0001193125-14-457127.txt : 20150309 0001193125-14-457127.hdr.sgml : 20150309 20141230162422 ACCESSION NUMBER: 0001193125-14-457127 CONFORMED SUBMISSION TYPE: S-1 PUBLIC DOCUMENT COUNT: 54 FILED AS OF DATE: 20141230 DATE AS OF CHANGE: 20150204 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Nexvet Biopharma plc CENTRAL INDEX KEY: 0001618561 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L2 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: S-1 SEC ACT: 1933 Act SEC FILE NUMBER: 333-201309 FILM NUMBER: 141316285 BUSINESS ADDRESS: STREET 1: NATL INST FOR BIOPROCESSING RESEARCH STREET 2: FOSTERS AVENUE, MOUNT MERRION CITY: BLACKROCK CO. DUBLIN STATE: L2 ZIP: 00000 BUSINESS PHONE: 353 1 215 8100 MAIL ADDRESS: STREET 1: NATL INST FOR BIOPROCESSING RESEARCH STREET 2: FOSTERS AVENUE, MOUNT MERRION CITY: BLACKROCK CO. DUBLIN STATE: L2 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: NEXVET BIOPHARMA Ltd DATE OF NAME CHANGE: 20140903 S-1 1 d775834ds1.htm FORM S-1 Form S-1
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As filed with the Securities and Exchange Commission on December 30, 2014

Registration No. 333-                

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Nexvet Biopharma public limited company

(Exact name of registrant as specified in its charter)

 

 

 

Ireland   2834   98-1205017

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

National Institute for Bioprocessing

Research and Training

Fosters Avenue, Mount Merrion

Blackrock, Co. Dublin, Ireland

+353 1 215 8100

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

 

Marjorie Sybul Adams

DLA Piper LLP (US)

1251 Avenue of the Americas

New York, NY 10020

Tel: (212) 335-4500

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

Marjorie Sybul Adams

Bruce Jenett

Andrew Ledbetter

DLA Piper LLP (US)

1251 Avenue of the Americas

New York, NY 10020

Tel: (212) 335-4500

 

Mark B. Weeks

John T. McKenna

Andrew S. Williamson

Cooley LLP

3175 Hanover Street

Palo Alto, CA 94304

Tel: (650) 843-5000

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   x  (Do not check if a smaller reporting company)    Smaller reporting company   ¨

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of Each Class of

Securities to be Registered

 

Proposed

Maximum

Aggregate

Offering Price (1)

 

Amount of

Registration Fee (2)

Ordinary Shares, $0.125 nominal value per share

  $60,000,000   $6,972

 

 

 

(1) Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. Includes the aggregate offering price of any additional ordinary shares the underwriters have the option to purchase to cover over-allotments, if any.
(2) Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

 

 

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


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The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS

Subject to Completion. Dated December 30, 2014

             Shares

 

LOGO

Ordinary Shares

 

 

Nexvet Biopharma public limited company is offering             ordinary shares. This is our initial public offering and no public market currently exists for our ordinary shares. We anticipate that the initial public offering price of our ordinary shares will be between $             and $             per share.

We have applied to list our ordinary shares on the Nasdaq Global Market under the symbol “NVET.”

We are an emerging growth company as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

Investing in our ordinary shares involves a high degree of risk. Before buying any ordinary shares, you should read carefully the discussion of material risks of investing in our ordinary shares under the heading “Risk Factors” beginning on page 11 of this prospectus.

 

 

 

    

Per Share

      

Total

 

Public offering price

   $           $     

Underwriting discount(1)

   $           $     

Proceeds, before expenses, to us

   $           $     

 

  (1) See the section of this prospectus titled “Underwriting” for a description of the compensation payable to the underwriters.

We have granted the underwriters an option to purchase up to an additional                 ordinary shares to cover over-allotments. The underwriters can exercise this option at any time within 30 days after the date of this prospectus.

Entities affiliated with Farallon Capital Management, L.L.C., which hold more than 5% of our ordinary shares and are affiliates of a director nominee, have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price. However, because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the ordinary shares on or about                    , 2015.

 

BofA Merrill Lynch   Cowen and Company

 

 

 

Piper Jaffray   JMP Securities

 

 

The date of this prospectus is                     , 2015.


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LOGO


Table of Contents

TABLE OF CONTENTS

Prospectus

 

Prospectus Summary

     1   

Risk Factors

     11   

Special Note Regarding Forward-Looking Statements

     43   

Industry and Market Data

     45   

Use of Proceeds

     46   

Dividend Policy

     47   

Capitalization

     48   

Dilution

     50   

Selected Consolidated Financial Data

     53   

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     55   

Business

     70   

Management

     98   

Executive Compensation

     107   

Principal Shareholders

     116   

Certain Relationships and Related Party Transactions

     119   

Description of Share Capital

     122   

Shares Eligible for Future Sale

     154   

Taxation

     157   

Underwriting

     169   

Legal Matters

     176   

Experts

     176   

Where You Can Find More Information About Us

     176   

Index to Consolidated Financial Statements

     F-1   

 

 

Neither we nor the underwriters have authorized anyone to provide you with information that is different from that contained in this prospectus or in any free writing prospectus we may authorize to be delivered or made available to you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters are offering to sell ordinary shares and seeking offers to buy ordinary shares only in jurisdictions where such offers and sales are permitted. The information contained in this prospectus is accurate only as of the date on the front of this prospectus, regardless of the time of delivery of this prospectus or any sale of ordinary shares. Our business, financial condition, results of operations and prospects may have changed since that date.

Through and including                 , 2015 (the 25th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the ordinary shares and the distribution of this prospectus outside the United States.


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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our ordinary shares. You should read this entire prospectus carefully, especially the section of this prospectus titled “Risk Factors” and our consolidated financial statements and the related notes included elsewhere in this prospectus, before making an investment decision. In this prospectus, unless the context otherwise requires, references to “we,” “us,” “our,” “Nexvet,” “Nexvet Biopharma plc” or the “Company” refer to Nexvet Biopharma public limited company and its consolidated subsidiaries.

Overview

We are a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals by developing and commercializing novel, species-specific biologics based on human biologics. Biologics are therapeutic proteins derived from biological sources. As a class, biologics have transformed human medicine in recent decades and represent some of the top-selling therapies on the market today. Our proprietary platform, which we refer to as “PETization,” is an algorithmic approach that enables us to rapidly create monoclonal antibodies that are designed to be recognized as “self” or “native” by an animal’s immune system, a property we refer to as “100% species-specificity.” PETization is also designed to build upon the safety and efficacy data from clinically tested human therapies to create new therapies for companion animals, thereby reducing clinical risk and development cost.

Biologics generally include monoclonal antibodies, or mAbs, which are targeted antibodies derived from identical, or clonal, cells, and fusion proteins, which are proteins created by joining two or more genes coded for separate proteins. Our first product candidate, NV-01, is a mAb that is a nerve growth factor, or NGF, inhibitor for the control of pain associated with osteoarthritis in dogs. NGF is a protein involved in growing and maintaining neural pathways and in neural signaling, including pain signals. NGF inhibitors seek to interrupt those signals to reduce pain. Our second product candidate, NV-02, is a mAb that is an NGF inhibitor for the control of pain associated with degenerative joint disease in cats. We expect data from our pivotal safety and efficacy studies for NV-01 by the end of 2015 and for NV-02 in 2016. Our third product candidate, NV-08, is a fusion protein that is a tumor necrosis factor, or TNF, inhibitor for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs. TNF is a protein that causes inflammation, and TNF inhibitors suppress this inflammation. If our proof-of-concept safety and efficacy studies for NV-08 are successful, we will progress this product into formal development. In addition, using PETization, we are seeking to advance one new product candidate into development per year, commencing in the second half of 2015.

Veterinary care is one of the fastest growing industries in the overall U.S. companion animal market and is estimated to reach $15.3 billion in 2014. We are targeting the companion animal therapeutics segment of the veterinary care industry. We estimate that in 2013 consumers spent $2.3 billion on companion animal therapeutics. This segment is currently dominated by synthetic chemical drugs commonly referred to as “small molecule” drugs. The size and growth of the veterinary care industry reflects many factors, including higher rates of companion animal ownership, improved quality of veterinary care, and the increasingly important role of companion animals in our lives, who are often considered members of our families. We believe these factors, together with the introduction of our product candidates with their favorable safety and compliance profiles, will increase overall demand for companion animal therapeutics.

 

 

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Product Pipeline

We have identified three lead product candidates, NV-01, NV-02 and NV-08. We submitted an investigational new animal drug application, or INAD, with the U.S. Food and Drug Administration, or the FDA, for NV-01 in 2012, for NV-02 in 2013 and for NV-08 in 2014.

 

LOGO

 

(1) Our proof-of-concept studies include four sequential studies: pharmacokinetics (P), preliminary safety (PS), immunogenicity (I) and safety and efficacy (SE).
(2) We have completed clonal cell manufacturing for NV-01, and we have accelerated and completed clonal cell manufacturing for NV-02 in order to rapidly advance its development. Material from manufactured clonal cells, from which biologics are created, is used in pivotal studies and is intended to be used later for commercial supply. The production of a high-yielding clonal cell line facilitates budgeting for commercial production.
(3) FDA protocol concurrence means the Center for Veterinary Medicine within the FDA fundamentally agrees with the design, execution and analyses proposed in the protocol and there is a commitment that it will not later alter its perspective on these issues unless public or animal health concerns appear that were not recognized at the time of the protocol assessment. We have obtained protocol concurrences to commence our pivotal safety and efficacy studies for NV-01.

Development of companion animal therapeutics is typically faster and less expensive than human drug development. It requires fewer clinical trials, requires fewer subjects and pre-clinical work and can be conducted directly in the target species. According to Pharmaceutical Commerce, companion animal therapeutics can obtain U.S. regulatory approval in under six years. We expect the costs to complete the development and manufacturing scale-up of each of our three lead product candidates to be approximately $13.0 to $15.0 million per candidate. In contrast, receipt of regulatory approval for human therapeutics may take 12 to 13 years and development can cost hundreds of millions of dollars per drug.

Our PETization Platform

Our PETization platform is a proprietary algorithmic approach that has demonstrated a reduction in the time and cost typically associated with the development of mAbs using conventional interspecies conversion methods. By applying our algorithms to analyze large data sets from our proprietary complementary deoxyribonucleic acid, or cDNA, library, PETization is designed to determine the minimal number of changes required in the mAb framework region to generate a 100% species-specific mAb that preserves the attraction between a biologic and its target, a property known as affinity. We have used PETization to successfully convert human and rodent mAbs into 100% species-specific canine, feline and equine mAbs, thereby leveraging their safety and efficacy profile for our companion animal therapies in development.

Using PETization, we are seeking to advance one new product candidate into development per year commencing in the second half of 2015. Our internal research team is studying mAbs that bind to canine, feline and equine targets relevant to pain, inflammation, cancer and other chronic conditions. We have also recently completed a survey of specialist veterinarians in the United States and the European Union, or the EU, to identify

 

 

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key areas of unmet medical need where mAbs could have a significant impact. The results of this survey are guiding our product development priorities.

We believe our PETization platform offers the following important advantages over other approaches to the design, discovery and development of mAbs in the veterinary care industry:

 

    Rapid creation of new products. PETization is designed to substantially reduce the time involved in the discovery process for new mAbs with high affinity, when compared to conventional discovery techniques.

 

    Cost efficiencies in production. mAbs with higher affinity require less active pharmaceutical ingredient to achieve a therapeutic dose, leading to lower cost of goods.

 

    Efficient development pathway. Harnessing existing donor mAb manufacturing, safety and clinical efficacy data can significantly reduce costs, time-to-market and regulatory and clinical risk.

 

    Scalability across species. PETization enables us to rapidly identify new product candidates for many indications across multiple species.

 

    Proprietary cDNA approach to mAb identification. Our proprietary cDNA library of mAb sequences allows us to use the natural variations found in mAbs to generate novel, species-specific mAbs.

We believe that our PETization platform will create differentiated, high-value companion animal therapies with better health outcomes through the following characteristics:

 

    Efficacy. PETized mAbs are designed to retain the efficacy of the donor mAbs.

 

    Safety. PETized mAbs match the structure of the target species more successfully than conventional approaches, thereby reducing the risk of immunogenicity.

 

    Ease of compliance. PETized mAbs are designed to be injected every four to six weeks, as compared to small molecule treatments, which can require daily or more frequent injections or oral dosing.

We believe that these product characteristics align favorably with veterinarian preferences and will contribute to the widespread market adoption of PETized mAbs.

We may also develop biologics outside of our PETization platform, such as NV-08. NV-08 is a proprietary fusion protein we have identified using internal research that has shown NV-08 to be a potent inhibitor of the inflammatory response.

Companion Animal Therapeutic Market Overview

The U.S. companion animal market, which includes veterinary care, food, supplies and over-the-counter medications, live animal purchases and services such as grooming and boarding, is estimated to exceed $58.5 billion in sales in 2014. Veterinary care, which includes sales of companion animal therapeutics, parasiticides and vaccines and other medical expenses for veterinarian visits, is one of the fastest growing industries in the overall U.S. companion animal market. We are targeting the companion animal therapeutics segment of the veterinary care industry. We estimate that in 2013 consumers spent $2.3 billion on companion animal therapeutics. This segment is currently dominated by small molecule drugs. Although a few mAbs have received conditional licensure in the United States, there are currently no mAbs for companion animals approved for marketing in the United States or the EU. Biologics, including mAbs, have grown to be the largest class of therapeutics within the top ten best-selling drugs for humans. We believe that mAbs will drive a similar trend in the companion animal therapeutics market.

 

 

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Historically, most companion animal therapeutics have been in areas overlapping with livestock health, notably vaccines, parasiticides and anti-infectives. Similar to human therapeutics, and given the safety and efficacy profile of biologics, we see opportunities for biologic therapies for companion animals in the areas of pain, inflammation, oncology, dermatology, allergy and gastrointestinal disease. We expect the market for companion animal biologic therapies to increase primarily due to:

 

    Higher standards and better care. Because owners are increasingly regarding their companion animals as important members of their families, owners are demanding better care and treatment options for their companion animals. In a 2011 survey by Kelton Research, 81% of respondents considered their dogs to be true family members. According to the American Pet Products Association, approximately 78% of U.S. dog owners treated their dogs with medications in 2010, as compared to 50% in 1998. In a 2010 poll by Associated Press, 35% of companion animal owners indicated they were willing to spend $2,000 to treat their companion animal for a serious medical condition.

 

    Aging companion animal population. Companion animals are living longer, leading to increased incidence of diseases commonly associated with aging, such as arthritis, diabetes, tumors and kidney disease. According to a 2013 report by Banfield Pet Hospital, the average lifespan of dogs increased from 10.5 years in 2002 to 11 years in 2012, and the average lifespan of cats increased from 11 years in 2002 to 12 years in 2012.

We believe these favorable demographics create a significant opportunity for companion animal biologic therapies.

Limitations of Current Standard of Care and the Promise of Biologics

Despite the growing market for veterinary care and favorable market dynamics, there are few treatment options approved for use in companion animals relative to the diversity of available human therapeutics. Current approved therapeutics for the management of many conditions, including pain, inflammation and cancer, are predominantly small molecule drugs. In recent years, particularly in inflammation and cancer, human drug development has increasingly focused on biologics, such as mAbs, which generally offer safety and efficacy profiles that make them attractive alternatives to small molecule drugs for many indications. We believe this creates a significant opportunity for us to develop first-in-class therapeutics for the unmet medical needs of companion animals utilizing our proprietary PETization platform.

Our Strategy

We strive to be at the forefront of companion animal therapeutic innovation by developing and commercializing a portfolio of biologics for companion animals. To achieve this goal, we intend to:

 

    leverage our proprietary PETization platform and experience to develop multiple companion animal therapeutics;

 

    focus on common conditions impacting the quality of life of companion animals to make a positive impact on their health;

 

    commercialize our lead product candidates with a direct sales force and distributors in the United States and through strategic alliances in international markets;

 

    educate veterinarians about the benefits of biologics compared to conventional treatments; and

 

    collaborate with leaders in human and veterinary biologics to bring to market the next generation of companion animal therapeutics.

 

 

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Risks Associated with Our Business

Our business is subject to the risks and uncertainties discussed more fully in the section of this prospectus titled “Risk Factors” immediately following this summary. In particular:

 

    We have a limited operating history, are not profitable and may never become profitable.

 

    We will require substantial additional financing to achieve our goals, and if we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce or terminate our product development, product portfolio expansion, other operations or commercialization efforts.

 

    Our success depends largely upon our ability to advance our product candidates through the various stages of development, especially through pivotal safety and efficacy studies. If we are unable to successfully advance or develop our product candidates, our business will be harmed.

 

    The discovery, development and manufacturing of biologics involves relatively novel technologies and an expensive and lengthy process with uncertain outcomes.

 

    The results of our proof-of-concept studies for our product candidates may not be predictive of the results in any future pivotal safety and efficacy studies, and we may not be able to obtain any regulatory approvals.

 

    We may be unable to obtain regulatory approval for our existing or future product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization efforts and adversely impact our potential to generate revenue, our business and our results of operations.

 

    If any of our product candidates are approved but do not gain meaningful market acceptance, we are not likely to generate significant revenue.

 

    Our product candidates, if approved, will face competition, and our failure to effectively compete may prevent us from achieving significant market penetration.

 

    Our commercial success will depend, in part, on obtaining and maintaining intellectual property protection for our product candidates.

Implications of Being an Emerging Growth Company

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and therefore we intend to take advantage of reduced disclosure and regulatory requirements in contrast to those otherwise generally applicable to public companies, including presenting only two years of audited financial statements and related financial disclosure, not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments. We may take advantage of these reduced disclosure and regulatory requirements until we are no longer an “emerging growth company.” In addition, the JOBS Act provides that an emerging growth company can delay adopting new or revised accounting standards until those standards apply to private companies. We have irrevocably elected not to avail ourselves of this delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.

 

 

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Corporate Information

Nexvet Australia Pty Ltd, formerly known as Nexvet Biopharma Pty Ltd, or Nexvet Australia, was incorporated in Australia in February 2010. In September 2014, Nexvet Biopharma Limited, a newly-formed Irish private company, became the parent company of Nexvet Australia and its subsidiaries pursuant to a transaction in which all of the holders of ordinary shares, preference shares, restricted share units and options and warrants to purchase ordinary shares of Nexvet Australia exchanged their holdings for equivalent ordinary shares, preference shares, restricted share units or options or warrants to purchase ordinary shares, as applicable, of Nexvet Biopharma Limited. We refer to this transaction as the “Irish Exchange.” Nexvet Biopharma Limited then re-registered as an Irish public limited company in September 2014. We refer to this re-registration as the “Re-registration” and we refer to the Irish Exchange and the Re-registration collectively as the “Irish Reorganization.” Nexvet Biopharma plc became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma plc and its subsidiaries as a continuation of the predecessor.

Unless otherwise indicated or the context otherwise requires, all dollar amounts presented in this prospectus are in U.S. dollars ($). This prospectus translates certain Australian dollar amounts into U.S. dollars at the exchange rates for A$ into US$. For assets and liabilities, the exchange rate at the balance sheet date is used. For revenue and expenses and gains and losses, a weighted-average exchange rate for the period is used to translate those elements. For transactions effected in Australian dollars, the exchange rate on the date of the transaction is used. Information not in U.S. dollars is identified by “€” for Euro-denominated amounts and “A$” for Australian dollar-denominated amounts.

Our principal executive offices are located at National Institute for Bioprocessing Research and Training, or NIBRT, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland, and our telephone number is +353 1 215 8100. Our internet address is www.nexvet.com. Information contained on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus and references to our website in this prospectus are inactive textual references only.

PETization, PETisation, Nexplora, Nexvet, our logo and our other registered or common law trademarks, trade names or service marks appearing in this prospectus are owned by us. Other trademarks, trade names or service marks appearing in this prospectus are the property of their respective owners. Solely for convenience, our trademarks and tradenames referred to in this prospectus appear without the ® or ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks and tradenames.

 

 

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The Offering

 

Ordinary shares we are offering

                 ordinary shares

 

Ordinary shares to be outstanding immediately after this offering

                 ordinary shares

 

Option to purchase additional ordinary shares

                 ordinary shares

 

Use of proceeds

We intend to use the net proceeds from this offering to complete the development and manufacturing scale-up of each of our three lead product candidates, to establish our sales force infrastructure in the United States for any approved products and for anticipated promotional and launch costs. We also intend to fund research to develop our pipeline of product candidates. We intend to use the remainder of the net proceeds from this offering for working capital and other general corporate purposes. See the section of this prospectus titled “Use of Proceeds.”

 

Proposed Nasdaq Global Market symbol

“NVET”

Entities affiliated with Farallon Capital Management, L.L.C., or Farallon, which hold more than 5% of our ordinary shares and are affiliates of a director nominee, have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price. However, because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering.

The number of ordinary shares to be outstanding immediately after the completion of this offering is based on 7,079,996 ordinary shares outstanding as of September 30, 2014 and excludes:

 

    1,766,998 ordinary shares issuable upon the exercise of warrants to purchase ordinary shares outstanding as of September 30, 2014, with a weighted-average exercise price of $8.50 per ordinary share;

 

    358,553 ordinary shares issuable upon the exercise of options outstanding as of September 30, 2014, with a weighted-average exercise price of $2.64 per ordinary share, and 141,792 ordinary shares issuable upon the exercise of options issued after September 30, 2014, with an exercise price of the nominal value of $0.125 per ordinary share;

 

    50,454 ordinary shares issuable upon the conversion of restricted share units outstanding as of September 30, 2014 and 16,427 ordinary shares issuable upon the conversion of restricted share units issued after September 30, 2014, with a conversion price of the nominal value of $0.125 per ordinary share;

 

    32 ordinary shares, including 12 ordinary shares issuable upon the conversion of Series A investment preference shares and 10 ordinary shares issuable upon the conversion of Series B preference shares, outstanding following the November 2014 four-for-five share consolidation, which represent certain shares that would have become fractional shares in the consolidation and new issuances to prevent any fractional shares as a result of the consolidation, all of which shares are being held in trust pending their redemption or sale;

 

 

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    201,960 ordinary shares reserved for future issuance under our 2013 Long Term Incentive Plan as of September 30, 2014; and

 

    1,280,000 ordinary shares reserved for future issuance under our 2014 Equity Incentive Plan, to be effective upon the completion of this offering.

Unless otherwise indicated or the context otherwise requires, all information in this prospectus reflects and assumes:

 

    the one-for-four share consolidation that occurred in August 2014 prior to the Irish Exchange, the completion of the Irish Reorganization in September 2014 and the four-for-five share consolidation that occurred in November 2014 following the completion of the Irish Reorganization;

 

    the automatic conversion of all of our outstanding preference shares as of September 30, 2014 into 5,937,138 ordinary shares upon the completion of this offering; and

 

    no exercise by the underwriters of their option to purchase up to an additional                 ordinary shares.

 

 

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Summary Consolidated Financial Data

The following tables summarize our consolidated financial data. We derived the summary consolidated statements of operations data for the years ended June 30, 2013 and 2014 from our audited consolidated financial statements included elsewhere in this prospectus. We derived the summary consolidated statements of operations data for the three months ended September 30, 2013 and 2014 and the balance sheet data as of September 30, 2014 from our unaudited consolidated financial statements included elsewhere in this prospectus. We have prepared the unaudited consolidated financial statements on the same basis as the audited consolidated financial statements, and, in the opinion of management, the unaudited consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for the fair statement of those financial statements. Our fiscal year ends on June 30, and references to any fiscal year are to our year ended June 30 in that year. You should read the following summary consolidated financial data in conjunction with the sections of this prospectus titled “Selected Consolidated Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results to be expected in the future, and our interim results are not necessarily indicative of the results that should be expected for the full year or any other period.

Nexvet Biopharma plc became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma plc and its subsidiaries as a continuation of the predecessor.

 

    Year Ended
June 30,
    Three Months Ended
September 30,
 
    2013     2014     2013     2014  
                (unaudited)  
    (in thousands, except share and per share
amounts)
 

Consolidated Statements of Operations Data:

       

Revenue

       

License and collaboration

  $ 244      $ —        $ —        $ —     

Other

    85        13        —          25   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

    329        13        —          25   

Operating expenses

       

Research and development

    2,722        5,617        1,240        2,539   

General and administrative

    2,103        4,426        568        2,818   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

    4,825        10,043        1,808        5,357   
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

    (4,496     (10,030     (1,808     (5,332

Other income (expense)

       

Research and development incentive income

    1,135        2,337        503        741   

Government grant income

    108        1,317        318        297   

Exchange (loss) gain

    —          (375     (30     1,984   

Interest income

    12        41        1        13   
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $ (3,241   $ (6,710   $ (1,016   $ (2,297
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to ordinary shareholders, basic and diluted(1)

  $ (3.62   $ (6.70   $ (1.02   $ (2.13
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average ordinary shares outstanding, basic and diluted(1)

    894,794        1,000,872        1,000,000        1,078,166   
 

 

 

   

 

 

   

 

 

   

 

 

 

Pro forma net loss attributable to ordinary shareholders, basic and diluted(1)

    $ (6,710     $ (2,297
   

 

 

     

 

 

 

Pro forma net loss per share attributable to ordinary shareholders, basic and diluted(1)

    $ (2.07     $ (0.33
   

 

 

     

 

 

 

Pro forma weighted-average ordinary shares outstanding, basic and diluted(1)

      3,242,004          7,015,321   
   

 

 

     

 

 

 

 

(1) See Notes 2 and 11 to our consolidated financial statements included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share attributable to ordinary shareholders and pro forma net loss per share attributable to ordinary shareholders.

 

 

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     September 30, 2014  
     Actual      Pro
Forma(1)
     Pro Forma
As
Adjusted(2)(3)
 
            (unaudited)         
            (in thousands)         

Consolidated Balance Sheet Data:

        

Cash

   $ 26,388       $ 26,388       $                

Total assets

     28,740         28,740      

Total liabilities

     2,693         2,693      

Convertible preference shares

     33,826         —        

Total shareholders’ (deficit) equity

     26,047         26,047      

 

(1) The pro forma column reflects the conversion of all outstanding preference shares into 5,937,138 ordinary shares upon the completion of this offering.
(2) The pro forma as adjusted column further reflects the sale of                 ordinary shares in this offering at an assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discount and estimated offering expenses payable by us.
(3) Each $1.00 increase (decrease) in the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) each of cash, total assets and total shareholders’ (deficit) equity on a pro forma as adjusted basis by approximately $         million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the underwriting discount. Similarly, each increase (decrease) of 1,000,000 in the number of ordinary shares we are offering would increase (decrease) each of cash, total assets and total shareholders’ (deficit) equity on a pro forma as adjusted basis by approximately $         million, assuming that the assumed initial public offering price remains the same, and after deducting the underwriting discount. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

 

 

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RISK FACTORS

Investing in our ordinary shares involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our ordinary shares. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our ordinary shares could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may have similar adverse effects on us.

Risks Related To Our Business

We have a limited operating history, are not profitable and may never become profitable.

We are a clinical-stage biopharmaceutical company focused on the therapeutics segment of the companion animal market, with a limited operating history. Since our formation in February 2010, our operations have been limited to the identification of product candidates and to the research and development of our lead product candidates, which primarily target pain associated with osteoarthritis in dogs (NV-01), pain associated with degenerative joint disease in cats (NV-02) and chronic inflammatory diseases, including atopic dermatitis, in dogs (NV-08). As a result, we have limited historical operations upon which you can evaluate our business and prospects, and we have not yet demonstrated an ability to successfully overcome the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in companion animal therapeutics. We do not have any products approved for sale, have not generated any revenue from product sales since our inception and do not expect to generate any revenue from product sales in the near future. We have incurred significant net losses since our inception. We incurred net losses of $3.2 million, $6.7 million, $1.0 million and $2.3 million for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, and as of September 30, 2014 we had an accumulated deficit of $14.1 million. This accumulated deficit has resulted principally from costs incurred in connection with research and development of our product candidates and general and administrative costs associated with our operations.

We expect to continue to incur net losses for the foreseeable future, and we expect these losses to increase as we continue our development of, and seek regulatory approvals for, our product candidates and begin commercialization activities in anticipation of regulatory approval. We will not be able to commercialize any product candidates until we successfully complete the required studies and they are approved by applicable regulatory authorities. In the United States, these authorities include the Center for Veterinary Medicine within the FDA and the Center for Veterinary Biologics within the Animal and Plant Health Inspection Service within the USDA. In Europe, these authorities include the European Medicines Agency, or the EMA. We refer to the FDA, the USDA and the EMA collectively as the “Regulatory Authorities.” Even if we succeed in developing and commercializing one or more product candidates, we expect to continue to incur net losses for the foreseeable future, and we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. If we fail to achieve or maintain profitability, it would adversely affect the value of our ordinary shares.

We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, product portfolio expansion, other operations or commercialization efforts.

Completing the development and obtaining regulatory approval of our product candidates will require substantial funds. We believe our cash balance of $26.4 million as of September 30, 2014, together with the net proceeds from this offering, will be sufficient to fund our anticipated level of operations for at least the next 24 months. Our operating plan may change as a result of many factors currently unknown to us, and we may seek additional funds sooner than planned through public or private equity or debt financings or other sources such as

 

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strategic collaborations. We have no current agreements or arrangements with respect to any such financings or collaborations, and any such financings or collaborations may result in dilution to our shareholders, the imposition of debt covenants and repayment obligations or other restrictions that may adversely affect our business or the value of our ordinary shares. Even if we believe we have sufficient funds on hand for our current or planned future business and operations, we may seek from time to time to raise additional capital based upon favorable market conditions or strategic considerations such as potential acquisitions.

Since our inception, nearly all of our resources have been dedicated to the research and development of our lead product candidates. We believe that we will continue to expend substantial resources for the foreseeable future for the development of our lead product candidates and any future product candidates we may choose to pursue. Because the outcome of our development activities is uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of any of our current or future product candidates and, if approved, successfully commercialize them.

Our future capital requirements will depend on many factors, including:

 

    the scope, progress, results and costs of researching and developing our current or future product candidates, including conducting proof-of-concept and pivotal safety and efficacy studies;

 

    the timing of, and the costs involved in, obtaining regulatory approvals for any of our current or future product candidates;

 

    the number and characteristics of the product candidates we pursue;

 

    whether we acquire or license any other companies, assets, intellectual property or technologies in the future;

 

    the cost of commercialization activities, if any of our current or future product candidates are approved for sale, including marketing, sales and distribution costs;

 

    the cost of manufacturing our current and future product candidates and any approved products we successfully commercialize;

 

    our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;

 

    the expenses needed to attract and retain skilled personnel;

 

    the costs associated with being a public company; and

 

    the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, if any arise, including litigation costs and the outcome of such litigation.

In addition, we may also have unanticipated costs. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate one or more of our product development, product portfolio expansion, other operations or commercialization efforts.

Our success depends largely upon our ability to advance our product candidates through the various stages of development, especially through pivotal safety and efficacy studies. If we are unable to successfully advance or develop our product candidates, our business will be harmed.

We currently have no products approved for commercial distribution and are focused primarily on the development of our lead product candidates, NV-01, NV-02 and NV-08. None of our product candidates have completed pivotal safety and efficacy studies and their commercial viability will depend on the success of these

 

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studies, receipt of regulatory approvals and the viability of manufacturing processes. For our first lead product candidate, NV-01, we have completed proof-of-concept studies, and we have commenced our pivotal efficacy study and expect to commence our pivotal safety study in the first quarter of 2015, both of which we expect to be complete by December 2015. For our second and third lead product candidates, NV-02 and NV-08, we have completed proof-of-concept studies for pharmacokinetics, preliminary safety and immunogenicity, and we expect our final proof-of-concept study, for efficacy, to be completed by mid-2015 for NV-02 and our preliminary proof-of-concept studies for safety and efficacy to be completed by the end of 2015 for NV-08.

The success of our business ultimately depends upon our ability to advance the development of our product candidates from proof-of-concept studies through pivotal safety and efficacy studies in a manner that meets extensive regulatory requirements, establish facilities capable of consistently manufacturing them in accordance with strict specifications and regulations, obtain approval for their sale by the Regulatory Authorities, and ultimately have our product candidates successfully commercialized by us or a strategic partner or licensee. The results of our ongoing research and development activities, including pivotal safety and efficacy studies, may not support or justify the continued development of our product candidates, and we may not receive approval from the Regulatory Authorities to advance the development of our product candidates. Failure to advance the development of one or more of our product candidates may have an adverse effect on our business.

Our product candidates must satisfy regulatory standards of purity, safety, potency and efficacy, and standards related to manufacturing, before we can advance or complete their development or they can be approved for sale. To satisfy these standards, we must engage in expensive and sometimes lengthy proof-of-concept and pivotal safety and efficacy studies and develop acceptable and cost effective manufacturing processes. Despite these efforts, our product candidates may not:

 

    offer therapeutic or other medical benefits over existing drugs or other product candidates in development to treat the same animal population;

 

    be proven to be safe and effective in pivotal safety and efficacy studies;

 

    have the desired effects;

 

    be free from undesirable or unexpected effects;

 

    meet applicable regulatory standards (for example, be shown to be pure, safe, potent and effective);

 

    be capable of being formulated and manufactured in commercially suitable quantities and at an acceptable cost; or

 

    be successfully commercialized by us or by our collaborators.

Even if we demonstrate favorable results in proof-of-concept studies for NV-01, NV-02 or NV-08, the results of pivotal safety and efficacy studies may not be sufficient to support the continued development of our product candidates. The development of companion animal therapeutics is subject to significant delays, setbacks and failures in all stages of development, including pivotal safety and efficacy studies, even after achieving promising results in proof-of-concept studies.

Accordingly, results from completed proof-of-concept studies of our product candidates may not be predictive of the results we may obtain in pivotal safety and efficacy studies. Furthermore, even if the data collected from proof-of-concept studies and pivotal safety and efficacy studies involving any of our product candidates demonstrate a satisfactory safety and efficacy profile, such results may not be sufficient to obtain regulatory approval from the Regulatory Authorities, which is required to market and sell a product.

 

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The discovery, development and manufacturing of biologics involves relatively novel technologies and an expensive and lengthy process with uncertain outcomes.

While many biologics have been approved for use in humans, apart from vaccines, relatively few recombinant proteins or antibodies have been approved for use in animals. There are unique risks and uncertainties associated with biologics, the discovery, development and manufacturing of which are subject to regulations that are complex and extensive. In addition, we develop biologics for companion animals using our proprietary PETization platform, which is a new platform that has not resulted in any commercialized products. Identification, optimization and manufacturing of biologics, including companion animal therapeutics, is a relatively new field in which unanticipated difficulties or challenges could arise. For example, there are no established practices or regulatory standards for pre-launch batch size manufacturing scale-up of a companion animal biological product candidate to commercial levels, which may cause our estimated manufacturing costs to materially increase due to unforeseen requirements from regulators or our third party manufacturer. Success in preliminary safety, proof-of-concept and prior target animal studies or pivotal studies, or success in studies of products similar to our product candidates but conducted in humans, does not ensure that our target animal studies or pivotal studies will be successful, and the results of development efforts by other parties may not be indicative of the results of our target animal studies, pivotal studies and other development efforts. We may be unable to identify biologics suitable for development or to achieve the potency and stability required for use in target animals. In particular, canine, feline and equine antibodies represent novel types of product candidates that may be difficult to identify through PETization or develop successfully.

Development of biologics, including companion animal therapeutics, is expensive and can take many years to complete, its outcome is inherently uncertain, and our development activities may not be successful. To gain approval to market an animal therapeutic for a particular species of animal, we must incur substantial expense for, and devote significant time to, pivotal safety and efficacy studies and provide the Regulatory Authorities with data that adequately demonstrate the safety and efficacy of that product in the target animal for the intended indication applied for in the new animal drug application, or NADA, product license or other regulatory filing. We rely on contract research organizations, or CROs, and other third parties to ensure the proper and timely conduct of our studies and development efforts, but we have limited influence over their actual performance. Pivotal safety and efficacy studies require adequate supplies of material and sufficient target animal enrollment. Delays in target animal enrollment can result in increased costs and longer development times that threaten the ability to complete the study. Pivotal safety and efficacy studies can be delayed or discontinued for a variety of reasons, including delays in or failure to:

 

    reach agreement on acceptable terms with study sites, which can be subject to extensive negotiation and may vary significantly among different sites;

 

    complete pivotal safety and efficacy studies due to deviations from study protocol or the occurrence of adverse events;

 

    address any safety concerns that arise during the course of testing;

 

    address any conflicts with new or existing laws or regulations;

 

    add new study sites; or

 

    manufacture sufficient quantities of formulated biologics of adequate quality for use in studies.

Even if we successfully complete pivotal safety and efficacy studies for our product candidates, we might not file the required regulatory submissions in a timely manner and may not receive regulatory approval for the product candidate. As a result, our product candidates may not successfully progress further through the drug development process or result in a commercially viable product.

 

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In addition, manufacturing biologics, especially in large quantities, is complex and may require the use of technologies that we may need to develop ourselves or in conjunction with third-party collaborators. Small changes in the manufacturing process can have a significant impact on product quality, consistency and yield. Such manufacturing requires facilities specifically designed and validated for this purpose and sophisticated quality assurance and quality control procedures. Biologics are also usually costly to manufacture. Manufacturing biologics may be more technically challenging, time-consuming and expensive than we anticipate or subject to other regulatory uncertainties. For example, human nerve growth factor inhibitor product candidates have been subject to classwide partial clinical holds imposed by the FDA in recent years due to the emergence of safety signals in humans, including rapidly progressive osteoarthritis, as a result of co-administration with non-steroidal, anti-inflammatory drugs. Classwide adverse effects may be seen in companion animals with the PETized product candidates we seek to manufacture and result in clinical holds or protocol revisions or otherwise cause delays or increased costs. We may be unable to manufacture biologics at full commercial scale and at an economical cost, if at all.

The results of our proof-of-concept studies for our product candidates may not be predictive of the results in any future pivotal safety and efficacy studies, and we may not be able to obtain any regulatory approvals.

Our product pipeline includes species-specific formulations of our lead product candidates. The results of our proof-of-concept studies, other initial development activities and any previous studies in animals conducted by us or conducted in humans by third parties may not be predictive of future results of our pivotal safety and efficacy studies. Proof-of-concept studies involve relatively small numbers of animals compared to pivotal studies. For example, our proof-of-concept study completed for the efficacy of NV-01 involved 26 dogs, while our pivotal efficacy study being conducted for NV-01 will involve approximately 200 dogs. Similarly, some of our proof-of-concept studies for NV-02 and NV-08 have involved as few as four animals. Failure can occur at any time during the conduct of these studies and other development activities. Even if our species-specific pivotal safety and efficacy studies and other development activities are completed as planned, the results may not be sufficient to pursue a particular line extension for any of our product candidates. Further, even if we obtain promising results from these studies, we may not successfully commercialize any particular product candidate. Because our product candidates are developed for a particular species, our ability to leverage our experience from the development of our lead product candidates into product candidates for other species will be limited.

We may be unable to obtain regulatory approval for our existing or future product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization efforts and adversely impact our potential to generate revenue, our business and our results of operations.

Our product candidates are in various stages of development, and our business currently depends entirely on their successful development, regulatory approval and commercialization. We currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our current or future product candidates. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of animal therapeutic products are subject to extensive regulation by the FDA (which regulates the manufacturing and distribution of animal drugs and pharmaceuticals), the USDA (which regulates the manufacturing and distribution of veterinary biological products to prevent, diagnose, and treat animal diseases), the EMA and other regulatory authorities, and regulations differ for each Regulatory Authority and from country to country.

Any delay or failure in obtaining applicable regulatory approval from any Regulatory Authority for the intended indications of our product candidates would delay or prevent commercialization of such product candidates and would adversely impact our business and prospects. Even if an approved product reaches market, circumstances could result in the need to withdraw a product from the market.

In order to market any product outside of the United States, including in the European Economic Area, or EEA (which is composed of 27 of the 28 member states of the EU, plus Norway, Iceland and Liechtenstein), and many other foreign jurisdictions, separate regulatory approvals are required. For example, in the EEA, companion

 

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animal therapeutics can only be commercialized after obtaining a marketing authorization. Before granting a marketing authorization, the EMA or the competent national authorities of the member states of the EEA assess the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

The approval procedures vary among countries and can involve additional studies and testing, and the time required to obtain approval may differ from that required to obtain approval from the Regulatory Authorities. Animal studies conducted in one country may not be accepted by regulatory authorities in other countries. Approval by the FDA or the USDA does not ensure approval by regulatory authorities in other countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or in the United States. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining approval in the United States. We may not be able to file for regulatory approvals or to do so on a timely basis and, even if we do file them, we may not receive necessary approvals to commercialize our lead product candidates in any market.

If any of our product candidates are approved but do not gain meaningful market acceptance, we are not likely to generate significant revenue.

Even if we obtain approvals from the Regulatory Authorities, our current or future product candidates may not achieve market acceptance among veterinarians and animal owners, and may not be commercially successful. Market acceptance of any of our current or future product candidates for which we receive approval depends on a number of factors, including:

 

    the safety of our lead product candidates and the prevalence and severity of adverse side effects as demonstrated in our pivotal safety and efficacy studies;

 

    the indications for which our lead product candidates are approved;

 

    the acceptance by veterinarians and animal owners of the product as a safe and effective treatment;

 

    the proper training regarding, and administration of, our lead product candidates by veterinarians;

 

    the relative convenience and ease of administration of our lead product candidates;

 

    the potential and perceived advantages of our product candidates over alternative treatments;

 

    the cost of treatment in relation to alternative treatments and willingness to pay for our lead product candidates, if approved, on the part of veterinarians and animal owners;

 

    the willingness of animal owners to pay for our lead product candidates, relative to other discretionary items, especially during economically challenging times;

 

    the effectiveness of our sales and marketing efforts and those of our collaborators and distributors; and

 

    the willingness of veterinarians to prescribe or administer our lead product candidates to the intended target animal population.

The market for therapeutic veterinary biologics such as our product candidates is very limited at present and will require education and outreach efforts to establish a therapeutic biologics market among veterinarian practices. If our lead product candidates do not achieve meaningful market acceptance, or if the market for our lead product candidates proves to be smaller than anticipated, we may never generate significant revenue.

 

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The commercial potential of a product candidate in development is difficult to predict. The market for our product candidates is uncertain and may be smaller than we anticipate, which could significantly and negatively impact our revenue, results of operations and financial condition.

It is difficult to estimate the commercial potential of any of our product candidates because of the emerging nature of the companion animal therapeutics segment of the veterinary care industry. This segment continues to evolve, and it is difficult to predict the market potential for what we believe to be the unmet medical needs of companion animals. This market potential will depend on important factors such as safety and efficacy compared to other available treatments, changing standards of care, preferences of veterinarians, the willingness of animal owners to pay for such products, and the availability of competitive alternatives that may emerge either during the product development process or after commercial introduction. In addition, our efforts to influence veterinarian preferences by educating them about the benefits of biologics compared to currently available treatments may not be successful. If the demand for our product candidates is less than we anticipate due to one or more of these or other factors, it could negatively impact our business, financial condition and results of operations. Further, the willingness of animal owners to pay for our product candidates, if approved, may be less than we anticipate and may be negatively affected by overall economic conditions.

Our product candidates, if approved, will face competition, and our failure to effectively compete may prevent us from achieving significant market penetration.

The companion animal therapeutics segment of the veterinary care industry is highly competitive and characterized by rapid technological change. Key competitive factors in our segment include, among others, the ability to successfully advance the development of a product candidate through pivotal safety and efficacy studies, the timing and scope of regulatory approvals, if ever achieved, average selling price of competing products and animal therapeutic products in general, the availability of raw materials, contract manufacturing and manufacturing capacity, manufacturing costs, establishing and maintaining intellectual property and patent rights and their protection, and sales and marketing capabilities.

We believe our main competitors are animal health companies that are developing products for use in companion animals, such as Aratana Therapeutics, Inc., Kindred Biosciences, Inc. and Zoetis, Inc. In addition, there are a number of large biopharmaceutical companies with animal health divisions, such as Bayer AG; Boehringer Ingelheim GmbH; Eli Lilly and Company (Elanco division); Merck & Co., Inc.; Sanofi S.A. (Merial division); and Novartis AG. If approved, we expect NV-01 and NV-02 will face competition from Deramaxx, marketed by Novartis; Metacam, marketed by Boehringer Ingelheim; Previcox, marketed by Merial; and Rimadyl, marketed by Zoetis, as well as from generic Meloxicam and Carprofen and other pain-treating products. We believe that Aratana and Kindred are developing, and that other companies may develop, similar profile products as well. In addition, private-label products may compete with our lead product candidates. If companion animal therapeutics customers increase their use of new or existing private-label products, our operating results and financial condition could be adversely affected.

We are a clinical-stage biopharmaceutical company with a limited operating history and many of our competitors have substantially more resources than we do, including financial, technical and sales resources. In addition, many of our competitors have more experience than we have in the development, manufacture, regulation and worldwide commercialization of companion animal therapeutics. We are also competing with academic institutions, governmental agencies and private organizations that are conducting research in the field of companion animal therapeutics. Our competition will be determined in part by the potential indications for which our lead product candidates are developed and ultimately approved by the Regulatory Authorities. Additionally, the timing of market introduction of some of our future products or of competitors’ products may be an important competitive factor. Accordingly, we expect the speed with which we can develop our product candidates, complete pivotal safety and efficacy studies and approval processes, and supply commercial quantities to market to be important competitive factors.

 

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If we are unable to attract or retain key employees, advisors or consultants, we may be unable to successfully develop our product candidates in a timely manner, if at all, or otherwise manage our business effectively.

As of September 30, 2014, we had 21 full-time employees, and we anticipate the need to increase the size of our organization, which will require us to hire, train, retain, manage and motivate current and additional employees, consultants or advisors with experience in a number of disciplines, including research and development, sales, finance, and manufacturing. Our success depends in part on our ability to attract and retain highly qualified key management, personnel and directors to develop, implement and execute our business strategy and operations, and oversee the activities of our consultants and vendors, as well as academic and corporate advisors or consultants that assist us in this regard. We are currently highly dependent upon the efforts of our management team to accomplish this, specifically including Mark Heffernan, our co-founder and Chief Executive Officer, David Gearing, our co-founder and Chief Scientific Officer, and Damian Lismore, our Chief Financial Officer. We do not have any “key man” insurance.

Although we have successfully attracted and retained key personnel in the past, we may not be able to continue to do so in the future on acceptable terms, if at all. In addition, competition for qualified personnel in the companion animal therapeutics segment of the veterinary care industry is intense, because there are a limited number of individuals who are trained or experienced in the field. We may also face difficulty in expanding and enhancing our operational, financial and management systems as we grow. If we lose any key employees, or are unable to attract or retain qualified key personnel, directors, advisors or consultants, the development of our product candidates could be significantly delayed or discontinued.

We rely on a single third-party manufacturer for supplies of our lead product candidates, and we intend to rely on third-party manufacturers for commercial quantities of any of our product candidates that may be approved.

We currently have no internal capability to manufacture the formulated product candidates for use in our studies or commercial supplies of any of our product candidates that may be approved, and we are entirely dependent upon third-party manufacturers for such supplies. We currently have a relationship with only one contract manufacturer, Lonza Sales AG, or Lonza, for the manufacturing of our lead product candidates for clinical testing purposes. Lonza may terminate the agreements we have entered into with them by, among other ways, prior written notice if the services cannot be completed due to technical or scientific reasons, subject to certain conditions. If Lonza does not perform as agreed or terminates our agreements, we may be required to replace Lonza, and we may be unable to do so on a timely basis, on similar terms or at all.

We also expect to rely upon third parties to produce materials required for the commercial production of our product candidates if we succeed in obtaining the necessary regulatory approvals. We may be unable to identify and reach agreement with a third-party manufacturer for our product candidates in a timely manner on commercially reasonable terms, or at all. Any delay in our ability to identify and contract with these third-party manufacturers on commercially reasonable terms, or at all, would have an adverse impact upon our current product development activities and future commercialization efforts.

The facilities used by Lonza or other third-party manufacturers we engage to manufacture the active pharmaceutical ingredients and formulated biologics will be subject to inspections by the Regulatory Authorities that will be conducted after we submit our NADA to and obtain approval by the FDA, or during a potential USDA licensing process for future product candidates or the EMA approval process. Among other things, these inspections may consider whether Lonza or other third-party manufacturers are following strict procedures associated with pharmaceutical manufacturing operations. We also expect our third-party manufacturers to produce supplies in conformity to our specifications and regulatory requirements and to maintain quality control and quality assurance practices and not to employ disqualified personnel. If our third-party manufacturers’ facilities or quality control and quality assurance practices do not comply with regulatory requirements, we may need to find alternative manufacturing facilities, which would adversely impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. Minor deviations in our manufacturing processes, such as temperature excursions or improper package sealing, could result in delays, inventory

 

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shortages, unanticipated costs, product recalls, product liability or regulatory action. In addition, a number of factors could cause production interruptions, including:

 

    equipment malfunctions;

 

    shortages of materials;

 

    changes in manufacturing production sites and limits to manufacturing capacity due to regulatory requirements, changes in types of products produced, shipping distributions or physical limitations;

 

    labor problems;

 

    natural disasters or power outages;

 

    terrorist activities; and

 

    the outbreak of any highly contagious diseases near our production sites.

These interruptions could result in launch delays, inventory shortages, recalls, unanticipated costs or otherwise adversely affect our operating results.

In accordance with good manufacturing practice, changing manufacturers may require the re-validation of manufacturing processes and procedures and may require further studies to show comparability between the materials produced by different manufacturers. Changing our current or future third-party manufacturers may be difficult, if possible for us, and could be extremely costly, which could result in our inability to manufacture our product candidates for an extended period of time and therefore a delay in the development or marketing of our product candidates. Further, in order to maintain our development timelines in the event of a change in our third-party manufacturer, we may incur significantly higher costs to manufacture our product candidates.

We currently rely on third parties to conduct all of our pivotal safety and efficacy studies and certain other development efforts. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our current or future product candidates.

We currently do not conduct our pivotal safety and efficacy studies, and we rely on CROs to conduct these studies. The third parties with whom we contract for the execution of our studies play a significant role in the conduct of these studies and the subsequent collection and analysis of data. However, these third parties are not our employees, and except for contractual duties and obligations, we have limited ability to control the amount or timing of resources that they devote to our programs. Although we rely on these third parties to conduct our studies, we remain responsible for ensuring that each of our studies is conducted in accordance with the development plan and protocol. Moreover, the Regulatory Authorities require us to comply with good laboratory practices and good clinical practices for conducting, monitoring, recording and reporting the results of our studies to ensure that the data and results are scientifically credible and accurate.

In addition, the execution of pivotal safety and efficacy studies and the subsequent compilation and analysis of the data produced requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. Many of our agreements with these third parties may be terminated by these third parties upon as little as 30 days’ prior written notice of a material breach by us that is not cured within 30 days. Many of these agreements may also be terminated by such third parties under certain other circumstances, including our insolvency or our failure to comply with applicable laws. In general, these agreements require such third parties to reasonably cooperate with us at our expense for an orderly winding down of services of such third parties

 

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under the agreements. If the third parties conducting our pivotal safety and efficacy studies do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our development protocols or good clinical practices, or for any other reason, we may need to enter into new arrangements with alternative third parties, which could be difficult and costly, and our pivotal safety and efficacy studies may be extended, delayed or terminated or may need to be repeated. If any of the foregoing were to occur, the regulatory approval for and commercialization of the product candidate being tested in such studies may be delayed or require us to utilize additional resources.

We currently have no direct sales organization. If we are unable to establish sales capabilities on our own, or maintain or establish new distribution relationships with third parties, we may not be able to market and sell our current or future product candidates, if approved, or generate product revenue.

We currently do not have a direct sales organization. In order to commercialize any of our current or future product candidates, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make or maintain arrangements with third parties to perform these services, and we may not be successful in doing so. We expect to establish a direct sales organization in the United States and to utilize distributors to commercialize our lead product candidates, which will be expensive and time-consuming. In jurisdictions outside of the United States, we intend to utilize companies with an established commercial presence to market our lead product candidates in those jurisdictions, but we may be unable to enter into or maintain such arrangements on acceptable terms, if at all.

We entered into a master collaboration, supply and distribution agreement, and a specific distribution agreement for NV-01, with Virbac S.A., or Virbac, an animal health pharmaceutical company, in November 2014. Pursuant to these agreements, we appointed Virbac as our sole and exclusive distributor of NV-01 and any other products for which we enter into a specific distribution agreement with Virbac in the veterinary field worldwide except for the United States and Canada (and for NV-08, also except for Japan, South Korea, Taiwan, the Philippines, Malaysia, Singapore, the People’s Republic of China, Indonesia, Thailand, India, Vietnam and Myanmar, because of pre-existing distribution rights). Virbac must provide clinical, regulatory, marketing and sales input via a joint steering committee, advise us in the drafting of regulatory submissions in the countries within the applicable territory, sell our products, meet or exceed minimum annual net sales obligations for each product, manage local complaints and transfer drug safety data, not apply for the registration of any trademark that is the same as or similar to any of our trademarks and launch the product within a specified time period after marketing authorization. Virbac may terminate these agreements if, among other things, we do not timely obtain a marketing authorization for NV-01 in Europe, there is a material failure to comply with the target product profiles for NV-01, there is a material deviation from a development plan for NV-01 or the distribution of all products covered by these agreements is prevented in certain important countries specified in these agreements as a result of a potential infringement of a third party’s intellectual property rights. If Virbac does not perform as agreed or terminates our agreements, we may be required to replace Virbac, and we may be unable to do so on a timely basis, on similar terms or at all.

We have no prior experience in the marketing, sale and distribution of companion animal therapeutics, and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain and motivate qualified individuals, generate sufficient sales leads, and effectively manage a sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. If we are not successful in commercializing any of our current or future product candidates, either on our own or through one or more distributors, we may never generate significant revenue and may continue to incur significant losses, which would adversely affect our financial condition and results of operations.

 

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Consolidation of our customers could negatively affect the pricing of any of our approved products.

Veterinarians will be our primary customers for any approved products. In recent years, there has been a trend towards the consolidation of veterinary clinics and animal hospitals. If this trend continues, these large clinics and hospitals could attempt to leverage their buying power to obtain favorable pricing from us or standardize the products they offer within their clinics or hospitals. Any resulting decrease in prices could have an adverse effect on our operating results and financial condition.

Our revenue, expenses and results of operations may be subject to significant fluctuations, which will make it difficult to compare our operating results from period to period.

We expect that our operating results will also vary significantly from quarter-to-quarter and year-to-year as a result of the initiation and success or failure of proof-of-concept studies or pivotal safety and efficacy studies, the timing of the formulation and manufacture of our product candidates or other development related factors. In addition, we recognized research and development incentive income of $1.1 million, $2.3 million, $0.5 million and $0.7 million for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, under the AusIndustry research and development tax incentive program. This incentive, which constituted our largest source of income in fiscal years 2013 and 2014, may not continue in future years if we no longer meet the eligibility requirements for the tax incentive or if the program is modified or terminated. Accordingly, our revenue, expense and results of operations for any period may not be comparable to the revenue, expense or results of operations for any other period.

Risks Related to Intellectual Property

Our commercial success will depend, in part, on obtaining and maintaining patent protection for our lead product candidates.

We do not have any issued patents for our lead product candidates at this time. However, we have filed patent applications covering various aspects of our lead product candidates. Our patent applications may never result in the issuance of patents, or patents issued to us may be dominated by the patents of third parties, including, for example, patents issued to analogous human drug, drug targets or biological compositions and their usages. Furthermore, even if they are unchallenged by third parties, our patents, if issued, may not adequately protect our intellectual property or prevent others from designing around their claims. In order to commercialize our lead product candidates in one or more species, we could be required to enter into third-party licenses or, if a license is not available on terms that we consider reasonable, we could be required to cease development or commercialization of one or more of our lead product candidates. Thus, if we cannot obtain ownership of issued patents covering our lead product candidates, our business and prospects would be adversely affected.

It is possible that no patents will issue to us that cover our lead product candidates, or that we will have little to no commercial protection against competing products. In such cases, we would then rely solely on other forms of exclusivity, such as regulatory exclusivity provided by the Federal Food, Drug and Cosmetic Act, if available, which may provide less protection to our competitive position.

Our commercial success depends upon our ability to develop, manufacture, market and sell our lead product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. In the future, it may become necessary for us to use the patented or proprietary technology of a third party to commercialize our own technology or products, in which case we would be required to obtain a license from such third party. A third party may hold intellectual property, including patent rights, that are important or necessary to the development of our lead product candidates. A license to such intellectual property may not be available on commercially reasonable terms, if at all. If we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies. Should we obtain a license, circumstances may arise where we are not able meet our obligations under the license, which could result in termination of the license agreement and impair our ability to develop or market our lead product candidates.

 

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Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any patents that issue. In September 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation, and switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The U.S. Patent and Trademark Office, or the USPTO, recently developed new regulations and procedures regarding aspects of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, in particular the first-to-file provisions, only became effective in March 2013. The full effect of these changes are currently unclear as the USPTO has not yet adopted all pertinent final rules and regulations, and the courts have yet to address all of the new provisions. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any patents that issue, all of which could have an adverse effect on our business and financial condition.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we might obtain in the future.

If a third party claims we are infringing on its intellectual property rights, we could incur significant expenses, or be prevented from further developing or commercializing our lead product candidates.

