Business

OUR BUSINESS

Development of Business.

The Company was incorporated under the Laws of England and Wales in June 2010. Effective October, 12, 2012, the year where the Company succeeded, as a reporting company of the initial Pharmaceutical and Biotechnology Division of her matrix Company, the predecessor of ND Pharma & Biotech Co. Ltd. The Company’s Registered Address are located at the heart of London. The Company maintain executive offices in southeast Europe, United States, Latin America and other countries. The Company is establishing a solid ground network of agents, distributors and sales force as well as operating plants and manufacturing contract in a number of countries worldwide, mainly The European Union and The United States.

Description of Business

The Company is intending to be a leading Life Science and High Technology company. The Company develops, manufactures, purchases and distributes one of the broadest range of high quality chemicals, biochemicals, brand products and industry solutions as well as certain equipment available throughout the world and also provides global biopharmaceutical services including research and development of pharmaceutical, biopharmaceutical, biotechnology, medical, healthcare, food & nutrition and agriculture and veterinary products. These products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The Company operates in a number of countries, with a plant and storage manufacturing capacity by all partner companies of approximately 52,000 of the 170,000 chemical and biochemical products it offers. The Company sells worldwide both directly and through a net of commercial entities and other agents and distributors schemes having an ever-growing portfolio of customers and clients spread into approximately 160 countries servicing products.

Products and Services

The Company provides products and services that focus on:

• research customers that use smaller quantities of our products in basic life science and high-technology R&D;

• manufacturing customers that use our products in larger quantities in lab-stage development and manufacturing; 

• life science customers who use our biopharmaceutical products and  services to facilitate the development, manufacturing and commercialization of biological and chemicals; and

• industrial and diagnostic companies that use our products in various forms of assays and testing as well as in clinical diagnostics and laboratory

The 3 main areas of business are: 

                                       Research provides reagents and consumables to life sciences and non-profit research organizations. 

                                      Applied provides raw materials and solutions for testing in clinical and industrial applications. 

                                      Commercial provides manufacturing raw materials for commercial products throughout its own divisions.

Sales and Distribution

Since 2012, the initial full year of operations, The Company sold products and services thru a network of partners, licensed companies, and other authorized economic operators to a number of accounts representing an increasing number of individual customers, including pharmaceutical companies, universities, commercial laboratories, industrial companies (food and beverages, veterinary, feed, agriculture, fisheries, crop and crop protection and development), biotechnology companies, non-profit organizations, governmental institutions, diagnostic, chemical and electronics companies and hospitals. Orders vary from one to another since the small orders in laboratory materials to the large-scale bulk orders to certain industrial sectors including food, health, nutrition, consumer brands, personal care, and others. The Company also makes its chemical products available in larger-scale quantities for use in manufacturing. 

As many other highly capitalized private companies ND Pharma & Biotech trading activities are developed thru a network of agents, distributors, subsidiaries, affiliates, etc. ND Pharma IS NOT A TRADING COMPANY and therefore DOES NOT sell directly to any third parties unless distribution agreements, supply contracts and licenses that may be authorized and/or issued by The Company or it´s official representatives on our behalf. Any offer, invitation to treat, pre-agreement, agreement, contract, license, or any other instrument of negotiation, etc, shall be construed over express and written license and/or permission from ND Pharma & Biotech priorly and as a preceptive pre-requisite, otherwise any form of negotiation construed in absence of such requirement will be invalid and claim for damages will be enforced under applicable laws in any territory and/or jurisdiction enforceable and/or where operations were established.

Customers and potential customers, wherever located, are encouraged to contact the Company by telephone or via its websites (www.ndpharmabiotech.com) and from this to other website, product-sites and micro-site available to make enquiries and eventually to place orders or obtain technical staff consultation. Alternatively company can be contacted directly through the different contact forms and writing an e-mail to the address: info@ndpharmabiotech.com, referencing the issue and/or product or service of interest. A commercial agent and/or a representative will contact you immediately. Shipments are made at least five days per week from all locations conducting manufacturing and/or distribution activities. The established system is quite simple and effective. Customers ask for quotation of products and services, quotes should be issued and accepted in accordance with our general sales conditions. Once payment is confirmed by our financial department, The Company strives to ship its products to customers on the same day a payment order is received and carries inventory levels which it believes to be appropriate to maintain/sustain this practice.

Patents, Trademarks, Industrial Secrets, Licenses and other IP Rights.

The Company holds approximately 500 IP right-protected elements from patent, patent applications, industrial secrets, marks, trademarks and trademark applications, and other IP Rights generator issues from a total documentary repository of +4´5 Million documents. company holds a number of significant trademarks in different fields and sectors from Food & Nutrition to Medical and Healthcare or Pharmaceutical fields. These trademarks are increasing and we developed an actual portfolio of development valued over +750 M€ by creditor agencies and expert research valuation companies, banks and other authorized operating agents.

