Fees
(Spain and Germany) European country 2 $ 3,073.32 $ 6,147
Investigator Grant patient 54 $ 8,800.00 $ 475,200
Study Document Translation Fees document page 164 $ 50.00 $ 8,200
Central Laboratory Services $ 30,612
Interactive Voice Response System (IVRS) -
for patient randomization and drug $ 127,335
supply management
Bioimaging Services $ 134,272
Study Drug Storage/Distribution Services $ 57,675
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TOTAL ESTIMATED PASS-THROUGH EXPENSES $ 1,072,418
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TOTAL ESTIMATED PROJECT COSTS $ 1,635,079
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