Our success will also depend on our ability to operate without infringing the patents and other proprietary intellectual property rights of third parties. This is generally referred to as having the “freedom to operate.” We work with our patent attorneys to review third party patents and patent applications that may affect our freedom to operate, and, when we think necessary, we take action to seek to limit or challenge claims made by patents or patent applications of third parties that may adversely affect our freedom to operate. However, the biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights. The defense and prosecution of intellectual property claims, interference proceedings and related legal and administrative proceedings, both in the United States and internationally, involve complex legal and factual questions. As a result, such proceedings are lengthy, costly and time-consuming, and their outcome is highly uncertain. We may become involved in protracted and expensive litigation in order to determine the enforceability, scope and validity of the proprietary rights of others, or to determine whether we have the freedom to operate with respect to the intellectual property rights of others.

Third parties may assert that we are employing their proprietary technology without authorization. For example, as a result of searching patent literature in support of patent protection and otherwise evaluating the patent landscape, we are aware of third party patents or patent applications in territories where we intend to commercialize our anti-NGF products, which contain granted claims, pending claims or claims for which patent offices have issued a notice of intention to grant with coverage that could potentially be asserted with respect to NV-01 and NV-02. While we do not believe such assertions would be valid or enforceable or otherwise materially adversely affect commercialization of NV-01 and NV-02, we may be incorrect in this belief. If any

 

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third party patent were held by a court of competent jurisdiction to cover aspects of any of our product candidates or any method of use of any of our product candidates, the holder of any such patent may be able to block our ability to develop and commercialize such product candidate unless we obtain a license under the applicable patent or limit or modify the formulation or use, or until such patent expires or is finally determined to be invalid or unenforceable. If a license to a third-party patent is needed, such a license may not be available on commercially reasonable terms or at all. Any successful assertion by a third party that one of our product candidates infringes one or more issued patents could materially affect our commercialization of that product candidate if such product candidate is approved.

There may be patents already issued, of which we are unaware, that might be infringed by the commercialization of one or more of our product candidates. Moreover, it is also possible that patents may exist that we are aware of, but that we do not believe are relevant to our current or future product candidates, which could nevertheless be found to block our freedom to market these product candidates. Patent applications are, in most cases, maintained in secrecy until approximately 18 months after the patent application is filed. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made. Therefore, patent applications relating to product candidates similar to ours may have already been filed by others without our knowledge. In the event that a third party has also filed a patent application covering our lead product candidates or other claims, we may have to participate in an adversarial proceeding, such as an interference or derivation proceeding in the USPTO or similar proceedings in other countries, to determine the priority of invention. In the event an infringement claim is brought against us, we may be required to pay substantial legal fees and other expenses to defend such a claim and, if we are unsuccessful in defending the claim, we may be prevented from pursuing the development and commercialization of a lead product candidate and may be subject to injunctions or awards for damages.

In the future, the USPTO or a foreign patent office may grant patent rights to our lead product candidates or other claims to third parties. Subject to the issuance of these future patents, the claims of which will be unknown until issued, we may need to obtain a license or sublicense to these rights in order to have the appropriate freedom to further develop or commercialize them.

Any required licenses may not be available to us on acceptable terms, if at all. If we need to obtain such licenses or sublicenses, but are unable to do so, we could encounter delays in the development of our lead product candidates, or be prevented from developing, manufacturing and commercializing our lead product candidates at all. If it is determined that we have infringed an issued patent and do not have the freedom to operate, we could be subject to injunctions, and compelled to pay significant damages, including punitive damages. In cases where we have in-licensed intellectual property, our failure to comply with the terms and conditions of such agreements could harm our business.

It is becoming common for third parties to challenge patent claims on any successfully developed product candidate or approved drug. Third-party preissuance submission of prior art to the USPTO, or post grant opposition, derivation, reexamination, inter partes review or interference proceedings, or other preissuance or post grant proceedings in the United States or other jurisdictions provoked by third parties may be necessary to determine the priority of inventions with respect to our patent applications or future issued patents. An unfavorable outcome could require us to cease using the related technology and commercializing our lead product candidates, or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies. Even if we successfully defend such litigation or proceeding, we may incur substantial costs and it may distract our management and other employees. We could be found liable for monetary damages if we are found to have willfully infringed a patent.

If we or our collaborators become involved in any patent litigation or other legal proceedings, we could incur substantial expense, and the efforts of our technical and management personnel could be significantly diverted. A negative outcome of such litigation or proceedings may expose us to the loss of our proprietary

 

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position or to significant liabilities, or require us to seek licenses that may not be available from third parties on commercially acceptable terms, if at all. We may be restricted or prevented from developing, manufacturing and selling our lead product candidates in the event of an adverse determination in a judicial or an administrative proceeding, or if we fail to obtain necessary licenses.

If our efforts to protect the proprietary nature of the intellectual property related to any of our current or future product candidates are not adequate, we may not be able to compete effectively in our market.

We intend to rely upon a combination of patents, trade secret protection, confidentiality and license agreements to protect the intellectual property related to our current product candidates and our development programs. Patents containing composition-of-matter claims on the active ingredients in pharmaceutical products, including companion animal therapeutics, are generally considered to be the strongest form of intellectual property protection, as such claims provide protection without regard to any particular method of use or manufacture. Patents containing claims directed to methods-of-use protect the use of a product for the specified methods. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. While our pending patent families contain pending composition-of-matter and method-of-use claims, our patents, if allowed, may not contain both types of claims.

The strength of patents in the field of companion animal therapeutics involves complex legal and scientific questions and can be uncertain. The patent applications that we own or license may fail to result in issued patents in the United States or in other foreign countries. Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. We also rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or for which we have not filed patent applications, processes for which patents are difficult to enforce and other elements of our product development processes that involve proprietary know-how, information or technology that is not covered by patents.

We require all of our employees to assign their inventions to us, and we endeavor to execute confidentiality agreements with all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology. However, we may not have executed such agreements with all parties who may have helped to develop our intellectual property or had access to our proprietary information, and our agreements may be breached.

Our trade secrets and other confidential proprietary information may be disclosed or competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market.

We may be involved in lawsuits to protect or enforce any future patents issued to us, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe any patents that may issue to us in the future, or the patents of our licensors that are licensed to us. To counter infringement or unauthorized use of any patents we may obtain, we may be required to file infringement claims, which can be expensive and time-consuming to litigate. In addition, if we or one of our future collaborators were to initiate legal proceedings against a third party to enforce a patent covering our current lead product candidates, or one of our future products, the defendant could counterclaim that the patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace grounds for a validity challenge and could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld

 

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relevant information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar claims before the USPTO, even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. There may be invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.

Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be unsuccessful, it could have an adverse effect on the price of our ordinary shares. Finally, we may not be able to prevent, alone or with the support of our licensors, misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

We have filed trademark applications for our company name in the United States and certain other countries, and we have filed trademark applications for certain proprietary technology in the United States; however, registration is not yet complete for these filings and failure to finally secure these registrations could adversely affect our business.

We have current registered trademarks for our company name and the word PETisation in Australia. We have filed further trademark applications for our company name and the word PETization (and similar derivations) in Australia, the United States, the EU and nine other foreign jurisdictions. These applications may not result in registered trademarks. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. Moreover, any name we propose to use with our lead product candidates in the United States must be approved by the Regulatory Authorities, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names, and have in the past objected (and may in the future object) to applicants’ proposed product names. If the Regulatory Authorities object to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the Regulatory Authorities.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on product candidates throughout the world could be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete with our lead product candidates in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property.

We rely on trade secrets to protect our technology, especially where we do not believe patent protection is obtainable, or prior to us filing patent applications on inventions we may make from time to time. However,

 

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trade secrets are difficult to protect. In order to protect our proprietary technology and processes, we also rely in part on agreements that contain confidentiality and intellectual property assignment provisions with our corporate and academic partners, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors.

These agreements may not effectively prevent disclosure of confidential information or result in the effective assignment to us of intellectual property and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information or other breaches of the agreements. In addition, others may independently discover our trade secrets and proprietary information, and in such case we could not assert any trade secret rights against such party. Enforcing a claim that a third party illegally obtained and is using our trade secrets is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

Obtaining and maintaining, if obtained, our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO, the European Patent Office and various other foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case, which would have an adverse effect on our business.

Risks Related to Government Regulation

The regulatory approval process is uncertain, requires us to utilize significant resources and may prevent us from obtaining approvals for the commercialization of some or all of our lead product candidates.

The research, testing, manufacturing, labeling, approval, selling, import, export, marketing and distribution of companion animal therapeutics are subject to extensive regulation by the Regulatory Authorities, and other regulatory authorities around the world whose regulations differ from country to country. We are not permitted to market any of our current or future product candidates in the United States until we successfully complete our product development and testing, demonstrate that we meet the standards for regulatory approval and receive approval of a NADA from the FDA, a product license from the USDA or foreign approval, as applicable. We have not submitted an application or received regulatory approval for any of our lead product candidates in any jurisdiction. Obtaining approval of a NADA from the FDA or a product license from the USDA is an uncertain process that requires us to utilize significant resources.

The Regulatory Authorities may delay, limit or deny approval of any of our lead product candidates for many reasons, including if:

 

    our proof-of-concept studies or pivotal safety and efficacy studies are found to have failed to comply with applicable regulatory standards, causing regulators to deem the data unreliable;

 

    we are unable to demonstrate to the satisfaction of the Regulatory Authority that the product candidate is safe and effective for the requested indication and meets all other regulatory standards;

 

    the Regulatory Authorities disagrees with our interpretation of data from our pivotal safety and efficacy studies and other development efforts;

 

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    we are unable to demonstrate that the product candidate’s benefits outweigh any safety or other perceived risks;

 

    the Regulatory Authority requires additional studies;

 

    the Regulatory Authority does not approve of the formulation, the labeling or the specifications of the product candidate;

 

    the Regulatory Authority fails to approve our manufacturing processes or facilities, or the manufacturing processes or facilities of third-party manufacturers with which we contract; and

 

    the approval policies or regulations of the Regulatory Authority significantly changes in a manner rendering the data from our studies insufficient for approval.

Each Regulatory Authority employs different regulatory standards, so we may require multiple manufacturing processes and facilities for the same product candidate or any approved product. In addition, failure to comply with the requirements of the Regulatory Authorities may subject us to administrative or judicially imposed sanctions, including: warning letters, civil and criminal penalties, injunctions, withdrawal of approved products from the market, product seizure or detention, product recalls, total or partial suspension of production, and refusal to approve pending NADAs or product licenses or supplements to approved NADAs or product licenses.

Regulatory approval of a NADA or supplemental NADA, or of a product license, is not guaranteed, and the approval process requires us to utilize significant resources, may take several years and is subject to the substantial discretion of the Regulatory Authorities. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon or repeat studies, or perform additional studies. If any of our current or future product candidates fails to demonstrate safety and efficacy in our studies, or for any other reason does not gain regulatory approval, our business and results of operations will be materially and adversely harmed.

Our ability to market our lead product candidates, if approved, will be limited to use for the treatment of the indications for which they are approved, and if we want to expand the indications for which we may market our lead product candidates, we will need to obtain additional regulatory approvals, which may not be granted.

We expect to seek FDA approval in the United States for our lead product candidates for pain associated with osteoarthritis in dogs (NV-01), pain associated with degenerative joint disease in cats (NV-02) and chronic inflammatory diseases, including atopic dermatitis, in dogs (NV-08). If our lead product candidates are approved, we may only market or advertise them for the treatment of indications for which they are approved, which could limit their adoption by veterinarians and companion animal owners. We may attempt to develop, promote and commercialize new treatment indications and protocols for our lead product candidates in the future, but we may not receive the approvals required to do so on a timely basis or at all. In addition, we would be required to conduct additional pivotal safety and efficacy studies to support our applications, which would utilize additional resources. Our lead product candidates are species-specific and cannot be used in species other than those for which they are being developed or are approved. If we do not obtain additional regulatory approvals, our ability to expand our business will be limited.

Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing and expensive regulatory obligations, including continued review, labeling and manufacturing requirements and other restrictions. Failure to comply with these regulatory obligations or the occurrence of unanticipated problems with our current or future product candidates could result in significant penalties.

If the Regulatory Authorities approve any of our current or future product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These

 

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requirements include submissions of safety and other post-marketing information and reports, establishment registration, and product listing, as well as continued compliance with good manufacturing practice as well as good laboratory practices and good clinical practices for any studies that we conduct post-approval.

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes and quality assurance, or failure to comply with regulatory requirements, may result in, among other things:

 

    restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary product recalls;

 

    fines, warning letters or holds on pivotal safety and efficacy studies;

 

    refusal by the Regulatory Authorities to approve pending applications or supplements to approved applications filed by us or our strategic collaborators, or suspension or revocation of product license approvals;

 

    product seizure or detention, or refusal to permit the import or export of products;

 

    injunctions or the imposition of civil or criminal penalties; and

 

    lawsuits from animal owners.

The Regulatory Authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our lead product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any regulatory approval that we may have obtained, and we may not achieve or sustain profitability, which would adversely affect our business.

Post-approval monitoring of products approved by the FDA is required by law, with reports to be provided to the FDA’s Surveillance and Compliance group. Reports of product quality defects, adverse events or unexpected results must be produced in accordance with the law. The USDA obtains information about adverse events via voluntary spontaneous reports and other surveillance activities. In the past, the USDA has proposed more stringent post-approval monitoring and reporting procedures for license holders, and it could do so in the future.

If approved, any of our current or future products may cause or contribute to adverse events that we are required to report to the Regulatory Authorities and, if we fail to do so, we could be subject to sanctions.

If we are successful in commercializing any of our current or future product candidates, the Regulatory Authorities will require that we report certain information about adverse events if those products may have caused or contributed to those adverse events. The timing of our obligation to report would be triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events we become aware of within the prescribed timeframe.

We may also fail to appreciate that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of our lead product candidates. If we fail to comply with our reporting obligations, the Regulatory Authorities could take action including criminal prosecution, the imposition of civil monetary penalties, seizure of our lead product candidates or delay in approval or clearance of future products.

 

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The misuse or extralabel use of our lead product candidates may harm our reputation or result in financial or other damages.

Our lead product candidates, if approved, will be limited for use under specific circumstances for the treatment of certain diseases and conditions in specific species. There may be increased risk of product liability if veterinarians, livestock producers, companion animal owners or others attempt extralabel use of our lead product candidates, including the use of our lead product candidates in species (including humans) for which they have not been approved. Furthermore, the use of our lead product candidates for indications other than those indications for which our lead product candidates have been approved may not be effective, which could harm our reputation and lead to an increased risk of litigation. If we are deemed by a governmental or regulatory agency to have engaged in the promotion of any of our lead product candidates for extralabel use, such agency could request that we modify our training or promotional materials and practices and we could be subject to significant fines and penalties, and the imposition of these sanctions could also affect our reputation and position within the industry. Any of these events could materially adversely affect our operating results and financial condition.

Legislative or regulatory reforms with respect to companion animal therapeutics may make it more difficult and costly for us to obtain regulatory clearance or approval of any of our current or future product candidates and to produce, market, and distribute our lead product candidates after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in the U.S. Congress or the EU that could significantly change the statutory provisions governing the testing, regulatory clearance or approval, manufacture, and marketing of regulated products. In addition, the Regulatory Authorities’ regulations and guidance are often revised or reinterpreted by the regulators in ways that may significantly affect our business and our lead product candidates. Similar changes in laws or regulations can occur in other countries. Any new regulations or revisions or reinterpretations of existing regulations in the United States or in other countries may impose additional costs or lengthen review times of any of our current or future product candidates.

We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

 

    changes to regulatory criteria for approval;

 

    changes to manufacturing methods;

 

    recall, replacement, or discontinuance of certain products;

 

    additional record keeping; and

 

    additional reporting requirements.

Each of these would likely entail substantial time and costs and could harm our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any future products would harm our business, financial condition and results of operations.

Our research and development relies on evaluations in animals, which may become subject to bans or additional regulations.

As a biopharmaceutical company with a focus on companion animal therapeutics, the evaluation of our existing and new products in animals is required to obtain marketing authorization for our lead product candidates. Animal testing in certain industries has been the subject of controversy and adverse publicity.

 

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Some organizations and individuals have attempted to ban animal testing or encourage the adoption of additional regulations applicable to animal testing. To the extent that the activities of such organizations and individuals are successful, our research and development, and by extension our operating results and financial condition, could be adversely affected. In addition, negative publicity about us or our industry could harm our reputation.

If our use of hazardous materials results in contamination or injury, we could suffer significant reputational or financial loss.

Our research activities involve the controlled use of certain hazardous chemical and biological materials from time to time. Notwithstanding the various regulations controlling the use and disposal of these materials, as well as the safety procedures we undertake, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of an accident or environmental discharge or exposure, we may be held liable for any resulting damages, which may negatively impact our operations, our financial resources or our ability to recruit new staff.

Future federal and state legislation may expose us to product liability claims.

Under current federal and state laws, companion animals are generally considered to be personal property of their owners and, as such, owners’ recovery for product liability claims involving their companion animals may be limited to the replacement value of the companion animals. Companion animal owners and their advocates, however, have filed lawsuits from time to time seeking non-economic damages such as pain and suffering and emotional distress for harm to their companion animal based on theories applicable to personal injuries to humans. If new legislation is passed to allow recovery for such non-economic damages, or if precedents are set allowing for such recovery, we could be exposed to increased product liability claims that could result in substantial losses to us if successful. In addition, some horses can be worth millions of dollars or more, and product liability for horses may be high.

Although we maintain product liability insurance and revise our coverage from time to time, we currently have a per-claim deductible of $5,000 on our global products liability policy, which may make the insurance of limited utility in many companion animal claims where the companion animal is valued at replacement value. Furthermore, the policy is subject to per-year policy limits of $20.0 million per year for non-U.S. jurisdiction claims and $5.0 million per year for U.S. jurisdiction claims, as well as other terms and conditions. Accordingly, it is possible that our insurance will not cover future product liability claims against us.

Risks Related to Taxation

We are a multinational organization faced with complex tax issues in many jurisdictions, and we could be obligated to pay additional taxes in various jurisdictions.

We are an Irish-registered corporation and we currently have subsidiaries in Australia, Ireland, the United States and the United Kingdom. We have historically operated primarily in Australia, and we have recently commenced operations in Ireland and the United States. Depending on our ability to develop and commercialize our lead product candidates, we may have additional operations around the world. As a multinational organization, we may be subject to taxation in several different jurisdictions with complex tax laws, the application of which can be uncertain. The amount of taxes we pay in these jurisdictions could increase substantially as a result of changes in applicable tax law, including increased tax rates, new tax laws or revised interpretations of existing tax laws and precedents. Such changes could have an adverse effect on our liquidity and results of operations. In addition, the tax authorities in these jurisdictions could review our tax positions and disagree with the approaches taken or our tax returns submitted and seek to impose additional tax, interest and penalties on us. In addition, the tax authorities in those jurisdictions could claim that we have additional tax, withholding tax or other tax filing requirements or could assert that certain benefits of tax treaties are not available to us or our subsidiaries. Furthermore, the tax authorities in one or more jurisdictions in which we do

 

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not currently believe we have a taxable presence could assert that we do have a taxable presence in that jurisdiction and on that basis assert that we have tax payment, withholding tax or other tax filing requirements in that jurisdiction. Any such claim or assertion could impact us and our results of operations.

Changes in our effective tax rate may reduce our net income in future periods.

We are organized as an Irish company, in part, to improve our ability to maintain a competitive worldwide effective corporate tax rate. Our effective tax rate, however, depends on the tax policies of the jurisdictions in which we operate. In general, under current Irish tax legislation, a company is regarded as resident for tax purposes in Ireland if the company is “centrally managed and controlled” in Ireland, or, in certain circumstances, if the company is incorporated in Ireland. We expect that our company will be centrally managed and controlled from Ireland and accordingly will be treated as an Irish tax resident. However, as a multinational organization, it is possible that we may not be regarded as being centrally managed and controlled in Ireland and instead be treated as a tax resident in another jurisdiction. If such a situation were to arise, it could adversely impact our tax position and our effective tax rate.

Trading income of an Irish resident company is generally taxable at the Irish corporation tax rate of 12.5%. Non-trading income of an Irish resident company, such as interest income, rental income or other passive income, is taxable at a rate of 25%. It is possible that in the future, whether as a result of a change in law in any jurisdiction or the practice of any relevant tax authority or as a result of any change in our business, we could become, or be regarded as having become, tax resident in a jurisdiction other than Ireland. Should we cease to be an Irish tax resident, we may be subject to a charge to Irish capital gains tax on any gain inherent in our assets. Our actual effective tax rate may vary from our expectation and that variance may be material. Additionally, the tax laws of Ireland, the United States, Australia and other jurisdictions could change in the future, and such changes could cause a material change in our effective tax rate. In addition, the changes currently proposed by the OECD and their action plan on Base Erosion and Profit Shifting could adversely impact our tax position and our business operations.

A number of factors may increase our future effective tax rates, including:

 

    the jurisdictions in which profits are determined to be earned and taxed;

 

    the resolution of issues arising from tax audits with various tax authorities;

 

    changes in the valuation of our deferred tax assets and liabilities;

 

    increases in expenses not deductible for tax purposes, including transaction costs and impairments of goodwill in connection with acquisitions;

 

    changes in available tax credits, including the research and development tax credit in Australia;

 

    changes in the taxation of share-based compensation;

 

    changes in tax laws or the interpretation of such tax laws, and changes in generally accepted accounting principles; and

 

    challenges to the transfer pricing policies related to our structure.

Our tax position could be adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation of such laws, treaties or regulations by the tax authorities in Ireland, the United States, Australia and other jurisdictions as well as being affected by certain changes currently proposed by the OECD. Such changes may be become more likely as a result of recent economic trends in the

 

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jurisdictions in which we operate, particularly if such trends continue. For example, a change in the Irish government’s stated policy of not increasing business taxation could cause a material and adverse change in our worldwide effective tax rate and we may have to take action, at potentially significant expense, to seek to mitigate the effect of such changes. In addition, any amendments to the current double taxation treaties between Ireland and other jurisdictions, including Australia and the United States, could subject us to increased taxation or irrecoverable withholding tax.

Failure to manage the risks associated with such changes, or misinterpretation of the laws relating to taxation, could result in costly audits, interest, penalties and reputational damage, which could adversely affect our business, results of our operations and our financial condition. In the normal course of business, we are currently open to inspection by the tax authorities in Ireland, Australia, the United States and the United Kingdom. We are not currently the subject of any ongoing tax audits.

Our ability to use existing tax loss carry forwards to reduce future tax payments may be limited if we experience a change in ownership, or if taxable income does not reach sufficient levels.

Our ability to use our net operating losses is subject to limitations and re-assessment due to ownership changes that have occurred or that may occur in the future under the laws of the jurisdictions in which we have net operating losses, which currently include Australia. In addition, use of net operating losses is restricted to income in those jurisdictions. For example, Nexvet Australia’s tax loss carry forwards comprised all $4.2 million and $7.1 million of our tax loss carry forwards as of June 30, 2014 and September 30, 2014, respectively. Given the change of ownership that occurred in September 2014 to Nexvet Australia, the Australian tax authorities could argue that there has been a change in the underlying business in Australia, which may result in these tax losses never being recoverable. Should this occur, future Australian taxable profits would be taxed at the full corporate rate, which is currently 30%. Depending on the actual amount of any limitation on our ability to use our tax loss carry forwards, a significant portion of our future taxable income could be taxable.

Additionally, tax law limitations may result in our net operating losses expiring before we have the ability to use them. In addition, financing and acquisition transactions that we may enter into in the future could significantly limit or eliminate our ability to realize any value from our net operating losses.

Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.

Our parent company is based in Ireland and we currently have subsidiaries in Australia, Ireland, the United States and the United Kingdom. If we succeed in growing our business, we expect to conduct increased operations through our subsidiaries in various tax jurisdictions pursuant to transfer pricing arrangements between our parent company and subsidiaries. If two or more affiliated companies are located in different countries, the tax laws or regulations of each country generally will require that transfer prices be the same as those between unrelated companies dealing at arms’ length and that appropriate documentation is maintained to support the transfer prices. While we believe that we operate in compliance with applicable transfer pricing laws and intend to continue to do so, our transfer pricing procedures are not binding on applicable tax authorities.

If tax authorities in any of these countries were to successfully challenge our transfer prices as not reflecting arms’ length transactions, they could require us to adjust our transfer prices and thereby reallocate our income to reflect these revised transfer prices, which could result in a higher tax liability to us. In addition, if the country from which the income is reallocated does not agree with the reallocation, both countries could tax the same income, resulting in double taxation. If tax authorities were to allocate income to a higher tax jurisdiction, subject our income to double taxation or assess interest and penalties, it would increase our consolidated tax liability, which could adversely affect our financial condition, results of operations and cash flows.

 

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We believe that we may be a passive foreign investment company for U.S. federal income tax purposes, which could subject U.S. Holders to adverse U.S. federal income tax consequences.

We believe that we may be a passive foreign investment company, or a PFIC, for U.S. federal income tax purposes in our current taxable year and we may be a PFIC in other taxable years. A foreign corporation like us generally will be a PFIC if either at least (i) 75% of its gross income is “passive income” or (ii) 50% of the gross value of its assets is attributable to assets that produce, or are held for the production of, passive income. We refer to the passive income test as the “PFIC Income Test” and the asset test as the “PFIC Asset Test.” The proceeds from this offering would be a passive asset under these rules and, if substantial enough, may cause us to meet the PFIC Asset Test for our taxable year that includes this offering (and in later years if we are not deploying the cash at a rate that would allow us to avoid meeting the PFIC Asset Test in such later years). If we are a PFIC in any taxable year in which you hold shares and you are a “U.S. Holder” (as described in the section of this prospectus titled “Taxation—Material United States Federal Income Tax Consequences to U.S. Holders), we always will be a PFIC with respect to your share ownership (subject to the QEF election discussed immediately below) unless you make an election to “purge” PFIC status as of the beginning of the first taxable year that we are not a PFIC (a year in which do not meet the PFIC Income Test or the PFIC Asset Test) or the first taxable year that you make a QEF election, if such election is made after the first year in which you held our ordinary shares and in which we are a PFIC, all as discussed further below. If we are a PFIC and you are a U.S. Holder and do not make a Qualified Electing Fund election, or QEF election, with respect to us or a mark-to-market election with respect to our ordinary shares, you will be subject to adverse tax consequences, including deferred tax and interest charges with respect to certain distributions on our ordinary shares, any gain realized on a disposition of our ordinary shares and certain other events. The effect of these adverse tax consequences could be materially adverse to you.

If you are a U.S. Holder and make a valid, timely QEF election for us, you will not be subject to those adverse tax consequences, but could recognize taxable income in a taxable year with respect to our ordinary shares in excess of any distributions that we make to you in that year, thus giving rise to so-called “phantom income” and to a potential out-of-pocket tax liability. If we are a PFIC with respect to any tax year, we will provide information to all electing shareholders needed to comply with the QEF election in time for each electing shareholder to make and maintain a timely QEF election, taking into account available extensions. If you are a U.S. Holder and make a valid, timely mark-to-market election with respect to our ordinary shares, you will recognize as ordinary income or loss in each year that we are a PFIC an amount equal to the difference between your basis in our ordinary shares and the fair market value of the ordinary shares, thus also possibly giving rise to phantom income and a potential out-of-pocket tax liability. Ordinary loss generally is recognized only to the extent of net mark-to-market gains previously included in income. If one or more of our subsidiaries is a PFIC, U.S. Holders will also need to make the QEF election with respect to each such subsidiary in order to avoid the adverse tax consequences described above. We intend to provide on a timely basis all information necessary for U.S. Holders to make the QEF election with respect to any of our subsidiaries that may be classified as a PFIC in any tax year. U.S. Holders should also be aware that the mark-to-market election generally will not be available with respect to any of our subsidiaries that is a PFIC, rendering such election less beneficial to U.S. Holders than the QEF election. See the section of this prospectus titled “Taxation—Material United States Federal Income Tax Consequences to U.S. Holders—Passive Foreign Investment Company Status and Related Tax Consequences.” We intend to determine on an annual basis whether we will be a PFIC with respect to any taxable year. As noted above, if we are a PFIC in any taxable year in which you own shares, you do not make a timely QEF election and you are a U.S. Holder, we will remain a PFIC with respect to your share ownership unless you make a “purging election.” The resulting liability from such an election could be substantial.

If the IRS determines that we are not a PFIC, and you previously paid taxes pursuant to a QEF election or a mark-to-market election, you may pay more taxes than you legally owe.

If the U.S. Internal Revenue Service, or IRS, makes a determination that we are not a PFIC and you previously paid taxes pursuant to a QEF election or mark-to-market election, then you may have paid more taxes

 

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than you legally owed due to such election. If you do not, or are not able to, file a refund claim before the expiration of the applicable statute of limitations, you will not be able to claim a refund for those taxes.

Risks Related to this Offering and Our Ordinary Shares

No active market for our ordinary shares exists or may develop, and you may not be able to resell your ordinary shares at or above the initial public offering price.

Prior to this offering, there has been no public market for our ordinary shares, and an active public market for our ordinary shares may not develop or be sustained after this offering. We and the representatives of the underwriters will determine the initial public offering price of our ordinary shares by arm’s-length negotiations, and the initial public offering price will not necessarily reflect the price at which investors in the market will be willing to buy and sell our ordinary shares following this offering. In addition, an active trading market may not develop following completion of this offering or, if it is developed, may not be sustained. The lack of an active market may impair your ability to sell your ordinary shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active market may also adversely affect our ability to raise capital by selling securities in the future, or impair our ability to in-license or acquire other product candidates, businesses or technologies using our ordinary shares as consideration.

The price of our ordinary shares could be subject to volatility related or unrelated to our operations and your investment in us could suffer a decline in value.

If a market for our ordinary shares develops following this offering, the trading price of our ordinary shares could be subject to wide fluctuations in response to various factors, some of which are beyond our control. These factors include those discussed elsewhere in this “Risk Factors” section of this prospectus and others, such as:

 

    results from, and any delays in, our current and future proof-of-concept and pivotal safety and efficacy studies;

 

    announcements of regulatory approval or disapproval of any of our current or future product candidates;

 

    delays in the commercialization of our current or future product candidates;

 

    manufacturing and supply issues related to our development programs and commercialization of our current or future product candidates;

 

    quarterly variations in our results of operations or those of our competitors;

 

    changes in our earnings estimates or recommendations by securities analysts;

 

    announcements by us or our competitors of new product candidates, significant contracts, commercial relationships, acquisitions or capital commitments;

 

    announcements relating to future development or license agreements including termination of such agreements;

 

    adverse developments with respect to our intellectual property rights or those of our principal collaborators;

 

    commencement of litigation involving us or our competitors;

 

    changes in our board of directors or management;

 

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    new legislation in the United States relating to the prescription, sale, distribution or pricing of companion animal therapeutics;

 

    product liability claims, other litigation or public concern about the safety of our lead product candidates or future products;

 

    market conditions in the companion animal market in general, or in the companion animal therapeutics segment in particular, including performance of our competitors; and

 

    general economic conditions in the United States and abroad.

In addition, the stock market in general, or the market for equity securities in our industry or industries related to our industry, may experience extreme volatility unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect the trading price or liquidity of our ordinary shares. Any sudden decline in the market price of our ordinary shares could trigger securities class-action lawsuits against us. If any of our shareholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the time and attention of our management would be diverted from our business and operations. We also could be subject to damages claims if we are found to be at fault in connection with a decline in our share price.

If securities or industry analysts do not publish research or reports about our company, or if they issue adverse or misleading opinions regarding us or our ordinary shares, our share price and trading volume could decline.

We do not currently have research coverage by securities and industry analysts, and if no significant coverage is initiated or maintained following this offering, the market price for our ordinary shares may be adversely affected. Our share price also may decline if any analyst who covers us issues an adverse or misleading opinion regarding us, our business model, our intellectual property or our share performance, or if our pivotal safety and efficacy studies and operating results fail to meet analysts’ expectations. If one or more analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline and possibly adversely affect our ability to engage in future financings.

Our principal shareholders and management own a significant percentage of our ordinary shares and will be able to exert significant control over matters subject to shareholder approval.

Upon the completion of this offering, based on shares outstanding as of December 30, 2014, our executive officers, directors, holders of five percent or more of our ordinary shares and their respective affiliates will beneficially own in the aggregate approximately         % of our outstanding ordinary shares. In addition, entities affiliated with Farallon have indicated an interest in purchasing up to an aggregate of $     million of our ordinary shares in this offering at the initial public offering price. The ownership percentage disclosed above does not reflect the potential purchase of any ordinary shares in this offering by such shareholders. As a result of their share ownership, these shareholders may have the ability to influence our management and policies and will be able to significantly affect the outcome of matters requiring shareholder approval such as elections of directors, amendments of our organizational documents or approvals of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our ordinary shares that you may feel are in your best interest as one of our shareholders.

We will have broad discretion regarding use of the net proceeds from this offering, and we may use them in ways that do not enhance our operating results or the market price of our ordinary shares.

Our management will have broad discretion regarding the use of the net proceeds from this offering, and we could spend the net proceeds in ways our shareholders may not agree with or that do not yield a favorable return, if at all. We intend to use the net proceeds from this offering to complete the development and manufacturing scale-up of each of our three lead product candidates, to establish our sales force infrastructure in the United States for any approved products and for anticipated promotional and launch costs. We also intend to fund research to develop

 

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our pipeline of other product candidates. We intend to use the remainder of the net proceeds from this offering for working capital and other general corporate purposes. We may also use a portion of the net proceeds to acquire or in-license additional product candidates or complementary assets or businesses; however, we currently have no agreements, commitments or understandings to complete any such transaction. Our actual use of these proceeds may differ substantially from our current intentions. If we do not invest or apply the proceeds from this offering in ways that improve our operating results or our prospects, our share price could decline.

Purchasers in this offering will experience immediate and substantial dilution in the book value of their investment.

The initial public offering price of our ordinary shares will be substantially higher than the pro forma net tangible book value per ordinary share before giving effect to this offering. Accordingly, if you purchase our ordinary shares in this offering, we estimate that you will incur immediate dilution of approximately $         per ordinary share, representing the difference between the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, and our pro forma as adjusted net tangible book value per ordinary share as of September 30, 2014.

In addition, following this offering, and assuming our sale of                 ordinary shares in this offering at the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, purchasers in this offering will have contributed approximately         % of the total gross consideration paid by shareholders to us to purchase ordinary shares through September 30, 2014 but will own only approximately         % of the ordinary shares outstanding immediately after this offering. Furthermore, if the underwriters exercise their option to purchase additional ordinary shares, our outstanding restricted share units are converted into ordinary shares or our outstanding options or warrants are exercised, you will experience further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section of this prospectus titled “Dilution.”

If we raise additional capital in the future, your level of ownership in us could be diluted or require us to relinquish rights.

Any issuance of securities we may undertake in the future to raise additional capital could cause the price of our ordinary shares to decline, or require us to issue shares at a price that is lower than that paid by holders of our ordinary shares in the past, which would result in those newly issued shares being dilutive.

Further, if we obtain funds through a debt financing or through the issuance of debt or preference securities, these securities would likely have rights senior to your rights as an ordinary shareholder, which could impair the value of our ordinary shares. Any debt financing we enter into may include covenants that limit our flexibility in conducting our business. We also could be required to seek funds through arrangements with collaborators or others, which might require us to relinquish valuable rights to our intellectual property or product candidates that we would have otherwise retained.

Sales of a substantial number of our ordinary shares in the public market could cause our share price to fall.

If our existing shareholders sell, or indicate an intention to sell, substantial amounts of our ordinary shares in the public market after the lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our ordinary shares could decline. Based upon the number of ordinary shares outstanding as of September 30, 2014, upon the completion of this offering, we will have             ordinary shares outstanding, assuming (i) the conversion of all outstanding preference shares into 5,937,138 ordinary shares, which we expect to automatically occur upon the completion of this offering, (ii) no exercise of the underwriters’ option to purchase              additional ordinary shares and (iii) no exercise of options or warrants and no conversion of restricted share units outstanding as of September 30, 2014. Of these outstanding ordinary shares, the             ordinary shares sold in this offering will be freely tradable, except that any ordinary shares acquired by our “affiliates” as that term is defined in Rule 144 promulgated under the Securities Act of 1933, as amended, or the Securities Act, including any

 

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ordinary shares acquired by entities affiliated with Farallon that have indicated an interest in purchasing ordinary shares in this offering, may only be sold if registered under the Securities Act or if such registration is not required, such as in compliance with Rule 144.

The lock-up agreements pertaining to this offering will expire 180 days from the date of this prospectus. The representatives of the underwriters, however, may permit our shareholders who are subject to these lock-up agreements to sell their ordinary shares prior to the expiration of the lock-up agreements. After the lock-up agreements expire, up to an additional                 ordinary shares will be eligible for sale in the public market,             of which shares are held by directors, executive officers and other affiliates (not taking into account any shares that may be purchased in this offering by entities affiliated with Farallon) and will be subject to volume limitations under Rule 144 under the Securities Act.

In addition, ordinary shares that are issuable upon exercise of outstanding options, conversion of outstanding restricted share units or reserved for future issuance under our equity incentive plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act. If these additional ordinary shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our ordinary shares could decline.

After this offering, the holders of                 ordinary shares, or approximately         % of our total outstanding ordinary shares as of September 30, 2014, will be entitled to rights with respect to the registration of their shares under the Securities Act, subject to the lock-up agreements described above. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. Any sales of securities by these shareholders could have an adverse effect on the trading price of our ordinary shares.

Participation in this offering by certain of our existing shareholders would reduce the available public float for our ordinary shares.

Entities affiliated with Farallon, which hold more than 5% of our ordinary shares and are affiliates of a director nominee, have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price. However, because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering. If the entities affiliated with Farallon were to purchase all of the ordinary shares for which they have indicated an interest in purchasing, they, together with our executive officers, directors and other owners of 5% or more of our outstanding ordinary shares and their respective affiliates, would beneficially own, in the aggregate, approximately     % of our outstanding ordinary shares after this offering, based on the number of shares outstanding as of December 30, 2014 and the assumed initial public offering price of $             per share, which is the midpoint of the price range set forth on the cover page of this prospectus.

If the entities affiliated with Farallon were allocated and were to purchase all or a portion of the ordinary shares for which they have indicated an interest in purchasing in this offering, such purchases would reduce the available public float for our ordinary shares because such shareholders would be restricted from selling the shares by a lock-up agreement they have entered into with the underwriters and by restrictions under applicable securities laws. As a result, any purchase of ordinary shares by such shareholders in this offering may reduce the liquidity of our ordinary shares relative to what it would have been had these shares been purchased by investors that were not affiliated with us.

Your rights as a shareholder will be governed by Irish law and differ from the rights of shareholders under U.S. law.

We are a public limited company under the laws of Ireland. Therefore, the rights of holders of ordinary shares are governed by Irish law and by our memorandum and articles of association, or our Articles. These

 

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rights differ from the typical rights of shareholders in U.S. corporations. In certain cases, facts that, under U.S. law, would entitle a shareholder in a U.S. corporation to claim damages may not give rise to a cause of action under Irish law entitling a shareholder in an Irish company to claim damages. For example, the rights of shareholders to bring proceedings against us or against our directors or officers in relation to public statements are more limited under Irish law than under the civil liability provisions of the U.S. securities laws.

You may have difficulties enforcing, in actions brought in courts in jurisdictions located outside the United States, judgments obtained in the U.S. courts under the U.S. securities laws. In particular, if you sought to bring proceedings in Ireland based on U.S. securities laws, the Irish court might consider:

 

    that it did not have jurisdiction;

 

    that it was not the appropriate forum for such proceedings;

 

    that, applying Irish conflict of laws rules, U.S. law (including U.S. securities laws) did not apply to the relationship between you and us or our directors and officers; or

 

    that the U.S. securities laws were of a penal nature or violated Irish public policy and should not be enforced by the Irish court.

You should also be aware that Irish law does not allow for any form of legal proceedings directly equivalent to the class action available in the United States. For further information with respect to your rights as a holder of our ordinary shares, see the section of this prospectus titled “Description of Share Capital.”

You may have difficulty in effecting service of process within the United States or enforcing judgments obtained in the United States.

We and several members of our senior management and board of directors are residents of countries other than the United States. Substantially all of our assets are located in Australia. As a result, it may not be possible for you to:

 

    effect service of process within the United States upon certain members of our senior management and board of directors and certain of the experts named in this prospectus or on us; or

 

    obtain discovery of relevant documents or the testimony of witnesses.

There is no system of reciprocal enforcement in Ireland of judgments obtained in the U.S. courts. Accordingly, a U.S. judgment against any of those persons or us may only be enforced in Ireland by the commencement of a new action before the Irish court based on the judgment of the U.S. court. Summary judgment against any of those persons or us, as the case may be, may be granted by the Irish court without requiring the issues in the U.S. litigation to be reopened on the basis that those matters have already been decided by the U.S. court provided that the Irish court is satisfied that:

 

    the U.S. judgment is for a definite sum of money;

 

    the U.S. judgment is not directly or indirectly for the payment of taxes or other charges of a like nature or a fine or other penalty (for example, punitive or exemplary damages);

 

    the U.S. judgment is final and conclusive;

 

    the Irish proceedings were commenced within the relevant limitation period;

 

    the U.S. judgment is provided by a court of competent jurisdiction (as determined by Irish law);

 

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    the U.S. judgment remains valid and enforceable in the court in which it was obtained; and

 

    the U.S. judgment is not obtained by fraud, did not violate Irish public policy, is not in breach of natural justice and is not irreconcilable with an earlier foreign judgment.

As a newly public company, we will incur significant additional costs, and our management will be required to devote substantial time and attention to our public reporting obligations.

As a publicly-traded company, we will incur significant additional legal, accounting and other expenses compared to historical levels. In addition, new and changing laws, regulations and standards relating to corporate governance and public disclosure, including the Dodd-Frank Wall Street Reform and Consumer Protection Act and the rules and regulations promulgated and to be promulgated thereunder, as well as under the Sarbanes-Oxley Act, the JOBS Act and the rules and regulations of the U.S. Securities and Exchange Commission, or the SEC, and The NASDAQ Stock Market, or Nasdaq, have created uncertainty for public companies and increased our costs and time that our board of directors and management must devote to complying with these rules and regulations. We expect these rules and regulations to increase our legal and financial compliance costs substantially and lead to diversion of management time and attention from revenue-generating activities.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to “emerging growth companies” may make our ordinary shares less attractive to investors.

We are an “emerging growth company” as defined in the JOBS Act, and, therefore, we may take advantage of reduced disclosure and regulatory requirements that are otherwise generally applicable to public companies, including presenting only two years of audited financial statements and related financial disclosure, not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments. We may take advantage of these reduced disclosure and regulatory requirements until we are no longer an “emerging growth company.” We may remain an “emerging growth company” until as late as June 30, 2020 (the fiscal year-end following the fifth anniversary of the completion of this initial public offering), although we may cease to be an “emerging growth company” earlier under certain circumstances, including if the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of any December 31, in which case we would cease to be an “emerging growth company” as of the following June 30, or if our gross revenue exceeds $1 billion in any fiscal year. In addition, the JOBS Act provides that an emerging growth company can delay adopting new or revised accounting standards until those standards apply to private companies. We have irrevocably elected not to avail ourselves of this delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.

The exact implications of the JOBS Act are still subject to interpretations and guidance by the SEC and other regulatory agencies, and we may not be able to take advantage of all of the benefits of the JOBS Act. In addition, investors may find our ordinary shares less attractive if we rely on the exemptions and relief granted by the JOBS Act. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares and our share price may decline or become more volatile.

Our prior audit firm previously advised us that we lacked proper internal controls to develop reliable financial statements. If we are not able to develop and maintain effective internal control over financial reporting we may be unable to accurately and timely report our financial results and our business could be harmed.

Our prior auditor previously audited our financial statements in accordance with generally accepted auditing standards in Australia, or Australian GAAS, for fiscal years 2012 and 2013, which were prepared in accordance with international financial reporting standards generally accepted in Australia, or Australian IFRS.

 

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Our prior auditor did not previously conduct any audits for any period in accordance with auditing standards generally accepted in the United States or the standards of the Public Company Accounting Oversight Board of our financial statements in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, or international financial reporting standards as issued by the International Accounting Standards Board.

Our prior auditor advised us that, through October 2013, the date of its report, there was a lack of (i) proper segregation of duties and (ii) competent and qualified financial reporting personnel for the development of policies and procedures relating to the financial reporting function and the preparation of reliable financial statements prepared in accordance with Australian IFRS.

Although we were not subject to Public Company Accounting Oversight Board requirements at the time, we believe that the conditions identified by our prior auditor constituted material weaknesses in our internal control over financial reporting during that period. A material weakness is defined under the standards issued by the Public Company Accounting Oversight Board as a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our financial statements may not be prevented or detected and corrected on a timely basis.

As of June 30, 2013, we only had six employees and primarily relied upon a third-party consultant to perform bookkeeping services and compile our financial statements. Subsequent to October 2013, we retained Damian Lismore, our Chief Financial Officer, as well as two other personnel within our financial reporting and accounting group, who collectively have experience in U.S. GAAP and the preparation of public company financial statements. Following Mr. Lismore’s retention we have implemented procedures to segregate duties within our financial reporting and accounting group; however, as a small company we are unable to completely segregate duties and must rely upon other controls. In addition, we have adopted accounting policies and procedures relating to the financial reporting function and we plan to further develop and formalize our financial reporting and accounting policies and procedures as we grow. As a result of these actions, we believe that we have remediated the above material weaknesses.

Although no material weaknesses were identified in connection with the preparation of our financial statements for fiscal year 2014, neither we nor our current independent registered public accounting firm conducted an evaluation of the operating effectiveness of our internal control over financial reporting as of June 30, 2014. We will be required to evaluate our internal control over financial reporting as required by Section 404 of the Sarbanes-Oxley Act for fiscal year 2016. In addition, under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act until we are no longer an “emerging growth company.” The rules governing the standards that must be met for our management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation.

We will continue the costly and challenging process of compiling the system and processing documentation necessary to perform the evaluation needed to comply with Section 404, and we may not be able to complete our evaluation or testing in a timely fashion. As we prepare for compliance with Section 404 of the Sarbanes-Oxley Act by implementing the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies that we may not be able to remediate in time to meet the compliance deadline imposed by the Sarbanes-Oxley Act for compliance. In addition, we may encounter problems or delays in completing the implementation of any requested improvements and receiving a favorable attestation in connection with the attestation provided by our independent registered public accounting firm. If we fail to achieve and maintain an effective internal control environment our business and share price could be harmed and our ability to report our financial results accurately and in a timely manner could be impaired.

We have never paid cash dividends, do not anticipate paying any cash dividends and our ability to pay dividends, or repurchase or redeem our ordinary shares, is limited by law.

We have never declared or paid cash dividends on our ordinary shares and do not anticipate paying any dividends on our ordinary shares in the foreseeable future. Any determination to pay dividends in the future will

 

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at the sole discretion of our board of directors after considering our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions and other factors our board of directors deems relevant, and subject to compliance with applicable laws (including the Irish Companies Acts, which require Irish companies to have distributable reserves available for distribution equal to or greater than the amount of the proposed dividend). Accordingly, the only opportunity to achieve a return on your investment in our company is expected to be if the market price of our ordinary shares appreciates and you sell your ordinary shares at a profit. The price of our ordinary shares prevailing in the market after this offering may not exceed the price that you pay.

A future transfer of your ordinary shares, other than one effected by means of the transfer of book-entry interests in DTC, may be subject to Irish stamp duty.

The rate of stamp duty (when applicable) on the transfer of shares in an Irish-incorporated company is 1% of the price paid, or the market value of the shares acquired, whichever is greater. Payment of Irish stamp duty is generally a legal obligation of the transferee. We expect that most of our ordinary shares will be traded through Depositary Trust Company, or DTC, or through brokers who hold such shares on behalf of customers through DTC. As such, the transfer of ordinary shares should be exempt from Irish stamp duty based on established practice of the Irish Revenue Commissioners. We have received confirmation from the Irish Revenue Commissioners that a transfer of our ordinary shares held through DTC and transferred by means of a book-entry interest would be exempt from Irish stamp duty. We have also received confirmation from the Irish Revenue Commissioners that certain transfers of our ordinary shares into (or out of) DTC would be exempt from Irish stamp duty. However, if you hold your ordinary shares directly of record, rather than beneficially through DTC (or through a broker that holds your ordinary shares through DTC), any transfer of your ordinary shares may be subject to Irish stamp duty. The potential for stamp duty to arise could adversely affect the price and liquidity of our ordinary shares. In addition, the terms of our eligibility agreement with DTC will require us to provide certain indemnities relating to Irish stamp duty to third parties. If liability were to arise as a result of the indemnities provided under the terms of the eligibility agreement, we may face unexpected costs that could adversely impact our results of operations.

Anti-takeover provisions in our Articles and under Irish law could make an acquisition of us more difficult, limit attempts by our shareholders to replace or remove our current directors and management team, and limit the market price of our ordinary shares.

Our Articles will contain provisions that may delay or prevent a change of control, discourage bids at a premium over the market price of our ordinary shares, and adversely affect the market price of our ordinary shares and the voting and other rights of the holders of our ordinary shares. These provisions will include:

 

    dividing our board of directors into two classes, with each class serving a staggered two-year term;

 

    permitting our board of directors to issue additional preference shares, with such rights, preferences and privileges as they may designate; and

 

    establishing an advance notice procedure for shareholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to our board of directors.

These provisions would apply even if the offer may be considered beneficial by some shareholders. In addition, these provisions may frustrate or prevent any attempts by our shareholders to replace or remove our current management team by making it more difficult for shareholders to replace members of our board of directors, which is responsible for appointing the members of our management.

 

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Irish law differs from the laws in effect in the United States with respect to defending unwanted takeover proposals and may give our board of directors less ability to control negotiations with hostile offerors.

We are subject to the Irish Takeover Rules. Under the Irish Takeover Rules, our board of directors is not permitted to take any action that might frustrate an offer for our ordinary shares once our board of directors has received an approach that may lead to an offer or has reason to believe that such an offer is or may be imminent, subject to certain exceptions. Potentially frustrating actions such as (i) the issue of shares, options, restricted share units or convertible securities, (ii) material acquisitions or disposals, (iii) entering into contracts other than in the ordinary course of business or (iv) any action, other than seeking alternative offers, which may result in frustration of an offer, are prohibited during the course of an offer or at any earlier time during which our board of directors has reason to believe an offer is or may be imminent. These provisions may give our board of directors less ability to control negotiations with hostile offerors than would be the case for a corporation incorporated in a jurisdiction of the United States.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections of this prospectus titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” All statements, other than statements of historical facts, contained in this prospectus, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products, are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “positioned,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management’s beliefs and assumptions, are not guarantees of future performance or development and involve known and unknown risks, uncertainties, and other factors, including:

 

    our ability to become profitable;

 

    our expected uses of the net proceeds to us from this offering;

 

    our expectation that our existing cash and the net proceeds from this offering will be sufficient to fund our anticipated level of operations for at least the next 24 months;

 

    our ability to secure additional financing when needed on acceptable terms;

 

    our expectation regarding the safety and efficacy of our lead product candidates;

 

    our ability to advance our lead product candidates through various stages of development, especially through pivotal safety and efficacy studies;

 

    our expectations regarding the future development of additional product candidates;

 

    our ability to obtain regulatory approval for our current or future product candidates under applicable regulatory requirements;

 

    the discovery, development and manufacturing of biologics involves relatively novel technology and an expensive and lengthy approval process with uncertain outcomes;

 

    our reliance on third-party manufacturers to manufacture and supply our lead product candidates for us and on third-party distributors to distribute our product candidates, if approved;

 

    the rate and degree of market acceptance and the successful commercial sale of our lead product candidates, if approved;

 

    regulatory and legal developments in the United States and foreign countries;

 

    the success of competing platforms or therapies that are or become available;

 

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    our ability to attract or retain key employees, advisors or consultants;

 

    our expectations and statements regarding the potential size, opportunity and growth potential of the companion animal therapeutics market, and our ability to effectively compete and achieve significant market penetration;

 

    our ability to obtain and maintain patent protection for our lead product candidates;

 

    the implementation of our business model and strategic plans for our business, products and technology; and

 

    developments and growth relating to our industry.

Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. As a result, any or all of our forward-looking statements in this prospectus may turn out to be inaccurate. We have included important factors in the cautionary statements included in this prospectus, particularly in the section of this prospectus titled “Risk Factors,” that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Moreover, we operate in a highly competitive and rapidly changing environment in which new risks often emerge. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this prospectus are made as of the date of this prospectus, and we do not assume any obligation to update any forward-looking statements except as required by applicable law.

 

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INDUSTRY AND MARKET DATA

Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market size, is based on information from our own management estimates and research and primary market research commissioned by us, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. This information, however, involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. In addition, projections, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section of this prospectus titled “Risk Factors.” These and other factors could cause our future performance to differ materially from the projections, assumptions and estimates. See the section of this prospectus titled “Special Note Regarding Forward-Looking Statements.”

The following reports present data, research opinions, or viewpoints published by each of the respective publishers thereof and are not representations of fact. Such reports speak as of their respective original publication dates (and not as of the date of this prospectus), and the opinions expressed in such reports are subject to change without notice. The industry publications, reports, surveys and forecasts containing the industry and market data cited in this prospectus are provided below:

 

    The American Pet Products Association, Pet Industry Market Size & Ownership Statistics, 2014.

 

    The AP-Petside.com Poll, conducted by GfK Roper Public Affairs & Media, 2010.

 

    Banfield Pet Hospital, State of Pet Health 2013 Report, 2013.

 

    Banfield Pet Hospital, State of Pet Health 2012 Report, 2012.

 

    The European Food Industry Federation, Facts and Figures, 2012.

 

    GfK Animal and Crop Health, Monoclonal Antibody (mAb) Opportunities: Overview report from qualitative study among key opinion leaders, June 2014. In total, 34 veterinarian specialists were interviewed (13 in the United States and seven in each of France, Germany and the United Kingdom).

 

    GfK Animal and Crop Health, Pain management in cats and dogs: Concept test, December 2013. This study was conducted in November and December 2013. In total, 390 general veterinarian practitioners were interviewed online, using WorldOne platform (150 in the United States and 80 in each of France, Germany and the United Kingdom).

 

    Kelton Research LLC, The Milo’s Kitchen Pet Parent Survey, 2011.

 

    Pharmaceutical Commerce, Animal-health pharmaceuticals are jumping the “ethical channel, May 2013.

 

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USE OF PROCEEDS

We estimate that the net proceeds to us from our sale of         ordinary shares in this offering will be approximately $         million, based on an assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discount and estimated offering expenses payable by us. If the underwriters exercise their over-allotment option in full, we estimate the net proceeds to us will be approximately $         million, after deducting the underwriting discount and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $         per ordinary share would increase (decrease) the net proceeds to us from this offering by approximately $         million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discount. Similarly, each increase (decrease) of 1,000,000 in the number of ordinary shares we are offering would increase (decrease) the net proceeds to us from this offering by approximately $         million, assuming the assumed initial public offering price stays the same, and after deducting the underwriting discount.

We intend to use the net proceeds from this offering to complete the clinical development and chemistry, manufacturing and controls development of each of our lead product candidates as follows:

 

    $4.0 million to complete our pivotal safety and efficacy studies for NV-01, our lead product candidate for the control of pain associated with osteoarthritis in dogs, plus an additional $9.0 million for chemistry, manufacturing and controls studies ($5.0 million), stability studies ($2.0 million), and regulatory compliance and other miscellaneous costs ($2.0 million); and

 

    $13.0 to $15.0 million to complete the development and manufacturing scale-up of each of NV-02, our lead product candidate for the control of pain associated with degenerative joint disease in cats, and NV-08, our lead product candidate for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs, which includes for each lead product candidate pivotal safety and efficacy studies ($4.0 million), chemistry, manufacturing and controls studies ($4.0 to $5.0 million), stability studies ($2.0 million), costs for proof-of-concept related activities ($1.0 million) and regulatory compliance and other miscellaneous costs ($2.0 to $3.0 million).

Our estimates to complete development of NV-01, NV-02 and NV-08 are preliminary. Total costs to develop each lead product candidate will depend on, among other factors, the potency and yield of the selected cell lines, costs associated with increasing the batch size to commercial levels and to meet regulatory obligations, costs associated with gathering and responding to information obtained in proof-of-concept studies and costs associated with the number of animals enrolled in and the duration of pivotal safety and efficacy studies. We do not expect that amounts spent to develop any one product candidate will significantly overlap with or reduce the costs to develop any other product candidate.

We intend to fund research activities to develop our pipeline of other product candidates in an amount of $6.0 to $7.0 million per year. Assuming one or more of our lead product candidates is approved for marketing, we intend to establish our sales force infrastructure in the United States. We intend to use the remainder of the net proceeds from this offering for working capital and general corporate purposes. We may also use a portion of the net proceeds to acquire or in-license additional product candidates or complementary assets or businesses; however, we currently have no agreements, commitments or understandings to complete any such transaction.

Other than as set forth above, we have not yet identified the amounts we intend to spend on each of these areas or the timing of the expenditures. The expected uses of the net proceeds from this offering represent our intentions based on our current plans and business conditions and are approximations. Our actual use of these proceeds may differ substantially from our current intentions. The timing and amount of our actual expenditures

 

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will be based on many factors, including cash flows from operations, the anticipated growth of our business and any future acquisitions that we may propose. Accordingly, our management will have broad discretion regarding the use of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds in this offering. Pending these uses, we intend to invest the net proceeds from this offering in short-term, interest bearing, investment-grade securities. We cannot predict whether these investments will yield a favorable return.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our ordinary shares and do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future. Any determination to pay dividends in the future will be at the discretion of our board of directors after considering our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions and other factors our board of directors deems relevant, and subject to compliance with applicable laws (including the Irish Companies Acts, which require Irish companies to have profits available for distribution equal to or greater than the amount of the proposed dividend). We may require distributions from our subsidiary companies, particularly Nexvet Australia, in order to pay dividends, which may subject us to dividend income tax.

