Your Solutions Group & Your Corporation
You r So l u ti o n s G ro up You r Corporation
Address 1 Address 2
Tel. 1 Tel. 2
Email 1 Email 2
Web 1 Web 2
Preliminary Proposal and
Manufacturing Consultant for
Best Opportunity for Business Development
AUGUST 28, 2011
Table . Contents
1 The Team .................................................................................................1
1.1 Your Corporation (Your Corp.) .....................................................1
1.2 Your Solutions Group Corporation (YSG) ....................................1
1.3 Primary Responsibility for Engineering Study...............................2
2 Scope of Services ....................................................................................3
2.1 Engineering Scope .......................................................................4
2.2 Marketing Scope ..........................................................................4
2.3 Economic Analysis – Rate of Return on Investment (ROR) .........4
3 Marketing Services Available ...................................................................4
3.1 Phase I .........................................................................................4
3.2 Phase II ........................................................................................7
3.3 Phase III 7
5 Contingencies ..........................................................................................8
6 Time For Execution ..................................................................................9
7 Fees For The Project ...............................................................................9
8 Additional Services Available ................................................................ 11
9 Responsibilities of the Client ................................................................. 12
10 Changes To Project Scope ....................................................... 12
11 Secrecy Undertakings ............................................................... 12
12 Termination Of The Work.......................................................... 13
Manufacturing Consultant for Pharmaceutical Start-up - eWork Markets ID 00000
The current situation you describe in your Request For Proposal (RFP) is the need for consultants with
executive level experience to assist you in the launch of an aggressive, proactive manufacturing and
marketing and business development activity for a new generic pharmaceutical company supplying oral and
injectable medical products. You require knowledgeable technical assistance with FDA regulations, set-up
and operation of manufacturing facilities, recommendations on manufacturing equipment needed to
compound, label, package and store topical products, facility and operation cGMP. The consultant must be
able to help file the necessary documents with FDA for generic prescription topicals. Must also be able to
advise on facility setup in compliance with cGMP and registration with the FDA. Specifics will be discussed
during programming meeting.
As business entrepreneurs your responsibility is to evaluate the viability of the business and perform market
research to help you assess the potential of the concept in your area of distribution. Included with the
aforementioned, is an analysis of the competitive situation, preparation of initial revenue projections and
establishment of what is generally known as financial metrics for the business; these include your minimum
attractive rate of return (MARR) and the actual after-taxes rate of return (ROR) for the business.
Your interest, it appears to us, is to perform a Market Analysis of the larger consumer, and commercial
national or global market for your product and see how your business could be properly positioned. Your
concept represents a product for the Health Care Sector, positioning should be somewhere in the Health Care
Equipment and Services Industry Group and more specifically in the Health Care Equipment and Supplies
From the onset, it appears that your competitors might be companies like Abbott Laboratories, Baxter, Bristol
Myers Squibb, Ortho Pharmaceuticals, Pfizer, Guidant, Wyeth Pharmaceuticals, Invacare, Medtronic and
Schering Plough. This is because most major pharmaceuticals also provide sterilized packaging for delivery of
medicines and disposable equipment for clinical and operating room uses. After the manufacturing process of
these, mostly, plastic products they are required to undergo a sterilization process which is usually carried out
in large autoclaves or irradiation before being shipped to market or filled with medicinal substances. Some of
these companies have several hundred million dollars in annual revenues foreign and domestically derived
from sales of medical products. Many have aggressive expansion goals which might include products like
yours. One of these business models might be just right for your project goals but the fact is that successful
business models change, adapt and are niche specific.
We would like you to understand that you are about to embark on a difficult and competitive task, fraught with
obstacles and pitfalls for entrepreneurs with limited resources. The government (FDA) vetting process is
extremely expensive, on the order of $90,000 to $650,000 just to review your single active ingredient
compound mixture. Additional active ingredients require similar fees. However, small businesses can obtain
partial waivers and exemptions for their marketing permits. Additionally, those small business which have
obtained U.S. Patents for their mixtures can obtain fee waivers and time extensions on the patents as
compensation for the lengthy FDA review process. YSG / YOUR CORP will provide your company with the
broad scope and in-depth knowledge of the regulations and market so that you can take the practical first
steps, well informed. We want YSG / YOUR CORP to be your first choice for this project.
