SERVICES AGREEMENT
This Agreement is effective this 23rd day of April, 1996, (the "Effective
Date") between Disease State Management, Inc., 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx
Xxxx 00000 ("DSMi" or "Vendor") and Xxxxxxx-Xxxxx Squibb Oncology/Immunology, a
division of Xxxxxxx-Xxxxx Squibb Company, X.X. Xxx 0000, Xxxxxxxxx, Xxx Xxxxxx
00000-0000 (hereinafter called "BMS"). Vendor agrees to provide services to BMS
under the terms set forth below.
A. SERVICES
Vendor will provide the product(s) or service(s) set forth, and to the
specifications set forth in the proposal incorporated herein as Attachment
A.
The product and all material elements as set forth on Attachment A are
subject to prior approval by BMS, such approval not to be unreasonably
withheld.
B. COMPENSATION
BMS will pay Vendor according to the terms or payment schedule set forth in
Attachment A hereto.
In the event that BMS shall request any changes in the concept,
specifications or scope of the product(s) or service(s) described on
Attachment A hereto, Vendor will notify BMS of the cost of such revisions
and will not proceed without prior approval.
If the compensation provision on Attachment A hereto is other than a flat
fee amount per element or for the entire project, Vendor will provide such
documentation in support of all xxxxxxxx as BMS may reasonably require.
C. CONFIDENTIALITY
Vendor shall treat as confidential and secret any and all BMS Confidential
Information. "BMS Confidential Information" shall include, but not be
limited to, information relating to BMS' past, present and future marketing
and research and development activities that may be disclosed to Vendor by
BMS and/or BMS' parent, subsidiary or affiliate companies and which are
identified in writing by BMS as confidential. BMS Confidential information
shall not include (i) information known by Vendor prior to disclosure from
BMS. (ii) information which is or becomes publicly known through no
wrongful act of Vendor, (iii) information that is independently developed
by Vendor, without use of information that otherwise constitutes BMS
Confidential Information, or (iv) information disclosed pursuant to law,
rule, regulation or pursuant to a court order, provided that BMS is given
10 days prior notice of such disclosure. Vendors obligations not to
disclose BMS Confidential Information to third parties shall survive the
termination of this Agreement for a period of five years. Vendor shall not
duplicate any material containing BMS Confidential
Information, except in the direct performance of its services under this
Agreement. Vendor shall return all copies of materials containing BMS
Confidential Information upon Vendor's completion of services under this
Agreement or upon any earlier termination of this Agreement for any reason
whatsoever.
BMS shall treat as confidential and secret any and all Vendor Confidential
Information. "Vendor Confidential Information" shall include, but not be
limited to, information relating to Vendor's past, present and future
systems development activities that may be disclosed to BMS and/or BMS'
parent, subsidiary or affiliate companies and which are identified in
writing by Vendor as confidential, except that in no event shall Vendor
Confidential Information include information relating to Vendor
deliverables under this agreement. Vendor Confidential lnformation shall
not include (i) information known by BMS prior to disclosure from Vendor,
(ii) information which is or becomes publicly known through no wrongful act
of BMS, (iii) information that is independently developed by BMS, without
use of information that otherwise constitutes Vendor Confidential
Information, or (iv) information disclosed pursuant to law, rule,
regulation or pursuant to a court order, provided that Vendor is given 10
days prior notice of such disclosure. BMS' obligations not to disclose
Vendor Confidential Information shall survive the termination of this
Agreement for a period of five years. BMS shall return all copies of
materials containing Vendor Confidential Information upon Vendor's
completion of services under this Agreement or upon any earlier termination
of this Agreement for any reason whatsoever.
D. INDEMNIFICATION
Each party shall indemnify and hold the other party harmless from and
against all liability, damages, penalties, losses, costs or expenses,
including attorneys' fees, arising from or in any way related to its
willful or negligent actions or omissions in performing the
responsibilities as described in this Agreement, or for any willful or
negligent breach of this Agreement. BMS shall indemnify and hold Vendor
harmless from and against all liability, damages, penalties, losses, costs
or expenses, including attorney's fees, arising from or in any way related
to any and all medical malpractice claims or litigations involving Vendor
arising from a patient's use of Megace-Registered Trademark-Oral
Suspension.
