LACTOFERRINE 95 (TM) by ND Pharma & Biotech Co.

Nature´s Best LACTOFERRINE Ultrapure Powder

www.ndpharmabiotech.com

Lactoferrine _________________

Lactoferrine, also known as lacto-transferrin, is a multifunctional protein of the transferrin family. The antimicrobial activity of lactoferrine is related to its affinity for Fe3 + (Therefore its high ability to compete in the free state with iron-dependent microorganisms), and direct action on the outer membrane of negative Gram bacteria. Many of these studies show that lactoferrine has interesting anti-infective, Immunomodulator and promotional properties of proper bowel ecology. During antibiotic therapy, lactoferrine may on one side increase susceptibility of bacteria to drug therapies and on the other, in synergy with probiotics, promote the growth of beneficial bowel bacterial strains (Lactobacillus or Bifid-bacterium) that depend less on the availability of iron.

About Us _________________ ND Pharma & Biotech Co. is a Biopharmaceutical, Biotechnology, Alimentary and Global Chemical Company specialized in Pharma, Food and Chemical Industries. Within the Food & Nutrition sector we operate in food marketing and international business development. Our people are experts in networking specialized in food ingredients and food technology with a strong focus on New Developments and Added-Value Products for diverse markets.

Thanks to its Quality Products and Excellence in Service our reputation has grown rapidly and we are currently serving European Markets through a network of distributors and agents companies in the United States, Russia, Latin America, Turkey, UAE, India, Bangladesh, South Africa and Canada.

www.ndpha rma www.ndpha biotech.com rmabiotech .net www.ndpha rmabiotech .org

Lactoferrine

_________________ Lactoferrine have: Antimicrobial proprieties: Low natural iron saturation - High affinity for iron - Stimulates cell growth - Modulates immune defences.

Ingredient: LACTOFERRIN 95% Product Description: is a freeze-dried protein purified directly from premium quality, fresh bovine milk and/or whey. It has a high affinity for iron and, therefore, is an excellent inhibitor of a wide range microorganisms that require iron for growth. As well as being necessary for normal growth of intestinal cells, lactoferrine functions as an antioxidant in iron mediated oxidation reactions and as an anti-inflammatory agent. It also may play an important role in the transport of iron across the duodenal mucosa. These proprieties make lactoferrine particularly suitable for selected food and pharmaceutical products.

Shelf-Life: 24 months from production date, in original unopened packing under recommended storage conditions.

Storage: Store in cool and dry place free from toxic chemicals and odours. Storage temperature: Ambient Storage humidity: <85% Packaging: 5-10 kg PE or Industrial 25 Kg Bag. Packaging materials are declared safe for use in contact with foodstuffs (EU Reg. 1935/2004 on General Requirements for all food contact materials and Regulation 10/2011 on plastic materials and articles intended to come into contact with food).

Lactoferrine 95 is a Product of The EU.

Lactoferrine

_________________ BSE/TSE statement

Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE) ND Pharma & Biotech Certifies that the product in object is from animal origin. Even if the item is derived from animal origin, this product can be considered TSE free (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy) free.

FOOD GRADE STATEMENT

ND Pharma & Biotech certifies that LACTOFERRINE 95 it’s in compliance with Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Regulation (EC) No. 853/2004 laying down specific hygiene rules on the hygiene of foodstuffs and Regulation CE 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

LACTOFERRINE 95 is manufactured in strict accordance with COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.

MELAMINE STATEMENT ND Pharma & Biotech certifies that MELAMINE is NOT used during the manufacturing of LACTOFERRINE 95 and so this molecule is absent in this product according to Reg. EU 594/2012.

LATEX STATEMENT ND Pharma & Biotech hereby confirms to the best of our knowledge and belief that the natural product LACTOFERRINE 95 is not expected to contain latex due to its origin. Furthermore, no latex is used or added during the production process.

GMO STATEMENT ND Pharma & Biotech certifies that LACTOFERRINE 95 does NOT contain and NOT derive from GMO (Genetically modified organism) in accordance with the following regulation: • Regulation EC/1829/03 of the European Parliament and the Council of 22 September 2003.

