Exhibit 6.1(b)(1)

Confidential

Investment AGREEMENT

This investment Agreement (the “Agreement”) is made and entered into as of March 28th , 2016 (the “Effective Date”), by and between medivie uk limited, a private company incorporated and operating under the laws of the United Kingdom with registered offices at The Willows 1, Mark Road Hemel Hempstead, Herts, United Kingdom, Hp2 7bn (“MDVI UK”) and Medivie USA Inc., a company incorporated under the laws of the State of Nevada, with the principal offices at 11319 Maple Street, Los Alamitos, California 90720 (“MDVI USA). Each of MDVI UK and MDVI USA are also referred to herein individually as a "Party", and together as the “Parties”. It is understood as follows:

Now, Therefore, the parties hereto hereby agree as follows:

Confidential

(A) This Agreement constitutes the full and entire understanding and agreement among the parties with regard to the subject matter hereof and supersedes and cancels any prior or contemporaneous agreements, understandings or discussions.

(B) Any term of this Agreement may be amended or waived only with the prior written consent of MDVI USA and MDVI UK.

(C) This Agreement shall be governed by the laws of the State of New York, without regard to the principles of conflict of law thereof. Exclusive jurisdiction is hereby granted to the courts of New York, New York.

(D) Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and are binding upon, the successors, assigns, heirs, executors, and administrators of the parties hereto.

(E) Unless otherwise provided in this Agreement, neither Party shall assign or transfer this Agreement or its respective rights, duties and obligations hereunder to any third party or parties without having obtained the prior written consent of the other Party, which consent shall not be unreasonably withheld.

(F) This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, and all of which together shall constitute one instrument.

(G) All notices and other communications required or permitted hereunder to be given to a party to this Agreement shall be in writing and shall be delivered by email, fax or hand delivery or by guaranteed courier, addressed to such party’s address as set forth below or at such other address as such party shall have furnished to each other party in writing in accordance with this provision:

[Signature page follows] 

Confidential

[Signature page to investment aGREEMENT]

IN WITNESS WHEREOF, the parties have executed this Investment Agreement as of the date first hereinabove set forth.

MASTER LICENSING AGREEMENT

This MASTER Licensing Agreement (this “Agreement”) is entered into on this 28 day of March, 2016 (“Effective Date”), by and between Medivie U.K., a company incorporated under the laws of England and Wales, bearing company registration number 8189870, with registered offices at The Willows 1, Mark Road Hemel Hempstead, Herts, United Kingdom, Hp2 7bn, its affiliates and subsidiaries (collectively, “MDVI UK”) and Medivie USA Inc., a company incorporated under the laws of the State of Nevada, with the principal offices at 11319 Maple Street, Los Alamitos, California 90720 (“Medivie USA”).

Each of MDVI UK and Medivie USA are also referred to herein individually as a "Party", and together as the “Parties”. It is understood as follows:

MDVI UK intends to invest in MDVI USA and in exchange Medivie USA shall issue Medivie USA’s securities to MDVI UK pursuant to an investment agreement to be entered between the Parties upon mutually agreeable terms.

Now, Therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged and in consideration of the mutual obligations undertaken herein, the Parties hereby agree as follows:

If MDVI UK fails to take actions to prosecute an infringement of the Licensed Intellectual Property pursuant to this Agreement within ninety (90) days from the date the Parties are aware of such infringement, then Medivie USA shall be entitled, but not be obligated, to take necessary actions and MDVI UK shall reimburse all Medivie USA for all the expenses related to such actions, and the remaining recovery amount from such proceedings shall vest with MDVI UK.

MDVI UK MAKES NO OTHER WARRANTIES, AND EXCEPT AS EXPRESSLY SET FORTH HEREIN, EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, WITH RESPECT TO THE LICENSED PRODUCT, ITS MERCHANTABILITY, OR ITS FITNESS FOR ANY PARTICULAR PURPOSE OR TO THE VALIDTY OR ENFORCEABILITY OF THE LICENSED INTELLECTUAL PROPERTY. Any breach of the representations and warranties as set forth herein constitutes a material breach of this Agreement.

Neither Party shall be liable to the other Party (whether under contract, tort (including negligence) or otherwise), for any indirect, special, punitive, incidental, consequential or exemplary damages, whether foreseeable or not, even if such Party is advised or should have known of the possibility thereof. The provisions of this Section 8 shall survive the termination of this Agreement for any reason whatsoever.

This Agreement shall be governed for all purposes by the laws of the state of New York and the competent courts in New York, New York shall have exclusive jurisdiction over any dispute arising from or related to the performance or interpretation of this Agreement.

Each Party to this Agreement shall be responsible for and bear all tax due in connection with the consummation of the transactions under this Agreement. To the extent required by applicable law, Medivie USA shall withhold or deduct any applicable taxes, from the payments to be made hereunder.

If any provision contained in this Agreement is determined to be void, invalid or unenforceable, in whole or in part, the remaining provisions and any partially enforceable provision will, nevertheless, be binding and enforceable, and the Parties hereby agree to substitute for the invalid provision a valid provision which most closely approximates the intent and the economic effect of the invalid provision.

This Agreement constitutes the entire understanding and agreement between the Parties with respect to the subject matter hereof and supersedes all prior or contemporaneous agreements, representations, warranties and understandings of the Parties, whether oral or written. No promise, inducement, representation or agreement, other than as expressly set forth herein, has been made to or by the Parties. This Agreement may be amended or modified and the observance of any term herein may be waived (either prospectively or retroactively, and either generally or in a particular instance) only by a written instrument signed by both Parties.

Unless otherwise provided in this Agreement, neither Party shall assign or transfer this Agreement or its respective rights, duties and obligations hereunder to any Third Party or parties without having obtained the prior written consent of the other Party, which consent shall not be unreasonably withheld.

This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which taken together shall constitute one and the same instrument.

The failure of any Party to enforce at any time, or for any period of time, any provision of this Agreement shall not be construed as a waiver of either such provision or of the right of such Party thereafter to enforce each and every provision of this Agreement.

All notices, requests, waivers and other communications made pursuant to this Agreement shall be in writing, to the address set forth herein in the preamble. Notices shall be deemed properly given if transmitted to the Party’s e-mail.

IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by it or on its behalf by its duly authorized officer as of the date first written above.

EXHIBIT A-1

Patents

PCT application number WO201304582, titled “Oral apparatus for optimizing user performance,” filed on September 17, 2012

EXHIBIT A-2

trademarks

U.S. trademark registration No. 4185114, international class 10; US classes 26, 39, 44

U.S, trademark application No. 86910732, international class 10; US classes 26, 39, 44

EXHIBIT B-1

Agreement, dated March 23, 2015, by and between Medivie Therapeutic Ltd., and Medivie UK LIMITED

Patent License Agreement, dated March 24, 2014, between OPRO International Limited and OPRO Mother and Baby Limited

EXHIBIT B-2

Master Purchase Order Agreement, dated December 1, 2015, by and between Toys “R” Us – Delaware, Inc. and Medivie Therapeutic Ltd

AGREEMENT

This Agreement (the “Agreement”) is entered into March 23, 2015, to be effective as of January 1, 2015, (the “Effective Date”), by and between Medivie Therapeutic Ltd, a company incorporated and operating under the laws of the State of Israel and publicly traded in The Tel Aviv Stock Exchange Ltd. (“Medivie IL”) and between Medivie UK LIMITED, a private company incorporated and operating under the laws of the United Kingdom and a subsidiary wholly owned by Medivie IL (“Medivie UK”).