E. PROFESSIONAL STANDARDS
Vendor represents that it has facilities, personnel, experience and
expertise sufficient in quality and it will perform all such assignments
and projects given it by BMS hereunder and agrees that it will perform all
such assignments and projects in a manner commensurate with professional
standards generally applicable to its industry.
F. OWNERSHIP OF MATERIALS
Any and all telephone scripts or written materials created by Vendor for
BMS in connection with this Agreement shall be the sole and exclusive
property of BMS. BMS
may use such work wherever and whenever it chooses. This Agreement shall
be deemed a transfer of copyright and any copyrightable subject matter
created by Vendor in such works. Vendor shall execute any and all
documents necessary to demonstrate or perfect such transfer. Vendor shall
not at any time in any manner during or after this Agreement, under any
circumstances, be entitled to or claim any right, title or interest herein
or any commission, fee or other direct or indirect benefit from BMS or BMS'
parent, subsidiary or affiliate companies, in respect of such works created
by Vendor hereunder. Vendor agrees to execute or cause its agents and/or
employees to execute any documents necessary or desirable to secure or
perfect BMS' legal rights and worldwide ownership in such works, including,
but not limited to documents relating to trademark and copyright
applications.
G. RELEASES
Any materials furnished hereunder which have not been created for BMS and
are subject to the rights of third parties shall be specifically identified
to BMS in writing. Vendor shall obtain (and deliver upon request to BMS)
releases for all names, photographs, illustrations, testimonials, and any
and all other materials used in works which Vendor prepares or uses. All
such releases shall run to BMS, its agents and employees where appropriate
and customary. Vendor's failure to obtain such releases or the obtaining
of such releases by Vendor shall in no way relieve Vendor of its
obligations in Paragraph F above except where the releases have been
obtained directly by BMS. Except for works that have been secured by
permission, Vendor warrants and covenants that all works provided by Vendor
shall be original and shall not infringe any copyright or violate any
rights of any persons or entities whatsoever.
H. DURATION OF AGREEMENT
1. Term
This Agreement is effective as of the Effective Date and shall continue in
full force and effect for twelve (12) months unless terminated by at least
ninety (90) days written notice by either party to the other, sent by
registered mail to the address for each party first set forth above, or to
such other address which a party may designate for its receipt of notices
hereunder.
2. Payment on Termination
Upon termination of this Agreement BMS is to pay for all authorized work in
process, and BMS shall assume Vendor's liability under and indemnify Vendor
with respect to all outstanding contracts made in connection with Vendor
services under this Agreement. Upon written notice of termination Vendor
shall take all steps necessary to wind up the work under this Agreement and
to mitigate BMS' liability therefore. Should Vendor terminate the
agreement, during a period of time during which BMS has the exclusive right
to the program as described in the Exclusivity section of this Agreement,
it shall not engage or participate in any other project involving the
development or implementation
of an interactive program primarily focused on Weight Enhancement for
patients with Cancer or AIDS for twelve months from the date of
termination. Vendor also agrees to perform services under this Agreement
the shorter of six months or until an alternative source for those services
can be obtained should it terminate this Agreement.
3. Transfer Upon Termination
Vendor shall transfer, assign and make available to BMS or BMS'
representative all property and materials in Vendor's possession or control
belonging to and paid for by BMS, and all information regarding BMS'
project(s) covered by this Agreement, as set forth in Paragraph C herein.
Vendor also agrees to give all reasonable cooperation toward transferring
with approval of third parties in interest all contracts and arrangements,
if any, properly entered into by Vendor in the performance of this
Agreement, and all rights and claims thereto and therein, upon being duly
released from the obligation thereof.
