Exhibit 10.7
This Agreement is by and between
TechniScan Medical Systems, Inc., 0000 Xxxxxx Xxxxxxxx Xxxx, Xxxxx
000, Xxxx Xxxx Xxxx, Xxxx 00000 (hereafter referred to as “Client”) and The Anson Group, L.L.C.,
(hereinafter referred to as “Anson”), 00000 X. Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxx, Xxxxxxx 00000, a
limited liability company organized under the Laws of
Indiana.
NOW THEREFORE, For the mutual covenants and valuable consideration expressed herein, the parties
hereby agree as follows:
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Purpose and Scope of Agreement |
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A. 1. |
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Purpose —Client wishes to secure the advice and services available
from Anson in matters relating to Client’s business, and Anson agrees, during the
Term of this Agreement, to provide or arrange such services as Client may request. |
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A. 2. |
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Scope of Agreement — Anson’s relationship with Client is that of an
independent consultant, and nothing in this Agreement is intended to, or should
be construed to, create a partnership, agency, joint venture or employment
relationship. Neither party is authorized to make any representation, contract
or commitment on behalf of the other party, unless specifically authorized in
writing to do so by the other party. |
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B. 1. |
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The specific responsibilities undertaken by Anson under this
Agreement shall be described in Project Assignments, which shall become part of
this Agreement when approved by the parties in writing. The Initial Project
Assignment is attached to this Agreement as Exhibit A. |
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Responsibilities of Client |
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C. 1. |
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Client shall be responsible for providing Anson with such
documentation and technical, clinical, or business information as Anson may
need in order to perform the services specified in this Agreement. Client shall
be responsible to assure that any and all information and documentation
provided to Anson is accurate and |
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complete, and is provided to Anson in the form and within the time limits
necessary for Anson to comply with its obligations hereunder. |
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Consulting Fees & Payments |
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D.1 |
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Consulting fee, invoicing and payment terms shall be in accordance
with the provisions of this section, except as otherwise provided in Project
Assignments, which may specify hourly, daily, fixed-fee or retainer fee
arrangements. |
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D.2 |
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Retainer Fee arrangements that are agreed upon in Project Assignments
shall specify a monthly maximum for the number of consulting hours to be provided
by Anson. Additional consulting time requested by the Client (Excess Hours) shall
be invoiced at rates set forth in a fee schedule to be provided to Client, unless
otherwise specified in the Project Assignment. |
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D. 3 |
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Expenses — Client shall reimburse Anson for reasonable expenses
incurred in performing the services defined herein, including, but not limited to,
airplane travel, copying, printing, freight, postage and supplies. |
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D. 4 |
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Invoices and Payments — Anson shall invoice Client monthly for
services provided and expenses incurred under this Agreement. Anson shall
provide reasonable documentation for expenses invoices. Client agrees to pay
such invoices within thirty (30) days of receipt. Invoices may contain
additional standard or specific payment terms and conditions. |
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Non-Disclosure of Confidential Information |
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E. 1. |
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As part of this Agreement, Anson will execute and abide by the Client
Confidentiality and non-disclosure Agreement attached hereto as Exhibit B.
Exhibit B shall be fully incorporated by reference herein. |
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E. 2. |
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This section E shall survive the termination of this Agreement and shall
constitute a post-termination obligation of the Parties |
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F. 1. |
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Term — This Agreement is effective as of the date of the last signature
required as set forth below and will terminate on the date set forth in the
Project Assignment, unless terminated earlier as set forth below. |
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F. 2. |
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Termination without Cause — Except as otherwise provided in a Project
Assignment, either Party may terminate this Agreement upon thirty (30) days
prior written notice to the other Party. |
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F. 3. |
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Termination for Cause — Either Party may terminate this Agreement, at
any time, if the other Party breaches the Agreement and fails to correct the
breach within thirty (30) days of receipt of written notice from the non-breaching
Party. |
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F. 4. |
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Payment — Client agrees to pay all invoices for consulting services
provided and expenses that were provided or incurred by Anson under this
Agreement prior to the effective date of Termination whether invoiced or not.