 

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CAPITALIZATION

The following table sets forth our cash and capitalization as of September 30, 2014 on:

 

    an actual basis;

 

    a pro forma basis after giving effect to the automatic conversion of our outstanding preference shares into 5,937,138 ordinary shares upon the completion of this offering; and

 

    a pro forma as adjusted basis to give further effect to our issuance and sale of              ordinary shares in this offering at the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting the underwriting discount and estimated offering expenses payable by us.

This table should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this prospectus.

 

     As of September 30, 2014  
     Actual     Pro
Forma
    Pro
Forma As
Adjusted(1)
 
     (unaudited)  
     (in thousands, except share and per
share amounts)
 

Cash

   $ 26,388      $ 26,388      $                
  

 

 

   

 

 

   

 

 

 

Shareholders’ (deficit) equity:

      

Euro deferred shares, €100 nominal value per share—400 issued and outstanding, actual; 400 shares issued and outstanding, pro forma and pro forma as adjusted

   $ 13      $ 13      $     

Ordinary shares, $0.125 nominal value per share—1,142,858 shares issued and outstanding, actual; 7,079,996 shares issued and outstanding, pro forma;              shares issued and outstanding, pro forma as adjusted

     142        885     

Convertible preference shares, $0.125 nominal value per share—5,937,138 shares issued and outstanding, actual; no shares issued and outstanding, pro forma and pro forma as adjusted

     33,826        —       

Additional paid-in capital

     7,929        41,012     

Accumulated other comprehensive income

     (1,768     (1,768  

Accumulated deficit

     (14,095     (14,095  
  

 

 

   

 

 

   

 

 

 

Total shareholders’ (deficit) equity

     26,047        26,047     
  

 

 

   

 

 

   

 

 

 

Total capitalization

   $ 26,047      $ 26,047      $     
  

 

 

   

 

 

   

 

 

 

 

(1) Each $1.00 increase (decrease) in the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) each of cash, total assets and total shareholders’ (deficit) equity on a pro forma as adjusted basis by approximately $         million, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, after deducting the underwriting discount. Similarly, each increase (decrease) of 1,000,000 in the number of ordinary shares we are offering would increase (decrease) each of cash, total assets and total shareholders’ (deficit) equity on a pro forma as adjusted basis by approximately $         million, assuming that the assumed initial public offering price remains the same, and after deducting the underwriting discount. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

 

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Outstanding ordinary shares reflected in the discussion and table above is based on 7,079,996 ordinary shares outstanding as of September 30, 2014 and excludes:

 

    1,766,998 ordinary shares issuable upon the exercise of warrants to purchase ordinary shares outstanding as of September 30, 2014, with a weighted-average exercise price of $8.50 per ordinary share;

 

    358,553 ordinary shares issuable upon the exercise of options outstanding as of September 30, 2014, with a weighted-average exercise price of $2.64 per ordinary share, and 141,792 ordinary shares issuable upon the exercise of options issued after September 30, 2014, with an exercise price of the nominal value of $0.125 per ordinary share;

 

    50,454 ordinary shares issuable upon the conversion of restricted share units outstanding as of September 30, 2014 and 16,427 ordinary shares issuable upon the conversion of restricted share units issued after September 30, 2014, with a conversion price of the nominal value of $0.125 per ordinary share;

 

    32 ordinary shares, including 12 ordinary shares issuable upon the conversion of Series A investment preference shares and 10 ordinary shares issuable upon the conversion of Series B preference shares, outstanding following the November 2014 four-for-five share consolidation, which represent certain shares that would have become fractional shares in the consolidation and new issuances to prevent any fractional shares as a result of the consolidation, all of which shares are being held in trust pending their redemption or sale;

 

    201,960 ordinary shares reserved for future issuance under our 2013 Long Term Incentive Plan as of September 30, 2014; and

 

    1,280,000 ordinary shares reserved for future issuance under our 2014 Equity Incentive Plan, to be effective upon the completion of this offering.

 

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DILUTION

If you invest in our ordinary shares in this offering, your ownership interest will be diluted immediately to the extent of the difference between the initial public offering price per ordinary share and the pro forma as adjusted net tangible book value per ordinary share immediately after the completion of this offering. Net tangible book value per ordinary share dilution to new investors represents the difference between the amount per ordinary share paid by purchasers of our ordinary shares in this offering and the pro forma as adjusted net tangible book value per ordinary share immediately after the completion of this offering.

Our historical net tangible book value as of September 30, 2014 was $26.0 million, or $22.79 per ordinary share. Our pro forma net tangible book value as of September 30, 2014 was $26.0 million, or $3.68 per ordinary share, after giving effect to the automatic conversion of all of our outstanding preference shares into 5,937,138 ordinary shares upon the completion of this offering.

After giving further effect to our sale of              ordinary shares in this offering at the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the underwriting discount and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of September 30, 2014 would have been approximately $         million, or $         per ordinary share. This amount represents an immediate increase in our pro forma net tangible book value of $         per ordinary share to existing shareholders and an immediate dilution of $         per ordinary share to new investors purchasing our ordinary shares in this offering at the assumed initial public offering price. The following table illustrates this dilution on a per ordinary share basis:

 

Assumed initial public offering price per ordinary share

      $                
     

Pro forma net tangible book value per ordinary share as of September 30, 2014, before giving effect to this offering

   $                   

Increase in pro forma net tangible book value per ordinary share attributable to new investors

     
  

 

 

    

Pro forma as adjusted net tangible book value per ordinary share after this offering

     
     

 

 

 

Dilution in net tangible book value per ordinary share to new investors in this offering

      $     
     

 

 

 

Each $1.00 increase (decrease) in the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as adjusted net tangible book value as of September 30, 2014 by approximately $         million, or approximately $         per ordinary share, and would increase (decrease) dilution to investors in this offering by approximately $         per ordinary share, assuming that the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the underwriting discount and estimated offering expenses payable by us.

Similarly, each increase (decrease) of 1,000,000 in the number of ordinary shares we are offering would increase (decrease) our pro forma as adjusted net tangible book value as of September 30, 2014 by approximately $         million, or approximately $         per ordinary share, and would increase (decrease) dilution to investors in this offering by approximately $         per ordinary share, assuming the assumed initial public offering price remains the same, and after deducting the underwriting discount. The pro forma as adjusted information is illustrative only, and we will adjust this information based on the actual initial public offering price and other terms of this offering determined at pricing.

If the underwriters exercise their over-allotment option to subscribe for              additional ordinary shares in full, our pro forma as adjusted net tangible book value will be $         million, or $         per ordinary share,         representing an increase to existing shareholders of $         per ordinary share, and an immediate dilution of $         per ordinary share to new investors, in each case assuming an initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus.

 

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The following table presents, on a pro forma as adjusted basis, as of September 30, 2014, the differences between existing shareholders and new investors purchasing ordinary shares in this offering with respect to the number of ordinary shares purchased from us, the total consideration paid in cash and the average price paid per ordinary share. The calculation below is based on the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting the underwriting discount and estimated offering expenses payable by us.

 

     Shares Purchased     Total
Consideration
    Average
Price Per
Share
 
     Number    Percent     Amount      Percent    

Existing shareholders

                   $                             $           

Investors participating in this offering

            
  

 

  

 

 

   

 

 

    

 

 

   

Total

        100   $           100  
  

 

  

 

 

   

 

 

    

 

 

   

Each $1.00 increase (decrease) in the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) total consideration paid by new investors, total consideration paid by all shareholders and the average price per ordinary share paid by all shareholders by $         million, $         million and $        , respectively, assuming the number of ordinary shares offered by us, as set forth on the cover page of this prospectus, remains the same, and before deducting the underwriting discount and estimated offering expenses payable by us.

If the underwriters exercise their over-allotment option to subscribe for             additional ordinary shares in full, the number of ordinary shares held by existing shareholders would be             , or approximately         % of the total number of ordinary shares outstanding after this offering, and the number of ordinary shares held by new investors would increase to             , or approximately         % of the total number of our ordinary shares outstanding after this offering.

The above discussion and tables are based on 7,079,996 ordinary shares outstanding as of September 30, 2014 and exclude:

 

    1,766,998 ordinary shares issuable upon the exercise of warrants to purchase ordinary shares outstanding as of September 30, 2014, with a weighted-average exercise price of $8.50 per ordinary share;

 

    358,553 ordinary shares issuable upon the exercise of options outstanding as of September 30, 2014, with a weighted-average exercise price of $2.64 per ordinary share, and 141,792 ordinary shares issuable upon the exercise of options issued after September 30, 2014, with an exercise price of the nominal value of $0.125 per ordinary share;

 

    50,454 ordinary shares issuable upon the conversion of restricted share units outstanding as of September 30, 2014 and 16,427 ordinary shares issuable upon the conversion of restricted share units issued after September 30, 2014, with a conversion price of the nominal value of $0.125 per ordinary share;

 

    32 ordinary shares, including 12 ordinary shares issuable upon the conversion of Series A investment preference shares and 10 ordinary shares issuable upon the conversion of Series B preference shares, outstanding following the November 2014 four-for-five share consolidation, which represent certain shares that would have become fractional shares in the consolidation and new issuances to prevent any fractional shares as a result of the consolidation, all of which shares are being held in trust pending their redemption or sale;

 

    201,960 ordinary shares reserved for future issuance under our 2013 Long Term Incentive Plan as of September 30, 2014; and

 

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    1,280,000 ordinary shares reserved for future issuance under our 2014 Equity Incentive Plan, to be effective upon the completion of this offering.

To the extent any of these outstanding warrants or options to purchase ordinary shares are exercised or any of these restricted share units are converted into ordinary shares, there will be further dilution to new investors. If all of our outstanding warrants and options to purchase ordinary shares as of September 30, 2014 were exercised, and all of our outstanding restricted share units as of September 30, 2014 were converted to ordinary shares, our pro forma as adjusted net tangible book value per ordinary share would be $         per ordinary share, representing an increase to existing shareholders of $         per ordinary share, and an immediate dilution of $         per ordinary share to new investors.

The foregoing discussion and tables do not reflect potential purchases by entities affiliated with Farallon, which hold more than 5% of our ordinary shares and are affiliates of a director nominee, that have indicated an interest in purchasing our ordinary shares in this offering as described in the section of this prospectus titled “Underwriting.”

 

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SELECTED CONSOLIDATED FINANCIAL DATA

We derived the selected consolidated statements of operations data for fiscal years 2013 and 2014 and the balance sheet data as of June 30, 2013 and 2014 from our audited consolidated financial statements included elsewhere in this prospectus. We derived the selected consolidated statements of operations data for the three months ended September 30, 2013 and 2014 and the balance sheet data as of September 30, 2014 from our unaudited consolidated financial statements included elsewhere in this prospectus. We have prepared the unaudited consolidated financial statements on the same basis as the audited consolidated financial statements, and, in the opinion of management, the unaudited consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, necessary for the fair statement of those financial statements. You should read the following selected consolidated financial data in conjunction with the section of this prospectus titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our consolidated financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results to be expected in the future, and our interim results are not necessarily indicative of the results that should be expected for the full year or any other period.

Nexvet Biopharma plc became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma plc and its subsidiaries as a continuation of the predecessor.

 

    Year Ended
June 30,
   

Three Months Ended
September 30,

 
    2013     2014     2013     2014  
                (unaudited)  
    (in thousands, except share and per share amounts)  

Consolidated Statements of Operations Data:

       

Revenue

       

License and collaboration

  $ 244      $ —        $ —        $ —     

Other

    85        13        —          25   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

    329        13        —          25   

Operating expenses

       

Research and development

    2,722        5,617        1,240        2,539   

General and administrative

    2,103        4,426        568        2,818   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

    4,825        10,043        1,808        5,357   
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

    (4,496     (10,030     (1,808     (5,332

Other income (expense)

       

Research and development incentive income

    1,135        2,337        503        741   

Government grant income

    108        1,317        318        297   

Exchange (loss) gain

    —          (375     (30     1,984   

Interest income

    12        41        1        13   
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $ (3,241   $ (6,710   $ (1,016   $ (2,297
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to ordinary shareholders, basic and diluted(1)

  $ (3.62   $ (6.70   $ (1.02   $ (2.13
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average ordinary shares outstanding, basic and diluted(1)

    894,794        1,000,872        1,000,000        1,078,166   
 

 

 

   

 

 

   

 

 

   

 

 

 

Pro forma net loss attributable to ordinary shareholders, basic and diluted(1)

    $ (6,710     $ (2,297
   

 

 

     

 

 

 

Pro forma net loss per share attributable to ordinary shareholders, basic and diluted(1)

    $ (2.07     $ (0.33
   

 

 

     

 

 

 

Pro forma weighted-average ordinary shares outstanding, basic and diluted(1)

      3,242,004          7,015,321   
   

 

 

     

 

 

 

 

(1) See Notes 2 and 11 to our consolidated financial statements included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share attributable to ordinary shareholders and pro forma net loss per share attributable to ordinary shareholders.

 

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     June 30,     September 30,  
     2013     2014         2014      
                 (unaudited)  
     (in thousands)  

Consolidated Balance Sheet Data:

      

Cash

   $ 483      $ 30,041      $ 26,388   

Total assets

     1,914        33,604        28,740   

Total liabilities

     1,231        8,735        2,693   

Convertible preference shares

     3,597        33,826        —     

Total shareholders’ (deficit) equity

     (2,914     (8,957     26,047   

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes included elsewhere in this prospectus. Nexvet Biopharma plc became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma plc and its subsidiaries as a continuation of the predecessor. The information contained in this discussion and analysis and set forth elsewhere in this prospectus includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section of this prospectus titled “Risk Factors,” our actual results could differ materially from the results described in or implied by the forward-looking statements.

Overview

We are a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals by developing and commercializing novel, species-specific biologics based on human biologics. As a class, biologics, which include mAbs and fusion proteins, have transformed human medicine in recent decades and represent some of the top-selling therapies on the market today. Our proprietary PETization platform is an algorithmic approach that enables us to rapidly create mAbs that are designed to be recognized as “self” or “native” by an animal’s immune system, a property we refer to as “100% species-specificity.” PETization is also designed to build upon the safety and efficacy data from clinically-tested human therapies to create new therapies for companion animals, thereby reducing clinical risk and development cost. Through PETization and other discovery research, we have developed our three lead product candidates: NV-01 for the control of pain associated with osteoarthritis in dogs, NV-02 for the control of pain associated with degenerative joint disease in cats and NV-08 for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs. We expect data from our pivotal safety and efficacy studies for NV-01 by the end of 2015 and for NV-02 in 2016. If our proof-of-concept safety and efficacy studies for NV-08 are successful, we will progress this product into formal development. Using PETization, we are seeking to advance one new product candidate into development per year, commencing in the second half of 2015.

Since our inception, we have been developing our PETization platform, completing proof-of-concept studies for NV-01, NV-02, NV-08 and other product candidates, establishing clonal cell lines, conducting market surveys regarding our lead product candidates and preparing for pivotal safety and efficacy studies. We also have focused on securing intellectual property, recruiting management and key employees and fundraising activities. We do not have any products approved for sale, have not generated any revenue from product sales since our inception and do not expect to generate any revenue from the sale of products in the near future. We have incurred significant net losses since our inception, including $3.2 million, $6.7 million, $1.0 million and $2.3 million for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, and as of September 30, 2014 we had an accumulated deficit of $14.1 million. This accumulated deficit has resulted principally from costs incurred in connection with research and development of our product candidates and general and administrative costs associated with our operations.

We will require additional capital until we can generate revenue in excess of operating expenses. We may seek such funding through public or private equity, debt financing or other sources, such as corporate collaborations and licensing arrangements. We may not be able to obtain financing on acceptable terms, or at all. The sale of additional equity would result in additional dilution to our shareholders, and the terms of any financing may adversely affect the rights of our shareholders. The incurrence of any debt financing could result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are unable to obtain funding, we could be forced to delay, reduce or eliminate our research and development programs or commercialization efforts, which could adversely affect our business prospects.

 

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Share Consolidations and Irish Reorganization

In August 2014, Nexvet Australia completed a one-for-four share consolidation pursuant to which each holder of ordinary shares received one ordinary share for every four ordinary shares held by such holder, and each holder of preference shares received one preference share for every four preference shares held by such holder. The number of ordinary shares that may be acquired upon exercise of options or warrants or upon conversion of restricted share units was similarly reduced on a one-for-four basis, with a proportionate adjustment to the exercise or conversion price, as applicable. Because Irish law requires the payment to an issuer of at least the nominal value per share in order to acquire such shares from the issuer, any options or restricted share units with a nil exercise or conversion price became exercisable or convertible, as applicable, at the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

In September 2014, Nexvet Australia completed the Irish Exchange, pursuant to which (i) Nexvet Biopharma Limited became the parent company of Nexvet Australia and its subsidiaries and (ii) holders of ordinary shares, preference shares, restricted share units and options and warrants to purchase ordinary shares of Nexvet Australia exchanged their holdings for equivalent ordinary shares, preference shares, restricted share units or options or warrants to purchase ordinary shares, as applicable, of Nexvet Biopharma Limited. Nexvet Biopharma Limited then re-registered as an Irish public limited company in September 2014. Nexvet Biopharma plc became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma plc and its subsidiaries as a continuation of the predecessor.

In November 2014, we completed a four-for-five share consolidation pursuant to which each holder of ordinary shares received four ordinary shares for every five ordinary shares held by such holder, and each holder of preference shares received four preference shares for every five preference shares held by such holder. The number of ordinary shares that may be acquired upon exercise of options or warrants or upon conversion of restricted share units was similarly reduced on a four-for-five basis, with a proportionate adjustment to the exercise or conversion price, as applicable.

Basis of Presentation

Revenue

License and collaboration revenue in fiscal year 2013 consisted of an upfront payment under a license and collaboration agreement. Upon execution of the agreement, we were entitled to the upfront payment without any further performance obligations. Other revenue consisted of an insurance refund.

Operating Expenses

The majority of our operating expenses have been research and development activities related to our lead product candidates and general and administrative costs associated with our business.

Research and Development Expense

Research and development costs are expensed as incurred and consist primarily of (i) payroll and related expense for all employees engaged in scientific research and development functions, including wages, related benefits and share-based compensation, (ii) fees for regulatory, professional and other consultants and (iii) development costs, including costs of drug discovery, safety, proof-of-concept studies and pivotal safety and efficacy studies, development of biological materials, and service providers. We are currently pursuing our NV-01, NV-02 and NV-08 lead product candidates and typically use our employee and infrastructure resources

 

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across multiple development programs. We track outsourced development costs by lead product candidates for billing and research and development incentive income purposes, but we do not allocate personnel or other internal costs related to development to specific product candidates.

We expect research and development expense to increase significantly for the foreseeable future as we continue to increase our headcount, commence and conduct pivotal safety and efficacy studies and further develop our lead product candidates. We expect research and development expense associated with NV-01 to be approximately $13.0 million over the next three years, which includes $4.0 million for the cost of our pivotal safety and efficacy studies plus an additional $9.0 million for chemistry, manufacturing and controls studies, stability studies and regulatory compliance and other miscellaneous costs. Our development of NV-02 and NV-08 is not as advanced as our development of NV-01. However, assuming development costs similar to those for NV-01, we estimate research and development expense for the development of each of NV-02 and NV-08 to be approximately $13.0 to $15.0 million.

Drug development is inherently unpredictable and the nature, specific timing and estimated costs of the efforts that will be necessary to complete the development of our lead product candidates are subject to numerous factors. For example, the nature, timing and amount of research and development expense incurred will depend largely upon the outcomes of current and future pivotal safety and efficacy studies for our lead product candidates as well as the related regulatory requirements, manufacturing costs and costs associated with the development of our lead product candidates. Factors that can influence the duration, cost and timing of our pivotal safety and efficacy studies and development of our lead product candidates include:

 

    the scope, rate of progress and expense of our ongoing, as well as any additional, pivotal safety and efficacy studies and other research and development activities;

 

    results of future pivotal safety and efficacy studies;

 

    potential changes in government regulation; and

 

    the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a lead product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

General and Administrative Expense

General and administrative expense consists primarily of non-research and development-related payroll and related expense for employees, consultants and directors, including wages, related benefits and share-based compensation. General and administrative expense also includes professional and consulting fees for legal, accounting, tax services and other general business services, as well other expenses such as travel, rent and facilities costs. We expect general and administrative expense to increase significantly as we begin operating as a public company and continue to build our corporate infrastructure globally and prepare to commercialize and market our products.

Other Income (Expense)

Research and Development Incentive Income

We are eligible under the AusIndustry research and development tax incentive program to obtain a cash amount from the Australian Taxation Office. The tax incentive is available to us on the basis of specific criteria with which we must comply. Although the research and development assistance is administered through the Australian Taxation Office, we have accounted for the government assistance outside the scope of Accounting

 

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Standards Codification, or ASC, Topic 740, Income Taxes, as an income tax benefit since we meet the applicable requirements to participate in the plan and the incentive is not linked to our income tax liability and can be realized regardless of whether we have generated taxable income. Research and development incentive income is recognized when the research and development activities have been undertaken and we have completed its assessment of whether such activities meet the relevant qualifying criteria. We intend to continue conducting research and development in Australia, and we expect to therefore remain eligible for this incentive.

Government Grant Income

We recognize government grant income at the fair value of the grant when it is received and all substantive conditions have been satisfied. We do not expect that future Australian government grant awards will be available.

Exchange (Loss) Gain

Exchange (loss) gain consists primarily of gains or losses due to foreign exchange translation, primarily reflecting changes in Australian and U.S. foreign exchange rates. Under U.S. GAAP, these losses relate to a translation of U.S. dollar-denominated bank accounts into Nexvet Australia’s Australian dollar functional currency and represent a non-cash item.

Interest Income

We earn interest on the cash balances held with financial institutions and recognize interest when earned.

Results of Operations

Results of operations for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014 were as follows:

 

     Year Ended
June 30,
   

Three Months Ended
September 30,

 
     2013     2014     2013     2014  
                 (unaudited)  
     (in thousands)  

Revenue

        

License and collaboration

   $ 244      $ —        $ —        $ —     

Other

     85        13        —          25   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     329        13        —          25   

Operating expenses

        

Research and development

     2,722        5,617        1,240        2,539   

General and administrative

     2,103        4,426        568        2,818   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     4,825        10,043        1,808        5,357   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,496     (10,030     (1,808     (5,332

Other income and expense

        

Research and development incentive income

     1,135        2,337        503        741   

Government grant income

     108        1,317        318        297   

Exchange (loss) gain

     —          (375     (30     1,984   

Interest income

     12        41        1        13   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (3,241   $ (6,710   $ (1,016   $ (2,297
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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Foreign Currency

Items included in our consolidated financial statements are measured using the currency of the primary economic environment in which we operate, referred to as the functional currency. Financial statements of companies operating outside the United States generally are measured using the local currency as the functional currency. Adjustments to translate those statements into United States dollars are recorded in other comprehensive income (loss), or OCI, as a net change in foreign currency translation. Non-cash currency translation adjustments in accumulated OCI were a gain of $0.1 million, $0.3 million and $0.2 million as of June 30, 2013 and 2014 and September 30, 2013, respectively, and a loss of $2.1 million as of September 30, 2014, and primarily relate to translation of U.S. dollar-denominated bank accounts from Nexvet Australia’s Australian dollar functional currency to U.S. dollars.

Foreign currency transactions are translated into the functional currency using the current exchange rate. For assets and liabilities, the exchange rate at the balance sheet date is used. For revenue and expenses and gains and losses, a weighted-average exchange rate for the period is used to translate those elements. The reporting currency of these consolidated financial statements is U.S. dollars. Losses from foreign currency translation for fiscal years 2013 and 2014 and the three months ended September 30, 2013 were nil, $0.4 million and $30,000, respectively, and gain from foreign currency translation for the three months ended September 30, 2014 was $2.0 million. These losses and gain relate to a translation of U.S. dollar-denominated bank accounts into our Australian dollar functional currency and are included in other income (expense).

Under U.S. GAAP, there is no offset of these two exchange-related items within the consolidated statements of operations and comprehensive loss. Accordingly, in addition to U.S. GAAP measures, management uses net loss excluding exchange (loss) gain to evaluate the business. Net loss excluding exchange (loss) gain is a non-GAAP financial measure. Management believes that the net loss excluding exchange (loss) gain is a better reflection of the underlying business performance. Net loss excluding exchange (loss) gain for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014 was as follows:

 

     Year Ended
June 30,
    Three Months Ended
September 30,
 
     2013      2014     2013     2014  
           (unaudited)  
     (in thousands)  

Net loss as reported

   $ 3,241       $ 6,710      $ 1,016      $ 2,297   

Exchange (loss) gain

     —           (375     (30     1,984   
  

 

 

    

 

 

   

 

 

   

 

 

 

Net loss excluding exchange (loss) gain

   $ 3,241       $ 6,335      $ 986      $ 4,281   
  

 

 

    

 

 

   

 

 

   

 

 

 

Comparison of Three Months Ended September 30, 2013 to Three Months Ended September 30, 2014

Revenue

Other revenue in the three months ended September 30, 2014 was $25,000, which was primarily attributable to a reimbursement of intellectual property costs.

Research and Development Expense

Research and development expense for the three months ended September 30, 2013 and 2014 was as follows:

 

    

Three Months Ended
September 30,

 
    

  2013  

    

  2014  

 
     (in thousands)  

Payroll and related

   $ 102       $ 464   

Consulting

     158         96   

Development costs

     980         1,979   
  

 

 

    

 

 

 

Total

   $ 1,240       $ 2,539   
  

 

 

    

 

 

 

 

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Research and development expense increased $1.3 million, or 108%, from $1.2 million in the three months ended September 30, 2013 to $2.5 million in the three months ended September 30, 2014, which was primarily attributable to a $1.0 million increase in development costs and a $0.4 million increase in payroll and related costs. The increase in development costs was mainly due to advancing the development of our lead product candidates, including proof-of-concept studies associated with NV-02, and manufacturing costs incurred in the three months ended September 30, 2014. The increase in payroll and related costs was mainly due to building our research and development team. In the three months ended September 30, 2013 and 2014, outsourced development costs were $0.8 million and $0.8 million, respectively, for NV-01 and $27,000 and $0.9 million, respectively, for NV-02.

General and Administrative Expense

General and administrative expense for the three months ended September 30, 2013 and 2014 was as follows:

 

    

Three Months Ended

September 30,

 
    

  2013  

    

  2014  

 
     (in thousands)  

Payroll and related

   $ 75       $ 759   

Consulting and legal fees

     237         1,536   

Other costs

     256         523   
  

 

 

    

 

 

 

Total

   $ 568       $ 2,818   
  

 

 

    

 

 

 

Our general and administrative expense increased $2.2 million, or 367%, from $0.6 million in the three months ended September 30, 2013 to $2.8 million in the three months ended September 30, 2014, which was attributable to a $0.7 million increase in payroll and related costs, a $1.3 million increase in accounting, consulting and legal fees associated with this offering and a $0.2 million increase in other costs. The increase in payroll and related costs was mainly due to building our general and administrative team. The increase in other costs was mainly due to increases in travel and property lease costs.

Research and Development Incentive Income

Research and development incentive income increased by $0.2 million, from $0.5 million in the three months ended September 30, 2013 to $0.7 million in the three months ended September 30, 2014, primarily due to our increase in qualifying expenditures in the three months ended September 30, 2014.

Government Grant Income

In each of the three months ended September 30, 2013 and 2014, we recognized $0.3 million in income from an Australian government grant.

Comparison of Fiscal Year 2013 to Fiscal Year 2014

Revenue

Revenue in fiscal year 2013 was $0.3 million, which was primarily attributable to an upfront payment pursuant to a license and collaboration agreement of $0.2 million and $0.1 million in other revenue from an insurance refund.

 

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Research and Development Expense

Research and development expense for fiscal years 2013 and 2014 was as follows:

 

     Year Ended
June 30,
 
     2013      2014  
     (in thousands)  

Payroll and related

   $ 642       $    1,162   

Consulting

     262         249   

Development costs

     1,818         4,206   
  

 

 

    

 

 

 

Total

   $ 2,722       $ 5,617   
  

 

 

    

 

 

 

Research and development expense increased $2.9 million, or 107%, from $2.7 million in fiscal year 2013 to $5.6 million in fiscal year 2014, which was primarily attributable to a $2.4 million increase in development costs and a $0.5 million increase in payroll and related costs. The increase in development costs was mainly due to advancing the development of our lead product candidates with proof-of-concept studies conducted and manufacturing costs incurred in fiscal year 2014. The increase in payroll and related costs was mainly due to building our research and development team.

In each of fiscal years 2013 and 2014, outsourced development costs were $1.4 million and $1.7 million, respectively, for NV-01, $0.1 million and $1.2 million, respectively, for NV-02 and $0.1 million and $0.5 million, respectively, for NV-08.

General and Administrative Expense

General and administrative expense for fiscal years 2013 and 2014 was as follows:

 

     Year Ended
June 30,
 
     2013      2014  
     (in thousands)  

Payroll and related

   $ 687       $ 1,498   

Consulting and legal fees

     911         1,753   

Other costs

     505         1,175   
  

 

 

    

 

 

 

Total

   $ 2,103       $ 4,426   
  

 

 

    

 

 

 

Our general and administrative expense increased $2.3 million, or 110%, from $2.1 million in fiscal year 2013 to $4.4 million in fiscal year 2014, which was attributable to an $0.8 million increase in payroll and related costs, an $0.8 million increase in consulting and legal fees and a $0.7 million increase in other costs. The increase in payroll and related costs was mainly due to building our general and administrative team. The increase in other costs was mainly due to increases in travel and marketing-related costs.

Research and Development Incentive Income

We applied for $1.1 million and $2.3 million for fiscal years 2013 and 2014, respectively, under the AusIndustry research and development tax incentive program. We received our fiscal year 2013 claim of $1.1 million in October 2013 and our fiscal year 2014 claim of $2.3 million in August 2014. Incentive income increased by $1.2 million, from $1.1 million in fiscal year 2013 to $2.3 million in fiscal year 2014, due to our increase in qualified expenditures in 2014.

 

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Government Grant Income

In fiscal year 2013, we were awarded an Australian government grant of $1.5 million, of which $0.1 million was recognized in fiscal year 2013 and $1.3 million was recognized in fiscal year 2014, and we expect to recognize $0.1 million in fiscal year 2015.

Liquidity and Capital Resources

We have incurred losses and negative cash flows from operations since our inception. As of September 30, 2014, we had an accumulated deficit of $14.1 million. Since inception, we have raised aggregate gross proceeds of $39.9 million from the sale of preference shares, ordinary shares, convertible notes and warrants. We believe our cash balance of $26.4 million as of September 30, 2014, together with the net proceeds from this offering, will be sufficient to fund our anticipated level of operations for at least the next 24 months. For the foreseeable future, we expect to continue to incur losses, which will increase significantly from historical levels as we expand our product development activities, seek regulatory approvals for our lead product candidates and begin commercialization activities in anticipation of regulatory approval.

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. Such financing may result in dilution to shareholders, imposition of debt covenants and repayment obligations or other restrictions that may affect our business. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plan.

Our future capital requirements will depend on many factors, including:

 

    the scope, progress, results and costs of researching and developing our current or future product candidates, including conducting proof-of-concept and pivotal safety and efficacy studies;

 

    the timing of, and the costs involved in, obtaining regulatory approvals for any of our current or future product candidates;

 

    the number and characteristics of the product candidates we pursue;

 

    whether we acquire or license any other companies, assets, intellectual property or technologies in the future;

 

    the cost of commercialization activities, if any of our current or future product candidates are approved for sale, including marketing, sales and distribution costs;

 

    the cost of manufacturing our current and future product candidates and any approved products we successfully commercialize;

 

    our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;

 

    the expenses needed to attract and retain skilled personnel;

 

    the costs associated with being a public company; and

 

    the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, if any arise, including litigation costs and the outcome of such litigation.

 

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Cash Flows

The following table shows a summary of our cash flows for the periods set forth below:

 

     Year Ended
June 30,
    Three Months Ended
September 30,
 
     2013     2014     2013     2014  
                 (unaudited)  
     (in thousands)  

Net cash used in operating activities

   $ (2,962   $ (5,944   $ (997   $ (1,349

Net cash used in investing activities

     (54     (514     (32     (185

Net cash provided by financing activities

     3,392        35,701        1,586        13   

Effect of exchange rate changes on cash

     88        315        53        (2,132

Net Cash Used in Operating Activities

For the three months ended September 30, 2014, net cash used in operating activities was $1.3 million. Net cash used in operating activities was primarily attributable to our net loss of $2.3 million and non-cash share-based compensation expense of $0.2 million, offset primarily by changes in our operating assets and liabilities of $0.7 million.

For the three months ended September 30, 2013, net cash used in operating activities was $1.0 million. Net cash used in operating activities was primarily attributable to our net loss of $1.0 million. Changes in our operating assets and liabilities resulted in a net offset.

For fiscal year 2014, net cash used in operating activities was $5.9 million. Net cash used in operating activities was primarily attributable to our net loss of $6.7 million, partially offset by changes in our operating assets and liabilities of $0.4 million, non-cash share-based compensation expense of $0.3 million and $0.1 million relating to non-cash depreciation and amortization.

For fiscal year 2013, net cash used in operating activities was $3.0 million. Net cash used in operating activities was primarily attributable to our net loss of $3.2 million and changes in our operating assets and liabilities of $0.4 million, partially offset by non-cash share-based compensation expense of $0.7 million.

Net Cash Used in Investing Activities

For the three months ended September 30, 2014, net cash used in investing activities was $0.2 million, which was solely attributable to purchases of property, plant and equipment.

For the three months ended September 30, 2013, net cash used in investing activities was $32,000, which was primarily attributable to purchases of property, plant and equipment.

For fiscal year 2014, net cash used in investing activities was $0.5 million, which was primarily attributable to purchases of property, plant and equipment.

For fiscal year 2013, net cash used in investing activities was $0.1 million, which was solely attributable to purchases of property, plant and equipment.

Net Cash Provided by Financing Activities

For the three months ended September 30, 2014, net cash provided by financing activities was $13,000, which is solely attributable to proceeds received from the issuance of ordinary shares.

 

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For the three months ended September 30, 2013, net cash provided by financing activities was $1.6 million. Net cash provided by financing activities was primarily attributable to gross proceeds of $1.7 million from the sale of our preference shares, offset by issuance costs of $0.1 million.

For fiscal year 2014, net cash provided by financing activities was $35.7 million. Net cash provided by financing activities was primarily attributable to gross proceeds of $36.4 million from the sale of our preference shares, offset by issuance costs of $1.3 million, of which $0.6 million was non-cash issuance costs in the form of warrants to advisors.

For fiscal year 2013, net cash provided by financing activities was $3.4 million. Net cash provided by financing activities was attributable to gross proceeds of $3.6 million from sale of our preference shares, offset by repayment of $0.2 million of notes to a related party.

Contractual Obligations and Commitments

The following table summarizes our principal contractual obligations and commitments, which are related to property leases and supplier purchase obligations, at June 30, 2014.

 

     Total      Less than
1 Year
     1 to 3
Years
     3 to 5
Years
     After 5
Years
 
     (in thousands)  

Operating leases(1)

   $ 475       $ 97       $ 205       $ 173       $ —     

Purchase obligations(2)

     1,670         1,670         —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 2,145       $ 1,767       $ 205       $ 173       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Represents future minimum lease payments under our non-cancelable operating lease, including our Melbourne facilities.
(2) Represents future payments pursuant to contracts with suppliers of goods and services to support our product development. We enter into agreements in the normal course of business with CROs for pivotal safety and efficacy studies and with vendors for pre-clinical research studies and other services and products for operating purposes which are cancelable at any time by us, generally upon 30 days prior written notice. These payments are not included in this table of contractual obligations.

Off-Balance Sheet Arrangements

Since inception, we have not engaged in the use of any off-balance sheet arrangements, such as structured finance entities, special purpose entities or variable interest entities.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and revenue, costs and expenses and related disclosures during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including those described below. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements included elsewhere in this prospectus, we believe that the estimates and assumptions involved in the following accounting policies may have the greatest potential impact on our consolidated financial statements.

 

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Research and Development Accruals

As part of the process of preparing our consolidated financial statements, we are required to estimate accrued research and development expenses. Examples of estimated accrued expenses include fees paid to vendors and clinical sites in connection with our pivotal safety and efficacy studies, to CROs in connection with our proof-of-concept or pivotal safety and efficacy studies and to contract manufacturers in connection with the production of our lead product candidates and formulated biologics.

We review new and open contracts and communicate with applicable internal and vendor personnel to identify services that have been performed on our behalf and estimate the level of service performed and the associated costs incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost for accrued expenses. The majority of our service providers invoice us monthly in arrears for services performed or as milestones are achieved in relation to our contract manufacturers. We make estimates of our accrued expenses as of each balance sheet date.

We base our accrued expenses related to proof-of-concept and pivotal safety and efficacy studies on our estimates of the services received and efforts expended pursuant to contracts with vendors, our internal resources, and payments to clinical sites based on animal enrollments. The financial terms of the vendor agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of animals and the completion of development milestones. We estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the related expense accrual accordingly on a prospective basis. If we do not identify costs that have been incurred or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. To date, we have not made any material adjustments to our estimates of accrued research and development expenses or the level of services performed in any reporting period presented.

Share-Based Compensation

We measure share-based compensation expense based on the fair value of share-based awards on the date of grant and recognize the corresponding compensation expense of the awards, net of estimated forfeitures, over the requisite service periods, which correspond to the vesting periods of the awards. To date, we have issued share options and restricted share units with service-based vesting conditions, and we record compensation expense for these awards using the straight-line method.

Determining the fair value of share-based awards at the grant date requires judgment, and our estimates of the fair value of our ordinary shares are highly complex and subjective. Upon the completion of this offering, the fair value of our ordinary shares will be based on the closing price of our ordinary shares on the Nasdaq Global Market.

We use the binomial option-pricing model to determine the fair value of share options. This determination is affected by our estimated fair value per ordinary share as well as assumptions regarding a number of other complex and subjective variables. These variables include the fair value of our ordinary shares, the expected term of the share option, our volatility over that expected term, expected dividend yield and risk-free interest rates. Restricted share units are valued at the fair value of the underlying ordinary shares as of the date of grant. See Note 13 to our consolidated financial statements included elsewhere in this prospectus for further details.

In addition to these assumptions, we estimate forfeitures based upon our historical experience. At each period end, we review the estimated forfeiture rate and make changes as factors affecting the forfeiture rate calculations and assumptions change.

 

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If any assumptions used in the binomial option-pricing model change significantly, share-based compensation for future awards may differ materially compared with the awards granted previously. For fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, share-based compensation expense was $0.7 million, $0.3 million, nil and $0.2 million, respectively. We had an aggregate of $1.0 million of unrecognized share-based compensation expense as of September 30, 2014, which we expect to recognize over an estimated period of 2.3 years for awards outstanding.

As permitted by Australian law, the board of directors of Nexvet Australia historically granted share options and restricted share units with an exercise or conversion price of nil. Because Irish law requires the payment to an issuer of at least the nominal value of shares in order to acquire such shares from the issuer, any options or restricted share units with a nil exercise or conversion price became exercisable or convertible, as applicable, at the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014. Contemporaneously with these awards and based upon information available at the time of grant, the board of directors, with the assistance of management, also determined the fair value of the shares underlying these awards for financial reporting purposes. The intention has been that all awards granted have been ascribed a value per ordinary share for financial reporting purposes equal to the fair value per ordinary share underlying those awards on the date of grant. Given the absence of a public trading market for our ordinary shares, and in accordance with the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, our board of directors has exercised reasonable judgment and considered numerous objective and subjective factors to determine the best estimate of the fair value of our ordinary shares at each grant date. These factors included:

 

    contemporaneous third-party valuations;

 

    current business conditions and projections;

 

    risks inherent to the development of our research and development programs, including the status of pivotal safety and efficacy studies for our lead product candidates;

 

    our financial condition, including cash on hand;

 

    our need for future financing to fund our research and development efforts and the commercialization of our lead product candidates, including the likelihood of achieving further funding or an initial public offering;

 

    the composition of, and changes to, our management team and board of directors;

 

    the rights and preferences of our preference shares relative to our ordinary shares;

 

    the lack of marketability of our ordinary shares; and

 

    external market and economic conditions and other trends and conditions affecting the pharmaceutical, veterinary care and biotechnology industries.

Based on the assumed initial public offering price of $         per ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, the aggregate intrinsic value of share-based awards outstanding as of September 30, 2014 was $         million, of which $         million related to vested share-based awards and $         million related to unvested share-based awards.

 

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Warrant Liability

We record certain assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements. As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value.

Our liabilities primarily consist of warrants that were issued to investors and financial advisors in connection with private placements of our securities in May 2014. The warrants permit the holders to purchase ordinary shares at exercise prices of $8.625 and $7.50 per share on or before May 2019. Because the warrants may be net exercised and are exercisable in U.S. dollars, and the functional currency of Nexvet Australia, the original issuer of the warrants, is Australian dollars, they were classified as a liability as of June 30, 2014 and were reclassified as shareholders’ equity in September 2014 following the Irish Reorganization (in which the original warrants were exchanged for warrants issued by Nexvet Biopharma plc) and the change in our functional currency to U.S. dollars.

Warrants recorded as liabilities ($5.4 million as of June 30, 2014) are valued at fair value using the binomial option-pricing model. The expected term used in the model has been adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions and behavioral considerations. At each balance sheet date, the outstanding warrants are revalued to their current fair value, with the difference in fair value recorded in the consolidated statements of operations and comprehensive loss.

We reclassified the warrants as shareholders’ equity in September 2014 following the Irish Reorganization and the change in our functional currency to U.S. dollars.

Jumpstart Our Business Startups Act

The JOBS Act provides that an “emerging growth company” can delay adopting new or revised accounting standards until those standards apply to private companies. We have irrevocably elected not to avail ourselves of this delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.

Income Taxes

We have historically filed income tax returns in Australia, and in the future also expect to file tax returns in Ireland and the United States.

As of September 30, 2014, we had total deferred tax assets of $7.1 million. Our management has evaluated the factors bearing upon the realizability of our deferred tax assets, which are comprised principally of tax loss carry forwards for Australian income tax purposes of $6.6 million. Our management concluded that a full valuation allowance was necessary to offset our net deferred tax assets due to our lack of taxable income prospects for the foreseeable future.

Change in Principal Auditor

In April 2014, our board of directors approved an audit committee recommendation to commence the required process in Australia to change our principal auditor. We informed Ernst & Young, or EY, that we wished to change our principal auditor to PricewaterhouseCoopers, or PwC, and EY submitted an application to the Australian Securities and Investment Commission, or ASIC, for consent to resign. In July 2014, ASIC advised EY

 

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in writing that it had approved EY’s application to resign, and EY formally resigned as our principal auditor. Following our receipt of PwC’s consent to act, in July 2014 our board of directors approved the engagement of PwC as the principal auditor of our financial statements to be prepared in accordance with U.S. GAAP. EY had previously audited our financial statements in accordance with Australian GAAS for fiscal years 2012 and 2013, which were prepared in accordance with Australian IFRS. EY did not previously conduct any audits for any period in accordance with auditing standards generally accepted in the United States or the standards of the Public Company Accounting Oversight Board of our financial statements in conformity with U.S. GAAP or international financial reporting standards as issued by the International Accounting Standards Board.

EY’s reports on our financial statements audited in accordance with Australian GAAS and prepared in accordance with Australian IFRS for fiscal years 2012 and 2013 and any subsequent interim period did not contain an adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles. There were: (i) no disagreements with EY on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures, which disagreements, if not resolved to the satisfaction of EY, would have caused EY to make reference to the subject matter of the disagreements in connection with its reports; and (ii) no reportable events of the type listed in paragraphs (A) through (D) of Item 304(a)(1)(v) of Regulation S-K issued by the SEC in connection with the audits in accordance with Australian GAAS of our financial statements prepared in accordance with Australian IFRS for fiscal years 2012 and 2013 and the subsequent interim period through the replacement of EY with PwC, except that EY advised us, through October 2013, the date of EY’s report, there was a lack of (i) proper segregation of duties and (ii) competent and qualified financial reporting personnel for the development of policies and procedures relating to the financial reporting function and the preparation of reliable financial statements prepared in accordance with Australian IFRS.

Neither we nor anyone acting on our behalf consulted with PwC at any time prior to their retention by us with respect to (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion that might be rendered on our financial statements, and neither a written report was provided to us nor oral advice was provided that PwC concluded was an important factor considered by us in reaching a decision as to the accounting, auditing or financial reporting issue, or (ii) any matter that was the subject of a disagreement or reportable events set forth in Item 304(a)(1)(iv) and (v), respectively, of Regulation S-K.

Recently Issued Accounting Pronouncements

In May 2014, the FASB issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers. This guidance requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about:

 

    Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations).

 

    Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations.

 

    Certain assets—assets recognized from the costs to obtain or fulfill a contract.

 

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This guidance will be effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. We are currently evaluating the impact that this guidance will have on our consolidated results of operations, financial position and cash flows.

In June 2014, the FASB issued ASU 2014-12, Compensation—Stock Compensation. This guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. A reporting entity should apply the existing guidance in ASC Topic 718, Compensation—Stock Compensation, as it relates to awards with performance conditions that affect vesting to account for such awards. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. If the performance target becomes probable of being achieved before the end of the requisite service period, the remaining unrecognized compensation cost should be recognized prospectively over the remaining requisite service period. The total amount of compensation cost recognized during and after the requisite service period should reflect the number of awards that are expected to vest and should be adjusted to reflect those awards that ultimately vest. The requisite service period ends when the employee can cease rendering service and still be eligible to vest in the award if the performance target is achieved. This guidance will be effective for annual reporting periods beginning after December 15, 2015. We are currently evaluating the impact that this guidance will have on our consolidated results of operations, financial position and cash flows.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40). This guidance defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures. Under the guidance, management is required to evaluate, for each annual and interim reporting period, whether it is probable that the entity will not be able to meet its obligations as they become due within one year after the date that the financial statements are issued or are available to be issued. When management identifies substantial doubt about the entity’s ability to continue as a going concern, additional disclosures are required. This guidance will be effective for annual reporting periods beginning after December 15, 2016. We do not expect the adoption of this guidance to have a material impact on our consolidated results of operations, financial position and cash flows.

Quantitative and Qualitative Disclosures about Market Risk

Interest Rate and Currency Fluctuation Risk

Our cash as of September 30, 2014 was deposited with several large commercial banks located in the United States and Australia. Our primary exposure to market risk for our cash is interest income sensitivity, which is affected by changes in the general level of U.S. and, to a lesser extent, Australian interest rates. However, because our cash is held in bank accounts, a sudden change in the interest rates associated with our cash balances would not be expected to have a material impact on our financial condition or results of operations.

We do not have any major foreign currency or derivative financial instruments. Cash is predominantly held in U.S. dollars. We have operations in different economic environments that use the local currency as the functional currency. This exposes us to currency exchange fluctuations.

 

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BUSINESS

Overview

We are a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals by developing and commercializing novel, species-specific biologics based on human biologics. As a class, biologics, which include mAbs and fusion proteins, have transformed human medicine in recent decades and represent some of the top-selling therapies on the market today. Our proprietary PETization platform is an algorithmic approach that enables us to rapidly create mAbs that are designed to be recognized as “self” or “native” by an animal’s immune system, a property we refer to as “100% species-specificity.” PETization is also designed to build upon the safety and efficacy data from clinically-tested human therapies to create new therapies for companion animals, thereby reducing clinical risk and development cost. Our first product candidate, NV-01, is a mAb that is a nerve growth factor, or NGF, inhibitor for the control of pain associated with osteoarthritis in dogs. Our second product candidate, NV-02, is a mAb that is an NGF inhibitor for the control of pain associated with degenerative joint disease in cats. We expect data from our pivotal safety and efficacy studies for NV-01 by the end of 2015 and for NV-02 in 2016. Our third product candidate, NV-08, is a fusion protein that is a tumor necrosis factor, or TNF, inhibitor for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs. If our proof-of-concept safety and efficacy studies for NV-08 are successful, we will progress this product into formal development. Using PETization, we are seeking to advance one new product candidate into development per year, commencing in the second half of 2015.

Veterinary care is one of the fastest growing industries in the overall U.S. companion animal market and is estimated to reach $15.3 billion in 2014. We are targeting the companion animal therapeutics segment of the veterinary care industry. We estimate that in 2013 consumers spent $2.3 billion on companion animal therapeutics. This segment is currently dominated by small molecule drugs. The size and growth of this market reflects many factors, including higher rates of companion animal ownership, increased availability and improved quality of veterinary care and the increasingly important role of companion animals in our lives, who are often considered members of our families. We believe these factors, together with the introduction of our product candidates with their favorable safety and compliance profiles, will increase overall demand for companion animal therapeutics.

Two of our lead product candidates, NV-01 and NV-02, are mAbs that are designed to neutralize disease-causing targets in the body. mAbs belong to a class of medicines called biologics, which have transformed human medicine in recent decades. They have had a significant impact in the treatment of a number of human conditions, including various cancers, inflammatory diseases and cardiovascular and neurological diseases. As a class, mAbs have an improved safety and efficacy profile in humans over small molecule drugs. Although a few mAbs have received conditional licensure in the United States, there are currently no mAbs for companion animals approved for marketing in the United States or the EU.

Our development pipeline includes the following lead product candidates:

 

    NV-01 is a mAb that is an NGF inhibitor targeting chronic pain associated with osteoarthritis in dogs. We commenced our pivotal studies in October 2014 and expect to receive data by the second half of 2015.

 

    NV-02 is a mAb that is an NGF inhibitor targeting chronic pain associated with degenerative joint disease in cats. We have commenced proof-of-concept studies, which we expect to be completed by mid-2015.

 

    NV-08 is a fusion protein that is a TNF inhibitor targeting inflammation, including atopic dermatitis, in dogs. We intend to complete proof-of-concept safety and efficacy studies by the end of 2015 prior to the commencement of a full development program.

 

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Our patent portfolio includes nine patent families related to our lead product candidates and indications, our platform technology, as well as other aspects of antibody function. Specifically, as of September 30, 2014, we had nine pending patent applications in the United States directed to our lead product candidates and indications, as well as approximately 90 other related pending patent applications in various foreign jurisdictions. If issued, patents in these families are expected to expire between 2032 and 2035.

Our Strategy

We strive to be at the forefront of companion animal therapeutic innovation by developing and commercializing a portfolio of biologics for companion animals. To achieve this goal, we intend to:

 

    Leverage our proprietary PETization platform and experience to develop multiple companion animal therapeutics. Our proprietary PETization platform enables the rapid translation of mAbs between species, positioning us to identify and develop multiple companion animal therapeutics. In addition, we have assembled a team of professionals that is highly experienced in the development and commercialization of companion animal and human therapeutics for global markets. We believe our platform and experience will enable us to develop and commercialize effective biologics for companion animals.

 

    Focus on common conditions impacting the quality of life of companion animals to make a positive impact on their health. Improving available therapies and addressing the unmet medical needs of dogs and cats will allow us to make an immediate positive impact on their health. For both dogs and cats, we intend to conduct our pivotal safety and efficacy studies in order to obtain regulatory approval for safer, more effective products than those that are currently available, in areas such as pain, inflammation and cancer. In addition, due to the toxicity of currently available treatments in cats particularly for pain management, we believe biologics can provide safe and effective treatment alternatives for a variety of chronic diseases and symptoms for which there are presently limited options.

 

    Commercialize our lead product candidates with a direct sales force and distributors in the United States and through strategic alliances in international markets. If our lead product candidates are approved for commercialization, we intend to recruit senior executives with animal health sales and marketing expertise and an energetic sales force we intend to train to understand the science and benefits of biologics. By adding complementary distributor relationships in the United States and strategic alliances in the EU and elsewhere, we believe we can optimize our penetration of the veterinary markets.

 

    Educate veterinarians about the benefits of biologics compared to conventional treatments. We intend to educate veterinarians about the benefits of biologics compared to currently available treatments and the advantages of our PETization platform over other approaches. We also intend to become the thought leaders in the field of companion animal therapeutics by publishing clinical and scientific data and analysis, working with key opinion leaders, presenting at leading veterinary conferences and engaging in outreach at major veterinary colleges.

 

    Collaborate with leaders in human and veterinary biologics to bring to market the next generation of companion animal therapeutics. We believe that universities, as well as pharmaceutical and animal health companies, present an opportunity to leverage our PETization platform. Through collaborations, we intend to design, develop, manufacture and bring to market the next generation of mAbs and complementary technologies.

In order to execute our strategy we have assembled a management team and board of directors who have held senior positions in leading biopharmaceutical and animal health companies and who have extensive experience in the discovery, development and commercialization of therapeutics.

 

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Market for Companion Animal Therapeutics

The American Pet Products Association, or the APPA, reported that U.S. consumer spending on companion animals increased 72% from 2003 to 2013, to $55.7 billion, representing a compound annual growth rate of 6%. U.S. companion animal ownership increased at a lower rate than consumer spending on companion animals, with dog ownership increasing 23% and cat ownership increasing 28% between 2002 and 2012. The following chart shows the growth in sales in the U.S. companion animal market from 2003 to 2013, with a predicted market figure exceeding $58.5 billion in 2014.

 

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Figure legend: Total U.S. Companion Animal Market 2003—2013 (with 2014 estimate)

The U.S. companion animal market includes veterinary care, food, supplies and over-the-counter medications, live animal purchases and services such as grooming and boarding. Veterinary care, which includes sales of companion animal therapeutics, parasiticides and vaccines and other medical expenses for veterinarian visits, is one of the fastest growing industries in the overall U.S. companion animal market and is estimated to reach $15.3 billion in 2014. We are targeting the companion animal therapeutics segment of the veterinary care industry. We estimate that in 2013 consumers spent $2.3 billion on companion animal therapeutics. This segment is currently dominated by small molecule drugs. Although a few mAbs have received conditional licensure in the United States, there are currently no mAbs for companion animals approved for marketing in the United States or the EU. Biologics, including mAbs, have grown to be the largest class of therapeutics within the top ten best-selling drugs for humans. We believe that mAbs will drive a similar trend in the companion animal therapeutics market.

Dogs and cats are among the most popular companion animals in the United States and the EU, which regions account for more than 75% of the global companion animal market. According to the APPA and the European Pet Food Industry Federation, there are approximately 95.6 million cats and 83.3 million dogs in the United States and approximately 66.5 million cats and 60.8 million dogs in the EU. In the United States, approximately 47% of households own at least one dog.

 

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Historically, most companion animal therapeutics have been in areas overlapping with livestock health, notably vaccines, parasiticides and anti-infectives. Similar to human therapeutics, and given the safety and efficacy profile of biologics, we see opportunities for biologic therapies for companion animals in the areas of pain, inflammation, oncology, dermatology, allergy and gastrointestinal disease. We expect the market for companion animal biologic therapies to increase primarily due to:

 

    Higher standards and better care. Because owners are increasingly regarding their companion animals as important members of their families, owners are demanding better care and treatment options for their companion animals. In a 2011 survey by Kelton Research, 81% of respondents considered their dogs to be true family members. According to the APPA, approximately 78% of U.S. dog owners treated their dogs with medications in 2010, as compared to 50% in 1998. In a 2010 poll by Associated Press, 35% of companion animal owners indicated they were willing to spend $2,000 to treat their companion animal for a serious medical condition.

 

    Aging companion animal population. Companion animals are living longer, leading to increased incidence of diseases commonly associated with aging, such as arthritis, diabetes, tumors and kidney disease. According to a 2013 report by Banfield Pet Hospital, the average lifespan of dogs increased from 10.5 years in 2002 to 11 years in 2012, and the average lifespan of cats increased from 11 years in 2002 to 12 years in 2012.

We believe these favorable demographics create a significant opportunity for companion animal biologic therapies.

The veterinarian market in the United States is primarily a private-pay environment, with less than 3% of companion animal owners covered by third-party insurance. Unlike the regulation in the human healthcare market, there are no government price constraints for companion animal products in the United States. This dynamic makes the recommendation of veterinarians a major factor in decisions made by companion animal owners. In addition, we believe better health outcomes for companion animals are more likely when veterinarians provide in-office care at regular intervals.

Companion Animal Market Dynamics

The development and commercialization of companion animal therapeutics, including mAbs, share many common features with human therapeutics, including the need to:

 

    demonstrate safety and efficacy in clinical trials;

 

    manufacture the therapeutics for commercial supply in facilities compliant with good manufacturing practice requirements;

 

    obtain marketing authorization from applicable regulatory authorities;

 

    market the therapeutics only for the indications permitted on the product label; and

 

    be safe for human handling and the environment.

Despite these similarities, the following factors create substantial advantages when developing therapeutics for animals versus humans:

 

    Reduced development risk. Many of the products approved in animals have originated from products approved or in development for use in humans. Harnessing existing manufacturing, safety and clinical efficacy data can significantly lower development risk.

 

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    Faster and less expensive. Development of companion animal therapeutics is typically faster and less expensive than human drug development. It requires fewer clinical trials, requires fewer subjects and pre-clinical work and can be conducted directly in the target species. According to Pharmaceutical Commerce, companion animal therapeutics can obtain U.S. regulatory approval in under six years. We expect the costs to complete the development and manufacturing scale-up of each of our three lead product candidates to be approximately $13.0 to $15.0 million per candidate. In contrast, receipt of regulatory approval for human therapeutics may take 12 to 13 years and development can cost hundreds of millions of dollars per drug.