I. INDEPENDENT CONTRACTORS
The parties to this Agreement are independent contractors and nothing
contained in this Agreement shall be construed to place the parties in the
relationship of employer and employee, partners, principal and agent, or
joint venture. Neither party shall have the power to bind or obligate the
other party nor shall either party hold itself out as having such
authority.
J. THIRD PARTY OBLIGATIONS
In connection with this Agreement, Vendor shall make no commitments or
disbursements, incur no obligations nor place any advertising, public
relations or promotional material for BMS' parent, subsidiary or affiliate
companies, nor disseminate any material of any kind using the name of BMS
and/or BMS' parent, subsidiary or affiliate companies or using their
trademarks, without the prior written approval of BMS.
K. GOVERNING LAW
This Agreement is entered into in the State of New Jersey and shall be
construed and governed under and in accordance with the laws of that State.
L. MISCELLANEOUS
1) The terms of this Agreement shall be binding upon BMS and Vendor and
their respective successors and permitted assigns. Notwithstanding the
foregoing, this Agreement is not assignable in whole or in part by Vendor
without the prior written consent of BMS. Factoring of accounts receivable
is not permitted.
2) The failure of either party to take action as a result of a breach of
this Agreement by the other party shall constitute neither a waiver of the
particular breach involved nor a waiver of either party's right to enforce
any or all provisions of this Agreement through any remedy granted by law
or this Agreement.
3) BMS is an Equal Opportunity Employer and does not discriminate against
any person because of race, color, creed, age, sex, or national origin.
Vendor represents that it has the same policy of Equal Opportunity
Employment.
4) The policy of BMS is to protect the health, safety and quality of life
of its employees and the public, and to exercise responsible stewardship of
natural resources that may be impacted by its activities. To realize this,
BMS is committed to maintaining programs and procedures for the
environmentally responsible management of facilities, materials, production
processes, products and packaging, transportation and distribution, waste
and ft minimization, energy, general business operations and contracted
goods and services. Vendor agrees with this policy and further
acknowledges that its performance under this Agreement shall be in strict
compliance with all applicable governmental laws and regulations and in
accordance with and in furtherance of this policy.
5) This Agreement contains the entire understanding of the parties with
respect to the subject matter contained herein, supersedes any prior
written or oral communications and may be modified in writing subject to
mutual agreement of the parties hereto.
6) The headings of each paragraph are for reference only and shall not be
construed as part of this Agreement.
7) Except for the obligation to pay money property due and owing, either
party shall be excused from any delay or failure in performance hereunder
caused by reason of any occurrence or contingency beyond its reasonable
control, including, but not limited to, failure of performance by the other
party, earthquake, labor disputes, riots, governmental requirements,
judicial requirements, inability to secure materials on a timely basis,
failure of computer equipment, failures or delays of sources from which
information or data is obtained and transportation difficulties.
IN WITNESS WHEREOF, the parties hereto, each by a duly authorized officer, have
entered in to this Agreement this 23 day of April, 1996.
Xxxxxxx-Xxxxx Squibb Disease State Management, Inc.
Oncology/Immunology 00 Xxxxxx Xxxxxx
a division of Xxxxxxx-Xxxxx Xxxxxxxxx, Xxx Xxxx 00000
Squibb Company
X.X. Xxx 0000
Xxxxxxxxx, Xxx Xxxxxx 00000
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxxx X. Xxxxxx
--------------------------- ---------------------------
Title: Vice President Title: Vice President, Sales
------------------------ ------------------------
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
WEIGHT ENHANCEMENT
PATIENT INTERVENTION PROGRAM
-----------------------------
FOR
XXXXXXX-XXXXX SQUIBB
ONCOLOGY/IMMUNOLOGY
PRESENTED BY
DISEASE STATE MANAGEMENT,-SM- INC.
