EXHIBIT 10.17
UNITED MEDICAL MANUFACTURING COMPANY
hereinafter called
UMM
and
SMITHKLINE XXXXXXX CORPORATION
hereinafter called
CLIENT
UMM agrees to provide Client with services for the development and manufacture
of a multi-analyte reflectance diagnostic instrument substantially in accordance
with UMM's proposal dated May 10, 1995 (the "Proposal"), which is incorporated
herein, subject to the following terms and conditions (the "Project"):
1. TERM
UMM 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 three (3) months
through Phases I and II of the Proposal (unless extended by mutual written
agreement), subject to the terms and conditions of this Agreement.
2. PAYMENT
UMM estimates that the price to the Client for performance of the Project will
be Two Hundred Thirteen Thousand Eight Hundred Dollars ($213,800.00) and Client
agrees to provide UMM with a purchase order within fifteen (15) days of signing
this Agreement. Client shall not be required to reimburse, and UMM shall not be
required to incur, any charges for performance in excess of the above price,
unless mutually agreed upon in writing. Client, through its representative Xx.
Xxxxxx Xxxxx or his designee, shall approve in advance any equipment purchases
or significant material purchases. 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). Client shall authorize
in advance the incurrence of expenses listed in Appendix C to the Proposal and
attached hereto, which expenses shall be invoiced separately when incurred in
accordance with the terms and conditions set forth in Appendix C.
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, photographs, inventions, improvements and other information and
work product developed or generated by or on behalf of UMM 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. (s)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 UMM 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. UMM
agree 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, UMM hereby irrevocably appoints Client as UMM's
attorney-in-fact for the purpose of executing such documents and instruments in
UMM's name. UMM 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 UMM employees conceive and first actually reduce to practice an invention
within the scope of the Project while working on the Project, UMM 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, UMM 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 above,
and Client agrees to pay such costs in addition to any other amounts payable
under this Agreement.
5. CONFIDENTIALITY
UMM 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. UMM 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
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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
UMM 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 Project as Client sees fit.
UMM will provide a high standard of professional service. UMM 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. UMM further warrants that it is, and will be, in compliance with good
manufacturing practices as required by the Food & Drug Administration.
7. INDEPENDENT CONTRACTORS
Client and UMM are independent contractors, are not related and shall not be
construed as co-employers, joint venturers, partners or otherwise. UMM 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 UMM's compensation for services performed under this
Agreement. Upon Client's request, UMM will provide Client with certificates of
insurance evidencing that its employees are covered by: (i) general liability
insurance with a minimum limit of $1 million combined single limit bodily injury
and property damage; and (ii) workmen's compensation insurance in the state in
which each UMM employee is employed.
8. FORCE MAJEURE
Neither Client nor UMM 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.
9. EARLY TERMINATION
Either party shall have the right to terminate this contract upon thirty (30)
days' written notice. In the event of early termination, UMM agrees to: (i)
provide Client with all reports, materials, or other deliverable items available
as of the date of termination, and
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(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 UMM including costs of termination,
within thirty (30) days of receipt of a final invoice, which invoice is subject
to review and approval by Client.
10. FURTHER ASSURANCES
Each of UMM and Client agree to work in good faith to execute a formal Supplier
Agreement between the parties prior to termination of the initial term of this
Agreement.
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 UMM.
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 CORPORATION UNITED MEDICAL
MANUFACTURING COMPANY
By /s/ W. V. Stoughton By /s/ Xxxx X. Xxxxxxx
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Title Title President
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Date Date December 12, 1995
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EXIGENT DIAGNOSTICS, INC.
X. XXXXXXX STOUGHTON
CHAIRMAN AND CEO
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
Preliminary Agreement by and between the undersigned and SB dated as of May 10,
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1995 (the "Agreement"). For purposes of this consent, "Effective Time of the
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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.
UNITED MEDICAL MANUFACTURING COMPANY
By:/s/ Xxxx X. Xxxxxxx
----------------------------------
Name: Xxxx X. Xxxxxxx
Title: President
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
Preliminary Agreement by and between the undersigned and SB dated as of August
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27, 1996, (the "Agreement"). For purposes of this consent, "Effective Time of
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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.
UNITED MEDICAL MANUFACTURING COMPANY
By:/s/ Xxxx X. Xxxxxxx
----------------------------
Name: Xxxx X. Xxxxxxx
Title: President
ANNEX C
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UNITED MEDICAL MANUFACTURING GENERAL TERMS AND CONDITIONS FOR MANUFACTURING
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SERVICES
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. Prices are FOB United Medical Manufacturing's dock.
. Unless specified, prices do not include packaging for shipping.
. If prices are denoted as estimates, then the final price will be
determined based on the final xxxx-of-materials.
. A lead time will be established in conjunction with customer which
balances customer forecasted demand, component lead times and inventory
management.
. Costs associated with requests for expedited orders will be determined and
proposed prior to implementing expedited order.
. If requested, Development labor time will be tracked using job order
numbers and will be billed monthly unless otherwise noted.
. Travel and miscellaneous expenses will be billed at cost plus 5%.
Travel expenses include:
Private auto mileage at 30c per mile.
Parking, tolls and fares.
Car rental, if required.
Airfare, if required.
Miscellaneous expenses include, but are not limited to:
Rooms and meals away from home base, if required.
. A purchase order for the full amount of any tooling must be provided to
United Medical prior to UMM placing the order.
. Payment terms are net 15 days after date of invoice.
. Unless otherwise noted, any proposal or estimate is valid for 30 days.
UNITED MEDICAL MANUFACTURING GENERAL TERMS AND CONDITIONS FOR DESIGN AND
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DEVELOPMENT SERVICES
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. Development labor rate is $60 per hour.
. "Time and Materials" is the actual time to perform the specified tasks
with the necessary resources or materials.
. Development labor time will be tracked using job order numbers and will be
billed monthly unless otherwise noted.
. Travel and miscellaneous expenses will be billed at cost plus 5%.
Travel expenses include:
Private auto mileage at 30c per mile (latest rate as determined
by the IRS).
Parking, tolls and fares.
Car rental, if required.
Airfare, if required.