The parties hereto are hereinafter sometimes referred to individually as a “Party” and collectively as “Parties”.

WHEREAS Medivie IL is the parent company of Medivie UK;

WHEREAS Medivie IL entered into three transactions (the “Transactions”) with Medivie UK as described in Section 2 herein;

WHEREAS the Parties wish to compensate each other for the services provided by either party in connection to the Transactions;

WHEREAS the parties wish to adopt the recommendations include in a Transfer Pricing Study draft dated December 2014 and prepared by Fahn Kanne Grant Thornton Israel, attached hereto as Appendix A;

NOW, THEREFORE, in consideration of the mutual covenants and conditions set forth herein, the Parties agree as follows:

2.1 The Parties hereby acknowledge that they have entered into three transactions:

The Parties hereby declare, affirm and undertake as follows:

Each Party will bear its own taxes and expenses resulting from this Agreement.

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives effective as of the date first above written.

Transfer Pricing Study

Medivie Therapeutic Ltd.

FY 2015

Final

February 2015

Contents

© 2015 Certified Public Accountants

Fahn Kanne & Co. is the Israeli member firm of Grant Thornton International Ltd.

Scope of Project

Medivie Therapeutic Ltd (“Medivie-IL”) has engaged Fahn Kanne & Co. Grant Thornton Israel (“Grant Thornton”) to provide guidance for the inter-company transactions between Medivie-IL and its subsidiary Medivie (UK) Ltd (“Medivie-UK” located in the UK for fiscal year (“FY”) ended December 31, 2015.

Both Medivie-IL and Medivie-UK are referred to throughout this report as “Medivie” or the “Company” or the “Group.”

This guidance provided for the arm’s length standard has been completed using transfer pricing methods described in section 85A of the Israeli Income Tax Ordinance - 1961 (the “Ordinance”) and the Income Tax Regulations (Determining Market Conditions) - 2006 (the “Regulations”).

The opinions expressed in this report reflect information furnished to Grant Thornton by the management of Medivie. Although the data used in this report has not been independently verified in all cases, Grant Thornton considers the information used in the analyses herein to be reliable. However, no warranty is therefore given as to the accuracy of such information.

If there were any changes in the business practice of the Group, this report would necessarily need to be updated. In any event, Grant Thornton assumes no obligation to revise this report to reflect such changes or any other events or conditions that occur subsequent to the issue date of this report.

Finally, neither this report nor any portions thereof shall be disseminated to third parties by any means, except as required by law, without prior written consent and approval of Grant Thornton. Neither Grant Thornton nor any individuals associated with this report shall be required by reason of this report to provide testimony or to appear in court or at other legal proceedings, unless specific arrangements to do so have been made.

Executive Summary

Grant Thornton has been engaged to provide guidance for the inter-company pricing with regard to certain transactions between Medivie-IL and its subsidiary Medivie-UK, for FY December 31, 2015, and to provide guidance to determine the arm’s length range for these inter-company transactions.

To complete this analysis, Grant Thornton (i) undertook a functional, risk and asset analysis of the related parties that participate in the inter-company transactions and (ii) applied the transfer pricing rules as promulgated under section 85A of the Ordinance and the Regulations.

Medivie was established in England in 2012 as a private company, part of the global OPRO Group. On April 2014 it was merged into a publicly listed Israeli company and changed its name to Medivie Therapeutic Ltd (TASE: MDVI.TA)

Medivie relies on a broad research base, developing, manufacturing and marketing oral accessories based on innovative technologies, for treatment of pain during labor, treatment of migraines and improving concentration and cognitive abilities.

Related Party Transactions

This report considered the following inter-company transactions between the related parties:

Summary of Results

The information presented in this report relies on data received from Medivie management, and is based on Grant Thornton’s understanding of the inter-company transactions between Medivie-IL and Medivie-UK.

Transaction A

The Comparable Uncontrolled Price (“CUP”) method was applied as the selected method to evaluate the arm’s-length nature of royalty payments for Medivie-UK’s grant of a license to Medivie-IL for the use of IP to produce, further develop and sell and market Products worldwide.

Grant Thornton performed a search for comparable transactions between unrelated entities that have entered into similar IP licensing agreements to Medivie-UK and Medivie-IL. The arm’s length range of royalties as a percent of net sales is between 3.50% and 6.00% with a median of 5%. Grant Thornton recommends that for FY 2015, Medivie-IL should pay Medivie-UK a royalty rate that falls within this range based on net sales generated by Medivie-IL for the Laboraide Products, thus reflecting a reasonable application of the arm’s length standard.

Regarding future development and production of products, Grant Thornton located two agreements that refer to use of existing technology in newly developed Products and the royalties as a percent of net sales is between 1.5% - 3.00% with a median of 2.25%. Grant Thornton recommends that for FY 2015, Medivie-IL should pay Medivie-UK a royalty rate that falls within this range based on net sales generated by Medivie-IL for future developed Products, thus reflecting a reasonable application of the arm’s length standard.

Transaction B

The Comparable Profits Method (“CPM”) was applied as the selected method to evaluate the arm’s-length nature of the future provision of administrative services by Medivie-UK to Medivie-IL. Medivie-UK was analyzed as the tested party with regard to the inter-company transaction, since it is the tested party with the least complex functions.

A Profit Level Indicator (“PLI”) of Mark up on Total Costs (“MTC”) was selected as the most reliable method to evaluate the arm’s length nature of the provision of administrative services from Medivie-UK to Medivie-IL.

The three-year (FY11-13) weighted average unadjusted inter-quartile range of MTC’s is between 2.2% and 6.1% with a median of 4.3%. Grant Thornton recommends that for FY 2015 Medivie-UK achieve a MTC that falls within the inter-quartile range, reflecting a reasonable application of the arm’s length standard.

Transaction C

The Comparable Uncontrolled Price Method (CUP) method was applied as the selected method to evaluate the arm’s-length nature of interest payments for Medivie-IL’s grant of a line of Credit to Medivie-UK.

Grant Thornton used an internal CUP that existed between NatWest Bank and Medivie-UK that was in place during the time of the grant of a line of credit.

After making an adjustment using the SWAP function in Bloomberg which converted the floating GBP interest to the fixed NIS equivalent, the result was a range of interest rates between 3.53% and 8.11%. Grant Thornton recommends that Medivie-IL should charge Medivie-UK an interest rate that is close to the mean rate of 5.82% fixed interest per annum, reflecting a reasonable application of the arm’s length standard.

