FDA Manufacturing Consultant

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					                    Your Solutions Group & Your Corporation

You r So l u ti o n s G ro up         You r Corporation
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Preliminary Proposal and
Marketing Plan

Manufacturing Consultant for
Pharmaceutical Start-up


          Best Opportunity for Business Development
          Strategy




             AUGUST 28, 2011
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                                            Table . Contents
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Introduction .....................................................................................................3

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

4     Assumptions.............................................................................................8

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




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Introduction                  .
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         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
           Industries.

           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


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the CFR for various areas such as: food, cosmetics and medicines are regulated by the Food and Drug
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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
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others, and all these agencies have their rules codified in the CFR.
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YSG and Your Corp. are experts in code review and procedural application for marketing of various products
and inventions.

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




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 Chapter

      1

Manufacturing Consultant for
Pharmaceutical Start-up
Best Opportunity for Business Development Strategy
 The Team

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:

                                Abbott Laboratories

                                Amgen

                                Baxter Dominican Republic

                                Bristol Myers Squibb

                                Merck Chemical

                                Merck Sharp & Dohme

                                Ortho Biologics

                                Ortho Pharmaceuticals

                                Pfizer

                                Schering Plough

                                Wyeth Pharmaceuticals

          Other potential local clients are:

                                Lily del Caribe, Inc.

                                Cordis LLC, a Johnson & Johnson Company

                                Proctor & Gamble Pharmaceuticals

                                Wyeth – Ayerst Lederle, Inc.

                                ROCHE Pharmaceuticals
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.

       Core Competencies

          • Fluent/familiar with global premarket and post-market regulatory requirements for
          medical devices.


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              • Relevant documentation and comprehensive, well-organized premarket dossiers for the
              following:

              -- United States: IDE, 510(k), PMA, BLA, NDA, Device Listings / Establishment
              Registration; and

              • 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
              recalls.

              • 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
              medical devices.

              • 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.

    Chapter

      2

Manufacturing Consultant for
Pharmaceutical Start-up
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


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              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
                the proposal

         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
                   pharmaceutical company.

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




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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
        line.

        The Marketing Plan prepared by YSG / YOUR CORP will, as a minimum, contain the
        following:

                Introduction
                Objectives
                Market Assessment

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         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
         Target Markets
         Geographic Areas Most Likely to Encompass the Target Market
         Primary Outlets
         Secondary Outlets
         Typical Consumer
         Dissemination of Product Attributes
         Positioning
         Pricing Structure
         Accessories, Parts, and Size Categories
         Sales and Profit Objectives
         Further Product Development
         Time Required to Introduce the Product
         Internal Evaluation
         Warehousing Locations and Product Shelf Life
         Distribution Methods
         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*
         Contract Options

          * Some items may not be relevant to your particular product and could be
          omitted

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
          involved.

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


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                      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
                      such as:

                              Allergan – pharmaceutical preparations

                              Biovail Laboratories        Inc.   –   manufacturing,   research    and
                               development

                              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


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4   Assumptions

     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
    different proposal.


5 Contingencies

    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.


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  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
  CLIENT.


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:


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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
   Recommendations

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
             Vaccines
             Infusions
             Injection Solutions
             Blood Plasma Products
             Juices
             Drops

        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



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          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


          Additional Comments
          This Quotation only include Mechanical and Computer Validation. Process validation is not
          included.

          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
      inspection, etc.)

     Schematic Detail Design Level: $75.00 per hour.

     Preliminary Detail Design Level: $85.00 per hour.

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     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
      representative.


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
          generic version.

          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
          CORP


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         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 theirnol@roqui.net,
         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.



         Cordially,

         ______________________                                 ____________________

         Your Name                                              Their Name, President

         President Your Corporation                             Your Solutions Group



     ACCEPTED AND AGREED

     By: _____________________________________

     Print Name: ______________________________

     Date: ___________________________________




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