EXHIBIT 10.19
AGREEMENT
Between
XXXXXX, INC.
hereinafter called
XXXXXX
and
SMITHKLINE XXXXXXX CORPORATION
hereinafter called
CLIENT
Xxxxxx agrees to provide Client with services for the design and development of
a Point of Care Diagnostic Analyzer substantially in accordance with Xxxxxx'x
proposal dated September 15, 1995 (the "Proposal"), which is incorporated
herein, subject to the following terms and conditions (the "Project"):
1. TERM
Xxxxxx will begin work on the Project within thirty (30) days of receipt of this
Agreement executed by Client and will continue for a period of seven (7) months,
from Phase 0 through Phase 4, subject to the terms and conditions of this
Agreement.
2. PAYMENT
Xxxxxx estimates that the price to the Client for performance of the Project
will be One Hundred Sixty-Seven Thousand Five Hundred Dollars ($167,500.00) as
set forth in the Fee Schedule. To initiate the Project, Client shall advance
Eight Thousand Dollars ($8,000) which amount shall be deducted from the final
invoice and Client shall provide Xxxxxx with a purchase order and executed
Authorization to Proceed. Prior to each Phase, Client shall provide Xxxxxx with
a purchase order or, to the extent same is not feasible, an Authorization to
Proceed executed by an authorized officer of Client. Xxxxxx shall present
invoices at the earlier of the end of each month or the end of each Phase which
shall be payable fifteen (15) days from the invoice date. If Client shall not
have paid any invoice twenty-two (22) days from the invoice date, Xxxxxx may
discontinue the Project until such invoice is paid in full and Xxxxxx'x
commitment to delivery dates shall be adjusted accordingly. In the event Client
fails to make payment with the applicable twenty-two (22) day period with
respect to at least two invoices, Xxxxxx may re-evaluate the noted payment
terms. Client shall not be required to
reimburse, and Xxxxxx shall not be required to incur, any charges for
performance in excess of the above price, unless mutually agreed upon in
writing. If Client or Xxxxxx requests activities that constitute a change of
scope from the Proposal or if additional information is discovered which
increases the complexity of the Project, Xxxxxx shall provide a work change
order ("WCO") which must be approved by Client. Pending approval of the WCO,
Xxxxxx shall not implement a change of scope. Upon termination of the Project,
and after all costs are available, any balance of payments by Client in excess
of actual costs and fees incurred shall be credited or refunded to Client,
unless said refund shall be less than One Hundred Dollars ($100.00). Certain
designated expenses are not included in the above estimated price and, when
authorized by Client, will be invoiced seperately when incurred as follows: (i)
travel time at a 50% rate, (ii) travel expenses at cost, (iii) marketing
expenses at cost, and (iv) materials and outside services at cost plus 15%.
3. OWNERSHIP
The parties agree that all Work (which shall include for purposes of this
Section all ideas, processes, methodologies, software, algorithms, formulae,
notes, outlines, paragraphs, inventions, improvements and other information and
work product developed or generated by or on behalf of Xxxxxx during the course
of its performance of the Project pursuant to this Agreement) shall be
considered "works made for hire" within the meaning of the Copyright Act of
1976, 17 U.S.C.(SS)101, and that Client is and shall be the sole author of the
Work, and the sole owner of all rights therein, including but not limited to all
rights of copyright. In the event any of the Work is deemed not to be a "work
made for hire," then Xxxxxx hereby transfers to Client, without further
consideration, all right, title, and interest to such Work, including any and
all patents, copyrights, trade secrets and other proprietary rights related
thereto. Xxxxxx agrees to promptly execute and deliver, or cause to be promptly
executed and delivered, all documents and instruments requested by Client to
evidence the foregoing assignment. Xxxxxx hereby irrevocably appoints Client as
Xxxxxx'x attorney-in-fact for the purpose of executing such documents and
instruments in Xxxxxx'x name. Xxxxxx represents and warrants that it has the
right to grant to Client sole right, title and interest in and to the Work, and
that ownership or use of the Work by Client will not constitute an infringement
of any third-party patent, copyright, trade secret or other proprietary right.
4. INVENTIONS
If Xxxxxx employees conceive and first actually reduce to practice an invention
within the scope of the Project while working on the Project, Xxxxxx will
promptly notify Client of the invention and shall be deemed to have assigned to
Client any and all of its rights to such invention. Upon request, within sixty
(60) days of the notification, Xxxxxx will also assist Client in preparing and
prosecuting an application for Letters Patent. The costs of providing such
assistance are not included in the Project estimate stated in Section 2
-2-
above, and Client agrees to pay such costs in addition to any other amounts
payable under this Agreement.