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Grant Thornton recommends testing current operations at least every year to monitor inter-company charges and adjust them, as necessary. In addition, Medivie-UK and Medivie-IL should review the factual materials presented in this report to ensure that it fairly represents the true nature of inter-company functions and transfers, due to the importance of the functional and risk analysis to select an appropriate pricing method and select comparable companies.

Business Overview

Medivie

Medivie was established in England in 2012 under the name of Opro Mother and Baby (later name was changed to Medivie (UK) Ltd) by Anthony Lovat, the founder of the OPRO Group, together with Capital International. During the past 20 years OPRO Group has become a world leader in developing and manufacturing dental protectors adapted for sports. Capital International is a financial services Company with vast experience in the global capital market, structured investments through partnering with leading global banks and is active in global real estate projects.

In April 2014 Opro Mother and Baby, merged into the shell company of Glycominds Ltd a publicly traded Company located in Israel. Glycominds Ltd is a medical device company that developed and commercialized autoimmune and chronic inflammatory disease management tools and services. Glycominds Ltd changed its name to Medivie Therapeutic Ltd (Medivie-IL) and is listed on the TASE (Tel Aviv Stock Exchange) as MDVI.

The OPRO Group has initially developed Laboraide, a Dental Support Device (DSD) using unique technology to help cope with the pain of childbirth and reduce the time of labor. As part of the founder agreement, all developments, pending patents and IP related to Laboraide or any other field excluding sports, were fully assigned to Medivie UK and, therefore, Medivie-UK owns all the intellectual property relating to this Product and the underlying technology. Medivie-IL is responsible for future registration of Patents and/or trademarks. Medivie-IL will pay for all future maintenance of these patents as part of its license agreement. During 2013, Medivie-UK started marketing and distributing Laboraide for use during childbirth.

Medivie-IL is entering into a royalty bearing licensing agreement with Medivie-UK that will grant Medivie-IL the right to produce, sell and use the technology to further develop Products. Medivie-IL will continue development of DSDs in the following fields:

Laboraide is a DSD developed by Medivie-UK designed to help cope with the pain of childbirth and reduce the time of labor. This is currently marketed and sold worldwide and Medivie-IL will be responsible for all future sales.

This is in a development stage that will facilitate the relaxation of the head muscles, prevent the contraction of the jaw muscles and increase blood flow to the brain for the prevention and relief of migraines to help cope with the pain of childbirth and reduce the time of labor.

This is in a development stage to develop a Product that will allow the exertion of the appropriate pressure in the jaws in order to improve concentration and cognitive activity.

This is in a development stage to develop modular pacifiers that assist with the correct growth of the child’s mouth structure and prevent future damage to the gums and teeth of the child.

Medivie-IL

Medivie-IL (previously Glycominds Ltd) was founded in 1998 and is an Israeli Company that is listed on the TASE. Medivie-IL is entering into a royalty bearing agreement with Medivie-UK to license the technology that has been developed by Medivie-UK to use the technology to produce, further develop and market and sell Products worldwide. The arm’s length royalty rate will be determined during the course of this report.

Medivie-IL will sell the current product Laboraide worldwide and is currently developing further the Migrainaide product and plans to market and sell it in 2015. These will undergo clinical trials and regulatory approvals such as CE and FDA will be obtained all financed by Medivie-IL. The latter Products are based on the underlying technology developed by Medivie-UK. Since Medivie-IL will finance all future R&D activities, Medivie-IL will become the owner of all related future IP (“future IP”).

All production, design and future development is being outsourced to Aran Research and Development Ltd, located in Israel and Medivie-IL is the entity that has contracted with them for their services. Production for Laboraide was previously carried out in the UK by an unrelated party.

Existing local unrelated distributors for the Laboraide Products distribute products to pharmacy & nursery chains, hospitals & clinics, pre-natal centres, and websites of local distributors. Sales will also be conducted through direct online marketing. Medivie-IL plans to expand its current network of distributors.

There is an interest bearing line of credit that was granted from Medivie-IL to Medivie-UK in May 2014 to finance production and other ongoing expenses. This will be in place for three years. This is analyzed further to determine the arm’s length rate of interest.

Medivie-IL as well as employees of the Company contracts with doctors and various service providers such as business consultants and accountants.

Medivie-UK

Medivie-UK (previously Opro Mother and Child) was founded in 2012 and is located in the UK. Medivie-UK was responsible for the development and production of Laboraide, a Dental Support Device (DSD) using unique technology designed by Medivie-UK to help cope with the pain of childbirth and reduce the time of labor. Medivie-UK owns all the intellectual property relating to this Product and the underlying technology. During 2013, Medivie-UK started marketing and distributing Laboraide for use during childbirth.

Medivie-UK and Medivie-IL are entering into an agreement whereby Medivie-UK will license its technology to Medivie-IL for the right to produce, further develop and market and sell Products worldwide as discussed throughout the report.

Medivie-IL will be responsible for worldwide sales of both Laboraide and future Products. However in circumstances where countries do not wish to transact with Israel for political reasons, sales will be conducted through Medivie-UK for certain non Israeli markets. Medivie-UK will issue invoices and sign sales agreements on behalf of Medivie-IL in its own name with clients. All risks will remain with Medivie-IL in these transactions. These revenues will be recorded in Israel. In issuing invoices on behalf of Medivie-IL, Medivie-UK will be providing administrative sales support services to Medivie-IL and will be reimbursed on an arm’s length cost plus basis to be determined in this report. It is unknown at this stage how material these sales will be or the exact nature of this activity and Grant Thornton advises that the transfer pricing policy is reviewed periodically and updated accordingly.

There are currently no employees in Medivie-UK.

Medivie Products

Medivie started marketing its first product ‘Laboraide’ in 2013. The product reduces pain & time of labor. Laboraide is a natural, non invasive oral device. The product received positive reviews from both women and the surrounding medical community (doctors, nurses, midwives).

In recent years there has been a massive increase in public awareness of alternative medicine, natural therapies and, more specifically, natural childbirth; principally avoiding caesarean surgery and the use of painkilling medication due to the side effects associated with it.

Laboraide is an innovative Dental Support Device (DSD) that limits the contraction of the jaws during labor, a fact that has been scientifically proven to be linked with the ability to reduce the feeling of pain, as well as shortening childbirth time.

Laboraide was tested by hundreds of women in studies and surveys, and was found to be helpful for women during the advanced stages of pregnancy and childbirth in two areas:

Pain

Reduces stress during labor and helps deal with the pain .

Time

Allows relaxation of the jaw, neck, and back muscles, and increases the isometric strength of the pelvic and core muscles, allowing efficient and targeted contractions which shortens the duration of labor.

Laboraide has the necessary regulatory permits to be marketed in the U.S., Canada and Europe (CE).

Laboraide is made of a flexible material that has no smell and/or taste and thus is ideal for use in the mouth: it fits naturally between the teeth and does not interfere with breathing, speaking, or any other activity during labor.

Laboraide comes in different thicknesses to enable the woman to use the device which best fits the structure of her mouth.

