*****NIT: HUGE
Charliebee Sunday, 03/29/15 02:03:06 PM
Re: None
Post # of 3146
NIT Enterprises, INC.
d/b/a (Nucleotide Industrial Technologies)
Short Term Operation Plan
March 2015
The following document will define the proposed operational plan for producing a product line that negates the effects of harmful X-Rays, Gamma Rays, and high energy Ultraviolet radiation for doctor, nurse, and patient protection from radiation sources in hospitals and medical facilities. The company's intellectual property technology uses a lightweight genetic mechanism to absorb radiation that does not require heavy metallic compounds.
1. Core competencies
The core competencies of NIT consist of sale of intellectual property products, through trade secrets purchase and/or joint venture with other companies. The marketing and toll manufacturing of proven products, and the potential licensing of those products will be in constant consideration.
The intellectual property is resident at NIT. Initial testing that defines the efficacy of the product line will be funded and monitored by NIT in coordination with Plastics Technologies Inc. (PTI). Development and execution of the initial marketing will be performed internally at NIT based on the initial test documentation. Initial production is planned for a local chemical facility that will be able to meet initial requirements based on Batch Protocols and Quality Assurance Protocols developed by NIT. Concurrent with this, a pilot production facility will be planned and funded to produce successive products. Once sufficient demand creates the need for more production, a second facility or a licensed facility at PTI will be brought on line to supply the need. Secondary suppliers of raw materials for production will be demanded of all facilities.
Personnel Include:
• Anthony (Tony) A. Gedeon
• N. Andrew (Andy) Greig
• Tom Brady – PTI
• Lance O. Anderson
• Bo Gimvang
• Joe Bishop
2. Products
NITE is a technology company with a patented lightweight genetic Nano-Structure product that negates the effects of harmful of X-Rays, Gamma Rays, and high energy Ultraviolet radiation. The company's initial market thrust will be licensing its technology into the medical market for doctor, nurse, and patient protection from radiation sources in hospitals and medical facilities. The company's technology uses a lightweight genetic mechanism to absorb radiation that does not require heavy metallic compounds.
The Company currently intends to enter into a Joint Venture with PTI, one of the largest worldwide plastics technology companies to develop lightweight flexible curtains, protection vests, and solid plastic radiation absorbers for medical personnel and patient protection. Existing protection companies will be licensed to produce the product within their existing distribution.
NITE has approached a major Sun block manufacturer to begin the process of licensing its UV technology to prevent genetic damage from the sun. The Company will later enter into the aircraft and space market for protection from ionizing radiation for both people and electronics. Such products will be in plastics and coatings. Being light weight is a critical advantage for these markets.
The Company plans to enter into the audited public market in the first quarter of 2016 with an S-1 filing.
3. Program Background
NIT has a patented product that provides shielding to negate the negative effects of high energy UV or ionizing radiation. NIT’s broad spectrum DNA/RNA nucleotide shield can absorb high energy photons from just greater than visible light, in UV-B at 300 nm, throughout the UV spectrum and into X-Rays and Gamma Rays, which are actually also photon in nature
NIT’s chief medical advisor and inventor of its UV and ionizing radiation blocks is Yin-Xiong Li, MD, Ph.D. (“Dr. Li”). Dr. Li’s foundation work in nucleotides for protection from high energy radiation has resulted in one granted patent in the US, a second in China, and a pending application in the US. NIT holds license to these patents. The granted US patent is for extracting the nucleotides in short ladders from DNA and RNA.
Extracted nucleotides do not have an organized form when placed in a binder requiring a reasonably large amount of nucleotides to get the desired effects in blocking radiation. This condition limited the technology to be applied only in situations where cost is not a factor. In the granted Chinese patent and pending US patent, Dr. Li has developed a method to put the nucleotides in an orderly form greatly increasing their effectiveness and greatly reducing cost. Most importantly this second level of nucleotide intellectual property provides a method to attach radiation reflecting nanoparticles to DNA/RNA for both UV and ionizing radiation protection. It further provides for more bond locations on the DNA/RNA to allow them to be dispersed in a macro-matrix to improve performance by providing an organized uniform structure. This makes them viable for industrial applications such as in paints and building materials where cost is a major factor. NIT expects significantly more intellectual property to be filed as it continues its development program for ionizing radiation planned herein.
Dr. Li’s work in UV-B and UV-C has been thoroughly developed and uniquely tested for protection on live DNA. Dr. Li’s live DNA tests give emphatic proof of protecting DNA from damage, which directly translates to protection from skin cancer and reduction in the effects of aging.