5. CONFIDENTIALITY
Xxxxxx acknowledges that it may be exposed or have access to trade secrets and
other confidential business information of Client or other entities with which
Client has business relationships. Such information, referred to hereinafter as
"Confidential Data," shall include all information concerning the business or
affairs or Client that is not known by or generally available to third parties,
including, without limitation, existing systems and programs and those in
development, customer lists, customer needs and requirements, employee lists,
salaries and benefits, and all data received in confidence by Client from third
parties. Xxxxxx agrees that during its business dealings with Client and
thereafter (i) it will hold all Confidential Data in the strictest confidence
and will not copy or disclose any portion thereof to any person or entity,
except its employees who have a need to know, without the prior written consent
of Client; (ii) it will comply, and cause each of its employees to comply, with
Client's policies on data and information security; (iii) it will not make any
use whatsoever of any Confidential Data except to perform services in connection
with the Work pursuant to this Agreement; and (iv) upon termination of its
business dealings with Client or at any time upon Client's request, it will
immediately return to Client all Confidential Data in its possession or in the
possession of its employees.
6. REPORTS AND USE OF RESULTS BY CLIENT
Xxxxxx agrees to render to Client written reports of its findings and progress
made during the term of the Agreement, at intervals agreed upon by the parties.
Client may use the results of the Projects as Client sees fit.
Xxxxxx will provide a high standard of professional service. Xxxxxx warrants
that services provided hereunder shall be performed in a competent and
workmanlike manner and that each item of Work furnished to Client pursuant to
this Agreement shall conform with its description and specifications as set
forth in the Proposal.
7. INDEPENDENT CONTRACTORS
Client and Xxxxxx are independent contractors, are not related and shall not be
construed as co-employers, joint venturers, partners or otherwise. Xxxxxx shall
be responsible for payment of all wages and/or salaries and benefits due to its
employees. Notwithstanding the above, Client will, if appropriate, deduct
applicable taxes from Xxxxxx'x compensation for services performed under this
Agreement. Upon Client's request, Xxxxxx will provide Client with certificates
of insurance evidencing that its employees are covered by; (i) general liability
insurance with a minimum limit of $1
-3-
million combined single limit bodily injury and property damage; and (ii)
workmen's compensation insurance in the state in which each Xxxxxx employee is
employed.
8. INDEMNITY
Client agrees to indemnify and hold Xxxxxx harmless from any and all claims or
suits, and all costs and expenses in connection therewith, for or arising out of
Xxxxxx'x performance under this Agreement, other than for injury or damage
occurring (i) as a result of a breach of this Agreement by Xxxxxx, or (iii) as a
result of the negligence or improper act or omission of Xxxxxx or any employee
or agent thereof. Notwithstanding the foregoing, Client's indemnity of Xxxxxx is
contingent upon Xxxxxx promptly notifying Client of any claim and/or suit
whereby Client may conduct and control the defense thereof with the cooperation
of Xxxxxx and may defend or settle such suit or claim in its discretion.
9. FORCE MAJEURE
Neither Client nor Xxxxxx shall be liable in any way for failure to perform any
provision of this Agreement (except the payment of monetary obligations) if such
failure is caused by any law, rule or regulation, or any cause beyond the
control of the party in default.
10. EARLY TERMINATION
Either party shall have the right to terminate this contract upon thirty (30)
days' written notice. In the event of early termination, Xxxxxx agrees to: (i)
provide Client with all reports, materials, or other deliverable items available
as of the date of termination, and (ii) refund the applicable pro rata portion
of the estimated payment as set forth in Section 2. In any event, Client agrees
to pay all appropriate and reasonable costs incurred or committed by Xxxxxx
including costs of termination, within thirty (30) days of receipt of a final
invoice, which invoice is subject to review and approval by Client.
-4-
11. GENERAL
This Agreement and the Proposal incorporated herein represent the entire
Agreement of the parties, and may be modified or amended only by mutual
agreement in writing. This Agreement shall not be assigned by either party
without the prior written consent of the other party, except that Client may
assign this Agreement to an affiliate without the prior written consent of
Xxxxxx. This Agreement shall be governed by and is to be construed in accordance
with the laws of and enforced within the jurisdiction of Pennsylvania.
SMITHKLINE XXXXXXX XXXXXX,INC.
CORPORATION
By /s/ X. Xxxxxxx Stoughton By /s/ Xxxxxx Xxxxxx
--------------------------- ---------------------------
Title President Title Vice President
------------------------ --------------------
Date 2/28/96 Date 12/7/95
-------------------- --------------------
-5-
CONSENT TO ASSIGNMENT
The undersigned hereby consents to the assignment by SmithKline Xxxxxxx
Corporation, a Pennsylvania corporation ("SB"), to Exigent Diagnostics, Inc., a
Delaware corporation ("Assignee"), of all of the rights of SB under the
Agreement by and between the undersigned and SB dated as of February 28, 1996,
(the "Agreement"). For purposes of this consent, "Effective Time of the
Assignment" means the effective time of the closing of Assignee's purchase of
the assets of SmithKline Xxxxxxx Diagnostic Systems Co., a Pennsylvania limited
liability company. In executing this consent, the undersigned agrees that SB
will be responsible for obligations arising under the Agreement prior to the
Effective Time of the Assignment and Assignee will be responsible for any
obligations arising under the Agreement after the Effective Time of the
Assignment.