• Regulation EC/1830/03 of the European Parliament and the Council of 22 September 2003 concerning traceability and labeling of genetically modified organisms (GMO).

Lactoferrine

_________________ IONIZING RADIATION STATEMENT

ND Pharma & Biotech certifies that LACTOFERRINE 95 is NOT treated with ionizing radiation according to the following Directives: • Directive 1999/2/EC of the European Parliament on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionizing radiation • Directive 1999/3/EC of the European Parliament on the establishment of a Community list of foods and food ingredients treated with ionizing radiation. To reduce the microbiological contamination, steam sterilization is used exclusively.

MATERIAL SAFETY DATA SHEET STATEMENT According to Annex II of the REACH Regulation 1907/2006/EC and following amendment 453/2010/EC Material Safety Data Sheet must be released only in case of dangerous goods. LACTOFERRINE 95 is a harmless natural product and not a dangerous substance. Therefore, there isn’t neither the legal obligation nor the necessity to issue a Safety Data Sheet.

NANOMATERIAL STATEMENT

LACTOFERRINE 95 doesn’t contain and can’t be considered as engineered nanomaterial. This raw material hasn’t been produced using nanotechnology.

EU Regulations 1223/2009 and 1169/2011 describe engineered nanomaterial as any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nano-scale.

Properties that are characteristic of the nano-scale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physic-chemical properties that are different from those of the non-nanoform of the same material; (u) ‘means of distance communication’ means any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the conclusion of a contract between those parties.

Lactoferrine

_________________ PESTICIDES STATEMENT

The product is NOT treated with PESTICIDES. The product is TREATED with PESTICIDES. In any case, the product in object is in compliance with the following Regulations: • Regulation 396/2005/EC and amendments 2006/125/EC, and amendments 149/2008/EC - 839/2008 on maximum residue levels of pesticides in food and feed of plant and animal origin.

RESIDUAL SOLVENTS STATEMENT Due to the fact extraction is not the production process to produce LACTOFERRINE 95, we declare that no solvent is used.

VEGETARIAN AND VEGAN STATEMENT

LACTOFERRINE 95 CONTAINS animal derivates. For this reason, is NOT suitable for VEGAN diets.

LEGISLATION STATEMENT

LACTOFERRINE 95 will be manufactured and packaged in accordance with all current relevant EU legislation.

The information stated is based upon the product formulation and the data provided by manufacturer at the date of issue of this booklet. It is the responsibility of ND Pharma & Biotech to ensure this information are appropriate and complete.

- ND Pharma & Biotech informs the customer of any change that could modify any of the above-mentioned declarations.

NOTA LEGAL IMPORTANTE · LEA DETENIDAMENTE Algunas aplicaciones de este producto pueden estar reguladas o restringidas por los estándares nacionales o internacionales (como por ejemplo en su uso para aditivos alimentarios, preparados a base de aditivos u otros ingredientes, en la industria farmacéutica, etc.). El comprador y el eventual usuario, bajo su exclusiva y entera responsabilidad, deben respetar esos estándares, órdenes de cualquier autoridad competente y todas las patentes y derechos de propiedad intelectual que pudieran existir; y deben cumplir con las leyes y normativa aplicables al producto y/o a su actividad. El comprador y el eventual usuario deben determinar, de manera independiente, la idoneidad de este producto para cualquier propósito particular, uso así como su modo de empleo. Hasta donde alcanza nuestro conocimiento, la información aquí recogida es exacta a la fecha de este documento. Ello no obstante, no realizamos ninguna garantía, expresa o implícita, ni aceptamos responsabilidad alguna en relación con esta información o su uso. Esta información debe ser usada por personas técnicamente especializadas a su solo riesgo y discreción y no se refiere al uso de este producto en combinación con cualquier otra sustancia o cualquier otro proceso. Esto no es una licencia bajo ninguna patente o cualquier otro derecho de propiedad intelectual o industrial. El usuario debe, por si solo, en todo caso, determinar la idoneidad de cualquier información o material para cualquier uso contemplado, el modo de empleo de conformidad con la legislación aplicable y si cualquier patente está siendo o ha sido infringida. Nos reservamos el derecho a añadir, suprimir o modificar la información aquí contenida en cualquier momento sin previo aviso.