Additionally, you may need a review of other parts of the Code of Federal Regulations (CFR) for your
company’s particular products and the facilities required to manufacture them in order to ensure achievement
of complete compliance with applicable regulations. As you may probably know, U.S. industry is regulated by
the CFR for various areas such as: food, cosmetics and medicines are regulated by the Food and Drug
Administration (FDA), the power utilities and other industries are regulated by the Environmental Protection
Agency (EPA), and the import/export industry is regulated by the Department of Commerce, among many
others, and all these agencies have their rules codified in the CFR.
YSG and Your Corp. are experts in code review and procedural application for marketing of various products
Your Solutions Group (YSG) partners from time to time with other consultants whose specialty is different
from or expands on theirs. For this task, YSG will be partnering with Your Corporation. Your Corporation will
have the principle responsibility of implementing this project. YSG staff are state-of-the-art pharmaceutical
consultants which will be consulted continuously throughout the progress of this project. Your Corporation
staff are business and product developers, we believe this is the perfect synergy for your project.
We hope the following preliminary proposal will describe in as much detail as is possible at this point, on how
to accomplish your project goals. Please note that Section 5 Contingencies, may not apply to your particular
project but we don’t know enough about it to discard the information and it may be useful to you. Some of the
information also applies to Trade Marks and Trade Names. We like our clients to be well informed.
Your Corporation administrates engineering, regulatory compliance, product marketing, patent process, and
environmental consulting services to several sectors of the economy including the manufacturing, chemical
process and pharmaceutical industries. The corporation sub-contracts additional professional personnel
licensed to offer such services, whenever necessary. The branch which deals with environmental solutions is
Your Corporation – Environmental Consultants.
Business solutions include Marketing Research / Analysis / Plans and complete Business Plans.
Marketing analysis for our client’s products profile the latest technology and products developed by competing
manufacturing companies world-wide, as also existing patents, trademarks and trade names, the market
share in certain product categories, production facilities, distribution channels, existing networks of suppliers
and contractors, a description of work under development, earnings and losses statements and an evaluation
of the competition.
Your Corp will engage in data mining for the client of all the major companies manufacturing similar products
to your business interests and will develop a detailed marketing analysis and plan for your product based on
this knowledge. The best manufacturing prospect will be identified as a model to follow and the remainders
will be ranked in order of importance to your product and areas of distribution.
At Your Corp, we believe there is a proven strategy for marketing services and products effectively and
profitably. Any review of the Marketing Plan should convey that your product is either so novel and innovative
that it creates a market in and of itself or is a natural extension of an already well established product line and
that your business closes a product loop or product line. Our competitors sometimes charge up to three times
as much as we do for similar research, however, we have ready access to a larger databank and our
overhead is generally lower.
Please visit our websites at www.the-tx.com and www.Yourcorp.com
Manufacturing Consultant for
Best Opportunity for Business Development Strategy
1.1 Your Corporation (Your Corp.)
Patent Development Consultants, Engineering Consultants, Regulatory Compliance
Consultants and Marketing and Business Consultants.
Your Corp. specializes in patent feasibility, regulatory compliance and development of
inventions of varying significance. Engineering specialties are in chemical, electronics,
mechanical and environmental. In business, our marketing focus necessarily combines
the systematic penetration approach and the flirtatious capture approach. Business
solutions include full metrics and financial statements with the goal of partnering with
Venture Capitalists (VC) and Angel Investors (AI) from sources domestic, foreign,
institutional or private.
Your Corp. provides its clients with access to:
More Than 50 Domestic Private Venture Capital (VC) Funds
Several Hundred Angel Investors (AI)
More Than 100 Federal And State Money Programs
Over 50 Micro-Enterprise Loan Sources
Over 50 Small Business Loan Sources
Over 200 Small Business Investment Companies, And
More Than 50 Unconventional Loan Programs
1.2 Your Solutions Group Corporation (YSG)
Information System Consultant, Project Management, Validation Consultant and
Manufacturing solutions consultants for the Pharmaceutical Industry.
YSG provides a full range of Technology, Business Process Re-engineering, ERP System
Implementation Assistance, Project Management, Manufacturing Process Automation
Laboratory Systems, Compliance services and Engineering services in both the business
management and manufacturing space.