XXXXXX.XXX
By: /s/ Xxxxxxx X. Xxxxxx
------------------------
Name: Xxxxxxx X. Xxxxxx
Title: President
Xxxxxx. Inc.
XXXXXX Proposal
SmithKline Xxxxxxx
Clinical Laboratories
0000 X. Xxxxxxxxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000
Phone (000) 000-0000
Fax (000)000-0000
Point of Care Analyzer
Product Design and Development
Prepared for:
Xxxxxx Xxxxxxx
Director Medical Marketing
September 15, 1995
Xxxxxx, Inc.
SmithKline Xxxxxxx
Point of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Contents
Xxxxxx Background and Experience 3
Relevant Experience and Capabilities 4
Program Definition 6
Program Assumptions 7
Program Outline 8
Phase 0 Applied Research: Foundational 9
Xxxxx 0 Xxxxxxx Xxxxxxxxxxx 00
Xxxxx 0 Applied Research: Concepts 13
(Optional)
Phase 3 Design Refinement & Visual Xxxx 00
Xxxxx 0 Pre-Production Design 17
Phase 5 Prototype Fabrication 18
Phase 6 Multiple Prototypes - Clinical Trials 20
Phase 7 Production Design 21
CAD Capability 22
Program & Fee Schedule 23
Terms & Conditions 24
Authorization to Proceed 26
2
SmithKline Xxxxxxx
Point of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Xxxxxx Background and Experience
Xxxxxx is built upon a solid foundation of engineering and
manufacturing knowledge. Currently, Xxxxxx takes approximately 75%
of projects from product research and conceptual design through
prototyping, production design and vendor sourcing and liaison. For
over 30 years, Xxxxxx has established a reputation within the
medical and consumer electronics industry as a stable, highly
competent product design firm that combines the appropriate degree
of innovation and creativity with pragmatic design for
manufacturability.
Xxxxxx has developed award-winning designs for the consumer and
medical industries. Xxxxxx has developed medical products, from
disposables and complex medical diagnostic products, as well as
point-of-care devices, for companies such as Bayer, Abbott, Xxxxxxx
& Johnson, Baxter, Sherwood, Coulter, etc.
The Xxxxxx Medical Services organization is comprised of resources
experienced in medical device design and engineering, medical user
research, and medical regulations and standards. We facilitate
medical clients in meeting their 1SO9000 and GMP requirements as
well as meeting medical industry design and engineering standards.
Xxxxxx has research resources experienced in providing design-based
user research and QFD analysis in the medical environment.
As part of its user-centered process, Xxxxxx offers a comprehensive
user interaction design practice. Our methodology combines applied
development and iterative testing, to develop and assure optimum
physical and cognitive interaction with the product or system,
Xxxxxx has specific experience in the design, testing and
implementation of user interfaces within medical systems. These
programs have included design for multiple product platforms for
domestic and international markets.
Xxxxxx features a full-service prototype shop, capable of producing
photographic quality visual models and production-like prototypes.
Xxxxxx is capable of producing models and prototypes virtually
without help from the outside. Xxxxxx employs rapid prototyping
techniques, including soft-mold casting, stereolithography, CNC,
and other methods. Our facility features 2D and Unix based 3D CAD
including Pro/ENGINEER and HP's 3D Solid Design Engineering
Software.
Xxxxxx is typically asked to maintain involvement throughout the
entire product development process. After the conceptualization,
development of mock-ups and prototypes we often, at the option of
our clients, assist in the development of the required production
documentation so that the product is ready for manufacture in a
timely manner.
0
XxxxxXxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Experience and Capabilities Specifically Relevant to the Point of
Care Analyzer
Xxxxxx has recently worked on programs similar in complexity to
SKB's proposed Point of Care Analyzer device. The following is an
overall view of our related experience:
. Xxxxxx has developed several products related to the
Point of Care Analyzer:
. PPG Point of Care Blood Gas Analyzer
. Several blood glucose monitors
. A wide variety of clinical laboratory products
for Baxter, Abbott, Bayer and Becton Xxxxxxxxx.
. Xxxxxx has over 30 years of extensive medical product
development experience including clinical and laboratory
products.
. We are experienced in both high-volume and low-volume,
plastic product design - Including disposables and
instrumentation. We work well with resin manufactures and
injection molders insuring the cost for molded plastic
parts is optimized.
. Xxxxxx'x experience includes development of global
products which address international variation in user
interface, ergonomics and design preferences.
. Xxxxxx has a user-centered approach to product
development employing applied research, including:
. User Research in the User's Environment/User
Interviews and videotape
. User Concept Evaluation Testing .
. Human Factors Evaluation
. Our user interaction design capabilities include:
. Design for imbedded and computer
interfaces
. Task analysis and usability testing
0
XxxxxXxxxx Xxxxxxx
Xxxxx of Cure Analyzer
September 15, 1995 . P-1317
XXXXXX
. Graphic interface design
. Interface prototyping
. Development, execution and analysis of iterative research and
usability testing
0
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Program Definition
SKB has requested that Xxxxxx, Inc. submit a proposal for the design
and development of a Point of Care Diagnostic Analyzer.