In the United States, the two main regulatory pathways for obtaining approval for companion animal therapeutics are the USDA, which regulates veterinary vaccines and certain biologics, and the FDA, which regulates veterinary pharmaceuticals and certain biotherapeutics. While our current lead product candidates are subject to regulation by the FDA, future product candidates may be subject to regulation by the USDA. Whether a product candidate is subject to regulation by the USDA or the FDA depends on the product’s immunological mechanism of action. The USDA can provide conditional licensure that allows a company to start selling a product after successful safety studies if the product has a reasonable expectation to demonstrate efficacy and the applicant must undertake to continue pivotal safety and efficacy studies to be granted full approval. Both the FDA and USDA regulatory pathways compare favorably to the regulatory pathway for human drug development with respect to time and cost to market. Illustrative examples of these regulatory pathways are compared in the following chart:

 

 

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Note: All timelines vary on a product-to-product basis.
(1) Conditional licensure granted under defined circumstances.
(2) Includes humanization, cloned cell production, good manufacturing process supply, animal toxicology and pharmacokinetics.

Limitations of Current Standard of Care and the Promise of Biologics

Overview

Despite the growing market for veterinary care and favorable market dynamics, there are few treatment options approved for use in companion animals relative to the diversity of available human therapeutics. Current approved therapeutics for the management of many conditions, including pain, inflammation and cancer are predominantly small molecule drugs. In recent years, particularly in inflammation and cancer, human drug development has increasingly focused on biologics, such as mAbs, which generally offer safety and efficacy profiles that make them attractive alternatives to small molecule drugs for many indications.

 

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Small Molecules

Historically, conventional animal drug development revolved around small (low molecular weight), chemically-synthesized molecules, commonly referred to as small molecules. They are typically formulated as oral dose forms that owners must administer to their companion animals, often daily or more frequently. There are concerns regarding the use of small molecule therapeutics in some areas of companion animal medicine. For example, many non-steroidal anti-inflammatory drugs, or NSAIDs, commonly prescribed for pain and inflammatory diseases, have black box warnings in their labeling of potentially serious side effects that limit their chronic use in dogs and largely preclude their chronic use in cats. Despite these side effects and due to the lack of treatment options, NSAIDs currently represent the most commonly prescribed therapy for pain management in dogs.

We believe that small molecule products as a class present significant limitations in the following areas:

 

    Toxicity. Many small molecule therapies carry the risk of increased toxicity due to off-target effects. Furthermore, small molecule therapies can result in toxicity and bleeding and, in extreme cases, death for certain breeds of dogs. For example, NSAID therapy can result in gastrointestinal toxicity in humans and animals, but in dogs it can also result in renal and hepatic toxicity. Treatment in cats is further complicated given their livers are unable to process NSAIDs effectively, further complicated by renal toxicity. For this reason, substantially all NSAIDs used in cats in the United States are approved for use for no more than three consecutive days.

 

    Administration challenges. Because many small molecule therapies typically suffer from a short half-life (time in the blood), they typically require daily or more frequent injections or oral dosing. In addition, because most small molecule products are administered orally, it is difficult to ensure the product is ingested and absorbed. As a result, daily or more frequent injections or oral dosing of small molecule products provides challenges to owners that increase the risk of poor compliance with the treatment regimen.

Biologics

Biologics are therapeutic proteins derived from biological sources and are distinct from chemically synthesized small molecule pharmaceuticals. Biologics generally include mAbs, which are targeted antibodies derived from identical, or clonal, cells, and fusion proteins, which are proteins created by joining two or more genes coded for separate proteins. Biologics also include biosynthetic proteins, such as human insulin and human growth hormone. In human medicine, the introduction of biologics, specifically mAbs, overcame many issues associated with small molecule-based therapeutics, and biologics have now grown to be the largest class of therapeutics within the top ten best-selling drugs in humans. Six of the top ten best-selling human drugs in 2013 were biologics, including Humira, Enbrel and Remicade for inflammatory diseases, Rituxan for oncology and inflammatory disease and Avastin and Herceptin for oncology, which collectively amounted to worldwide sales in 2013 of $49.8 billion (or 64% of the top ten drugs’ revenue). We believe that mAbs will drive a similar trend in the companion animal therapeutics segment.

Although a few mAbs have received conditional licensure in the United States, there are currently no mAbs for companion animals approved for marketing in the United States or the EU. We believe this creates a significant opportunity for us to develop first-in-class therapeutics for the unmet medical needs of companion animals utilizing our proprietary PETization platform. We believe a number of factors have prevented mAbs from reaching the animal health market, which PETization is designed to address:

 

    Research and development priorities. We believe that constrained research and development budgets at major pharmaceutical companies and their animal health divisions, along with limited research and development budgets among our competitors, have contributed to their focusing on small molecule therapies, reformulations and line extensions while overlooking mAbs as a development priority. In contrast, we are completely focused on biologics for companion animals.

 

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    Development and manufacturing costs. There is a perceived high cost associated with the development and manufacture of mAbs and therapeutic proteins at commercial scale. Given that veterinary care represents a smaller market than certain human healthcare opportunities, the profitability profile and cost-benefit ratios historically have not been attractive to many major pharmaceutical companies. Our PETization platform is designed to develop mAb therapeutics cost-effectively, and we believe our manufacturing processes will result in low costs and attractive gross margins.

 

    Immunogenicity. Improperly designed biologics can induce a significant negative immune response, or immunogenicity. This is the body’s reaction to the identification of material as foreign and not “self” or “native,” resulting in the biologic being inactivated and cleared from the body, thereby diminishing or removing its therapeutic effect. Although mAb therapies are used to treat many diseases in humans, these drugs cannot be used routinely to treat animal diseases since they will be recognized as foreign. PETization is designed to produce 100% species-specific mAbs that minimize the risk of immunogenicity.

The Advantages of our PETization Platform

Our proprietary PETization platform addresses certain significant shortcomings of existing treatment options by rapidly translating mAbs between species for use in the treatment of animal diseases. PETization is designed to determine the minimal number of changes required in the mAb framework region to generate a mAb that preserves the attraction between a biologic and its target, a property known as affinity, while minimizing the likelihood of immunogenicity because the entire sequence making up the crucial framework regions of the mAb is more likely to be recognized as “self” or “native” by the animal’s immune system, a property we refer to as “100% species-specificity.” PETization is designed to avoid the need for the conventional method of affinity maturation, which based on our experience can require six to 18 months to complete, depending on the project, and which can increase the foreign sequence content, thereby increasing the risk of immunogenicity. We believe we are the only clinical-stage biopharmaceutical company completely focused on bringing a 100% species-specific biologics portfolio to the companion animal therapeutics market.

We believe our PETization platform offers the following important advantages over other approaches to the design, discovery and development of mAbs in the veterinary care industry:

 

    Rapid creation of new products. We have demonstrated, by multiple examples in proof-of-concept studies, that PETization can substantially reduce the time involved in the discovery process with a high probability of successfully retaining the affinity of the donor mAb when compared to conventional discovery techniques. We believe this will allow us to accelerate new product candidates into the development phase.

 

    Cost efficiencies in production. By retaining the affinity of the donor mAbs using PETization, our processes require less active pharmaceutical ingredient to achieve a therapeutic dose, helping maximize production efficiency and lower the cost of goods.

 

    Efficient development pathway. Typically, candidate mAbs for PETization are potent and in a class of mAbs with similar properties and about which a large amount of manufacturing, safety and clinical efficacy data are available. We believe harnessing this existing data will reduce the cost and time-to-market for our lead product candidates as well as reduce regulatory and clinical risk during development.

 

    Scalability across species. PETization enables us to rapidly identify new product candidates for many indications across multiple species.

 

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    Proprietary cDNA approach to mAb identification. Our proprietary cDNA library of mAb sequences allows us to use the natural variations found in mAbs to generate novel, species-specific mAbs. We believe this approach will provide future product candidates with lower development risk and a valuable time and cost advantage over competitors.

We believe that our PETization platform will create differentiated, high-value companion animal therapies with better health outcomes through the following characteristics:

 

    Efficacy. PETization is designed to rapidly translate mAbs between species while retaining the affinity of the donor mAb. This in turn leads to retained potency in treating the targeted indication.

 

    Safety. In customizing mAb therapies for target species, PETization matches the structure of the target species more successfully than conventional approaches, thereby reducing the risk of immunogenicity. We believe this benefit increases the safety of our mAbs.

 

    Ease of compliance. PETized mAbs are designed to be injected every four to six weeks to maintain therapeutic levels. This compares favorably to the daily or more frequent injections or oral dosing required with many small molecule therapies. As a result, we expect that compliance with the treatment regimen will significantly increase.

We believe that these product characteristics align favorably with veterinarian preferences and will contribute to the widespread market adoption of PETized mAbs. As injectable products are typically administered at veterinary clinics, our lead product candidates would offer veterinarians the opportunity to monitor compliance by seeing animals on a more regular basis. According to a proprietary report we commissioned from GfK in June 2014, all of the 34 veterinarians surveyed, who included oncologists and specialists in inflammatory, metabolic and cardiovascular diseases and pain management, were interested in mAbs being developed for companion animals.

How our PETization Platform Works

Our PETization platform is a proprietary algorithmic approach that has demonstrated a reduction in the time and cost typically associated with the development of mAbs using conventional interspecies conversion methods, such as complementarity-determining region, or CDR, grafting and subsequent affinity maturation. By comparison with CDR grafting and subsequent affinity maturation, we believe PETization, which entails a single computational design step, can significantly reduce the time required for laboratory work.

An antibody is generally made up of two short, or “light,” chains and two longer, or “heavy,” chains of amino acids arranged in a specific sequence. At one end of the chains are the CDRs, which allow the antibody to bind to its target. Between the CDRs are framework regions, which are typically species-specific, that determine the immune response caused by the antibody. If these sequences of amino acids in the framework regions do not match ones that occur naturally in the target animal, the antibody could induce a significant negative immune response. These non-matching sequences must therefore be identified and adjusted to create an antibody that retains the therapeutic benefits while matching the target animal’s naturally-occurring sequences. Minimizing the changes to these sequences results in the converted antibody being more likely to be recognized as “self” or “native” by the target’s immune system. By applying our algorithms to analyze large data sets from our proprietary cDNA library, PETization is designed to determine the minimal number of changes required in the mAb framework region to generate a 100% species-specific mAb that preserves the affinity between a biologic and its target. The following figures illustrate the differences between conventional interspecies conversion methods and PETization in developing mAbs.

 

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By limiting comparison to single sequences, CDR grafting results in more required changes than by comparing pooled cDNA sequences from the same species through PETization. More changes increase the likelihood that the resulting converted antibody will lose affinity for its target. Restoration of affinity lost by CDR grafting can increase the foreign sequence content, thereby increasing the risk of immunogenicity. Minimized changes are thus advantageous and desirable, and PETization minimizes the changes required during interspecies conversion, thereby reducing the risk of immunogenicity.

 

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Our proprietary PETization algorithm compares the sequences of the heavy and light chains of a donor mAb to a database of known heavy and light chains from the target veterinary species. The algorithm determines the minimal number of changes at each position in the amino acid sequences required to convert donor mAb heavy and light chain sequences into mAb sequences containing only amino acids identified within the target species. The resulting “100% species-specific” mAb sequences carry a lower risk of rejection due to immunogenicity and the affinity is preserved, which maintains the function of the donor antibody. We have used PETization to successfully convert human and rodent mAbs into canine, feline and equine mAbs, thereby leveraging their safety and efficacy profile for our companion animal therapies in development.

 

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Figure legend: PETization produces 100% species-specific mAbs for dogs (NV-01), cats (NV-02) and horses of equivalent NGF inhibiting potency in vitro. Comparison is made to a negative control antibody that does not interact with NGF (immunoglobulin G, or IgG).

Using PETization, we have produced our lead canine and feline mAbs candidates, NV-01 and NV-02 (see figure above), from a rodent mAb that is an NGF inhibitor. Given the lack of mAbs available in companion animal therapeutics, there is little published information on the production or properties of mAbs for these species. We believe that our expertise in the area of canine, feline and equine mAbs will produce significant benefits for the treatment of companion animal diseases.

In addition, we believe our substantive expertise in this area will enable us to:

 

    generate new intellectual property and product candidates;

 

    utilize advanced manufacturing processes to reduce our cost of goods;

 

    inform and improve our clinical studies and regulatory applications;

 

    make additional therapeutic options available to veterinarians; and

 

    attract academic, clinical and commercial collaborators.

Portfolio Development

We have established internal processes to identify and prioritize our target mAbs to be PETized, culminating in a target product profile for each potential mAb therapeutic. Preferred features of donor mAbs that we consider for PETization include:

 

    the donor mAb has demonstrated safety and efficacy in human clinical trials;

 

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    the donor mAb retains its function, binding to the same target in the companion animal species;

 

    the target has a comparable mechanism of action in companion animals as in humans; and

 

    the disease in the target species that the mAb will target is of commercial significance.

Selected donor mAbs are PETized. The PETized mAb is manufactured at small scale and its biological properties are confirmed in appropriate biological test systems, including initial proof-of-concept and safety and efficacy studies to develop an initial target product profile. The target product profile is tested with clinical key opinion leaders or through surveys of veterinarians. We also meet with U.S. regulators to discuss regulatory pathway and determine jurisdiction (the USDA or the FDA).

We believe that external validation of our scientific, technical, clinical and commercial activities is a key foundation for our future success. Consequently, we participate in scientific conferences and publish in scientific journals. For example, we have recently presented data on our programs at conferences in the United States and the EU and published two peer-reviewed papers in scientific journals. We intend to continue and grow our collaborations with veterinary research and clinical groups.

Product Pipeline

We have identified three lead product candidates, NV-01, NV-02 and NV-08. We submitted an INAD with the FDA for NV-01 in 2012, for NV-02 in 2013 and for NV-08 in 2014.

 

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(1) Our proof-of-concept studies include four sequential studies: pharmacokinetics (P), preliminary safety (PS), immunogenicity (I) and safety and efficacy (SE).
(2) We have completed clonal cell manufacturing for NV-01, and we have accelerated and completed clonal cell manufacturing for NV-02 in order to rapidly advance its development. Material from manufactured clonal cells, from which biologics are created, is used in pivotal studies and is intended to be used later for commercial supply. The production of a high-yielding clonal cell line facilitates budgeting for commercial production.
(3) FDA protocol concurrence means the Center for Veterinary Medicine within the FDA fundamentally agrees with the design, execution and analyses proposed in the protocol and there is a commitment that it will not later alter its perspective on these issues unless public or animal health concerns appear that were not recognized at the time of the protocol assessment. We have obtained protocol concurrences to commence our pivotal safety and efficacy studies for NV-01.

 

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NV-01 – Canine Pain

Overview

NV-01 is a 100% species-specific mAb targeting NGF, discovered through PETization and developed as a long-acting analgesic for chronic pain, specifically osteoarthritis, in dogs. NV-01 is a PETized mAb based on the sequence of aD11, a rodent mAb about which academic publications and related data have been available for more than 20 years. We selected aD11 for PETization based upon its potency. Pain can be a result of chronic diseases, such as osteoarthritis, or produced via trauma, surgery, cancer or infection. Osteoarthritis is a degenerative condition associated with aging affecting the joint tissues and, with the exception of joint replacement surgery, there are no curative treatments. The incidence of osteoarthritis in dogs has increased by 38% since 2007 according to a 2012 Banfield Pet Hospital study. We have commenced our pivotal efficacy study for NV-01 and have obtained protocol concurrence from the FDA. We expect to commence our pivotal safety study for NV-01 in the first quarter of 2015.

Market Opportunity and Current Treatment Limitations

The market for canine pain management products has been growing over the last 15 years. In the United States alone, sales of such products increased from less than $10 million in 1995 to $262 million in 2013, representing a compound annual growth rate of approximately 12%, following the introduction of Rimadyl, an NSAID, in 1996. The U.S. canine pain market is currently dominated by several NSAIDs, which accounted for over 83% of canine pain medication sales in 2013.

NSAIDs account for the largest number of adverse drug events reported to the FDA, including vomiting, gastrointestinal bleeding, diarrhea and liver and kidney toxicities. We believe that the limitations of NSAIDs create a significant commercial opportunity for the development of a novel, long-acting treatment for chronic pain that has comparable efficacy to NSAIDs without their adverse events. This view is supported by the proprietary report we commissioned from GfK in December 2013, which revealed that, of the 390 veterinarians surveyed in the United States, United Kingdom, France and Germany, between 93% and 97% reported they would use a product such as NV-01 for the treatment of chronic pain in dogs.

Our Solution

NV-01 is a PETized mAb that inhibits the activity of NGF in dogs. NGF is elevated in the joints of dogs with osteoarthritis. NGF is produced by nerve cells, chondrocytes, which are cells that produce and maintain cartilage, and a variety of inflammatory and immune cells. It acts on pain-sensing nerve fibers to increase their excitability and increase the sprouting of new nerve fibers into inflamed tissues. mAbs targeting NGF have been extensively studied in humans through to Phase 3 clinical studies and have been shown to be effective in managing osteoarthritic pain in patients.

NV-01 has been found to be safe and well tolerated following intravenous infusion in dogs and has displayed a prolonged elimination half-life, or the time it takes to lose half of its effect, after a single injection. NV-01 has been shown to reduce pain scores in an acute, canine model of inflammatory pain, with efficacy comparable to meloxicam, a standard NSAID used in canine osteoarthritis, and repeated administration did not induce a neutralizing antibody response.

 

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In a proof-of-concept study, NV-01 was given to nine dogs with chronic lameness due to osteoarthritis and was shown to reduce canine brief pain inventory, or CBPI, pain scores, with a duration of action of at least four weeks. NV-01 was well tolerated in all of the dogs. CBPI is an owner assessment tool for measuring pain severity and pain interference that is recognized by the FDA as a positive outcome, or endpoint, for approval. This data was recently published in the peer-reviewed American Journal of Veterinary Research and is illustrated in the figures below.

 

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Figure legend: Summary data from proof-of-concept study of NV-01 in nine dogs with osteoarthritis. The treatment group improved significantly (using a standard measure of statistical significance, P<0.05) in both CBPI pain severity scores and pain interference scores at both the two-week and four-week timepoints. P-value is the probability that study results are due to random fluctuations and not the effect of NV-01. A low P-value means the study results have a low probability of being due to chance and a high probability of being due to NV-01’s effects.

A randomized, placebo-controlled, 26-dog study also confirmed that NV-01 could significantly reduce pain scores at two and four weeks following a single administration. This study used both CBPI and the Client Specific Outcome Measures, or CSOM, another owner assessment tool recognized by the FDA as an approval endpoint. The magnitude of the effect seen following a single injection of NV-01 was comparable to that observed in the literature with daily NSAIDs at two and four weeks using the CBPI endpoint. Once again, NV-01 was well tolerated. These data were presented by Professor Duncan Lascelles of North Carolina State University at the American College of Veterinary Internal Medicine 2014 Forum and the CBPI and CSOM data are illustrated in the figures below.

 

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Figure legend: Summary data from a blinded, placebo-controlled study of NV-01 in 26 dogs with osteoarthritis using both CBPI and CSOM assessment. The CBPI assessment shows significantly improved pain severity scores for the group treated with NV-01 on both days 14 and 28, as compared to no statistically significant changes for the placebo group (using a standard measure of statistical significance, P<0.05). The

 

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CSOM assessment shows significantly more dogs improved their pain scores and had results deemed a “success” rather than a “failure” following treatment with NV-01, as compared to the placebo group (using a standard measure of statistical significance, P<0.05). “Success” was determined where all CSOM scores improved or stayed the same and there was a total positive score change of two or more.

The data we have generated in proof-of-concept studies in osteoarthritic dogs have provided us with further confidence to move NV-01 forward into full development and are similar to the efficacy seen in human clinical trials with human NGF-neutralizing mAbs.

Additional proof-of-concept studies are currently underway to explore the efficacy of NV-01 in other indications, such as osteosarcoma, a common tumor affecting bone, and pruritus, pain and discomfort associated with itch. Should these studies be successful, we may seek to expand our label claims via supplemental approvals subject to demonstrable success in larger clinical trials.

NV-01 Status

We have completed the production of a stable, high-expressing clonal cell line at Lonza, our third-party contract manufacturer, and we have completed stability, purification and formulation studies. Material from manufactured clonal cells, from which biologics are created, is used in our pivotal clinical safety and efficacy studies and is intended to be used later for commercial supply. Pilot batch scale-up has shown that NV-01 is expressed at high concentrations and is stable in liquid or freeze-dried formulations. The material has been vialed for our pivotal safety and efficacy studies.

We have obtained the necessary protocol concurrences and have commenced our pivotal efficacy study and expect to commence our pivotal safety study in the first quarter of 2015. We expect to receive data from our pivotal safety and efficacy studies by December 2015. If successful, we expect to commence the phased filing process for regulatory approval with the FDA in the first half of 2016 and to apply for marketing authorization with the European Medicines Agency, or EMA, at the end of 2016.

NV-01 Pivotal Safety and Efficacy Studies

The NV-01 pivotal safety and efficacy studies will enroll at least 200 dogs with naturally-occurring osteoarthritis. The study will take place at veterinary clinics in various locations in the United States and the EU. The dogs will be randomized into treatment groups with a 2:1 ratio of NV-01-treated to placebo-treated study subjects. A sample size re-estimation will be performed by an independent statistician during the study to check the assumptions made in the original sample size calculations. The statistician will look at the difference between the two treatment groups to evaluate whether the study is adequately powered to deliver a definitive outcome. This process will confirm the validity of the planned sample size, recommend an additional number of cases (which may extend the length of the study) or confirm that a futility criterion was met (indicating that the study would be unable to achieve its objective). Each dog will receive three treatments at 28-day intervals. Efficacy will be measured using two different owner-administered assessment tools, the CSOM and CBPI, together with veterinarian assessments of pain and lameness. The study will be double-blinded, meaning participants and veterinarians will be unaware of which treatment group will be receiving NV-01 or a placebo. CSOM, CBPI and veterinarian assessments will be measured at enrollment and on days 14, 28, 56 and 84. The CSOM measures activities that have become difficult or have changed for the dog as a result of osteoarthritis. For the CSOM assessment, precise activities that have changed in dogs as a result of osteoarthritis are defined and re-evaluated at each assessment. The relative ability to perform such activities is assigned a numerical score at each observation. A comparison of change in CSOM score between enrollment and day 28 is the primary endpoint for the efficacy evaluation. CSOM assessments on other days, CBPI assessments and veterinarian pain and lameness assessments are secondary endpoints.

The FDA typically mandates that a blinded owner assessment be used as the primary endpoint for studies involving osteoarthritis and has concurred with our protocol. Since CSOM activities are specific to the individual dog and involve only those activities where it is possible for a change in behavior to be detected as a

 

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result of treatment, we consider CSOM to be more discriminating, and therefore more likely to show a significant difference between treatment groups, than other assessment tools.

NV-02 – Feline Pain

Overview

NV-02 is a 100% species-specific mAb targeting NGF, discovered through PETization and developed as a long-acting analgesic for chronic pain, specifically for the pain associated with degenerative joint disease, including osteoarthritis, in cats. NV-02 is a PETized mAb derived from aD11, the same rodent mAb as NV-01, about which academic publication and related data have been available for more than 20 years. We have initiated regulatory preparations with the FDA and EMA, have commenced proof-of-concept studies, which we expect to complete in mid-2015, and expect to commence pivotal safety and efficacy studies for NV-02 in cats in the second half of 2015. We anticipate being able to leverage much of the information and regulatory feedback from NV-01 and to apply these to NV-02, thereby facilitating its rapid development.

Medical Need and Market Opportunity

The lack of NSAIDs in the United States approved for use in cats for longer than three days has resulted in an increased use of opioids. In 2013, 37% of U.S. veterinarians surveyed reported the use of opioids for cats, according to a report we commissioned from GfK in December 2013. Given the potential for serious adverse events, sales of feline-specific NSAIDs in the United States were approximately $8 million in 2013. Cats lack key drug detoxification pathways in their livers and are susceptible to renal toxicity. mAbs are not metabolized by the liver or kidneys and therefore are not expected to have these side effects. We believe the introduction of a safe and effective pain management product class, such as NGF inhibitor mAbs, will result in significant sales, similar to the growth dynamic observed when NSAIDs were introduced for the canine pain market in the mid-1990s. We believe we are the only company committed to the development of mAbs for the management of chronic pain in cats.

We believe that NV-02 can achieve a significant market share for the treatment of pain in cats. This view is supported by a proprietary report we commissioned from GfK in December 2013, which revealed that, of the 390 veterinarians surveyed in the United States, United Kingdom, France and Germany, between 86% and 98% would use a product such as NV-02 for the treatment of chronic pain in cats.

Our Solution

NV-02 has been found to be safe and well tolerated following subcutaneous injection and intravenous infusion and to have a prolonged elimination half-life after a single injection. Repeated administration did not induce a neutralizing antibody response in a study of four cats.

 

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In a separate study, NV-02 was also shown to reduce lameness scores in an acute feline model of inflammatory pain, with efficacy comparable to meloxicam, a standard NSAID used in acute feline pain management. Our data suggest that NV-02 has an attractive efficacy profile as a treatment for chronic pain in cats.

 

LOGO

Figure legend: Exploratory study data demonstrating NV-02 significantly reduced lameness due to inflammatory pain in five cats at day six following a single administration (using a standard measure of statistical significance, P<0.05). Pain reduction was comparable to daily oral meloxicam. Mean scores ± standard deviation used.

NV-02 Status and Next Steps

We have generated stable, high-expressing clonal cell lines producing NV-02 and are undertaking stability, purification and formulation studies. We have commenced a double-blinded, placebo-controlled proof-of-concept study in 36 cats with degenerative joint disease, which we expect to be complete in mid-2015. Subject to the satisfactory completion of this study, we expect to be in a position to commence pivotal safety and efficacy studies in the second half of 2015, with results expected by the second half of 2016. If successful, we expect to commence the phased filing process for regulatory approval with the FDA in the first half of 2017.

NV-08  –  Canine Inflammation

Overview

NV-08 is a proprietary fusion protein that is a TNF inhibitor for canine inflammatory diseases. We identified a proprietary variant of the TNF-receptor in dogs outside of our PETization platform, and, using fusion protein technology, we created NV-08. NV-08, a canine biologic analogous to Enbrel, a leading human fusion protein, has been selected for further development for the treatment of chronic inflammatory diseases, including atopic dermatitis, a major skin condition in dogs. We have demonstrated in a pre-clinical study that NV-08 has improved potency compared to Humira, a leading human mAb. We have commenced proof-of-concept studies, which we expect to complete by the end of 2015. If our proof-of-concept safety and efficacy studies for NV-08 are successful, we will progress this product into formal development.

 

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Market Opportunity and Current Treatment Limitations

Chronic inflammatory diseases affect a number of organ systems in dogs and cats, similar to the effects seen in humans. Examples include atopic dermatitis, arthritis, inflammatory bowel disease, type 1 diabetes and cardiovascular disease. Atopic dermatitis is a common condition in dogs of all ages, estimated to affect approximately 10% of all dogs. Dogs with atopic dermatitis display skin lesions with itching that often lead to further damage and infection which exacerbates their symptoms.

Atopic dermatitis is currently treated with various approaches, including dietary supplements, topical shampoos, emollients and ointments, anti-histamines, NSAIDs and immunosuppressant drugs such as oral steroids and Atopica, marketed by Novartis. Although potent immunosuppressant drugs, like Atopica, can be effective in controlling the clinical signs of itch, they can also have serious side effects and can be expensive. Apoquel, a Janus kinase-inhibitor introduced by Zoetis in 2014, has demonstrated efficacy in controlling itch, but it carries several label warnings. The U.S. label states it is not for use in dogs less than 12 months or those with serious infections, and it may increase susceptibility to infections and tumors. Its chronic use in the field (post-launch) has not yet been fully evaluated.

We believe that a treatment possessing similar efficacy to Atopica and Apoquel, but with improved safety and convenience of administration, would be well received by veterinarians.

Our Solution

NV-08 is a fusion protein that links a canine antibody’s tail region, which binds to receptors to activate the immune system, with the extracellular domains of the canine TNF receptor. NV-08 acts in an analogous manner to the human therapeutic fusion protein, Enbrel, to bind and inhibit the activity of the important inflammatory mediator TNF-a. We have identified a novel TNF receptor variant in dogs, which is the portion of NV-08 that binds TNF with high affinity.

There is published evidence to demonstrate the involvement of TNF in canine atopic dermatitis and to support further development for this indication. For example, third-party studies have shown TNF messenger ribonucleic acid, or mRNA, which carries genetic information, to be elevated in lesional canine atopic dermatitis as has TNF protein expression. In a small study in humans with moderate-severe atopic dermatitis, administration of a TNF inhibitor mAb demonstrated a significant improvement in clinical symptoms.

 

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We have demonstrated that NV-08 can neutralize canine TNF in cell culture systems with potency equivalent to the human TNF inhibitor drug Enbrel (a fusion protein) and significantly greater than the human TNF inhibitor drug Humira (a mAb). NV-08 has also been shown to be well tolerated and non-immunogenic when given by repeated injection in four dogs.

 

LOGO

Figure legend: Incubation with canine TNF in cell cultures demonstrates that NV-08 is equipotent with the human TNF inhibitor drug Enbrel and approximately ten times more potent than the human TNF inhibitor drug Humira.

Given the central role TNF plays in inflammation in human disease, there is potential to explore the efficacy of NV-08 in additional indications including arthritis, inflammatory bowel disease and pemphigus, a skin-blistering autoimmune disease, in dogs.

NV-08 Status and Next Steps

We filed an INAD with the FDA in December 2014 and expect to engage with FDA regulators in 2015. We expect to complete preliminary proof-of-concept safety and efficacy studies by the end of 2015. If these are successful and achieve their endpoints, we will progress NV-08 into formal development, which will include the manufacture of a clonal cell line and additional pivotal studies required for FDA and EMA approval.

Next Generation Product Candidates

Using PETization, we are seeking to advance one new product candidate into development per year commencing in the second half of 2015. Our internal research team is studying mAbs that bind to canine, feline and equine targets relevant to pain, inflammation, cancer and other chronic conditions. We have also recently completed a survey of specialist veterinarians in the United States and the EU to identify key areas of unmet medical need where mAbs could have a significant impact. The results of this survey are guiding our product development priorities.

We also intend to explore the commercialization of the PETization platform as it relates to human mAbs through our wholly-owned subsidiary, Tevxen Limited. Tevxen Limited is exploring the strategy of utilizing algorithms built for human mAb identification to improve the selection process for developing human mAbs.

 

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Process Development, Manufacturing and Distribution

We currently have no internal capability to manufacture the formulated product candidates for use in our studies or commercial supplies of any of our product candidates that may be approved, and we are entirely dependent upon third-party manufacturers for such supplies. We have contracted with Lonza, a leading producer of human active pharmaceutical (or biopharmaceutical) ingredients, for the manufacturing of our lead product candidates for clinical testing purposes, and subject to an agreement on acceptable terms for commercial supply, we intend to continue to utilize Lonza as our primary supplier in the future. As a part of our ongoing evaluation of manufacturing providers, we intend to continue to evaluate alternatives in the near term for active pharmaceutical ingredient and finished drug product for commercial supply to mitigate risks.

In addition, we depend on third parties to supply all of our required raw materials and finished products for our pre-clinical, proof-of-concept and pivotal safety and efficacy studies. We believe that the raw materials that we require to manufacture our lead product candidates are readily available commodities commonly used in the biopharmaceutical industry. We also expect to rely upon third parties to produce materials required for the commercial production of our lead product candidates if we succeed in obtaining the necessary regulatory approvals.

We currently do not have a direct sales organization. In order to commercialize any of our current or future product candidates, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make or maintain arrangements with third parties to perform these services, and we may not be successful in doing so. We expect to establish a direct sales organization in the United States and to utilize distributors to commercialize our lead product candidates, which will be expensive and time-consuming. In jurisdictions outside of the United States, we intend to utilize companies with an established commercial presence to market our lead product candidates in those jurisdictions, but we may be unable to enter into or maintain such arrangements on acceptable terms, if at all.

Production Agreements with Lonza

We entered into service agreements with Lonza for each of NV-01 and NV-02 in December 2012 and December 2013, respectively, which contain substantially similar terms. Pursuant to these agreements, Lonza has agreed to perform cell culture evaluation, purification evaluation, master cell bank creation and material supply for clinical studies for each of these product candidates. The agreements may be terminated by either of us upon (i) prior written notice if the services cannot be completed due to technical or scientific reasons, provided that the parties attempt in good faith to resolve the issues within 60 days and subject to certain compensation to be paid to Lonza for services performed, expenses incurred, and the costs of terminating any commitments entered into in connection with the respective agreement, (ii) a material breach of the agreement by the other party, subject to a cure period or (iii) the other party being unable to pay its debts, entering into liquidation or receivership or ceasing to carry on its business.

In addition, we may terminate the agreements at any time upon 30 days’ prior written notice to Lonza, subject to certain compensation to be paid for services performed, expenses incurred, and the costs of terminating any commitments entered into in connection with each agreement, plus a contractually-specified amount. If we default with respect to any payment due under the agreements, Lonza may suspend services or treat the agreement as repudiated upon ten days’ prior written notice.

License Agreements with Lonza

In connection with engaging Lonza as our sole manufacturer for two of our lead product candidates, we entered into license agreements with Lonza for each of NV-01 and NV-02 in December 2012 and December 2013, respectively, which contain substantially similar terms. Pursuant to these agreements, we obtained non-exclusive, worldwide licenses under certain Lonza know-how and patent rights to use, develop, manufacture, market, sell,

 

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offer for sale, distribute, import, and export each of the NV-01 product and NV-02 products, as such products are produced through the use of Lonza’s proprietary system of cell lines, vectors and know-how, with the right to grant sublicenses of the manufacturing rights under certain conditions.

In consideration for the license with respect to the NV-01 product, we agreed to pay Lonza for all NV-01 product manufactured under Lonza’s system and patents (i) a low, single-digit royalty (subject to reduction under certain circumstances) of the net selling price of the NV-01 product manufactured by Lonza; (ii) if the NV-01 product is manufactured by us or one of our strategic partners, a low, single digit royalty (subject to reduction under certain circumstances) of the net selling price of the NV-01 product plus an annual lump sum payment commencing with the initiation of treatment in a pivotal efficacy study performed under veterinary good clinical practices; or (iii) if the NV-01 product is manufactured by any third party other than us or one of our strategic partners, a low, single-digit royalty (subject to reduction under certain circumstances) of the net selling price of the NV-01 product plus an annual lump sum payment commencing with the start date of the applicable sublicense to such third party for manufacture.

In consideration for the license with respect to the NV-02 product, we also agreed to pay Lonza for all NV-02 product manufactured under Lonza’s system and patents (i) a low, single-digit royalty (subject to reduction under certain circumstances) of the net selling price of the NV-02 product manufactured by Lonza or (ii) if the NV-02 product is manufactured by us, one of our strategic partners, or any other party, a low, single-digit royalty (subject to reduction under certain circumstances) of the net selling price of the NV-02 product plus an annual lump sum payment commencing with the initiation of treatment in a pivotal efficacy study performed under veterinary good clinical practices with FDA protocol concurrence or the start date of the applicable sublicense for manufacture.

Our royalty obligation will continue on a product-by-product and country-by-country basis until the later of (i) the expiration of all valid claims included in the patents licensed to us under the applicable agreement for the manufacture of such product and (ii) ten years after the first commercial sale of the applicable product following marketing authorization.

The license agreements will continue until the expiration of the licensed patent rights, or for so long as the licensed know-how remains secret and substantial, whichever is later. We may terminate each license agreement for any reason upon 60 days’ prior written notice to Lonza. Either party may terminate each license agreement upon (i) a breach of such license agreement by the other party, subject to a 30-day cure period, or (ii) the other party being unable to pay its debts, entering into liquidation or receivership or ceasing to carry on its business. Additionally, Lonza may terminate each license agreement if we knowingly oppose or dispute, or assist any third party to oppose or dispute, any of the patent rights licensed thereunder.

Distribution-Related Agreements with Virbac

We entered into a master collaboration, supply and distribution agreement, or the Master Agreement, and a specific distribution agreement, or SDA, for NV-01 with Virbac in November 2014. Pursuant to the Master Agreement, we appointed Virbac as our sole and exclusive distributor of NV-01 and any other products for which we enter into an SDA with Virbac in the veterinary field worldwide except for the United States and Canada. For NV-08, the territory would also exclude Japan, South Korea, Taiwan, the Philippines, Malaysia, Singapore, the People’s Republic of China, Indonesia, Thailand, India, Vietnam and Myanmar because of pre-existing distribution rights. We refer collectively to the applicable area as the “Territory.” After a specified period, we will have the right to distribute and sell the product ourselves in the Territory. If we do so, we have agreed to make a lump sum payment to Virbac and Virbac shall become the sole but not exclusive distributor for such product in the Territory.

Pursuant to the Master Agreement, Virbac must provide clinical, regulatory, marketing and sales input via a joint steering committee, advise us in the drafting of regulatory submissions in the countries within the

 

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Territory, sell our products, meet or exceed minimum annual net sales obligations for each product, manage local complaints and transfer drug safety data, not apply for the registration of any trademark that is the same as or similar to any of our trademarks and launch the product within a specified time period after marketing authorization. We have agreed to develop the products in accordance with a development plan agreed to with Virbac and to use commercially reasonable efforts to obtain and maintain market authorization of the products, all at our own cost. We have agreed to manufacture (through third-party manufacturers) and supply the product to Virbac on a cost-plus basis. Virbac must pay to us certain milestone payments for our research and development work for our products, as well as fees based on Virbac’s net sales of the product reduced by specified amounts intended to reflect certain costs of goods and costs of selling, each as provided in the SDA for the product.

Pursuant to the Master Agreement, Virbac may not distribute any competing product in a country where a marketing authorization has been obtained for a period of five years from Virbac’s first commercial arm’s length bona fide sale of one of our products in certain European countries specified in the Master Agreement. Virbac has the first option right to negotiate an SDA with us for our future products in the Territory. If we receive a bona fide proposal from a third party for the assignment of the registration dossier (containing information necessary for obtaining a marketing authorization) for any products covered by the Master Agreement, we have agreed to notify Virbac, which will have the right to make an offer to purchase the registration dossier.

The Master Agreement (and any SDA) has an initial term of ten years from the date of Virbac’s first commercial arm’s length bona fide sale of a product in certain European countries specified in the Master Agreement and, unless otherwise agreed by the parties, will automatically renew for successive periods of two years each. Each party may terminate the Master Agreement for the other party’s uncured material breach or insolvency. Virbac may terminate the Master Agreement if we do not timely obtain a marketing authorization for NV-01 in Europe, there is a material failure to comply with the target product profiles for NV-01, there is a material deviation from a development plan for NV-01 or the distribution of all products covered by the agreement is prevented in certain important countries specified in the Master Agreement as a result of a potential infringement of a third party’s intellectual property rights. Each party may terminate the applicable SDA if the commercial margin for the product falls below a certain threshold. Virbac may terminate an SDA if the distribution of the applicable product is prevented in certain important countries specified in the Master Agreement as a result of a potential infringement of a third party’s intellectual property rights, or there is a material deviation from a development plan.

The SDA for NV-01 specifies the conditions under which Virbac will place orders to us for the provision of NV-01 in accordance with a target product profile, the marketing authorization in Europe, the product specifications and specific terms of Virbac’s distributions of NV-01. These terms include milestone payments for our receipt of our first marketing authorization in Europe for NV-01 and Virbac’s first commercial arm’s length bona fide sale of one of NV-01 in certain European countries specified in the Master Agreement, as well as fees to us based on the net sales of NV-01 reduced by specified amounts intended to reflect certain costs of goods and costs of selling, as provided in the SDA.

Competition

The companion animal therapeutics segment of the veterinary care industry is highly competitive and characterized by rapid technological change. Key competitive factors in our industry include, among others, the ability to successfully advance the development of a lead product candidate through pivotal safety and efficacy studies; the timing and scope of regulatory approvals, if ever achieved, average selling price of competing products and animal therapeutic products in general, the availability of raw materials, contract manufacturing and manufacturing capacity, manufacturing costs, establishing and maintaining intellectual property and patent rights and their protection, and sales and marketing capabilities.

 

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We believe our main competitors are animal health companies that are developing products for use in companion animals, such as Aratana Therapeutics, Inc., Kindred Biosciences, Inc. and Zoetis, Inc. In addition, there are a number of large biopharmaceutical companies with animal health divisions, such as Bayer AG; Boehringer Ingelheim GmbH; Eli Lilly and Company (Elanco division); Merck & Co., Inc.; Sanofi S.A. (Merial division); and Novartis AG. If approved, we expect NV-01 and NV-02 will face competition from Deramaxx, marketed by Novartis; Metacam, marketed by Boehringer Ingelheim; Previcox, marketed by Merial; and Rimadyl, marketed by Zoetis, as well as from generic Meloxicam and Carprofen and other pain-treating products. We believe that Kindred and Aratana are developing, and that other companies may develop, similar profile products as well. In addition, private-label products may compete with our lead product candidates. If companion animal therapeutics customers increase their use of new or existing private-label products, our operating results and financial condition could be adversely affected.

We are a clinical-stage biopharmaceutical company with a limited operating history and many of our competitors have substantially more resources than we do, including financial, technical and sales resources. In addition, many of our competitors have more experience than we have in the development, manufacture, regulation and worldwide commercialization of companion animal therapeutics. We are also competing with academic institutions, governmental agencies and private organizations that are conducting research in the field of companion animal therapeutics. Our competition will be determined in part by the potential indications for which our lead product candidates are developed and ultimately approved by the Regulatory Authorities. Additionally, the timing of market introduction of some of our future products or of competitors’ products may be an important competitive factor. Accordingly, we expect the speed with which we can develop our lead product candidates, complete pivotal safety and efficacy studies and approval processes, and supply commercial quantities to market to be important competitive factors.

Research and Development

Research and development expense consists primarily of employee compensation for internal research personnel, fees for regulatory, professional and other consultants and third party development costs. Research and development expense was $2.7 million, $5.6 million, $1.2 million and $2.5 million for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively.

Strategy for Protection of Proprietary Technology

We intend to rely upon a combination of patents, trade secret protection, confidentiality and license agreements to protect the intellectual property related to our current and future lead product candidates and our development programs. We also rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or for which we have not filed patent applications, processes for which patents are difficult to enforce and other elements of our product development processes that involve proprietary know-how, information or technology that is not covered by patents.

Patents

Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, novel discoveries, product development technologies and other know-how, to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business. We also rely on trademarks, trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary position.

 

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As for the product candidates we develop and intend to commercialize, as a normal course of business, we intend to pursue composition and therapeutic use patents, as well as novel indications for our product candidates within the animal health field. We have also pursued patents with respect to our proprietary PETization platform.

Our patent estate includes patent applications with claims directed to our PETization platform, our NV-01, NV-02 and NV-08 product candidate compositions, several of our pipeline product candidate compositions that are currently under development or are under consideration for future development and therapeutic uses of such product candidate compositions. As of September 30, 2014, our patent estate included on a worldwide basis nine separate patent families with a total of approximately 99 pending patent applications, including approximately 90 pending foreign patent applications and nine pending patent applications in the United States. Six of these patent families are directed to compositions and methods related to our mAb products currently in research or development. These products have a novel combination of recipient compatibility and high affinity as a result of our innovative design process whereby the donor antibody is modified so that no amino acid in its variable or framework regions is foreign to the intended host in any position. As a result, the therapeutic antibody is more likely to be seen as “self” or “native” and will therefore be less likely to induce a neutralizing antibody response. This in turn will permit repeat dosing without reduction in efficacy or product half-life. Patents from these applications, if issued, are expected to expire between 2032 and 2035.

For our PETization platform, we own one pending patent application in the United States and pending patent applications in various foreign jurisdictions, including Australia, Canada, China, Europe, Japan, New Zealand, Korea, Singapore and Taiwan. These applications are directed to methods of producing non-immunogenic species-specific antibodies via our proprietary PETization platform and to compositions produced via such methods. Patents in this family, if issued, are expected to expire in 2032.

For NV-01, we own one pending patent application in the United States and pending patent applications in various foreign jurisdictions, including Australia, Brazil, Canada, China, Europe, India, Japan, Korea, Malaysia, New Zealand, Russia, Singapore and the United Kingdom. These applications are directed to canine-specific NGF-neutralizing antibody compositions and methods of preparing and using the canine-specific antibodies for treating various diseases or conditions in dogs. Patents in this family, if issued, are expected to expire in 2032. NV-01 builds upon the mAb aD11, about which academic publications and related data have been available for more than 20 years.

For NV-02, we own one pending patent application in the United States and pending patent applications in various foreign jurisdictions, including Australia, Brazil, Canada, China, Europe, India, Japan, Korea, Malaysia, New Zealand, Russia, Singapore and the United Kingdom. These applications are directed to feline-specific NGF-neutralizing antibody compositions and methods of preparing and using the feline-specific antibodies for treating various diseases or conditions in cats. Patents in this family, if issued, are expected to expire in 2032. NV-02 builds upon the mAb aD11, about which academic publications and related data have been available for more than 20 years.

For NV-08, we own one pending patent application in the United States and pending patent applications in various foreign jurisdictions, including Australia, Canada, China, Europe, Japan, New Zealand, Singapore and South Korea. These applications are directed to a fusion protein comprising the canine p80 receptor for TNF-alpha and a canine Fc derived from canine IgG-B. Also claimed are methods of preparing and using such fusion proteins for therapy in dogs in need. Patents in this family, if issued, are expected to expire in 2033.

We own one patent family that describes for the first time the Fc effector functions of the four subclasses of canine immunoglobulin, and applications in this family are directed to mAbs and fusion protein products having modified (either decreased or increased) effector activity in dogs. This family has one pending patent application in the United States and 14 patent applications pending in 14 foreign jurisdictions. Patents in this family, if issued, are expected to expire in 2032.

 

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We own two other patent families related to mAb products currently in research or development. Together, these families include two pending patent applications in the United States and 18 patent applications pending in 13 foreign jurisdictions. Patents in these two families, if issued, are expected to expire in 2032.

We own one pending patent family related to canine-specific antibodies or antigen binding fragments with specificity for canine TNF, and methods of preparing and using such antibodies for immunotherapy in dogs. This family has one pending patent application in the United States and nine patent applications pending in foreign jurisdictions. Patents in this family, if issued, are expected to expire in 2032.

Finally, we have recently filed a U.S. patent application related to NGF inhibitor antibodies for the treatment of chronic itching. This family has one pending patent application in the United States, and, once it reaches the national filing stage, we will apply in any applicable foreign jurisdictions. Patents in this family, if issued, are expected to expire in 2035.

Government Regulation

The development and testing, regulatory approval, import, distribution, marketing, sale and post-marketing oversight of veterinary care products are each governed by the laws and regulations of each country in which we intend to sell our lead product candidates. To comply with these regulatory requirements, we have established processes and resources to provide oversight of the development, regulatory approval and launch of our lead product candidates and their maintenance in the market.

Requirements for Approval of Veterinary Medicinal Products Worldwide

We operate as a global company, and therefore, we are developing all of our lead product candidates with a global regulatory strategy. We intend to initially market our lead product candidates in the United States and the EU.

As a condition for the regulatory approval for sale of veterinary medicinal products, regulatory agencies worldwide generally require that a product to be used for animals be demonstrated to:

 

    be safe for the intended use in the intended species;

 

    have substantial evidence of effectiveness for the intended use;

 

    have a defined manufacturing process that ensures that the product can be made with high quality and consistency; and

 

    be safe for humans handling the product and for the environment.

Safety

To determine that a new veterinary medicine is safe for use, the Regulatory Authorities require developers to provide data from one or more target animal safety studies generated in the species of interest in a laboratory environment tested at doses higher than the intended label dose, over a period of time determined by the intended length of dosing of the product. In the case of the FDA, a review of the design of the safety study and the study protocol can be completed prior to initiation of the study to help assure that the data generated will meet FDA requirements. Scientific advice can be also obtained from the EMA.

These studies are conducted under rigorous quality processes, including good laboratory practices, to assure integrity of the data. They are designed to clearly define a safety margin, identify any potential safety concerns and establish a safe dose for the product. In addition, safety data from pivotal studies conducted under good clinical practice standards are evaluated to assure that the product will be safe in the target population.

 

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Furthermore, because safety and efficacy studies must conform to the Veterinary International Conference on Harmonization guidelines, which are established under an international program aimed at harmonizing technical requirements for veterinary product registration, they can be utilized by regulatory bodies in the United States, the EU, Japan, Canada, New Zealand and Australia.

Efficacy

Early proof-of-concept studies may be conducted in the species of interest in a laboratory environment to establish efficacy and the dose range for each product. Data regarding drug absorption via different routes of administration and the relationship of the dose to efficacy are studied. When an effective dose is established, a study protocol to test the product in “real world” conditions is developed prior to beginning the study. In the case of the FDA, the pivotal efficacy study protocol can be submitted for review and concurrence prior to study initiation, to help assure that the data generated will meet requirements. Scientific advice can be also obtained from the EMA.

The pivotal efficacy study must be conducted with the formulation of the product that is intended to be commercialized and is a multi-site, randomized, controlled study, generally with a placebo control. To reduce bias in the study, individuals doing the assessment are not told whether the subject is in the group receiving the treatment being tested or the placebo group. In both the United States and the EU, the number of subjects enrolled in pivotal efficacy studies is required to be approximately 100 to 150 animal subjects treated with the test product and a suitable number of subjects in the control group that receive the placebo. In many cases, a pivotal study may be designed with clinical sites in both the United States and the EU, and this single study may satisfy regulatory requirements in both jurisdictions.

Chemistry, Manufacturing and Controls

To assure that the product can be manufactured consistently, regulatory agencies require developers to provide documentation of the process by which the active pharmaceutical ingredient is made and the controls applicable to that process that assure the active pharmaceutical ingredient and the formulation of the final commercial product meet certain criteria, including quality, purity, and stability. After a product is approved, developers are required to communicate with the regulatory bodies any changes in the procedures or manufacturing site. Both the active pharmaceutical ingredient and the commercial formulations are required to be manufactured at facilities that engage in pharmaceutical good manufacturing practices.

Environmental and Human Safety

U.S. law requires sponsors to provide an environmental impact statement for products given at the home of the animal’s owner or in a veterinary clinic or hospital. If products might result in some type of environmental exposure or release, the environmental impact must be assessed. For approval in the EU, a risk assessment for potential human exposure is required.

Labeling

The intended label for the product, and also any information regarding additional research that has been conducted with the product, must be submitted to the FDA and other regulatory bodies for review. In addition, advertising and promotion of veterinary care products is controlled by regulations in many countries. These rules generally restrict advertising and promotion to those claims and uses that have been reviewed and approved by the applicable agency.

United States

Three federal regulatory agencies regulate the health aspects of veterinary care products in the United States: the FDA, the USDA, and the Environmental Protection Agency, or EPA.

 

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The Center for Veterinary Medicine at the FDA regulates animal pharmaceuticals and certain biopharmaceuticals under the Federal Food, Drug and Cosmetic Act. The Animal and Plant Health Inspection Service at the Center for Veterinary Biologics at the USDA regulates veterinary vaccines and certain biologics pursuant to the Virus, Serum, Toxin Act. The EPA Office of Pesticide Programs regulates veterinary pesticides under the Federal Insecticide, Fungicide and Rodenticide Act.

All of our current lead product candidates are animal pharmaceuticals, biopharmaceuticals or biologics regulated by the FDA, and the USDA has advised us that it expects to regulate certain potential product candidates currently in research. Manufacturers of veterinary pharmaceuticals and biologics must demonstrate that their products are safe, effective, and produced by a consistent method of manufacture. While their procedures vary, both the USDA and the FDA conduct post-approval monitoring of products, require submission of reports of any product quality defects, adverse events or unexpected results and may conduct regulatory inspections from time to time.

Regulatory Process at the FDA

Under the Federal Food, Drug, and Cosmetic Act, a new animal drug may not be sold into interstate commerce unless it is the subject of an approved new animal drug application, or NADA, the subject of an administrative NADA (for generic drugs), there is a conditional licensure or the drug is included in the FDA’s index of legally-marketed unapproved new animal drugs for minor species.

To begin the development process for products in the United States, an INAD submission is made to the FDA. Pre-development meetings may be held with the FDA to reach general agreement on the plans for providing the data necessary to fulfill requirements for a NADA. Testing submitted in support of an application to the FDA generally must be conducted in accordance with good laboratory practices, and certain research conducted at research facilities will be subject to additional requirements of the Animal Welfare Act, which affords oversight of animal study subjects. During development, pivotal protocols may be submitted to the FDA for review and concurrence prior to conducting the required studies. Data on manufacturing, safety and efficacy (major technical sections) must be submitted to the FDA for review in the NADA, with review conducted according to timelines specified in the Animal Drug User Fee Act.

Once the data have been submitted and the review completed for each technical section—safety, efficacy and chemistry, manufacturing and controls, or CMC—the FDA issues a technical section complete letter pertaining to each section upon successful review. When complete letters have been received for the major technical sections, a draft of the Freedom of Information Summary is compiled by the sponsor, and the proposed product labeling, and all other relevant information, is submitted to FDA for review. An administrative NADA submission is the final step after complete letters are received for all technical sections of a NADA.

After approval, reports of any and all adverse events must be submitted on a regular basis to the FDA and other ongoing recordkeeping and compliance requirements will apply, including those relating to manufacturing, advertising, labeling and any changes to the product.

Regulatory Process at the USDA

Under federal law, including the Virus-Serum-Toxin Act, producers of veterinary biologics in the United States must have a U.S. Veterinary Biologics Establishment License and a U.S. Veterinary Biological Product License for each product. To qualify for an establishment license, an applicant also must qualify for at least one product license. For those entities or individuals wishing to market imported veterinary biological products in the United States, a U.S. Veterinary Biological Product Permit is required.

To begin the development process for veterinary biological products regulated by the USDA, an Application for U.S. Veterinary Biological Product License is filed with the USDA. Meetings may be held with

 

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the USDA to reach general agreement on the plans for providing the data necessary to fulfill requirements for an approval, and a licensing plan, including pivotal study protocols, may be submitted to the USDA for review and comment prior to initiating work that will be used to support product licensure. During development, data on manufacturing, including purity and potency, safety and efficacy must be submitted to the USDA for review. Once all data have been submitted and reviewed, the USDA issues its decision. Unlike the FDA, there are no timelines specified by law for the USDA’s review. The USDA also offers conditional licensure. Conditional licensure is available in order to meet an emergency condition, limited market, local situation or special circumstance and, when granted, allows a manufacturer to develop full efficacy data while marketing a product for which it has demonstrated purity, safety and a reasonable expectation of efficacy.

After licensure, manufacturers must contemporaneously record and maintain information related to adverse events of which they become aware (which may be reviewed upon inspection), and manufacturers are obligated to inform the USDA immediately when they are aware of problems with the purity, potency, safety, efficacy, preparation, testing or distribution of a product. Manufacturers are responsible for maintaining the compliance of the product post-licensure.

European Union and the EMA Regulatory Process

The EMA regulates the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. The EMA’s veterinary review section is distinct from the review section for human medicines. To perform these evaluations the EMA utilizes a specific scientific committee, the Committee for Medicinal Products for Veterinary Use. The EMA considers applications submitted by companies for the marketing authorization of veterinary medicinal products and evaluates whether or not the medicines meet the necessary quality, safety and efficacy requirements. Assessments conducted by the EMA are based on scientific criteria and are intended to ensure that veterinary medicines reaching the marketplace have a positive risk-benefit balance in favor of the animal population for which they are intended. Based on the EMA’s recommendation, a centralized marketing authorization is granted by the EMA, which allows the product to be marketed in all of the EU states, together with Norway, Lichtenstein and Iceland. The EMA is also responsible for various post-authorization and maintenance activities, including the assessment of modifications or extensions to an existing marketing authorization.

To obtain a marketing authorization from the EMA, an application for marketing authorization must be submitted. This application is the EMA’s equivalent of the FDA’s NADA and includes data from studies showing the quality, safety and efficacy of the product. The EMA reviews and evaluates the data. For each application, a rapporteur and co-rapporteur are appointed from the members of the EMA. Their role is to lead the scientific evaluation and prepare the assessment report. The rapporteur can utilize experts to assist in performing the assessment. The assessment report is critiqued by the co-rapporteur and other members of the EMA before the EMA makes its determination. The final opinion of the EMA is generally given within 210 days of the submission of an application, but the EMA makes the final decision on the approval of products. In general, the requirements for regulatory approval of a veterinary medicinal product in the EU are similar to those in the United States, requiring demonstrated evidence of purity, safety, efficacy and consistency of manufacturing processes.

Rest of World

Other countries around the world have their own regulatory requirements for approving and marketing veterinary medicinal products. In Japan, before granting marketing authorization, the Ministry of Agriculture, Forestry and Fisheries examines each veterinary medicinal product by categories including name, ingredient, composition, manufacturing methods, administration and dose, indications or effects and adverse reactions on the basis of data submitted by the applicant. In Australia, the Australian Pesticides and Veterinary Medicines Authority is the government authority for the registration of all agricultural and veterinary products, and it assesses applications from manufacturers of veterinary pharmaceuticals and related products.

 

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Many country-specific laws and regulations include requirements for labeling, safety, efficacy and manufacturers’ quality control procedures designed to assure the consistency of the products, as well as company records and reports. With the exception of those countries that have well-developed veterinary product regulation, the regulatory agencies of many other countries typically refer to the Regulatory Authorities and other international animal health entities, including the World Organisation for Animal Health and the Codex Alimentarius Commission, in establishing standards and regulations for veterinary pharmaceuticals and vaccines.