YSG staff has been a well-regarded provider of Manufacturing Business Integrated
Support Solutions, often on a repeated and/or continuous basis. Below is a partial list of
our current clients:
Baxter Dominican Republic
Bristol Myers Squibb
Merck Sharp & Dohme
Other potential local clients are:
Lily del Caribe, Inc.
Cordis LLC, a Johnson & Johnson Company
Proctor & Gamble Pharmaceuticals
Wyeth – Ayerst Lederle, Inc.
1.3 Primary Responsibility for Engineering Study and Marketing Plan
YSG staff will partner with Your Corporation to meet this project’s goals and will have
limited input. However, contract coordination will be made through YSG since they are a
Certified Affiliate of eWork Markets.
Your Corporation will be responsible to provide the elements described in the Scope of
Work for this proposal under a separate agreement with YSG.
• Fluent/familiar with global premarket and post-market regulatory requirements for
• Relevant documentation and comprehensive, well-organized premarket dossiers for the
-- United States: IDE, 510(k), PMA, BLA, NDA, Device Listings / Establishment
• Apply for FDA Certificates
• Prepare for and support international product recalls by writing recall procedures,
performing Health Hazard Evaluations, determining recall classification, preparing
consumer/customer notifications, preparing and submitting agency notifications (i.e.,
reports of corrections and removals), documenting effectiveness checks, and terminating
• Preparation of Formal Responses to FDA-483 citations and Warning Letters, Notified
Body/Registrar nonconformities, and other analogous international agency citations.
• Fluent with FDA complaint handling and adverse event reporting requirements for
• Genuine understanding and experience with FDA Quality Systems, GMP regulations,
and corresponding best-practices implementation solutions required.
• Understand how to triage complaints to determine which will require investigation.
• Perform and/or review complaint and failure investigations.
• Apply risk-based assessment to complaints.
• Apply standardized adverse event reporting criteria to determine event reportability.
• Prepare adverse event reports and submit to various regulatory agencies.
Manufacturing Consultant for
Best Opportunity for Business Development Strategy
2 Scope of Services
We would necessarily require further information as to the scope of your request, and the
specific service, but for now we can outline the basic concepts which will be more fully
developed if we are awarded the project. In addition to engineering and economic
analysis, we envision a three phase implementation of strategy to introduce your product
(s) to the market:
2.1. Engineering Scope
2.1.1. YSG / YOUR CORP is to provide CLIENT with the specific methods and process
calculations to understand the requirements and system to install, and operate said medical
products manufacturing facility (i.e.: oral and injectables, etc.) in an upscale version ready
for marketing. The level of detail is schematic and/or preliminary design.
2.1.2. YSG / YOUR CORP is to provide CLIENT the best engineering estimate for the space and
projected startup costs to install, operate and market said medical products manufacturing
facility. Including sterilization techniques
2.1.3. YSG / YOUR CORP will consult on CLIENT’s behalf all rules (i.e.: FDA, ASTM, NDH,
NIOSH, NIST, AMA, etc.) and standard industry specifications to substantiate all aspects of
2.1.4. YSG / YOUR CORP will engage in equipment recommendation, selection and facility
requirements on behalf of the CLIENT in relation to the manufacturing facilities required,
depending on the medical products to manufacture
2.2. Marketing Scope
2.2.1 YSG / YOUR CORP will assess the total national and global market for said medical
products and make a recommendation to move forward with a complete business
plan and production development in a given region, with or without the help of a major
2.3. Economic Analysis – Return on Investment (ROR)
2.3.1. YSG / YOUR CORP will perform an after taxes return on investment (ROR) analysis in
relation to the cost of the facilities and equipment to be purchased and the size of the
market in CLIENT’s recommended distribution area.
2.3.2. Based on the results of 2.3.1, YSG / YOUR CORP will benchmark sales objectives for the
CLIENT, based on local prices for similar markets. Sales forecasts will be drawn from this.
This is a critical metric for marketing.
2.3.3. Based on the results of 2.3.1 and 2.3.2, YSG / YOUR CORP will perform a breakeven
analysis for the entire business venture. This will indicate the time required to break even
and possibly establish a new minimum attractive rate of return (MARR) for the CLIENT.