Miscellaneous expenses include, but are not limited to:
Rooms and meals away from home base, if required.
. A purchase order for the full amount of any tooling must be provided to
United Medical prior to UMM placing the order.
. Payment terms are net 15 days after date of invoice.
. Unless otherwise noted, any proposal or estimate is valid for 30 days.
. An endorsement of this agreement or a purchase order for 25% of the
estimate constitutes acceptance of the agreement and acknowledges
acceptance of the terms and conditions.
Proposal
The Competitive Advantage of Choosing
United Medical Manufacturing
United Medical Manufacturing is uniquely well qualified to handle the design,
development and manufacture of the point of care reflectance system. In fact, we
can bring a number of unique attributes to this project which will spell
competitive advantage for SmithKline Xxxxxxx Clinical Laboratories, and which
will help assure the rapid, cost-effective development and manufacture of the
point of care reflectometer system.
We realize that selecting a development, and ultimately, manufacturing partner
is an extremely important decision. SmithKline Xxxxxxx Clinical Laboratories
(SBCL) needs a partner who can support the market entry of the point of care
reflectometer system, enhance your image, meet your product design demands, and
comply with regulatory requirements.
Among the factors which make United Medical Manufacturing the right choice to
manufacture the reflectometer, the following are particularly important
A Proven Track Record provides assurance that we will do the job right. United
Medical Manufacturing (UMM) has all the resources to help you succeed. UMM is a
world leader in the design and manufacture of hand-held (portable) reflectance
meters for the blood glucose market and clinical analyzers. We have manufactured
more than 2,000,000 of these meters in the past six years. We are FDA GMP
registered for class II and class III medical device manufacturing, and our ISO
9001 certification is pending. (We have been audited and recommended for
certification by TUV Product Services of Germany.)
Experience in a company is really the experience of its people. We have years of
experience in manufacturing meters which combine electronics, optics, and
chemistry in an integrated system--exactly like the SmithKline reflectometer. In
fact, there is probably no medical manufacturer with more experience that is
specifically relevant to your project. Because this is a specialized kind of
design and manufacturing, our experience will be invaluable, both in the
long-term management of the project and in achieving significant savings through
the design and development program.
We believe that good companies consist of quality people unified in their focus
and commitment. At United Medical manufacturing, our engineers are committed to
designing and developing products of the highest quality. A design that
integrates all aspects of its marketability, functionality, reliability,
serviceability, and manufacturability can prevent costly delays and rework
later.
Expertise in optics and reflectance technology to support the SmithKline design
and manufacturing program is particularly deep at UMM. We have performed the
design and development of similar devices (especially analyzers) requiring
optics, low power, and the utilization of chemistries as part of the system. In
fact, this is a key differentiation factor from straightforward electronic
design... the device and chemistry must be designed and work together as an
integrated system. We understand the necessary tasks to ensure the rapid, yet
thorough, co-development of an instrument and the disposeable. We have learned
the problem areas to avoid in a reflectance system, and the potential
opportunities for improvement. Our experience in this area will prove extremely
valuable in rapidly getting to market.
Quality vendors and suppliers are another key to a successful manufacturing
process. Because of our extensive experience in manufacturing blood glucose
meters and
coagulation analyzers, we have established a network of quality vendors who
supply components very similar to those required in the SmithKline meter. Having
a reliable supplier network in place reduces overhead costs and minimizes the
risk of selecting a supplier whose poor quality or lack of responsiveness do not
support the design and manufacturing goals of this project. It fundamentally
reduces the time to market.
Manufacturing processes must fulfill the potential of the product design. The
process must produce consistent quality and timely delivery. United Medical
Manufacturing has created a focused factory environment to handle the demands of
various kinds of manufacturing processes. We have created the following three
areas:
High volume, repetitive manufacturing
Mid-range volume manufacturing
Low volume, highly customized manufacturing
The benefit to SmithKline Xxxxxxx Clinical Laboratories is that your
manufacturing will be handled in a dedicated area, specifically designed to
accommodate your anticipated volumes. This means a cost effective application of
the services required to support the program. You do not financially subsidize
other programs.
Quality is a way of life at United Medical Manufacturing. It's the one component
that goes into everything we build. Our work has been found to be in strict
compliance with the FDA's "good manufacturing practices" in the course of
rigorous audits by our clients and the FDA. Also, as mentioned above, we have
been audited and recommended for certification under ISO 9001, which includes
manufacturing and design services. In addition, UMM is certified under EN 46001
to manufacture and ship medical devices to Europe.
United Medical Manufacturing takes pride in being 100% medical device
manufacturing. We believe that medical device manufacturing especially class II
and class III products requires a higher level of care. We also understand the
healthcare industry and the major trends such as cost containment that effect
both UMM and our customers.
Investment in the future to provide our customers with cost effective services.
United Medical Manufacturing continues to invest in the future with improvements
to our equipment and facilities to ensure our customers are receiving efficient
and high quality manufacturing services. We are expanding our facilities for
optimization of our high volume operation. This will further streamline the work
flow and effectively utilize point-of-use storage. We are currently installing a
new SMD system which will increase our throughput by 400% and reduce set-up time
from eight (8) hours to five (5) minutes. These high-volume improvements will
provide tremendous benefits and savings for the SBCL program.
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The SmithKline Xxxxxxx Clinical Laboratories and United Medical Product
Development Partnership
United Medical Manufacturing has established procedures to assure quality in
every phase of a project. This is the approach we will bring to your point of
care reflectometer system project. Specifically, we propose to use our
concurrent engineering process--a proven method of working with clients to
guarantee clear, comprehensive communication, a fertile exchange of ideas and
insights, rapid prototyping. and high-quality manufacturing processes. This
process results in a cost-effective design to the customer's requirements.
Enclosed in Appendix A is a Xxxxx chart with an approximate timeline for the
proposed concurrent engineering process. Based on the SBCL estimated
requirements, United Medical has outlined the approach and milestones in this
chart. Upon establishing an initial product specification, United Medical will
be able to provide a more accurate assessment of the program scope and schedule.
Similar to the approach outlined in your RFP, UMM's proposed concurrent
engineering process is divided into five phases which integrate the activities
of marketing, financial analysis, research and development, manufacturing,
quality control, and project management.