Employees

As of September 30, 2014, we had 21 full-time employees. Of these employees, 13 were in research and development, including clinical and regulatory functions, and eight were in general and administrative functions. We have never had a work stoppage and our employees are not represented by labor unions or covered by collective bargaining agreements.

Corporate Information

Nexvet Australia was incorporated in Australia in February 2010. In September 2014, Nexvet Biopharma Limited, a newly-formed Irish private company, became the parent company of Nexvet Australia and its subsidiaries pursuant to a transaction in which all of the holders of ordinary shares, preference shares, restricted share units and options and warrants to purchase ordinary shares of Nexvet Australia exchanged their holdings for equivalent ordinary shares, preference shares, restricted share units or options or warrants to purchase ordinary shares, as applicable, of Nexvet Biopharma Limited. We refer to this transaction as the “Irish Exchange.” Nexvet Biopharma Limited then re-registered as an Irish public limited company in September 2014. We refer to this re-registration as the “Re-registration” and we refer to the Irish Exchange and the Re-registration collectively as the “Irish Reorganization.”

Our principal executive offices are located at NIBRT, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland, and our telephone number is +353 1 215 8100. Our internet address is www.nexvet.com. Information contained on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus and references to our website in this prospectus are inactive textual references only.

Properties

Our corporate headquarters are located at NIBRT, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland, where we occupy approximately 80 square meters of office space pursuant to a lease that expires in September 2015 with an option to extend the lease for an additional year. We lease approximately 274 square meters of office space in Melbourne, Australia pursuant to a lease that expires in January 2019. We also occupy approximately 130 square meters of office space and laboratory facility at Monash University, Melbourne, Australia on a monthly facility access and use agreement and are in negotiations to extend this term. We do not own any real property. We intend to enter into a lease for office space in San Francisco, California. We believe the facilities we lease and intend to lease will be adequate to support our operations for the foreseeable future.

Legal Proceedings

We are not currently a party to any legal proceedings. We may be subject from time to time to various claims and legal actions during the ordinary course of our business.

 

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MANAGEMENT

The following table provides information regarding our executive officers, directors and director nominee, including their ages and positions, as of December 30, 2014:

 

Name

  

Age

    

Position

Executive Officers

     

Mark Heffernan, Ph.D.

     38       Chief Executive Officer and Director

David Gearing, Ph.D.

     53       Chief Scientific Officer

Damian Lismore

     55       Chief Financial Officer

Geraldine Farrell

     45       Vice President Operations and General Counsel

Colin Giles, Ph.D.

     63       Vice President Clinical and Regulatory Affairs

Non-Employee Directors and Director Nominee

     

Chris Brown(1)(2)

     56       Chairman of the Board

Ashraf Hanna, Ph.D., M.D.(3)

     47       Director

Cormac Kilty, Ph.D.(2)(3)

     61       Director

Joseph McCracken, DVM(1)(2)

     61       Director

John Payne(1)

     67       Director

Graeme Wald, Ph.D.(3)

     52       Director

Rajiv Patel(4)

     43       Director nominee

 

(1) Member of the compensation committee.
(2) Member of the nominating and corporate governance committee.
(3) Member of the audit committee.
(4) Mr. Patel is expected to join our board of directors, and be appointed to the compensation committee, upon the completion of this offering.

Executive Officers

Mark Heffernan, Ph.D., one of our co-founders, has served as our Chief Executive Officer and a member of our board of directors since April 2011. In 2003, Dr. Heffernan co-founded Opsona Therapeutics Ltd., an Irish biotechnology company focused on human mAbs and other molecules for inflammatory diseases and cancer, where he served as founder and Chief Executive Officer from January 2004 to March 2011 and as a Director from January 2004 to December 2011. Prior to co-founding Opsona Therapeutics, Dr. Heffernan worked in research and development and business development roles for Antisense Therapeutics Limited and Metabolic Pharmaceuticals Pty Ltd., spin-outs from Circadian Technologies Limited in Australia. Dr. Heffernan has a B.Sc. (Hons.) in Biochemistry and Pharmacology and a Ph.D. in Biochemistry from Monash University in Australia. We believe Dr. Heffernan is qualified to serve as a member of our board of directors based on his executive experience in the biopharmaceutical industry, his extensive knowledge of our company, his experience developing and commercializing mAbs for inflammatory diseases and his experience in raising capital for biotechnology companies.

David Gearing, Ph.D., one of our co-founders, has served as our Chief Scientific Officer since September 2010. From January 2000 to September 2007, Dr. Gearing served as the Chief Research Officer and Director of Research at CSL Ltd, a specialty biopharmaceutical company based in Melbourne, Australia. From January 1996 to January 2000, he served as Vice President and founder at Millennium Biotherapeutics, Inc., a biopharmaceutical company. From August 1994 to December 1995, Dr. Gearing served as Director of Molecular Biology at SyStemix, a stem cell and gene therapy company. From January 1990 to August 1994, he served as a staff scientist at Immunex Corporation, a biopharmaceutical company. Dr. Gearing has also served as entrepreneur-in-residence at the Queensland Brain Institute, University of Queensland and as Professor at the Monash Institute of Medical Research. Dr. Gearing has a B.Sc. (Hons.) in Biochemistry from Leeds University and a Ph.D. in Biochemistry and Molecular Biology from Monash University and also trained at the Cancer Research Unit of the Walter and Eliza Hall Institute in Melbourne, Australia.

 

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Damian Lismore has served as our Chief Financial Officer since November 2013. From August 2005 to August 2013, Mr. Lismore served as Chief Financial Officer and Company Secretary of Biota Holdings Limited, an Australian-listed biotechnology company. From April 2002 to August 2005, he served as Managing Director of MNT Innovations, the commercial arm of the Cooperative Research Centre for MicroTechnology, a partnership of research, industry and government focused on developing new technologies. Mr. Lismore served as General Manager Australia of Analytica Limited from February 2001 to April 2002. From May 2000 to December 2000, he served as Chief Operating Officer of MebWeb Limited. From April 1996 to May 2000, Mr. Lismore was a member of the Group Executive Committee and served as Group Financial Controller and General Manager of Buying and Finance at Sigma Company Limited, an Australian-listed pharmaceutical wholesaler and manufacturer. From 1986 to 1996, Mr. Lismore served in various roles, the most recent as Senior Manager with Price Waterhouse (now PricewaterhouseCoopers) in Australia, and from 1980 to 1986 he served in various accounting roles at Deloitte Haskins & Sells (now Deloitte LLP) in the United Kingdom. He is a member of the Institute of Chartered Accountants in Australia, a Fellow of the Institute of Chartered Accountants in Ireland, and is a graduate of the Australian Institute of Company Directors. Mr. Lismore has a Bachelor of Accountancy with Honors from University of Ulster.

Geraldine Farrell has served as our Vice President Operations and General Counsel since August 2013. Ms. Farrell served as a senior lawyer at Griffith Hack, an intellectual property firm in Australia, from November 2008 to July 2013. Prior to joining Griffith Hack, Ms. Farrell was an attorney at Freehills (now Herbert Smith Freehills) and Minter Ellison, both large Australian law firms. Ms. Farrell has more than 18 years’ experience as an intellectual property and commercial lawyer. Ms. Farrell is a graduate of the Australian Institute of Company Directors, and has served as a director on several private company boards of directors, government organizations and not-for-profit entities. Ms. Farrell has a Bachelor of Science in Pharmacology and Physiology, a Bachelor of Laws, and a Master of Laws (Intellectual Property), all from Monash University.

Colin Giles, Ph.D., has served as our Vice President of Clinical and Regulatory Affairs since November 2013. From March 2007 to November 2013, Dr. Giles was an independent consultant in the veterinary care industry. From July 1985 to March 2007, Dr. Giles was employed at Pfizer Animal Health and served in various roles, most recently as its Vice President for Veterinary Medicine Pharmaceuticals R&D from 2001 to 2006. From July 1977 to July 1985, Dr. Giles was a Research Fellow and then Lecturer in Veterinary Medicine at Royal Veterinary College. From April 1974 to July 1977, Dr. Giles was a practicing veterinary surgeon in the United Kingdom. He has served on various boards relating to veterinary medicine for companion animals and wildlife. Dr. Giles is a veterinary graduate and Ph.D. of the Royal Veterinary College, University of London, United Kingdom.

Non-Employee Directors and Director Nominee

Chris Brown has served our Chairman of the Board since November 2013. He is a Director of Preshafood Pty Ltd, a juice company, and served as its Chairman from December 2010 until July 2014. Mr. Brown has served as the principal of Gibbs Hill Pty Ltd., a corporate finance and strategic business advisory firm, since October 2006. Mr. Brown served as Director (Investment Banking) of Investec Wentworth, a financial services business from July 2002 to March 2006, a Director and Melbourne Head of Corporate Finance of Rothschild Australia, a financial services firm, from January 1994 to October 2000, and a Director and Co-head of Mergers & Acquisitions (Australia) at Merrill Lynch, a financial services firm, from July 1992 to January 1994. Mr. Brown was a Director and Chairman of Senetas Corporation, an Australian-listed public information technology encryption company, from May 2011 to April 2013 and the Founding Chairman of The Conversation Media Group Ltd, a not-for profit academic news organization, from April 2010 to September 2012. Mr. Brown has a Bachelor of Laws from University of Adelaide, South Australia. We believe Mr. Brown is qualified to serve as a member of our board of directors based on his extensive experience as a corporate advisor, guiding multiple companies through their initial public offerings, strategic transactions and growth in their industries.

Ashraf Hanna, Ph.D., M.D. has served as a member of our board of directors since September 2014. Dr. Hanna has served as the Vice President of Commercial and Medical Affairs Finance at Genentech Inc., a biotechnology company, since March 2009 and served as its Vice President of Alliance Management and

 

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Portfolio Planning from January 2006 to March 2009. He also served as the Chief Financial Officer for the Genentech Foundation from January 2006 to March 2009. Prior to Genentech, Dr. Hanna served as Vice President of Strategic Planning at Tanox, Inc. from August 2001 to December 2005, and prior to that he served as senior associate and Engagement Manager at McKinsey and Company, a management consulting firm. Dr. Hanna has a B.A. in Physics from the University of Chicago, attended the Harvard Business School, has a Ph.D. in Physics from Harvard University and has an M.D. from the University of Massachusetts. We believe Dr. Hanna is qualified to serve as a member of our board of directors based on his significant finance and management experience in biopharmaceutical companies, including public companies.

Cormac Kilty, Ph.D., has served as a member of our board of directors since November 2013. Dr. Kilty was employed as Chief Executive Officer of Argutus Medical Ltd. from March 2008 to December 2010 and as a scientific advisor to EKF Diagnostics Ltd., which acquired Argutus Medical. Dr. Kilty was the founder of Biotrin Holdings Ltd., a virology diagnostics company, which was sold in 2008 to DiaSorin S.p.A. Dr. Kilty is also a founder and past Chairman of the Irish BioIndustry Association from 2003 to 2007. From 2005 to 2009, Dr. Kilty served as co-founder and Chairman of Opsona. From February 1986 to June 1990, Dr. Kilty served as the Group Leader and subsequently Director of Research and Development and Technology Planning Assessment in Switzerland for Baxter Healthcare’s Diagnostics Division. Since 2011, Dr. Kilty has served as an Adjunct Associate Professor of Medicine and Medicinal Chemistry at University College Dublin, Ireland. Dr. Kilty has a B.Sc. in Zoology and a Ph.D. in Zoology and Biochemistry from University College Dublin. He carried out post-doctoral research in protein chemistry and immunology at the University of Texas at Austin and at University College Dublin. We believe Dr. Kilty is qualified to serve as a member of our board of directors based on his scientific background as well as his extensive executive experience and leadership in the biopharmaceutical industry.

Joseph McCracken, DVM, has served as a member of our board of directors since September 2014. Since September 2013, Dr. McCracken has worked as a consultant to and served on the boards of directors of several biopharmaceutical companies focusing on the design and implementation of corporate strategy and business development initiatives. From February 2011 to September 2013, Dr. McCracken served as the Vice President and Global Head of Business Development and Licensing for Hoffmann-La Roche Inc., a research-focused healthcare company, where he was responsible for global licensing activities, and from October 2009 to February 2011 he served as General Manager, Roche Pharma Japan and Asia Regional Head, Roche Partnering, for F. Hoffman-LaRoche Ltd., a subsidiary of F. Hoffmann-La Roche AG and was based in Tokyo. From August 2000 to October 2009, Dr. McCracken served as Vice President, Business Development at Genentech. From November 1997 to August 2000, Dr. McCracken served as Vice President of Worldwide Business and Technology Development at Rhone-Poulenc Rorer S.A, a French chemical and pharmaceutical company, and Vice President of Technology Licensing and Alliances at Aventis Pharma, a pharmaceutical company. Dr. McCracken has a B.S. in Microbiology, an M.S. in Pharmacology and a Doctorate of Veterinary Medicine from The Ohio State University. We believe Dr. McCracken is qualified to serve as a member of our board of directors based on his extensive biopharmaceutical company operational experience and veterinary qualifications, including with international and public companies.

John Payne has served as a member of our board of directors since December 2013. Since 2012, Mr. Payne has served as founder and Chief Executive Officer of Pet Health Innovations, LLC, an animal health consulting company. From 2005 to January 2012, Mr. Payne was employed with MMI, Inc., which operates the Banfield, Pet Hospital, where he served as a Senior Vice President from 2005 to 2006, as Executive Vice President from 2006 to 2007 and as President and Chief Executive Officer from 2007 to January 2012. While serving as President and Chief Executive Officer of MMI, Mr. Payne also served as a member of the Mars Global Petcare team from 2009 to 2012. From 2000 to 2005, Mr. Payne served as President and General Manager for North America of Bayer Health Care, Animal Health Division, and as a member of the Human and Animal Health Division’s Global Health Care Team. Mr. Payne is the current chairman of the American Humane Association, dedicated to the protection of animals and children from cruelty, abuse and neglect. Mr. Payne has a B.A. in Secondary Education from St. Bernard College and an M.B.A from Rockhurst University. We believe Mr. Payne is qualified to serve as a member of our board of directors based on his 40 years of experience in the veterinary care industry guiding some of the world’s largest consumer companion animal care and veterinary service brands.

 

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Graeme Wald, Ph.D., has served as a member of our board of directors since November 2013. Dr. Wald is the founder of Gravitas Consulting & Investments Pty Ltd, which advises life science companies on valuations and strategy, where he has served since March 2012. Since November 2012 he has also served as Investment Director with BioScience Managers Ltd. From September 2003 to January 2012, Dr. Wald served at Wilson HTM Investment Group Limited, an investment advisory company, as an analyst in the biotechnology, pharmaceutical and healthcare sector. Dr. Wald was a senior analyst at Burdett Buckeridge Young Limited, a corporate advisory and asset management firm, from May 2002 to September 2003. From May 2001 to May 2002, Dr. Wald served as a transport analyst at UBS, a global financial services firm, in Australia. From November 1999 to May 2001, Dr. Wald served as a fund manager at Fedsure Asset Management Co Pty Ltd, an investment and asset management firm. From July 1996 to October 1999, Dr. Wald served as a chemical, pharmaceuticals and healthcare analyst at Merrill Lynch, a financial management and advisory company, in South Africa. Dr. Wald is a graduate of the Australian Institute of Company Directors. He has a B.Sc. in Chemistry and Applied Chemistry, a B.Sc. (Hons) in Applied Chemistry, a Ph.D. in Chemistry and an M.B.A., all from the University of the Witwatersrand, South Africa. We believe Dr. Wald is qualified to serve as a member of our board of directors based on his extensive experience in finance and understanding of our industry. Dr. Wald has notified our board of directors of his intention to resign as a director by June 30, 2015.

Rajiv Patel is a nominee to our board of directors and is expected to join our board of directors upon the completion of this offering. Mr. Patel is currently a Managing Member, portfolio manager and member of the global investment committee at Farallon, an investment management firm that he joined in 1997. From 1993 to 1995, Mr. Patel worked at Donaldson, Lufkin & Jenrette as an investment banker in the project finance department, specializing in infrastructure, shipping and satellites. Mr. Patel has an M.B.A. from Stanford University’s Graduate School of Business and a B.S. in Operations Research and Industrial Engineering from Cornell University. We believe Mr. Patel, who is associated with a significant shareholder with which we have an important relationship, is qualified to serve as a member of our board of directors based on his extensive professional experience in investment management and the financial markets.

Board Composition

Certain members of our board of directors were elected pursuant to the provisions of our shareholders agreement. Under the shareholders agreement, our shareholders have agreed to appoint directors as follows: (i) an independent chairman (Mr. Brown); (ii) up to two directors appointed by the holders of our Series A investment preference shares, or our SIRPS preference shares (Dr. Kilty and Dr. Wald); (iii) up to two directors appointed by the ordinary shareholders (Dr. McCracken and Dr. Hanna); (iv) one director appointed by the holders of our Series B preference shares (Mr. Payne); and (v) our Chief Executive Officer (Dr. Heffernan). If we do not complete a qualifying initial public offering (which is an underwritten initial public offering on Nasdaq which results in gross proceeds to us of at least $40.0 million and priced at a price per share of not less than two times the then applicable Series B preference share conversion price) by September 2015, we will appoint a director designated by funds associated with Farallon. The shareholders agreement will terminate upon the completion of this offering. Pursuant to an understanding with Farallon, our board of directors plans to appoint Mr. Patel, an affiliate of Farallon, to our board of directors, conditioned upon (i) the completion of this offering and (ii) entities affiliated with Farallon holding at least 2,000,000 of our ordinary shares immediately upon completion of this offering.

Our board of directors is composed of seven members and (assuming Mr. Patel joins our board of directors as described above) will be composed of eight members upon the completion of this offering. There are no family relationships among any of our directors, director nominee and executive officers. Our board of directors will be divided into two classes with staggered two-year terms. At each annual meeting of shareholders to be held after this initial classification, the successors to directors whose terms then expire will serve until the second annual meeting following their election and until their successors are duly elected and qualified. The

 

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authorized number of directors may be changed only by resolution of our board of directors. Upon completion of this offering, our directors will be divided among the two classes, as follows:

 

    Class I, whose members will be Mr. Brown, Dr. Kilty, Mr. Payne and Dr. Wald. The terms of the Class I directors will expire at our 2015 annual meeting of shareholders; and

 

    Class II, whose members will be Dr. Hanna, Dr. Heffernan, Dr. McCracken and Mr. Patel (assuming Mr. Patel joins our board of directors as described above). The terms of the Class II directors will expire at our 2016 annual meeting of shareholders.

We expect that any additional directorships resulting from an increase in the number of directors will be distributed between the two classes so that, as nearly as possible, each class will consist of one-half of the total number of directors. Our directors will hold office until their successors have been elected and qualified or until their earlier death, resignation, disqualification or removal by the affirmative vote of the holders of a majority of the outstanding shares entitled to vote on the election of directors. The division of our board of directors into two classes with staggered two-year terms may delay or prevent a change of our management or a change of control.

Board Leadership Structure

Our Articles, as well as our Corporate Governance Guidelines, will provide our board of directors with flexibility to combine or separate the positions of Chairman of the Board and Chief Executive Officer in accordance with its determination that utilizing one or the other structure is in the best interests of our company. We have currently separated these positions with Mr. Brown serving as Chairman of the Board and Dr. Heffernan serving as Chief Executive Officer. Our board of directors believes that the separation of these positions strengthens the independence of our board of directors. The Chairman of the Board facilitates communications between members of our board of directors and works with management in the preparation of the agenda for each meeting of our board of directors. All of our directors are encouraged to make suggestions for agenda items or pre-meeting materials.

Our board of directors has concluded that our current leadership structure is appropriate at this time. However, our board of directors periodically reviews our leadership structure and may make such changes in the future as it deems appropriate.

Role of Board in Risk Oversight Process

Our board of directors’ role in risk oversight includes receiving reports from members of management regarding material risks faced by us and applicable mitigation strategies and activities, at least on a quarterly basis. The reports cover the critical areas of operations, sales and marketing, technology, and legal and financial affairs. Our board of directors and its committees consider these reports, discuss matters with management and identify and evaluate strategic or operational risks, and determine appropriate initiatives to address those risks.

Director Independence

Nasdaq rules require that independent directors comprise a majority of a listed company’s board of directors within a specified period of the completion of an initial public offering. Our board of directors has reviewed its composition, the composition of its committees and the independence of each director and director nominee. Our board of directors has determined that none of our directors or director nominee has a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these individuals is “independent” as that term is defined under the applicable rules and regulations of the SEC and the listing requirements and rules of Nasdaq, except for Dr. Heffernan, our Chief Executive Officer. In making this determination, our board of directors considered the current and prior relationships that each director and director nominee has with our company and all other facts and circumstances

 

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our board of directors deemed relevant in determining their independence, including the beneficial ownership of our capital shares by each non-employee director and director nominee.

Board Committees

Our board of directors has established the following committees: an audit committee, a compensation committee and a nominating and corporate governance committee. The composition and responsibilities of each committee are described below. Directors will serve on these committees until their resignation or until otherwise determined by our board of directors. We will adopt an audit committee, a compensation committee and a nominating and corporate governance committee charter prior to completion of this offering, copies of which will be available on our website at www.nexvet.com. Information contained on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus and references to our website in this prospectus are inactive textual references only.

Audit Committee. Our audit committee will oversee our accounting and financial reporting process. The responsibilities of this committee will include, among other things:

 

    appointing our independent registered public accounting firm to perform audit services and any permissible non-audit services;

 

    evaluating the objectivity and independence of our independent registered public accounting firm and the individuals assigned to the engagement team as required by law;

 

    reviewing our annual and quarterly consolidated financial statements and reports and discussing our consolidated financial statements and reports with our independent auditors and management;

 

    reviewing with our independent registered public accounting firm and management any significant issues that arise regarding accounting principles and financial statement presentation, and matters concerning the scope, adequacy, and effectiveness of our internal controls and disclosure controls and procedures;

 

    establishing procedures for the receipt, retention, and treatment of complaints received by us regarding internal controls, accounting, or auditing matters;

 

    establishing procedures for the confidential, anonymous submissions by employees regarding accounting, internal controls, or accounting matters; and

 

    reviewing and, if appropriate, approving proposed related party transactions.

Both our independent registered public accounting firm and management periodically will meet separately with our audit committee.

The members of our audit committee are Dr. Hanna, Dr. Kilty and Dr. Wald. Dr. Hanna serves as chairman of the audit committee. Our board of directors has determined that all of the members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and Nasdaq. Our board of directors has determined that Dr. Hanna is an “audit committee financial expert” as defined under the applicable rules of the SEC and has the requisite financial sophistication under Nasdaq rules. In arriving at these determinations, our board of directors examined each audit committee member’s scope of experience and the nature of their employment in corporate finance, accounting and related areas. Our board of directors has determined that all of the members of our audit committee are independent directors as defined in Rule 10A-3(b)(1) promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the applicable rules and regulations of Nasdaq.

 

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Compensation Committee. Our compensation committee will adopt and administer the compensation policies, plans and benefit programs for our executive officers and all other members of our executive team. The responsibilities of this committee will include, among other things:

 

    reviewing and making recommendations to our board of directors with respect to the compensation of our Chief Executive Officer, and reviewing and approving the compensation of our other executive officers;

 

    reviewing and approving corporate and personal performance goals and objectives relevant to executive compensation;

 

    reviewing and making recommendations to our board of directors with respect to the adoption of equity-based compensation, incentive compensation and other employee benefit plans;

 

    administering the issuance of options and other equity incentive arrangements under our equity incentive plans;

 

    establishing executive compensation policies; and

 

    reviewing and approving any employment agreements or arrangements with our executive officers.

Our compensation committee will review the risks associated with our compensation policies and practices, including an annual review of our risk assessment of our compensation policies and practices for employees. We structure our compensation to address company-wide risk. This is accomplished in part by tying compensation to corporate goals and individual performance goals. These goals can be adjusted annually to address risks identified in the annual risk assessment. We also use a mix of different compensation elements to balance short-term awards versus long-term awards to align compensation with our business strategy and shareholders’ interests. We believe the combination of base salary, performance-based cash awards and share-based incentive awards with multi-year vesting periods is balanced and serves to motivate our employees to accomplish our business plan without creating risks that are reasonably likely to have a material adverse effect on our company.

The current members of our compensation committee are Mr. Brown, Dr. McCracken and Mr. Payne. Dr. McCracken serves as the chairman of the compensation committee. Mr. Patel is expected to join our compensation committee upon the completion of this offering (assuming Mr. Patel joins our board of directors at such time as described above), at which time Mr. Brown is expected to resign from our compensation committee. Our board of directors has determined that all of the members of our compensation committee are independent directors under the applicable rules and regulations of the SEC and Nasdaq, a “non-employee director” as defined in Rule 16b-3 promulgated under the Exchange Act and an “outside director” as that term is defined in Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code.

Nominating and Corporate Governance Committee. Our nominating and corporate governance committee is responsible for, among other things, making recommendations regarding corporate governance, the composition of our board of directors, identification, evaluation and nomination of director candidates, and the structure and composition of committees of our board of directors.

The responsibilities of this committee include, among other things:

 

    determining criteria for identifying, evaluating and recommending candidates for our board of directors and its committees;

 

    identifying, evaluating, and recommending individuals for membership on our board of directors and its applicable committees;

 

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    considering shareholder nominations of candidates for election to our board of directors;

 

    reviewing and evaluating director performance on our board of directors and applicable committees of our board of directors and determining whether continued service on our board of directors or on such committees of our board of directors is appropriate;

 

    developing, reviewing and recommending a set of corporate governance policies and principles; and

 

    reviewing our governing documents, including our Articles, and recommending changes to our board of directors.

The current members of our nominating and corporate governance committee are Mr. Brown, Dr. Kilty and Dr. McCracken. Mr. Brown serves as the chairman of the nominating and corporate governance committee. Our board of directors has determined that all of the members of our nominating and corporate governance committee are independent directors under the applicable rules and regulations of Nasdaq.

Compensation Committee Interlocks and Insider Participation

No member of our compensation committee is, or has at any time during the past year been, one of our officers or employees. None of our executive officers currently serves, or in the past year has served, as a member of our board of directors or compensation committee of any entity that has one or more executive officers serving on our board of directors or compensation committee.

Code of Business Conduct and Ethics

Upon completion of this offering, we will post to our website a copy of our code of business conduct and ethics that applies to all of our officers, including those officers responsible for financial reporting, directors and employees. We also intend to post amendments to this code, or any waivers of its requirements, on our website, as permitted under SEC rules and regulations. Our website is www.nexvet.com. Information contained on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus and references to our website in this prospectus are inactive textual references only.

Non-Employee Director Compensation

We currently provide cash compensation to certain of our non-employee directors. From time to time, we have also granted option awards and restricted share units to certain of our non-employee directors as compensation for their services. The compensation of Dr. Heffernan, a director and our Chief Executive Officer, is discussed in the section of this prospectus titled “Executive Compensation.” Starting in fiscal year 2015, directors who are also our employees will not receive additional compensation for their service as directors. The following table sets forth information regarding compensation earned by our non-employee directors and director nominee during fiscal year 2014.

 

Name

  

Fees Earned or
Paid in Cash (1)

    

Equity
Awards (1)(2)

    

Total

 

Current Directors and Director Nominee

        

Chris Brown

   $ 36,716       $ 18,357       $ 55,073   

Ashraf Hanna, Ph.D., M.D.(3)

     —           —           —     

Cormac Kilty, Ph.D.

     6,119         —           6,119   

Joseph McCracken, DVM(3)

     —           —           —     

John Payne

     23,253         16,063         39,316   

Graeme Wald, Ph.D.(4)

     6,119         —           6,119   

Rajiv Patel(5)

     —           —           —     

Retired Directors

        

Andrew Gearing, Ph.D.

     6,967         —           6,967   

Peter Howard

     24,477         16,063         40,540   

Paul Wood, Ph.D.

     27,820         33,503         61,323   

 

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(1) Dollar amounts reflect the U.S. dollar equivalent of the amounts paid to our directors in Australian dollars.
(2) Reflects the grant date fair value of all awards made during fiscal year 2014 calculated using the assumptions described in Note 13 to our consolidated financial statements included elsewhere in this prospectus. As of June 30, 2014, our non-employee directors held the following share-based awards: Mr. Brown, options to purchase 7,080 ordinary shares; Mr. Payne, restricted share units to acquire 6,195 ordinary shares; Dr. Gearing, options to purchase 8,850 ordinary shares; Mr. Howard, options to purchase 6,195 ordinary shares; and Dr. Wood, options to purchase 12,920 ordinary shares.
(3) In September 2014, Dr. Hanna and Dr. McCracken joined our board of directors and, in connection therewith, each received restricted share units to acquire 8,820 ordinary shares. The restricted share units vested on September 30, 2014 as to 620 ordinary shares and will vest in three quarterly tranches of 1,400 ordinary shares and then in eight quarterly tranches of 500 ordinary shares.
(4) Dr. Wald has notified our board of directors of his intention to resign as a director by June 30, 2015.
(5) Mr. Patel is a director nominee and is expected to join our board of directors upon the completion of this offering.

Our board of directors has adopted a director compensation policy for all non-employee directors, to be effective upon completion of this offering, pursuant to which non-employee directors will be compensated for their services on our board of directors and employees who serve as directors will no longer receive separate compensation for such service. Pursuant to the policy:

 

    each non-employee director will receive an annual cash retainer of $40,000 or an equivalent number of ordinary shares for the director’s service during the year;

 

    the Chairman of the Board will receive an annual cash retainer of $80,000 for the Chairman’s service during the year;

 

    the chairman of the audit committee will receive an additional annual fee of $15,000 for the chairman’s service during the year and each audit committee member will receive $7,500 for the member’s service during the year;

 

    the chairman of the compensation committee will receive an additional annual fee of $10,000 for the chairman’s service during the year and each compensation committee member will receive $5,000 for the member’s service during the year; and

 

    the chairman of the nominating and corporate governance committee will receive an additional annual fee of $7,500 for the chairman’s service during the year and each nominating and corporate governance committee member will receive $3,500 for the member’s service during the year.

The policy further provides for the grant of equity awards as follows:

 

    each non-employee director appointed to our board of directors following this offering will receive an annual grant of options to purchase 3,600 ordinary shares with an exercise price of the nominal value of $0.125 per ordinary share, except that non-employee directors who are U.S. residents will receive a comparable grant of restricted share units. The options or restricted share units will vest quarterly in arrears over a 12-month period; and

 

    each new non-employee director will receive an initial grant of options to purchase 6,000 ordinary shares with an exercise price of the nominal value of $0.125 per ordinary share, except that non-employee directors who are U.S. residents will receive a comparable grant of restricted share units. The options or restricted share units will vest quarterly in arrears over a 36-month period.

Each director is also entitled to be reimbursed for reasonable travel and other expenses incurred in connection with attending meetings of our board of directors and any committee on which he or she serves.

 

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EXECUTIVE COMPENSATION

As an “emerging growth company” as defined in the JOBS Act, we are not required to include a Compensation Discussion and Analysis section and have elected to comply with the scaled disclosure requirements applicable to emerging growth companies. The following is a discussion of compensation arrangements of our named executive officers, or NEOs, which consist of our principal executive officer and the next two most highly compensated executive officers, for fiscal year 2014. Our NEOs for fiscal year 2014 were as follows:

 

    Mark Heffernan, Ph.D., Chief Executive Officer;

 

    David Gearing, Ph.D., Chief Scientific Officer; and

 

    Damian Lismore, Chief Financial Officer.

2014 Summary Compensation Table

The following table sets forth the compensation awarded to, earned by or paid for services in all capacities by our NEOs during fiscal year 2014. The compensation described in this table and throughout this section does not include medical, group life insurance or other benefits that are available to all of our salaried employees.

 

Name and Principal Position

  

Year

    

Salary(1)

   

Bonus(1)(2)

    

Option
Awards(1)(3)

    

All Other
Compensation(1)

   

Total(1)

 

Mark Heffernan, Ph.D.

     2014       $ 244,852      $ 90,810       $ 143,192       $ 53,543 (4)    $ 532,397   

Chief Executive Officer

               

David Gearing, Ph.D.

     2014         240,673        89,036         143,192         —          472,901   

Chief Scientific Officer

               

Damian Lismore

     2014         149,650 (5)      39,469         110,148         —          299,267   

Chief Financial Officer

               

 

(1) Dollar amounts reflect the U.S. dollar equivalent of the amounts paid to our NEOs. The amounts were converted to U.S. dollars from Australian dollars using the applicable exchange rates for A$ into US$. Of this amount, Australian residents received superannuation (a government-required retirement program) contributions at the statutory rate of 9.25% or 9.5% (depending on the date the contribution was due) of base salary in fiscal year 2014.
(2) Represents amounts earned in fiscal year 2014 as bonuses awarded by our board of directors based on the achievement of company goals related to financing and corporate activities and advancement of our development programs.
(3) Represents the grant date fair value of all awards (other than the award to Dr. Heffernan for his service as a director) made during fiscal year 2014 calculated using the assumptions described in Note 13 to our consolidated financial statements included elsewhere in this prospectus.
(4) Represents $21,417 in cash and $32,126 in the grant date fair value of options received by Dr. Heffernan in fiscal year 2014 for his service as a director. The option grant date fair value was determined using the assumptions described in Note 13 to our consolidated financial statements included elsewhere in this prospectus.
(5) Mr. Lismore joined us in November 2013 and the amount reflects a partial year of service.

 

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Outstanding Equity Awards as of June 30, 2014

The following table sets forth information regarding outstanding option awards held by our NEOs as of June 30, 2014.

 

    

Grant Date

     Option Awards  
            Number of Securities    
Underlying Unexercised
Options
    Option
Exercise
Price(3)
    

Option
Expiration
Date

 

Name

     

Exercisable

    

Unexercisable

      

Mark Heffernan, Ph.D.

     11/5/2013                 27,611 (1)    $ 0.125         11/4/2020   
     11/5/2013                 6,195 (2)      0.125         11/4/2020   

David Gearing, Ph.D.

     11/5/2013                 27,611 (1)      0.125         11/4/2020   

Damian Lismore

     11/5/2013                 21,239 (1)      0.125         11/4/2020   

 

(1) Grant vests in equal annual installments as to 33% of the underlying ordinary shares on each of November 5, 2014, 2015 and 2016.
(2) 100% of the grant vests to underlying ordinary shares on November 5, 2014.
(3) As of June 30, 2014, the exercise price per share was nil, which was revised to the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

Employment Agreements

The following summarizes the employment agreements of our NEOs, which we entered into in December 2014. The employment agreements set forth the terms and conditions of employment, including base salary, bonuses, eligibility to receive our standard employee benefit plans, equity awards and the acceleration of the vesting of share options held by the NEO upon the occurrence of certain conditions. Dr. Heffernan’s and Mr. Lismore’s employment agreements are each conditioned on his signing our standard proprietary information and inventions agreement, and Dr. Gearing’s employment agreement contains standard confidential information, invention assignment and non-competition provisions.

Mark Heffernan, Ph.D.

Dr. Heffernan has served as our Chief Executive Officer since April 2011 and as a member of our board of directors since August 2014. Following completion of this offering, he will continue to serve in that role in an “at will” capacity, will continue to be nominated by us for election to our board of directors and is expected to be based in the San Francisco Bay Area. Dr. Heffernan will receive a base salary of $450,000. He will also be eligible for an annual cash bonus of up to 45% of his annual base salary for the year in which the bonus is granted, based on his achievement of personal objectives and our achievement of corporate objectives determined by our board of directors or Compensation Committee. Contingent on his relocation to the San Francisco Bay Area prior to May 1, 2015 (or such other date as agreed to by our board of directors), Dr. Heffernan will be entitled to a one-time relocation allowance pursuant to which we will reimburse up to $119,700 of his relocation expenses (which he must repay to us if he voluntarily resigns without “good reason” within 12 months of the completion of this offering), as well as reimbursement of up to $25,000 for vacation travel in each of fiscal years 2016, 2017 and 2018.

As soon as practicable after the pricing of this offering, we have agreed to grant Dr. Heffernan a nonstatutory stock option to purchase 100,000 of our ordinary shares at the greater of $15.00 per share or the public offering price, vesting 20% upon closing of this offering and thereafter in substantially equal quarterly installments on the last day of each of the next 16 calendar quarters. Dr. Heffernan will also be eligible to receive annual equity awards of up to $1.0 million in value, which may vest on service, performance or other conditions established by our board of directors. Upon a “change in control,” all equity awards held by Dr. Heffernan will become 100% vested and exercisable in full.

 

 

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David Gearing, Ph.D.

Dr. Gearing has served as our Chief Scientific Officer since September 2010. Following completion of this offering, he will continue to serve in that role and is expected to continue to be based in Melbourne, Australia. Dr. Gearing will receive a base salary of $325,000 (inclusive of statutory superannuation fund contributions, currently at a rate of 9.5%). He will also be eligible for an annual cash bonus of up to 40% of his annual base salary for the year in which the bonus is granted, based on his achievement of personal objectives and our achievement of corporate objectives determined by our board of directors.

As soon as practicable after the pricing of this offering, we have agreed to grant Dr. Gearing a nonstatutory stock option to purchase 100,000 of our ordinary shares at the greater of $15.00 per share or the public offering price, vesting 20% upon closing of this offering and thereafter in substantially equal quarterly installments on the last day of each of the next 16 calendar quarters. Dr. Gearing will also be eligible to receive annual equity awards of up to $300,000 in value, which may vest on service, performance or other conditions established by our board of directors. Upon a “change in control,” all equity awards held by Dr. Gearing will become 100% vested and exercisable in full.

Damian Lismore

Mr. Lismore has served as our Chief Financial Officer since November 2013. Following completion of this offering, he will continue to serve in that role in an “at will” capacity and is expected to be based in the San Francisco Bay Area. Mr. Lismore will receive a base salary of $350,000. He will also be eligible for an annual cash bonus of up to 40% of his annual base salary for the year in which the bonus is granted, based on his achievement of personal objectives and our achievement of corporate objectives determined by our board of directors or Compensation Committee. Contingent on his relocation to the San Francisco Bay Area prior to May 1, 2015 (or such other date as agreed to by our board of directors), Mr. Lismore will be entitled to a one-time relocation allowance pursuant to which we will reimburse up to $50,700 of his relocation expenses (which he must repay to us if he voluntarily resigns without “good reason” within 12 months of the completion of this offering), as well as reimbursement of up to $10,000 for vacation travel in each of fiscal years 2016, 2017 and 2018.

As soon as practicable after the pricing of this offering, we have agreed to grant Mr. Lismore a nonstatutory stock option to purchase 100,000 of our ordinary shares at the greater of $15.00 per share or the public offering price, vesting 20% upon closing of this offering and thereafter in substantially equal quarterly installments on the last day of each of the next 16 calendar quarters. Mr. Lismore will also be eligible to receive annual equity awards of up to $400,000 in value, which may vest on service, performance or other conditions established by our board of directors. Upon a “change in control,” all equity awards held by Mr. Lismore will become 100% vested and exercisable in full.

Severance-Related Provisions

We may terminate Dr. Heffernan’s or Mr. Lismore’s employment at any time and for any reason, with or without cause, upon written notice. If we do so for “cause,” such executive officer would only be entitled to the prorated amount of his base salary and any accrued and used vacation or benefits through the termination date. If we do so without “cause” or either Dr. Heffernan or Mr. Lismore resigns for “good reason,” such executive officer would be entitled to continued payment of his base salary and health insurance premiums for himself and his eligible dependents for six months, a cash amount approximating the value of the annual equity award he would have received in the year of his termination (prorated through his termination date), and full acceleration of the vesting of his options and any annual equity awards (which will be exercisable for the remainder of the option term as if employment had not terminated). If either Dr. Heffernan or Mr. Lismore is terminated without “cause” or resigns for “good reason” immediately prior to, upon, or within 12 months following a “change of control,” he will be entitled to these same benefits, except that the salary continuation and health insurance premium payments will continue for 12 months rather than six months.

 

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We may terminate Dr. Gearing’s employment at any time by giving him six months’ written notice, or 12 months’ written notice if we terminate his employment immediately prior to, upon or within 12 months following a “change of control.” If we so terminate Dr. Gearing, he is entitled to a cash amount approximating the value of the annual equity award he would have received in the year of his termination (prorated through his termination date), and full acceleration of the vesting of his options and any annual equity awards (which will be exercisable for the remainder of the option term as if employment had not terminated). We may terminate Dr. Gearing summarily without notice or any payment in lieu of notice if he commits serious misconduct, he commits a serious or persistent breach of any material term or condition of his employment agreement, he refuses or fails to comply with our lawful and reasonable directive that is not timely rectified, he engages in any fraudulent or dishonest conduct or other specified conditions arise that impact his ability to perform his duties or may bring us into disrepute.

Each of Dr. Heffernan, Dr. Gearing and Mr. Lismore may terminate his employment at any time by giving us three months’ notice, and in this case all of his unvested options and annual equity awards will not vest or be exercisable on the date his employment terminates.

Certain Definitions

For purposes of each of our NEOs’ employment agreement, a “change in control” means: (i) a merger or consolidation or the sale, or exchange by our shareholders of all or substantially all of our capital stock, where our shareholders immediately before such transaction do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting equity of the surviving or acquiring entity in substantially the same proportion as before such transaction; (ii) any transaction or series of related transactions to which we are a party in which in excess of 50% of our voting power is transferred, other than a transfer in which our shareholders immediately before such transfer do not obtain or retain, directly or indirectly, more than 50% of the beneficial interest in the voting equity of the entity to which the voting power of our company was transferred; or (iii) the sale or exchange of all or substantially all of our assets, other than a sale or transfer one of our subsidiaries in which our shareholders immediately before such sale or exchange do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting equity of the entity acquiring our assets in substantially the same proportion as before such transaction.

For purposes of each of Dr. Heffernan’s and Mr. Lismore’s employment agreement:

 

    “Cause” means: (i) his gross negligence, gross misconduct or refusal to perform his duties and responsibilities to us (including any willful act or omissions that have a material adverse effect on our reputation or financial statements) after receiving a written description of such failure and been provided with 30 days to cure such failure, or his material breach of fiduciary duties to us; (ii) his conviction of, or plea of nolo contendere to, a felony; or (iii) his engagement in acts of embezzlement or material dishonesty; and

 

    “Good reason” means his resignation within 90 days after one of the following conditions has come into existence without his consent: (i) the material breach by us of any of our obligations under the employment agreement; (ii) a material reduction of his duties, position or responsibilities or his removal from such position and responsibilities, or a reduction in the level of supervisor within the organization to whom he reports; (iii) a material reduction in his base salary, unless such reduction is made in connection with a company-wide cost reduction effort; (iv) our requirement that he report to a new primary work location; or (v) a material reduction in the kind or level of employee benefits to which he is entitled immediately prior to such reduction with the result that his overall benefits package is significantly reduced such that the reduction constitutes a “material negative change” to his employment relationship (within the meaning of Section 1.409A-1(n)(2) of the United States Treasury Regulations), unless such reduction is made in connection with a company-wide cost reduction effort of similar scope for all similarly situated employees.

 

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Employee Benefit Plans

2012 Employee Share Option Plan

In August 2012, our board of directors adopted our employee share option plan, or the 2012 Plan. Pursuant to the 2012 Plan, we issued 264,386 ordinary shares at a purchase price of $4.20 per share to employees (including executive officers), consultants and each member of our board of directors who could purchase such shares with an interest-free, limited recourse loan payable to us. These limited recourse loans were not collateralized and were not recourse to the assets of the borrower, except to the extent of the ordinary shares issued. Because the loans were the sole consideration for the ordinary shares issued, we accounted for these arrangements as share options since the substance is similar to the grant of an option, with a deemed exercise price equal to the loan amount. The fair value of the notional share option was expensed in 2013 when vested with a corresponding credit to additional paid in capital.

The loans were repayable within 30 days of the termination of service to us of the employee, director or consultant. Failure to pay back the loan within that time frame would have resulted in the relinquishment of those shares by the shareholder. The balance outstanding as of each of June 30, 2013 and 2014 was $1.0 million and as of September 30, 2014 was nil. We do not recognize a separate receivable for limited recourse loans. The 2012 Plan is no longer in use.

Andrew O’Brien resigned from our board of directors in November 2013 and subsequently repaid his loan under the 2012 Plan. In August 2014, for the remaining eight loans under the 2012 Plan, we repurchased 145,069 ordinary shares at a purchase price of $6.35 per ordinary share to satisfy the outstanding loans, and we issued to each former holder of such ordinary shares an option to purchase a number of ordinary shares equal to the number of ordinary shares repurchased with an exercise price of $6.35 per ordinary share. The new options expire in February 2018, consistent with the original repayment date of the loan. With respect to Dr. Heffernan, his $0.3 million loan amount was satisfied with a repurchase by us of 52,040 ordinary shares and the grant of an option to purchase the same number of ordinary shares. With respect to Dr. Gearing, his $0.3 million loan amount was satisfied with a repurchase by us of 46,372 ordinary shares and the grant of an option to purchase the same number of ordinary shares. As a result of the repurchases, all of the limited recourse loans have been repaid.

2013 Long Term Incentive Plan

In September 2013, our board of directors approved a long-term incentive plan for our employees (including executive officers), directors and consultants, pursuant to which in November 2013 we issued share options to purchase 215,799 ordinary shares and restricted share units to acquire 29,214 ordinary shares to employees, directors and consultants. The underlying ordinary shares had a fair value of $5.15 per share, but the awards had an exercise or conversion price, as applicable, of nil, as permitted under Australian law. Because Irish law requires the payment to an issuer of at least the nominal value of shares in order to acquire such shares from the issuer, any options or restricted share units with a nil exercise or conversion price became exercisable or convertible, as applicable, at the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014. In September 2014, we also issued share options to purchase 16,800 ordinary shares and restricted share units to acquire 21,240 ordinary shares to employees, directors and consultants. The underlying ordinary shares had a fair value of $6.35 per ordinary share, but the awards had an exercise or conversion price of the nominal value of $0.10 per ordinary share, which nominal value became $0.125 per ordinary share in connection with the four-for five share consolidation in November 2014. Except for share options and restricted share units held by directors (which vest either beginning in September 2014 and quarterly thereafter or in November 2014), share options and restricted share units held by employees and consultants vest in three equal tranches in November 2014, November 2015 and November 2016. We revised this plan in September 2014 in connection with the Irish Exchange and refer to this plan as our 2013 Plan.

 

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As of September 30, 2014, 201,960 ordinary shares were reserved for future issuance under the 2013 Plan. The 2013 Plan will be terminated in connection with this offering and, accordingly, no ordinary shares will be available for issuance under the 2013 Plan following the completion of this offering. The 2013 Plan will continue to govern outstanding awards granted thereunder.

Appropriate adjustments will be made in the number of authorized ordinary shares and other numerical limits in our 2013 Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a share split or other change in our capital structure.

The 2013 Plan is administered by our board of directors. Subject to the provisions of our 2013 Plan, the board of directors determines, in its discretion, the persons to whom, and the times at which, awards are granted, as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between us and the holder of the award. The board of directors has the authority to construe and interpret the terms of our 2013 Plan and awards granted under our 2013 Plan.

In the event of a change of control as described in our 2013 Plan, the acquiring or successor entity may assume or continue all or any awards outstanding under our 2013 Plan or substitute substantially equivalent awards. Any awards which are not assumed or continued in connection with a change of control or are not exercised or settled prior to the change of control will terminate effective as of the time of the change of control. The board of directors may provide for the acceleration of vesting of any or all outstanding awards upon such terms and to such extent as it determines, except that the vesting of all awards held by members of our board of directors who are not employees will automatically be accelerated in full. Our 2013 Plan also authorizes the board of directors, in its discretion and without the consent of any participant, to cancel each or any outstanding award denominated in ordinary shares upon a change of control in exchange for a payment to the participant with respect to each share subject to the cancelled award of an amount equal to the excess of the consideration to be paid per ordinary share in the change of control transaction over the exercise price per ordinary share, if any, under the award.

2014 Equity Incentive Plan

In September 2014, our board of directors adopted, and in November 2014 our shareholders approved, the 2014 Equity Incentive Plan, or the 2014 Plan, to become effective as of the day immediately preceding the day on which the offering is completed. We intend to use the 2014 Plan following the completion of this offering to provide incentives that will assist us to attract, retain, and motivate employees, including officers, consultants and directors. We may provide these incentives through the grant of share options, restricted share units, performance shares and units and other cash-based or share-based awards.

A total of 1,280,000 of our ordinary shares are initially authorized and reserved for issuance under the 2014 Plan. This reserve will automatically increase on July 1, 2015 and each subsequent anniversary through 2024, by an amount equal to the lesser of:

 

    Four percent of the number of our ordinary shares issued and outstanding on the immediately preceding June 30; and

 

    An amount determined by our board of directors.

The ordinary shares available under the 2014 Plan will not be reduced by awards settled in cash, but will be reduced by ordinary shares withheld to satisfy tax withholding obligations with respect to ordinary share options (but not other types of awards). The gross number of ordinary shares issued upon the exercise of options exercised by means of a net exercise or by tender of previously-owned ordinary shares will be deducted from the ordinary shares available under the 2014 Plan. Notwithstanding the foregoing, and subject to adjustment as described below, the maximum aggregate number of ordinary shares that may be subject to issuance at any given time under the 2014 Plan in connection with outstanding awards shall not exceed a number equal to ten percent of our total issued and outstanding ordinary shares (calculated on a non-diluted basis).

 

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Appropriate adjustments will be made in the number of authorized ordinary shares and other numerical limits in the 2014 Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a share split or other change in our capital structure. Ordinary shares subject to awards which expire or are cancelled or forfeited will again become available for issuance under the 2014 Plan.

The 2014 Plan generally will be administered by the compensation committee of our board of directors. Subject to the provisions of the 2014 Plan, the compensation committee will determine in its discretion the persons to whom and the times at which awards are granted, the sizes of such awards and all of their terms and conditions. The compensation committee will have the authority to construe and interpret the terms of the 2014 Plan and awards granted under it. The 2014 Plan provides, subject to certain limitations, for indemnification by us of any director, officer or employee against all reasonable expenses, including attorneys’ fees, incurred in connection with any legal action arising from such person’s action or failure to act in administering the 2014 Plan.

The 2014 Plan will authorize the compensation committee, without further shareholder approval, to provide for the cancellation of share options with exercise prices in excess of the fair market value of the underlying ordinary shares in exchange for new options or other equity awards with exercise prices equal to the fair market value of the underlying ordinary shares or a cash payment.

Awards may be granted under the 2014 Plan to our employees, including officers, directors or consultants or those of any present or future parent or subsidiary corporation or other affiliated entity. All awards will be evidenced by a written agreement between us and the holder of the award and may include any of the following:

 

    Share options. The compensation committee may grant nonstatutory share options or incentive share options (as described in Section 422 of the Code), each of which gives its holder the right, during a specified term (not exceeding ten years) and subject to any specified vesting or other conditions, to purchase a number of our ordinary shares with an exercise price per share determined by the administrator, which may not be less than the fair market value of an ordinary share on the date of grant. The maximum term of any share option granted under the 2014 Plan will be seven years.

 

    Restricted share units. Restricted share units represent rights to receive ordinary shares (or their value in cash) at a future date without payment of a purchase price, other than the nominal value per ordinary share as required by Irish law, subject to vesting or other conditions specified by the administrator. Holders of restricted share units have no voting rights or rights to receive cash dividends unless and until ordinary shares are issued in settlement of such awards. However, the administrator may grant restricted share units that entitle their holders to dividend equivalent rights.

 

    Performance awards. Performance awards, consisting of either performance shares or performance units, are awards that will result in a payment to their holder only if specified performance goals are achieved during a specified performance period. The administrator establishes the applicable performance goals based on one or more measures of business performance enumerated in the 2014 Plan, such as revenue, gross margin, net income or total shareholder return. To the extent earned, performance awards may be settled in cash, in ordinary shares or a combination of both in the discretion of the administrator. Holders of performance shares or performance units have no voting rights or rights to receive cash dividends unless and until ordinary shares are issued in settlement of such awards. However, the administrator may grant performance shares that entitle their holders to dividend equivalent rights.

 

   

Cash-based awards and other share-based awards. The administrator may grant cash-based awards that specify a monetary payment or range of payments or other share-based awards that specify a

 

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number or range of ordinary shares or units that, in either case, are subject to vesting or other conditions specified by the administrator. Settlement of these awards may be in cash or ordinary shares, as determined by the administrator. The holder of such an award will have no voting rights or right to receive cash dividends unless and until ordinary shares are issued pursuant to the award. The administrator may grant dividend equivalent rights with respect to other share-based awards.

In the event of a change of control as described in the 2014 Plan, the acquiring or successor entity may assume or continue all or any awards outstanding under the 2014 Plan or substitute substantially equivalent awards. The compensation committee may provide for the acceleration of vesting of any or all outstanding awards upon such terms and to such extent as it determines. Any awards which are not assumed, continued or substituted for in connection with a change of control or are not exercised or settled prior to the change of control will terminate effective as of the time of the change of control. Notwithstanding the foregoing, except as otherwise provided in an award agreement governing any award as determined by the compensation committee and subject to applicable law, any award that is not assumed, continued or substituted for in connection with a change of control shall become fully vested and exercisable and/or settleable immediately prior to, but conditioned upon, the consummation of the change of control. The 2014 Plan will also authorize the compensation committee, in its discretion and without the consent of any participant, to cancel each or any outstanding award denominated in shares upon a change of control in exchange for a payment to the participant with respect to each share subject to the cancelled award of an amount equal to the excess of the consideration to be paid per ordinary share in the change of control transaction over the exercise price per share, if any, under the award.

The 2014 Plan will continue in effect until it is terminated by our board of directors, provided, however, that all awards will be granted, if at all, within ten years of its effective date. The board of directors may amend, suspend or terminate the 2014 Plan at any time, provided that without shareholder approval the 2014 Plan cannot be amended to increase the number of shares authorized, change the class of persons eligible to receive incentive share options or effect any other change that would require shareholder approval under any applicable law or listing rule.

Indemnification

To the fullest extent permitted by Irish law, our Articles contain indemnification for the benefit of our directors and executive officers. However, as to our directors and company secretary, this indemnity is limited by the Irish Companies Acts, which prescribe that an advance commitment to indemnify only permits a company to pay the costs or discharge the liability of a director or company secretary where judgment is given in favor of the director or company secretary in any civil or criminal action in respect of such costs or liability, or where an Irish court grants relief because the director or company secretary acted honestly and reasonably and ought fairly to be excused. Any provision whereby an Irish company seeks to commit in advance to indemnify its directors or company secretary over and above the limitations imposed by the Irish Companies Acts will be void, whether contained in its articles of association or any contract between the company and the director or company secretary. This restriction does not apply to our executive officers who are not directors, the company secretary or other persons who would be considered “officers” within the meaning of the Irish Companies Acts.

We are permitted under our Articles and the Irish Companies Acts to take out directors’ and officers’ liability insurance, as well as other types of insurance, for our directors, officers, employees and agents. In order to attract and retain qualified directors and officers, we expect to purchase and maintain customary directors’ and officers’ liability insurance and other types of comparable insurance.

We have entered, and intend to continue to enter, into separate indemnification agreements with our directors and executive officers, in addition to the indemnification provided for in our Articles. These agreements, among other things, provide that we will to the extent permitted under our Articles and the Irish Companies Acts indemnify and provide expense advancement for our directors and executive officers for certain

 

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expenses, including attorneys’ fees, judgments, fines, and settlement amounts incurred by a director or executive officer in any action or proceeding arising out of their services as one of our directors or executive officers, or any of our subsidiaries or any other company or enterprise to which the person provides services at our request. At present, there is no pending litigation or proceeding involving any of our directors or executive officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation or proceeding that may result in a claim for indemnification.

The indemnification provisions in our Articles may discourage shareholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might benefit us and our shareholders. A shareholder’s investment may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. Insofar as indemnification for liabilities under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. There is no pending litigation or proceeding naming any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.

 

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PRINCIPAL SHAREHOLDERS

The following table sets forth information known to us regarding the beneficial ownership of our ordinary shares as of December 30, 2014, for each of our directors, our director nominee, each of our named executive officers, all of our directors, director nominee and executive officers as a group and each person or group of affiliated persons who is known by us to own beneficially more than five percent of our outstanding ordinary shares. The table is based upon information supplied by officers, directors, director nominee and principal shareholders.

We have determined beneficial ownership in accordance with the rules of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose, including for purposes of Section 13(d) or 13(g) of the Exchange Act. In calculating the number of ordinary shares beneficially owned by a person and the percentage ownership of that person, we deemed outstanding all ordinary shares underlying options or warrants held by that person that are currently exercisable or exercisable within 60 days from December 30, 2014, or the measurement date, and all restricted share units that are convertible within 60 days from the measurement date. These ordinary shares, however, are not deemed outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated and subject to community property laws where applicable, we believe the persons named in the following table have sole voting and investment power with respect to all ordinary shares shown as beneficially owned by them. Each shareholder’s percentage ownership is based on 7,169,862 ordinary shares outstanding as of December 30, 2014, assuming the automatic conversion of all of our outstanding preference shares into 5,937,160 ordinary shares upon the completion of this offering. Percentage ownership after this offering assumes our sale of ordinary shares in this offering, but no other transactions in our securities after the measurement date.

Unless otherwise indicated, the address of each beneficial owner is c/o NIBRT, Fosters Avenue, Mount Merrion Blackrock, Co. Dublin, Ireland.