Medivie has a global distribution network for Laboraide in Asia, Latin America and Europe. The Company has the required regulatory permits for the distribution of Laboraide in the US, Europe and Canada and is currently exploring the US and Canada as potential markets and looking at ways to penetrate these markets. Medivie intends to continue expanding its marketing and distribution operations, both online and through local distributors. At the time of writing this report, Medivie-IL has entered into a Memorandum of Understanding (MOU) with Sinopharm, one of the largest pharmaceutical companies in China and sales are expected in 2015.

The migraine field, which has high clinical potential, has been selected by Medivie as a leading research subject for the year 2015 with sales planned at last quarter of 2015. The Product is planned to be named Migrainaide and is based on technology developed by Medivie-UK. As a consequence, Medivie IL will be working on the ongoing development of a dedicated DSD that will facilitate the relaxation of the head and jaw muscles and increase blood flow to the brain for the prevention, treatment and relief of migraines.

Also in the pipeline for future developments are Products that will allow the exertion of the appropriate pressure in the jaws in order to improve concentration and cognitive activity known as ADHD and product for Mouth & Gums that will develop modular pacifiers that assist with the correct growth of a child’s mouth structure and prevent future damage to the gums and teeth of the child. Medivie-IL is financing this development and will result future IP related to this Product.

Organizational Structure

Figure 1 below illustrates the relevant organizational structure of the Group and relevant inter-company transaction.

Figure 1

Industry Overview¹

The industry that Medivie currently operates in is the ‘Birth support services & pain reduction market’.

There are various “Pregnancy & childbirth support” services in the market, all intended to give the mother a sense of control and calmness throughout the pregnancy and birth.

Products pertaining to pregnancy & childbirth:

Existing solutions to pain:

Migraine is a common form of headache and may appear in varying degrees of severity up to completely incapacitating the sufferer.

About 12% of the world adult population suffers from migraines. Existing treatment methods offer effective relief to about 60% of suffering patients.

The migraine market was assessed at USD 3.3 billion in 2011 and is expected to rise to USD 5.8 billion in 2021²

The most common treatment is medication, yet this treatment is not effective for all those who suffer.

Functional Analysis

The purpose of the functional analysis is to present the functions, risks and intangibles of the related companies that will be used to identify comparable, uncontrolled transactions. The following points highlight why a functional analysis is essential to the development of a transfer-pricing policy. The functions undertaken by each related party typically correlate with the extent to which that entity bears risk and is responsible for developing intangible assets.

The determination of the functions performed and risks assumed is based on a review of documents and analyses provided by Medivie as well as interviews conducted with its management.

Medivie-UK

Medivie-UK was established in 2012 and is located in England. There are currently no employees.

The OPRO Group has initially developed Laboraide, a Dental Support Device (DSD) using unique technology to help cope with the pain of childbirth and reduce the time of labor. As part of the founder agreement, all developments, pending patents and IP related to Laboraide or any other field excluding sports, were fully assigned to Medivie UK and, therefore, Medivie-UK owns all the intellectual property relating to this Product and the underlying technology. Medivie-UK licenses its IP to Medivie-IL and receives royalties as compensation. Medivie-UK has pending patents relating to the Laboraide Products. Medivie-IL is responsible for future registration of Patents and/or trademarks and will pay for all future maintenance of these patents as part of its license agreement. During 2013, Medivie-UK started marketing and distributing Laboraide for use during childbirth.

Medivie-IL will be responsible for the worldwide sales of Products. However in circumstances where countries do not wish to transact with Israel for political reasons, it is expected that in the future sales will be conducted through Medivie-UK for certain non Israeli markets. Medivie-UK will issue invoices and sign sales agreements on behalf of Medivie-IL in its own name with clients. All risks will remain with Medivie-IL in these transactions. These revenues will be recorded in Israel. In issuing invoices on behalf of Medivie-IL, Medivie-UK will be providing administrative sales support services to Medivie-IL and will be reimbursed on an arm’s length cost plus basis to be determined in this report for these services. It is unknown at this stage how material these sales or the exact nature of this activity and whether Medivie-UK will employ or contract with people/Companies and Grant Thornton advises that the transfer pricing policy is reviewed periodically and updated accordingly.

There is an interest bearing line of credit that was granted from Medivie-IL to Medivie-UK in order to finance production, existing debt and some other ongoing expenses. The line of credit was effective from May 1^st 2014 for 3 years. The value of the line of Credit is for approximately 1.2 million New Israeli Shekels with the option to increase that amount under the same terms and conditions. Interest is being calculated on a quarterly basis. The arms length interest is being determined in this report.

Medivie-IL

Medivie-IL is responsible for licensing the technology from Medivie-UK to produce, further develop, market and sell Products worldwide.

Medivie-IL as well as employees of the Company contracts with doctors and various service providers such as business consultants and accountants.Below are the functions of Medivie-IL;

Corporate Management

Medivie-IL employs all the senior management including the CEO, Chairman, CFO, Chief Scientist and VP Business and Development who are responsible for operations and finance of the Group, the marketing and sales strategy and product development and production strategy. Medivie-IL as the licensee of the technology decides the general direction and leadership of the Group and sets the Group’s global strategy, road map, and budget.

Further Development and Production

Medivie-IL will be further developing and producing new Products under the license agreement it is entering into with Medivie-UK. Medivie-IL will finance all future R&D activities and will become the owner of all related future IP (future IP).

Medivie is currently developing the Migrainaide product and plans to market and sell these in 2015. These will undergo clinical trials and regulatory approvals such as CE and FDA will be obtained. The latter Products are and will be based on the underlying technology developed by Medivie-UK.

All production, design and future development is being outsourced to Aran Research and Development Ltd, located in Israel. Aran is an Israeli public company traded on the Tel-Aviv Stock Exchange (TASE). Established in 1982, the Aran employs a 140-strong workforce, consisting mainly of engineers, product designers, and technicians. Aran deals in three main areas of activity: Product development, engineering and manufacturing services.

Medivie-IL is the entity that has contracted with Aran and finances their services to Medivie. Medivie-IL is overseeing this entire process and gets the final say on Product development and manufacturing.

Sales and Marketing

Sales are performed or will be performed through unrelated distributors. All distributors will be selected by Medivie-IL and contracts will be entered into with Medivie-IL with Medivie-IL overseeing the sales activity of the distributors. Existing local unrelated distributors for the Laboraide Products distribute products to pharmacy & nursery chains, hospitals & clinics, pre-natal centres, and websites of local distributors. Sales will also be conducted through direct online marketing. Medivie-IL plans to expand its current network of distributors.

The Company’s marketing model is creating strategic partnerships with leading distribution companies in a territorial division. Most distribution agreements require purchasing an annual minimum quantity of units and an offline/online marketing & advertising strategic plan.

Medivie-IL has recently signed MOU with Sinopharm one of the largest and leading distributors of medical products in China with a sales turnover estimated at around 33 billion USD per annum.

The Company has the required regulatory permits for the distribution of Laboraide in the US, Europe and Canada and is currently exploring the US and Canada as potential markets and looking at ways to penetrate these markets.

