Product Elements

EX-10.32 4 p72383a4exv10w32.txt EXHIBIT 10.32 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., 1635 E. 18th Street, Tucson, AZ ###-###-#### ("ImaRx") and INC RESEARCH(R), Inc., together with its subsidiaries and legal affiliates, 4700 Falls of Neuse Road, Suite 400, Raleigh, NC 27609 ("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:

The parties shall submit all invoices and communications to the addresses listed below: Erica Forsyth, Clinical Operations Manager ImaRx Therapeutics, Inc. Attention: Accounts Payable 1635 18th Street Tucson, AZ 85719-68 Patricia A. Bland Vice President, Proposals and Contracts Department 4700 Falls of Neuse Road Suite 400 Raleigh, North Carolina ###-###-#### Tel: (919 ###-###-#### Fax: (703) 234-0535 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/ BRADFORD A. ZAKES By: /s/ KAREN M. WALL ------------------------------- ------------------------------- Name: Bradford A. Zakes Name: Karen M. Wall ----------------------------- ----------------------------- Title: COO Title: General Counsel ---------------------------- ---------------------------- Date: 9/11/06 Date: 9/11/06 ----------------------------- ----------------------------- 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:

START UP LETTER OF AGREEMENT - ----------------------------------------------------------------------------------------------------------------------------------- CLINICAL DATA MANAGEMENT (ORACLE CLINICAL REMOTE DATA CAPTURE) - ----------------------------------------------------------------------------------------------------------------------------------- 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 - ----------------------------------------------------------------------------------------------------------------------------------- BIOSTATISTICS - ----------------------------------------------------------------------------------------------------------------------------------- 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 - ----------------------------------------------------------------------------------------------------------------------------------- MEDICAL WRITING - ----------------------------------------------------------------------------------------------------------------------------------- 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 --------------------- SUB-TOTAL: $ -- - ----------------------------------------------------------------------------------------------------------------------------------- PROJECT MANAGEMENT AND ADMINISTRATIVE SUPPORT - ----------------------------------------------------------------------------------------------------------------------------------- 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 - ----------------------------------------------------------------------------------------------------------------------------------- TOTAL INC RESEARCH DIRECT COSTS $ 562,661 - ----------------------------------------------------------------------------------------------------------------------------------- PASS-THROUGH EXPENSES - ----------------------------------------------------------------------------------------------------------------------------------- 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 - ----------------------------------------------------------------------------------------------------------------------------------- TOTAL ESTIMATED PASS-THROUGH EXPENSES $ 1,072,418 - ----------------------------------------------------------------------------------------------------------------------------------- - ----------------------------------------------------------------------------------------------------------------------------------- TOTAL ESTIMATED PROJECT COSTS $ 1,635,079 - -----------------------------------------------------------------------------------------------------------------------------------