The UV work, when licensed from Dr. Li, included a developed and tested Sunblock and ISO level documentation on the Sunblock product. NIT also acquired extensive product documentation which included preparation of a 510k application to the FDA with the license and acquisition.
4. The Radiation Problem
Medical personnel and airline pilots and crew are exposed to far greater radiation than other professions. Radiation is a severe problem for all electronics in satellites and high altitude aircraft. Radiation hardened electronics were developed for spacecraft during the US space program, but these techniques were never employed in high flying aircraft and utility and power plant control systems. This is a well-publicized concern in the media today fueled by concerns about the prediction of sun eruptions disabling potentially critical electronic controls in such applications as nuclear power plants in the coming year. Similarly, Homeland Security and military departments are concerned about the radiation aspect of small nuclear devices and electromagnetic pulse (EMP) generation.
There has never been a mechanism developed to shield ionizing radiation without using heavy metals such as lead, heavy water, or rare earths. However, Dr. Li discovered that nucleotides can actually transmute X-Ray and Gamma Ray radiation (which are photon in nature) into infrared photons without destruction of the nucleotide. This transmutation process is a monumental breakthrough in radiation protection.
Dr. Li further developed a method of bonding heavy metals and rare earths to the side of the DNA and RNA ladder increasing the shielding effectiveness. This is the first invention of its kind to develop a light weight method of shielding ionizing. NIT’s initial tests show a light weight coating of 50 thousandths of an inch performed as well as 4 tenths of an inch of lead. The implications for extending the life of satellites and high altitude electronic are astounding considering their initial cost. If the life of a satellite is extended by say 20% it could mean a savings of billions of dollars compared to replacement and re-launch costs.
5. Initial Production and Planning
Laboratory testing and field trials of initial formulations supervised by Dr. Li, Greig, and Gedeon revealed surfaces treated with nucleotides produced from DNA absorbed UV radiation. Further testing indicated X-rays and Gamma rays are also absorbed by NIT technology.
NIT plans to develop a source of raw material for DNA nucleotide production in the US. The raw material source will be contracted to provide an initial production batch qualified by NIT batch and QA protocols. If successful, a long term contract for raw materials will be pursued. A secondary source of raw materials will also be sought concurrently with contracting for primary source.
An initial purchase of processed DNA nanoparticles from abroad will be completed and used to develop mixes of nanoparticles and media for specific industrial and medical product purposes. This pilot production laboratory will be built to supply PTI with the necessary NIT products to combine with plastic formulations in their laboratories for developing radiation absorbing products. Development of successful plastic formulations and products will lead to long term raw nucleotide production requirement and development of a pilot production plant to meet the raw material needs of PTI. A second production line for products that support airline pilot and crew protection needs as well as products manufactured for use in space systems and components will also be developed alongside the PTI production line.
Development of the pilot production facility as well as the marketing of the final products will lead to the undertaking of new developments for radiation absorbing materials. To accomplish this, NIT will develop a consortium of investors to jointly sponsor and fund several major product development and engineering projects and, set about to hire an experienced individual to manage these projects for the combined cooperatives. The investment funding will provide sufficient credibility for the newly formed NIT to quickly identify additional customers and also to attract and hire a small but highly experienced professional staff to carry out the contracted technical development and support for the NIT consortium and other NIT customers. As NIT grows and broadens its customer base, it will continue to perform research that supports development of new products for the base. It will also continue to hire highly experienced professional and technical staff necessary to provide high quality products to industrial and the medical companies.
6. Elements of the operating plan
Four primary elements and analysis comprise this section:
• Company timeline
• Staffing plan
• Budget
• Production
Company timeline: NIT expects to exercise this operations plan to support development of products to compound with PTI plastics within the next six months. As our first target market, we will work with PTI to help them develop radiation absorbing plastics for the medical market. Next steps include:
1. Procurement of raw DNA nanoparticles from abroad to start NIT production testing and development – one month from initial investment
2. Concurrently, search for DNA raw material source in continental US
3. Development of Master Production, Batch and QA Protocols for production of raw DNA nanoparticles as well as production of DNA/media mixtures for specific applications – one month
4. Develop test program to provide details characterizing product to be delivered to PTI – one month concurrent with #3
5. Completion of support laboratory to produce test products for PTI use in their laboratories – concurrent with #3
6. Produce product samples – two weeks
7. Complete pilot production plant for delivering raw DNA nanoparticles as well as DNA/Media mixtures required by customers – six months
8. Review customer requirements analysis and development of marketing materials – two weeks
9. Initial marketing meeting - 36 weeks after receipt
• Following initial marketing, NIT expects to expand the customer base from plastics to the aerospace market where our extremely light nanotechnology product line can be used for protection from ionizing radiation for both people and electronics. Such products will be compounded in plastics and clothing and used in specialized coatings. New customers will expect to conduct self-testing of the product line in their own laboratories and environment. NIT personnel will be available to support these efforts and contribute where possible to the final analysis of the product line. This period is expected to last from four to six months.