Assets Employed

Tangible assets

Medivie-IL operates from rented offices situated in Raanana in Israel and is the owner of standard office equipment.

Medivie-UK owns no significant tangible assets.

Intangible assets

Medivie-UK holds the IP to the technology. The production, further development and global marketing and sales will be conducted by Medivie-IL as the licensee of the technology. Medivie-IL will finance all future R&D activities and will become the owner of all related future IP (future IP).

Risks Assumed

Research & Development Risk

The market in which Medivie operates in is characterized by rapid technological change, frequent new product introductions, changes in customer requirements and evolving industry standards. Medivie-IL will finance all aspects of future R&D and patent applications related to the Products it wishes to sell. It is therefore imperative for Medivie-IL to continually contribute to the development of innovative products relating to the Dental Support Devices (DSD). As such, the R&D required, carries potentially large costs, which will be borne by Medivie-IL. In addition, failure to meet R&D budgets and timetables may jeopardize the price competitiveness of Medivie-IL’s products and subsequently affect the entire company’s sales. Medivie-IL bears all risks relating to its future R&D activities, including the cost of product failure, due to its status as the licensee of the intangible property and future owner of IP.

Market Risk

Market risk includes decline in sales due to demand conditions within the market, or the inability to further develop the market. Uncertainties in the market also include fluctuations in cost of raw materials, pricing, and inventory levels.

If for some reason, the market for Medivie’s products decline, both Medivie-IL’s and Medivie-UK’s income will decrease. Therefore, both entities share the market risk as Medivie-UK is the owner of the IP and Medivie-IL is the licensee of this technology being responsible for success or failure of marketing strategy and distribution.

Currency Fluctuation Risk

Currency Fluctuation risk relates to the potential variability of profits that can arise because of changes in foreign exchange rates.

The royalties are paid as a percentage of revenue calculated in ILS and transferred in GBP according to the end period exchange rate and so therefore both Medivie-IL and Medivie-UK can be subject to exchange rate losses.

Product Warranty/Liability Risk

Product liability and warranty risk arises when a company’s products fail to perform at contractual standards and the company is required to correct defective product performance. A product liability claim could result in costs to a company’s reputation, and consequently in a decline in revenues. As the licensee of the technology relating to the Products and the financier of future development and all production, and the entity that provides the warranty, Medivie-IL bears the risks related to any contingency suffered by the products concerning the quality of the product sold on its general sales and sales to clients through its channel partners. Medivie-IL has taken out product liability insurance.

Inventory Risk

Inventory risk relates to the losses associated with carrying finished product and raw material inventories. Losses include obsolescence, shrinkage, or market collapse such that products are only saleable at prices that produce a loss. Medivie-IL bears these risks as they are the licensee of the IP and responsible for production and the sales and marketing of the Products.

Relevant Transfer Pricing Regulations

Israel’s transfer pricing rules are set out in section 85A to the Israeli Tax Ordinances and in the Regulations promulgated under section 85A.

§85A Transfer pricing of international transactions

“Means of control” and “Together with another” – as defined in clause 88;

“Credit” – including any debt;

“Special relations” – including relations between a person and a relative, as well as control of one of the parties to the transaction over the other, or control of one person over the parties to the transaction, directly or indirectly, alone or together with another;

“Control” – holding, directly or indirectly, of 50% or more in one of the means of control in at least one day in a tax year;

“Relative” – as defined in clause 76(d).

Income Tax Regulations (Determining Market Conditions) – 2006

“By virtue of my powers pursuant to §s 85A(e) and 243 of the Israeli Income Tax Ordinance (hereinafter – the “Ordinance”), and with the approval of the Finance Committee of the Israeli Parliament, I hereby regulate the following regulations:

In these regulations –

“Range of values” – Range of values between the lowest value and the highest value, as obtained in comparison with similar transactions;

“The inter-quarterly range” – The values located between the 25th percentile and the 75th percentile in the range of values;

“Comparative characteristics” – All of the following:

“International transaction” – A transaction being examined and which complies with all of the following:

“Similar transaction” – All of these, on condition that, in the event that there were no identical comparative characteristics, adjustments were made, such that the impact of the difference in the comparative characteristics on the results obtained will be cancelled:

“Similar party” – A person, the comparative characteristics of whom are similar or identical to those of the party being examined;

“Party being examined” – A party to an international transaction who fulfils the following two conditions:

“Profit margin” – The margin of profit or loss, as applicable, to be determined on the basis of one of the following methods:

In comparing similar transactions, the following provisions shall apply:

Regulations 2 and 3 shall not apply to a one-time international transaction that was approved by the tax assessing officer as a one-time transaction and the transaction shall be reported as if the price or the conditions were determined, as applicable, between parties not having a special relationship.

These regulations shall apply to an international transaction that was conducted on or after the date the regulations were publicized. However, an investigation of market conditions that was conducted prior to the publication of the regulations shall be viewed as having been done in accordance with the regulations, for a period of two years following the date of publication, on condition that it was conducted in accordance with accepted guidelines that were issued by the OECD organization or members states of that organization.”

Selection of Method According to the Regulations

The Regulations set out the arm’s length standard, the documentation requirements and the transfer pricing methods that will be relied upon in determining whether an arm’s length price has been established.

In addition, the Regulations stipulate that for purposes of determining if the international transaction being carried out is a market condition transaction, an investigation of the market conditions shall be conducted on the basis of one of the following methods and according to the following hierarchy:

Economic Analysis –
Transaction A

In FY 2015, Medivie-IL has entered into a license agreement to license IP from Medivie UK for further development, production and sales of Products. Medivie-IL will pay Medivie-UK a royalty.

The arm’s length standard requires related companies to conduct inter-company transactions as if they were unrelated. Grant Thornton searched for uncontrolled transactions similar to the transaction between Medivie-IL and Medivie-UK. The objective of this search was to identify comparable transactions giving rise to arm’s length prices or levels of profitability that can be attributed to Medivie-IL and Medivie-UK in the transaction under review.

Selection of transfer pricing method

Comparable Uncontrolled Price Method (“CUP”)

The application of the CUP method requires identification of a transaction between controlled and uncontrolled parties that is comparable in nature to the grant of license by Medivie-UK to Medivie-IL. The primary issue of concern in the CUP methodology is having uncontrolled transactions that are sufficiently similar in terms of geographic location, products, contractual terms, and other business conditions to the transaction under analysis. The circumstances surrounding that provision of rights, or the transactions must be so similar that reliable adjustments can be made to account for the effect on price of any differences between the transactions.

External CUP data exists for such IP licensing transactions. Grant Thornton Israel performed a search for comparable transactions between unrelated entities that have entered into similar IP licensing agreements.

The Israeli Transfer Pricing regulations prefer the CUP over all other methods when available. Since the Israeli Regulations show a preference to the CUP method, further analyses of other methods was not required and were rejected in favour of the CUP method. Therefore, the CUP method can be applied to determine the appropriate pricing for the grant of an IP license between Medivie-IL and Medivie-UK.