00 XXXXXX XXXXXX
XXXXXXXXX, XXX XXXX 00000
000-000-0000
WEIGHT ENHANCEMENT
PROGRAM OVERVIEW
NEEDS ASSESSMENT
DSMI-SM-, under the direction of Xxxxxxx-Xxxxx Squibb, Oncology/Immunology, will
perform a comprehensive needs assessment to establish the fundamental goals,
objectives and data sets for the intervention protocol. The needs assessment
portion of the project development shall include:
I. Establishment of an Expert Consultation Panel. The panel will consist of
an Oncologist, an Immunologist, a Dietitian, a Nurse, a Social Worker and a
DSMI-SM- clinical development staff member. Recruitment of the clinical
consultants shall be the responsibility of and at the discretion of BMS.
Contracting of the clinical consultants shall be the responsibility of
DSMI-SM-. BMS agrees to review/accept advisory board recommendations. The
panel will assist in the development of the following:
A. Intervention protocol E. Baseline parameters
B. Program goals F. Inclusion/exclusion criteria
C. Data sets G. Appropriate DRG/ICD - 9 codes
D. Outcomes evaluation protocol
II. DSMI-SM- will perform a review of preprinted published materials to provide
a listing of available educational resources pertaining to Anorexia or
Cachexia secondary to a diagnosis of Cancer or AIDS. BMS will direct
DSMi-SM- towards specific organizations which can provide such materials.
2
WEIGHT ENHANCEMENT
PROGRAM GOALS
PATIENTS ON MEGACE-REGISTERED TRADEMARK- THERAPY
1. Patient Intervention (Behavioral Goals):
A. Improve patient understanding and awareness with respect to:
1. Pharmacologic Therapy
2. Nutritional Needs & Guidelines
3. Critical Symptoms
4. Associated Risk Factors
5. Exercise Protocols
6. Improved Body Weight
B. Enhance Patient Motivation and Confidence with respect to:
1. Pharmacologic Therapy
2. Nutritional Needs & Guidelines
3. Critical Symptoms
4. Associated Risk Factors
5. Exercise Protocols
6. Improved Body Weight
C. Enhance Compliance with respect to:
1. Pharmacologic Therapy
2. Nutritional Needs & Guidelines
3. Exercise Protocols
4. Critical Symptoms
D. Facilitate the appropriate use of referral resources with respect to:
1. Nutritional Interventions
2. Pharmacologic Therapy
3. Modification of Associated Risk Factors
4. Health Care Team
E. Facilitate appropriate and timely communication of critical symptoms
and patient compliance concerns to health care providers.
F. Enhance communication of information between patient and health care
providers.
3
WEIGHT ENHANCEMENT
PROGRAM GOALS
AT RISK PATIENTS NAIVE TO MEGACE-REGISTERED TRADEMARK- THERAPY
This intervention program will help patients, who are in advanced stages of
Cancer/AIDS who may have failed on other interventions, with reaching the
following behavioral goals and help the health care provider determine if/when
the patient is a candidate for Megace-Registered Trademark- therapy.
I. Patient Intervention (Behavioral Goals):
A. Improve patient understanding and awareness with respect to:
1. Pharmacologic Therapy
2. Nutritional Needs & Guidelines
3. Critical Symptoms
4. Associated Risk Factors
5. Exercise Protocols
6 Demonstrated Weight Loss
7. Severe Appetite Depression
8. Improved Body Weight
B. Enhance Patient Motivation and Confidence with respect to:
1. Pharmacologic Therapy
2. Nutritional Needs & Guidelines
3. Critical Symptoms
4. Associated Risk Factors
5. Exercise Protocols
6. Improved Body Weight
C. Enhance Compliance with respect to:
1. Nutritional Needs & Guidelines
2. Exercise Protocols
3. Critical Symptoms
4. Improved Body Weight
D. Facilitate the appropriate use of referral resources with respect to:
1. Pharmacologic Therapy
2. Nutritional Interventions
3. Modification of Associated Risk Factors
4. Health Care Team
E. Facilitate appropriate and timely communication of critical symptoms
and patient compliance concerns to health care providers.