3 Marketing Services Available
3.1 Phase I
3.1.1. Records Review and Reconnaissance
YSG / YOUR CORP has direct access to sources of marketing information within
several Market Sectors, Industry Groups and specific industries. This information
summarizes the latest technology and products developed by the major companies in
the Sector world-wide, as also existing patents, trademarks and trade names held by
the companies, the market share in certain product categories, location of facilities,
distribution channels, existing networks of suppliers and contractors, a description of
work under development, earnings and losses statements and an evaluation of their
competition. YSG / YOUR CORP will engage in data mining for the CLIENT of all the
major domestic companies in the industry having similar products or services to your
business and will develop a detailed marketing plan for your product based on this
knowledge. The best prospect to be imitated within the market will be identified and
the remainders will be ranked in order of importance to your product or service.
3.1.2. YSG / YOUR CORP will conduct a full regulatory review of the CLIENT’s service.
This review will be done according to the specific agency rules that apply to the
particular product or service being marketed. PLEASE NOTE: In some instances it
may be necessary for the CLIENT to pay certain application fees associated with
permits or government review procedures, once an application is submitted. All of the
specific regulatory aspects will be previously identified for the CLIENT along with any
waivers or exemptions which may apply for your company’s particular project.
3.1.3. Product liability and insurance costs will be evaluated and summarized.
3.1.4. In addition to government rules, there may be industry specific standards which apply
to products sold or services rendered in the United States. Certain industries are
more dependent on these standards, industry practices, norms and specifications,
than others. Depending on your particular business you may need to follow methods
or specifications from institutions such as FDA, NDH, ASTM, ANSI, ASME, AICHE,
IEEE, UL, NFPA, etc. YSG / YOUR CORP will conduct a full specification review of
the CLIENT’s product.
3.1.5. The reports in Sections 3.1.1, 3.1.2, 3.1.3 and 3.1.4 will be forwarded to the CLIENT
and constitute the results of the Data Mining and Reconnaissance task.
3.1.6. Evaluation and Report Preparation
YSG / YOUR CORP will prepare for the CLIENT a Marketing Plan which will be
exclusively developed and tailored according to the criteria of the chosen major
company identified in 3.1.1 and on the basis of how well your product conforms to the
established rules, norms, selection criteria, required manufacturing facilities and
existing similar product lines of the selected major company. Any review of the
Marketing Plan should convey that your product is a natural extension of an already
well established product line or that your business closes a product loop or product
The Marketing Plan prepared by YSG / YOUR CORP will, as a minimum, contain the
Existing Product Categories
Major Business Segments and Revenues
Product Placement or Opening in Product Line
Marketing Scenarios and Cost Structures *
Optimum Production Quotas *
Costs Associated With Variable Production *
Suggested Retail Price Computation
Product Placement into Existing Channels of Distribution
Implementation Strategy and Tactics
Geographic Areas Most Likely to Encompass the Target Market
Dissemination of Product Attributes
Accessories, Parts, and Size Categories
Sales and Profit Objectives
Further Product Development
Time Required to Introduce the Product
Warehousing Locations and Product Shelf Life
Advertising and Promotion
Sensitivity Analysis *
Product Liability Assessment *
Evaluation of Patent Strength *
Evaluation of Trade Mark Registration and Copyrights*
Royalty Rate Structures and Cash Sale Valuation*
* Some items may not be relevant to your particular product and could be
3.1.7. YSG / YOUR CORP will develop for the CLIENT Royalty Rate Structures
and Cash Sale Valuation Tables based on remaining patent life for both
exclusive assignment and non-exclusive assignment of any patent or patents
3.1.8. YSG / YOUR CORP will recommend specific contingencies to initial rejection,
develop some critical financial metrics, contact 25 companies world wide
about your product and present photos and promotional write-up.
3.1.9. YSG / YOUR CORP will prepare a brief MS Power Point presentation of
the salient points of the Final Reports.
3.1.10. If specifically requested by CLIENT, follow-ups and continuing contacts via
promotional material and presentation letters on CLIENTS behalf, beyond
those included in Section 2.1.6, including a brief updated Market Research
Report, will be billed at the following rates: $500 / 200 campaign material
packets forwarded and $300 / 75 campaign material packets forwarded. This
task can also be broken down by hours of marketing and advertising
exposure. It is recommended that this option be exercised every quarter to
keep your business abreast of changes in the industry
3.2. Phase II
3.2.1. Under this task, YSG / YOUR CORP will prepare for the CLIENT a complete
Business Plan for your product(s) once more information is known.