• Simultaneous with the initial client testing, a) NIT will begin searching for a long term marketing company to establish brand and a campaign for our product line; b) hire more clinical and professional personnel to support development of the necessary protocols, processes and procedures to handle marketing, sales, quality, finance and manufacturing; and c) NIT will conduct a country wide search for other production companies for our products that meet ISO 9000 standards for quality control and repeatability. This effort is expected to take another four to six months.
Staffing Plan:
NIT will use the staff on hand augmenting them with consultants and contracted personnel up until the completion of the pilot production facility and first sale of product or the first testing of a product by an interested client (including PTI). Upon nearing that event, planning to develop management, marketing and sales staff will be started. As indicated above, professionals in microbiology, finance, sales, marketing, quality assurance, manufacturing and management will be added to the NIT staff for control and promotion of the medical industry LOB.
Budget:
Initial source of Raw DNA Material: NIT will procure from abroad raw DNA material that meets initial standup testing and production planning needs. An initial contract will be developed through ARCCO Singapore to procure the necessary DNA nanoparticles for use in our testing program. It is estimated this initial procurement will be $65,000 (ARCCO contract estimated at $40,000). Dr. Li consulting for development estimated at $50,000.
Develop continental source of Raw DNA Material: Concurrently start researching US production facilities for US sources of raw materials for DNA nanoparticle development. This is estimated at $15,000. Once identified, a long term contract to produce raw DNA material will be established with the production facility. First order is to be generated 6 months after identification for no less than $150,000.
Development of Protocols: NIT has the necessary formulae and mixing directions on hand for development of ISO 9000 series protocols for Production Specification, Batch sizing and Quality Assurance. These protocols will be developed in house, vetted by resident experts and formally approved by the NIT board of directors as intellectual property and trade secrets. A total of $35,000 of labor is estimated for this task.
Development of Test Program: NIT will develop a test program to characterize the mixed DNA nanoparticle/media for clients that defines the products a) thermal stability, b) mechanical stability, c) optimal concentration for each effort, d) proof of efficacy for each effort, and e) sizing most appropriate for each media.
Product Laboratory Development: NIT will stand up a laboratory with the necessary tools and components to mix the raw DNA material with a variety of media to support both medical and aerospace company needs. This laboratory will serve as a basis for the future pilot production plant that will produce products for PTI as well as other industrial clients. This development is estimated to cost $50,000.
Production of Product Samples: Upon completion of the production laboratory, the laboratory will be provided the final Batch Protocol for producing eight pints, four quarts and two gallons of each product. Raw material vetting, mixing, production and bottling will be observed by NIT personnel to verify protocols are followed. Upon completion of four production runs (two each for Industrial and Medical LOBs), a quality assurance check will be performed on samples from each production run in accordance with our Quality Assurance Protocol to assure NIT that the production runs are accurate and repeatable. The laboratory production samples will be provided to PTI to support their plastics product testing.
NIT intends to develop a pilot production facility that will decompose raw DNA material into the right construction for mixing with various media. Two distinct production lines are envisioned based upon evaluation of client requirements to date. One is a mixed media line for compounding with plastics and the other is a mixed media line for production of a coating for clothing materials, electronic parts, plastics, resins and glass. A Quality Protocol will be used by NIT staff to verify the resulting products are valid reproductions of our patented product line. Initial sales or client testing needs will also be subcontracted to the same local production facility which will have a laboratory for just such efforts. NIT must ensure quality products are produced and must have a process in place to test the product coming off the line for correct formulary. Estimated cost for this effort is indicated above.
Upon completion of first sale from the pilot production facility, NIT will begin a search for production facilities that meet ISO 9000 conditions for quality and repeatability and conduct a cost benefit analysis to determine how much manufacturing will be passed to the selected facility prior to establishing a secondary source of product. That analysis should be completed within 3 months of first sale. The new marketing program to larger entities will be leveraged and the requisite licensing contracts, agreements and materials must be developed at that time to protect the company investment and intellectual property. Estimated cost for this effort is $75,000. Long term production contracts will be based on volume and will be negotiated separately.
AI
Veni, Vidi, Vici 