In order to identify potential similar IP licensing transactions, Grant Thornton performed a search using KtMine³, to determine an appropriate royalty to be charged between Medivie-IL and Medivie-UK for the license agreement.

To identify the comparable IP licensing transactions/agreements, Grant Thornton performed a search including the following search steps;

³ KtMine is an interactive intellectual property database that provides direct access to royalty rates, actual license agreements and detailed agreement summaries.

The above search steps resulted in 186 potential comparable license agreements.

Grant Thornton reviewed the potential comparable IP licensing agreements and examined contractual comparability (further development, right to manufacture and sell), special relations between potentially comparable licensee and licensor (i.e. related or controlled parties), date of agreement, royalty base, any milestone payments and contractual terms that are comparable to the controlled transaction. Finally, Grant Thornton identified 12 comparable licensing transactions.

Economic Analysis Results

The results of the 12 comparable software licensing transactions identified through Grant Thornton’s research to determine the appropriate arm’s-length royalty range within which Medivie-IL and Medivie-UK should operate as a percentage of net sales is presented below;

A royalty rate that falls within the arm’s length range established above should be considered to meet the arm’s length principle.

It should be noted that during the search that was performed two agreements were located that provide a royalty rate in cases where future Products are developed by the licensee and which incorporate the licensed IP. This could be indicative of arm’s length royalty rate for future Migrainaide and ADHD Products that are currently being developed by Medivie-IL but which incorporate technology owed by Medivie-UK. The results of these two agreements are below;

A royalty within the range of 1.5% - 3.0% established above for future developed Products by Medivie-IL incorporating IP of Medivie-UK should be considered to meet the arm’s length process.

Economic Analysis –
Transaction B

In FY 2015, Medivie-UK is expected to provide administrative sales support services to Medivie-IL. These services are beneficial in nature. If the above services would not have been provided to Medivie-IL by Medivie-UK, Medivie-IL would have been required to hire a third party contractor for provision of such services.

The arm’s length standard requires related companies to conduct inter-company transactions as if they were unrelated. Grant Thornton searched for uncontrolled transactions similar to the transaction between Medivie-UK and Medivie-IL. The objective of this search was to identify comparable transactions giving rise to arm’s length prices or levels of profitability that can be attributed to Medivie-IL and Medivie-UK in the transaction under review.

In order to determine the appropriate return Medivie-UK should earn for the provision of administrative support services to Medivie-IL, Grant Thornton relied on the Comparable Profits Method (“CPM”) also known as the Transactional Net Margin Method (“TNMM”). The application of the CPM involves establishing a range of profit level indicators (“PLI’s”) for selected comparable firms that provide comparable services. In this analysis, Grant Thornton applied the Mark-up on Total Costs (“MTC”) (operating profit/total costs) as the PLI. Medivie-UK was chosen as the tested party for this transaction as it is the entity with the least complex functions and does not own valuable intangibles related to the provision of its services.

Selection of Comparable Independent Companies

The search process performed herein involved identifying companies engaged in similar activities to those performed by the tested party in the course of the inter-company transactions under review.

Grant Thornton’s research methodology to identify comparable companies involved a number of steps that evaluated both qualitative and quantitative factors comprising the following:

The search process performed herein involved identifying companies located in Europe engaged in similar activities to those performed by the tested party in the course of the inter-company transaction under review. To determine what an appropriate level of profit should be for provision of the tested party services, Grant Thornton performed a search using Thomson Reuters One Source database⁴ for comparable administrative providers (who provide invoicing services, back office services, secretarial services, payroll services, sales/business process support, customer support services and data processing entry services) similar to the nature of services that will be provided by Medivie-UK.

⁴ Thomas Reuters uses the following databases; Thomson Reuters Fundamentals, published September 2014.

Grant Thornton searched for companies in the following US SIC and NAICS 2012 codes:

US SIC

NAICS 2012

Grant Thornton searched for Comparables that included the following key words in their business descriptions;

The above steps produced a sample of 240 potentially comparable companies for further review.

Determine Adequacy of Financial Data

The next step in the search process eliminated inactive companies, companies with less than two consecutive years of positive operating profit, or companies that did not have sufficient financial data for purposes of this study. Companies with insufficient business descriptions were also eliminated. The sample companies’ income statements in the databases were examined to ensure that they had three years of financial data from 2011 to 2013. This research step produced a sample of 176 potentially comparable companies for further review.

Establish Functional and Product Comparability

Grant Thornton reviewed the short business descriptions, websites and annual returns where available for the remaining 176 companies to establish whether the companies performed functions similar to those that Medivie-UK will perform. To identify comparable independent administrative support service providers, a search was conducted to identify companies fitting the following criteria:

The functional and risk evaluation increased the probability that the final set of comparable companies faced similar market and business risks and would produce reliable economic results consistent with those generated by independent comparable companies. After a review of their business descriptions, 167 companies were eliminated.

Grant Thornton then examined the remaining nine companies’ profit and loss statements for further qualitative analysis, and this comprehensive examination rejected no companies, leaving a final set of nine comparable service providers.

Economic Analysis Results

Uncontrolled Companies Profitability Analysis

The results of the comparable companies identified through Grant Thornton’s research determine the appropriate arm’s-length profitability range within which Medivie-UK should operate.

Table 1 below presents the MTC ratios for the selected comparable companies during the 2011 to 2013 fiscal period;

Table 1 – Range of Arm’s Length MTC’s for FY’s 2011-2013

As shown in Table 1, the three-year (FY11-13) weighted average unadjusted inter-quartile range of MTC’s is between 2.2% and 6.1% with a median of 4.3%. A MTC rate that falls within the arm’s length range established above should be considered to meet the arm’s length principle.

Economic Analysis –
Transaction C

The following is a description of the pricing methods considered and selected to evaluate the arm’s length nature of the Line of Credit granted by Medivie-IL to Medivie-UK according to the Israeli Regulations. The benchmarking analysis conducted was used to evaluate the arm’s length nature of the transfer pricing policy for the line of credit.

According to section 85A of Israel’s Income Tax Ordinance (New Version) – 1961 (hereinafter – the “Israeli Tax Ordinance”) and the Income Tax Regulations (Determining Market Conditions) – 2006 (hereinafter – the “Regulations”) promulgated there under, an international transaction between related parties shall be reported at arm’s length, according to market terms. For purposes of determining whether an international transaction is carried out at arm’s length, an investigation of the market conditions shall be conducted, in which the international transaction should be compared to similar transactions of the party being examined, on the basis of methods defined under the Regulations. The income tax ordinance was amended in respect of the application of TP legislation on related party lending transactions. Following this amendment, the provisions of article 85A do not apply to certain lending transactions (with capital characteristics) that meet detailed criteria.

