CONSULTING AGREEMENT
Exhibit 10.30
This Consulting Agreement (the “Agreement”) is entered into as of July 21, 2008 (the “Effective
Date”) by and between Kips Bay Medical, LLC (the “Company”) and Symbios Clinical, Inc. (“Symbios”).
WHEREAS, the Company desires to engage Symbios for the purpose of assisting the Company in,
clinical activities, as requested on a case-by-case basis during the period of this Agreement; and
WHEREAS, Symbios is willing and able to provide consulting services to the Company according to the
terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants contained
below, the parties agree as follows:
1. Engagement for Consulting Services. Pursuant to the terms of this Agreement,
the Company hereby engages Symbios and Symbios hereby accepts such engagement, to consult with the
Company with respect to its business upon the Company’s request. Symbios is an independent
contractor, and unless specifically authorized in writing by Company, Symbios shall have no
authority to act on behalf of or bind the Company in any way by any promise, representation, or
agreement. Unless specifically authorized in writing by Symbios the Company shall have no
authority to act on behalf of or bind Symbios in any way by any promise, representation, or
agreement. No employee or other person working for or on behalf of a party shall be considered to
be an employee of the other party under any circumstance or for any purpose, including but not
limited to, healthcare or other employee benefits, workmen’s compensation and unemployment
insurance; payment of Federal and State income taxes; estimated taxes; any sales, use and services
taxes; and all other Federal, State, local, and foreign taxes of any nature imposed with respect to
any services or payment under this Agreement.
2. Services to be Rendered
2.1 Statements of Work. Symbios agrees to provide services to the Company as
requested by the Company in connection with activities to be specified during the period of this
Agreement. The consulting services to be performed by Symbios shall be set forth in a statement of
work (“Statement of Work”) executed by the parties and in the form attached to this Agreement.
Each Statement of Work shall set forth (a) a description of the services to be performed and work
to be delivered (the “Deliverables”), as well as specifications therefore (“Specifications”); (b)
the timing of performance; (c) compensation; and (d) other information specific to the project.
Symbios may at its discretion subcontract work outlined in the Statement of Work. Any such work
shall involve an agreement between Symbios and the subcontractor, and will not alter the terms of
this Agreement. A Statement of Work shall be valid and enforceable when signed by an authorized
representative of both parties. Additional work shall not be performed beyond the description,
time and cost stated in the Statement of Work, unless an additional or amended Statement of Work is
executed by an authorized representative of both parties.
2.2 Ownership.
(a) Symbios Documents and Other Technology. Unless otherwise set forth in the
relevant Statement of Work, all document templates used or developed by Symbios in performing the
services hereunder (“Symbios Documents”) shall at all times remain the sole and exclusive property
of Symbios, excluding any Confidential Information of Company contained therein. Symbios hereby
grants to Company a non-exclusive, royalty-free, limited license, to use the Symbios Documents
solely in
conjunction with the Deliverables. Any other technology or materials used by Symbios in the
performance of any services hereunder shall be set forth in the relevant Statement of Work, and the
Statement of Work shall also set forth the ownership rights of the parties in such technology or
materials.
(b) Ownership of Intellectual Property. Except for the portion of the Symbios
Documents not containing Confidential Information, Company will own all right, title and interest
in and to any and all Deliverables, Specifications or other materials developed, originated or
conceived by Symbios in the performance of its obligations under this Agreement (including, but not
limited to, all inventions, ideas, processes, trade secrets, methods, formulas, algorithms, data,
programs, works of authorship, improvements, designs, devices, and techniques conceived or
originated by Symbios with use of Confidential Information or in the course of providing services
hereunder) regardless of the form in which it is provided to Company. Subject to Symbios’
ownership rights in the Symbios Documents as set forth in Section 2.2(a), Symbios hereby assigns to
Company all right, title and interest in and to such Deliverables, Specifications and other
materials, whether or not patentable or registrable under copyright or similar statutes, made or
conceived or reduced to practice or learned by Symbios, either alone or jointly with others, as a
result of Symbios’ performance of this Agreement. Where applicable, original works of authorship
that are made by Symbios, either alone or jointly with others, as a result of Symbios’ performance
under this Agreement and which are protectable by copyright are “works made for hire,” pursuant to
the United States Copyright Act (17 U.S.C., §101).