The Company is aware of the desirability for patent and trademark protection for its products. The Company believes that other than its brand names, no single patent, license or trademark (or related group of patents, licenses or trademarks) is material in relation to its business as a whole. In addition to patents and other existing IP rights, the Company relies on trade secrets and proprietary know-how. The Company seeks protection of these trade secrets and proprietary know-how, in part, through confidentiality and proprietary information agreements. The Company makes efforts to require its employees, directors, consultants and advisors, outside scientific collaborators and sponsored researchers, other advisors and other individuals and entities to execute confidentiality agreements upon the start of employment, consulting or other contractual relationships with the Company. These agreements provide that all confidential information developed or made known to the individual or entity during the course of the relationship is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees and some other parties, the agreements provide that all inventions conceived by the individual will be the Company’s exclusive property. These agreements may not provide meaningful protection for or adequate remedies to protect the Company’s technology in the event of unauthorized use or disclosure of information. Furthermore, the Company’s trade secrets may otherwise become known to, or be independently developed by, its competitors. Despite this, our Legal and Regulatory department are highly aware of any infringement of such rights pertaining to The Company to execute our legal rights and remedies to its total extent. 

Competition

The markets for the Company’s products, services and technologies are both competitive and price sensitive. The Company believes it is a major supplier of biochemical and organic chemical products used in scientific research and testing laboratories, including industrial applications, genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic, environmental and other high technology manufacturing. The Company offers approximately 200,000 chemical, biologic and equipment items, some of which are unique with limited demand including some rare and ultra-rare molecules, active principle´s and other. There are many competitors that offer a narrower range of chemicals and many others offering a broader range of equipment products.

In all product areas, the Company competes primarily on the basis of customer service, product availability, quality and price. The Company’s main marketing vehicles include its websites starting from the main one www.ndpharmabiotech.com and all derived as well as catalogs both electronically and alternatively printed (The Company maintains a sustainable policy of “paper-free” business), and other marketing materials designed and made on behalf of our existing brands and future developments. These catalogs may be supplemented with advertisements in life science, chemical and other scientific journals and trade publications, the mailing and e-mailing of special product brochures, the electronic distribution of various advertisements and product data, social media, news releases related to new product offerings and through personal visits with customers from management, sales and technical representatives.

Compliance With Regulations

In The European Union

REACH/ECHA, the EU legislation covering the manufacturing and importation of chemicals, became law in 2007. A number of substances were registered under REACH in 2012. The next batch of substance registrations is due in 2013. Over the next five and one half years, the number of registrations will increase significantly. Additionally, the amount of products imported or manufactured must be monitored and more information must be passed along the supply chain. The costs to comply with REACH depend on the behavior of the other participants in the supply chain. So far, the costs have not been greater than what we expected. The GHS is altering the rules for classification, labeling and, to some extent, the content of our MSDSs. In 2012 the system was implemented in the U.S. Countries in Asia and South America will follow soon. All hazardous products in our product portfolio will be affected and have to be reclassified.

In the United States

The Company believes that it is in compliance in all material respects with federal, state and local regulations relating to the manufacture, sale and distribution of its products. The following are brief summaries of some of the federal, national, territorial and other existing laws and regulations which may have an impact on the Company’s business. These summaries are only illustrative of the extensive regulatory requirements of federal, state and local governments and are not intended to provide the specific details of each law or regulation. The Company intends to maintain compliance with existing laws within all territories and countries where is maintaining operations.

The Company also conducts its global business in compliance with or analogous to the following statutes and regulations as promulgated in the more than 50 countries into which we sell our products. 