Selection of CUP transfer pricing method

The Comparable Uncontrolled Price (CUP) method compares the price charged for a service in a controlled transaction to the price charged for a service in a comparable uncontrolled transaction. In general, intercompany loans and advances must include a market rate of interest. An arm’s length rate of interest is generally considered a rate of interest which was charged, or would have been charged, at the time the indebtedness arose, in independent transactions with or between unrelated parties under similar circumstances. All relevant factors should be considered, including the principal amount and duration of the loan, the security involved, the credit standing of the borrower, and the interest rate prevailing at the time the loan was granted. This is considered to be analogous to the CUP method, and since information regarding similar debt securities is readily available, we thus determined the CUP method to be the most reliable method to analyze the arm’s length range of rates for the intercompany loans.

It should be noted that at the time of the granting of the line a credit, an overdraft facility was granted by NatWest Bank in the UK to Medivie-UK which results in a potential internal CUP.

It should be noted at this stage that an Altman-Z was performed but this did not yield reliable results because the Company is in a start-up status and it is difficult to derive a reliable credit rating equivalent.

Application of the CUP

Grant Thornton applied the internal CUP method to benchmark the interest rates on the intercompany loans. Grant Thornton used the overdraft facility provided by NatWest Bank as the basis for the analysis. The overdraft facility was signed September 2013 and an overdraft facility was granted with a limit of 125,000 GBP (similar to amount of Medivie-IL’s line of credit granted to Medivie-UK) with a floating charge as follows;

The bank rate was 0.5% on September 2013.

Use of Bloomberg

The loans under analysis bear interest at a fixed rate whereas the overdraft facility is a floating rate. In addition the line of credit was granted in NIS and the overdraft was in GBP. In order to adjust for comparability, we used the swap manager function on Bloomberg to perform a swap analysis which converted the floating rate to a fixed yield NIS equivalent for three years maturity.

We used the same issue date and length to maturity as for the intercompany line of credit granted.

We performed the swap on both the 2.37% and 7% floating rate above prime rate to determine an arm’s length range. The snapshots from Bloomberg below illustrate the results;

Conversion of 2.37% to calculate leg 1 (fixed rate)

A conversion from GBP 2.37% floating rate to fixed NIS rate resulted in 3.53% fixed rate.

Conversion of 7.00% to calculate leg 1 (fixed rate)

A conversion from GBP 7.00% floating rate to fixed NIS rate resulted in 8.11% fixed rate.

Results

The results from above indicate an arm’s length rate of interest between 3.53% and 8.11%. We would consider targeting the mean result of 5.82% as an appropriate arm’s length interest payment.

Conclusion

The information presented in this report relies on data received from Medivie management, and is based on Grant Thornton’s understanding of the inter-company transactions between Medivie-IL and Medivie-UK.

Transaction A

The Comparable Uncontrolled Price (CUP) method was applied as the selected method to evaluate the arm’s-length nature of royalty payments for Medivie-UK’s grant of a license to Medivie-IL for the use of IP to produce, further develop and sell and market Products worldwide.

Grant Thornton performed a search for comparable transactions between unrelated entities that have entered into similar IP licensing agreements to Medivie-UK and Medivie-IL. The arm’s length range of royalties as a percent of net sales is between 3.50% and 6.00% with a median of 5%. Grant Thornton recommends that for FY 2015, Medivie-IL should pay Medivie-UK a royalty rate that falls within this range based on net sales generated by Medivie-IL for the Laboraide Products, thus reflecting a reasonable application of the arm’s length standard.

Regarding future development and production of products, Grant Thornton located two agreements that refer to use of existing technology in newly developed Products and the royalties as a percent of net sales is between 1.5% - 3.00% with a median of 2.25%. Grant Thornton recommends that for FY 2015, Medivie-IL should pay Medivie-UK a royalty rate that falls within this range based on net sales generated by Medivie-IL for future developed Products, thus reflecting a reasonable application of the arm’s length standard.

Transaction B

The Comparable Profits Method (CPM) was applied as the selected method to evaluate the arm’s-length nature of the future provision of administrative services by Medivie-UK to Medivie-IL. Medivie-UK was analyzed as the tested party with regard to the inter-company transaction, since it is the tested party with the least complex functions.

A PLI of MTC was selected as the most reliable method to evaluate the arm’s length nature of the provision of administrative services from Medivie-UK to Medivie-IL.

The three-year (FY11-13) weighted average unadjusted inter-quartile range of MTC’s is between 2.2% and 6.1% with a median of 4.3%. Grant Thornton recommends that for FY 2015 Medivie-UK achieve a MTC that falls within the inter-quartile range, reflecting a reasonable application of the arm’s length standard.

Transaction C

The Comparable Uncontrolled Price Method (CUP) method was applied as the selected method to evaluate the arm’s-length nature of interest payments for Medivie-IL’s grant of a line of Credit to Medivie-UK.

Grant Thornton used an internal CUP that existed between NatWest Bank and Medivie-UK that was in place during the time of the grant of a line of credit.

After making an adjustment using the SWAP function in Bloomberg which converted the floating GBP interest to the fixed NIS equivalent, the result was a range of interest rates between 3.53% and 8.11%. Grant Thornton recommends that Medivie-IL should charge Medivie-UK an interest rate that is close to the mean rate of 5.82% fixed interest per annum, reflecting a reasonable application of the arm’s length standard.

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Grant Thornton recommends testing current operations at least every year to monitor inter-company charges and adjust them, as necessary. In addition, Medivie-UK and Medivie-IL should review the factual materials presented in this report to ensure that it fairly represents the true nature of inter-company functions and transfers, due to the importance of the functional and risk analysis to select an appropriate pricing method and select comparable companies.

Sincerely yours,

/s/ Fahn Kanne & Co.

Fahn Kanne & Co.

Certified Public Accountants (Isr.)

Amendment to agreement between medivie therapeutics ltd and medivie UK.

This Amendment (the “Amendment”) is made as of May 26^th, 2016 (“Effective Date”), by and between Medivie therapeutics Ltd., a company incorporated and operating under the laws of the State of Israel and publicly traded in the Tel-Aviv Stock Exchange Ltd. (“Medivie IL”) and Medivie UK LIMITED, a private company incorporated and operating under the laws of the United Kingdom and a subsidiary wholly owned by Medivie IL (“Medivie UK”).

WHEREAS, Medivie IL and Medivie UK have entered into an agreement dated March 23, 2015, pursuant to which Medivie IL and Medivie UK provided to Medivie UK a credit line bearing interest (the “Agreement”);

WHEREAS, Medivie IL and Medivie UK now desire to amend the term of the Agreement as more particularly set forth below.

NOW, THEREFORE, the Parties hereto, intending to be legally bound, hereby agree to the following amendment:

Medivie UK undertakes to pay Medivie IL, a 5.8% fixed interest per annum (the “Interest”) for a credit line of up to US$1,000,000 provided by Medivie IL (the “Credit Line”)

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the Effective Date.