IMPORTANT LEGAL WARNING · READ CAREFULLY Some applications of this product may be regulated or restricted by national or international standards (i.e. for food additives, the pharmaceutical industry, etc.). The buyer and the eventual user, in his sole and entire liability, shall respect those standards, orders of any relevant authority and all existing patents and intellectual properties rights; and shall comply with the laws and the regulations applicable to the product and/or to his activity. The buyer and the eventual user must independently determine the suitability of this product for any particular purpose and its manner of use. To our present knowledge, the information contained herein is accurate as of the date of this document. However, we do not make any warranty, express or implied, or accepts any liability in connection with this information or its use. This information is for use by technically skilled persons at their own discretion and risk and does not relate to the use of this product in combination with any other substance or any other process. This is not a license under any patent or other proprietary right. The user alone must alone finally determine suitability of any information or material for any contemplated use, the manner of use in compliance with relevant legislations and whether any patents are infringed. We reserve our right to make additions, deletions, or modifications to the information at any time without prior notification.

Lactoferrine 95

Technical Data Sheet

LACTOFERRINE EU 95% (FDA) (bLF)

Parameter Product Name Appearance Assay (HPLC) LF (%) of protein Identity Protein Moisture Ash Iron Saturation Melamine Calcium Chloride Phosphorous Potassium Sodium Lead Heavy metals (as Lead) Arsenic (as) Nitrate Nitrite Solubility (ml/10ml@5%sol) pH solution 2%@20ºC Foreign matter Sediment ADMI/5g Aerobic plate count/g Bacillus cereus/g Coliforms E. Coli

Enterobacter sakazakii/100g Clostridium perfringens/g Shigella/g Sulphite reducing clostridia spores/g Enterobacteriaceae/g Yeast and Moulds/g Coagulase+ve staoh aureus/g Inhibitory substance ug/ml

Salmonella/25g Listeria/25g Residual Pesticides Storage Temp Conclusion Deputy Head Research Labs

Specification Lactoferrine Red fine powder (with some variations) ≥95% Min NMR conforms to structure ≥95% ≤1.5% ≤1.5% 10-20% ≤0.50ppm 0.0083 mg/100g 1000 mg/100g 0.0053 mg/100g 1.2 mg/100g 210 mg/100g ≤0.03ppm ≤5ppm ≤0.01ppm ≤100ppm ≤2ppm <0.1 5.5-6.5 Absent (Class I) A ≤50 ≤50 Absent Absent

Absent (ESAK020405) Absent Absent ≤25 Absent <1 Absent <0.003 Absent Absent absent Room Temperature (under 30ºC) Meets requirements of this Specification

ND Pharma & Biotech · Regulatory Statement

LACTOFERRINE 95®

LACTOFERRINE 95 is manufactured in strict accordance with COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.

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EU REGULATION · SPECS

_________________________________________________________________________

Bovine Lactoferrine (bLF) is a protein that occurs naturally in cows' milk.

It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.

Production process: Bovine Lactoferrine is isolated from skimmed milk or cheese whey via ion

exchange and subsequent ultrafiltration steps. Finally it is dried by freeze drying or spraying and the

large particles are sieved out.

It is a virtually odorless, light pinkish powder.