3. Period of the Contract
3.1 Term. The contract period shall extend one year from the date of this Agreement
and shall renew automatically for a period of one year unless terminated as provided herein.
3.2 Termination. Either party may terminate the Agreement: (a) at any time upon
written notice, effective 14 days after receipt by the other party of the notice; (b) due to a
material breach of this Agreement by the other party, which is not cured within ten (10) days of
receipt of written notice thereof; or (c) at any time effective immediately upon notice to the
other party if a party files a petition of any type as to its bankruptcy, is declared bankrupt,
becomes insolvent, makes an assignment for the benefit of creditors, goes into liquidation or
receivership, or otherwise loses legal control of its business.
3.3 Effect of Termination.
(a) Return of Confidential Information; Submission of Materials. Within thirty (30)
days of termination of this Agreement for any reason, Symbios will return or destroy all copies of
the Confidential Information (as defined in Section 5), and will provide written certification of
destruction, if requested by Company. Upon termination of this Agreement for any reason, any work
undertaken by Symbios up to the date of termination, whether or not completed, will be submitted to
Company within ten (10) days after the effective date of termination and Symbios shall not retain
any copies thereof except that Symbios may retain those portions of the Symbios Documents that do
not contain any Confidential Information.
(b) Payment. Company’s sole obligation on termination shall be the pro rata payment
to Symbios of fees earned and the entirety of any approved expenses incurred by Symbios as a result
of work actually performed prior to the effective date of the termination.
(c) Survival. Sections 2.2, 3.3, and 5 through 12 will survive termination or
expiration of this Agreement for any reason.
4. Compensation
4.1 Fees and Expenses. For the consulting services described herein, Symbios fees
vary based on the volume of work and the level of expertise required. The fees charged for
specific projects will be as expressly set forth in the applicable Statement of Work. Symbios
shall be reimbursed by the
Company for pre-approved expenses incurred by Symbios in performing duties under this
Agreement, including, without limitation travel, supplies, shipping, and third-party vendor
services expenses incurred by Symbios in rendering services. Reimbursement of such expenses shall
be made on the basis of
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itemized statements submitted by Symbios. Upon request, Symbios shall make
available any supporting documentation (e.g. receipts) for such expenses.
4.2 Payment. Symbios will invoice the Company on a monthly basis for time and
expenses incurred during the previous month. Upon acceptance of the Deliverables by Company
pursuant to the applicable Statement of Work, payment of fees and reimbursement for expenses shall
be made within fifteen (15) days of receipt of an itemized monthly invoice and evidence of
expenditures from Symbios.
5. Confidential Information - The parties recognize that all of the Company’s
proprietary and/or confidential information including, but not limited to, operating methods,
technology, ideas, data, devices, trade secrets, inventions, patents, patent applications,
trademarks, trademark applications, processes, improvements, know how, other works of authorship,
designs, marketing and regulatory strategy, customer lists, and any other proprietary or
confidential information (“Confidential Information”) of the Company is unique and was developed or
acquired at great cost to and investment by the Company. As such, any Confidential Information
obtained by Symbios from the Company since the Effective Date, regardless of the form in which it
was disclosed, shall be kept secret and not revealed, divulged, used, or made known to anyone,
except as required by law (based on the opinion of Symbios’ legal counsel and provided that Symbios
provides the Company with reasonable advance notice of such required disclosure, use, release or
divulgence) or to discharge Symbios’ duties described herein.
5.1 Information is not confidential or proprietary if it is in the public domain at the time
the Company discloses it to Symbios, was known to Symbios prior to the Effective Date and disclosed
under no duty of confidentiality, or becomes known to Symbios from a source independent of the
Company and such source is under no duty of confidentiality to Company.
5.2 Symbios may disclose confidential and proprietary information acquired as a result of this
Agreement only to its employees, agents or affiliates who (a) have a need to know such information
for the purpose of Symbios’ performance hereunder, and (b) are subject to a confidentiality or
nondisclosure agreement substantially similar to the confidentiality and nondisclosure terms set
forth in this Agreement that protects as confidential any information disclosed as a result of this
Agreement.