F. Enhance communication of information between patient and health care
providers.
4
WEIGHT ENHANCEMENT
PROGRAM GOALS
II. BUSINESS GOALS WHICH MAY BE ENHANCED:
X. XXXXXXX-XXXXX SQUIBB, ONCOLOGY/IMMUNOLOGY
1. Enhance competitive position
2. Encourage drug compliance/secure adherence to therapy
3. Strengthen customer commitment to BMS partnership
4. Provide powerful customer driven selling tool
5. Enhance alliance with major home health care providers
6. Enhance economic position
7. Enhance leadership position in Oncology
8. Strengthen leadership position in HIV
9. Identify patients at high risk
B. INDEPENDENT PRACTICE
1. Early identification of high risk patients
2. Encourage drug compliance/secure adherence to therapy
3. Strengthen patient/provider relationships
4. Empower patients to take an active role in self-management
5. Encourage adherence to established treatment guidelines
5
WEIGHT ENHANCEMENT
PROGRAM SCHEDULE
See the "Program Intervention Description" section for details about each of the
interventions. The selected intervention schedule will be delivered to patients
who are currently on Megace-Registered Trademark- therapy or high risk patients
who are not currently on Megace-Registered Trademark- therapy. Note that the
term "provider" is used to denote a case manager or another health care provider
designated to receive communications regarding the patient.
RATIONALE
The use of physician extenders to provide frequent encouragement, reinforcement
and tracking of targeted symptoms has been shown in models for other disease
entities to improve compliance and the perceived well being of the patient.
Intensive intervention in early stages of a program will facilitate success of
program goals.
I. STANDARD PROTOCOL: (SEE SCHEMATIC, PAGE 7)
MONTH 1:
2 Telephone Interventions
2 Demand Published Patient Reports
2 Demand Published Physician Reports
1 Related Pre-Printed Materials
- Patient Enrollment via standard BRM
- Initial telephone intervention within 7 days of the BRM entry into the
database
- Telephone interventions to patient every other week
- Demand Published Patient Report to follow each telephone intervention
- Demand Published Physician Report to follow each telephone intervention
- Related Pre-Printed Materials to be sent with Patient Report
MONTH 2:
1 Telephone Intervention
1 Demand Published Patient Report
1 Demand Published Physician Report
1 Related Pre-Printed Materials
- Demand Published Patient Report to follow telephone intervention
- Demand Published Provider Report to follow telephone intervention
- Related Pre-Printed Materials to be sent with Patient Report
MONTH 3:
1 Telephone Intervention
1 Demand Published Patient Report
1 Demand Published Physician Report
- Demand Published Patient Report to follow telephone intervention
- Demand Published Physician Report to follow telephone intervention
6
STANDARD PROTOCOL SUMMARY:
- Interactive Voice Recognition Telephone Interventions = 4
- Demand Published Patient Reports = 4
- Demand Published Physician Reports = 4
- Related Pre-Printed Materials = 2
Week # 1 2 3 4 5 6 7 8 9 10 11 12 total
--------------------------------------------------------------------------------
Telephone Call * * * * 4
Patient Report * * * * 4
Physician Report * * * * 4
Preprinted * * 2
Materials
7
II. OPTIONAL MONTHLY PROTOCOL:
The Standard Protocol intervention schedule would be greatly enhanced
by extending the protocol as follows:
MONTHS 4, 5, AND 6:
1 Telephone Intervention
- Telephone Interventions provided monthly
Month # 4 5 6 total
---------------------------------------
Telephone Call * * * 3
MONTHLY INTERVENTION PROTOCOL SUMMARY:
- Interactive Voice Recognition Telephone Interventions = 3
PLEASE FIND ADDENDUM ON PAGE 16 OF THIS PROPOSAL FOR AN ADDITIONAL
FOLD-IN OPTION TO THIS PROTOCOL.