Physical-Chemical properties of Bovine Lactoferrin (bLF):

Moisture: < 4,5 %

Ash: < 1,5 %

Arsenic: < 2,0 mg/kg

Iron: < 350 mg/kg

Protein: > 93 % of which bovine Lactoferrine (bLF): > 95 % of which other proteins: < 5,0 %

pH (2 % solution, 20 °C): 5,2-7,2

Solubility (2 % solution, 20 °C): complete

Information given corresponds to the current state of our knowledge (May 2019)

LEGAL STATEMENT

The information contained within this brochure is provided for our customer´s use only and We accept no liability to any third parties, reflecting our current knowledge and experience of the product. All products are supplied in accordance within our general terms and conditions of sale. We can accept no liability for the effects of any chemical combinations or mixtures of the product which are carried out by customers or third parties. In using the product our customers are reminded to comply with all relevant legal, administrative and regulatory requirements and procedures relating to its use and the protection of the environment.

Any decision of purchase, distribution, order of this product will imply that the buyer understands and accepts all legal warnings and indications expressed within this document and is legally bind by ND Pharma & Biotech, it´s commercial companies, subsidiaries, distributors and agents thru Our General Terms and Conditions.

DTS · Dairy Tech Solutions S.A.U. DTS · DAIRY TECH SOLUTIONS S.A.U. FISCAL/VAT NUMBER A70594536 ___________________ REGISTERED OFFICE Juan de la Cierva, 5, Polígono Industrial de La Grela-Bens 15008, La Grela, La Coruña, Spain Phone (+34) 991 94 50 79 sales@lactoferrine.es www.lactoferrine.es

_________________________________________________________________________

DAIRY TECH SOLUTIONS S.A.U. BANK ACOUNT BANCO DE SABADELL S.A. Registered Office Avenida Oscar Esplá, 37, 03007, Alicante, Spain CIF A08000143

IBAN ES54 0081 7610 7200 0192 8396 SWIFT BSABESBBXXX

________________________________________________

DAIRY TECH SOLUTIONS S.A. is a wholly owned subsidiary of The ND Pharma & Biotech Co. ND Pharma & Biotech is active worldwide in Pharma, Nutrition, Agriculture, Industrial, Performance Materials and Chemicals. The company creates innovative products and services that helps to improve life according with its motto of Making Life Better®. ND Pharma & Biotech products are used in a wide range of end markets and applications from human and animal nutrition, healthcare, life sciences, cosmetics, pharmaceuticals, automotive, transport, coatings, housing, electrics and electronics, crop protection , food preservation, disinfection and hygiene, etc. ND Pharma Food Specialties portfolio focuses on accelerating profitable and innovative growth of this Company Division Portfolio. Market-driven growth, innovation and increased presence in emerging economies are key drivers of our main strategy. We are within the global leaders in the field with a current portfolio of + 200.000 product references and + 800 own proprietary technologies and developments. Headquartered in England, UK, and proudly operating worldwide. More information can be found at www.ndpharmabiotech.com, and subsidiary websites as www.ndpharmabiotech.net and Corporate site www.ndpharmabiotech.org or writing us to info@ndpharmabiotech.com, stating clearly the motive of your communication, information needed, and contact data, both personal and institutional.

ND Pharma & Biotech – We do Science for You.™

For more information, contact us now: info@ndpharmabiotech.com

www.ndpharmabiotech.com

herein is accurate, nothing contained herein can be construed to imply any Although diligent care has been used to ensure that the information provided representation or warranty for which we assume legal responsibility, including without limitation any warranties as to the accuracy, currency or completeness of this

information or of non infringement of third party intellectual property rights. The content of this document is subject to change without further notice. Please contact us for the latest version of this document or for further information. Since the user’s product formulations, specific use applications and conditions of use are beyond

our control; we make no warranty or representation regarding the results that may be obtained by the user. It shall be the responsibility of the user to determine the

suitability of our products for the user’s specific purposes and the legal status for the user’s intended use of our products.

The General Terms of Conditions of Sale of ND Pharma & Biotech´s Food Specialties apply to and are part of all our offers, agreements, sales, deliveries and all other dealings. The applicability of any other terms and conditions is explicitly rejected and superseded by our General Terms and Conditions of Sale. The current version of

our General Terms and Conditions of Sale can be found at www.ndpharmabiotech.net, a hard copy will be forwarded upon your request.