5.3 It is agreed by the parties that the unauthorized disclosure or use of Company’s
Confidential Information would cause immediate or irreparable injury to Company which would not
adequately be compensated by monetary damages. Symbios therefore acknowledges and agrees that
Company may obtain any temporary or permanent injunctive relief necessary to prevent such
disclosure or use, or threat of disclosure or use in addition to other remedies otherwise available
at law or in equity.
5.4 Upon request, all proprietary or confidential documents or electronic information
(including all information and Symbios work product containing Confidential Information) provided
to or generated by Symbios will be returned to the Company or will be destroyed in accordance with
the Company’s instructions except that the Company, in its sole discretion, may allow in writing
Symbios to use certain Confidential Information. No individual Symbios employee assigned to a
project for Company will be allowed to work on a project for a directly competing product during
and for a period of 12 months following the termination of this Agreement. Symbios has established
procedures to ensure that all work and information associated with the affected projects would be
effectively separated through establishment of a “Chinese wall”. All files and activity would be
appropriately segregated to protect Confidential Information and eliminate the possibility of
conflict of interest. In any event, Symbios shall notify Company if Symbios has agreed to perform
services for any person or entity that would be reasonably deemed by Company to be a direct
competitor. Company may terminate this Agreement at any time immediately upon written notice to
Symbios if, in its sole judgment, a conflict of interest exists or is imminent.
6. Warranties, Indemnification and Limitation of Liability.
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6.1 Warranties. Symbios represents and warrants the following to Company: (a)
Symbios’ performance of the terms of this Agreement does not breach any other arrangement or
agreement to which Symbios or any of its employees are a party, or create any conflict of interest
on the part of Symbios or any of its employees whatsoever; (b) all Deliverables will conform to the
Specifications (the failure of the Deliverables to so match the Specifications will be promptly
cured by Symbios at the Company’s request during the term of this Agreement); and (c) the Symbios
Documents will not infringe any patent, copyright, trade secret or other intellectual property
rights of any third party.
6.2 Indemnification. Symbios will indemnify, defend and hold Company harmless against
any and all losses, damages, demands, costs and expenses, including reasonable attorney’s fees,
arising from any suit, claim or proceeding brought against Company by a third party relating to:
(i) use of the Symbios Documents and other technology; and (ii) a breach by Symbios of its
obligations under this Agreement, including, without limitation, the representations and warranties
described in Section 6.1. The Company will promptly notify Symbios of any such claim, and will
assist Symbios in defending the action by providing, at Symbios’ expense, the information and
assistance Symbios reasonably needs.
Company agrees to defend, indemnify and hold Symbios harmless against any and all losses, claims,
demands, judgments and liability, including reasonable attorney’s fees, resulting from the
Company’s gross negligence or intentional misconduct under this Agreement, except to the extent
that such losses, costs, claims, demands, judgments or liability are due to Symbios’s negligence or
wrongful act(s).
6.3 Limitation of Liability. Neither party will be liable to the other for any
special, incidental, consequential, indirect, or punitive damages (including, without limitation,
loss of profits), even if advised of the possibility thereof.
7. Waiver and Modification; Severability - No breach of any provision of this
Agreement by the parties can be waived unless it is in writing. Waiver of one breach shall not be
deemed a waiver of any other breach of the same or any other provision in the Agreement. This
Agreement can be modified only by written agreement of both parties. If any provision of this
Agreement is found unenforceable under any of the laws or regulations applicable thereto, that or
provision term will be deemed stricken from this Agreement, but such invalidity or unenforceability
will not invalidate any of the other terms or provisions of this Agreement.
8. Governing Law - The laws of Minnesota govern the validity, construction, and
performance of this Agreement.
9. Entire Agreement; Assignment; Binding Effect. - This document and all
attachments hereto constitute the entire Agreement of the parties. In the event of a conflict
between the terms of this Agreement and any Statement of Work, the terms of the Statement of Work
shall control. For the convenience of the parties hereto, this Agreement may be executed in any
number of counterparts, each of which shall be deemed an original for all purposes, and all of
which, taken together, shall upon execution and delivery of identical counterparts by both of the
parties, comprise a single agreement. This Agreement supersedes any and all prior oral or written
agreements, arrangements, or communications by and between the parties with respect to the subject
matter hereof. Symbios shall not assign any of its rights or obligations under this Agreement
without the prior written consent of Company. This Agreement shall be binding on the parties
hereto and their respective successors and permitted assigns.
