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Exhibit 10.33
[ETHICON ENDO-SURGERY LETTERHEAD]
February 28, 1996
Xx. Xxxx Xxxxx, CEO
MediOual Systems, Inc.
0000 Xxxx Xxxx Xxxxx, Xxxxx 000
Xxxxxxxxxxx, XX 00000
Re: CONSULTING AGREEMENT
Dear Xx. Xxxxx:
Representatives of Ethicon Endo-Surgery, Inc. ("Ethicon") and your
company, MediOual Systems, Inc. (referred to as "Consultant"), have had
discussions concerning the desirability of Consultant rendering professional
consulting services to Ethicon in the solution of agreed upon problems. Ethicon
wants to engage such services, and Consultant wants to render them, subject to
the following Agreement which shall become effective upon the last date of
signature of this Agreement by both parties.
1. Consultant shall use its best efforts to provide consulting services to
Ethicon as described below, to keep Ethicon advised of the progress of the work,
to permit any representative of Ethicon to inspect from time to time the results
of its consulting services as are susceptible of inspection, to provide Ethicon
with reports, specifications, drawings, models, and the like, as are appropriate
to the nature of the services which Consultant will perform, and to keep records
of hours worked and cost of materials used, as well as other reasonable
out-of-pocket expenses, which such records Ethicon's representative may examine
upon reasonable notice to Consultant.
2. Any confidential information acquired by Consultant from Ethicon
concerning existing or contemplated machines, products, processes, techniques,
or know-how, or any information or data developed pursuant to the performance of
the consulting services below shall not be disclosed by Consultant to others or
used for Consultant's own benefit without the written consent of Ethicon.
Consultant's obligations under this paragraph and under Paragraph 3 below shall
survive the expiration or termination of this Agreement.
3. (a) Any * or * or *
Consultant in connection with or during the performance of services for Ethicon
shall * . Consultant, * to Ethicon other
than * for * in the event this Agreement shall have
terminated, but at * , shall * to
Ethicon all * , including * , as may be
* to enable Ethicon to * such * ,
* by * or
* Confidential portions have been omitted and filed separately with the
Commission.
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otherwise in * and to * to said * ,
* Ethicon or its * , their * .
Consultant shall render assistance as Ethicon may require in any *
* .
Consultant, as part of the services to be performed below, shall *
* of its * , properly * for use as * ,
and shall * such * to * when requested or at the termination of
the * .
(b) Any copyrightable work whether published or unpublished created by
Consultant in connection with or during the performance of services below shall
be considered a work made for hire, to the fullest extent permitted by law and
all right, title and interest therein, including the worldwide copyrights, shall
be the property of Ethicon as the employer and party specially commissioning
such work. In the event that any such copyrightable work or portion thereof
shall not be legally qualified as a work made for hire, or shall subsequently be
so held to not be a work made for hire, Consultant agrees to assign, and does
hereby so assign to Ethicon, all right, title and interest in and to such work
or portion thereof, including but not limited to the worldwide copyrights,
extensions of such copyrights, and renewal copyrights therein, and further
including all rights to reproduce the copyrighted work in copies or
phonorecords, to prepare derivative works based on the copyrighted work, to
distribute copies of the copyrighted work, to perform the copyrighted work
publicly, to display the copyrighted work publicly, and to register the claim of
copyright therein. Consultant, without charge to Ethicon, shall duly execute,
acknowledge, and deliver to Ethicon all further papers, including assignments
and applications for copyright registration or renewal, as may be necessary to
enable Ethicon to publish or protect such works by copyright or otherwise in any
and all countries and to vest title to said works in Ethicon, or its nominees,
their successors or assigns, and shall render all such assistance as Ethicon may
require in any proceeding or litigation involving the rights in such works.
4. Should Consultant's services below require the employment by Consultant
of third party personnel, Consultant shall employ only those whose employment
shall be approved by Ethicon in writing and who have for the benefit of Ethicon
executed an agreement containing provisions of the character and scope of
Paragraphs 2 and 3 above; except that Ethicon may waive the requirement that
such agreements be executed in the case of stenographic and certain other
nonprofessional personnel regularly employed at Consultant's place of business
and whose work is performed strictly in accordance with Consultant's directions.
5. Ethicon reserves the right to discontinue at any time any work upon
which Consultant shall have been engaged for Ethicon in which event Ethicon
shall be obligated to pay Consultant only for work done by Consultant and cost
of materials for which Consultant has become obligated in connection with the
contemplated services up to the date of such discontinuance.