The following program has been developed in somewhat general terms
since the physical size and final characertistics of the instrument
will evolve as the program is underway.
Xxxxxx understands that we will be working with SKB marketing and
engineering, as well as the staff of contract manufacturers specified
by SKB. Xxxxxx has had experience developing team relationships with
other contract manufacturers in the past.
Our design effort will focus on developing a range of possibilities
for the design and user interaction design of the Point of Care
analyzer that are appropriate for initial U.S., then global
distribution.
The design effort will focus on SKB's request for a functionally
elegant medical device. Xxxxxx will concentrate on product usability,
including user interface design to develop a product suitable for the
user and the working environment. Xxxxxx will focus on designing an
instrument that can be efficiently manufactured and assembled by the
specified contract manufacturer, in the quantities and within target
costs specified by SKB. Xxxxxx will focus on appearance issues,
developing appropriate overall forms, design details, color, finish
and graphics that will support an appearance suitable for SKB.
Taken from the text of Xxxxxx X. Xxxxx, Ph.D. letter concerning The
Product Definition: "SKB is interested in developing a hand-held
reflectometer/luminometer for Point of Care chemistry and
immunochemistry testing. The meter would have the following
characteristics:"
. AC/DC powered
. reflectometer with multiple wavelength capabilities
. luminescence capabilities
. reagents would be run on a test card inserted into the
device
. test cards would have 1-4 tests (multiple detectors)
. testing information would be coded on test card
. five line LCD
. serial port
. temperature control
. alpha-numeric control
. onboard QC
. inexpensive (less the $1,000 to make)
. error detection/diagnostics
. wireless transfer of data (line of sight)
0
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Program Assumptions
For the purposes of this proposal, Xxxxxx has assumed the following:
. SKB, and the contract manufacturer, will be responsible for the
electrical and software engineering of the Point of Care
Analyzer. Xxxxxx will work with SKB and the contract
manufacturer's engineering departments on specific engineering
issues while developing our program responsibilities. Xxxxxx will
assume responsibility for the development of the user interface
design, (Please Note: Xxxxxx does not perform software code
development but will work closely with programmers while
developing the user interface design).
. SKB will be responsible for the development of the disposable
test cards and the associated chemistry for the Point of Care
Analyzer. Xxxxxx has had extended experience in the development
of disposables and related low cost molding design configurations
and assemblies. Xxxxxx will work closely with SKB in developing
the instrument design to accommodate the disposable. We would be
pleased to work with SKB on the development of the disposable, if
requested. The development of the disposable is not part of this
proposal.
. Xxxxxx will have access to any pertinent marketing research known
by SKB, to assist in defining the appearance and use of the Point
of Care Analyzer.
. SKB will inform Xxxxxx of any known labeling and/or regulatory
requirements for U.S. and international sale.
. Xxxxxx will not be responsible for performance testing and
regulatory approvals for the Point of Care Analyzer.
. For cost estimating purposes we have assumed that all of the
meetings scheduled at SKB will take place at their Van Nuys
facilities.
0
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Program Outline
This Program Outline carries the Point of Care Analyzer through
conceptual design to production design. Each new phase is predicated
on the development of the product during the previous phase. An
overall description of the complete design program is offered at the
beginning of the program to give SKB and Xxxxxx beginning guidelines
for determining the cost required to carry this project to conclusion.
It can be expected, as the program moves through its various phases,
the guidelines may alter. If this should be the case, the program will
be modified because of new information suggested and agreed upon by
SKB and Xxxxxx.
0
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Phase 0 Applied Research: Foundational
Objective
The Xxxxxx team will observe a sampling of typical Point of Care Analyzer target
users and use environments. Xxxxxx designers will observe, videotape and
interview potential users, regarding the complete process of storing,
retrieving, preparation, using and restoring the product, disposables and
reagents. In addition, the purchase decision making process will be identified
so that key features and benefits are prioritized prior to design. In this phase
the designers will observe opportunities for innovation and problem solving
first hand and prepare themselves with relevant information required to develop
concept solutions in Phase 1.
Please Note Applied Research is a qualitative research program, designed to
allow designers to observe and evaluate device design in the use environment.
These programs are not intended as substitutes for qualitative market studies.
Procedure
. Prior to Start-Up Meeting
We ask that SKB supply Xxxxxx with any existing and applicable design,
engineering and marketing documentation they may have compiled on the
competition for review.
. Start-Up Requirements Workshop at SKB
A project kick-off meeting will be held to introduce and understand the
roles of key people involved in the project, and to discuss the product
requirements, the project deliverables, and schedule. It is important to
address marketing, design and manufacturing issues at this time, Attending
this meeting will be representatives from SKB, the Xxxxxx design team, and
the contract manufacturer. Of specific importance will be a delineation of
known components and the definition of the disposable. This information
will allow Xxxxxx begin to layout components for access and ease-of-use. In
addition, this meeting is an opportunity for briefing interface designers
with any existing interaction rules and task analysis, if available.