Patent licence agreement

THIS AGREEMENT is made the 24^th day of March 2014

BETWEEN:

BACKGROUND:

IT IS AGREED as follows:

In this Agreement, the following words shall have the following meanings:

The Licensor hereby grants to the Licensee, subject to the provisions of this Agreement, a sole licence in the Field to use the Patents, with the right to sub-license, subject to clause 2.3 below, to develop, manufacture, have manufactured, use and sell Licensed Products but only in the Field in the Territory. Accordingly, the Licensor shall, during the term of this Agreement, be entitled to use the Patents itself in the Territory in the Field but shall not license third parties to develop, manufacture, have manufactured use and sell Licensed Products in the Field and the Territory. If the Licensor during the term of this Agreement generates any improvements to the technology contained in the claims of the Patents it shall license the same to the Licensee according to the terms of this Agreement. If the Licensee generates any such improvements:

Both Parties shall promptly disclose improvements generated by them or on their behalf to the other Party to give effect to the above provisions.

The Parties shall execute such formal licenses as may be necessary or appropriate for registration with Patent Offices and other relevant authorities in particular territories. In the event of any conflict in meaning between any such licence and the provisions of this Agreement, the provisions of this Agreement shall prevail wherever possible. Prior to the execution of the formal licence(s) (if any) referred to in clause 2.2, the Parties shall so far as possible have the same rights and obligations towards one another as if such licence(s) had been granted. The Parties shall use reasonable endeavours to ensure that, to the extent permitted by relevant authorities, this Agreement shall not form part of any public record.

The Licensee shall be entitled to grant sub-licences of its rights under this Agreement to any person, provided that:

It is acknowledged and agreed that no licence is granted by the Licensor to the Licensee other than the licence(s) expressly granted by the provisions of this clause 2. The foregoing notwithstanding, Licensee may use the services of third parties in order to take instructions exclusively from Licensee to file and prosecute national phase applications related to the Patent on behalf of and in the name of the Licensor. Without prejudice to the generality of the foregoing the Licensor reserves all rights under the Patents outside the Field.

The Licensee shall ensure that all of the Licensed Products marketed by it and its sub-licensees are of satisfactory quality and comply with all applicable laws and regulations in each part of the Territory, including without limitation in connection with clinical trials, CE marking and other approvals, standards and marketing authorisations under the regulations of the FDA, the EMEA, the MHRA and other equivalent bodies in the Territory.

The Licensee shall be exclusively responsible for the technical and commercial development and manufacture of Licensed Products by it or on its behalf and for incorporating any modifications or developments thereto that may be necessary or desirable and for all Licensed Products sold or supplied by it or on its behalf, and accordingly the Licensee shall indemnify the Licensor in the terms of clause 5.2.

Each Party (‘Receiving Party’) undertakes:

The provisions of clause 2.7 shall not apply to confidential and other information which the Receiving Party can demonstrate by reasonable, written evidence:

The Receiving Party shall procure that all of its employees, contractors and sub-licensees pursuant to this Agreement (if any) who have access to any of the Disclosing Party’s information to which clause 2.7 applies, shall be made aware of and subject to these obligations and shall have entered into written undertakings of confidentiality at least as restrictive as clause 2.7.

In consideration of being granted the licence hereunder the Licensor shall on or before the Commencement Date pay the Licensor the sum of ONE POUND (£1). The Licensor hereby acknowledges the sufficiency of this consideration.

The Licensee shall at its own cost and expense:

Provided that the Licensee shall keep the Licensor regularly informed by means of quarterly written updates of all its activities in this regard and their consequences. Furthermore, if the Licensee wishes to abandon any such application or not to maintain any such Patent (or to cease funding such application or Patent) it shall give 3 months’ prior written notice to the Licensor and on the expiry of such notice period the Licensee shall cease to be licensed under the patent application or patent identified in the notice. If, within 30 days of any renewal date, the Licensee has not renewed the Patent in question and the Licensor has not received documentary evidence of such renewal by that deadline, the Licensor shall provide with a written notice for such failure to renew the Patents. If such written notice is not answered within 7 business days, Licensor may terminate this Agreement on immediate written notice.

The Licensee shall indemnify the Licensor against any loss, damages, costs or expenses which are awarded against or incurred by the Licensor as a result of any claim or threatened claim concerning the use by the Licensee or any of its sub-licensees of the Patents or otherwise in connection with the manufacture, use or sale of or any other dealing in any of the Licensed Products by the Licensee or its Affiliates or any of its sub-licensees.

Notwithstanding any other provision of this Agreement, neither Party shall be liable to the other Party to this Agreement in contract, tort, negligence, breach of statutory duty or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by that other Party or its Affiliates of an indirect or consequential nature including without limitation any economic loss or other loss of turnover, profits, business or goodwill including without limitation loss of business, loss under current or future contracts, disaster recovery costs or administrative costs, even if that Party has been advised of the likelihood of any of the aforesaid occurring.

This Agreement, and the licenses granted hereunder, shall come into effect on the Commencement Date and, unless terminated earlier in accordance with this clause 6, shall continue in force on a country by country basis until the date on which all the Patents have expired or been revoked without a right of further appeal and on such date this Agreement and the licenses granted hereunder shall terminate automatically by expiry.

Neither Party shall have any liability or be deemed to be in breach of this Agreement for any delays or failures in performance of this Agreement which result from circumstances beyond the reasonable control of that Party. The Party affected by such circumstances shall promptly notify the other Party in writing when such circumstances cause a delay or failure in performance and when they cease to do so.

This Agreement may only be amended in writing signed by duly authorised representatives of the Licensor and Licensee.

No failure or delay on the part of either Party to exercise any right or remedy under this Agreement shall be construed or operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy.

If any provision or part of this Agreement is held to be invalid, amendments to this Agreement may be made by the addition or deletion of wording as appropriate to remove the invalid part or provision but otherwise retain the provision and the other provisions of this Agreement to the maximum extent permissible under applicable law.

Neither Party shall act or describe itself as the agent of the other, nor shall it make or represent that it has authority to make any commitments on the other’s behalf.

In this Agreement:

The validity, construction and performance of this Agreement shall be governed by English law and shall be subject to the exclusive jurisdiction of the English courts to which the parties hereby submit, except that a Party may seek an interim injunction and enforce a judgment awarded it by the English courts in any court of competent jurisdiction.

Each Party agrees to execute, acknowledge and deliver such further instruments, and do all further similar acts, as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

Neither Party shall make any press or other public announcement concerning any aspect of this Agreement, or make any use of the name of the other Party in connection with or in consequence of this Agreement, without the prior written consent of the other Party.

This Agreement, including its Schedules, sets out the entire agreement between the Parties relating to its subject matter and supersedes all prior oral or written agreements, arrangements or understandings between them relating to such subject matter. The Parties acknowledge that they are not relying on any representation, agreement, term or condition which is not set out in this Agreement.

This Agreement does not create any right enforceable by any person who is not a party to it (‘Third Party’) under the Contracts (Rights of Third Parties) Act 1999, but this clause does not affect any right or remedy of a Third Party which exists or is available apart from that Act.

Schedule 1

The Patents

GB patent application GB1200157.4, titled “Oral apparatus for optimising user performance”, filing date 6 January 2012.

PCT application number WO2013045892, titled “Oral apparatus for optimising user performance”, filing date 17 September 2012.

AGREED by the Parties through their authorised signatories.