This approach divides the program into phases and identifies specific
deliverables for each phase. The time line conceptually comprise the milestones
and schedule. These would be tailored for the specific project.
(Appendix B describes UMM's general approach to concurrent engineering with
details of the major tasks.)
. Phase 1 involves assessing and defining the product concept in terms of
market potential and technical requirements.
Clearly, SBCL has completed the key aspects of this phase in determining
the market opportunity. However, at the outset, by working closely to
review the product concept and refine it as appropriate, SBCL and United
Medical Manufacturing will develop a uniform understanding of technical and
marketing objectives that can assure overall success of the project.
United Medical often recommends utilizing a very useful communication tool
called Quality Function Deployment (QFD) to review the product concept.
This process integrates customer benefits, product attributes with
engineering and manufacturing tradeoffs. The outcomes of the QFD are
usually the Customer Requirements Document or a Marketing Requirements
Document which will help to further define the product specifications.
While SBCL has established a core concept, United Medical recommends
utilizing the QED process for two reasons. First, this process could
strengthen the product specification which translates into designing a
better product earlier. Second, this provides an excellent forum for
starting the communication between SBCL and United Medical Manufacturing to
familiarize UMM personnel with the product. By providing a common
understanding for the point of care system and valuable insight for all
team members to the various aspects of the program, the team will be moving
in the same direction, resulting in a faster start.
The QFD process has been very successful for our customers in establishing
customer requirements and the initial product specifications. This ensures
the product is market-driven by customer needs. After completion of the QED
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process, the baseline knowledge about the system is established among all
team members. Now the development program will be at full speed.
. Phase 2 involves a careful analysis of feasibility and functionality
issues, including design studies to determine the methods for lowest cost
of manufacturing and assembly without compromising quality requirements.
This is a very critical phase. It identifies and resolves potential
problems early in the process which saves time and money later.
Phase 2 analyzes tradeoffs and synergies between the various functional
requirements. These product and process synergies include decisions about
functionality, quality, reliability, and manufacturability. This is in the
form of feature cost analysis and design tradeoffs.
As the design proceeds, there may be mutually exclusive design goals
discovered. Before any significant tradeoff is implemented, United Medical
will immediately contact SBCL for approval. Although not anticipated,
prohibitively costly or conflicting requirements are sometimes identified.
Again any such issues will be reviewed promptly with SBCL at an appropriate
location.
The formal documentation generated in the feasibility section of Phase 2
are: 1) a Design plan. 2) a Manufacturing plan and 3) Quality and
Reliability plan. During the functional analyses. United Medical will hold
informal initial design walkthroughs. These walkthroughs will be
constructively critiqued to continually improve the design. SBCL has an
open invitation to participate in any of these informal meetings. Upon
completion of Phase 2, a formal Initial Design review will be held at SBCL
. Phase 3 involves the detailed design and development program. This includes
the creation of prototypes to complete the development process and to check
the evolved concept against the established goals. This provides a baseline
for the final product design and development process. At this point, UMM
and SBCL will work together to optimize the system design.
United Medical Manufacturing strongly believes in "design for manufacture".
We believe it is essential for experienced manufacturing personnel to be
actively involved in the design and development process. By developing
manufacturing processes in parallel with the product development, the
manufacturing partner can and should improve the design. This influence
increases manufacturing quality and reduces overall program costs. We
believe United Medical's expertise in manufacturing Class II and Class III
medical devices uniquely qualifies us to provide this necessary support for
the SmithKline Xxxxxxx point of care reflectance system.
The prototype phase is most beneficial when it is coordinated by the
manufacturing partner as part of our overall concurrent engineering
process. This is congruent with United Medical's focus to design with
manufacturability in mind. This also provides valuable insight of the
system for integration into the manufacturing processes. The knowledge
gained from this prototype development is then integrated forward into the
key areas of pilot production and full-scale manufacturing. With United
Medical as the manufacturing partner as well as the product development
partner. SBCL gets the best of both worlds. Our intent is to develop
prototypes which resemble the end manufactured products as closely as
possible. It is our experience that these prototypes
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increase product quality while shortening the total time to get the product
to market. Upon completion of Phase 3, a formal review will be held at
United Medical or SBCL
. Phase 4 involves the development of a pilot production run to develop and
verify documentation, set-up, assembly methods, and manufacturing
processes. This also includes assembly and test fixture development. Phase
4 will be coordinated by a UMM manufacturing engineer. The UMM
manufacturing engineer's early contributions to the design will now reap
huge "dividends" in this phase. Those "dividends" combined with expertise
in the management and coordination of pilot production will provide the
basis for a smooth transition into manufacturing. In conjunction with SBCL,
UMM will determine the number of pilot production units to meet the
necessary requirements
United Medical's culture of "Continuous Improvement" provides the impetus
for "fine tuning" the manufacturing processes. This will optimize the
manufacturing effort and will contribute to the program's overall success.
. Phase 5 involves the organization and launch of full-scale manufacturing.
At this point the total team becomes involved in the process of continuous
quality improvement to increase quality and decrease production costs or
time frames.
Success is not determined by simply providing a product, it is determined by
your customers' value of that product. SBCL has an impeccable reputation for
providing its customers with high quality medical products and services. Your
name is synonymous with this quality and responsiveness. Like SBCL, United
Medical Manufacturing's reputation is one of manufacturing excellence and
quality. We understand that for SBCL to be successful, its products must be of
the highest quality. As your manufacturing partner, United Medical realizes that
if SBCL is successful then we will be successful. Therefore, we must provide
total customer satisfaction through the quality and workmanship of our
manufacturing services. United Medical is truly excited about the prospects of
partnering with SBCL to develop and manufacture the idea for a point of care
reflectometer system.
Meetings and Communication. We believe communication is the key to successful
development programs. The frequency of meetings would likely vary during the
project. During the first few weeks, the first technical meetings and project
meetings would most likely be daily in order to develop a working baseline about
the system. Later during the project, weekly or bi-weekly meetings may suffice.
It will be the responsibility of the team to determine the appropriate meeting
schedule and locations. All meeting minutes will be documented and distributed
to SBCL and UMM.