. Research Preparation
Based on the target market defined by SKB, Xxxxxx will arrange personal
interviews with a sampling of 8 to 10 users, within a variety of use
environments. This sampling will include laboratory personnel, as well as
relevant nursing and medical staff with no experience with this type of
device. Confidentiality will be a critical requirement of this process.
0
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
. Contextual Inquiry
The Xxxxxx research team will observe and videotape the subjects as they
interact with various similar products within their work environment. The
subjects will also be interviewed regarding product interaction, job and
environment requirements. The videotapes will be analyzed to identify
requirements relating to product performance and ease-of-use.
. Research Documentation and Evaluation
Based on the primary research Xxxxxx will document its findings,
identifying user issues, and potential areas for product improvements or
features. Xxxxxx recommends a simple Quality Function Deployment Matrix for
documentation and analysis. In addition, a preliminary task analysis will
be prepared, to guide in interaction design.
. Phase Review Meeting at SKB
A meeting will be held to review the research and Xxxxxx'x evaluation of
the users needs and preferences and product opportunities. This meeting
will conclude Phase 0.
Deliverables:
. User interaction requirements document
. Videotapes
. Transcripts of key interviews
. Research documentation
00
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Phase 1 Concept Development
Objective
Xxxxxx will begin to develop preliminary design concepts based on the user
research presented to SKB at the end of Phase 0.
Procedure
. Preliminary Design Concepts
Based on knowledge gained from the start-up meeting and user research,
Xxxxxx will begin development of several concept designs of the Point of
Care Analyzer. Each concept will be developed in quick-sketch form and
solid foam volume study models to allow a better understanding of the
design direction.
. Preliminary Layouts Developed
Xxxxxx will begin to develop accurate layouts on CAD to determine size and
various proportions of different approaches.
. User Interaction Concepts
Xxxxxx will develop a series of rough visual models based on the User
Interaction Requirements document and user research developed during Phase
0. These rough visual models will incorporate the discoveries made, and
reported on, during Phase 0. The rough visual models will be used by Xxxxxx
during Phase 2 - Applied Research: Concepts.
Based on an initial task analysis, options will be explored for the
operation protocol. It is expected that an appropriate range of display and
input techniques will be explored. These concepts can then be evaluated,
along with the respective cost implications of each option.
Based on the user interaction requirements, several interaction concepts
will be developed. Promising interaction concepts will be refined and
presented for testing in Phase 2.
. Phase Review Meeting at SKB
Xxxxxx will present its recommended design directions to SKB. The
presentation will use sketch renderings and foam study models to
communicate the suggested design directions. Digitally-generated
representations of the display graphics and interaction scenarios will also
be presented. The outcome of the review will be a selection of an estimated
three concepts for further development in Phase 2. In addition, a project
schedule and budget will be reviewed. This meeting will conclude Phase 1.
00
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Deliverables:
. Task analysis
. Concept sketches
. Preliminary layouts
. Rough foam models for research
. Interaction design concepts for research
00
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Phase 2 Applied Research: Concepts
Objective
We are aware that SKB has retained a market research firm to help develop the
direction the product will take in the market place. Phase 2 is intended to
supplement that effort.
Xxxxxx will have users evaluate the design concepts and rough visual models
which were presented to SKB at the end of Phase 1. Xxxxxx recommends user
research at this phase to allow users to evaluate designs and interact with the
design team. In addition, user interface concepts will be tested with users,
allowing for the definition of an interaction concept that best satisfies the
user's abilities and needs. In this phase, the interaction of the user and the
immediate environment will be observed and videotaped. Users will be interviewed
regarding their preferences. From this evaluation, the design team can determine
a design direction preferred by the user which is based on the design's ability
to meet customer needs. This design direction may be a hybrid of several design
concepts.
. Research Preparation
Based on the target market defined by SKB, Xxxxxx will arrange personal
interviews with a sampling of 8 to 10 users within a variety of use
environments. This sampling will include laboratory personnel as well as
relevant nursing and medical staff with no experience with this type of
device. Confidentiality will be a critical requirement of this process.
. Contextual Inquiry
The Xxxxxx research team will observe and videotape the subjects as they
interact with design and interface concepts within their work environment.
The subjects will also be interviewed. The videotapes will be analyzed to
identify requirements relating to performance of design and interface
concepts.
. Research Documentation and Evaluation
Based on the primary research Xxxxxx will document its findings,
identifying user issues, and potential areas for product improvements.
Xxxxxx recommends a simple Quality Function Deployment Concept Selection
Matrix for documentation and determination of a design direction. In
addition, the task analysis and user interaction guideline will be
prepared, to guide the development of the user interface.
. Phase Review Meeting at SKB
A meeting will be held to review the research and Xxxxxx'x evaluation of
the design and interface concepts. All project team members should be
present to determine a design direction that best meets user,
manufacturing, marketing and performance requirements. The final design
direction may be a hybrid of several design concepts, with refinements
based on user needs.