* Confidential portions have been omitted and filed separately with the
Commission.
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6. During the term of this Agreement, including any renewals or extensions
thereof, and for a period of * thereafter, Consultant agrees not to
* for * involving the *
* of any * relating to the
* without a * from Ethicon.
7. Ethicon hereby offers to engage and Consultant accepts engagement by
Ethicon of Consultant's professional services as set forth in Appendix A (copy
attached) and as further set forth as follows:
C.U.P.I.D. Project - Development of Protocol/Table Shells/Analytic
Plan
C.U.P.I.D. Project - Ongoing Data Processing and Analysis for HMOs
C.U.P.I.D. Project - Chart Abstraction, Data Collection and Analysis
for HMOs Physician BenchMark Databases - Data Processing and
Analysis, Creation of Physician-specific databases for Ethicon.
8. In consideration of its acceptance of this Consulting Agreement and of
its performance of the professional services as specifically set forth in
Paragraph 7 above, Ethicon shall pay Consultant as set forth in Appendix A, but
in no event shall Ethicon be required to pay an amount which exceeds *
* of any of the * set forth in Appendix A without the mutual
consent of the parties.
9. Consultant represents that it does not have an obligation, whether
express or implied, to any third party that would interfere, hamper or limit his
ability to render the professional services as described above. In conducting
other activities, Consultant will not take a position or represent interests
that conflict with Ethicon's interest during the initial term or any extended
term of this Agreement.
10. Consultant shall not assign this Agreement or any part thereof without
Ethicon's prior written approval. Ethicon may, without Consultant's consent,
assign or extend this Agreement including all rights and obligations hereunder
at any time to any of its affiliates, or to any entity acquiring substantially
all of Ethicon's assets to which this Agreement relates.
11. For the purpose of this Agreement and all services to be provided
under this Agreement, Consultant shall be and shall be deemed to be, an
independent contractor and not the agent or employee of Ethicon. Consultant
shall be solely responsible for the payment when applicable of any licenses,
taxes, or any and all other costs associated with Consultant's complying with
pertinent laws and regulations. Consultant agrees that it will not be entitled
under this Agreement to participate in any benefit plans which Ethicon or its
affiliates sponsor for its employees.
12. The term of this Agreement shall be for one (1) year from the date set
forth below unless renewed or otherwise extended by mutual written agreement.
*Confidential portions have been omitted and filed separately with the
Commission.
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13. Any controversy or claim arising out of or relating to this Agreement,
or the parties' decision to enter into this Agreement, or the breach thereof,
shall be settled by arbitration in accordance with the provisions, then
obtaining, of the Commercial Arbitration Rules of the American Arbitration
Association, and judgment upon the award rendered by the arbitrator(s) may be
entered in any court having jurisdiction thereof. The arbitration shall be held
in Cincinnati, Ohio and the arbitrators shall apply the substantive law of Ohio
except that the interpretation and enforcement of this arbitration provision
shall be governed by the Federal Arbitration Act. The arbitrators shall not
award either party punitive damages and the parties shall be deemed to have
waived any right to such damages.
14. The validity and interpretation of this Agreement and the legal
relations of the parties to it shall be governed by the internal laws of the
State of Ohio.
15. This document contains the entire agreement between the parties and
supersedes all preexisting agreements between the parties respecting its subject
matter. Modification of this Agreement shall only be effective if made in
writing and signed by both parties.
This Agreement is signed below in duplicate on the dates set forth below
by an authorized representative for each of the respective parties.
Consultant Ethicon Endo-Surgery, Inc.
By: /s/ Xxxx Xxxxx By: /s/ Xxxxxxxx X. Xxxxxxxxx
------------------- ---------------------------------
Xxxx Xxxxx, CEO Xxxxxxxx X. Xxxxxxxxx, Vice President
Sales and Marketing
Date: 4/1/96 Date: 3/28/96
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APPENDIX A
CUSTOMER UTILIZATION BY PROCEDURE INFORMATION DATABASE (C.U.P.I.D.) PROJECT
REVISED PROPOSAL
Study Types
1. Analysis of billing (claims) information from clients for patients based on
procedures or other parameters.
2. Analysis of information mased on chart review of patients based on procedures
or other parameters.
3. Analysis of electronic chart-based information of patients based on
procedures or other parameters
Objective
The objective would be to help clients, including HMO's, provider/hospitals, and
physicians, analyze their current modalities of therapy and determine where
there might be opportunities to convert current treatment modalities to
videoscopic procedures.