3.2.2. Marketing media (i.e.: newspaper, radio, TV. Internet, etc.) advertising
recommendations and contacts will be established. Logo, design graphics and
brand establishment will be conducted. Application for Trademark Registration will
be made if necessary.
3.2.3. YSG / YOUR CORP will provide CLIENT with checklists for maintaining and
monitoring your Marketing Plan as established in Phase I.
3.2.4. YSG / YOUR CORP will prepare for the CLIENT business recommendations and
strategies for obtaining funding for your business and will present the developed
Business Plan to at least ten (10) venture capitalists and/or angel investors
specializing in CLIENT’S business concepts.
3.2.5. YSG / YOUR CORP will meet and present CLIENT’s product(s) to
pharmaceutical company officials authorized to make decisions on product
development and acceptance.
3.3 Phase III
3.3.1. Privately held pharmaceutical companies are also an alternative which
should be considered. A similar approach will be followed for companies
Allergan – pharmaceutical preparations
Biovail Laboratories Inc. – manufacturing, research and
Clariant LSM – organic chemicals for cancer treatment
Droguería San Juan – medicines wholesale and distribution
Ex – Lax Inc. – manufacturer
IVAX Pharmaceuticals Caribe, Inc. – generic drug manufacturing,
export traded markets
Mayne Pharma (PR) Inc. – pharmaceutical products
Medis Corporation Inc. - pharmaceutical products
MOVA Pharmaceutical – pharmaceutical contract manufacturing
Sanofi Synthelabo – distribution of pharmaceutical products
YSG / YOUR CORP assumes and shall be held harmless, that the product does not need any
further medical or pharmacological development. If not, an additional proposal could be submitted
to further develop your product.
YSG / YOUR CORP assumes and shall be held harmless, that there are no significant safety
issues related to the product.
YSG / YOUR CORP assumes that CLIENT is somewhat familiar with Patent Law and is
aware that in no way is YSG / YOUR CORP or any of its employees, associates and collaborators
allowed to solicit, negotiate or participate as co-inventors of anything the CLIENT is presenting at
this time for evaluation and marketing.
YSG / YOUR CORP assumes that the owner understands that a complete Business Plan to
be presented to Venture Capitalists (VC) and Angel Investors (AI) could be developed under a
In relation to patent disposition, the first, and the most desirable, is to sell or license exclusively
your patent to a major manufacturer. This is called patent assignment by the USPTO, and must be
notified under certain circumstances. Arguably, the next favorable alternative, is to license your
patent non-exclusively to any of several manufacturers. Again this is known as assigning your
patent and certain federal requirements also apply.
After that, the 17 or 20 year monopoly granted by the government or governments, depending on
where you have filed, allows you to manufacture and sell your own patented product. This
however, requires a considerable business investment. At this juncture, certain undesirable issues
gain importance, such as: product liability, patent infringement by the competition, legal costs,
insurance costs, manufacturing, distribution, advertising and everything else usually associated
with a business.
If demonstrable value to industry can be established, then promoting your invention or product to
an industry standard such as ANSI, IEEE, or ASTM would provide enormous prestige to the
owners and could almost certainly translate into greater sales.
Finally, the last alternative but not necessarily the worst is to just sit on your patent and wait for
someone to infringe your rights and then take them to court for a settlement or a judgment. This is
risky, because it may never happen and because not all judges agree with monopolizing
technology, and the latest Microsoft court case in relation to Media Players is a good case in
point. Nevertheless, hardship to the small inventor carries considerable weight under the law, and
some relief by way of injunctions and compensation for punitive damages have been awarded.
By way of a concluding remark to this section, a last ditch effort could be made to entice a major
manufacturer to buy your patents just so that they are guaranteed that your discoveries will not be
there to interfere with something they are already planning to take to market in a few years. If
enough probable interest is generated by assorted companies both large and small, this is a good
enough leverage to threaten a larger company’s future campaigns. They are sometimes forced to
buy out the competition.
If international filing of your patents has not occurred we can assist you. YSG / YOUR CORP can
assist you in all of these aspects.
6 Time For Execution
YSG / YOUR CORP shall work with the CLIENT a reasonable schedule in accordance with the
needs of the CLIENT.