00
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Deliverables:
. User interaction requirements document
. Videotapes
. Transcripts of key interviews
. A research report including documentation of the chosen design direction
00
Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Phase 3 Design Development & Visual Model
Objective
To develop and refine a single design to a visual model level. To refine the
chosen interface design using computer simulation. The design direction will
require additional refinement before fabrication of a visual model.
Procedure
. Design Development
Based on results of the research in Phase 2, Xxxxxx will develop and refine
the most promising concept, and then update the rough visual model to
reflect those changes.
. Layouts Updated
Xxxxxx will also update the selected layout as more is learned about the
internal components, and the acceptance of the selected design by the
users.
. Preliminary Cost Analysis
Xxxxxx will generate a rough, ballpark, tooling and part cost estimate
based on the current design. This assessment should not be construed as a
formal production estimate, but as a check towards the cost targets
specified by SKB at the beginning of the program. Local vendors will be our
source for this, and later cost reviews.
. Design Documentation
Xxxxxx will generate a preliminary drawing package (layout and control
drawings) that will be used by our model makers to fabricate the visual
model. The drawings will define external dimensions and details that are
important to the appearance and user interaction of the Point of Care
Analyzer. Consultation with SKB's mechanical engineering staff should
identify appropriate formats for CAD file transfer.
. Visual Model Fabrication
Xxxxxx will fabricate one visual model of the Point of Care Analyzer
design. The model will visually represent the approved design to date and
will be of such quality that it will be suitable for marketing photography.
The model will not house electronics and will not be functional, however
external mechanical details, such as sliding doors or hinged covers, will
function. Color/finish and graphics will be applied to the model.
. Ul Simulation
Xxxxxx will generate an interactive simulation of the chosen interface
design. This computer model will relay fundamental elements of the protocol
in the interaction design to date. The simulation can run on a variety of
platforms; it is currently envisioned on a Macintosh computer.
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XxxxxXxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
. Phase Review Meeting at SKB
Xxxxxx will present the visual model and updated interface simulation at a
phase review meeting to be held at SKB. This review will serve as formal
definition of the industrial and interaction design freeze for the Point of
Care Analyzer. This meeting will conclude Phase 3.
Deliverables:
. Preliminary product design
. Ballpark tooling and part cost analysis
. One visual model
. Updated interface simulation
Please note: Xxxxxx recommends a concept validation market study be conducted at
this time, to assure that the final design is evaluated by users before
production design and tooling is started. Xxxxxx can conduct research, if
requested, and will submit a proposal at that time.
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Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Phase 4 Pre-Production Design
Objective
The objective of this phase is to develop a pre-production documentation package
that will enable Xxxxxx to fabricate a prototype in Phase 5.
Procedure
. Design Modifications
Xxxxxx will incorporate the modifications requested by SKB at the end of
the Phase 3 review meeting.
. Pre-Production Design
Xxxxxx will produce a pre-production design drawing package that will
incorporate the latest design modifications. The pre-production design
drawings will be used by Xxxxxx to fabricate a final prototype of the
design in Phase 5.
Please Note: If appropriate, Xxxxxx will execute the pre-production design
via 3D solid modeling CAD platform.
. Camera-Ready Art
Housing:
Xxxxxx will provide camera-ready artwork and files for all housing graphics
and nomenclature, including corporate identity, product identity and
operational graphics. It is expected that regulatory and corporate identity
samples will be provided by SKB.
Display (LCD):
Xxxxxx will provide camera-ready artwork and files for the custom LCD
display. Graphics will incorporate the system addressing requirements
specified by SKB's electronic designers and will include active variations,
if any, (Active variations are graphics for animated or dynamic elements of
the display not apparent in default mode(s), such as blinking or moving
elements.)
. Review Meeting at SKB
A meeting will be held at SKB to review the pre-production drawing package
and to determine prototyping requirements for initial evaluation and for
clinical submittal. This meeting will conclude Phase 4.
Deliverables
. Preliminary production design package including housing, chassis and
internal mechanical elements
. Housing camera-ready art
. LCD display camera-ready art
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Phase 5 Prototype Fabrication
Objective
The objective of this phase will be to fabricate one working prototype
of the Point of Care Analyzer. We are aware that ten Beta Site units
are scheduled for fabrication. We have elected to address those ten
units under the next phase. The single prototype developed during the
xxxxx, Xxxxx 0 will be checked for dimensional accuracy and finally
approved by SKB. Once that approval has been received, Xxxxxx will use
parts of the first prototype and create flexible rubber molds from
which urethane parts will be cast for the Beta Site Units.
Procedure
. Prototype Internal Components
At the conclusion of Phase 4, SKB, Xxxxxx and the contract
manufacturer, will finalize definition of the internal operating
components. This will include electronic assemblies and any
mechanical or system-specific components. Working or
representative samples, of unavailable internal components will
be provided by Xxxxxx.