10. Force Majeure. Neither party shall be liable for its failure to perform any
of its obligations under this Agreement due to any circumstances beyond its reasonable control,
including, without limitation, acts of government, riots, disturbance, war, strikes, prolonged
shortage of supplies, fire, flood, and other natural disasters, provided that the party
experiencing the delay promptly notifies the other of the delay.
11. Notices. Any notice required or permitted to be given under this Agreement
will be in writing and will be deemed effective on the personal delivery of that notice, if mailed,
forty-eight (48) hours after being
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deposited in the United States mail, postage prepaid, and
addressed to the party to whom it is directed at the address set forth above (or such other address
provided in writing to the other party).
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed for and on behalf
of each through their employee or agent duly authorized to execute this Agreement, to be effective
as of the date provided on the first page of this Agreement.
For:
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Symbios Clinical, Inc. | For: | Kips Bay Medical, LLC | |||||
By:
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/s/ Xxxx Xxxxxx
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By: | /s/ Xxxx Xxxxxxx
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|||||
Name:
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Xxxx Xxxxxx | Name: | Xxxx Xxxxxxx | |||||
Title:
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President and CEO | Title: | Vice President |
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STATEMENT OF WORK
Summary of Work:
Symbios Clinical will manage data for the Kips Bay Medical study (protocol# 08-001), titled “eSVS
Mesh External Saphenous Vein Support Trial”
Scope of Work:
The following material assumptions apply to this Attachment
| • | # Sites: 6 | ||
| • | # Patients: 120 | ||
| • | Study Type: Medical Device IDE | ||
| • | Geography: Multiple investigational sites internationally | ||
| • | Clinical Database: ClinDex |
Description of Services, Budget and Payment Scheduled
The parties acknowledge the cost uncertainties inherent to this Work Order, and that the costs in
this Work Order are based on incomplete information and/or information exchanged by the parties. In
the event that during the study, Company requests that Symbios Clinical provide services that
differ significantly from the assumptions laid forth in this Statement of Work, the parties agree
that that monthly payment amount will be adjusted to reflect the change in the level or timing of
services. Such adjustments must be agreed to by the parties in writing.
The following are the services and fees corresponding to this Statement of Work:
| • | Database Development |
| o | Creation of case report forms and fields in ClinDex including edit checks. Development of study reports for managing study and reporting study progress. Includes validation and 21CFR Part 11 compliance statement. | ||
| o | $19,000 payable upon completion of database (excluding edit checks and defined reports) | ||
| o | $5,000 payable upon completion of edit checks and defined reports |
| • | Patient Binder Preparation |
| o | Create patient binder (print CRFs and tabs, collate in patient binders, ship to site). Track and replenish patient binders as needed. | ||
| o | $10 per patient binder payable when sent to sponsor |
| • | Data Entry |
| o | First and second pass double data entry. | ||
| o | $3 per CRF per entry payable upon completion each data entry pass |
| • | Data Review |
| o | Review all data for accuracy and completeness. Create discrepancy clarification forms and communicate with sites to resolve discrepancies. | ||
| o | $10 per patient per CRF payable upon completion of review |
| • | Database Maintenance |
| o | Ongoing maintenance of database, backups, database user administration | ||
| o | $250 per month payable at the end of each month, pro-rated for partial months |
| • | Achieving |
| o | Final achieving of database and transfer of data to sponsor. | ||
| o | $1,500 payable upon deliverable and acceptance of archived data on storage media |
Invoicing will be done monthly and contain any of the above applicable fees incurred in the prior
month.
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For:
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Symbios Clinical, Inc. | For: | Kips Bay Medical, LLC | |||||
By:
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/s/ Xxxx Xxxxxx
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By: | /s/ Xxxx Xxxxxxx
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|||||
Name:
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Xxxx Xxxxxx | Name: | Xxxx Xxxxxxx | |||||
Title:
|
President and CEO | Title: | Vice President |
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