It has been indicated that the project start date is 01/02/2007, however, the Records Review and
Reconnaissance will only start when a signed authorization to begin is received from the CLIENT.
Travel and Per Diem costs will be billed only for authorized field trips outside of the normal working
area. An estimate of any required travel will be presented to the CLIENT in the Final Proposal.
A Draft Report will be submitted to the CLIENT for review and comments.
The total time to complete the work is one (1) month, thirty (30) days (240 hours) for Engineering
Scope, Economic Analysis Scope, and Marketing Scope
Thirty (30) days (240 hours) for Phase I, Phase II and Phase III
Permit Approval, Installation, Operation and Quality Control Validation Procedures, 120 to 150
days (6 to 7 months).
The total time to complete all aspects of work is 8 to 9 months.
All times to complete the work are subject to reasonable negotiation prior to project acceptance by
7 Fees For The Project
YSG / YOUR CORP shall receive, as compensation for the work included in the Engineering
Scope, Economic Analysis Scope, and Marketing Scope, the lump sum amount of SIX
THOUSAND ONE HUNDRED TWENTY FIVE AND 00/100 DOLLARS ($6,125).
This lump sum fee will be invoiced as follows:
65% with the Draft for Engineering, Economic Analysis, and Marketing Scope Feasibility
Recommendations Report. Including Draft Applications for FDA marketing permit(s) through
the proper exploration of all applicable waivers and exemptions for Small Business Owners.
35% with the and Final Feasibility Reports including Application Submittal for FDA marketing
permits through waivers and exemptions.
All quoted fees are subject to reasonable negotiation prior to project acceptance by CLIENT.
If, however, CLIENT additionally chooses Phase I, Phase II and Phase III implementation, YSG /
YOUR CORP shall receive, as compensation for the work included in the Scope of Work, the lump
sum amount of TEN THOUSAND EIGHT HUNDRED AND 00/100 DOLLARS ($10,800).
The lump sum fee will be invoiced as follows:
30% with the Data Mining and Reconnaissance Reports
30% with the Draft for Engineering, Economic Analysis, and Marketing Scope Phase I, and Phase
II and Phase III, Feasibility Recommendations Report.
10% with the Company Presentation & Observations and Agreements Final Report and
10% with the Phase I, Phase II and Phase III, Business Plan Draft Report
10% with the Phase I, Phase II and Phase III, Marketing Media Networking / Logo Design Graphics
10% with the Final Business Plan / VC/AI Contacts & Presentations / Checklists
All quoted fees are subject to reasonable negotiation prior to project acceptance by CLIENT.
Once all preliminary feasibility studies are complete and FDA marketing permits are solicited.
Then FDA Qualification procedures and protocols for installation, quality control and operation are
required at your facility for manufacturing, compounding, packaging, labeling and storage, before
final permits are issued.
Example of Similar Project Pricing:
Glatt Equipment - Lines for Liquid and Paste Dosage Forms
Blood Plasma Products
Pricing Explanation & Approximate Times for Fees to be Invoiced:
(All Qualification Procedures to be Submitted for FDA Approval)
Development of Installation Qualification (IQ) Glatt Equipment 1 - 80 hrs - $6,400
Development of Operational Qualification (OQ) Glatt1 - 120 hrs - $9,600
Execution of Installation Qualification document (IQ) Glatt 1 - 80 hrs - $6,400
Execution of Operational Qualification document (OQ) Glatt 1 - 200 hrs - $16,000
Generation of Installation Qualification Final Report Glatt 1 - 40 hrs - $3,200
Generation of Operational Qualification Final Report Glatt1 - 40 hrs - $3,200
Development of Installation Qualification (IQ) Glatt 2 - 40 hrs - $3,200
Development of Operational Qualification (OQ) Glatt 2 - 40 hrs - $3,200
Execution of Installation Qualification document (IQ) Glatt 2 - 80 hrs - $6,400
Execution of Operational Qualification document (OQ) Glatt 2 - 200 hrs - $16,000
Generation of Installation Qualification Final Report Glatt 2 - 40 hrs - $3,200
Generation of Operational Qualification Final Report Glatt 2 - 40 hrs - $3,200
Deviation reporting management - 80 hrs - $6,400
This Quotation only include Mechanical and Computer Validation. Process validation is not
Subtotal Quote $86,400
Estimate Quote for Process Validation - 120 hours - $9,000
Total Estimated FDA Qualification Procedures for Installation, Operation and Quality Control and
Final Permit Approval (ex Permit Fees): $95,400
GRAND TOTAL (ex Facility and FDA Permit Fees): $106,200
8 Additional Services Available
Federal And State Monies For Your Business (Profit And Non-Profit)
Government Contracts And Grants : FDA, CDC, USAMRID, GSA, Etc.