. Prototype Fabrication
Xxxxxx will fabricate one prototype housing capable of accepting
SKB's and the contract manufacturer's internal components. The
prototype materials will resemble, as closely as possible,
production solutions. The prototype can be used to test and
evaluate engineering details, mechanical details and internal
component fit checks. The prototype cannot survive impacting or
flame testing.
Please Note: If 3D solids CAD platform is utilized for the design
documentation, Xxxxxx may execute the prototype housing originals
via rapid prototyping techniques. Such prototype components
provide an optimum design check, given their design fidelity, and
closely approximate mechanical properties of injection-molded
parts. External vendor costs for these services are
indeterminable before design and are, therefore, not included in
this proposal. This prototype may also serve as a pattern for
production of multiple prototypes.
. Review Meeting at SKB
A meeting will be held at SKB to deliver the prototype. SKB,
Xxxxxx and the contract manufacturer will evaluate the prototype
in relation to fit checks, user interaction and
manufacturability. Formal mechanical or regulatory testing of the
prototype is not included in this proposal. This meeting will
conclude Phase 5.
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Xxxxx of Care Analyzer
September l5, 1995 . P-1317
XXXXXX Deliverables
. One Point of Care Analyzer prototype
. Modified design package
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Phase 6 Multiple Prototypes - Clinical Trials
Objective
SKB has determined they will need ten (10) functional prototypes for
clinicals in the second quarter, 1996...according to the POCT Product
Development Plan we have been reviewing. The date may change. The
process outlined here should not. We have not estimated this phase at
this time.
Procedure
. Prototype #1 As a Master Pattern
Whether the parts are hand fabricated, CNC'd, or stereolithed,
the first set can become master patterns, from which rubber molds
can be made, and the ten Beta units can be cast from urethane.
These will become the clinical information-gathering units, we
assume.
Deliverables
. Functional pre-production prototypes for clinical information
gathering at ten Beta sites.
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Xxxxxxxxxx Xxxxxxx
Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX Phase 7 Production Design
Objective
After evaluation of prototype #1, Xxxxxx will complete the
pre-production documentation bringing the complete housing package to
a production level, suitable for release to SKB, and eventual release
to the contract manufacturer for implementation.
Procedure
. Design Revisions
Xxxxxx will document all changes from the outcome of the
prototype evaluation. It is assumed, for the purposes of this
proposal, that the changes will be minimal. Should it be
determined that a major revisions need to take place, Xxxxxx will
evaluate the change's effect on cost and schedule.
. Production Design Documentation
Production Drawing Package
Part drawings and assembly drawings will be upgraded to a
level suitable for release to SKB and U. S. Medical.
Xxxx of Materials
Included in this documentation package will be a Xxxx of
Materials that will describe all of the parts that make up
the exterior housing and internal mounting brackets for the
analyzer.
Camera-Ready Art:
Required updates will be added to the housing and display
camera-ready art.
. Vendor Quotations
Xxxxxx will assist SKB and the contract manufacturer in acquiring
production quotes for tooling and part costs, lead time
schedules, etc.
. Phase Review Meeting
Delivery of the production documentation package will conclude
Phase 7. SKB will be asked by Xxxxxx to approve the documentation
package.
Deliverables:
. Production drawing package
. Xxxx of Materials
. Production artwork
. Color and graphic specification
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
CAD Capability
Software:
SGH has several CAD software platforms available. The platform to be
used is based on the nature of the design and the requirements of the
project. We maintain the latest releases of the following
applications:
Pro/ENGINEER Full 3-D solid modeling software (Unix Based)
Hewlett Packard Full 3-D solid modeling software (Unix Based)
Solid Designer
Hewlett Packard ME 10 2-D drafting software (Unix Based)
AutoCAD 2-D drafting and 3-D wire frame
software (DOS based)
Ashlar Vellum 2-D drafting and 3-D wire frame
software (Macintosh)
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX ....................................................................
Program & Fee Schedule
....................................................................
Phase 0 Time Estimate
Applied Research: Foundational 3-4 weeks $ 13,500
....................................................................
Phase 1 Time Estimate
Concept Development 5-6 weeks $22,500 - $27,000
....................................................................
Phase 2 Time Estimate
Applied Research: Concepts 3-4 weeks $36,000 - $39,000
....................................................................
Phase 3 Time Estimate
Design Development 6-7 weeks $45,000 - $55,000
& Visual Model
....................................................................
Phase 4 Time Estimate
Pre-Production Design 5-6 weeks $28,000 - $33,000
....................................................................
Phase 5 Time Estimate
Prototype Fabrication To be determined
....................................................................
Phase 6 Time Estimate
Multiple Prototypes To be determined
....................................................................
Phase 7 Time Estimate
Production Design To be determined
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Terms & Conditions
. Xxxxxx, Inc. will invoice at the end of each month or at the end
of a phase, whichever occurs first; invoices are due 15 days
from the invoice date and Xxxxxx allows a 7 day grace period. If
payment is not received 22 days after date of invoice, Xxxxxx has
the option to discontinue all project-related activities until
the invoice is paid in full. Xxxxxx will be released from all
commitments to delivery dates should this occur.