A project status meeting, would be scheduled on a monthly basis separate from
the technical meetings. The meetings could be held at either location at
SmithKline's option. The appropriate personnel would attend as necessary and a
project status report will be provided at the meeting. Minutes of the meeting
including action item assignments will be provided within 1 week following the
meeting unless a joint decision to do otherwise.
The project team meetings should include a complete cross section of the
organization that will be responsible for the product. Again, specific
involvement at the meetings may vary during the course of the development.
However, the overall team should be comprised of personnel from marketing,
regulatory affairs, quality, product development, purchasing, manufacturing,
finance, clinical affairs, and service. Depending on the structure of your
organization, additional responsibilities may be independently represented.
Groups such as
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reliability, safety, planning and technical publications may also be represented
on the overall project team.
Responsibilities. United Medical Manufacturing realizes that SmithKline Xxxxxxx
Clinical Laboratories is ultimately responsible to their customers for the
product. Again, we sincerely value a long-term relationship and therefore
provide the quality that is necessary to maintain your excellent reputation. We
have found it beneficial to clarify our understanding of the roles and
responsibilities of both companies in the design and development and
manufacturing programs. If these do not represent your requirements, please let
us know and we can discuss.
. SBCL has the primary responsibility to define the customer requirements,
marketing requirements
. UMM and SBCL will work together to develop a product specification. (We
realize the product specification will evolve through the program.)
This specification should include but not be limited to:
- reliability criteria
- functional performance
- quality criteria
- specific standards as requirements
. United Medical has the responsibility to design, develop and manufacture a
point of care reflectance system that meets the product specification.
Furthermore, United Medical has the responsibility to identify and
highlight any conflicting or high risk requirement as soon as possible.
. United Medical will utilize its experience and expertise to suggest ideas
to improve the success of the program. This includes suggesting the early
development of a "Test Stand" to aid in the evolution of development of the
disposeable and the reflectometer. This is dependent on the stage of the
disposeable.
. United Medical has the responsibility to design, develop and manufacture in
accordance with GMP and FDA standards.
. SBCL has the responsibility to clinically evaluate and accept the final
design.
. SBCL has the responsibility to review and approve the design at various
stages of the program.
. United Medical has the responsibility to manufacture and deliver the SBCL
point of care systems at the agreed quantity with the agreed terms.
. United Medical and SBCL share the responsibility to evaluate the product
performance in the field and continually improve the product for
performance, quality and manufacture through quarterly meetings.
. United Medical is charged with continually searching for product and
process improvements which will be mutually beneficial.
. Both partners should support the needs and concerns of each other and
together create a formidable team.
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Quality Assurance through Compliance.
United Medical Manufacturing is committed to product development and
manufacturing which meet or exceed customer's expectations. It is our normal
operating procedure to establish customer expectations as early as possible. To
understand SBCL's expectations, United Medical would request/identify a list of
the standards with which the product must comply. The standards are assigned to
the appropriate discipline to incorporate your requirements into the
specification and design. All design and development tasks will adhere to those
standards. Where appropriate, United Medical will design and build with XX000,
XXX, XXX0X0-0 and VDE approved parts. In addition, at the appropriate point in
the project, we would review and audit the design where needed prior to
submission to the regulating body.
As an FDA registered manufacturer, all of our products are designed and
manufactured in compliance with current GMPs.
Continuous Improvement to Strengthen Partnership.
UMM believes it is important to continue to strive for improvement in all areas.
This includes periodically reviewing the effectiveness and performance of our
relationship with SBCL.
The performance and status of the project will be included in various design
review meetings. Each review meeting will also generate a set of "action items"
assignments. This will provide a mechanism for identification of critical and
important areas.
After the manufacturing begins, United Medical Manufacturing proposes periodic
partnership meetings which would include top level management from both
companies. These meetings would be a forum to review the effectiveness of the
partnership and to identify areas for improvement to strengthen the partnership.
The partners would review the overall performance of the partnership and discuss
systemic and organizational improvements as necessary. As the partnership
extends, strategic issues for both organizations could be shared which should
result in mutual benefits for both SBCL and United Medical Manufacturing.
United Medical is committed to a corporate philosophy of continuous quality
improvement. We strive to challenge the norms and extend our manufacturing
leadership by continually searching for ways to improve our processes and
services. Our continuous quality improvement teams represent a true partnership
commitment. The teams have included customers (partners) along with UMM R&D,
Manufacturing, Purchasing, Finance, Management and Quality Services personnel.
The team's members are the key people who are "closest" to the problem or
opportunity. They identify opportunities for improvement, perform necessary
analyses, and then make and implement their recommendations. Recommendations are
reviewed by our Continuous Quality Improvement Process (CQIP) steering committee
and by our customers to prior to implementation. The recommendations are also
reviewed to determine any beneficial applications to other areas of the company.
Finally, United Medical periodically conducts "customer satisfaction" surveys
which address areas for improving operations and relations with our customers.
We are committed to total customer satisfaction and if at any time SBCL is not
satisfied with UMM's performance, you are invited to call Xxxx X. Xxxxxxx, the
president of UMM.
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Design Services
As the development and manufacturing partner, United Medical Manufacturing
offers a very competitive cost structure for our experienced engineering
services. Our primary business focus is on turnkey manufacturing. Therefore, as
part of our commitment to the manufacturing partnership, UNM will provide to
SmithKline Xxxxxxx engineering product design and development services at only
$60 per hour. (Note: This is in 1995 dollars.)
We believe this offers SBCL extremely high value for our experience and
expertise. Because manufacturing is our primary goal, it also provides UMM with
additional incentives to complete the design and development program as early as
possible and to ensure the product is of high quality and very manufacturable.
Our initial estimates are
Phase 1 Product Definition $ 76,800
Phase 2 Feasibility/Design Tradeoffs $137,000
Phase 3 Derailed Design $270,000
Phase 4 Pilot Production $175,000/1/
Phase 5 Full-Scale Production Unit Cost
TBD
. This estimate does not include any tooling or mold charges.