Federal Venture Capital (VC) Money Programs
VC Clubs And Associations
Angel Investor Contacts
Many of the federal programs include yearly renewal for additional government funds.
YSG / YOUR CORP shall receive the following fees, as compensation for on-going and
continuous additional consulting services:
Marketing and Business related activities: $45.00 - $55.00 per hour.
Economic Analysis and Financial Metrics related activities: $55.00 - $65.00 per hour.
Patent filing and maintenance related activities: $65.00 - $75.00 per hour.
Engineering related activities (i.e.: feasibility studies, designs, permits, construction
Schematic Detail Design Level: $75.00 per hour.
Preliminary Detail Design Level: $85.00 per hour.
Final Detail Design Level: $105.00 per hour.
9 Responsibilities of the Client
The CLIENT shall be responsible for the following:
Supplying YSG / YOUR CORP with information about the patent(s) and or Trade Marks in
existence for the product and where they are registered, be it in the U.S., European Union,
Asia, etc., anything which is already in the public domain.
Provide to YSG / YOUR CORP any photos or existing promotional material.
Provide to YSG / YOUR CORP any existing medical brochures associated with your product.
Indicating to YSG / YOUR CORP if there are any intentions to further develop the product,
changes that may be made, or additionally associated patents which may be sought.
Provide YSG / YOUR CORP any information about advertising and promotional goals.
Corresponding through e-mail or other means with the consultant to fine tune strategies.
10 Changes To Project Scope
YSG / YOUR CORP has prepared this work scope based on our understanding of CLIENT
needs. The cost of doing the specific project described herein is based on similar work done
previously. Any significant variation to the scope presented herein will be discussed with the
CLIENT and additional funding requests will be prepared and submitted prior to starting any
new work. No work will be done until receiving previous approval from the CLIENT authorized
11 Secrecy Undertakings
YSG / YOUR CORP shall agree to undertake that it will keep the technical information
disclosed by the CLIENT to YSG / YOUR CORP in strict confidence, and to use the same
only for the preparation of the design of CLIENT’s Marketing Plan.
YSG / YOUR CORP will sign any Non-Disclosure or Non-Compete Agreement (ND/NC)
specified and required by the CLIENT. If not available, we can provide CLIENT with a
The obligations of YSG / YOUR CORP mentioned above shall not apply to any of the
following technical information, except if specifically contained in the ND / NC Agreement:
That which is published or otherwise available to the public domain at the time or receipt
thereof by YSG / YOUR CORP
That which becomes published or otherwise available to the public domain after receipt
thereof by YSG / YOUR CORP through no act or failure to act on the part of YSG / YOUR
All documents filed with government agencies become part of the public record.
Similarly YSG / YOUR CORP requests that CLIENT maintain the contents of this proposal,
including, all methods, procedures and strategies as confidential material due to competitive
aspects of doing business.
12 Termination Of The Work
The CLIENT may terminate the work at any time by giving YSG / YOUR CORP written notice
of the termination of the work one (1) week in advance of the termination date. The CLIENT
shall pay YSG / YOUR CORP the services performed and the reimbursable expenses due to
the termination date. There shall be no penalty for termination of this agreement.
All payments are to made to: Your Corporation P.O. Box 0000 Texas, TX 00000-0000.
Contact with respect to this proposal should be made to: YSG at firstname.lastname@example.org,
www.the-tx.com or Your@prtc.net, info@Yourcorp.com or through eWork Markets.
The CLIENT may accept this proposal by signing and returning a copy of this document
which becomes a part of the standard eWork Markets Business Consulting Agreement. A
standard eWork Markets Business Consulting Agreement will be forwarded as soon as
this document or some negotiated form of same, is accepted and agreed upon.
Your Name Their Name, President
President Your Corporation Your Solutions Group
ACCEPTED AND AGREED
Print Name: ______________________________