 

           

Percent of Outstanding

Shares

 

Name of Beneficial Owner

  

Ordinary Shares

Beneficially

Owned

    

Prior to

this

Offering

   

After this

Offering

 

Named Executive Officers, Directors and Director Nominee:

       

Mark Heffernan, Ph.D.(1)

     286,423         4.0             

David Gearing, Ph.D.(2)

     390,828         5.4     

Damian Lismore(3)

     25,951         *     

Chris Brown(4)

     17,680         *     

Ashraf Hanna, Ph.D., M.D.(5)

     2,020         *     

Cormac Kilty, Ph.D.(6)

     133,164         1.9     

Joseph McCracken, DVM(7)

     2,020         *     

John Payne(8)

     7,995         *     

Graeme Wald(9)

     20,671         *     

Rajiv Patel(10)(13)(15)(19)

     2,474,996         31.5     

All directors, director nominee and executive officers as a group (12 persons)(11)

     3,385,435         42.5     

5% or Greater Shareholders:

       

Adage Capital Partners, LP(12)

     825,000         11.2     

Akubra Investors, LLC(13)

     779,164         10.6     

AustralianSuper Pty Ltd ATF AustralianSuper(14)

     455,096         6.3     

Bushranger Funding, LLC(15)

     840,296         11.4     

Foresite Capital Fund II, LP(16)

     733,332         10.0     

Irrus Investments Nominee Limited(17)

     662,134         9.1     

One Funds Management Limited ATF Asia Pacific Healthcare
Fund II(18)

     864,272         11.9     

Ute Holdings, LLC(19)

     855,536         11.6     

 

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* Represents beneficial ownership of less than 1% of the outstanding ordinary shares.
(1) Includes 229,959 ordinary shares, and 52,040 ordinary shares issuable upon the exercise of options within 60 days of the measurement date, held by Mark Heffernan and his spouse, Patricia Heffernan, as trustees for M&T Heffernan A/C, as to which Dr. Heffernan and Ms. Heffernan, have shared voting and dispositive power.
(2) Includes 83,664 ordinary shares held by DJGearing Pty Ltd, as trustee for Gearing Family Superannuation Fund, and 260,792 ordinary shares, and 46,372 ordinary shares issuable upon the exercise of options within 60 days of the measurement date, held by Gearing Family Pty Ltd as trustee for Gearing Family A/C, as to which David Gearing and his spouse, Julie Gearing, have shared voting and dispositive power.
(3) Includes 20,804 ordinary shares, and 5,147 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date, held by Glenariff Superannuation Pty Ltd, as to which Mr. Lismore and his spouse, Martina Lismore, have shared voting and dispositive power.
(4) Includes 8,800 ordinary shares held by Elsing Pty Ltd, as to which Mr. Brown has sole voting and dispositive power, and 8,880 ordinary shares issuable upon the exercise of options within 60 days of the measurement date.
(5) Includes 1,400 ordinary shares issuable upon the exercise of options within 60 days of the measurement date.
(6) Includes 1,800 ordinary shares issuable upon the exercise of options within 60 days of the measurement date.
(7) Includes 1,400 ordinary shares issuable upon the exercise of options within 60 days of the measurement date.
(8) Includes 900 ordinary shares issuable upon the conversion of restricted share units within 60 days of the measurement date.
(9) Includes 7,548 ordinary shares, and 2,831 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date, held by JanCutz Pty Ltd, and 6,176 ordinary shares, and 2,316 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date, held by Wald Funds Pty Ltd, as to which Mr. Wald has sole voting and dispositive power. Also includes 1,800 ordinary shares issuable upon the exercise of options within 60 days of the measurement date.
(10) Mr. Patel is a director nominee and is expected to join our board of directors upon the completion of this offering.
(11) Includes 688,313 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date, 110,892 ordinary shares issuable upon the exercise of options within 60 days of the measurement date, and 3,700 ordinary shares issuable upon the conversion of restricted share units within 60 days of the measurement date.
(12) Includes 225,000 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. Adage Capital Partners, GP, LLC, or ACPGP, serves as the general partner of Adage Capital Partners, LP, or the Fund, and as such has discretion over the portfolio of securities beneficially owned by the Fund. Adage Capital Advisors, LLC, or ACA, is the managing member of ACPGP and directs ACPGP’s operations. Robert Atchinson and Phillip Gross are the managing members of ACA. Mr. Atchinson and Mr. Gross disclaim beneficial ownership of the reported securities except to the extent of their pecuniary interest therein. The address of Adage Capital Partners, L.P. is 200 Clarendon Street, 52nd Floor, Boston, Massachusetts 02110.
(13) Includes 212,500 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. The members of Akubra Investors, LLC, or Akubra, are: FCIP XR 2014, L.L.C., or FCIP XR; and Noonday Special Situation Partners, L.P., or NSSP. FCIP XR and NSSP together are referred to as the Farallon Akubra Funds. Farallon Capital Institutional Partners, L.P., or FCIP, is the sole member of FCIP XR and may be deemed to beneficially own the ordinary shares owned indirectly by FCIP XR. Farallon Partners, L.P., or FP, is the general partner of FCIP and may be deemed to beneficially own the ordinary shares owned indirectly by FCIP XR. NGP, L.L.C., or NGP, is the general partner of NSSP and may be deemed to beneficially own the ordinary shares owned indirectly by NSSP. Farallon is the manager of NGP and may be deemed to beneficially own the ordinary shares owned indirectly by NSSP. As managing members of Farallon and of FP, with the power to exercise investment discretion, each of Michael Fisch, Richard Fried, Daniel Hirsch, David Kim, Monica Landry, Michael Linn, Rajiv Patel, Thomas Roberts, Jr., Andrew Spokes, John Warren and Mark Wehrly, or collectively, the Farallon Managing Members, may be deemed to beneficially own the ordinary shares indirectly owned by each of the Farallon Akubra Funds. Each of the Farallon Akubra Funds, FCIP, FP, NGP, Farallon and the Farallon Managing Members disclaims beneficial ownership of the ordinary shares held by Akubra. The address of Akubra is One Maritime Plaza, Suite 2100, San Francisco, California 94111.
(14) Includes 59,344 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. Dr. Chris Nave and Dr. Stephen Thompson, of BCP2 Pty Ltd, as attorney and manager of AustralianSuper Pty Ltd as trustee for AustralianSuper, have voting and dispositive power with respect to these ordinary shares. The address of AustralianSuper Pty Ltd ATF AustralianSuper is c/o Brandon Capital Partners, Level 9, 278 Collins Street, Melbourne, Victoria, 3000, Australia.
(15) Includes 229,172 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. The members of Bushranger Funding, LLC, or Bushranger, are: FCP XR 2014, L.L.C., or FCP XR; Farallon Capital Institutional Partners III, L.P., or FCIP III; and Farallon Capital AA Investors, L.P., or FCAAI. FCP XR, FCIP III, and FCAAI together are referred as the Farallon Bushranger Funds. Farallon Capital Partners, L.P., or FCP, is the sole member of FCP XR and may be deemed to beneficially own the ordinary shares owned indirectly by FCP XR. FP is the general partner of FCP and of FCIP III and may be deemed to beneficially own the ordinary shares owned indirectly by FCP and FCIP III. Farallon AA GP, L.L.C., or FAAGP, is the general partner of FCAAI and may be deemed to beneficially own the ordinary shares owned indirectly by FCAAI. FP is the sole member of FAAGP and may be deemed to beneficially own the ordinary shares owned indirectly by FCAAI. As managing members of FP with the power to exercise investment discretion, each of the Farallon Managing Members may be deemed to beneficially own the ordinary shares indirectly owned by each of the Farallon Bushranger Funds. Each of the Farallon Bushranger Funds, FCP, FP, FAAGP and the Farallon Managing Members disclaims beneficial ownership of the ordinary shares held by Bushranger. The address of Bushranger is One Maritime Plaza, Suite 2100, San Francisco, California 94111.

 

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(16) Includes 200,000 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. As managing member of Foresite Capital Management II, LLC, James Tananbaum has voting and dispositive power with respect to these ordinary shares. Foresite Capital Management II, LLC, is the general partner of Foresite Capital Fund II, LP. The address of Foresite Capital Fund II, LP is c/o Foresite Capital Management, LLC, 101 California Street, Suite 4100, San Francisco, California 94111.
(17) Includes 80,250 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. Aidan O’Driscoll, as the authorized director of Irrus Investments Nominee Limited, has voting and dispositive power with respect to these ordinary shares. The address of Irrus Investments Nominee Limited is No. 1 Grants Row, Second Floor, Mount Street Lower, Dublin 2, Ireland.
(18) Includes 90,900 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. Justin Epstein, as the authorized director of One Funds Management Limited, the trustee for Asia Pacific Healthcare Fund II, has voting and dispositive power with respect to these ordinary shares. The address of One Funds Management Limited ATF Asia Pacific Healthcare Fund II is Level 13, 20 Hunter Street, Sydney, New South Wales, 2000, Australia.
(19) Includes 233,328 ordinary shares issuable upon the exercise of warrants within 60 days of the measurement date. The members of Ute Holdings, LLC, or Ute, are: FCOI II Special Situation 2014, Ltd., or FCOI II SS; Farallon Capital Institutional Partners II, L.P., or FCIP II; and Farallon Special Situation Partners VI, L.P., or FSSP VI. FCOI II SS, FCIP II, and FSSP VI together are referred to as the Farallon Ute Funds. Farallon Capital Offshore Investors II, L.P., or FCOI II, is the sole owner of FCOI II SS and may be deemed to beneficially own the ordinary shares owned indirectly by FCOI II SS. FP is the general partner of FCOI II SS and of FCIP II and may be deemed to beneficially own the ordinary shares owned indirectly by FCOI II SS and FCIP II. Farallon Partners GP VI, L.L.C., or FPGP VI, is the general partner of FSSP VI and may be deemed to beneficially own the ordinary shares owned indirectly by FSSP VI. FP is the sole member of FPGP VI and may be deemed to beneficially own the ordinary shares owned indirectly by FSSP VI. As managing members of FP with the power to exercise investment discretion, each of the Farallon Managing Members may be deemed to beneficially own the ordinary shares indirectly owned by each of the Farallon Ute Funds. Each of the Farallon Ute Funds, FCOI II, FP, FPGP VI and the Farallon Managing Members disclaims beneficial ownership of the ordinary shares held by Ute. The address of Ute is One Maritime Plaza, Suite 2100, San Francisco, California 94111.

Entities affiliated with Farallon have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price, or an aggregate of              shares based on an initial public offering price of $             per share, the midpoint of the price range set forth on the cover page of this prospectus. Because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering. If these entities purchase any of these shares, the number of shares beneficially owned by them after this offering, and the percentage of our ordinary shares beneficially owned by them after this offering, will differ from that set forth in the table above. In addition, if these entities purchase all of these shares, the number of shares beneficially owned by all of our executive officers, directors and shareholders who beneficially own more than 5% of our outstanding ordinary shares after this offering would increase from              to             , and the percentage of ordinary shares beneficially owned by this group after this offering would decrease from approximately     % to approximately     %.

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

Since July 1, 2011, there has not been any transaction or series of similar transactions to which we were or are a party in which the amount involved exceeded or exceeds $120,000 and in which any of our directors or executive officers, any holder of more than five percent of any class of our voting securities or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than the arrangements described in the sections of this prospectus titled “Management—Non-Employee Director Compensation” and “Executive Compensation” and the transactions set forth below. We believe that we have executed all of the transactions set forth below on terms no less favorable to us than we could have obtained from unaffiliated third parties.

Loan Repayment

In May 2012, David Gearing, one of our co-founders and our Chief Scientific Officer, loaned us $0.2 million, accruing interest at 15% per annum. In February 2013, we repaid the loan together with $21,000 in accrued interest.

Consulting Agreements

Andrew Gearing is a former director, one of our co-founders and a brother of David Gearing, one of our co-founders and our Chief Scientific Officer. Andrew Gearing serves on the board of directors of Biocomm Squared Pty Ltd. In December 2013, we entered into a consulting agreement with Biocomm Squared Pty Ltd for research and development support services, which was amended in April 2014. In addition, we entered into an agreement with Biocomm Squared Pty Ltd in November 2011 for assistance in obtaining partnering arrangements with Japanese entities. We paid Biocomm Squared Pty Ltd $0.1 million and $0.2 million for fiscal years 2013 and 2014, respectively, related to these agreements.

Robert Gearing is the brother of David Gearing, one of our co-founders and our Chief Scientific Officer, and owns and operates Ridge Biotechnology Consulting, LLC. In April 2011 and April 2012, we entered into consulting agreements with Ridge Biotechnology Consulting, LLC for the provision of manufacturing consulting services, and we entered into a new consulting agreement with Ridge Biotechnology Consulting, LLC in January 2014. We paid Ridge Biotechnology Consulting, LLC $0.1 million for fiscal year 2014 related to these agreements.

SIRPS and Series B Financings

Between March 2013 and June 2013, Nexvet Australia issued an aggregate of 293,915 SIRPS preference shares to various existing and new shareholders at the price of $5.10 per share, for aggregate gross consideration of $1.5 million. Between July 2013 and September 2013, Nexvet Australia issued an aggregate of 72,442 SIRPS preference shares to four new investors at the price of $5.25 per share, for aggregate gross consideration of $0.4 million. Between September 2013 and December 2013, Nexvet Australia issued an aggregate of 863,725 SIRPS preference shares at the price of $5.15 per share to new and existing shareholders, for aggregate gross consideration of $4.4 million. In addition, Nexvet Australia issued 8,849 SIRPS preference shares for professional services rendered in connection with the SIRPS preference shares financing (the equivalent of A$50,000). Each SIRPS preference share was consolidated on a one-for-four basis in August 2014, then exchanged on a one-for-one basis for SIRPS preference shares in connection with the Irish Exchange and then consolidated on a four-for-five basis in November 2014.

In April 2014 and May 2014, Nexvet Australia issued an aggregate of 4,200,006 Series B preference shares in a private placement transaction at the purchase price of $7.50 per share and warrants to purchase an aggregate of 1,574,998 ordinary shares with an exercise price of $8.625 per ordinary share to 27 investors for aggregate gross consideration of $31.5 million. Each Series B preference share was consolidated on a one-for-four basis in August 2014, then exchanged on a one-for-one basis for Series B preference shares in connection

 

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with the Irish Exchange and then consolidated on a four-for-five basis in November 2014. In addition to the warrants issued to the Series B shareholders, further warrants to purchase 192,000 ordinary shares were issued to advisors with an exercise price of $7.50 per share.

The following table summarizes the ordinary shares, preference shares and warrants purchased by our executive officers, directors and holders of five percent or more of our capital shares and their affiliated entities since July 1, 2011 that involved an amount over $120,000:

 

Investors

  

Ordinary

Shares

    

SIRPS

Preference

Shares

    

Series B

Preference

Shares

    

Warrants to

Purchase

Ordinary Shares

    

Total

Purchase

Price

 

Mark Heffernan, Ph.D.

     214,560         4,424         —           —         $ 329,482   

David Gearing, Ph.D.

     335,256         —           —           —           635,787   

Participation in this Offering

Entities affiliated with Farallon, which hold more than 5% of our ordinary shares and are affiliates of a director nominee, have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price. However, because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering.

Shareholders Agreement

In connection with our Series B preference share financing, we amended and restated our shareholders agreement pursuant to which we have undertaken to provide registration rights to the holders of our Series B preference shares. In connection with this offering, we expect each holder of our Series B preference shares to enter into an agreement with us that would grant the holder certain demand, Form S-3 and piggyback registration rights. We amended and restated the shareholders agreement in August 2014 in connection with the Irish Exchange. Parties to the shareholders agreement include all of our executive officers and directors, other than John Payne, directly or indirectly through trusts for their benefit (Mark Heffernan, Chief Executive Officer and a director; David Gearing, Chief Scientific Officer; Damian Lismore, Chief Financial Officer; Geraldine Farrell, Vice President Operations and General Counsel; and Colin Giles, Vice President Clinical and Regulatory Affairs; Chris Brown, Chairman of the Board; Cormac Kilty, director; and Graeme Wald, director), and all of our five percent or greater shareholders (Adage Capital Partners, LP; Akubra Investors, LLC; Australian Super Pty Ltd; Bushranger Funding, LLC; Foresite Capital Fund II, LP; Irrus Investments Nominee Limited; One Funds Management Limited ATF Asia Pacific Healthcare Fund II; and Ute Holdings, LLC). As of September 30, 2014, the holders of 5,967,004 ordinary shares, including the ordinary shares issuable upon the automatic conversion of our Series B preference shares and upon exercise of outstanding warrants, or their permitted transferees, are entitled to request these registration rights. For a description of these registration rights, please see the section of this prospectus titled “Description of Share Capital—Registration Rights.” The shareholders agreement terminates upon the completion of this offering.

Sales of Convertible Notes

From August 2010 through December 2011, Nexvet Australia issued A$1.4 million in an aggregate amount of notes convertible into ordinary shares to nine accredited investors. The convertible notes converted into 534,545 ordinary shares at A$2.59 per ordinary share upon the closing of our seed financing round.

 

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The following table summarizes purchases of convertible notes by our executive officers, directors and holders of more than five percent of our ordinary shares and their affiliated entities since July 1, 2011 that involved an amount over $120,000:

 

Investors

  

Convertible
Notes
(Principal
Amount)

    

Ordinary

Shares

(Issued upon
Conversion)

 

David Gearing, Ph.D.

   $ 341,662         124,734   

Cormac Kilty, Ph.D.

     360,839         131,367   

Policy for Approval of Related Party Transactions

Our audit committee will be responsible for reviewing and approving all transactions in which we are a participant and in which any parties related to us, including our executive officers, directors, beneficial owners of more than five percent of our securities, immediate family members of the foregoing persons, and any other persons whom our board of directors determines may be considered related parties, has or will have a direct or indirect material interest. If advance approval is not feasible, the audit committee has the authority to ratify a related party transaction at the next audit committee meeting. For purposes of our audit committee charter, a material interest is deemed to be any consideration received by such a party in excess of $100,000 per year.

In reviewing and approving such transactions, the audit committee shall obtain, or shall direct our management to obtain on its behalf, all information that our committee believes to be relevant and important to a review of the transaction prior to its approval. Following receipt of the necessary information, a discussion shall be held of the relevant factors if deemed to be necessary by our committee prior to approval. If a discussion is not deemed to be necessary, approval may be given by written consent of our committee. This approval authority may also be delegated to the chairman of the audit committee in respect of any transaction in which the expected amount is less than $250,000. No related party transaction may be entered into prior to the completion of these procedures.

The audit committee or its chairman, as the case may be, shall approve only those related party transactions that are determined to be in, or not inconsistent with, the best interests of us and our shareholders, taking into account all available facts and circumstances as our committee or the chairman determines in good faith to be necessary. These facts and circumstances will typically include, but not be limited to, the material terms of the transaction, the nature of the related party’s interest in the transaction, the significance of the transaction to the related party and the nature of our relationship with the related party, the significance of the transaction to us, and whether the transaction would be likely to impair (or create an appearance of impairing) the judgment of a director or executive officer to act in our best interest. No member of the audit committee may participate in any review, consideration or approval of any related party transaction with respect to which the member or any of his or her immediate family members is the related party, except that such member of the audit committee will be required to provide all material information concerning the related party transaction to the audit committee.

 

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DESCRIPTION OF SHARE CAPITAL

The following summary describes our share capital that will be in effect upon completion of this offering. Because the following is only a summary, it does not purport to be complete or to contain all of the information which may be important to you and is qualified in its entirety by reference to the Irish Companies Acts and the complete text of our Articles.

Authorized Share Capital

Upon the completion of this offering, our authorized share capital will be €40,000, divided into 400 Euro deferred shares with a nominal value of €100.00 per share, and $12,600,000, divided into 100,000,000 ordinary shares with a nominal value of $0.125 per share and 10,000,000 undesignated preference shares with a nominal value of $0.01 per share.

The authorized and issued share capital includes 400 Euro deferred shares which are required in order to satisfy statutory requirements for the re-registration of an Irish private limited company into an Irish public limited company. The holders of the Euro deferred shares are not entitled to receive any dividend or distribution, to attend, speak or vote at any general meeting, and have no effective rights to participate in the assets of our company.

We may issue shares subject to the maximum authorized share capital contained in our Articles. The authorized share capital may be increased or reduced by a resolution approved by a simple majority of the votes cast at a general meeting of our shareholders (referred to under Irish law as an “ordinary resolution”). Our authorized share capital may be divided into shares of such nominal value as the resolution shall prescribe. As a matter of Irish law, the directors of a company may issue new ordinary or preference shares without shareholder approval once authorized to do so by the memorandum and articles of association or by an ordinary resolution adopted by the shareholders at a general meeting. The authorization may be granted for a maximum period of five years, at which point it must be renewed by the shareholders by an ordinary resolution. We expect that we will seek to renew such general authority at a general meeting before the end of that five-year period.

The rights and restrictions to which the ordinary shares will be subject are prescribed in our Articles. Our Articles permit our board of directors, without shareholder approval, to determine the terms of the preference shares that we may issue. Our board of directors is authorized, without obtaining any vote or consent of the holders of any class or series of shares, unless expressly provided by the terms of that class or series of shares, to provide from time to time for the issuance of other classes or series of shares and to establish the characteristics of each class or series, including the number of shares, designations, relative voting rights, dividend rights, liquidation and other rights, redemption, repurchase or exchange rights and any other preferences and relative, participating, optional or other rights and limitations not inconsistent with applicable law.

Issued Share Capital

Upon the completion of this offering, our issued share capital will be €40,000, divided into 400 Euro deferred shares with a nominal value of €100.00 per share, and $        , divided into              ordinary shares with a nominal value of $0.125 per share. Our Euro deferred shares will each be paid up to one quarter of its nominal value.

Our ordinary shares issued pursuant to this offering will be issued credited as fully-paid.

Preemption Rights, Share Warrants and Share Options

Under Irish law, certain statutory preemption rights apply automatically in favor of shareholders where shares are to be issued for cash. However, we have opted out of these preemption rights in our Articles as permitted under Irish law. Irish law requires this opt-out to be renewed at least every five years by a resolution approved by not less than 75% of the votes cast at a general meeting of the shareholders (referred to under Irish law as a “special resolution”). If the opt-out is not renewed, shares issued for cash must be offered to our existing

 

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shareholders on a pro rata basis to their existing shareholding before the shares may be issued to any new shareholders. The statutory preemption rights do not apply (i) where shares are issued for non-cash consideration (such as in a share-for-share acquisition), (ii) to the issue of non-equity shares (that is, shares that have the right to participate only up to a specified amount in any income or capital distribution) or (iii) where shares are issued pursuant to an employee share option or similar equity plan.

Our Articles provide that, subject to any shareholder approval requirement under any laws, regulations or the rules of any stock exchange to which we are subject, our board of directors is authorized, from time to time, in its discretion, to grant such persons, for such periods and upon such terms as it deems advisable, options to purchase such number of shares of any class or classes or of any series of any class as our board of directors may deem advisable, and to cause warrants or other appropriate instruments evidencing such options to be issued. The Irish Companies Acts provide that directors may issue share warrants or options without shareholder approval once authorized to do so by the articles of association or an ordinary resolution of shareholders. We will be subject to the rules of Nasdaq and the Irish Companies Acts, which require shareholder approval of certain equity plan and share issuances. Our board of directors may issue shares upon exercise of warrants or options without shareholder approval or authorization (up to the relevant authorized share capital limit).

Share Options and Restricted Share Units

As of September 30, 2014, we had outstanding share options to purchase 358,553 ordinary shares and restricted share units to acquire 50,454 ordinary shares, all of which were subject to vesting requirements. The original nil exercise price of certain of these options and the original nil conversion price of certain of these restricted share units were revised to the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

Warrants

As of September 30, 2014, we had outstanding warrants to purchase up to 1,766,998 ordinary shares, with a weighted-average exercise price of $8.50 per ordinary share.

The subscription agreement for the sale of our Series B preference shares provides that if our board of directors approves an initial public offering of our ordinary shares and warrants to purchase at least 200,000 ordinary shares remain outstanding at that time, then our board of directors must ensure, subject to the relevant rules of the applicable stock exchange, that such warrants will be listed as part of the undertaking of that initial public offering. We expect this right will be waived in connection with this offering.

Some of these warrants have a net exercise provision under which its holder may elect to pay to us the nominal value of the applicable shares, in lieu of payment of the exercise price in cash, surrender the warrant and receive a net amount of ordinary shares based on the fair market value of our ordinary shares at the time of exercise of the warrant after deduction of the aggregate exercise price. Each of these warrants also contains provisions for the adjustment of the exercise price and the aggregate number of ordinary shares issuable upon the exercise of the warrant in the event of share splits, reorganizations, reclassifications and consolidations.

Registration Rights

In connection with our Series B preference share financing, we amended and restated our shareholders agreement pursuant to which we have undertaken to provide registration rights to the holders of our Series B preference shares. In connection with this offering, we expect each holder of Series B preference shares to enter into an agreement with us that would grant the holder certain demand, Form S-3 and piggyback registration rights for the ordinary shares issuable upon the automatic conversion of the Series B preference shares, as described below. We refer to the ordinary shares with these registration rights as “registrable securities.” These holders have agreed not to exercise any registration rights they may acquire until the date beginning 180 days after the date of this prospectus.

 

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The following is a summary of the proposed registration rights.

Demand Registration Rights

Holders of registrable securities representing at least 10% of our outstanding ordinary shares may, on not more than two occasions, request that we register all or a portion of their registrable securities. However, we will not be required to effect a registration on Form S-1 if we have previously effected a registration on Form S-1 in the six-month period preceding the request for registration on Form S-1. In an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions, to limit the number of ordinary shares such holders may include.

Form S-3 Registration Rights

Holders of registrable securities representing at least five percent of our outstanding ordinary shares can make a written request that we register their shares on Form S-3 if we are eligible to file a registration statement on Form S-3. These holders may make an unlimited number of requests for registration on Form S-3. In an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions, to limit the number of ordinary shares such holders may include.

Piggyback Registration Rights

In the event that we determine to register any of our securities under the Securities Act, either for our own account or for the account of other security holders, the holders of registrable securities will be entitled to certain “piggyback” registration rights allowing the holders to include their registrable securities in such registration, subject to certain marketing and other limitations. As a result, whenever we propose to file a registration statement under the Securities Act, other than with respect to a registration related to employee benefit plans or corporate reorganizations, the holders of registrable securities are entitled to notice of the registration and have the right, subject to limitations that the underwriters may impose on the number of ordinary shares included in the registration, to include their registrable securities in the registration.

Expenses of Registration

We will pay the registration expenses of the holders of ordinary shares registered pursuant to the demand, Form S-3, and piggyback registration rights described above. We will also pay the fees of one counsel to the selling holders.

Expiration of Registration Rights

The demand, Form S-3 and piggyback registration rights described above will expire, with respect to any particular shareholder, when that shareholder can sell all of its ordinary shares without registration and without restrictions under applicable securities laws, including volume limitations.

Dividends

Under Irish law, dividends and distributions may only be made from distributable reserves. Distributable reserves generally means accumulated realized profits less accumulated realized losses and includes reserves created by way of capital reduction. In addition, no distribution or dividend may be made unless our net assets are equal to, or in excess of, the aggregate of our called up share capital plus undistributable reserves and the distribution does not reduce our net assets below such aggregate. Undistributable reserves include the share premium account, the capital redemption reserve fund and the amount by which our accumulated unrealized profits, so far as not previously utilized by any capitalization, exceed our accumulated unrealized losses, so far as not previously written off in a reduction of capital approved by the Irish High Court without restriction, or a reorganization of capital.

 

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The determination as to whether or not we have sufficient distributable reserves to fund a dividend must be made by reference to our “relevant accounts.” The “relevant accounts” will be either the last set of unconsolidated annual audited financial statements or other financial statements properly prepared in accordance with the Irish Companies Acts, which give a “true and fair view” of our unconsolidated financial position and accord with accepted accounting practice.

Our Articles authorize our board of directors to declare dividends without shareholder approval to the extent they appear justified by profits lawfully available for distribution. Our board of directors may also recommend a dividend to be approved and declared by the shareholders at a general meeting. Our board of directors may direct that the payment be made by distribution of assets, shares or cash, and no dividend issued may exceed the amount recommended by our board of directors. Dividends may be declared and paid in the form of cash or non-cash assets and may be paid in dollars or any other currency.

Our board of directors may deduct from any dividend payable to any shareholder any amounts payable by such shareholder to us in relation to our ordinary shares.

Our board of directors may also authorize us to issue shares with preference rights to participate in dividends we declare. The holders of preference shares may, depending on their terms, rank senior to the ordinary shares in terms of dividend rights or be entitled to claim arrears of a declared dividend out of subsequently declared dividends in priority to ordinary shareholders.

For information about the Irish tax issues relating to dividend payments, please see the section of this prospectus titled “Taxation—Irish Tax Considerations—Irish Dividend Withholding Tax.”

Bonus Shares

Under our Articles, upon recommendation of our board of directors, the shareholders by ordinary resolution may authorize our board of directors to capitalize any amount for the time being standing to the credit of any of our reserves (including any capital redemption reserve fund or share premium account) or to the credit of profit and loss account for issuance and distribution to shareholders as fully paid up bonus shares on the same basis of entitlement as would apply in respect of a dividend distribution.

Share Repurchases and Redemptions

Overview

Our Articles provide that any ordinary share that we have agreed to acquire shall be deemed to be a redeemable share. Accordingly, for Irish law purposes, the repurchase of ordinary shares by us may technically be effected as a redemption of those shares as described under “—Repurchases and Redemptions.” If our Articles did not contain such provision, repurchases by us would be subject to many of the same rules that apply to purchases of ordinary shares by subsidiaries described under “—Purchases by Subsidiaries,” including the shareholder approval requirements described below, and the requirement that any purchases on market be effected on a “recognized stock exchange,” which, for purposes of the Irish Companies Acts, includes Nasdaq.

Except where otherwise noted, references elsewhere in this prospectus to repurchasing or buying back our ordinary shares refer to the redemption of ordinary shares by us or our purchase of ordinary shares by one of our subsidiaries, in each case in accordance with our Articles and Irish law as described below.

Repurchases and Redemptions

Under Irish law, subject to the conditions summarized below a company may issue redeemable shares and may only redeem them out of distributable reserves or the proceeds of a new issue of ordinary shares for that purpose. As described in “—Dividends,” we do not expect to have any distributable reserves for the foreseeable

 

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future. We may only issue redeemable shares if the nominal value of the issued share capital that is not redeemable is not less than 10% of the nominal value of our total issued share capital. All redeemable shares must also be fully-paid and the terms of redemption of the shares must provide for payment on redemption. Redeemable shares may, upon redemption, be cancelled or held in treasury. Based on the provision of our Articles described above, shareholder approval will not be required to redeem our ordinary shares.

We may also be given an additional general authority to purchase our own shares on market, which would take effect on the same terms and be subject to the same conditions as applicable to purchases by our subsidiaries as described below.

Our board of directors may also issue preference shares, which may be redeemed at the option of either us or the shareholder, depending on the terms of such preference shares. Please see “—Authorized Share Capital” above for additional information on preference shares.

Repurchased and redeemed shares may be cancelled or held as treasury shares. The nominal value of treasury shares held by us at any time must not exceed 10% of the nominal value of our issued share capital. We may not exercise any voting rights in respect of any shares held as treasury shares. Treasury shares may be cancelled by us or re-issued subject to certain conditions.

Purchases by Subsidiaries

Under Irish law, an Irish or non-Irish subsidiary may purchase our ordinary shares either on market or off market. For one of our subsidiaries to make purchases on market of our ordinary shares, the shareholders must provide general authorization for such purchase by way of ordinary resolution. However, as long as this general authority has been granted, no specific shareholder authority for a particular on market purchase by a subsidiary of our ordinary shares is required. For a purchase by a subsidiary off market, the proposed purchase contract must be authorized by special resolution of our shareholders before the contract is entered into. The person whose ordinary shares are to be bought back cannot vote in favor of the special resolution and, for at least 21 days prior to the special resolution being passed, the purchase contract must be on display or must be available for inspection by our shareholders at our registered.

In order for one of our subsidiaries to make an on market purchase of our ordinary shares, such shares must be purchased on a “recognized stock exchange.” Nasdaq, on which we have applied to list our ordinary shares, is specified as a recognized stock exchange for this purpose by Irish law.

The number of ordinary shares held by our subsidiaries at any time will count as treasury shares and will be included in any calculation of the permitted treasury share threshold of 10% of the nominal value of our issued share capital. While a subsidiary holds any of our shares, it cannot exercise any voting rights in respect of those shares. The acquisition of our ordinary shares by a subsidiary must be funded out of distributable reserves of the subsidiary.

Lien on Shares, Calls on Shares and Forfeiture of Shares

Our Articles provide that we will have a first and paramount lien on every share that is not a fully-paid-up share for all amounts payable at a fixed time or called in respect of that share. Subject to the terms of their allotment, directors may call for any unpaid amounts in respect of any shares to be paid, and if payment is not made, the shares may be forfeited. However, directors may only call for any unpaid amounts in respect of any Euro deferred shares to be paid in the event and for the purposes of our winding up. These provisions are customary in the articles of association of an Irish public company limited by shares such as our company and will only be applicable to shares that have not been fully-paid-up.

 

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Consolidation and Division; Subdivision

Under our Articles, we may, by ordinary resolution, consolidate and divide all or any of our share capital into shares of larger nominal value than our existing shares or subdivide our shares into smaller amounts than are fixed by our Articles.

Reduction of Share Capital

We may, by ordinary resolution, reduce our authorized share capital. We also may, by special resolution and subject to confirmation by the Irish High Court, reduce or cancel our issued share capital in any manner permitted by the Irish Companies Acts.

Annual Meetings of Shareholders

We will be required to hold an annual general meeting within 18 months of our incorporation and thereafter at intervals of no more than 15 months from the previous annual general meeting, provided that an annual general meeting is held in each calendar year following the first annual general meeting and no more than nine months after our fiscal year-end. We will hold our first annual general meeting in 2015.

Notice of an annual general meeting must be given to all of our shareholders and to our auditors. Our Articles provide for a minimum notice period of 21 days, which is the minimum permitted under Irish law.

The only matters which must, as a matter of Irish law, be transacted at an annual general meeting are the presentation of the annual accounts, balance sheet and reports of the directors and auditors, the appointment of new auditors and the fixing of the auditor’s compensation (or delegation of same). If no resolution is made in respect of the reappointment of an existing auditor at an annual general meeting, the existing auditor will be deemed to have continued in office.

Our Articles provide that a resolution on other proposals may only be proposed at an annual general meeting if (i) it is proposed by or at the direction of our board of directors, (ii) it is proposed at the direction of the Irish High Court, (iii) it constitutes the nomination of one or more persons for election to our board of directors in compliance with the procedures as set out in our Articles, (iv) it is proposed on the requisition in writing of such number of members as is prescribed by, and is made in accordance with, Section 132 of the Irish Companies Act or (v) the chairman of the meeting decides, in his or her absolute discretion, that the resolution may properly be regarded as within the scope of the relevant meeting.

Our Articles provide that shareholder nominations of persons to be elected to our board of directors at an annual general meeting must be made following written notice to our secretary executed by a shareholder accompanied by certain background and other information specified in our Articles. Such written notice and information must be received by our secretary not less than 90 days nor more than 150 days before the first anniversary of the date of our proxy statement was first released for the prior year’s annual general meeting.

Extraordinary General Meetings of Shareholders

Extraordinary general meetings of our company may be convened by (i) our board of directors, (ii) on requisition of our shareholders holding not less than 10% of the paid-up share capital of our carrying voting rights, (iii) on requisition of our auditors or (iv) in exceptional cases, by order of the Irish High Court. Extraordinary general meetings are generally held for the purpose of approving shareholder resolutions as may be required from time to time. At any extraordinary general meeting only such business shall be conducted as is set forth in the notice thereof.

Notice of an extraordinary general meeting must be given to all our shareholders and to our auditors. Under Irish law and our Articles, the minimum notice periods are 21 days in writing for an extraordinary general meeting to approve a special resolution and 14 days in writing for any other extraordinary general meeting.

 

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In the case of an extraordinary general meeting convened by our shareholders, the proposed purpose of the meeting must be set out in the requisition notice. Upon receipt of any such valid requisition notice, our board of directors has 21 days to convene a meeting of our shareholders to vote on the matters set out in the requisition notice. This meeting must be held within two months of the receipt of the requisition notice. If our board of directors does not convene the meeting within such 21-day period, the requisitioning shareholders, or any of them representing more than one half of the total voting rights of all of them, may themselves convene a meeting, which meeting must be held within three months of our receipt of the requisition notice.

If our board of directors becomes aware that our net assets are not greater than half of the amount of our called-up share capital, it must convene an extraordinary general meeting of our shareholders not later than 28 days from the date that they learn of this fact to consider how to address the situation.

Quorum for General Meetings

Our Articles provide that no business shall be transacted at any general meeting unless a quorum is present. One or more of our shareholders present in person or by proxy holding not less than a majority of our issued and outstanding ordinary shares entitled to vote at the meeting in question constitute a quorum.

Adjournment of Meetings

Our Articles provide that if within one hour after the time appointed for a general meeting a quorum is not present, the meeting will stand adjourned to the same day in the next week at the same time and place or otherwise as our board of directors determines, unless convened by shareholder requisition, in which case the meeting is dissolved. If at the adjourned meeting a quorum is not present within one hour after the time appointed for the meeting the shareholders present shall be a quorum.

If a quorum is present, the chairman of the meeting may adjourn a general meeting with the consent of, and must adjourn the meeting at the direction of, the shareholders. No business may be transacted at any adjourned meeting other than the business left unfinished at the meeting at which the adjournment took place. New notice must be given for meetings adjourned for 30 days or more.

Voting

Our Articles provide that our board of directors or its chairman may determine the manner in which the poll is to be taken and the manner in which the votes are to be counted.

Each shareholder is entitled to one vote for each ordinary share that he or she holds as of the record date for the meeting. Voting rights may be exercised by shareholders registered in our share register as of the record date for the meeting or by a duly appointed proxy, which proxy need not be a shareholder of ours. Where interests in shares are held by a nominee trust company, such company may exercise the rights of the beneficial holders on their behalf as their proxy. All proxies must be appointed in the manner prescribed by our Articles, which permit shareholders to notify us of their proxy appointments electronically in such manner as may be approved by our board of directors.

In accordance with our Articles, our board of directors may from time to time authorize us to issue preference shares. These preference shares may have such voting rights as may be specified in the terms of such preference shares (e.g., they may carry more votes per share than ordinary shares or may entitle their holders to a class vote on such matters as may be specified in the terms of the preference shares). Treasury shares or our shares held by our subsidiaries will not be entitled to be voted at general meetings of shareholders.

Irish law requires special resolutions of our shareholders at a general meeting to approve certain matters. Examples of matters requiring special resolutions include:

 

    amending our objects or memorandum of association;

 

    amending our Articles;

 

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    approving a change of our name;

 

    authorizing the entering into of a guarantee or provision of security in connection with a loan, quasi-loan or credit transaction to a director or connected person;

 

    opting out of preemption rights on the issuance of new shares;

 

    re-registration of our company from a public limited company to a private company;

 

    variation of class rights attaching to classes of shares (where the memorandum and articles of association do not provide otherwise);

 

    purchase of our ordinary shares off market;

 

    reduction of issued share capital;

 

    sanctioning a compromise/scheme of arrangement with creditors or shareholders;

 

    resolving that we be wound up by the Irish courts;

 

    resolving in favor of a shareholders’ voluntary winding-up; and

 

    setting the re-issue price of treasury shares.

Variation of Rights Attaching to a Class or Series of Shares

Under our Articles and the Irish Companies Acts, any variation of class rights attaching to our issued shares must be approved by a special resolution of our shareholders of the affected class or with the consent in writing of the holders of 75% of all the votes of that class of shares.

The provisions of our Articles relating to general meetings apply to general meetings of the holders of any class of our shares except that the necessary quorum is determined in reference to the shares of the holders of the class. Accordingly, for general meetings of holders of a particular class of our ordinary shares, a quorum consists of the holders present in person or by proxy representing at least one half of the issued shares of the class.

Inspection of Books and Records

Under Irish law, shareholders have the right to: (i) receive a copy of our Articles and any act of the Irish Government which alters our memorandum; (ii) inspect and obtain copies of our minutes of general meetings and resolutions; (iii) inspect and receive a copy of the register of shareholders, register of directors and secretaries, register of directors’ interests and other statutory registers maintained by us; (iv) receive copies of balance sheets and directors’ and auditors’ reports which have previously been sent to shareholders prior to an annual general meeting; and (v) receive balance sheets of any of our subsidiaries which have previously been sent to shareholders prior to an annual general meeting for the preceding ten years. Our auditors will also have the right to inspect all our books, records and vouchers. The auditors’ report must be circulated to the shareholders with our financial statements prepared in accordance with Irish law 21 days before the annual general meeting and must be read to the shareholders at our annual general meeting.

Acquisitions

An Irish public limited company may be acquired in a number of ways, including:

 

    a court-approved scheme of arrangement under the Irish Companies Acts. A scheme of arrangement with shareholders requires a court order from the Irish High Court and the approval of a majority in number representing 75% in value of the shareholders present and voting in person or by proxy at a meeting called to approve the scheme;

 

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    through a tender or takeover offer by a third party for all of our shares. Where the holders of 80% or more of our ordinary shares have accepted an offer for their shares in our company, the remaining shareholders may also be statutorily required to transfer their shares. If the bidder does not exercise its “squeeze out” right, then the non-accepting shareholders also have a statutory right to require the bidder to acquire their shares on the same terms. If our shares were to be listed on the main securities market of the Irish Stock Exchange or another regulated stock exchange in the EU, this threshold would be increased to 90%; and

 

    it is also possible for us to be acquired by way of a merger with an EU-incorporated company under the EU Cross-Border Mergers Directive 2005/56/EC. Such a merger must be approved by a special resolution. If we are being merged with another EU company under the EU Cross-Border Mergers Directive 2005/56/EC and the consideration payable to our shareholders is not all in the form of cash, our shareholders may be entitled to require their shares to be acquired at fair value.

Irish law does not generally require shareholder approval for a sale, lease or exchange of all or substantially all of a company’s property and assets.

Appraisal Rights

Generally, under Irish law, shareholders of an Irish company do not have dissenters’ or appraisal rights. Under the European Communities (Cross-Border Mergers) Regulations 2008 governing the merger of an Irish company limited by shares such as our company and a company incorporated in the EEA, a shareholder (i) who voted against the special resolution approving the merger or (ii) of a company in which 90% of the shares are held by the other party to the merger has the right to request that we acquire its shares for cash at a price determined in accordance with the share exchange ratio set out in the merger agreement.

Corporate Governance

Our Articles allocate authority over our day-to-day management to our board of directors. Our board of directors may then delegate our management to committees of our board of directors (consisting of one or more members of our board of directors) or executive officers, although our board of directors will remain responsible, as a matter of Irish law, for the proper management of our affairs. The proceedings of committees are governed by the Articles regulating the proceedings of directors. A vote at any committee meeting will be determined by a majority of votes of the members present.

Our board of directors has a standing audit committee, a compensation committee and a nominating and corporate governance committee, with each committee comprised solely of independent directors, as prescribed by Nasdaq rules. We have also adopted corporate governance policies, including a code of conduct and an insider trading policy.

The Irish Companies Acts provide for a minimum of two directors. Our Articles provide that our board of directors may determine the size of our board of directors from time to time.

Our board of directors shall be divided into two classes, designated Class I and Class II. The term of the initial Class I directors shall terminate on the date of the 2015 annual general meeting, and the term of the initial Class II directors shall terminate on the date of the 2016 annual general meeting. At each annual general meeting of shareholders, beginning in 2015, successors to the class of directors whose term expires at that annual general meeting will be elected for a two-year term. If the number of directors is changed, any increase or decrease shall be apportioned among the classes so as to maintain the same number of directors in each class as nearly as possible or as the Chairman of the Board may determine in his or her discretion. In no case will a decrease in the number of directors shorten the term of any incumbent director. A director may hold office until the annual general meeting of the year in which his or her term expires and until his or her successor is elected and duly qualified, subject to his or her prior death, resignation, retirement, disqualification or removal from office.

 

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Directors are elected by ordinary resolution at a general meeting. Irish law requires majority voting for the election of directors, which could result in the number of directors falling below the prescribed minimum number of directors due to the failure of nominees to be elected. Accordingly, our Articles provide that if, at any general meeting of our shareholders, the number of directors is reduced below the minimum prescribed by our Articles due to the failure of any person nominated to be a director to be elected, then, in such circumstances, the nominee or nominees who receive the highest number of votes in favor of election will be elected in order to maintain such prescribed minimum number of directors. Each director elected in this manner will remain a director (subject to the provisions of the Irish Companies Acts and our Articles) only until the conclusion of our next annual general meeting unless he or she is reelected.

Under the Irish Companies Acts and notwithstanding anything contained in our Articles or in any agreement between us and a director, the shareholders may, by an ordinary resolution, remove a director from office before the expiration of his or her term at a meeting held on no less than 28 days’ notice and at which the director is entitled to be heard. The power of removal is without prejudice to any claim for damages for breach of contract (e.g. employment contract) that the director may have against us in respect of his removal.

Our Articles provide that our board of directors may fill any vacancy occurring on our board of directors. Any director of any class elected to fill a vacancy resulting from an increase in the number of directors of such class shall hold office for a term that shall coincide with the remaining term of that class.

Legal Name; Formation; Fiscal Year; Registered Office

Nexvet Biopharma Limited was incorporated in Ireland in August 2014 as a private limited company (registration number 547923). Nexvet Biopharma Limited then re-registered as a public limited company known as Nexvet Biopharma public limited company in September 2014. Our fiscal year ends on June 30 and our registered address is 88 Harcourt Street, Dublin 2, Ireland.

Duration; Dissolution; Rights upon Liquidation

The duration of our company will be unlimited. We may be dissolved and wound up at any time by way of a shareholders’ voluntary winding up or a creditors’ winding up. In the case of a shareholders’ voluntary winding up, a special resolution of shareholders is required. Our company may also be dissolved by way of court order on the application of a creditor, or by the Companies Registration Office as an enforcement measure where we have failed to file certain returns.

If our Articles contain no specific provisions in respect of a dissolution or winding up, then, subject to the priorities of any creditors, the assets will be distributed to our shareholders in proportion to the paid-up nominal value of the shares held. Our Articles provide that our ordinary shareholders are entitled to participate pro rata in a winding up, but their right to do so may be subject to the rights of any preference shareholders to participate under the terms of any series or class of preference shares.

Uncertificated Shares

Holders of our ordinary shares will not have the right to require us to issue certificates for their shares, except for legended shares. We will only issue uncertificated ordinary shares.

No Sinking Fund

Our ordinary shares do not have sinking fund provisions.

Transfer and Registration of Shares

Our transfer agent will maintain the share register, registration in which will be determinative of ownership of our ordinary shares. A shareholder of our company who holds shares beneficially will not be the

 

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holder of record of such shares. Instead, the depository (for example, Cede & Co., as nominee for DTC) or other nominee will be the holder of record of those shares. Accordingly, a transfer of shares from a person who holds such shares beneficially to a person who also holds such shares beneficially through a depository or other nominee will not be registered in our official share register, as the depository or other nominee will remain the record holder of any such shares.

A written instrument of transfer is required under Irish law in order to register on our official share register any transfer of shares (i) from a person who holds such shares directly to any other person, (ii) from a person who holds such shares beneficially but not directly to a person who holds such shares directly, or (iii) from a person who holds such shares beneficially to another person who holds such shares beneficially where the transfer involves a change in the depository or other nominee that is the record owner of the transferred shares. An instrument of transfer is also required for a shareholder who directly holds shares to transfer those shares into (or out of ) his or her own broker account. Such instruments of transfer may give rise to Irish stamp duty, which must be paid prior to registration of the transfer on our official Irish share register. However, a shareholder who directly holds shares outside of DTC may transfer those shares into DTC without giving rise to Irish stamp duty provided that: (i) there is no change in beneficial ownership of the shares; and (ii) at the time of the transfer into (or out of) DTC there is no agreement in place for the sale of the shares by the beneficial owner to a third party.

Any transfer of our ordinary shares that is subject to Irish stamp duty will not be registered in the name of the buyer unless an instrument of transfer is duly stamped and provided to the transfer agent. We, in our absolute discretion and insofar as the Irish Companies Acts or any other applicable law permits, may, or may procure that a subsidiary of our company shall, pay Irish stamp duty arising on a transfer of our ordinary shares on behalf of the transferee of such ordinary shares. If stamp duty resulting from the transfer of such ordinary shares which would otherwise be payable by the transferee is paid by our company or any subsidiary of our company on behalf of the transferee, then in those circumstances, we shall, on our behalf or on behalf of our subsidiary, be entitled to (i) seek reimbursement of the stamp duty from the transferee, (ii) set-off the stamp duty against any dividends payable to the transferee of those ordinary shares and (iii) claim a first and permanent lien on the ordinary shares on which stamp duty has been paid by us or our subsidiary for the amount of stamp duty paid. Our lien shall extend to all dividends paid on those ordinary shares. Our Articles delegate the authority to execute an instrument of transfer on behalf of a transferring party by the directors to a person.

In order to help ensure that the official share register is regularly updated to reflect trading of our ordinary shares occurring through normal electronic systems, we intend to regularly produce any required instruments of transfer in connection with any transactions for which we pay stamp duty, subject to the reimbursement and set-off rights described above. In the event that we notify one or both of the parties to a share transfer that we believe stamp duty is required to be paid in connection with the transfer and that we will not pay the stamp duty, the parties may either themselves arrange for the execution of the required instrument of transfer (and may request a form of instrument of transfer from us for this purpose) or request that we execute an instrument of transfer on behalf of the transferring party in a form determined by us. In either event, if the parties to the share transfer have the instrument of transfer duly stamped (to the extent required) and then provide it to our transfer agent, the buyer will be registered as the legal owner of the relevant shares on our official Irish share register, subject to the suspension right described below.

Our directors may suspend registration of transfers from time to time, not exceeding 30 days in aggregate each year.

Differences in Corporate Law Between Ireland and The State Of Delaware

We, and our relationships with our shareholders, are governed by Irish corporate law and not by the corporate law of any U.S. state. As a result, our directors and shareholders are subject to different responsibilities, rights and privileges than are applicable to directors and shareholders of U.S. corporations. We have set below a

 

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summary of the differences between the provisions of the Irish Companies Acts applicable to us and the Delaware General Corporation Law relating to stockholders’ rights and protections. This summary is not intended to be a complete discussion of the respective rights and it is qualified in its entirety by reference to Irish law and Delaware law. Before investing, you should consult your legal advisor regarding the impact of Irish corporate law on your specific circumstances and reasons for investing.

The rights of our shareholders will be governed by applicable Irish law, including the Irish Companies Acts, and by our Articles. The statements in this section are qualified in their entirety by reference to, and are subject to, the detailed provisions of the Irish Companies Acts and our Articles.

 

    

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Authorized Capital    Under Delaware law, the board of directors without stockholder approval may approve the issuance of authorized but unissued shares of capital stock that are not otherwise committed for issuance.    Under Irish law, the directors of a company may issue new ordinary or preference shares without shareholder approval once authorized to do so by the memorandum and articles of association or by an ordinary resolution adopted by the shareholders at a general meeting. The authorization may be granted for a maximum period of five years, at which point it must be renewed by the shareholders by an ordinary resolution.
Reduction of Capital    Under Delaware law, a corporation, by an affirmative vote of a majority of the board of directors, may reduce its capital by reducing or eliminating the capital represented by shares of capital stock which have been retired, by applying to an already authorized purchase redemption, conversion or exchange of outstanding shares of its capital stock some or all of the capital represented by shares being purchased, redeemed, converted or exchanged or any capital that has not been allocated to any particular class of capital stock or by transferring to surplus capital some or all of the capital not represented by any particular class of its capital stock or the capital associated with certain issued shares of its par value capital stock. No reduction of capital may be made unless the assets of the corporation remaining after the reduction are sufficient to pay any debts for which payment has not otherwise been otherwise provided.    A company may, by ordinary resolution, reduce its authorized share capital in any way. A company also may, by special resolution and subject to confirmation by the Irish High Court, reduce or cancel its issued share capital in any way permitted by the Irish Companies Acts.

 

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Preemption Rights; Consideration for Shares   

 

Under Delaware law, unless otherwise provided in a corporation’s certificate of incorporation or any amendment thereto, or in the resolution or resolutions providing for the issue of such shares adopted by the board of directors pursuant to authority expressly vested in it by the provisions of its certificate of incorporation, a stockholder does not, by operation of law, possess preemptive rights to subscribe to additional issuances of the corporation’s capital stock.

  

 

Under Irish law, certain statutory preemption rights apply automatically in favor of shareholders where shares are to be issued for cash. However, we have opted out of these preemption rights in our Articles as permitted under Irish law. Because Irish law requires this opt-out to be renewed at least every five years by special resolution, our Articles provide that this opt-out must be so renewed if it is to remain effective. If the opt-out is not renewed, shares issued for cash must be offered to existing shareholders of the company on a pro rata basis to their existing shareholding before the shares may be issued to any new shareholders. Statutory preemption rights do not apply (i) where shares are issued for non-cash consideration (such as in a share-for-share acquisition), (ii) to the issue of non-equity shares (that is, shares that have the right to participate only up to a specified amount in any income or capital distribution) or (iii) where shares are issued pursuant to an employee share option or similar equity plan.

 

Under Irish law, a company is prohibited from allotting shares without consideration. Accordingly, at least the nominal value of the shares issued underlying any restricted share award, restricted share unit, performance share awards, bonus shares or any other share-based grants must be paid pursuant to the Irish Companies Acts.

Dividends, Distributions, Repurchases and Redemptions   

 

Dividends and Distributions

 

Under Delaware law, unless otherwise provided in a corporation’s certificate of incorporation, directors may declare and pay dividends upon its capital stock either (i) out of its surplus or (ii) if the corporation does

  

 

Dividends and Distributions

 

Under Irish law, dividends and distributions may only be made from distributable reserves. Distributable reserves generally means accumulated realized profits less accumulated realized losses and includes reserves

 

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not have surplus, out of its net profits for the fiscal year in which the dividend is declared or the preceding fiscal year.

 

The excess, if any, at any given time, of the net assets of the corporation over the amount so determined to be capital is surplus. Net assets means the amount by which total assets exceed total liabilities.

 

Dividends may be paid in cash, in property, or in shares of the corporation’s capital stock.

  

created by way of capital reduction. In addition, no distribution or dividend may be made unless the net assets of a company are equal to, or in excess of, the aggregate of that company’s called up share capital plus undistributable reserves and the distribution does not reduce that company’s net assets below such aggregate. Undistributable reserves include the share premium account, the capital redemption reserve fund and the amount by which a company’s accumulated unrealized profits, so far as not previously utilized by any capitalization, exceed that company’s accumulated unrealized losses, so far as not previously written off in a reduction of capital approved by the Irish High Court without restriction, or a reorganization of capital.

 

The determination as to whether or not a company has sufficient distributable reserves to fund a dividend must be made by reference to the “relevant accounts” of that company. The “relevant accounts” will be either the last set of unconsolidated annual audited financial statements or other financial statements properly prepared in accordance with the Irish Companies Acts, which give a “true and fair view” of a company’s unconsolidated financial position and accord with accepted accounting practice.

 

Dividends may be declared and paid in the form of cash or non-cash assets and may be paid in dollars or any other currency.

  

Share Repurchases and Redemptions

 

Under Delaware law, any stock of any class or series may be made subject to redemption by the corporation at its option or at the option of the holders of such stock or upon the happening of

  

Share Repurchases and Redemptions

 

Our Articles provide that any ordinary share that we agree to acquire shall be deemed to be a redeemable share. Accordingly, for purposes of Irish law, the repurchase of ordinary shares

 

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   a specified event; provided however, that immediately following any such    by us may technically be effected as a redemption.
  

redemption the corporation must have outstanding one or more shares of one or more classes or series of stock, which share, or shares together, have full voting powers.

 

Any stock which may be made redeemable may be redeemed for cash, property or rights, including securities of the same or another corporation, at such time or times, price or prices, or rate or rates, and with such adjustments, as stated in the certificate of incorporation or in the resolution or resolutions providing for the issue of such stock adopted by the board of directors.

 

Every corporation may purchase, redeem, receive, take or otherwise acquire, own and hold, sell, lend, exchange, transfer or otherwise dispose of, pledge, use and otherwise deal in and with its own shares; provided, however, that no corporation may (i) purchase or redeem its own shares of capital stock for cash or other property when the capital of the corporation is impaired or when such purchase or redemption would cause any impairment of the capital of the corporation, except that a corporation other than a non-stock corporation may purchase or redeem out of capital any of its own shares which are entitled upon any distribution of its assets, whether by dividend or in liquidation, to a preference over another class or series of its shares, or, if no shares entitled to such a preference are outstanding, any of its own shares, if such shares will be retired upon their acquisition and the capital of the corporation reduced; (ii) purchase, for more than the price at which they may then be redeemed, any of its shares which are redeemable at the option of the corporation; or (iii) redeem any of

  

 

Under Irish law, we may issue redeemable shares and redeem them out of distributable reserves or the proceeds of a new issue of shares for that purpose. We may only issue redeemable shares if the nominal value of the issued share capital that is not redeemable is not less than 10% of the nominal value of our total issued share capital. All redeemable shares must also be fully-paid and the terms of redemption of the shares must provide for payment on redemption.

 

We may also be given authority to purchase our shares on market by our shareholders at a general meeting, which would take effect on the same terms and be subject to the same conditions as applicable to purchases by our subsidiaries.

 

Our board of directors may also issue preference shares, which may be redeemed at the option of either us or the shareholder, depending on the terms of such preference shares.

 

Repurchased and redeemed shares may be cancelled or held as treasury shares. The nominal value of treasury shares held by us at any time must not exceed 10% of the nominal value of our issued share capital. We may not exercise any voting rights in respect of any shares held as treasury shares. Treasury shares may be canceled by us or re-issued subject to certain conditions.