The Chemical Safety Information, Site Security and Fuels Regulatory Relief Act of 1999, and the regulations promulgated thereunder, regulate the handling and storage of certain flammable fuels and require an associated risk management program. The CAA, as amended, and the regulations promulgated thereunder, regulate the emission of harmful pollutants to the air outside of the work environment. Federal or state regulatory agencies may require companies to acquire permits, perform monitoring and install control equipment for certain pollutants. The Chemical Facility Anti-Terrorism Standard and the regulations promulgated thereunder, regulate facilities that manufacture, use, store or distribute certain chemicals above a listed Screening Threshold Quantity. A regulated facility must complete and submit a Chemical Security Assessment Tool, Top-Screen by January 19, 2008 or within 60 calendar days of coming into possession of the listed chemicals at or above the listed Screening Threshold Quantity. If required by the DHS, the facility must complete and submit to the DHS, a Security Vulnerability Assessment and Site Security Plan. The Company may have several sites subject to this standard. The CWA, as amended, and the regulations promulgated thereunder, regulate the discharge of harmful pollutants into the waters of the United States. Federal or state regulatory agencies may require companies to acquire permits, perform monitoring and treat wastewater before discharge to the waters of the United States or a POTW. The CERCLA and the SARA, and the regulations promulgated thereunder, require notification of certain chemical spills and notification to state and local emergency response groups of the availability of MSDSs and the quantities of hazardous materials in the Company’s possession. SARA, and the regulations promulgated thereunder, also stress the importance of permanent remedies and innovative treatment technologies to clean up hazardous waste sites. The EPCRA, as amended, and the regulations promulgated thereunder, regulate MSDSs, chemical inventories and chemical release reporting. The EPCRA also requires coordinated emergency planning with state and local agencies. The OSHA, including the Hazard Communication Standard (Right to Know), and the regulations promulgated thereunder, require the labeling of hazardous substance containers, the supplying of MSDSs on hazardous products to customers and hazardous substances to which an employee may be exposed in the workplace, the training of employees in the handling of hazardous substances and the use of the MSDSs, along with other health and safety programs.The PPA, as amended, and the regulations promulgated thereunder, focus on reducing the amount of pollution through cost-effective changes in production and raw materials usage. Pollution prevention also includes other practices that increase efficiency in the use of energy, water or other natural resources, and protect our resource base through conservation. The RCRA, as amended, and the regulations promulgated thereunder, require certain procedures regarding the treatment, storage and disposal of hazardous waste. The TSCA, and the regulations promulgated thereunder, require reporting, testing and pre-manufacture notification procedures for certain chemicals. Exemptions are provided from some of these requirements with respect to chemicals manufactured in small quantities solely for R&D use. The DOT has promulgated regulations pursuant to the HMTA referred to as the HMR, which set forth the requirements for hazard labeling, classification, packaging of chemicals and shipment modes for products destined for shipment in interstate commerce. The HMTA, and the regulations promulgated thereunder, seek to protect against risks to life, property and the environment that are inherent in the transportation of hazardous materials in intrastate, interstate and foreign commerce. HMTA regulates the transportation of dangerous goods via air, highway, rail and water. The Company ships and receives materials subject to the HMTA.

In the US and allied Territories.

The USDA, APHIS and VS regulate the importation and exportation of animal-derived materials to ensure that exotic animal and poultry diseases are not transferred. The DEA enforces the controlled substances laws and regulations of the U.S. The DEA has issued licenses to several partner companies websites to permit importation, manufacture, research, analysis, distribution and export of certain products regulated by the DEA. The Company screens customer orders involving products regulated by the DEA to verify that a license, if necessary, has been obtained. The NRC licenses and regulates the nation’s civilian use of byproduct, source and special nuclear materials in order to ensure the adequate protection of public health and safety, promote common defense and security and protect the environment. The NRC has issued licenses to several partner companies to permit exportation of certain products regulated by the NRC. The Company screens customer orders involving products regulated by the NRC to verify that a license, if necessary, has been obtained. The DOC promulgated the Export Administration Regulations pursuant to the EAA, as amended, to regulate the export of certain products to specific destinations by requiring a special export license. The Company will obtain several and appropriate export licenses per year from the DOC in order to fulfill strictly with requirements. The Company reviews orders of specific regulated materials being exported to certain destinations to ensure if the proper license is obtained. The CDC regulates select agents and toxins. The HHS and the USDA published final rules, which implement the provisions of the Bioterrorism Act, setting forth the requirements for possession, use, and transfer of select agents and toxins. The CDC has issued one site license to the main partner company and some of our manufacturers within the United States of America to permit the storage and transfer of these materials. The Public Health Security Act and the Bioterrorism Act regulate the imports of food and certain food substances. The Bioterrorism Act requires that the FDA receive prior notice of food items imported into the U.S. and register facilities handling such items. The Company has placed application to be registered under the Bioterrorism Act to enable the importation and handling of these items. The Company engages principally in the business of selling products that are not foods or food additives, drugs or cosmetics within the meaning of the FDCA. However, a number of the Company’s products are subject to labeling, manufacturing and other provisions of the FDCA.  the Company verifies that its partners and associates are properly registered with the U.S. Department of State’s Directorate of Defense Trade Controls as a manufacturers and exporters of products listed on the U.S. Munitions List. The Company reviews orders of these regulated materials being exported to certain destinations to ensure the proper license is obtained. The Company’s import declarations to the CBP represent several thousand entries and individual transaction lines from numerous countries. Within the Company’s U.S. operations, imports encompass a wide array of harmonized tariff codes. These codes are largely represented in Chapters 28, 29 and 38 of the U.S. Harmonized Tariff Schedule, representing organic and inorganic chemicals and compounds and miscellaneous chemical products. These imports are subject to the Tariff Act of 1930, the Customs Modernization Act of 1993 and Title 19 of the Code of Federal Regulations.

For more information, please visit our commercial website:

www.ndpharmabiotech.net