/1/ This does not include pilot production units. The cost of the pilot
production units is dependent on the design and on the number of units
required. It also does not any regulatory agency approval fees (UL,
etc.), although it does include support time.
These are rough estimates based on development programs of similar devices. We
will perform these services on a "Time and Materials" basis. We will track and
charge only the actual time required to accomplish the necessary tasks. Upon
completion of the Product Definition, we will be in a better position to provide
a more accurate schedule and cost assessment.
Based on our experience with similar programs, we estimate that we could be
completed with the design and development within 10 months after starting.
Depending on component lead times and clinical testing, the full-scale
production could occur within 12 months after starting.
UMM's general terms and conditions are included in Appendix C.
Conclusion
United Medical Manufacturing is exceptionally qualified to provide SmithKline
Xxxxxxx Clinical Laboratories with design and manufacturing services which will
translate your concept for point of care analyzer into a high quality, cost
effective system. Our experience and expertise will provide insight to get you
there faster and cheaper with less product introduction problems. The conclusion
is clear: United Medical Manufacturing is the best qualified company to partner
with designing and manufacturing the SBCL reflectometer as part of your point of
care analyzer system. We urge you to select United Medical Manufacturing.
8
Appendix A.
Estimated Schedule for the Design, Development and Documentation for the
SmithKline Xxxxxxx Clinical Laboratories Point of Care Reflectometer
9
[GRAPH APPEARS HERE]
A graph appears on this page which lists task names on the far left from
top to bottom followed by a section on the top center from the left to right
listing quarters and three milestone subsections within each quarter. Solid bars
next to each task and their position relative to each quarter and milestone
indicate the progress and the time each task is estimated to take. The chart has
the label "Preliminary" on the top right hand corner. The task list reflects the
different phases of development (e.g. Phase 1 followed by Phase 2).
[GRAPH APPEARS HERE]
The graph which began on the previous page continues onto this page and
again lists task names on the far left from top to bottom followed by a section
on the top center from left to right listing quarters and three milestone
subsections with in each quarter. Solid bars next to each task and their
position relative to each quarter and milestone indicate the progress and the
time each task is estimated to take. The chart has the label "Preliminary" on
the top right hand corner. The task list reflects the different phases of
development.
[GRAPH APPEARS HERE]
The graph ends on this page and again lists task names on the far left
from top to bottom followed by a section on the top center from left to right
listing quarters and three milestone sub sections within each quarter. Solid
bars next to each task and their position relative to each quarter and milestone
indicate the progress and the time each task is estimated to take. The chart has
the label "Preliminary" on the top right hand corner. The task list reflects the
different phases of development.
Appendix B
Detailed Schedule and Description of Work
This appendix contains our initial estimate for the schedule and scope of the
work needed accomplish design, developing and documenting the SmithKline Xxxxxxx
point of care diagnostic reflectometer.
Objective: The purpose of this project is to design, develop, and manufacture
diagnostic devices for SmithKline Xxxxxxx Clinical Laboratories. The preliminary
requirements are outlined in Xx. Xxx Xxxxx'x RFP.
Product Profile and Goals
-------------------------
The diagnostic device has the following preliminary characteristics:
. AC/DC power
. reflectometer with multiple wavelength capabilities
. capable of reading reagents on test cards inserted into meter
. capable of reading multiple (1-4) tests per card (multiple
detectors)
. capable of decoding test information from the test card (what test
to perform, parameters of reagents etc.)
. LCD (five (5) lines)
. Serial communications port/access
. temperature control
. Alpha-numeric keypad input capability
. onboard QC -- realtime testing
. error detection/diagnostics -- built-in-test
. capable of wireless transfer of data (line of sight)
. inexpensive (less than $1000 to make) -- Transfer price
We propose utilizing a concurrent engineering approach to the design and
development of this device. The following details our approach based on our
design and control quality system procedure. It is very similar to the three
phase approach outlined in your RFP. (in fact we mapped our phases into a three
phase schedule.)
SmithKline Development Phases UMM Development Phases
----------------------------- ----------------------
Phase 1 - Product Specification Phase 1: Product Definition
Phase 2: Feasibility/Tradeoffs
--- Result: Product Xxxxxxxxxxxxx
Xxxxx 0 - Xxxxxxxxxxx Xxxxx 0: Design/Development
--- Result: Detailed Design
and Documentation
Phase 3 - Production Phase 4: Pilot Production
Phase 5: Full-Scale Production
The following provides a more detailed account of this approach.
Approach
--------
1. Phase 1: Product Definition Concept Development
2. Phase 2: Preliminary Design/Feasibility Phase.
3. Phase 3: Design and Development Phase.
4. Phase 4: Pilot Production
5. Xxxxx 0: Full scale Production
13
Phase 1: Product Definition/Concept Development Phase
-----------------------------------------------------
Reviewing Smithkline's Requirements --Initial Meeting
Preliminary Hazard Analysis.
QFD-- Preliminary Concept Review
Mockup
User Interface Research
Phase 2: Preliminary design/Feasibility Phase
---------------------------------------------
System Analysis:
Mechanical Analysis
Electronic Analysis.
Software Analysis.
Test station for Disposeable Analysis
Industrial design
Functional Specification.
Quality Plan
Reliability Plan
Manufacturing Plan
Initial Manufacturing Analysis
Technical Risk Assessment.
Design Alternative Analysis.
Feasibility Phase Review and Approval.
Phase 3: Detailed Design and Development Phase
----------------------------------------------
Mechanical Design
Environmental Test Plan
Electronic Design:
Hardware Detailed Design Specification.
Circuit Design.
Material and Component Specifications.
Drawings: Schematics, BOM's.
Theory of Operation.
Hardware Design Review 1.
Printed Circuit Board Design and Layout.
Electronic Component Reliability Report.
Hardware Test Plan.
Hardware Design Review 2.
Build Pre-Prototypes.
Hardware Detailed Test Protocol.
Software Design:
Software Detailed Design Specification.
CASE Diagrams and Data Dictionary.
Process Specifications and Pseudo Code.
Software Test Plan.
Software Design Review.
Coding.
Software Detailed Test Protocol.
Mechanical Design (Enclosure)
Detailed Design Specification
FMEA
Assembly Drawings -- exploded view
Quality Services Plan
Hazard Analysis.