Methods
Three methods are proposed:
1. Study based entirely on a review and compilation of information from billing
or claims information systems;
2. Study based on a combination of billing/claims information and a targeted
chart review of select patients, and
3. Compile a database of select "benchmark' physicians, based on electronic
chartbased information supplied by those physicians.
Design
All studies will involve a retrospective analysis of patients with select
profiles or treatments at select managed care or provider locations. The data
will be gathered through electronic downloads and/or chart review using the
MediQual Systems, Inc. abstraction and glossary methodology. Ethicon
Endo-Surgery, Inc. will develop, with the assistance of MediQual and other
parties, a proprietary glossary specific to Ethicon Endo-Surgery's needs.
Patient Identification
Patients will be uniquely identified based on an initial electronic review of
the claims or charts using CPT-4 or ICD-9 codes or other Ethicon Endo-Surgery
designated parameters. These patients will then undergo a review of electronic
information alone or review of electronic information plus additional chart
abstraction.
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Settings
The settings will consist of those selected by Ethicon Endo-Surgery for this
study. This will consist of either select outpatient settings, select inpatient
settings, select physician practices, or a blend of settings. The data from
these settings will be gathered and analyzed on an individual basis and made
available to the client, Ethicon EndoSurgery, or both. The number of patients
analyzed will vary by setting. The quoted source of the data may be MediQual,
Ethicon Endo-Surgery, or the client itself, depending upon individual project
preferences. Comparative information from MediQual's comparative database is
available for inpatient settings only and is available for use in these studies.
Patient Follow-Up
In all studies, the proposed follow-up time period would be up to twelve (12)
months following the sentinel procedure event, with other data (up to six [6]
months) being collected before the sentinel event. Depending upon the nature of
the situation, additional follow-up, beyond the above period, may be available.
The actual time period shall be dynamic by customer.
Sample Size
The studies will include all patients at the individual setting with the exact
number to be determined for each project. Other criteria may be used if
statistical comparisons of certain sub-groups will be undertaken. Generally,
claims will be analyzed for the entire population, whereas charts will be
reviewed for a subset of the population.
Patient Characteristics
A number of characteristics will be used to describe the patients, and, where
comparisons are done, to ascertain whether the patients in the various treatment
arms are comparable. These include a variety of uni-variate analyses comparing
age, gender, diagnosis, co-morbidity, etc. Exclusion criteria will be further
delineated as part of the formal protocol, whereas charts will be reviewed for a
subset of the population.
Data Gathering Options
For the electronic portion of the study, MediQual will gather the electronic
information which is available on these patients. If the chart review option is
used, the inpatient MediQual glossary used for gathering information on a
consistent basis would be reviewed, edited, and supplemented (after joint
discussions between Ethicon EndoSurgery and MediQual ) in order to ascertain
which data elements may need to be collected in both the outpatient and the
inpatient settings. These data elements may include patient demographic
information, historical information, co-morbidity data, symptoms, physical
findings, diagnostic test results, lab results, use of certain surgical
techniques, health care utilization data, monitoring and follow-up data, and
educational interventions. Of note, some of these data elements may be gathered
either manually or electronically (depending on availability of the information)
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Appendix A - Revised C. U. P. I. D. Proposal
2/16/96
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Study Outcomes
The final reports will contain a variety of tables and analyses, with the output
to be determined after discussions between Ethicon Endo-Surgery and MediQual The
output will probably include the following:
1. Number of patients who received a targeted procedure, by surgical technique
used
2. Number of patients eligible for treatment with videoscopic techniques
3. Diagnostic procedures preceding and following the surgery, by surgical
technique used
4. Baseline descriptions:
a) Co-morbidity
b) Demographic characteristics (age, sex, race, insurance classifications,
etc.)
c) Number of patients treated by the type of physician
5. Complications, by surgical technique
6. Resource consumption by surgical technique:
a) Physician visits
b) Hospitalization rates
c) ER visits
d) Clinic visits
e) Charges/payments (if available)
7. Unique morbidity, utilization, and other factors will be developed with
MediQual but be proprietary to Ethicon Endo-Surgery.
Analyses
The statistical significance of differences in outcomes will be evaluated, when
appropriate, by both uni-variate means (t-test for means and chi-squared test
for proportions). Comparisons to other settings may be possible once a
sufficient database is accumulated.