8
WEIGHT ENHANCEMENT
PROGRAM INTERVENTION DESCRIPTION
See the "Program Schedule" section for an outline of the protocol for delivering
these program components. Note that the term "provider" is used to refer to a
physician, case manager or other health care provider designated to receive
communications regarding the patient.
BUSINESS REPLY MAIL (BRM)/PROGRAM DESCRIPTION
- Up to two (2) page pre-printed mailer designed for distribution by
providers to patients and return via postage paid mail response by
patient to DSMI-SM-
- Brief assessment for identifying patient data (e.g., name, phone
number, best time to contact) necessary for DSMISM to initiate a
telephone call to patient
- Program description includes a brief program overview
TELEPHONE INTERVENTIONS
- Five (5) minute telephone calls placed by operator to patients
according to patient's preferred contact times and the program
intervention schedule
- Cost-efficient interface: operator-initiated contact to identify
patient and transfer to automated, voice response system
- Option to reconnect with a live operator during or after voice
response interaction
- High appeal voice response system using a recorded human voice versus
computer synthesized speech
- Patient responds in normal speaking voice versus pushing touch tone
buttons
- Self-report follow-up assessment of relevant medical and behavioral
factors: update on disease status, prescribed treatment including
diet, exercise, and medications, patient motivation, treatment
barriers, patient knowledge indicators regarding symptom
identification and disease self-management
- Patient receives personalized questions and clinically appropriate
feedback driven by expert system to promote patients' awareness of
their condition and adherence to their treatment regimen
- Allows identification of patient concerns
- Adds vital progress information to the longitudinal patient database
PATIENT REPORTS
- One to four page, single sided, laser printed, on-demand published
report including text that is personalized based upon enrollment
responses, and graphics that are personalized to patient's gender
- Mailed to patient within a week after each telephone intervention
- Personalized and pre-printed materials reinforce patient awareness and
knowledge regarding their condition and promote treatment adherence
9
PHYSICIAN REPORTS
- One page laser printed, on-demand published report integrating
patient's follow-up and enrollment data
- Mailed to patient's provider within a week after each patient
interactive voice response intervention
- "At-a-glance" format provides efficient documentation of critical
patient data, ready for insertion into the medical record
- Facilitates identification of patient education needs and hard-to-
manage patients, appropriate allocation of health care resources, and
timely modification of treatment regimens
- Enhances patient-provider communication
ORGANIZATIONAL DATA REPORTS
- Standard comprehensive data reports and aggregate information will be
provided to BMS. Configuration of standard reports to be
determined by DSMI-SM-'s Systems and Engineering staff. Nonstandard
reports will be developed by DSMI-SM-'s staff at the request of BMS.
DSMI-SM-/BMS will establish customary and reasonable developmental and
production fees for the aforementioned nonstandard reports
- To insure confidentiality and security of program database, reports to
BMS on program data to include aggregate patient information only
10
WEIGHT ENHANCEMENT
PROGRAM DEVELOPMENT
Program development will proceed in two stages. During the first stage, to be
completed within 45 days of contract signing, DSMI-SM-/BMS will establish and
convene an expert advisory panel meeting to determine: intervention goals,
protocol structure, required data sets, educational requirements, high risk
behaviors, available resources and modifiable behaviors. DSMI-SM- will provide a
panel summary report to BMS. Additionally, no later than signature date plus 45
days, DSMI-SM- will deliver preliminary program components to be used by BMS to
market the program. These components will include five (5) copies for each of
the following prototypes of the program: sample marketing brochure, sample
business reply mail/program description, sample personalized patient report
(including partial Greek text), and sample personalized physician report
(including partial Greek text). In addition, a voice response call-in telephone
demonstration will be designed specifically for BMS.
The second stage of program development will require a maximum of 150 additional
days to deliver a fully operational program, including the following components:
- Business reply mail/program description (design/layout and print
specifications)
- Design, development and production of personalized patient reports
- Design, development and production of personalized physician reports
- Design, development and production of Interactive Voice Response
interventions
- Marketing brochure and sales presentation aid
The program development schedules shall be based upon the selected protocol and
shall not exceed the aforementioned 150 developmental days.