Integrate Software.
14
Debug Electronic Hardware.
Debug Software.
Execute Electronic Hardware Test Protocol
Execute Software Test Protocol
System Design Review.
Environmental Testing
Shock and Vibration
EMI and RFI
Temperature
Update Electronic Design.
Update Software Design.
Produce Pilot Prototype Enclosures
Build Prototypes
FMEA Analysis (Component and Process).
Fault Tree Analysis.
Final Hazard Analysis.
Execute (Final) Electronic Hardware Test Protocol.
Execute (Final) Software Test Protocol.
Functional Audit.
Design and Development Phase Review and Approval (Design frozen)
Phase 4: Pilot Production
-------------------------
Manufacturing Process Design
Assembly Procedures
Fixture Development
Test Procedures
Test Fixture Development
Process Validation
Build XXX xxxxx xxxxx
Xxxxxxxx Xxxxxxxxxxxxx Xxxxxxx
Xxxxx 0: Full-Scale Production
------------------------------
Final enclosure tooling Defined
Production enclosure specifications
Production enclosure drawings (materials can affect drwgs)
Major Tasks
-----------
The following is a brief (summary) description of some of the major tasks:
----
Phase 1: Product Definition and Assessment
Initial Meeting -- (SmithKline, UMM)
------------------------------------
Review the general requirements such as the user profile, the typical
application environment, competing products, instrument size, weight and shape
constraints. Review other design goals such as serviceability, cleanability. We
would also discuss the interaction of the instrument with the chemistry. This
includes assessing the card reader requirements (if the chemistry card is
already defined), the chemistry's characteristics and behaviors, any dosing or
sample detection requirements (sensing when sample application occurs), flow
rates, control solutions and standards, calibration requirements etc.
Quality Functional Deployment/Customer Requirements
---------------------------------------------------
UMM recommends utilizing a QFD or similar approach to defining key customer
requirements. This approach provides benefits which are twofold: 1) it defines
the key features based on the needs of the users/customers and on a competitive
analysis, 2) it provides a forum for the development to obtain a common vision
of the concept. When
15
facilitated properly, this becomes a very powerful communication tool as well as
rapidly developing a baseline concept for the reflectometer. This saves
considerable time and money by preventing misunderstandings and providing a
common focus. The QFD does not result in a final product definition, but
provides for early tradeoffs and considerations.
Mockup Fabrication (optional -- Not included in estimate)
---------------------------------------------------------
A full scale mockup of the analyzer will be fabricated in order to validate the
design with users and refine the over all size proportion and user interface.
The mock up will contain no working parts but will simulate the user interface
and visual detailing of the enclosure.
UMM could rapidly generate LCD screens to perform user interface research, if
this is required. Our internally developed computer aided software (CASE) tool
provides SmithKline with the opportunity to quickly assess user interface
considerations.
User Evaluation (Focus Groups if necessary -- not included in estimate)
-----------------------------------------------------------------------
Upon availability of the mockup and all the materials required to execute a test
on the system, consideration should be given to execute and analyze a hands-on
evaluation of the system. The objective of the evaluation will be to identify
ergonomic, work flow and design refinements to be incorporated into the system
prototype. Activities included user: research design, session execution,
results, analysis and an executive summary of product design requirements. This
effort has proven to be extremely beneficial in providing more insight to the
user's needs and wants. Please note this activity is usually performed by the
Marketing company, however, UMM can identify an Industrial Design/Market
Research company who can perform this analysis.
Program management will review the information and determine what or if any,
chances or refinements to make. Meeting minutes will be recorded and provided.
Phase 2: Feasibility and Design Tradeoffs
System Analysis
---------------
The System Analysis is an in-depth review and analysis of the product
Requirements and Design Goals as presented in the QFD or customer requirements
definition, The purpose of the System Analysis is to determine the optimum
architecture to satisfy the requirements for the device. The System Analysis
will also evaluate the hardware and software tradeoffs, to obtain the best
"system" solution.
Functional Specifications
-------------------------
Functional Specifications will be developed from the Requirements Document. The
Functional Specifications will include:
1. "How" the Requirements will be met.
2. What electronic hardware will be used.
3. How the User Interface will function.
4. The Normal mode of operation.
5. Other modes of operation, including Setup, Test, and Errors as applicable.
6. Operating Specifications including input voltage and frequency,
temperature range, humidity, etc.
7. Enclosure dimensions, shape, material, gauge, and finish.
Other items as deemed necessary will be included.
Layout Update
-------------
The system layout will be updated to include any refinement or adjustments that
are a results of the user evaluation. The layout will finalize the location and
mounting of all interior and exterior component. The exterior surface detailing
of the enclosure will be
16
developed to include the color and finish specifications Industrial [design
input will be provided to insure that any changes to the enclosure are
integrated into the design as they occur.
Phase 3: Detailed Design
Mechanical Preliminary Design Review
------------------------------------
A meeting will be scheduled with Program Management in order to review the
concepts. Program management will determine which direction or combination of
concepts to develop further. Meeting minutes will be recorded and provided.
Hardware Detailed Design Specification
--------------------------------------
The Hardware Detailed Design Specification documents the electronics design in
detail, including a Theory of Operation, circuit description, etc. It references
other design documents such as the schematics, Xxxx of Materials, wiring
diagrams and component specifications to provide a complete encapsulation of the
electronics design.
Circuit Design
--------------
The electronic circuit design task will include circuit design and component
selection. Tradeoffs pertaining to features, performance, availability, and cost
will be evaluated to choose the optimum parts for the application. The component
selection will focus on existing components readily available in the anticipated
quantities, which can be integrated together to provide the lowest finished
product cost, with the highest system quality and reliability.
Drawings; Schematic, Xxxx of Materials
--------------------------------------
The circuit design (schematic and Xxxx of Materials) will be documented with a
Computer Aided Design (CAD) package. The Xxxx of Materials will specify the
component manufacturer and part number, with approved sources of supply.
Hardware Design Review 1
------------------------
The focus of the first Hardware Design Review is the circuit design and
component selection. The review is performed as a top-down review. It begins by
looking at the overall design, then the components selected, and ends after
analyzing each circuit node. This review confirms that the design is in
agreement with the Functional Specification.