 

 

 

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   its shares, unless their redemption is authorized by Delaware law and then only in accordance with its certificate of incorporation.   
  

Purchases by Subsidiaries

 

Under Delaware law, shares of a corporation’s capital stock may be acquired by subsidiaries of that corporation without stockholder approval. Such capital stock owned by a majority owned subsidiary are neither entitled to vote nor counted as outstanding for quorum purposes.

 

  

Purchases by Subsidiaries

 

Under Irish law, a company’s subsidiaries may purchase shares of that company either on market on a recognized stock exchange such as Nasdaq or off market.

 

For one of our subsidiaries to make on market purchases of our ordinary shares, our shareholders must provide general authorization for such purchase by way of ordinary resolution. However, as long as this general authority has been granted, no specific shareholder authority for a particular on market purchase by a subsidiary of our ordinary shares is required. For a purchase by a subsidiary of our shares off market, the proposed purchase contract must be authorized by special resolution of our shareholders before the contract is entered into. The person whose ordinary shares are to be bought back cannot vote in favor of the special resolution and, for at least 21 days prior to the special resolution being passed, the purchase contract must be on display or must be available for inspection by our shareholders at our registered office.

 

The number of shares held by our subsidiaries at any time will count as treasury shares and will be included in any calculation of the permitted treasury share threshold of 10% of the nominal value of our issued share capital. While a subsidiary holds our shares, such subsidiary cannot exercise any voting rights in respect of those shares. The acquisition of our ordinary shares by a subsidiary must be funded out of distributable reserves of the subsidiary.

 

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Election of Directors    Under Delaware law, a corporation must have at least one director. The number of directors of a corporation is fixed by, or in the manner provided in, the bylaws, unless the certificate of incorporation fixes the number of directors, in which case a change in the number of directors must be made by amendment of the certificate of incorporation. Delaware law does not contain specific provisions requiring a majority of independent directors.    The Irish Companies Acts provide for a minimum of two directors. Our Articles provide that our board of directors may determine the size of our board of directors from time to time and also contain details regulating the appointment of directors, including upon a vacancy.
Removal of Directors    Under Delaware law, unless otherwise provided in the certificate of incorporation, directors may be removed from office, with or without cause, by a majority stockholder vote, except: (i) in the case of a corporation whose board of directors is classified, stockholders may effect such removal only for cause; and (ii) in the case of a corporation having cumulative voting, if less than the entire board of directors is to be removed, no director can be removed without cause if the votes cast against such director’s removal would be sufficient to elect such director if then cumulatively voted at an election of the entire board of directors, or, if there are classes of directors, at an election of the class of directors of which such director is a part.    Under the Irish Companies Acts and notwithstanding anything contained in our Articles or in any agreement between us and a director, the shareholders may, by an ordinary resolution, remove a director from office before the expiration of his or her term at a meeting held on no less than 28 days’ notice and at which the director is entitled to be heard. The power of removal is without prejudice to any claim for damages for breach of contract (e.g., employment contract) that the director may have against us in respect of his or her removal.
Quorum of the Board of Directors   

 

The quorum necessary for transaction of business by the board of directors shall consist of a majority of the total number of directors unless the certificate of incorporation or bylaws require a greater number.

  

 

The quorum necessary for transaction of business by our board of directors may be fixed by our board of directors and unless so fixed will be a majority of the directors in office.

Duties of Directors    Under Delaware law, a company’s directors are charged with fiduciary duties of care and loyalty. The duty of care requires that directors act in an informed and deliberate manner and inform themselves, prior to making a business decision, of all relevant material information reasonably    Our directors have certain statutory and fiduciary duties. All of our directors have equal and overall responsibility for the management of our company (although directors who also serve as employees will have additional responsibilities and duties arising under their employment

 

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   available to them. The duty of care also requires that directors exercise care in overseeing and investigating the conduct of corporate employees. The duty of loyalty may be summarized as the duty to act in good faith, not out of self-interest, and in a manner which the director reasonably believes to be in the best interests of the corporation and its stockholders. A party challenging the propriety of a decision of a board of directors bears the burden of rebutting the applicability of the presumptions afforded to directors by the “business judgment rule.” If the presumption is not rebutted, the business judgment Rule attaches to protect the directors and their decisions. Notwithstanding the foregoing, Delaware courts may subject directors’ conduct to enhanced scrutiny in respect of defensive actions taken in response to a threat to corporate control and approval of a transaction resulting in a sale of control of the corporation.    agreements and it is likely that more will be expected of them in compliance with their duties than non-executive directors). The principal directors’ duties include the common law fiduciary duties of good faith and exercising due care and skill. The statutory duties include ensuring the maintenance of proper books of account, having annual accounts prepared, having an annual audit performed and the duty to maintain certain registers and make certain filings as well as disclosure of personal interests. For public limited companies like us, directors are under a specific duty to ensure that the secretary is a person with the requisite knowledge and experience to discharge the role.
Conflicts of Interest of Directors   

Under Delaware law, a contract or transaction in which a director has an interest will not be voidable solely for this reason if (i) the material facts with respect to such interested director’s relationship or interest in the contract or transaction are disclosed or are known to the board of directors, and the board of directors in good faith authorizes the transaction by the affirmative vote of a majority of the disinterested directors, (ii) the material facts with respect to such interested director’s relationship or interest in the contract or transaction are disclosed or are known to the stockholders entitled to vote on such transaction, and the transaction is specifically approved in good faith by vote of the majority of shares entitled to vote thereon, or (iii) the contract or transaction is fair to the corporation as of the time it is authorized, approved or ratified. The mere fact that an

  

As a matter of Irish law, a director is under a general fiduciary duty to avoid conflicts of interest. Under Irish law, directors who have a personal interest in a contract or proposed contract with a company are required to declare the nature of their interest at a meeting of the directors of that company. A company is required to maintain a register of declared interests, which must be available for shareholder inspection.

 

Our Articles provide that a director must declare any interest he or she may have in a contract with us at a meeting of our board of directors or otherwise provide notice to our board of directors. No director shall be prevented by his or her office from contracting with us, provided that he or she has declared the nature of his or her interest in the contracts and the contract or transaction has been

 

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   interested director is present and voting on a transaction in which he or she is interested will not itself make the transaction void. Under Delaware law, an interested director could be held liable for a transaction in which such director derived an improper personal benefit.   

approved by a majority of our disinterested directors.

 

Under our Articles, a director of ours may be a director of, other officer of, or otherwise interested in, any company promoted by us or in which we are interested, and such director will not be accountable to us for any compensation or other benefit received from such employment or other interest. Our Articles further provide that (i) no director will be prevented from contracting with us because of his or her position as a director, (ii) any contract entered into between a director and us will not be subject to avoidance and (iii) no director will be liable to account to us for any profits realized by virtue of any contract between such director and us because the director holds such office or the fiduciary relationship established thereby. A director of ours will be at liberty to vote in respect of any transaction in which he or she is interested, provided that such director discloses the nature of his or her interest prior to consideration of the transaction and any vote thereon.

Indemnification of Officers and Directors   

 

Delaware law permits a corporation to indemnify, and to advance expenses to, officers and directors for actions taken in good faith and in a manner they reasonably believed to be in, or not opposed to, the best interests of the corporation, and with respect to any criminal action that they had no reasonable cause to believe was unlawful.

 

 

 

  

 

Irish law permits indemnification for the benefit of a company’s directors and executive officers. However, as to directors and company secretary, this indemnity is limited by the Irish Companies Acts, which prescribe that an advance commitment to indemnify only permits a company to pay the costs or discharge the liability of a director or company secretary where judgment is given in favor of the director or company secretary in any civil or criminal action in respect of such costs or liability, or where an Irish court grants relief because the director or company secretary acted honestly and reasonably and ought fairly to be excused. Any provision whereby an Irish company seeks to

 

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      commit in advance to indemnify its directors or company secretary over and above the limitations imposed by the Irish Companies Acts will be void, whether contained in its articles of association or any contract between the company and the director or company secretary. This restriction does not apply to executive officers who are not directors, the company secretary or other persons who are considered “officers” within the meaning of the Irish Companies Acts.
Limitation on Director
Liability
  

 

Under Delaware law, a corporation may include in its certificate of incorporation a provision that limits or eliminates the personal liability of directors to the corporation and its stockholders for monetary damages for a breach of fiduciary duty as a director. However, a corporation may not limit or eliminate the personal liability of a director for: any breach of the director’s duty of loyalty to the corporation or its stockholders; acts or omissions in bad faith or which involve intentional misconduct or a knowing violation of law; intentional or negligent payments of unlawful dividends or unlawful share purchases or redemptions; or any transaction in which the director derives an improper personal benefit.

  

 

Under Irish law, a company may not exempt its directors from liability for negligence or a breach of duty. However, where a breach of duty has been established, directors may be statutorily exempted by an Irish court from personal liability for negligence or breach of duty if, among other things, the court determines that they have acted honestly and reasonably, and that they may fairly be excused as a result.

 

Under Irish law, shareholders may not agree to exempt a director or officer from any claim or right of action the shareholder may have, whether individually or in the right of a company, on account of any action taken or the failure to take any action in the performance of his or her duties to that company.

Annual Meetings    Under Delaware law, an annual meeting of stockholders is required. Any stockholder or director my apply to the Delaware Chancery Court for an order for a corporation to hold an annual meeting if the corporation has failed to hold an annual meeting for a period of 13 months after its last annual meeting.    We will be required to hold an annual general meeting at intervals of no more than 15 months from the previous annual general meeting, provided that an annual general meeting is held in each calendar year following the first annual general meeting and no more than nine months after our fiscal year-end. Any annual general meeting we hold may be held outside Ireland if a resolution so authorizing has been passed at the preceding annual general meeting.

 

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The only matters that must, as a matter of Irish law, be transacted at an annual general meeting are the presentation of the annual accounts, balance sheet and reports of the directors and auditors, the appointment of new auditors and the fixing of the auditor’s compensation (or delegation of same). If no resolution is made in respect of the reappointment of an existing auditor at an annual general meeting, the existing auditor will be deemed to have continued in office.

 

The provisions of our Articles relating to general meetings shall apply to every such general meeting of the holders of any class of shares except that the necessary quorum shall be one person holding or representing by proxy at least one-half of the issued shares of such class.

Proxy    Under Delaware law, at any meeting of stockholders, a stockholder may designate another person to act for such stockholder by proxy, but no such proxy may be voted or acted upon after three years from its date, unless the proxy provides for a longer period.    Under the Irish Companies Acts, at any meeting of shareholders, a shareholder may designate another person to attend, speak and vote at the meeting on their behalf by proxy, but no such proxy shall be voted or acted upon at any subsequent meeting, unless the proxy expressly provides for this.
Special/Extraordinary General Meetings   

 

Under Delaware law, special meetings of stockholders may be called by the board of directors or by such other person or persons authorized to do so by the corporation’s certificate of incorporation or bylaws. At a special meeting, only the business set forth in the notice of meeting may be conducted.

 

 

 

 

  

 

Extraordinary general meetings may be convened (i) by our board of directors, (ii) on requisition of our shareholders holding not less than 10% of the paid up share capital of our carrying voting rights, (iii) on requisition of our auditors or (iv) in exceptional cases, by order of a court. Extraordinary general meetings are generally held for the purpose of approving shareholder resolutions of our company as may be required from time to time. At any extraordinary general meeting only such business shall be conducted as is set forth in the notice thereof.

 

 

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In the case of an extraordinary general meeting convened by our shareholders, the proposed purpose of the meeting must be set out in the requisition notice. Upon receipt of any such valid requisition notice, our board of directors has 21 days to convene a meeting of our shareholders to vote on the matters set out in the requisition notice. This meeting must be held within two months of the receipt of the requisition notice. If our board of directors does not convene the meeting within such 21-day period, the requisitioning shareholders, or any of them representing more than one half of the total voting rights of all of them, may themselves convene a meeting, which meeting must be held within three months of our receipt of the requisition notice.

Record Date; Notice Provisions   

Under Delaware law, unless otherwise provided in the certificate of incorporation or bylaws or under other portions of Delaware law, written notice of any meeting of the stockholders must be given to each stockholder entitled to vote at the meeting not less than ten nor more than 60 days before the date of the meeting and must specify the place, if any, date, hour, means of remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting, the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the meeting, and, in the case of a special meeting, the purpose or purposes of the meeting.

 

  

Our Articles provide that our board of directors may fix in advance a record date (i) to determine the shareholders entitled to notice of or to vote at a meeting of the shareholders that is no more than 90 days and no less than ten days before the date of the meeting and (ii) for the purpose of determining the shareholders entitled to receive payment of any dividend, or in order to make a determination of shareholders for any other proper purpose that is no more than 90 days prior to the date of payment of the dividend or the date of any other action to which the determination of shareholders is relevant. The record date may not precede the date upon which the resolution fixing the record date is adopted by the directors.

 

If the register of shareholders is closed in connection with a meeting, it must be closed for at least five days preceding the meeting and the record date for determination of the shareholders entitled to receive notice

 

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of, and to vote at, that meeting will be the date of the closing of the register of shareholders.

 

Notice of an annual or extraordinary general meeting must be given to all our shareholders and to our auditors.

 

Our Articles provide for a minimum notice period of 21 days for an annual general meeting, which is the minimum permitted under Irish law. In addition, under Irish law and our Articles, the minimum notice periods are 21 days’ notice in writing for an extraordinary general meeting to approve a special resolution and 14 days’ notice in writing for any other extraordinary general meeting.

Voting Rights    Delaware law provides that, unless otherwise provided in the certificate of incorporation, each stockholder is entitled to one vote for each share of capital stock held by such stockholder.   

Each of our shareholders is entitled to one vote for each ordinary share that he or she holds as of the record date for the meeting.

 

Irish law requires approval of certain matters by “special resolutions” of the shareholders at a general meeting. A special resolution requires the approval of not less than 75% of the votes of our shareholders cast at a general meeting at which a quorum is present. Ordinary resolutions, by contrast, require a simple majority of the votes our shareholders cast at a general meeting at which a quorum is present.

 

Irish law also distinguishes between “ordinary business” and “special business.” Most matters are deemed “special” with the exception of declaring a dividend, the consideration of the accounts, balance sheets and the reports of the directors and auditors, the election of directors, the re-appointment of the retiring auditors and the fixing of the compensation of the auditors, all of which are deemed to be “ordinary business.”

 

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Action by Written Consent   

Under Delaware law, unless otherwise provided in the certificate of incorporation or bylaws, any action required or permitted to be taken at a meeting of stockholders may be taken without a meeting if a written consent to the action is signed by stockholders holding at least a majority of the voting power. If a different proportion of voting power is required for an action at a meeting, then that proportion of written consents is also required.

  

The Irish Companies Acts provide that shareholders may approve a resolution without a meeting if (i) all shareholders sign the written resolution and (ii) our Articles permit written resolutions of shareholders. Our Articles provide that our shareholders have the right to take action by written consent only where such consent is unanimous.

Derivative or Other Suits   

Under Delaware law, a stockholder may bring a derivative action on behalf of the corporation to enforce the rights of the corporation. Generally, a person may institute and maintain such a suit only if such person was a stockholder at the time of the transaction that is the subject of the suit or his or her shares thereafter devolved upon him or her by operation of law. Delaware law also requires that the derivative plaintiff make a demand on the directors of the corporation to assert the corporate claim before the suit may be prosecuted by the derivative plaintiff, unless such demand would be futile.

 

An individual also may commence a class action suit on behalf of himself or herself and other similarly situated stockholders where the requirements for maintaining a class action have been met.

  

In certain limited circumstances, a shareholder may be entitled to bring a derivative action on our behalf if a wrong committed against us would otherwise go unredressed.

 

The principal case law in Ireland indicates that to bring a derivative action a person must first establish a prima facie case (i) that a company is entitled to the relief claimed and (ii) that the action falls within one of the five exceptions derived from case law, as follows:

 

•   where an ultra vires or illegal act is perpetrated;

 

•   where more than a bare majority is required to ratify the “wrong” complained of;

 

•   where the shareholders’ personal rights are infringed;

 

•   where a fraud has been perpetrated upon a minority by those in control; and

 

•   where the justice of the case requires a minority to be permitted to institute proceedings.

      Irish law also permits shareholders of a company to bring proceedings against that company where its affairs

 

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      are being conducted, or the powers of the directors are being exercised, in a manner oppressive to the shareholders or in disregard of their interests. The court can grant any relief it sees fit and the usual remedy is the purchase or transfer of the shares of any shareholder.
Business Combinations    Under Delaware law, with limited exceptions, a merger, consolidation or sale of all or substantially all of the assets of a Delaware corporation must be approved by the board of directors and a majority of the issued and outstanding shares entitled to vote thereon. However, Section 203 of the DGCL generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless, among other exceptions, such transactions are approved by the board of directors before such interested stockholder became such.   

Shareholder approval in connection with a business combination involving us would be required under the following circumstances:

 

•   in connection with a scheme of arrangement, both a court order from the Irish High Court and the approval of a majority in number representing 75% in value of the shareholders present and voting in person or by proxy at a meeting called to approve such a scheme;

 

•   through a tender or takeover offer by a third party for all of the shares of the company; and

 

•   in connection with an acquisition of us by way of a merger with an EU company under the EU Cross-Border Mergers Directive 2005/56/EC by a special resolution of the shareholders.

 

Irish law does not generally require shareholder approval for a sale, lease or exchange of all or substantially all of a company’s property and assets.

Appraisal Rights    Under Delaware law, holders of shares of any class or series of stock of a constituent corporation in a merger or consolidation have the right, in certain circumstances, to dissent from such merger or consolidation by demanding payment in cash for their shares equal to the fair value of such shares, exclusive of any element of value arising from the accomplishment or expectation of the merger or consolidation, as determined by a    Generally, under Irish law, shareholders of an Irish company do not have dissenters’ or appraisal rights. Under the European Communities (Cross-Border Mergers) Regulations 2008 governing the merger of an Irish company limited by shares such as the company and a company incorporated in the EEA, a shareholder (i) who voted against the special resolution approving the merger or (ii) of a company in which

 

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court in an action timely brought by the corporation or the dissenters. Delaware law grants dissenters appraisal rights only in the case of mergers or consolidations and not in the case of a sale or transfer of assets or a purchase of assets for stock, regardless of the number of shares being issued. No appraisal rights are available for shares of any class or series of stock that are listed on a national securities exchange or held of record by more than 2,000 holders, unless the agreement of merger or consolidation requires the holders thereof to accept for such shares anything other than: shares of stock of the surviving corporation; shares of stock of another corporation, which shares of stock are either listed on a national securities exchange or held of record by more than 2,000 holders; cash in lieu of fractional shares of the stock described in the first two points above; or some combination of the above.

 

In addition, appraisal rights are not available for stockholders of a surviving corporation in a merger if the merger did not require the vote of the stockholders of the surviving corporation.

   90% of the shares are held by the other party to the merger, has the right to request that the company acquire his or her shares for cash at a price determined in accordance with the share exchange ratio set out in the merger agreement.
Amendments of Constituent Documents   

 

Under Delaware law, a corporation may amend its certificate of incorporation, from time to time, in any and as many respects as may be desired, so long as its certificate of incorporation as amended would contain only such provisions as it would be lawful and proper to insert in an original certificate of incorporation filed at the time of the filing of the amendment; and, if a change in stock or the rights of stockholders, or an exchange, reclassification, subdivision, combination or cancellation of stock or rights of stockholders is to be made,

  

 

Irish companies may only alter their memorandum and articles of association by the passing of a special resolution of shareholders. A special resolution under Irish law requires the approval of not less than 75% of the votes cast.

 

 

 

 

 

 

 

 

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such provisions as may be necessary to effect such change, exchange, reclassification, subdivision, combination or cancellation.

 

The board of directors must adopt a resolution setting forth the amendment proposed, declaring its advisability and either calling a special meeting of the stockholders entitled to vote in respect thereof for the consideration of such amendment or directing that the amendment proposed be considered at the next annual meeting of the stockholders. A majority of the outstanding shares entitled to vote thereon and a majority of the outstanding shares of each class entitled to vote thereon as a class must vote in favor of the amendment.

 

The holders of the outstanding shares of a class must be entitled to vote as a class upon a proposed amendment, whether or not entitled to vote thereon by the certificate of incorporation, if the amendment would increase or decrease the aggregate number of authorized shares of such class, increase or decrease the par value of the shares of such class, or alter or change the powers, preferences, or special rights of the shares of such class so as to affect them adversely.

  
Dissolution and winding up   

Upon the dissolution of a Delaware corporation, after satisfaction of the claims of creditors, the assets of that corporation would be distributed to stockholders in accordance with their respective interests, including any rights a holder of shares of preference shares may have to preferred distributions upon dissolution or liquidation of the corporation.

 

 

 

  

The rights of our shareholders to a return of our assets on dissolution or winding up, following the settlement of all claims of creditors, may be prescribed in our Articles or the terms of any preference shares we issue from time to time. The holders of our preference shares in particular may have the right to priority in the event of our dissolution or winding up. If our Articles contain no specific provisions in respect of dissolution or winding up, then, subject to the priorities of any creditors, the assets

 

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will be distributed to our shareholders in proportion to the paid-up nominal value of the shares held. Our Articles provide that our ordinary shareholders are entitled to participate pro rata in a winding up, but their right to do so may be subject to the rights of any preference shareholders to participate under the terms of any series or class of preference shares.

 

We may be dissolved and wound up at any time by way of a shareholders’ voluntary winding up or a creditors’ winding up. In the case of a shareholders’ voluntary winding up, a special resolution of shareholders is required. We may also be dissolved by way of court order on the application of a creditor, or by the Companies Registration Office as an enforcement measure where we have failed to file certain returns.

Enforcement of Judgment Rendered by U.S. Court   

 

A judgment for the payment of money rendered by a court in the United States based on civil liability generally would be enforceable elsewhere in the United States.

  

 

A judgment for the payment of money rendered by a court in the United States based on civil liability would not be automatically enforceable in Ireland. There is no treaty between Ireland and the United States providing for the reciprocal enforcement of foreign judgments. The following requirements must be met before the U.S. judgment will be deemed to be enforceable in Ireland:

 

•   the U.S. judgment must be for a definite sum;

 

•   the U.S. judgment is not directly or indirectly for the payment of taxes or other charges of a like nature or a fine or other penalty (for example, punitive or exemplary damages);

 

•   the U.S. judgment must be final and conclusive;

 

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•   the Irish proceedings were commenced within the relevant limitation period;

 

•   the U.S. judgment must be provided by a court of competent jurisdiction (as determined by Irish law); and

 

•   the U.S. judgment remains valid and enforceable in the U.S. court in which it was obtained.

 

An Irish court will also exercise its right to refuse judgment if the U.S. judgment was obtained by fraud, violated Irish public policy, is in breach of natural justice or is irreconcilable with an earlier foreign judgment.

 

Anti-Takeover Provisions

Irish Takeover Rules and Substantial Acquisition Rules

A transaction in which a third party seeks to acquire 30% or more of our voting rights and any other acquisitions of our securities will be governed by the Irish Takeover Panel Act 1997 and the Irish Takeover Rules made thereunder, or the Irish Takeover Rules, and will be regulated by the Irish Takeover Panel. The “General Principles” of the Irish Takeover Rules and certain important aspects of the Irish Takeover Rules are described below.

General Principles

The Irish Takeover Rules are built on the following General Principles which will apply to any transaction regulated by the Irish Takeover Panel:

 

    in the event of an offer, all holders of securities of the target company must be afforded equivalent treatment and, if a person acquires control of a company, the other holders of securities must be protected;

 

    the holders of securities in the target company must have sufficient time and information to enable them to reach a properly informed decision on the offer; where it advises the holders of securities, the board of directors of the target company must give its views on the effects of the implementation of the offer on employment, employment conditions and the locations of the target company’s place of business;

 

    a target company’s board of directors must act in the interests of that company as a whole and must not deny the holders of securities the opportunity to decide on the merits of the offer;

 

    false markets must not be created in the securities of the target company, the bidder or any other company concerned by the offer in such a way that the rise or fall of the prices of the securities becomes artificial and the normal functioning of the markets is distorted;

 

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    a bidder can only announce an offer after ensuring that he or she can fulfill in full the consideration offered, if such is offered, and after taking all reasonable measures to secure the implementation of any other type of consideration;

 

    a target company may not be hindered in the conduct of its affairs longer than is reasonable by an offer for its securities; and

 

    a “substantial acquisition” of securities, whether such acquisition is to be effected by one transaction or a series of transactions, shall take place only at an acceptable speed and shall be subject to adequate and timely disclosure.

Mandatory Bid

Under certain circumstances, a person who acquires shares, or other voting securities, of a company may be required under the Irish Takeover Rules to make a mandatory cash offer for the remaining outstanding voting securities in that company at a price not less than the highest price paid for the securities by the acquiror, or any parties acting in concert with the acquiror, during the previous 12 months. This mandatory bid requirement is triggered if an acquisition of securities would increase the aggregate holding of an acquiror, including the holdings of any parties acting in concert with the acquiror, to securities representing 30% or more of the voting rights in a company, unless the Irish Takeover Panel otherwise consents. An acquisition of securities by a person holding, together with its concert parties, securities representing between 30% and 50% of the voting rights in a company would also trigger the mandatory bid requirement if, after giving effect to the acquisition, the percentage of the voting rights held by that person, together with its concert parties, would increase by 0.05% within a 12-month period. Any person, excluding any parties acting in concert with the holder, holding securities representing more than 50% of the voting rights of a company is not subject to these mandatory offer requirements in purchasing additional securities.

Voluntary Bid; Requirements to Make a Cash Offer and Minimum Price Requirements

If a person makes a voluntary offer to acquire our outstanding ordinary shares, the offer price must not be less than the highest price paid for our ordinary shares by the bidder or its concert parties during the three-month period prior to the commencement of the offer period. The Irish Takeover Panel has the power to extend the “look back” period to 12 months if the Irish Takeover Panel, taking into account the General Principles, believes it is appropriate to do so.

If the bidder or any of its concert parties has acquired our ordinary shares (i) during the 12-month period prior to the commencement of the offer period that represent more than 10% of our total ordinary shares or (ii) at any time after the commencement of the offer period, the offer must be in cash (or accompanied by a full cash alternative) and the price per ordinary share must not be less than the highest price paid by the bidder or its concert parties during, in the case of (i), the 12-month period prior to the commencement of the offer period or, in the case of (ii), the offer period. The Irish Takeover Panel may apply this Rule to a bidder who, together with its concert parties, has acquired less than 10% of our total ordinary shares in the 12-month period prior to the commencement of the offer period if the Irish Takeover Panel, taking into account the General Principles, considers it just and proper to do so.

An offer period will generally commence from the date of the first announcement of the offer or proposed offer.

Substantial Acquisition Rules

The Irish Takeover Rules also contain rules governing substantial acquisitions of shares and other voting securities which restrict the speed at which a person may increase his or her holding of shares and rights over shares to an aggregate of between 15% and 30% of the voting rights of the company. Except in certain

 

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circumstances, an acquisition or series of acquisitions of shares or rights over shares representing 10% or more of the voting rights of the company is prohibited, if such acquisition(s), when aggregated with shares or rights already held, would result in the acquirer holding 15% or more but less than 30% of the voting rights of the company and such acquisitions are made within a period of seven days. These rules also require accelerated disclosure of acquisitions of shares or rights over shares relating to such holdings.

Frustrating Action

Under the Irish Takeover Rules, our board of directors is not permitted to take any action that might frustrate an offer for our shares once our board of directors has received an approach that may lead to an offer or has reason to believe that such an offer is or may be imminent, subject to certain exceptions. Potentially frustrating actions such as (i) the issue of shares, options, restricted share units or convertible securities, (ii) material acquisitions or disposals, (iii) entering into contracts other than in the ordinary course of business or (iv) any action, other than seeking alternative offers, which may result in frustration of an offer, are prohibited during the course of an offer or at any earlier time during which our board of directors has reason to believe an offer is or may be imminent. Exceptions to this prohibition are available where:

 

    the action is approved by our shareholders at a general meeting; or

 

    the Irish Takeover Panel has given its consent, where:

 

    it is satisfied the action would not constitute frustrating action;

 

    our shareholders holding more than 50% of the voting rights state in writing that they approve the proposed action and would vote in favor of it at a general meeting;

 

    the action is taken in accordance with a contract entered into prior to the announcement of the offer, or any earlier time at which our board of directors considered the offer to be imminent; or

 

    the decision to take such action was made before the announcement of the offer and either has been at least partially implemented or is in the ordinary course of business.

Shareholders’ Rights Plan

Irish law does not expressly authorize or prohibit companies from issuing share purchase rights or adopting a shareholder rights plan as an anti-takeover measure. However, there is no directly relevant case law on the validity of such plans under Irish law. In addition, such a plan would be subject to the Irish Takeover Rules and the General Principles underlying the Irish Takeover Rules. Our Articles allow our board of directors to adopt a shareholder rights plan upon such terms and conditions as our board of directors deems expedient and in the best interests of us, subject to applicable law.

Subject to the Irish Takeover Rules, our board of directors also has power to issue any of our authorized and unissued shares on such terms and conditions as it may determine and any such action should be taken in our best interests. It is possible, however, that the terms and conditions of any issue of preference shares could discourage a takeover or other transaction that holders of some or a majority of the ordinary shares believe to be in their best interests or in which holders might receive a premium for their shares over the then-market price of the shares.

Disclosure of Interests in Shares

Under the Irish Companies Acts, our shareholders must notify us if, as a result of a transaction, the shareholder will become interested in five percent or more of our voting shares, or if as a result of a transaction a shareholder who was interested in five percent or more of our voting shares ceases to be so interested. Where a

 

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shareholder is interested in five percent or more of our voting shares, the shareholder must notify us of any alteration of his or her interest that brings his or her total holding through the nearest whole percentage number, whether an increase or a reduction. The relevant percentage figure is calculated by reference to the aggregate nominal value of the voting shares in which the shareholder is interested as a proportion of the entire nominal value of our issued share capital (or any such class of share capital in issue). Where the percentage level of the shareholder’s interest does not amount to a whole percentage, this figure may be rounded down to the next whole number. We must be notified within five business days of the transaction or alteration of the shareholder’s interests that gave rise to the notification requirement. If a shareholder fails to comply with these notification requirements, the shareholder’s rights in respect of any of our shares it holds will not be enforceable, either directly or indirectly. However, such person may apply to the court to have the rights attaching to such shares reinstated.

In addition to these disclosure requirements, we, under the Irish Companies Acts, may, by notice in writing, require a person whom we know or have reasonable cause to believe to be, or at any time during the three years immediately preceding the date on which such notice is issued to have been, interested in shares comprised in our relevant share capital to: (i) indicate whether or not it is the case and (ii) where such person holds or has during that time held an interest in our shares, to provide additional information, including the person’s own past or present interests in our shares. If the recipient of the notice fails to respond within the reasonable time period specified in the notice, we may apply to the Irish court for an order directing that the affected shares be subject to certain restrictions, as prescribed by the Irish Companies Acts, as follows:

 

    any transfer of those shares or, in the case of unissued shares, any transfer of the right to be issued with shares and any issue of shares, shall be void;

 

    no voting rights shall be exercisable in respect of those shares;

 

    no further shares shall be issued in right of those shares or in pursuance of any offer made to the holder of those shares; and

 

    no payment shall be made of any sums due from us on those shares, whether in respect of capital or otherwise.

The court may also order that shares subject to any of these restrictions be sold with the restrictions terminating upon the completion of the sale.

In the event we are in an offer period pursuant to the Irish Takeover Rules, accelerated disclosure provisions apply for persons holding an interest in our securities of one percent or more.

Certain other provisions of Irish law or our Articles may be considered to have anti-takeover effects, including those described under the following captions: “—Authorized Share Capital” (regarding issuance of preference shares), “—Preemption Rights, Share Warrants and Share Options,” “—Corporate Governance,” “—Differences in Corporate Law Between Ireland and The State Of Delaware—Election of Directors,” “—Differences in Corporate Law Between Ireland and The State Of Delaware—Removal of Directors,” “—Differences in Corporate Law Between Ireland and The State Of Delaware—Amendments of Constituent Documents,” and “—Differences in Corporate Law Between Ireland and The State Of Delaware—Special/Extraordinary General Meetings.”

Listing

We have applied to list our ordinary shares on the Nasdaq Global Market under the symbol “NVET.”

Transfer Agent and Registrar

Upon the completion of this offering, the transfer agent, and registrar for our ordinary shares will be American Stock Transfer & Trust Company, LLC. The transfer agent and registrar’s address is 6201 Fifteenth Avenue, Brooklyn, New York 11219.

 

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SHARES ELIGIBLE FOR FUTURE SALE

Prior to this offering, there has been no public market for our ordinary shares. We cannot predict the effect, if any, that market sales of our ordinary shares or the availability of our ordinary shares for sale will have on the market price of our ordinary shares prevailing from time to time. Nevertheless, sales of substantial amounts of our ordinary shares in the public market could adversely affect the market price of our ordinary shares and could impair our future ability to raise capital through the sale of our equity securities.

Based on the number of our ordinary shares outstanding as of September 30, 2014, assuming the issuance of              ordinary shares in this offering, we will have              ordinary shares outstanding, assuming conversion of our outstanding preference shares into 5,937,138 ordinary shares, no exercise of the underwriters’ option to purchase             ordinary shares, no exercise of options or warrants and no conversion of restricted share units outstanding as of September 30, 2014. Of these outstanding ordinary shares, the              ordinary shares sold in this offering will be freely tradable, except that any ordinary shares acquired by our “affiliates” as that term is defined in Rule 144 promulgated under the Securities Act, including any ordinary shares acquired by entities affiliated with Farallon that have indicated an interest in purchasing ordinary shares in this offering, may only be sold in compliance with the limitations described below. The remaining              of our ordinary shares will continue to be deemed “restricted securities” as defined under Rule 144. These ordinary shares may be sold in the public market only if registered or if they qualify for an exemption from registration under Rule 144 or Rule 701 promulgated under the Securities Act, which we summarize below. In addition, each of our directors and officers and shareholders holding substantially all of our outstanding ordinary shares have entered into market stand-off agreements with us or lock-up agreements with the representatives of the underwriters whereby they have agreed not to sell any of their ordinary shares for 180 days following the date of this prospectus. In addition, of the 358,553 ordinary shares that were subject to options outstanding as of September 30, 2014, options to purchase 147,769 of such ordinary shares were vested as of such date and, upon exercise, these ordinary shares will be eligible for sale subject to the lock-up agreements described below and Rules 144 and 701 under the Securities Act. Upon conversion, the 50,454 ordinary shares that were subject to restricted share units outstanding as of September 30, 2014 will also be eligible for sale subject to the lock-up agreements described below and Rules 144 and 701 under the Securities Act. Subject to the provisions of Rule 144 and Rule 701, ordinary shares that are restricted securities will be available for sale in the public market as follows:

 

Date

  

Number of
Shares

On the date of this prospectus

  

At various times beginning 181 days after the date of this prospectus

  

Lock-Up Agreements

We, each of our directors and officers and shareholders holding substantially all of our outstanding ordinary shares have agreed, subject to specified exceptions, that, without prior the written consent of Merrill Lynch, Pierce, Fenner & Smith Incorporated and Cowen and Company, LLC, they will not offer, sell, contract to sell, pledge, grant any option to sell, or otherwise dispose of, directly or indirectly, any of our ordinary shares or securities convertible into or exercisable for our ordinary shares, or warrants or other rights to purchase our ordinary shares during the 180-day period following the date of this prospectus. Merrill Lynch, Pierce, Fenner & Smith Incorporated and Cowen and Company, LLC may, in their sole discretion, permit early release of shares subject to the lock-up agreements.

In addition to the restrictions contained in the lock-up agreements described above, our shareholders agreement obligates certain shareholders to enter into market stand-off and lock-up agreements that would impose restrictions on the ability of such holders to offer, sell or transfer our ordinary shares for a period of 180 days following the date of this prospectus.

 

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Rule 144

In general, under Rule 144 as currently in effect, once we have been subject to public company reporting requirements for at least 90 days, a person who is not deemed to have been one of our affiliates for purposes of the Securities Act at any time during the 90 days preceding a sale and who has beneficially owned the ordinary shares proposed to be sold for at least six months, including the holding period of any prior owner other than our affiliates, is entitled to sell those ordinary shares, upon the expiration of the lock-up agreements described above, without complying with the manner of sale, volume limitation or notice provisions of Rule 144, subject to compliance with the public information requirements of Rule 144. If such a person has beneficially owned the ordinary shares proposed to be sold for at least one year, including the holding period of any prior owner other than our affiliates, then that person is entitled to sell those ordinary shares without complying with any of the other requirements of Rule 144.

In general, under Rule 144 as currently in effect, our affiliates or persons selling ordinary shares on behalf of our affiliates are entitled to sell upon the expiration of the lock-up agreements described above, within any three-month period beginning 90 days after the date of this prospectus, a number of ordinary shares that does not exceed the greater of:

 

    1% of the number of our ordinary shares then outstanding, which will equal approximately              ordinary shares immediately after this offering, assuming no exercise of the over-allotment option; or

 

    the average weekly trading volume of our ordinary shares on Nasdaq during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.

Sales under Rule 144 by our affiliates or persons selling ordinary shares on behalf of our affiliates are also subject to certain manner of sale provisions and notice requirements and to the availability of current public information about us. In addition, if the number of ordinary shares being sold under Rule 144 by an affiliate during any three-month period exceeds 5,000 shares or has an aggregate sale price in excess of $50,000, the seller must file a notice on Form 144 with the SEC and Nasdaq concurrently with either the placing of a sale order with the broker or the execution of a sale directly with a market maker.

Rule 701

In general, under Rule 701 of the Securities Act, an employee, officer, director, consultant or advisor who purchased ordinary shares from us in connection with a compensatory share or option plan or other written agreement before the effective date under the Securities Act of the registration statement of which this prospectus forms a part, is eligible to resell those ordinary shares in reliance on Rule 144, but without compliance with certain restrictions, including the holding period contained in Rule 144. However, the ordinary shares issued pursuant to Rule 701 are subject to the lock-up agreements described above and in the section of this prospectus titled “Underwriting” and will only become eligible for sale upon the expiration of those agreements.

Registration of Shares Issued Pursuant to Benefits Plans

We intend to file registration statements under the Securities Act after the effective date of this offering to register ordinary shares to be issued pursuant to our employee benefit plans. As a result, any ordinary shares issued or options or rights exercised under our 2013 Plan, 2014 Plan or any other benefit plan after the effectiveness of such registration statements will also be freely tradable in the public market, subject to the market stand-off and lock-up agreements discussed above. However, such ordinary shares held by affiliates will still be subject to the volume limitation, manner of sale, notice and public information requirements of Rule 144. As of September 30, 2014, we had outstanding share options to purchase 358,553 ordinary shares and restricted share units to acquire 50,454 ordinary shares, 259,098 of which were subject to vesting requirements. The

 

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original nil exercise or conversion price of certain of these options and restricted share units, as applicable, was revised to the nominal value per ordinary share in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

Registration Rights

In connection with our prior financings, we amended and restated our shareholders agreement pursuant to which we have undertaken to provide registration rights to the holders of our Series B preference shares. In connection with this offering, we expect each holder of our Series B preference shares to enter into an agreement with us that would grant the holder certain demand, Form S-3 and piggyback registration rights for the ordinary shares issuable upon the automatic conversion of the Series B preference shares. As of September 30, 2014, the holders of 5,967,004 ordinary shares, including the ordinary shares issuable upon the automatic conversion of our Series B preference shares and upon exercise of outstanding warrants, or their permitted transferees, are entitled to request these registration rights. Such registration would result in these ordinary shares becoming fully tradable without restriction under the Securities Act immediately upon the effectiveness of such registration, except for ordinary shares purchased by affiliates. These holders have agreed not to exercise any registration rights they may acquire until the date beginning 180 days after the date of this prospectus. See the section of this prospectus titled “Description of Share Capital—Registration Rights” for additional information.

 

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TAXATION

Irish Tax Considerations

Scope of Discussion

The following is a summary of the material Irish tax considerations applicable to certain investors who are the beneficial owners of our ordinary shares. To the extent that the summary sets forth specific legal conclusions under Irish tax law, this summary represents the opinion of Ernst & Young Business Advisors. This summary is based on existing Irish tax law and our understanding of the practices of the Irish Revenue Commissioners as of the date of this prospectus. Legislative, administrative or judicial changes may modify the tax consequences described in this summary, possibly with retroactive effect. Furthermore, we can provide no assurances that the tax consequences contained in this summary will not be challenged by the Irish Revenue Commissioners or will be sustained by an Irish court if they were to be challenged.

This summary does not constitute tax advice and is intended only as a general guide. This summary is not exhaustive and shareholders should consult their own tax advisors about the Irish tax consequences (and the tax consequences under the laws of other relevant jurisdictions) which may arise as a result of being a shareholder in our company including the acquisition, ownership and disposition of our ordinary shares. Furthermore, this summary applies only to shareholders who will hold our ordinary shares as capital assets and does not apply to categories of shareholders, such as dealers in securities, trustees, insurance companies, collective investment schemes, pension funds or shareholders who have, or who are deemed to have, acquired their shares by virtue of an office or employment (performed or carried on in Ireland).

Irish Tax on Chargeable Gains

Irish-Resident Shareholders

A disposal of our ordinary shares by a shareholder who is resident or ordinarily resident in Ireland for Irish tax purposes may, depending on the circumstances (including the availability of certain exemptions and reliefs, and taking into account the price paid or treated as paid for the shares), give rise to a chargeable gain or an allowable loss for the purposes of Irish tax on chargeable gains. The current rate of capital gains tax in Ireland is 33%.

Non–Resident Shareholders

Shareholders that are not resident or ordinarily resident in Ireland for Irish tax purposes should not be liable to Irish tax on chargeable gains realized on a disposal of our ordinary shares unless such shares are used, held or acquired for the purpose of a trade or business carried on by such a shareholder in Ireland through a branch or an agency.

A shareholder who is an individual and who is temporarily non-resident in Ireland may, under Irish anti-avoidance legislation, still be liable to Irish tax on any chargeable gain realized on a disposal of our ordinary shares during the period in which the individual is non-resident.

Irish Dividend Withholding Tax

Our company does not anticipate paying dividends for the foreseeable future. However, if in the future we were to pay a dividend or make a distribution to our shareholders, that distribution may be subject to dividend withholding tax, or DWT, at the standard rate of Irish income tax (currently 20%) unless one of the exemptions described below applies.

For DWT purposes, a dividend includes any distribution made to shareholders, including cash dividends, non-cash dividends and any additional shares taken in lieu of a cash dividend. We are responsible for

 

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withholding DWT at source in respect of the distributions made and remitting the tax withheld to the Irish Revenue Commissioners.

General Exemptions

Certain shareholders (both individual and corporate) are entitled to an exemption from DWT. In particular, dividends paid to a non-Irish resident shareholder will not be subject to DWT where the shareholder is beneficially entitled to the dividend and is:

 

    an individual shareholder resident for tax purposes in a “relevant territory” and the individual is neither resident nor ordinarily resident in Ireland;

 

    a corporate shareholder resident for tax purposes in a “relevant territory”, provided that the corporate shareholder is not under the control, whether directly or indirectly, of a person or persons who is or are resident in Ireland;

 

    a corporate shareholder that is not resident for tax purposes in Ireland and that is ultimately controlled, directly or indirectly, by persons resident in a “relevant territory”;

 

    a corporate shareholder that is not resident for tax purposes in Ireland and whose principal class of shares (or those of its 75% parent) is substantially and regularly traded on a recognized share exchange in a “relevant territory” or on such other share exchange as may be approved by the Irish Minister for Finance; or

 

    a corporate shareholder that is not resident for tax purposes in Ireland and is wholly-owned, directly or indirectly, by two or more companies where the principal class of shares of each of such companies is substantially and regularly traded on a recognized share exchange in a “relevant territory” or on such other share exchange as may be approved by the Irish Minister for Finance;

and provided that, in all cases stated above (but subject to the matters described below) the shareholder has provided the relevant Irish DWT declaration form to his or her broker before the record date of the dividend (in the case of shares held through DTC) or to our transfer agent at least seven business days before such record date (in the case of shares held outside of DTC).

A list of “relevant territories” for the purposes of DWT (as of the date of this prospectus) is set forth below and this list is subject to change:

 

Albania   

Czech Republic

  

Italy

  

Netherlands

  

Slovenia

Armenia   

Denmark

  

Japan

  

New Zealand

  

South Africa

Australia   

Egypt

  

Republic of Korea

  

Norway

  

Spain

Austria   

Estonia

  

Kuwait

  

Pakistan

  

Sweden

Bahrain   

Finland

  

Latvia

  

Panama

  

Switzerland

Belarus   

France

  

Lithuania

  

Poland

  

Thailand

Belgium   

Georgia

  

Luxembourg

  

Portugal

  

Turkey

Bosnia and Herzegovina   

Germany

  

Macedonia

  

Qatar

  

Ukraine

Bulgaria   

Greece

  

Malaysia

  

Romania

  

United Arab Emirates

Canada   

Hong Kong

  

Malta

  

Russia

  

United Kingdom

Chile   

Hungary

  

Mexico

  

Saudi Arabia

  

United States of America

China   

Iceland

  

Moldova

  

Serbia

  

Uzbekistan

Croatia    India    Montenegro    Singapore    Vietnam
Cyprus    Israel    Morocco    Slovak Republic    Zambia

It is the responsibility of each individual shareholder to determine whether or not they are “resident” for tax purposes in a “relevant territory.”

 

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Prior to paying any future dividend, our company will enter into an agreement with an institution which is recognized by the Irish Revenue Commissioners as a “qualifying intermediary” and which satisfies the requirements for dividends to be paid to certain shareholders free from DWT where such shareholders hold their shares through DTC, as described below. The agreement will generally provide for certain arrangements relating to distributions in respect of those shares that are held through DTC. The agreement will provide that the “qualifying intermediary” shall distribute or otherwise make available to Cede & Co., as nominee for DTC, any cash dividend or other cash distribution to be made to holders of the Deposited Securities, after we deliver or causes to be delivered to the “qualifying intermediary” the cash to be distributed.

We will rely on the information received directly or indirectly from brokers and its transfer agent in determining where shareholders reside and whether they have furnished the required U.S. tax information, as described below. Shareholders who are required to furnish Irish DWT declaration forms in order to receive their dividends without DWT, should note that those declarations forms are only valid for five years and new DWT declarations forms must be completed and filed before the expiration of that five year period to enable the shareholder continue to receive dividends without DWT.

In most cases, individual shareholders resident in a “relevant territory” should complete a non-resident Form V2A and corporate shareholders resident in a “relevant territory” should complete a non-resident Form V2B. Where a shareholder is neither an individual nor a corporate body but is resident in a “relevant territory,” that shareholder should complete a non-resident Form V2C. Shareholders should contact their brokers or own tax advisors should they have any questions regarding Irish DWT.

Shares Held by U.S. Resident Shareholders

Dividends paid on our ordinary shares that are owned by residents of the U.S. should not be subject to DWT, subject to the completion and delivery of the relevant forms to us.

Residents of the U.S. who hold their shares through DTC should be entitled to receive dividends without DWT provided that the address of the beneficial owner of the shares in the records of the broker holding such shares is in the United States. This is subject to confirmation from the Irish Revenue Commissioners. We would strongly recommend that such shareholders ensure that their information has been properly recorded by their brokers (so that such brokers can further transmit the relevant information to a qualifying intermediary appointed by us).

Residents of the U.S. who hold their shares outside of DTC will be entitled to receive dividends without DWT provided that the shareholder has completed the relevant Irish DWT declaration form and this declaration form remains valid. Such shareholders must provide the relevant Irish DWT declaration form to our transfer agent at least seven business days before the record date of the dividend payment to which they are entitled. We would strongly recommend that such shareholders complete the relevant Irish DWT declaration form and provide them to our transfer agent as soon as possible after acquiring shares in our company.

If a U.S. resident shareholder is entitled to an exemption from DWT but receives a dividend subject to DWT, that shareholder may be entitled to claim a refund of DWT from the Irish Revenue Commissioners, subject to certain time limits and provided the shareholder is beneficially entitled to the dividend.

Shares Held by Residents of “Relevant Territories” Other Than the United States

Shareholders who are residents of “relevant territories” other than the United States, and who are entitled to an exemption from DWT, must complete the relevant Irish DWT declaration form in order to receive dividends without DWT.

Shareholders must provide the relevant Irish DWT declaration form to their brokers (so that such brokers can further transmit the relevant information to a qualifying intermediary appointed by us) before the record date of the dividend to which they are entitled (in the case of shares held through DTC), or to our transfer agent at least seven business days before such record date (in the case of shares held outside of DTC). We would

 

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strongly recommend that such shareholders complete the relevant Irish DWT declaration form and provide that form to their brokers or our transfer agent as soon as possible after acquiring shares in our company.

If a shareholder who is resident in a “relevant territory” and is entitled to an exemption from DWT receives a dividend subject to DWT, that shareholder may be entitled to claim a refund of DWT from the Irish Revenue Commissioners, subject to certain time limits and provided the shareholder is beneficially entitled to the dividend.

Notwithstanding the foregoing, this exception from DWT does not apply to an individual shareholder that is resident or ordinarily resident in Ireland or to a corporate entity that is under the control, whether directly or indirectly, of a person or persons who is or who are resident in Ireland. However, other exemptions from DWT may still be available to that shareholder. In addition, it may also be possible for certain shareholders to rely on a double tax treaty to limit the applicable DWT.

Shares Held by Irish Resident Shareholders

Most Irish tax resident or ordinarily resident shareholders (other than Irish resident companies that have completed the relevant Irish DWT declaration forms and where this declaration form remains valid) will be subject to DWT in respect of dividends or distributions received from an Irish resident company.

Irish tax resident or ordinarily resident shareholders that are entitled to receive dividends without DWT, must complete the relevant Irish DWT declaration form and provide the declaration form to their brokers (so that such brokers can further transmit the relevant information to a qualifying intermediary appointed by us) before the record date of the dividend to which they are entitled (in the case of shares held through DTC), or to our transfer agent at least seven business days before such record date (in the case of shares held outside of DTC).

Irish tax resident or ordinarily resident shareholders who are not entitled to an exemption from DWT and who are subject to Irish tax should consult their own tax advisors.

Shares Held by Other Persons

A shareholder that does not fall within one of the categories specifically mentioned above may nonetheless fall within other exemptions from DWT provided that the shareholder has completed the relevant Irish DWT declaration form and this declaration form remains valid.

If any such shareholder is exempt from DWT but receives a dividend subject to DWT, that shareholder may be entitled to claim a refund of DWT from the Irish Revenue Commissioners, subject to certain time limits.

Income Tax on Dividends Paid

As an Irish resident company, Irish income tax may arise for certain shareholders in respect of any dividends received from us.

Non-Resident Shareholders

A shareholder that is not resident or ordinarily resident in Ireland for Irish tax purposes and who is entitled to an exemption from DWT generally has no liability to Irish income tax or other similar charges in respect of any dividends received from us. An exception to this position may apply where a shareholder holds our ordinary shares through a branch or agency in Ireland through which a trade is carried on.

A shareholder that is not resident or ordinarily resident in Ireland for Irish tax purposes and who is not entitled to an exemption from DWT generally has no additional liability to Irish income tax or other similar

 

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charges on any dividends received from us. An exception to this position may apply where a shareholder holds our ordinary shares through a branch or an agency in Ireland through which a trade is carried on. In these circumstances, the shareholder’s liability to Irish tax is effectively limited to the amount of DWT withheld by us.

Irish Resident Shareholders

Irish resident or ordinarily resident shareholders may be subject to Irish income tax and any other similar charges on dividends received from us. Credit should be available against this Irish tax payable for any DWT withheld by us.

Capital Acquisitions Tax

CAT consists principally of gift tax and inheritance tax. A gift or inheritance of our ordinary shares (including where such shares are held in DTC) may attract a charge to CAT irrespective of the place of residence, ordinary residence or domicile of the transferor or the transferee of the shares. This is because a charge to CAT may arise on a gift or inheritance which comprises of property situated in Ireland. Our ordinary shares are regarded as property situated in Ireland for CAT proposes because our share register must be retained in Ireland. The person who receives the gift or inheritance is primarily liable for any CAT that may arise.

CAT is levied at a rate of 33% above certain tax-free thresholds. The appropriate tax-free threshold is dependent upon (i) the relationship between the donor and the donee and (ii) the aggregation of the values of previous gifts and inheritances received by the donee from persons within the same group threshold. Gifts and inheritances passing between spouses are exempt from CAT. Shareholders should consult their own tax advisors as to whether CAT is creditable or deductible in computing any domestic tax liabilities.

Irish Stamp Duty

The rate of stamp duty (where applicable) on the transfer of shares in an Irish incorporated company is 1% of the price paid, or the market value of the shares acquired, whichever is greater. Where a charge to Irish stamp duty applies it is generally a liability for the transferee. Irish stamp duty may, depending on the manner in which our ordinary shares are held, be payable in respect of the transfer of our ordinary shares.

Irish Stamp Duty—DTC Arrangements

On the basis that most of our shares are expected to be held through DTC, or through brokers who hold shares on behalf of their customers through DTC, the transfer of such shares should be exempt from Irish stamp duty based on established practice of Irish Revenue Commissioners. We have received confirmation from the Irish Revenue Commissioners that a transfer of our shares held through DTC and transferred by means of a book-entry interest would be exempt from Irish stamp duty. We also received confirmation from the Irish Revenue Commissioners that certain transfers of our ordinary shares into (or out of) DTC would be exempt from Irish stamp duty.

Shares Held Through DTC

A transfer of our ordinary shares effected by means of the transfer of book-entry interests in DTC should not be subject to Irish stamp duty.

Shares Held Outside of DTC or Transferred Into or Out of DTC

A transfer of our ordinary shares where any of the parties to the transfer hold the shares outside of DTC may be subject to Irish stamp duty. A shareholder should be entitled to transfer our ordinary shares into (or out of) DTC without giving rise to Irish stamp duty provided (i) there is no change in beneficial ownership of the shares; and (ii) at the time of the transfer into (or out of) DTC there is no agreement in place for the sale of the shares by the beneficial owner to a third party.

 

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To avoid Irish stamp duty on transfers of our ordinary shares any directly registered shareholder may wish to consider opening a broker account, and any person who wishes to acquire our ordinary shares may wish to consider holding such shares through DTC.

DTC Requirement

In order for DTC, Cede & Co. and National Securities Clearing Corporation, or NSCC, which provides clearing services for securities that are eligible for the depository and book-entry transfer services provided by DTC and registered in the name of Cede & Co., which entities are referred to collectively as the DTC Parties, to agree to provide services with respect to our ordinary shares, we expect to enter into a composition agreement with the Irish Revenue Commissioners under which we will agree to pay or procure the payment of any obligation for any Irish stamp duty or similar Irish transfer or documentary tax with respect to our ordinary shares, on (i) transfers to which any of the DTC Parties is a party or (ii) which may be processed through the services of any of the DTC Parties and the DTC Parties have received confirmation from the Irish Revenue Commissioners that during the period that such composition agreement remains in force, the DTC Parties shall not be liable for any Irish stamp duty with respect to our ordinary shares.

In addition, to assure the DTC Parties that they will not be liable for any Irish stamp duty or similar Irish transfer or documentary tax with respect to our ordinary shares under any circumstances (including as a result of a change in applicable law), and to make other provisions with respect to our ordinary shares required by the DTC Parties, we and our transfer agent expect to enter into a Special Eligibility Agreement for Securities, with DTC, Cede & Co. and NSCC, or the DTC Eligibility Agreement.

The DTC Eligibility Agreement provides for certain indemnities of the DTC Parties by us and                                 (as to which we have agreed to indemnify                                 ) and also provides that DTC may impose a global lock on our ordinary shares or otherwise limit transactions in the shares, or cause the shares to be withdrawn, and NSCC may, in its sole discretion, exclude our ordinary shares from its continuous net settlement service or any other service, and any of the DTC Parties may take other restrictive measures with respect to our ordinary shares as it may deem necessary and appropriate, without any liability on the part of any of the DTC Parties, (i) at any time that it may appear to any of the DTC Parties, in any such party’s sole discretion, that to continue to hold or process transactions in our ordinary shares will give rise to any Irish stamp duty or similar Irish transfer or documentary tax liability with respect to our ordinary shares on the part of any of the DTC Parties or (ii) otherwise as DTC’s rules or the NSCC’s rules provide.

THE IRISH TAX CONSIDERATIONS SUMMARIZED ABOVE ARE FOR GENERAL INFORMATION ONLY. EACH SHAREHOLDER SHOULD CONSULT HIS OR HER OWN TAX ADVISOR AS TO THE PARTICULAR TAX CONSEQUENCES THAT MAY APPLY TO SUCH SHAREHOLDER.

Material United States Federal Income Tax Consequences to U.S. Holders

The following summary describes the material U.S. federal income tax consequences to U.S. Holders (as defined below) of owning and disposing of our ordinary shares acquired in this offering.

This summary addresses only the U.S. federal income tax considerations for U.S. Holders that hold our ordinary shares as capital assets. This summary does not address all U.S. federal income tax matters that may be relevant to a particular U.S. Holder. Each prospective investor should consult a professional tax advisor with respect to the tax consequences of an investment in our ordinary shares. This summary does not address tax considerations applicable to a holder of our ordinary shares that may be subject to special tax rules, including the following:

 

    dealers in securities or currencies;

 

    financial institutions;

 

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    regulated investment companies;

 

    real estate investment trusts;

 

    tax-exempt entities (including private foundations);

 

    insurance companies;

 

    persons holding ordinary shares as a part of a hedging, integrated, conversion or constructive sale transaction or a straddle;

 

    persons that own, directly, indirectly or as a result of certain constructive ownership rules, ordinary shares representing 10% or more of the total combined voting power of all classes of our ordinary shares;

 

    traders in securities that elect to use a mark-to-market method of accounting;

 

    persons liable for alternative minimum tax;

 

    U.S. Holders whose “functional currency” is not the U.S. dollar; or

 

    U.S. tax expatriates and certain former citizens and long-term residents of the United States.