© ND Pharma & Biotech Co. - Food Specialties 2019| UK | www.ndpharmabiotech.com|

General Terms & Conditions

Applicable to all operations in absence of specific agreement/contract DTS (Dairy Tech Solutions SAU) General Terms and Conditions of Sale

1. Applicability: The general terms and conditions of sale shall apply to any and all offers, confirmations and agreements between the Seller and the Buyer, unless wholly and or partially agreed otherwise, explicitly and in writing. The Buyer’s general terms and conditions will not apply, and no reference now or in the future to the Buyer’s general terms and conditions will have any effect on these offers, confirmations and agreements, unless wholly or partly agreed otherwise, explicitly and in writing. Seller in these conditions means ND Pharma & Biotech Co Ltd Registered Offices in London, England, UK and/or the Commercial Company DTS S.A.U. with Registered Offices in La Coruña, Spain. It also applied to all subsidiaries, sister companies or partners since commercializing products under ND Pharma & Biotech trademarks, label, commercial names or proprietary developments and technology.

2. Agreement: All quotations of Seller will be without engagement. A sales agreement is concluded only after Seller’s written confirmation of an order.

Each delivery shall stand as a separate transaction and any failure to deliver shall have no consequences for the Agreement with respect to other deliveries.

3. Delivery: Unless expressly agreed otherwise, terms of delivery shall be set in accordance with Incoterms 2000 plus latest amendments. The Buyer shall submit shipping information required for Product delivery to the Seller via email preferably or facsimile or by other means agreed upon by the Parties, at least five working days before the scheduled shipment. Should the Buyer fail to timely submit shipping instructions, the time of delivery of the Product shall be at least extended by the overdue period. Consequently Seller shall not be liable for non-delivery or for any delay in delivery. The Seller shall transfer the shipping details to the Buyer via electronic mail, facsimile or by other means agreed upon by the Parties, within five days after shipment of the Product. Seller shall to the best of his ability observe the time of delivery agreed upon. However, delays shall not entitle Buyer to claim cancellation of the Agreement and/or indemnification. An agreement which does not accurately specify the delivery times, or in which other specifications are missing, shall not become binding upon Seller until the missing delivery times and or specifications have been communicated to Seller and have been agreed upon. Quantity and quality of the products shall be established at the Seller’s loading place by or on behalf of Seller, and the findings shall be accepted as conclusive evidence of the quality and quantity of the products. Buyer or his representative shall have the right to attend, provided Seller has been timely informed of the intention to do so. Seller may deviate up to 5% from the agreed quantities, and the sum to be paid by Buyer shall be adapted accordingly.

4. Prices, taxes and levies: Prices are subject to change without prior notification, unless they are expressly designated as firm for a specific period, in conformity with a written quotation or sales acceptance issued by Seller.

Unless otherwise indicated, prices are exclusive of any taxes, levies and other charges, whether of a general or of a special nature, which shall be charged to Buyer.

5. Payment: The product shall be invoiced prior to its dispatch. All duties, taxes or other governmental charges, if due, shall be shown separately on the invoice. Buyer shall pay in such a way that Seller’s bank account as printed on its invoice will be credited for the full amount in the currency invoiced without any deduction for whatsoever reason, for good value, at the latest on the agreed due date. If payment is due on a Sunday or holiday, payment should be made on the following banking day. If payment is due on Saturday, payment has to be made on the preceding Friday. Should the Buyer fail to pay an invoice, the Seller shall be entitled to temporarily suspend all shipments until receipt of the outstanding amount from the Buyer. Interest will be charged on payment received after due date at Libor rate + 3% where Libor shall be the one month interest rate as quoted by the BBA (British Bankers Association). Should the buyer fail to pay in accordance with the specified payment terms, buyer shall pay a penalty of 0.1% of the outstanding amount for each overdue day.

6. Retention of title: As long as Buyer has not paid the full purchase price, title in the products remains with Seller. If payment is not made in time or in full, Buyer shall at Seller’s first request return the products to Seller. Failing this, Seller shall be entitled, without prejudice to his other rights and remedies, to take back the sold products without any summons, notice of default or judicial intervention being required. As long as Seller retains title in the

products sold, said products shall be used only by Buyer himself for processing or working up in the normal conduct of his business.