Printed Circuit Board Design and Layout
---------------------------------------
The printed circuit board (PCB) design will be done on a CAD system. A printed
circuit board component assembly drawing will also be generated. It will show
all components on the board(s). The PCB will be designed to meet regulatory and
agency approval as stated in the Functional Specifications. The PCB will include
transient protection, electrostatic discharge protection, and RFI filtering as
stated in the Functional Specifications.
Hardware Test Plan
------------------
The Hardware Test Plan outlines what equipment is required, and what tests will
be performed on the electronic hardware.
Hardware Design Review 2
------------------------
The focus of the second Hardware Design Review is the printed circuit board
design and Hardware Test Plan. The review begins by re-verifying any outstanding
issues from the first review, and ends after reviewing the printed circuit board
layout and Hardware Test Plan.
Build Pre-Prototypes
--------------------
17
Electronic Technicians will assemble, build, and aid in the testing and
debugging of the pre-prototype units.
Hardware Test Protocol
----------------------
The Hardware Test Protocol will detail the test steps to be performed for each
test specified in the Hardware Test Plan.
Software Detailed Design Specification
--------------------------------------
The Software Detailed Design Specification documents the software design in
detail, including the overall architecture, communication protocols. algorithms,
etc. It references other design documents such as the Data Flow Diagrams, Data
Dictionary, Structure charts, State Transition Diagrams, process specifications
and pseudo-code to provide a complete encapsulation of the software design.
CASE Diagrams and Data Dictionary
---------------------------------
The software will be designed using structured design techniques. Computer Aided
Software Engineering (CASE) tools will be used to generate Data Flow Diagrams,
State Transition Diagrams, Structure Charts and a Data Dictionary. The Data Flow
Diagrams embody a `process model', which shows how data flows between internal
processes, which perform data transformations. State Transition Diagrams specify
the logic of transitions between different states in terms of conditions and
actions. The Data Dictionary defines the data elements which communicate
information between processes or storage.
Process Specifications and Pseudo Code
--------------------------------------
The `process model' described by the Data Flow Diagrams is a hierarchical
description, which at the lowest level is described by Process Specifications
detailing the logic. These P-specs are usually English language descriptions or
Pseudo Code.
Software Test Plan
------------------
The Software Test Plan outlines what equipment is required, and what tests will
be performed on the software program.
Soft Design Review
------------------
The focus of the Software Design Review is to review and critique the software
design as described by the Software Detailed Design Specification, including the
CASE Diagrams, Data Dictionary, Pseudo Code, and Software Test Plan. These
documents are analyzed for internal consistency and logic, and to determine if
the Functional Specification is met in the design as described.
Software Coding
---------------
For ease of maintainability, the software program will be written in "C".
Structured, modular programming techniques, with source level documentation will
be included.
Software Test Protocol
----------------------
The Software Test Protocol will specify in detail how the software will be
tested, and what results will he expected. The protocol will include both "black
box" and "white box" testing. "Black box" testing is based on having no
knowledge of the actual implementation of the software program, and therefore
tests combination of input stimuli to monitor output results. "White box"
testing is based on knowledge of the software program, and specifically tests
functions and modules `in isolation' for proper performance. This usually
requires the use of emulation equipment or debuggers.
Execute Software Test Protocol
------------------------------
18
After the preliminary testing and debug has been completed, a formal software
test will be performed per the Software Test Protocol. The test results will be
compiled and documented, and will state the expected and actual results
obtained.
Mechanical Design and development
---------------------------------
Based on the results of the design review, a final design direction for the
analyzer enclosure will be developed. The design will be developed in the form
of a scale layout, perspective renderings and exploded views depicting
preliminary part count and assembly methods,
Develop a complete layout of the reflectometer housing. The layout will include
the approximate size and location of the P.C. boards, power supply connector
interfaces, chassis and enclosures, a 3-D computer model of the analyzer will be
developed in order to define the preliminary component to component interfaces
and the attachment and assembly of the enclosure. The data base will be provided
to Program Management for review and updates. The updated data base will be
continually refined as we move through the development program.
Materials and Process Identification
------------------------------------
UMM, will determine the appropriate materials and manufacturing processes for
the production unit. This determination will be based on the ultimate
manufacturing quantities environment of use, appearance and cost.
Documentation of the process will be provided.
Mechanical Design Review
------------------------
This will review the enclosure and its internal components and structure.
Final Design Review
-------------------
A meeting will be scheduled with Program Management in order to review the final
design direction, provide input and to provide approval to proceed to the next
phase. Meeting minutes will be recorded and provided.
FMEA Matrix
-----------
A Failure Modes and Effects Analysis (FMEA) Matrix will be developed. The matrix
will address any component that, as a result of the design direction, is
determined to be an active component of the system.
Enclosure Design Review
-----------------------
During the design layout activity, periodic reviews with Program Management will
be scheduled in order to keep abreast of program progress and address any
changes in a timely manner. It is anticipated that the computer model will be
viewed on an available CAD system followed by a discussion and review of the
plots. Meeting minutes will be recorded and provided.
Detailed Component Drawings
---------------------------
From the 3-D computer layout of the system, individual part files will be
created. The individual components will then be detailed as prototype part
drawings for the housing components. This activity will address part design,
material, hardware, color and finish specifications. All individual components
will be maintained in a 3-D format to facilitate back annotation into the system
layout. This will insure proper part to part fit and provide the ability to make
chances as they may arise. The drawings will be provided in both print and
compatible disc format.
Vendor Review and Cost Update
-----------------------------
Review the prototype drawings package with selected vendors in order to
determine preliminary piece part costs, lead times and preliminary tooling
estimates.
19
Part Drawings Review
--------------------
Upon completion of the part drawings and vendor review, UMM will schedule a
review with Program Management. The purpose of the review will be to insure that
all prototype criteria have been met and to discuss any chances or modifications
that may be required prior to the fabrication of the prototype. Meeting minutes
will be recorded and provided.
Prototype Fabrication
---------------------
UMM will develop a functional, working prototype to ensure design intent has
been accomplished. This should confirm achievement of the customer's
requirements.