If two invoices throughout the course of a project exceed the 22
day limit, Xxxxxx has the option to re-evaluate payment terms to
a COD or pre-payment basis.
. Xxxxxx requires that a purchase order be issued at the beginning
of each phase as that phase is approved by both parties.
. At times a purchase order cannot be generated quickly enough to
maintain critical project schedule requirements. In this case,
Xxxxxx will provide the client an "Authorization to Proceed"
document that must be signed by an authorized member of the
client's company before work can continue.
. Xxxxxx requires an advance be paid at the beginning of the
project and will provide the client with an invoice for the
advance. Xxxxxx has the option not to commence work until the
advance is received. The entire amount of the advance will be
deducted from the final invoice at the conclusion of the project.
. Invoices covering authorized travel for Xxxxxx staff will be
submitted for payment immediately and separately following such
travel. Travel time is billed at 50% rate. Out-of-pocket travel
expenses including airfare and accommodations are not included in
the fee schedule. Travel expenses are billed at cost.
. Market research expenses for facility rentals, videotaping, and
payment for participants are not included in the fee schedule.
. All anticipated meetings have been included in this estimate. If
additional meetings are requested, it may result in a WCO (Work
change order).
. All designs and concepts conceived by Xxxxxx under the terms of
this agreement shall become the property of the client upon
payment of the final invoice. Xxxxxx will not knowingly infringe
upon the rights of another patent. Xxxxxx will cooperate with the
client to help secure patent rights at the client's expense.
. Sales tax will be in addition to the Fee Schedule and is
applicable to the Prototype Fabrication. Production Design and
Graphic Artwork phases, for California companies only.
. The Fee Schedule does not include materials (blueprints, model
supplies, long distance phone calls, etc.) or outside services
(graphic services, sheet metal fabrication. etc.) required for
the project.
. Materials and Outside Services (M&OS) will be billed at cost plus
15%. M&OS costs are generally 3-5% of design phases and 10-20%
of phases that involve model building and prototyping. The actual
costs are dependent upon the scale and complexity of each
project.
. Prototypes are a part of most product design projects. It must be
understood that the prototype will address the functional
requirements of the design, but may not resolve issues that only
become evident after the prototype is fabricated and evaluated.
Modifications to the design may be required under a WCO for an
additional phase before the project can resume.
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Xxxxx of Care Analyzer
September l5, 1995 . P-1317
XXXXXX
. If the client or Xxxxxx requests activities that constitute a
change of scope from this proposal, or if information is
discovered by either party that increases the complexity of the
program. Xxxxxx will generate a WCO that will be presented to the
client for approval. Xxxxxx will not proceed with change of scope
requests until a WCO is signed by the client. A delay in approval
may impact the program's schedule.
. To the best of Xxxxxx'x knowledge, all designs and concepts
conceived by Xxxxxx under the terms of this Agreement do not
infringe any United States patent or patent of another nation.
However, Xxxxxx does not represent or warrant that such designs
will not infringe any United States patent or patent of another
nation or subsequently issued patent and Xxxxxx expressly
disclaims any liability for any such patent infringement. Note:
at client's option and expense, Xxxxxx, through its outside
patent counsel, can perform a patent search to provide some
assurances that designs and concepts conceived under the terms of
this agreement do not infringe any issued United States or other
nation's patent.
. Client agrees to indemnify and hold Xxxxxx harmless from and
against any liability for any third party claim or suit for
injury and/or damage based on any alleged defect in any product
or material supplied by client to Xxxxxx, unless such injury
and/or damage was due in whole or in part to any negligent or
improper act or omission of Xxxxxx or any employee or agent
thereof.
. Client additionally agrees to indemnify and hold Xxxxxx harmless
from and against any liability for any third party claim or suit
for injury and/or damage based on any alleged defect in any
product or material sold by client and manufactured by or for
client utilizing any information or services provided by Xxxxxx
to client on this project. Client's obligation under this
paragraph shall be contingent upon Xxxxxx giving client prompt
notice of any such claim and/or suit, the right to conduct and
control the defense thereof, with the right to defend or settle,
and cooperation of Xxxxxx in any such defense.
Please consider this proposal good for 30 days.
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Xxxxx of Care Analyzer
September 15, 1995 . P-1317
XXXXXX
Authorization to Proceed
To initiate the first phase of the program outlined in this proposal,
Xxxxxx requires a purchase order, a signed Authorization to Proceed,
and an advance in the amount of $8,000.
If the processing of a purchase order will delay a critical start
date, Xxxxxx will start work upon receipt of the advance and this
form, signed by an authorized employee. A purchase order must be
received within five days of the project start for work to continue.
For each subsequent phase, a signed Authorization to Proceed, a
purchase order, and an advance must be received before work can
continue.
This document will confirm that Xxxxxx has authorization to proceed on
the work outlined in the first phase of this proposal.
-----------------------------------------------
Authorization Signature
-----------------------------------------------
Title
-------------------
Date
-----------------------------------------------
Xxxxxx, Inc.
-------------------
Date
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