This section F.4 shall survive the termination of this Agreement and shall
constitute a post-termination obligation of the Client. |
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G. 1. |
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Successors — All the terms and conditions of this Agreement shall be
binding upon and shall inure to the benefit of the successors and assigns of each
party. Neither party may assign this agreement without the consent of the other
party, which shall not be unreasonably withheld |
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G.2. |
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Entire Agreement — This Agreement, and all exhibits and attachments as
defined or described herein, set forth the entire agreement and supercedes all prior
agreements and understandings, written and oral, between the parties with respect to
the services provided under this Agreement. |
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G. 3. |
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Governing Law — The parties agree and understand that this Agreement and
all documents executed pursuant thereto shall be interpreted and enforced in
accordance with the laws of the State of Indiana, USA, notwithstanding any state’s
choice of all rules to the contrary. Further, Anson will abide by the laws of the
United States, or the laws of the state of Indiana, in performance of its obligations
under this agreement. |
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G. 4. |
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Severability — In the event that any term or provision of this Agreement
is held by a court of competent jurisdiction to be invalid, void or unenforceable,
the remaining provision will nevertheless continue in full force. |
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G. 5. |
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Non-Waiver — The failure by any party at any time to require performance
of any provision hereof shall not affect its right later to require such performance. |
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G.6. |
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Limitation of Liability — Except for breaches of confidentiality as provided
in the attached Confidentiality Agreement between Client and Anson, |
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Client agrees that Anson’s damages for liability, adjudicated to be the
responsibility of Anson, for claims by Client or any third party which are related
to any activities Anson undertakes hereunder, shall be limited to the amount which
is the lesser of (1) the amounts covered by any third party commercial insurance
policy maintained by Anson or (2) the amount equal to the sum of payments made to
Anson within the preceding calendar year for the specific services from which the
claim arose. |
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G. 7. |
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Notices — All notices, requests, waivers and other communications
required or permitted to be given pursuant to this Agreement shall be in writing and
shall be effective when either served by personal delivery, or by registered or
certified mail addressed to the parties at the addresses set forth on page one of
this Agreement. |
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G. 8. |
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Amendment — This Agreement may not be changed, modified or amended
except in writing, signed by all parties hereto, and any attempt at oral modification
hereto shall be void and of no effect. |
IN WITNESS WHEREOF, the parties have executed this Agreement as of the dates set forth below:
00000 X. Xxxxxxxx Xxxxxx, Xxxxx 000 • Xxxxxx, XX 00000
Phone: (000) 000-0000 • Fax: (000) 000-0000
Exhibit A
TechniScan Medical Systems, Inc.
Project Assignment
TSC-pa-01
This Project Assignment (PA) describes services that Anson will provide to
TechniScan Medical
Systems, Inc. (“Client”) under the
General Consulting Agreement dated May 1, 2006. The commencement
date of this PA shall not be later than May 8, 2006. All additions and changes to this PA shall be
documented by Anson and approved or acknowledged in writing by the parties.
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1. |
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Objectives and Scope — to support TechniScan’s regulatory approval process including
the development of a clinical design plan that can be incorporated
into TechniScan’s 510(k) and the 510(k) application. |
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2. |
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Specific Services — work with regulatory and medical communities to develop a
clinical protocol designed to compare traditional
B-Mode ultrasound imaging of the breast
with TechniScan’s transmission ultrasound technology; assist with the development,
submission and FDA review of a pre-IDE submission and the subsequent 510(k) application. |
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3. |
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Deliverables — submit clinical study plan, predicates and intended use statement to
FDA for review as a pre-IDE submission by May 22, 2006; submit 510(k) application within
30 days after the completion of the clinical study plan. |
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4. |
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Responsibilities of Anson — Anson shall use its best effort to provide services under
this agreement in a timely and effective manner and to respond to inquiries and
communications from Client within a maximum of 24-hours. All services to Client shall be
provided by, or under the direct supervision of Xxxxxxx Xxxxxxxx. |
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5. |
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Responsibilities of Client: |
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a) |
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Client shall provide such information and updates on the status, activities,
events, plans and strategies of the company as are reasonably required or requested by
Anson in providing services under this PA. |
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b) |
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Client shall designate one or more individuals as the primary contact(s),
responsible to provide information and to approve reports, invoices and changes and
additions to this PA. |
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a) |
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Consulting Fees — Client agrees to pay Anson on a(n) hourly fee basis for
consulting services provided under this PA. Please see the attached 2006 Anson Group
Fee document. Fees shall not exceed $200 per hour. |
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b) |
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Invoices and Payment — Anson will invoice Client for services provided under
this PA. Client agrees to pay such invoices upon receipt. Payment shall be made in U.S.