The entire program development includes the following tasks:
PHASE I
- Consultation with BMS to finalize program specifications. Such
consultation will establish: BMS disease management team's program
objectives and marketing and business goals. BMS will provide
DSMI-SM- with an overview in writing no later than contract signing
date plus 45 days.
- Development of and consultation with expert panel as described.
- BMS/DSMI-SM- will establish a formal developmental reporting and
review process. DSMI-SM- will provide BMS a comprehensive project
developmental overview annotating clinical development completion
dates for individual modules. Additionally, formal review conference
dates will be established no later than 45 days after contract
signing. The finalization of program parameters, graphics design or
these formal review/signoff dates is essential in order to meet the
proposed delivery schedule.
- Integration of market research/client/clinical information to finalize
program content.
11
PHASE II
- Finalize design of graphic presentation for pre-print and on-demand
published materials
- Coordination of personalized clinical copy with personalized graphics
- Design of systems configuration
- Systems programming for internal reporting for on-demand publishing,
interactive voice response, and outcomes analysis
- Voice recording and training of the voice response system
- Identification of appropriate educational brochures and materials
PHASE III
- Testing of the operable program
- Proof reading/editing pre-printed and on-demand published materials
- Upon completion of operational testing DSMI-SM- shall begin
enrollment of patients at the discretion of BMS.
PHASE IV: PILOT PROGRAM
DSMi-SM- shall conduct a pilot test for a maximum of 100 patients, currently on
Megace-Registered Trademark- therapy, recruited by BMS, to determine the
efficiency of the intervention process. The pilot test shall include the
completion of the Standard Protocol (see pages 6 and 7 of this proposal).
Upon completion of the Pilot Program, DSMi-SM- shall begin patient enrollment.
Patients will receive program interventions described under the "Program
Intervention Description" on pages 9 and 10 of this proposal.
12
WEIGHT ENHANCEMENT
PROGRAM MARKETING AND TRAINING
DSMI-SM- will provide 2 full day training sessions to BMS staff or
representatives to assist in the marketing and training efforts for the program.
Additional training and marketing support shall be available to BMS. Such
support may include:
- Development of marketing and/or training strategies and procedures
- Coordination and/or presentations for meetings and seminars with
payors/sponsoring organizations
- Individual phone and/or in-person consultation with payors/sponsoring
organizations
- Written correspondence with payors/sponsoring organizations
- Preparation of written materials and/or phone demonstrations for the
payors/sponsoring organizations
Fees for this additional expert consultation shall reflect reasonable and
customary charges.
PROGRAM OPERATION
As DSMI-SM-'s program development team nears completion of the program, a
program operation team will be assembled to participate in testing the system.
This facilitates a smooth transition period for the shift from the development
to the operations staff. DSMI-SM- will maintain responsibility for managing its
in-house staff and its subcontractors who are involved in ongoing operations of
the program interventions. Quality assurance measures are included in the
interactive program interventions and DSMI-SM-'s internal reporting systems.
DATABASE DEVELOPMENT
The program database will be constructed and maintained using a standard
Relational Data Base Management System (DBMS). The primary record index will be
based upon patient identification. All information collected at enrollment and
during all subsequent interventions will be stored in the database. The record
schema(s) will be developed according to the specific question sets and data
required by the proposed program. Data may be imported or exported off-line
using a variety of industry standard formats, or on-line using DSMI-SM-'s SQL
Server interface. DSMI-SM- will use industry standard procedures for insuring
the confidentiality and security of the program database.
13
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
PRODUCT DEVELOPMENT FEES
The product development fees for the intervention protocols are:
Standard Protocol: [*****]
Optional Monthly Protocol: [*****]
PRODUCT DEVELOPMENT FEES ARE PAYABLE ACCORDING TO THE FOLLOWING SCHEDULE:
A pilot phase of 100 patients will be conducted over a 6 month study period.