7. Default by Buyer: If buyer does not, not timely or not properly fulfill any obligation, and also if Buyer is confronted with a winding up petition, winding up, liquidation or dissolution of his business, or an application for or granting of an official moratorium, Seller shall have the right to give notice or termination of the whole or part of the Agreement or of suspension of its performance in whole or in part. This shall be done by registered letter, without any further notice of default or intervention of any court being required, and without Seller being liable for damages, without prejudice to all other rights of Seller. As soon as any of the above mentioned circumstances has arisen, all claims Seller has with respect to Buyer shall immediately become payable.

8. Warranty: Seller makes no guarantees, warranties, representations express or implied, including warranty of merchantability or fitness for a particular use or otherwise, except that the product sold hereunder shall conform, on the date of delivery, to the agreed upon specifications.

9. Claims and liability: Except in case of gross negligence or willful misconduct, the Seller shall not be liable for any loss or damage resulting from use of the product sold hereunder in any manufacturing process or in combination with other substances. Claims on account of quantity, quality or damage to the product are waived unless made by the Buyer in writing and substantiated with the findings of an independent surveyor, within fourteen (14) days from the date of delivery. Seller shall not be liable for indirect or consequential damages, except in the case of gross negligence or willful misconduct. Seller’s liability shall never exceed the value of the product, in respect of which the claim is made, at the moment of sale. Seller shall not be liable for any damage, whatever its nature, directly or indirectly arising from or relating to the use, processing, sale or distribution of the products, and Buyer shall indemnify, protect and hold Seller harmless against any claim in this respect.

10. Force majeure: Force majeure shall mean all circumstances reasonably beyond control of Seller and affecting Seller’s ability to produce, acquire, sell or deliver the products in the manner meant in the Agreement. This shall include, but not limited to, actions beyond Seller’s such as: wars, military actions, blockades, other international sanctions, fires, floods, strikes, insurrections, riots, embargoes, stock shortages, transportation delays or requests of any governmental authority or agency, or either party’s compliance therewith, or by governmental probation, regulation or priority, the inability of the seller to obtain on terms deed by him to be practicable, any feedstock or other raw material or from any other delay or failure due to any cause beyond Seller’s control, similar or dissimilar to any such causes. Seller shall not be liable to buyer for any loss or damage arising from non compliance, or from failure to comply in time or in full, with any obligation caused by force majeure. Seller shall have the right to allocate, in a manner that Seller considers reasonable, the quantities of products available to Seller among his customers and his own requirements.

11. Applicable law: The present Agreement shall be governed by British and/or Spanish laws, (in dependence of the company acting as Seller), and therefore the European Union Law. The United Nations Convention on contracts for the International Sale of Goods, concluded at Vienna, the April, 11, 1980 shall not be applicable to the Agreement. All disputes arising from or in connection with the Agreement shall be subject to the judgment of the Courts of election of Seller, without prejudice to Seller’s right to summon Buyer before the judge competent at the latter’s domicile.

12. Separability: These terms and conditions shall be deemed separable, and if any portion thereof is held to be invalid for any reason, the remainder shall not be deemed invalid but remain in full force and effect.

13. Assignment: Neither party shall assign the Agreement without written consent of the other party, the sole exception being that Seller may assign the Agreement in whole or in part to any of his subsidiaries or associated companies.

© 2019 ND Pharma & Biotech · DTS (Dairy Tech Solutions SAU)

ND Pharma & Biotech A Biopharma, Biotech, Alimentary and Global Chemical Company offering +210.000 Product References _______________________________________ For more information, please write to: info@ndpharmabiotech.com (Ref:Lactoferrine 95) DISTRIBUTED by

Juan de la Cierva, 5, Polígono Industrial de La Grela-Bens 15008, La Grela, La Coruña, Spain Phone (+34) 991 94 50 79 sales@lactoferrine.es www.lactoferrine.com