Dollars by a check drawn on a U.S. bank, or by wire transfer to the account listed on
the invoice. Other standard or specific payment terms may be listed on the invoice. |
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c) |
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Expenses — As provided in the General Consulting Agreement, Anson shall invoice
for reimbursement of reasonable expenses incurred in providing services to Client
including, but not limited to, airplane travel, copying, printing, freight, postage and
supplies. |
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7. |
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Term — This PA shall commence on the last date of execution below and continue in
effect until it is completed or terminated by written agreement of the Parties, or by
termination of the General Consulting Agreement. |
Agreed and Accepted:
00000
X. Xxxxxxxx Xxxxxx, Xxxxx 000 • Xxxxxx, XX 00000
Phone: (000) 000-0000 • Fax: (000) 000-0000
(Techniscan Medical Systems)
Project Assignment
(TMS-01)
This Project Assignment (PA) describes services that The Anson Group (“Anson”) will provide to
Techniscan Medical Systems, Inc. (“Client”) under the
General Consulting Agreement executed May 3,
2006. The commencement date of this PA shall not be later than April 9, 2008. All additions and
changes to this PA shall be documented by Anson and approved or acknowledged in writing by the
parties.
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1. |
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Objectives and Scope — To assist Client in achieving FDA product marketing
approvals by providing timely regulatory affairs and quality system
compliance support. |
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2. |
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Specific Services |
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a) |
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To advise and assist Client in responding to the March 31, 2008 FDA’s
request for addition information in support of the K073469 Premarket Notification
(“510K”) submission filed in October 2007. |
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Provide recommendations and meet with management and staff to
develop and agree upon a response plan and timetable. |
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Undertake specific research, draft documentation and other
relevant tasks as requested by Client. |
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b) |
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Advise and assist Client in planning and executing future FDA
marketing approvals. |
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Review Client business goals and current FDA marketing approval plans. |
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Review current QA system compliance status and FDA
submission documentation capabilities. |
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Develop and deliver to Client recommendations for
improving FDA marketing approval plans to reduce risk of delays and cost
over-runs. |
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| Techniscan Medical Systems 1.
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project asssignment TMS-01
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3. |
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Responsibilities of Anson — Anson shall use its best effort to provide services under this
agreement in a timely and effective manner and to respond to inquiries and communications from
Client within a maximum of 24-hours. All services to Client shall be provided by, or under the
direct supervision an Xxxxx Xx |
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4. |
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Responsibilities of Client: |
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a) |
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Client shall provide such information and updates on the status, activities,
events, plans and strategies of the company as are reasonably required or requested by
Anson in providing services under this PA. |
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b) |
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Client shall designate one or more individuals as the primary contact(s),
responsible to provide information and to approve reports, invoices and changes and
additions to this PA. |
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a) |
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Consulting Fees (Including 10% discount) |
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Regulatory Associate (Xxxxxxx Xxxxx; Xxxxxx Xxxxxxx): $180/hour |
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Senior Regulatory Consultant (Xxxx Xxxx): $225/hour |
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Principal: (Xxxxxxx Xxxxxx; Xxxxxx Xxxxxxxxxx): $315/hour |
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Administrative Services: $40/hour |
Travel
time is billed at ½ the above hourly
rate
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c) |
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Invoices and Payment — Anson will invoice Client for services provided under
this PA. Client agrees to pay such invoices upon receipt. Payment shall be made in U.S.
Dollars by a check drawn on a U.S. bank or by wire transfer to the account listed on
the invoice. Other standard or specific payment terms may be listed on the invoice. |
Client agrees to accept electronic invoices.
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d) |
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Expenses — As provided in the General Consulting Agreement, Anson shall
invoice for reimbursement of reasonable expenses incurred in providing services |
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| Techniscan Medical Systems 1.
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project asssignment TMS-01
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to Client including, but not limited to, airplane travel, copying, printing,
freight, postage and supplies. |
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6. |
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Term — This PA shall commence on the last date of execution below and continue in
effect until it is completed or terminated by written agreement of the Parties, or by
termination of the General Consulting Agreement. |
Agreed and Accepted:
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| Techniscan Medical Systems 1.
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project asssignment TMS-01
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