Timing and Possible Points of Delay
The timing for this project is dependent upon a number of factors as described
below:
- Protocol development and finalization ( * )
- Depends on availability of personnel at Ethicon Endo-Surgery, MediQual, and
outsiders (at Ethicon Endo-Surgery's discretion) to come for *
meetings. The lead role will be taken by MediQual with periodic reviews at
Ethicon Endo-Surgery involving key personnel (clinicians, statisticians,
outcomes personnel, etc.).
- Depends on internal delays at Ethicon Endo-Surgery for protocol approval.
- Data gathering - electronic only
- Depending on the availability and quality of data ( * ).
* Confidential portions have been omitted and filed separately with the
Commission.
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Appendix A - Revised C. U. P. I . D. Proposal
2/16/96
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Data gathering (chart abstraction) ( * )
- Actual abstraction can take, depending on the setting and number of
abstractors, * .
- Delays may develop due to IRB approval (may or may not be necessary) and
availability of staff at the setting to identify patients and pull medical
records.
- Development of analytic plan, table shells, and programming ( * )
- This will run concurrently with the protocol development and the data
gathering.
Data analysis and reporting (electronic only)
- Depending on data quality ( * ).
- Data analysis and reporting (chart abstraction) ( * )
- This time may increase if there are special analyses performed, above and
beyond what is in the analytic plan.
- Benchmark databases
- Development of the public inpatient databases will take *
- Development of the CUPID electronic and electronic/manual summary database
will take * after the data is available for those plans which will
be in the database
- Development of the summary database for the physicians with electronic
charts will depend on both the time to develop the protocol and the time to
gather and analyze the data. Due to the variety of chart types and the
different ways of collecting the data points, protocol development and
cleaning up of the tapes could be a fairly major undertaking.
Overall, it is estimated that the initial development plan will take *
with data gathering and analysis at each additional setting, depending on the
type of study and the delays at the setting, taking * . Of note,
MediQual has the resources to undertake analysis or data gathering at numerous
study sites concurrently.
BUDGET
Administrative Data Analysis
- Project Development - electronic download ( * )
- Develop protocol
- Develop analytic plan
- Develop table shells
* Confidential portions have been omitted and filed separately with the
Commission.
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- Provision of analysis
- If data tape is clean ( * )
- If data tape is dirty ( * /hour for tape cleanup)
Chart Abstraction
- Project development - electronic download and manual abstraction ( * )
- Develop protocol
- Develop glossary and data entry tools
- Develop analytic plan
- Develop table shells
- Data gathering
- Manual abstraction ( * per chart, depending on complexity of data
elements)
- Provision of analyses
- MediQual performed analysis ( * per site)
Example of Chart Abstraction Project
Manual abstraction of 100 charts @ * per chart *
MediQual performed analysis *
Abstractor travel *
------
*
Note: Abstraction costs will vary, based on the complexity of the final data
elements chosen, and the number of charts chosen to abstract. Travel costs
will vary, based on the site's geographic location.
Development of both protocols concurrently ( * )
- Synergy of plan would permit the development to cost less for both projects (
- Individual institution data provision as above
"Benchmark" Datasets - Four different types of benchmark datasets are available
and these include:
- Compilation of the inpatient state databases which contain physician level
information
- Compilation of the electronically derived data, as described above
- Compilation of the electronically and chart reviewed data, as described above
- Compilation of the data supplied by physicians based on their electronic
charts
* Confidential portion has been omitted and filed separately with the
Commission.
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Appendix A - Revised C. U. P. I. D. Proposal
2/16/96
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Option 1: Inpatient physician level detail from 8 states (Public Data)
Custom database on top 5-10% performers overall ( * ) - or
Custom database, physician license numbers supplied by Ethicon
electronically ( * )
Option 2: Compilation of the electronically derived claims data, as above
Provision of database on all plans - assuming no changes ( * )
Option 3: Compilation of the electronically derived and chart reviewed
information
Provision of database on all plans - assuming no changes ( * )
Option 4: Compilation of the data supplied by physicians electronic charts
(Note: This option assumes identical protocol and analytic plan to
the C.U.P.I.D. project; if any changes or new work are necessary, a
new protocol and/or analytic plan must be devised for additional
fees)
Processing fees for electronic information ( * /hour)
Provision of the database for all sites collected ( * )
Note: The above quoted figures do not include such items as travel, honoraria to
individuals or institutions, or other out-of-pocket expenses.
* Confidential portions have been omitted and filed separately with the
Commission.