Presentation
------------
UMM will schedule a meeting with Program Management/(Customer) to present the
assembled prototype. Program Management will review the prototype and determine
the requirements for further development. Meeting minutes will be recorded and
provided.
Phase 4: Pilot Production
Assembly Procedures
-------------------
The complete procedures package will be developed which details the
manufacturing process and component assemblies.
Fixture Development
-------------------
The design, development and documentation of any fixtures necessary for
performing the assembly procedures.
Test Procedures
---------------
This includes any electrical and functional tests (GenRad circuit tests, final
functional load test, etc.) to ensure unit functions as specifies.
Test Fixture Development
------------------------
This is the design, development and documentation for any necessary test
fixtures.
Process Validation
------------------
An FMEA will be performed on the processes to identify processes required to be
validated. The validation of the processes ensures consistent, reliable
manufacturing processes.
Environmental Tests
-------------------
Pre-prototype units will be submitted to a test laboratory to confirm they pass
the environmental specifications. Operating temperature, humidity, Electrostatic
Discharge (ESD), Radio Frequency Interference (RFI). and Electromagnetic
Interference (EMI) testing will be performed as stated in the Environmental Test
Plan.
Pilot Production Run
--------------------
UMM will manufacture a specified number of reflectometers to verify the assembly
processes and procedures are correct. The number of units will be determined by
SmithKline Xxxxxxx and United Medical Manufacturing.
Pilot Production Acceptance and Approval
----------------------------------------
A formal acceptance and delivery meeting will be schedule.
Full-Scale Production Schedule
------------------------------
20
UMM will develop a master production schedule based on anticipated forecasts and
lead time availability for specified components.
Vendor Review
-------------
Preview clinical unit drawing package with selected molding vendor in order to
determine mold preferences and part design strategy particular to that vendor.
Production Part Drawings
------------------------
Develop production part drawings for the enclosure components to include
modifications and refinements determined from the use of the prototype units.
Drawings Review
---------------
The purpose of the review will be to insure that all molding and manufacturing
criteria have been met and to discuss any changes or modifications that may be
required.
Drawing Revisions
-----------------
Should any changes or modifications be required, UMM will revise the drawings
and submit them for review and approval.
Phase 5: Full-Scale Production
21
Appendix C
General Terms and Conditions
22
United Medical Manufacturing General Terms and Conditions for Design and
------------------------------------------------------------------------
Development Services
--------------------
. Development labor rate is $60 per hour.
. "Time and Materials" is the actual time to perform the specified tasks
with the necessary resources or materials.
. Development labor time will be tracked using job order numbers and
will be billed monthly unless otherwise noted.
. Travel and miscellaneous expenses will be billed at cost plus 5%.
- Travel expenses include:
Private auto mileage at 30 cents
per mile (latest rate as
determined by the IRS).
Parking, tolls and fares.
Car rental, if required.
Airfare, if required.
- Miscellaneous expenses include, but are not limited to:
Rooms and meals away from home base, if required.
. A purchase order for the full amount of any tooling must be provided
to United Medical prior to UMM placing the order.
. Payment terms are net 15 days after date of invoice.
. Unless otherwise noted, any proposal or estimate is valid for 30 days.
. An endorsement of this agreement or a purchase order for 25% of the
estimate constitutes acceptance of the agreement and acknowledges
acceptance of the terms and conditions.
23
United Medical Manufacturing General Terms and Conditions for
-------------------------------------------------------------
Manufacturing Services
----------------------
. Prices are FOB United Medical Manufacturing's dock.
. Unless specified, prices do not include packaging for shipping.
. If prices are denoted as estimates, then the final price will be
determined based on the final xxxx-of-materials.
. A lead time will be established in conjunction with customer which
balances customer forecasted demand, component lead times and
inventory management.
. Costs associated with requests for expediated orders will be
determined and proposed prior to implementing expedited order.
. If requested, Development labor time will be tracked using job order
numbers and will be billed monthly unless otherwise noted.
. Travel and miscellaneous expenses will be billed at cost plus
5%.
- Travel expenses include:
Private auto mileage at 30 cents per mile.
Parking, tolls and fares.
Car rental, if required.
Airfare, if required.
- Miscellaneous expenses include, but are not limited to:
Rooms and meals away from home base, if required.
. A purchase order for the full amount of any tooling must be provided
to United Medical prior to UMM placing the order.
. Payment terms are net 15 days after date of invoice.
. Unless otherwise noted, any proposal or estimate is valid for 30 days.
24
[GRAPH APPEARS HERE]
A graph begins on this page and lists the task names on the far left
from top to bottom followed by small sections along the top from left to right
which cover the duration, start, finish, cost, work, produces and resources for
each task listed on the far left. The duration, the start date, the finish date,
the cost of each task, etc. is given for the various tasks. These sections on
the top are then followed by a section from left to right listing quarters and
three milestones subsections within each quarter. Solid bars next to each task
and their position relative to each quarter and milestone indicate the progress
and time each task is estimated to take. The task list reflects the different
phases of development.
[GRAPH APPEARS HERE]
The graph continues on this page and lists the task names on the far
left from top to bottom followed by small sections along the top from left to
right which cover the duration, start, finish, cost, work, produces and
resources for each task listed on the far left. The duration, the start date,
the finish date, the cost of each task, etc. is given for the various tasks.
These sections on the top are then followed by a section from left to right
listing quarters and three milestones subsections within each quarter. Solid
bars next to each task and their position relative to each quarter and milestone
indicate the progress and time each task is estimated to take. The task list
reflects the different phases of development.
[GRAPH APPEARS HERE]
The graph ends on this page and lists the task names on the far
left from top to bottom followed by small sections along the top from left to
right which cover the duration, start, finish, cost, work, produces and
resources for each task listed on the far left. The duration, the start date,
the finish date, the cost of each task, etc. is given for the various tasks.
These sections on the top are then followed by a section from left to right
listing quarters and three milestones subsections within each quarter. Solid
bars next to each task and their position relative to each quarter and milestone
indicate the progress and time each task is estimated to take. The task list
reflects the different phases of development.