BMS agrees to pay an initial payment of [*****] to commence this pilot phase.
Successful completion of the pilot phase will be judged by outcomes agreeable to
BMS in its sole judgment. Should BMS decide to move forward with full rollout
of this weight enhancement patient intervention program, the balance of the
development fee, [*****], will be payable to DSMi-TM- within 30 days of the
decision to move forward. At the same time a decision will be made whether or
not to proceed with the optional monthly protocol. Should BMS decide not to
move forward after completion of the pilot phase, the initial payment of
[*****] is not refundable to BMS and BMS relinquishes all ownership rights to
this weight enhancement patient intervention program.
Developmental fees will cover:
- Clinical
- Expert Consultation: DSMi-SM shall fund all travel, honorarium
and associated fees involved in the convening of the Expert
Advisory Panel Meeting described under "Program Overview" in this
proposal. Any additional requirements for expert consultation
beyond the services of the "Expert Consultation Panel" shall be
at the sole expense of BMS.
- Clinical Content
- Intervention Algorithms
- Systems
- Database Development
- On-Demand Publishing
- Voice Training (IVR)
- Call Center Integration
- Testing and Debugging
- Graphics/ Communication
- Logo Design
- Layout (preprinted and on-demand materials)
- Illustration Development
- Voice Recording/Studio
- Primary Marketing Materials
- Print Materials
- Operational Voice Demonstration
- Sales Materials
14
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [****], have been
separately filed with the Commission.
Printing fees for all pre-printed materials (e.g., marketing brochure, BRM,
program description) will be the responsibility of BMS. DSMI-SM- will furnish
estimates for printing costs upon determination of volumes and final
specifications.
PROGRAM OPERATION FEES
The per patient program fee is [*****] for the "Standard Protocol"
intervention.
The per patient program fee is [*****] for the "Optional Monthly Protocol"
intervention.
Program operational fees are payable at the time of patient enrollment. In the
event of a patient withdrawal from the intervention program, DSMI-SM- will
prorate the remaining expenses. For telephone time utilized during a
conversation between a patient and another health care resource which is
initiated by the follow-up call operator, there will be a charge of [*****] per
minute.
EXCLUSIVITY
During the Exclusivity Period defined below, BMS will agree to provide DSMI-SM-
with payments representing the selected protocol program operation costs for no
fewer than 3000 patients per year. For a period beginning with the date this
Agreement is signed and ending 12 months from date DSMI-SM- completes Phase III
of the program (the "Exclusivity Period"), DSMI-SM- agrees not to engage or
participate in any other project involving the development or implementation of
an interactive program primarily focused on weight enhancement for patients with
Anorexia or Cachexia secondary to a diagnosis of Cancer or AIDS. At the
conclusion of the Exclusivity Period, provided at least 5000 patients have
enrolled in the program, BMS shall have the right, but not the obligation, to
negotiate an exclusive arrangement for an interactive program primarily focused
on weight enhancement for patients with Anorexia or Cachexia secondary to a
diagnosis of Cancer or AIDS. In the event such negotiations are unsuccessful,
BMS shall have the right to match any bona fide offer made to DSMI-SM- for an
interactive program primarily focused on weight enhancement for patients with
Anorexia or Cachexia secondary to a diagnosis of Cancer or AIDS. This right of
first refusal shall endure for a period of twelve months from the conclusion of
the Exclusivity Period.
CONSULTING
A per diem fee plus direct expenses is required for consultation services
performed by DSMI-SM- or its consultants. Such fees would be required for
activities performed for parties outside BMS on behalf of the program and/or
activities beyond the program development/marketing and training operations
functions outlined in this proposal.
CUSTOMIZATION
Any customization will constitute a revision to the intervention protocol (i.e.,
additional patient and/or physician reports and/or variations in on-demand or IV
content). Any logo design used on the demand published reporting is limited to
black and white/grayscale. DSMI-SM- shall furnish estimates for development and
delivery to BMS prior to undertaking any revision.