This summary is based upon the provisions of the Code, the United States Treasury Regulations promulgated thereunder and administrative and judicial interpretations of the Code and the United States Treasury Regulations, all as currently in effect, and all subject to differing interpretations or change, possibly on a retroactive basis. This summary does not address any estate, gift, state, local, non-U.S. or other tax consequences, except as specifically provided herein. Furthermore, we can provide no assurance that the tax consequences contained in this summary will not be challenged by the IRS or will be sustained by a court if challenged.

For purposes of this summary, a “U.S. Holder” means the beneficial owner of our ordinary shares that is, for U.S. federal income tax purposes:

 

    an individual who is a citizen or resident of the U.S. (as determined under U.S. federal income tax rules);

 

    a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States or of any political subdivision thereof;

 

    an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or

 

    a trust if it (i) is subject to the primary supervision of a court within the United States and one or more U.S. persons have the authority to control all substantial decisions of the trust or (ii) has in effect a valid election under applicable United States Treasury Regulations to be treated as a U.S. person.

If a partnership or an entity treated as a partnership for U.S. federal income tax purposes holds ordinary shares, the U.S. federal income tax treatment of a partner in the partnership will generally depend on the status of the partner and the activities of the partnership. Partnerships holding ordinary shares or partners in such partnerships should consult their own tax advisors regarding the particular U.S. federal income tax consequences of the ownership and disposition of ordinary shares.

 

 

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The following summary is not a substitute for careful tax planning and advice. Each prospective investor is urged to consult its tax advisor concerning the U.S. federal income tax consequences of the issues discussed herein, in light of their particular circumstances, as well as any considerations arising under the laws of any foreign, state, local or other taxing jurisdiction.

Taxation of Distributions on Ordinary Shares

Subject to the discussion under “—Passive Foreign Investment Company Status and Related Tax Consequences” below, the gross amount of any distribution (including amounts, if any, withheld in respect of Irish withholding tax) actually or constructively received by a U.S. Holder with respect to our ordinary shares will be taxable to the U.S. Holder as a dividend to the extent of the U.S. Holder’s pro rata share of our current or accumulated earnings and profits as determined under U.S. federal income tax principles. Distributions to a U.S. Holder in excess of its pro rata share of our earnings and profits will be treated first as a return of capital that reduces a U.S. Holder’s tax basis in such ordinary shares (thereby increasing the amount of gain or decreasing the amount of loss that a U.S. Holder would recognize on a subsequent disposition of our ordinary shares), and then as gain from the sale or exchange of such ordinary shares. In the event we make distributions to holders of ordinary shares, we may or may not calculate our earnings and profits under U.S. federal income tax principles. If we do not do so, any distribution may be required to be regarded as a dividend, even if that distribution would otherwise be treated as a non-taxable return of capital or as capital gain. If a U.S. Holder receives a distribution in Euros the amount of the distribution will be the U.S. dollar value on the date the distribution is received by the U.S. Holder. The amount of any distribution of property other than cash will be the fair market value of that property on the date of distribution. The amount of the dividend will generally be treated as foreign-source dividend income to U.S. Holders.

Non-corporate U.S. Holders will generally be eligible for the preferential U.S. federal rate on qualified dividend income, provided that we are a “qualified foreign corporation,” the shares on which the dividend is paid are held for a minimum holding period, and other requirements are satisfied.

A “qualified foreign corporation” includes a foreign corporation that is not a PFIC in the year of the distribution or in the prior tax year and that is (i) eligible for the benefits of an income tax treaty with the United States, if such treaty contains an exchange of information provision and the United States Treasury Department has determined that the treaty is satisfactory for purposes of the legislation or (ii) in the event (i) does not apply, a foreign corporation whose shares are readily traded on an established securities market in the United States.

The United States and Ireland have an income tax treaty which contains an exchange of information provision and the U.S. Treasury Department has made a determination that such treaty is satisfactory for purposes of an Irish corporation being a “qualified foreign corporation.” We expect to be eligible for the benefits of this treaty; however, it is uncertain at this time. In addition, we have applied to list our ordinary shares on Nasdaq, which is an established securities market in the United States and for the ordinary shares to be readily tradable on Nasdaq in the current year. Accordingly, dividends we pay on our ordinary shares may meet the conditions required for the reduced tax rate provided we are not a PFIC in the year in which the dividend is paid or in the preceding year. As discussed in greater detail below, we believe that we may be a PFIC for our current taxable year, and in future years we may be a PFIC. In addition, our ordinary shares may not be considered readily tradable on an established securities market in the United States. Potential investors should consult their own tax advisors as to the application and availability of these preferential tax rates.

Distributions to U.S. Holders generally will not be eligible for the dividends received deduction generally allowed to U.S. corporations in respect of dividends received from other U.S. corporations.

Taxation of Sale, Exchange or Other Taxable Disposition of Ordinary Shares

Upon the sale, exchange or other taxable disposition of an ordinary share, a U.S. Holder generally will recognize gain or loss equal to the difference between the amount realized upon the sale, exchange or other

 

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disposition and such U.S. Holder’s tax basis in the ordinary share. If the U.S. Holder receives Euros in the transaction, the amount realized on the sale, exchange or other taxable disposition of the ordinary shares will be the U.S. dollar value of the Euros received, which is determined for cash basis taxpayers on the settlement date for the transaction and for accrual basis taxpayers on the trade date (although accrual basis taxpayers can also elect the settlement date). Subject to the discussion under “—Passive Foreign Investment Company Status and Related Tax Consequences” below, any such gain or loss will generally be capital gain or loss and will generally be long-term capital gain or loss if the U.S. Holder’s holding period for the ordinary shares transferred exceeds one year on the date of the sale or disposition. Long-term capital gains of non-corporate U.S. Holders derived with respect to the disposition of ordinary shares are currently subject to tax at reduced rates. The deductibility of capital losses is subject to several limitations. The gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes.

Passive Foreign Investment Company Status and Related Tax Consequences

Special U.S. federal income tax rules apply to U.S. Holders owning shares of a PFIC. A foreign corporation generally will be classified as a PFIC for U.S. federal income tax purposes in any taxable year in which either:

 

    at least 75% of its gross income is “passive income”; or

 

    on average at least 50% of the gross value of its assets is attributable to assets that produce passive income or are held for the production of passive income.

For this purpose, passive income generally includes, among other things, dividends, interest, rents, royalties, gains from the disposition of passive assets and gains from commodities and securities transactions. In determining whether a foreign corporation is a PFIC, the foreign corporation must take into account its proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least 25%, by value, of the shares.

Based on current estimates of our gross income, gross assets and the nature of our business, we believe that we may be a PFIC for U.S. federal income tax purposes for our current taxable year and there is no assurance that we will not be a PFIC in any other taxable year. In particular, the proceeds from this offering would be a passive asset and could cause us to meet the asset test for our taxable year that includes this offering. In addition, we do not expect to generate gross income from operations during our current taxable year, which would cause us to meet the income test for our taxable year. If we fail to deploy sufficient cash in later taxable years to avoid meeting the asset test, or we are not generating sufficient active income, we could meet either or both PFIC tests in such later years.

A U.S. Holder will be subject to different taxation rules with respect to an investment in our ordinary shares depending on whether such U.S. Holder makes a Qualifying Election Fund, or QEF, election or a mark-to-market election with respect to his or her investment in our ordinary shares. Our status as a PFIC depends on meeting either the income test or the asset test described above. These tests are calculated on an annual basis; therefore, our counsel cannot definitively determine as of the date of this prospectus whether we will qualify as a PFIC for any particular year.

If a U.S. Holder makes a valid, timely QEF election with respect to our ordinary shares, the U.S. Holder must report for U.S. federal income tax purposes its pro rata share of our ordinary earnings and net capital gain, if any, for each taxable year for which we are a PFIC that ends with or within its taxable year, regardless of whether or not it received any distributions on the ordinary shares it owns. No portion of any such inclusions of ordinary earnings would be eligible to be treated as “qualified dividend income.” If a U.S. Holder is a non-corporate U.S. Holder, any such net capital gain inclusions would be eligible for taxation at the preferential capital gain tax rates. A U.S. Holder’s adjusted tax basis in its ordinary shares would be increased to reflect any

 

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taxed but undistributed earnings and profits. Any distribution of earnings and profits that previously had been taxed would not be taxed again when a U.S. Holder receives such distribution (nor would distributions in excess of our earnings and profits), but it would result in a corresponding reduction in the adjusted tax basis in its ordinary shares. A U.S. Holder would not, however, be entitled to a deduction for its pro rata share of any net losses that we incur with respect to any year. A U.S. Holder generally would recognize capital gain or loss on the sale, exchange or other disposition of our ordinary shares and would be taxed as described under “—Taxation of Sale, Exchange or Other Taxable Disposition of Ordinary Shares.”

A U.S. Holder may make a timely QEF election with respect to its investment in our ordinary shares by filing one copy of IRS Form 8621 with its U.S. federal income tax return for the first year in which it holds our ordinary shares. Retroactive QEF elections generally may be made only by filing a protective statement with such return and if certain other conditions are met or with the consent of the IRS. If we are a PFIC with respect to any tax year, we intend to provide U.S. Holders with all necessary information on a timely basis in order to enable them to make and maintain a QEF election as described above. We will make the determination as to whether we meet the tests to be a PFIC on an annual basis as soon as reasonably practicable after the close of each taxable year and, if we meet such tests with respect to any taxable year, we expect to post all such necessary information on our website in a timely manner for our U.S. Holders making QEF elections to make and maintain such elections. A U.S. Holder may make a separate election to defer the payment of taxes on undistributed income inclusions under the QEF election rules, but if deferred, any such taxes will be subject to an interest charge.

If we are a PFIC and any of our subsidiaries are PFICs, a U.S. Holder may need to make the QEF election with respect to each such subsidiary in order to avoid the adverse tax consequences described below. We intend to provide U.S. Holders with all information necessary in order for them to make the QEF election with respect to any of our subsidiaries that may be classified as a PFIC in any tax year in the same manner as described above. The mark-to-market election described below generally will not be available with respect to any of our subsidiaries that are PFICs, rendering such election less beneficial to a U.S. Holder than the QEF election.

Provided that our ordinary shares are “marketable stock,” which we believe they would be, a U.S. Holder may make a mark-to-market election with respect to our ordinary shares. If a U.S. Holder makes a valid, timely mark-to-market election with respect to our ordinary shares, it will include in income each year in which we are a PFIC an amount equal to the excess, if any, of the fair market value of the ordinary shares as of the close of its taxable year over its adjusted basis in such ordinary shares. A U.S. Holder is allowed a deduction for the excess, if any, of the adjusted basis of the ordinary shares over their fair market value as of the close of your taxable year for any year in which we are a PFIC. Deductions are allowable, however, only to the extent of any net mark-to-market gains on the ordinary shares included in its income for prior taxable years. Amounts included in a U.S. Holder’s income under a mark-to-market election are treated as ordinary income. Ordinary loss treatment applies to the deductible portion of any mark-to-market loss on the ordinary shares to the extent the amount of such loss does not exceed the net mark-to-market gains previously included for such ordinary shares. A U.S. Holder’s basis in the ordinary shares will be adjusted to reflect any such income or loss amounts and will be reduced by distributions received. Distributions will not be includable in income, except to the extent they exceed a U.S. Holder’s tax basis in its ordinary shares. Gain or loss recognized on a sale or other disposition of our ordinary shares will be treated as ordinary income or loss unless we are not a PFIC for the taxable year in which such sale or other disposition occurs. If a U.S. Holder makes a mark-to-market election, it will be effective for our taxable year for which the election is made and all subsequent taxable years unless our ordinary shares are no longer marketable shares or the IRS consents to the revocation of the election.

If we or one of our subsidiaries is a PFIC and a U.S. Holder does not make a QEF or mark-to-market election with respect to its investment in our ordinary shares, it would be subject to special rules with respect to (i) any excess distribution (i.e., the portion of any distributions it receives on our ordinary shares in a taxable year in excess of 125% of the average annual distributions it received in the three preceding taxable years, or, if

 

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shorter, its holding period for the ordinary shares), and (ii) any gain realized on the sale, exchange or other disposition of ordinary shares. Under these special rules:

 

    the excess distribution or gain would be allocated ratably over the holding period for the ordinary shares;

 

    the amount allocated to the current taxable year (and any other year prior to the year in which we were a PFIC) would be taxed as ordinary income and would not be “qualified dividend income”; and

 

    the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax to which it would have been subject for that year, and an interest charge for the deemed tax deferral would be imposed with respect to the resulting tax attributable to each such other taxable year.

Although a determination as to our PFIC status will be made annually, an initial determination that we are a PFIC will generally apply for subsequent years to a U.S. Holder who held ordinary shares while we were a PFIC, whether or not we meet the test for PFIC status in those years. A U.S. Holder who makes the QEF election discussed above for our first tax year in which the U.S. Holder holds (or is deemed to hold) our ordinary shares and for which we are determined to be a PFIC, however, will not be subject to the PFIC tax and interest charge rules (or the denial of basis step-up at death) discussed above in respect to such shares. In addition, such U.S. Holder will not be subject to the QEF inclusion regime with respect to such shares for the tax years in which we are not a PFIC. On the other hand, if the QEF election is not effective for each of our tax years in which we are a PFIC and the U.S. Holder holds (or is deemed to hold) our ordinary shares, the PFIC rules discussed above will continue to apply to such shares unless the holder makes a purging election and pays the tax and interest charge with respect to the gain inherent in such shares attributable to the pre-QEF election period. Such election also can be made by a U.S. Holder in order to make a QEF election other than for the first taxable year in which we are a PFIC (and in which the U.S. Holder owns our ordinary shares).

If a U.S. Holder owns ordinary shares during any taxable year that we are treated as a PFIC, it will be required to file IRS Form 8621 (regardless of whether a QEF or mark-to-market election is made).

The rules dealing with PFICs and with the QEF and mark-to-market elections are very complex and are affected by various factors in addition to those described above. Prospective investors should consult their own tax advisors regarding the application of the PFIC rules to our ordinary shares, the availability and advisability of making a QEF or mark-to-market election.

If we are not treated as a PFIC, and you paid taxes as if we were a PFIC, then you may be able to claim a refund for taxes you paid in excess of the taxes you actually owed. If you do not timely make such a refund claim, then your refund will be disallowed and you will bear more taxes than you actually owe.

Information Reporting and Backup Withholding

Distributions paid with respect to ordinary shares and proceeds from a sale, exchange or redemption of ordinary shares made within the United States or through certain U.S.-related financial intermediaries may be subject to information reporting to the IRS and possible U.S. backup withholding. Backup withholding will not apply, however, to a U.S. Holder who furnishes a correct taxpayer identification number and makes any other required certification on IRS Form W-9 or that is a corporation or entity that is otherwise exempt from backup withholding. Backup withholding is not an additional tax. Amounts withheld as backup withholding may be credited against such holder’s U.S. federal income tax liability, and such holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing an appropriate claim for refund with the IRS and furnishing any required information in a timely manner. U.S. Holders of ordinary shares should consult their tax advisors regarding the application of the U.S. information reporting and backup withholding rules.

 

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U.S. Holders who (i) own immediately after the transfer at least 10% by vote or value of our ordinary shares or (ii) have transferred more than $100,000 in a 12-month period to a foreign corporation will be required to file an IRS Form 926. For purposes of determining the total dollar value of ordinary shares purchased by a U.S. Holder in this offering, ordinary shares purchased by certain related parties (including family members) are included. Substantial penalties may be imposed upon a U.S. Holder who fails to comply with this reporting obligation.

In addition, under U.S. federal income tax law and temporary and proposed Treasury Regulations, individual citizens or residents of the United States who hold certain “specified foreign financial assets” that exceed certain thresholds (the lowest being holding specified foreign financial assets with an aggregate value in excess of: (i) $50,000 on the last day of the tax year or (ii) $75,000 at any time during the tax year) are required to report information relating to such assets. The definition of “specified foreign financial assets” generally includes not only financial accounts maintained in foreign financial institutions, but also, unless held in accounts maintained by a financial institution, any stock or security issued by a non-U.S. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person, and any interest in a foreign entity. U.S. Individual Holders may be subject to these reporting requirements unless their ordinary shares are held in an account at a U.S. financial institution. Significant penalties may apply for failure to satisfy the reporting obligations described above.

Additionally, a U.S. Holder holding our ordinary shares should consider their possible obligation to file a Form TD F 90-22.1—Foreign Bank and Financial Accounts Report—with respect to the ordinary shares.

U.S. Holders should consult with their own tax advisors regarding their reporting obligations, if any, as a result of their purchase, ownership or disposition of our ordinary shares.

3.8% Medicare Tax on Unearned Income

Individuals, estates and trusts are subject to a tax of 3.8% on “net investment income” (or undistributed “net investment income,” in the case of estates and trusts) for each taxable year, with such tax applying to the lesser of such income or the excess of such person’s adjusted gross income (with certain adjustments) over a specified amount. The specified amount is $250,000 for married individuals filing jointly, $125,000 for married individuals filing separately, $200,000 for other individuals and the dollar amount at which the highest income tax bracket for estates and trusts begins. Net investment income includes net income from interest, dividends, annuities, royalties and rents and net gain attributable to the disposition of investment property. Special rules apply and certain elections are available for certain U.S. Holders that are subject to the 3.8% tax on net investment income and hold shares in a PFIC. Potential investors should consult with their own tax advisors regarding the application of the net investment income tax to them as a result of their investment in our ordinary shares.

 

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UNDERWRITING

Merrill Lynch, Pierce, Fenner & Smith Incorporated and Cowen and Company, LLC are acting as representatives of each of the underwriters named below. Subject to the terms and conditions set forth in an underwriting agreement among us and the underwriters, we will agree to sell to the underwriters, and each of the underwriters will agree, severally and not jointly, to subscribe from us, the number of ordinary shares set forth opposite its name below.

 

Underwriter   

Number of

Ordinary Shares

Merrill Lynch, Pierce, Fenner & Smith
Incorporated

  

Cowen and Company, LLC

  

Piper Jaffray & Co.

  

JMP Securities LLC

  
  

 

Total

  
  

 

Subject to the terms and conditions set forth in the underwriting agreement, the underwriters will agree, severally and not jointly, to subscribe for all of the ordinary shares sold under the underwriting agreement if any of these ordinary shares are subscribed for. If an underwriter defaults, the underwriting agreement will provide that the subscription commitments of the non-defaulting underwriters may be increased or the underwriting agreement may be terminated.

We will agree to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to make in respect of those liabilities.

The underwriters are offering the ordinary shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel, including the validity of the ordinary shares, and other conditions contained in the underwriting agreement, such as the receipt by the underwriters of officer’s certificates and legal opinions. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

Entities affiliated with Farallon, which hold more than 5% of our ordinary shares and are affiliates of a director nominee, have indicated an interest in purchasing up to an aggregate of $             million of our ordinary shares in this offering at the initial public offering price. However, because these indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, less or no shares to these entities, and such entities could determine to purchase more, less or no shares in this offering.

Commissions and Discounts

The representatives have advised us that the underwriters propose initially to offer the ordinary shares to the public at the initial public offering price set forth on the cover page of this prospectus and to dealers at that price less a concession not in excess of $                 per ordinary share. After the initial offering, the initial public offering price, concession or any other term of this offering may be changed.

The following table shows the initial public offering price, underwriting discount and proceeds before expenses to us. The information assumes either no exercise or full exercise by the underwriters of their option to subscribe for additional ordinary shares.

 

    

Per Share

    

Without Option

    

With Option

 

Public offering price

   $                    $                    $                

Underwriting discount

   $         $         $     

Proceeds, before expenses, to us

   $         $         $     

 

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The expenses of this offering, not including the underwriting discount, are estimated at $            , which includes an amount not to exceed $         that we have agreed to reimburse the underwriters for certain FINRA-related expenses incurred by them in connection with this offering.

Option to Subscribe for Additional Ordinary Shares

We have granted an option to the underwriters, exercisable for 30 days after the date of this prospectus, to subscribe for up to                      additional ordinary shares at the initial public offering price, less the underwriting discount. If the underwriters exercise this option, each will be obligated, subject to conditions contained in the underwriting agreement, to subscribe for a number of additional ordinary shares proportionate to that underwriter’s initial amount reflected in the above table.

No Sales of Similar Securities

We, our executive officers and directors and substantially all of our other existing security holders have agreed not to sell or transfer any ordinary shares or securities convertible into, exchangeable for, exercisable for, or repayable with ordinary shares, for 180 days after the date of this prospectus without first obtaining the written consent of Merrill Lynch, Pierce, Fenner & Smith Incorporated and Cowen and Company, LLC. Specifically, we and these other persons have agreed, with certain limited exceptions, not to directly or indirectly:

 

    offer, pledge, sell or contract to sell any ordinary shares;

 

    sell any option or contract to purchase any ordinary shares;

 

    purchase any option or contract to sell any ordinary shares;

 

    grant any option, right or warrant to purchase any ordinary shares;

 

    lend or otherwise dispose of or transfer any ordinary shares;

 

    request or demand that we file a registration statement related to the ordinary shares; or

 

    enter into any swap or other agreement that transfers, in whole or in part, the economic consequence of ownership of any ordinary shares whether any such swap or transaction is to be settled by delivery of ordinary shares or other securities, in cash or otherwise.

This lock-up provision applies to ordinary shares and to securities convertible into or exchangeable or exercisable for or repayable with ordinary shares. It also applies to ordinary shares owned now or acquired later by the person executing the agreement or for which the person executing the agreement later acquires the power of disposition.

Nasdaq Global Market Listing

We have applied to list our ordinary shares on the Nasdaq Global Market under the symbol “NVET.”

Before this offering, there has been no public market for our ordinary shares. The initial public offering price will be determined through negotiations between us and the representatives. In addition to prevailing market conditions, the factors to be considered in determining the initial public offering price are:

 

    the valuation multiples of publicly traded companies that the representatives believe to be comparable to us;

 

    our financial information;

 

    the history of, and the prospects for, our company and the industry in which we compete;

 

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    an assessment of our management, its past and present operations, and the prospects for, and timing of, our future revenue;

 

    the present state of our development; and

 

    the above factors in relation to market values and various valuation measures of other companies engaged in activities similar to ours.

An active trading market for the ordinary shares may not develop. It is also possible that after this offering the ordinary shares will not trade in the public market at or above the initial public offering price.

The underwriters do not expect to sell more than five percent of the ordinary shares in the aggregate to accounts over which they exercise discretionary authority.

Price Stabilization, Short Positions and Penalty Bids

Until the distribution of the ordinary shares is completed, SEC rules may limit underwriters and selling group members from bidding for and purchasing our ordinary shares. However, the representatives may engage in transactions that stabilize the price of the ordinary shares, such as bids or purchases to peg, fix or maintain that price.

In connection with this offering, the underwriters may purchase and sell our ordinary shares in the open market. These transactions may include short sales, purchases on the open market to cover positions created by short sales and stabilizing transactions. Short sales involve the sale by the underwriters of a greater number of ordinary shares than they are required to purchase in this offering. “Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional ordinary shares described above. The underwriters may close out any covered short position by either exercising their option to subscribe for additional ordinary shares or purchasing ordinary shares in the open market. In determining the source of ordinary shares to close out the covered short position, the underwriters will consider, among other things, the price of ordinary shares available for purchase in the open market as compared to the price at which they may purchase ordinary shares through the option granted to them. “Naked” short sales are sales in excess of such option. The underwriters must close out any naked short position by purchasing ordinary shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of our ordinary shares in the open market after pricing that could adversely affect investors who subscribed for ordinary shares in this offering. Stabilizing transactions consist of various bids for or purchases of ordinary shares made by the underwriters in the open market prior to the completion of this offering.

The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representatives have repurchased ordinary shares sold by or for the account of such underwriter in stabilizing or short covering transactions.

Similar to other purchase transactions, the underwriters’ purchases to cover the syndicate short sales may have the effect of raising or maintaining the market price of our ordinary shares or preventing or retarding a decline in the market price of our ordinary shares. As a result, the price of our ordinary shares may be higher than the price that might otherwise exist in the open market. The underwriters may conduct these transactions on the Nasdaq Global Market, in the over-the-counter market or otherwise.

Neither we nor any of the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our ordinary shares. In addition, neither we nor any of the underwriters make any representation that the representatives will engage in these transactions or that these transactions, once commenced, will not be discontinued without notice.

 

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Electronic Distribution

In connection with this offering, certain of the underwriters or securities dealers may distribute prospectuses by electronic means, such as e-mail.

Other Relationships

Some of the underwriters and their affiliates have engaged in, and may in the future engage in, investment banking and other commercial dealings in the ordinary course of business with us or our affiliates. They have received, or may in the future receive, customary fees and commissions for these transactions.

In addition, in the ordinary course of their business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers. Such investments and securities activities may involve securities and/or instruments of ours or our affiliates. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

Notice to Prospective Investors in the European Economic Area

In relation to each Member State of the European Economic Area, or a Relevant Member State, no offer of ordinary shares may be made to the public in that Relevant Member State other than:

 

    to any legal entity which is a qualified investor as defined in the Prospectus Directive;

 

    to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representatives; or

 

    in any other circumstances falling within Article 3(2) of the Prospectus Directive;

provided that no such offer of ordinary shares shall require us or the representatives to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.

Each person in a Relevant Member State who initially acquires any ordinary shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed that it is a “qualified investor” within the meaning of the law in that Relevant Member State implementing Article 2(1)(e) of the Prospectus Directive. In the case of any ordinary shares being offered to a financial intermediary as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the ordinary shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any ordinary shares to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or in circumstances in which the prior consent of the representatives has been obtained to each such proposed offer or resale.

We, the representatives and their affiliates will rely upon the truth and accuracy of the foregoing representations, acknowledgements and agreements.

This prospectus has been prepared on the basis that any offer of ordinary shares in any Relevant Member State will be made pursuant to an exemption under the Prospectus Directive from the requirement to

 

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publish a prospectus for offers of shares. Accordingly any person making or intending to make an offer in that Relevant Member State of shares which are the subject of this offering may only do so in circumstances in which no obligation arises for us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive in relation to such offer. Neither we nor the underwriters have authorized, nor do they authorize, the making of any offer of shares in circumstances in which an obligation arises for us or the underwriters to publish a prospectus for such offer.

For the purpose of the above provisions, the expression “an offer to the public” in relation to any shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase or subscribe the shares, as the same may be varied in the Relevant Member State by any measure implementing the Prospectus Directive in the Relevant Member State and the expression “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.

Notice to Prospective Investors in the United Kingdom

In addition, in the United Kingdom, this prospectus is being distributed only to, and is directed only at, and any offer subsequently made may only be directed at persons who are “qualified investors” (as defined in the Prospectus Directive) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, or the Order, and/or (ii) who are high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This prospectus must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this prospectus relates is only available to, and will be engaged in with, relevant persons.

Notice to Prospective Investors in Switzerland

The shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX, or on any other stock exchange or regulated trading facility in Switzerland. This prospectus has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this prospectus nor any other offering or marketing material relating to the shares or this offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this prospectus nor any other offering or marketing material relating to this offering, us or the shares has been or will be filed with or approved by any Swiss regulatory authority. In particular, this prospectus will not be filed with, and the offer of shares will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA, and the offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of shares.

Notice to Prospective Investors in the Dubai International Financial Centre

This prospectus relates to an Exempt Offer in accordance with the Offered Securities Rules of the Dubai Financial Services Authority, or DFSA. This prospectus is intended for distribution only to persons of a type specified in the Offered Securities Rules of the DFSA. It must not be delivered to, or relied on by, any other person. The DFSA has no responsibility for reviewing or verifying any documents in connection with Exempt Offers. The DFSA has not approved this prospectus nor taken steps to verify the information set forth herein and

 

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has no responsibility for the prospectus. The shares to which this prospectus relates may be illiquid and/or subject to restrictions on their resale. Prospective purchasers of the ordinary shares offered should conduct their own due diligence on the shares. If you do not understand the contents of this prospectus you should consult an authorized financial advisor.

Notice to Prospective Investors in Australia

No placement document, prospectus, product disclosure statement or other disclosure document has been lodged with the Australian Securities and Investments Commission, or ASIC, in relation to this offering. This prospectus does not constitute a prospectus, product disclosure statement or other disclosure document under the Corporations Act 2001, or the Corporations Act, and does not purport to include the information required for a prospectus, product disclosure statement or other disclosure document under the Corporations Act.

Any offer in Australia of the shares may only be made to persons, or the “Exempt Investors,” who are “sophisticated investors” (within the meaning of Section 708(8) of the Corporations Act), “professional investors” (within the meaning of Section 708(11) of the Corporations Act) or otherwise pursuant to one or more exemptions contained in Section 708 of the Corporations Act so that it is lawful to offer the shares without disclosure to investors under Chapter 6D of the Corporations Act.

The shares applied for by Exempt Investors must not be offered for sale in Australia in the period of 12 months after the date of allotment under this offering, except in circumstances (i) where disclosure to investors under Chapter 6D of the Corporations Act would not be required pursuant to an exemption under Section 708 of the Corporations Act or otherwise or (ii) where the offer is pursuant to a disclosure document which complies with Chapter 6D of the Corporations Act. Any person acquiring shares must observe such Australian on-sale restrictions.

This prospectus contains general information only and does not take account of the investment objectives, financial situation or particular needs of any particular person. It does not contain any securities recommendations or financial product advice. Before making an investment decision, investors need to consider whether the information in this prospectus is appropriate to their needs, objectives and circumstances, and, if necessary, seek expert advice on those matters.

Notice to Prospective Investors in Hong Kong

The shares have not been offered or sold and will not be offered or sold in Hong Kong, by means of any document, other than (i) to “professional investors” as defined in the Securities and Futures Ordinance (Cap. 571) of Hong Kong and any rules made under that Ordinance or (ii) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of that Ordinance. No advertisement, invitation or document relating to the shares has been or may be issued or has been or may be in the possession of any person for the purposes of issue, whether in Hong Kong or elsewhere, which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the Securities and Futures Ordinance and any rules made under that Ordinance.

Notice to Prospective Investors in Japan

The shares have not been and will not be registered under the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948, as amended) and, accordingly, will not be offered or sold, directly or indirectly, in Japan, or for the benefit of any Japanese Person or to others for re-offering or resale, directly or indirectly, in Japan or to any Japanese Person, except in compliance with all applicable laws, regulations and ministerial

 

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guidelines promulgated by relevant Japanese governmental or regulatory authorities in effect at the relevant time. For the purposes of this paragraph, “Japanese Person” shall mean any person resident in Japan, including any corporation or other entity organized under the laws of Japan.

Notice to Prospective Investors in Singapore

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor under Section 274 of the Securities and Futures Act, Chapter 289 of Singapore, or the SFA, (ii) to a relevant person pursuant to Section 275(1), or any person pursuant to Section 275(1A), and in accordance with the conditions specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA.

Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is:

 

  (a) a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or

 

  (b) a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor,

securities (as defined in Section 239(1) of the SFA) of that corporation or the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferred within six months after that corporation or that trust has acquired the shares pursuant to an offer made under Section 275 of the SFA except:

 

  (a) to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;

 

  (b) where no consideration is or will be given for the transfer;

 

  (c) where the transfer is by operation of law;

 

  (d) as specified in Section 276(7) of the SFA; or

 

  (e) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore.

 

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LEGAL MATTERS

The validity of the ordinary shares we are offering will be passed upon for us by ByrneWallace, Dublin, Ireland. Certain other legal matters relating to this offering will be passed upon for us by DLA Piper LLP (US), New York, New York. The underwriters are being represented by Cooley LLP, Palo Alto, California.

EXPERTS

The consolidated financial statements as of June 30, 2013 and 2014 and for each of fiscal years 2013 and 2014 included in this prospectus have been so included in reliance on the report of PricewaterhouseCoopers, Melbourne, Australia, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.

WHERE YOU CAN FIND MORE INFORMATION ABOUT US

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the ordinary shares being offered by this prospectus. This prospectus does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the ordinary shares offered by this prospectus, we refer you to the registration statement and its exhibits. Where we make statements in this prospectus as to the contents of any contract or any other document, for the complete text of that document, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.

You can read our SEC filings, including the registration statement of which this prospectus is a part, over the Internet at the SEC’s website at www.sec.gov. You may also read and copy any document we file with the SEC at its public reference facilities at 100 F Street, NE, Washington, DC 20549. You may also obtain copies of the document at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, NE, Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference facilities.

In connection with this offering, we will be subject to the information reporting requirements of the Exchange Act, and we will file reports, proxy statements and other information with the SEC. We also intend to furnish our shareholders with annual reports containing our consolidated financial statements audited by an independent public accounting firm. We maintain a website at www.nexvet.com. Information contained on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus and references to our website in this prospectus are inactive textual references only. Upon completion of this offering, you may access our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

Report of Independent Registered Public Accounting Firm

     F-2   

Consolidated Balance Sheets as of June 30, 2013 and 2014 and September 30, 2014 (unaudited)

     F-3   

Consolidated Statements of Operations and Comprehensive Loss for the years ended June  30, 2013 and 2014 and the three months ended September 30, 2013 and 2014 (unaudited)

     F-4   

Consolidated Statements of Changes in Convertible Preference Shares and Shareholders’ (Deficit) Equity for the years ended June 30, 2013 and 2014 and the three months ended September 30, 2014 (unaudited)

     F-5   

Consolidated Statements of Cash Flows for the years ended June  30, 2013 and 2014 and the three months ended September 30, 2013 and 2014 (unaudited)

     F-6   

Notes to Consolidated Financial Statements

     F-7   

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of Nexvet Biopharma public limited company,

We have audited the accompanying consolidated balance sheets of Nexvet Biopharma public limited company and its subsidiaries as of June 30, 2013 and 2014, and the related consolidated statements of operations and comprehensive loss, of changes in convertible preference shares and shareholders’ deficit, and of cash flows for each of the two years in the period ended June 30, 2014. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Nexvet Biopharma public limited company and its subsidiaries as of June 30, 2013 and 2014, and the results of their operations and their cash flows for each of the two years in the period ended June 30, 2014 in conformity with accounting principles generally accepted in the United States of America.

As discussed in Notes 1 and 16 of the consolidated financial statements, Nexvet Biopharma public limited company underwent a corporate reorganization by way of a share-for-share exchange and completed a share consolidation.

/s/ PricewaterhouseCoopers

Melbourne, Australia

September 4, 2014 (except for Notes 1 and 16, as to which the date is December 30, 2014)

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

CONSOLIDATED BALANCE SHEETS

 

    June 30,    

September 30,

2014

   

Pro Forma
September 30,
2014

 
        2013             2014          
         

(unaudited)

 
    (in thousands, except share and per share
amounts)
 

Assets

       

Current assets

       

Cash

  $ 483      $ 30,041      $ 26,388     

Other income receivable

    1,010        2,404        721     

Prepaid expenses and other

    374        643        1,003     
 

 

 

   

 

 

   

 

 

   

Total current assets

    1,867        33,088        28,112     
 

 

 

   

 

 

   

 

 

   

Property, plant and equipment, net

    47        514        626     

Intangible assets, net

    —          2        2     
 

 

 

   

 

 

   

 

 

   

Total assets

  $ 1,914      $ 33,604      $ 28,740     
 

 

 

   

 

 

   

 

 

   

Liabilities, Convertible Preference Shares and Shareholders’ Deficit

       

Current liabilities

       

Accounts payable

  $ 679      $ 870      $ 397     

Accrued expenses

    552        2,299        2,181     

Lease incentive liability

    —          28        26     
 

 

 

   

 

 

   

 

 

   

Total current liabilities

    1,231        3,197        2,604     
 

 

 

   

 

 

   

 

 

   

Lease incentive liability

    —          103        89     

Warrants

    —          5,435        —       
 

 

 

   

 

 

   

 

 

   

Total noncurrent liabilities

    —          5,538        89     
 

 

 

   

 

 

   

 

 

   

Total liabilities

  $ 1,231      $ 8,735      $ 2,693     
 

 

 

   

 

 

   

 

 

   

Commitments and contingencies (Note 14)

       

Convertible preference shares

       

SIRPS, $0.125 nominal value per share, 4,000,000 authorized—792,117 and 1,737,132 shares issued and outstanding as of June 30, 2013 and 2014, respectively, actual

  $ 3,597      $ 8,177      $ —        $ —     

Series B, $0.125 nominal value per share, 8,000,000 authorized—nil and 4,200,006 shares issued and outstanding as of June 30, 2013 and 2014, respectively,
actual

    —          25,649        —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Total convertible preference shares

  $ 3,597      $ 33,826      $ —        $ —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Shareholders’ (deficit) equity

       

Ordinary shares, $0.125 nominal value per share—20,000,000 shares authorized and 1,264,386, 1,268,810 and 1,142,858 shares issued and outstanding as of June 30, 2013 and 2014 and September 30, 2014 (unaudited), respectively, actual; 100,000,000 shares authorized and 7,079,996 shares issued and outstanding as of September 30, 2014, pro forma

  $ 124      $ 126      $ 142      $ 885   

Euro deferred shares, €100 nominal value per share, 400 authorized—nil, nil and 400 shares issued and outstanding as of June 30, 2013 and 2014 and September 30, 2014 (unaudited), respectively, actual; 400 shares issued and outstanding as of September 30, 2014, pro forma

    —          —          13        13   

Convertible preference shares

       

SIRPS, $0.125 nominal value per share, 4,000,000 authorized—1,737,132 shares issued and outstanding as of September 30, 2014 (unaudited), actual; nil shares issued and outstanding as of September 30, 2014, pro forma

    —          —          8,177        —     

Series B, $0.125 nominal value per share, 8,000,000 authorized—4,200,006 shares issued and outstanding as of September 30, 2014 (unaudited), actual; nil shares issued and outstanding as of September 30, 2014, pro forma

    —          —          25,649        —     

Additional paid-in capital

    1,979        2,342        7,929        41,012   

Accumulated other comprehensive income (loss)

    71        373        (1,768     (1,768

Accumulated deficit

    (5,088     (11,798     (14,095     (14,095
 

 

 

   

 

 

   

 

 

   

 

 

 

Total shareholders’ (deficit) equity

    (2,914     (8,957   $ 26,047      $ 26,047   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total liabilities, convertible preference shares and shareholders’ deficit

  $ 1,914      $ 33,604       
 

 

 

   

 

 

     

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

     Year Ended June 30,     Three Months Ended September 30,  
     2013     2014             2013                     2014          
                 (unaudited)  
     (in thousands, except share and per share amounts)  

Revenue

        

License and collaboration

   $ 244      $ —        $ —        $ —     

Other

     85        13        —          25   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     329        13        —          25   

Operating Expenses

        

Research and development

     2,722        5,617        1,240        2,539   

General and administrative

     2,103        4,426        568        2,818   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     4,825        10,043        1,808        5,357   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,496     (10,030     (1,808     (5,332

Other Income (Expense)

        

Research and development incentive income

     1,135        2,337        503        741   

Government grant income

     108        1,317        318        297   

Exchange (loss) gain

     —          (375     (30     1,984   

Interest income

     12        41        1        13   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (3,241   $ (6,710   $ (1,016   $ (2,297
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to ordinary shareholders, basic and diluted

   $ (3.62   $ (6.70   $ (1.02   $ (2.13
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average ordinary shares outstanding, basic and diluted

     894,794        1,000,872        1,000,000        1,078,166   
  

 

 

   

 

 

   

 

 

   

 

 

 

Pro forma net loss attributable to ordinary shareholders, basic and diluted

     $ (6,710     $ (2,297
    

 

 

     

 

 

 

Pro forma net loss per share attributable to ordinary shareholders, basic and diluted (unaudited)

     $ (2.07     $ (0.33
    

 

 

     

 

 

 

Pro forma weighted-average ordinary shares outstanding, basic and diluted (unaudited)

       3,242,004          7,015,321   
    

 

 

     

 

 

 

Comprehensive Loss

        

Net loss

   $ (3,241   $ (6,710   $ (1,016   $ (2,297

Net change in foreign currency translation adjustments

     58        302        205        (2,141
  

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

   $ (3,183   $ (6,408   $ (811   $ (4,438
  

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERENCE SHARES AND SHAREHOLDERS’ (DEFICIT) EQUITY

(in thousands, except share amounts)

 

    Convertible
Preference Shares
      Ordinary Shares       Ordinary Shares
    Subject to Limited    
Recourse Loans
    Euro Deferred
Shares
    Convertible
Preference Shares
   

Additional
Paid-in
Capital

   

Accumulated

Other
Comprehensive
Income (Loss)

   

Accumulated
Deficit

   

Total
Shareholders’
(Deficit) Equity

 
   

Shares

   

Amount

   

Shares

   

Amount

    Shares     Amount    

Shares

   

Amount

   

Shares

   

Amount

         

Balance as of July 1, 2012

    —        $ —          200,000      $ 25        —        $ —          —        $ —          —        $ —        $ (15   $ 13      $ (1,847   $ (1,824

Subdivision of shares

    —          —          265,455        33        —          —          —          —          —          —          (33     —          —          —     

Issuance of ordinary shares

    —          —          534,545        66        —          —          —          —          —          —          1,396        —          —          1,462   

Issuance of SIRPS convertible preference shares, nil issuance costs

    498,199        2,093        —          —          —          —          —          —          —          —          —          —          —          —     

Issuance of ordinary shares subject to limited recourse loans

    —          —          —          —          264,386        —          —          —          —          —          —          —          —          —     

Issuance of SIRPS convertible preference shares, nil issuance costs

    293,918        1,504        —          —          —          —          —          —          —          —          —          —          —          —     

Share-based compensation expense

    —          —          —          —          —          —          —          —          —          —          631        —          —          631   

Exchange difference on translation of foreign operations

    —          —          —          —          —          —          —          —          —          —          —          58        —          58   

Net loss

    —          —          —          —          —          —          —          —          —          —          —          —          (3,241     (3,241
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of June 30, 2013

    792,117      $ 3,597        1,000,000      $ 124        264,386      $ —          —        $ —          —        $ —        $ 1,979      $ 71      $ (5,088   $ (2,914
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Issuance of ordinary shares—payment of limited recourse loan

    —        $ —          9,706      $ 1        (9,706   $ —          —        $ —          —        $ —        $ 36      $ —        $ —        $ 37   

Issuance of ordinary shares

    —          —          4,424        1        —          —          —          —          —          —          21        —          —          22   

Issuance of SIRPS convertible preference shares, net of issuance costs of $294

    945,015        4,580        —          —          —          —          —          —          —          —          —          —          —          —     

Issuance of Series B convertible preference shares, net of issuance costs of $1,021

    4,200,006        25,649        —          —          —          —          —          —          —          —          —          —          —          —     

Share-based compensation expense

    —          —          —          —          —          —          —          —          —          —          306        —          —          306   

Exchange difference on translation of foreign operations

    —          —          —          —          —          —          —          —          —          —          —          302        —          302   

Net loss

    —          —          —          —          —          —          —          —          —          —          —          —          (6,710     (6,710
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of June 30, 2014

    5,937,138      $ 33,826        1,014,130      $ 126        254,680      $ —          —        $ —          —        $ —        $ 2,342      $ 373      $ (11,798   $ (8,957
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Issuance of ordinary shares and Euro deferred shares

    —        $ —          2      $ —          —        $ —          400      $ 13        —        $ —        $ —        $ —        $ —        $ 13   

Ordinary shares no longer subject to limited recourse loan

    —          —          109,611        14        (109,611     —          —          —          —          —          (14     —          —          —     

Share repurchase

    —          —          —          —          (145,069     —          —          —          —          —          —          —          —          —     

Issuance of share warrants

    —          —          —          —          —          —          —          —          —          —          5,435        —          —          5,435   

Issuance of ordinary shares—conversion of share-based compensation

    —          —          19,115        2        —          —          —          —          —          —          (2     —          —          —     

Reclassification into shareholders’ equity

    (5,937,138     (33,826     —          —          —          —          —          —          5,937,138        33,826        —          —          —          33,826   

Share-based compensation expense

    —          —          —          —          —          —          —          —          —          —          168        —          —          168   

Exchange difference on translation of foreign operations

    —          —          —          —          —          —          —          —          —          —          —          (2,141     —          (2,141

Net loss

    —          —          —          —          —          —          —          —          —          —          —          —          (2,297     (2,297
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance as of September 30, 2014

    —        $ —          1,142,858      $ 142        —        $ —          400      $ 13        5,937,138      $ 33,826      $ 7,929      $ (1,768   $ (14,095   $ 26,047   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     Year Ended June 30,     Three Months Ended
September 30,
 
     2013     2014     2013     2014  
          

(unaudited)

 
     (in thousands)  

Cash Flows from Operating Activities

        

Net loss

   $ (3,241   $ (6,710   $ (1,016   $ (2,297

Adjustments to reconcile net loss to cash used in operating activities:

        

Share-based compensation expense

     710        298        —          195   

Depreciation and amortization expense

     11        56        4        37   

Other

     —          22        —          —       

Changes in assets and liabilities:

        

Other income receivable

     (679     (1,338     (481     1,683   

Prepaid expenses and other

     (377     (250     141        (360

Accounts payable, accrued expenses and lease liability

     614        1,978        355        (607
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (2,962     (5,944     (997     (1,349
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Investing Activities

        

Purchase of property, plant and equipment

     (54     (512     (31     (185

Purchase of intangible assets

     —          (2     (1     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (54     (514     (32     (185
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Financing Activities

        

Proceeds from issuance of ordinary shares

     —          37        —          13   

Proceeds from issuance of convertible preference shares and warrants

     3,597        35,664        1,586        —     

Repayments of note payable to related party

     (205     —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by financing activities

     3,392        35,701        1,586        13   
  

 

 

   

 

 

   

 

 

   

 

 

 

Effect of exchange rate changes on cash

     88        315        53        (2,132
  

 

 

   

 

 

   

 

 

   

 

 

 

Net increase (decrease) in cash

     464        29,558        610        (3,653

Cash at beginning of year

     19        483        483        30,041   
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash at end of year

   $ 483      $ 30,041      $ 1,093      $ 26,388   
  

 

 

   

 

 

   

 

 

   

 

 

 

Supplemental Disclosure

        

Cash paid for interest during period

   $ 27      $ —        $ —        $ —     

Conversion of note payable into ordinary shares

     1,368        —          —          —     

Offering costs in connection with (convertible preference shares and warrants) recorded in equity

     —          1,315        110        —     

Issuance of share options for accrued consulting services

     —          22        —          102   

The accompanying notes are an integral part of these consolidated financial statements.

 

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NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1.    Organization and Description of Business

Nexvet Biopharma public limited company and its subsidiaries (the “Company”) is a clinical stage biopharmaceutical company focused on transforming the therapeutic market for companion animals by developing and commercializing novel, species-specific biologics based on human biologics. As a class, biologics, which include monoclonal antibodies (“mAbs”) and fusion proteins, have transformed human medicine in recent decades and represent some of the top-selling therapies on the market today. The Company’s proprietary platform, which it refers to as “PETization,” is an algorithmic approach that enables the Company to rapidly create mAbs that are designed to be recognized as “self” or “native” by an animal’s immune system, a property referred to as “100% species-specificity.” PETization is also designed to build upon the safety and efficacy data from clinically tested human therapies to create new therapies for companion animals, thereby reducing clinical risk and development cost. The Company’s first product candidate, NV-01, is a mAb that is a nerve growth factor inhibitor for the control of pain associated with osteoarthritis in dogs. The Company’s second product candidate, NV-02, is a mAb that is a nerve growth factor inhibitor for the control of pain associated with degenerative joint disease in cats. The Company expects data from its pivotal safety and efficacy studies for NV-01 by the end of 2015 and for NV-02 in 2016. The Company’s third product candidate, NV-08, is a fusion protein that is a tumor necrosis factor inhibitor for the treatment of chronic inflammatory diseases, including atopic dermatitis, in dogs. If its proof-of-concept safety and efficacy studies for NV-08 are successful, the Company will progress this product into formal development. Using PETization, the Company is seeking to advance one new product candidate into development per year commencing in the second half of 2015.

The Company has experienced losses since its inception and had an accumulated deficit of $5.1 million, $11.8 million and $14.1 million as of June 30, 2013 and 2014 and September 30, 2014, respectively. For the foreseeable future, management expects the Company to continue to incur losses and negative cash flows, which will increase significantly from historical levels as the Company expands its development activities, seeks regulatory approvals for its lead product candidates and begins to commercialize any approved products. To date, the Company has been funded primarily through sales of capital shares. Management believes the Company’s cash of $26.4 million as of September 30, 2014 will be sufficient to fund its operations for at least the next 12 months.

The Company will require additional capital until such time as the Company can generate revenue in excess of operating expenses. The Company may seek such funding through public or private equity, debt financing or other sources, such as corporate collaborations and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all. The sale of additional equity would result in additional dilution to the Company’s shareholders, and the terms of any financing may adversely affect the rights of the Company’s shareholders. The incurrence of any debt financing could result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict the Company’s operations. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs or commercialization efforts, which could adversely affect its business prospects.

In August 2014, the Company completed a one-for-four share consolidation. Each holder of ordinary shares and preference shares received one ordinary share or preference share for every four ordinary shares or preference shares held by such holder. The number of ordinary shares that may be acquired upon exercise of options or warrants or upon conversion of restricted share units was similarly reduced on a one-for-four basis, with a proportionate adjustment to the exercise or conversion price, as applicable.

 

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In September 2014, Nexvet Biopharma Limited, a newly-formed Irish private company, became the parent company of Nexvet Australia Pty Ltd, formerly known as Nexvet Biopharma Pty Ltd (“Nexvet Australia”), and its subsidiaries pursuant to a transaction in which all of the holders of ordinary shares, preference shares, restricted share units and options and warrants to purchase ordinary shares of Nexvet Australia exchanged their holdings for equivalent ordinary shares, preference shares, restricted share units or options or warrants to purchase ordinary shares, as applicable, of Nexvet Biopharma Limited. Nexvet Biopharma Limited then re-registered as an Irish public limited company in September 2014 (the “Irish Reorganization”). Nexvet Biopharma public limited company became the parent company of Nexvet Australia pursuant to the Irish Reorganization, and for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma public limited company and its subsidiaries as a continuation of the predecessor. The capital structure presented is that of Nexvet Biopharma public limited company.

In November 2014, the Company completed a four-for-five share consolidation. Each holder of ordinary shares and preference shares received four ordinary shares or four preference shares for every five ordinary shares or five preference shares held by such holder. The number of ordinary shares that may be acquired upon exercise of options or warrants or upon conversion of restricted share units was similarly reduced on a four-for-five basis, with a proportionate adjustment to the exercise or conversion price, as applicable.

2.    Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying consolidated financial statements of the Company include the operations of all its wholly-owned subsidiaries and have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Such operations include the Company, Nexvet Australia, NVIP Pty Limited, Nexvet UK Limited and Nexvet US, Inc. All intercompany balances and transactions have been eliminated in consolidation. The Company’s fiscal year ends on June 30, and references to any fiscal year are to the Company’s year ended June 30 in that year.

Unaudited Interim Financial Information

The accompanying interim consolidated financial statements and related disclosures as of September 30, 2014 and for the three months ended September 30, 2013 and 2014 are unaudited and have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2014 and the results of its operations and comprehensive loss and its cash flows for the three months ended September 30, 2013 and 2014. The financial data and other information disclosed in these notes related to the three months ended September 30, 2013 and 2014 are unaudited. The results for the three months ended September 30, 2013 and 2014 are not necessarily indicative of results to be expected for fiscal year 2015, any other interim periods or any future year or period.

Use of Estimates

The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the period. Significant items subject to such estimates and assumptions include research and development incentive income, research and development accruals, share-based payments, intangibles, valuation of warrants, options and restricted share units and deferred income taxes. Actual results could differ from those estimates.

 

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Unaudited Pro Forma Information

The Company’s board of directors has authorized the confidential submission of a registration statement on Form S-1 with the U.S. Securities and Exchange Commission in connection with a proposed initial public offering. If the offering is consummated, all outstanding convertible preference shares will automatically convert into ordinary shares on a one-for-one basis. The accompanying unaudited pro forma balance sheet as of September 30, 2014 has been prepared to give effect to the automatic conversion of all outstanding preference shares into 5,937,138 ordinary shares as though the proposed initial public offering had occurred on September 30, 2014.

In the accompanying statements of operations and comprehensive loss, pro forma basic and diluted net loss per share attributable to ordinary shareholders for fiscal year 2014 and for the three months ended September 30, 2014 have been prepared to give effect to the automatic conversion of all outstanding convertible preference shares into ordinary shares, as though the proposed initial public offering had occurred at the beginning of the period presented or the issuance date of the convertible preference shares, if later.

Net Loss Per Share

Net loss per share information is determined using the two-class method, which includes the weighted-average number of ordinary shares outstanding during the period and other securities that participate in dividends (a participating security). The Company’s convertible preference shares are participating securities as defined by Accounting Standards Codification (“ASC”) Topic 260-10, Earnings Per Share. Net loss per share disclosures for all periods have been revised to give effect to the one-for-four share consolidation that took place in August 2014 and the four-for-five share consolidation that took place in November 2014.

Under the two-class method, basic net loss per share applicable to ordinary shareholders is computed by dividing the net loss applicable to ordinary shareholders by the weighted-average number of shares of ordinary shares outstanding for the reporting period.

Diluted net loss per share gives effect to all potentially dilutive securities, including convertible preference shares and shares issuable upon the exercise or conversion, as applicable, of outstanding warrants, share options and restricted share units, using the treasury shares method. For fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, the Company has excluded the effects of all potentially dilutive shares, which include convertible preference shares, warrants to purchase ordinary shares, ordinary share options, restricted share units and the ordinary shares issued subject to limited recourse loans, from the weighted-average number of ordinary shares outstanding as their inclusion in the computation for all periods would be anti-dilutive due to net losses.

Cash

As of June 30, 2013 and 2014 and September 30, 2014, the Company’s cash consisted of cash deposited in a business operating account or in short-term deposit accounts of less than 90 days’ duration.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company receives license and collaboration revenue from a single customer. The Company also receives research and development incentive income and grants from the Australian government.

The Company’s cash is deposited with several large commercial banks located in the United States and Australia that are federally insured or guaranteed, limiting the amount of credit exposure to any one financial institution. The Company’s cash balances with these financial institutions often exceed the amount insured.

 

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The Company is subject to risks common to companies in the biotechnology industry. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, any products developed may not obtain necessary government regulatory approval and any approved products may not be commercially viable. The Company operates in an environment of substantial competition from other animal health companies, some of which have substantially more resources at their disposal. In addition, the Company is dependent upon the services of its employees and consultants, as well as third-party contract research organizations and manufacturers.

Fair Value Measurements

The Company records certain assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements. As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value.

 

    Level 1—Unadjusted quoted prices in active, accessible markets for identical assets or liabilities.

 

    Level 2—Other inputs that are directly or indirectly observable in the marketplace.

 

    Level 3—Unobservable inputs that are supported by little or no market activity.

The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

The Company’s material financial instruments include cash, other income receivables, accrued liabilities and warrants. The carrying amounts of these instruments are considered to be representative of their respective fair values because of the short-term nature of those investments. The Company has determined its warrants liability to be Level 3 fair value measurement.

Other Income Receivable

Other income receivable is recorded at the invoiced amount where available.

Nexvet Australia is eligible under the AusIndustry research and tax development tax incentive program to obtain a cash amount from the Australian Taxation Office (“ATO”). The tax incentive is available to Nexvet Australia on the basis of specific criteria with which Nexvet Australia must comply. Specifically, Nexvet Australia must have revenue of less than A$20 million and cannot be controlled by income tax exempt entities. Tax incentives are classified as other income receivables and were $1.0 million, $2.4 million and $0.7 million for fiscal years 2013 and 2014 and the three months ended September 30, 2014, respectively.

Property, Plant and Equipment

Property, plant and equipment are recorded at acquisition cost, net of accumulated depreciation and impairment. Depreciation on property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful life of machinery and equipment is three to 20 years. Leasehold improvements are amortized on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Upon retirement or sale of an asset, its cost and related accumulated depreciation or accumulated amortization are removed from the property accounts and any gain or loss is included in the results of operations. Maintenance and repairs are expensed as incurred.

 

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Intangible Assets

The Company accounts for intangible assets under ASC 350, Intangibles—Goodwill and Other, which consists of internal use computer software costs. Costs which include acquiring off the shelf software and licenses that are expected to provide future period financial benefits are capitalized to computer software intangibles. No material internal or external costs are incurred in making the software ready for use. Maintenance costs are expensed as incurred. Amortization is calculated on a straight-line basis over periods ranging from one to three years.

Impairment of Long-Lived Assets

The Company reviews its tangible and intangible assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of the asset may not be fully recoverable. Recoverability of assets is measured by a comparison of the carrying amount of an asset to the estimated undiscounted cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge will be recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. There were no impairments of long-lived assets during fiscal years 2013 or 2014 or during the three months ended September 30, 2013 or 2014.

Foreign Currency

Items included in the Company’s consolidated financial statements are measured using the currency of the primary economic environment in which the Company operates, referred to as the functional currency. Financial statements of companies operating outside the United States generally are measured using the local currency as the functional currency. Adjustments to translate those statements into United States dollars are recorded in other comprehensive income (loss) (“OCI”) as a net change in foreign currency translation. Non-cash currency translation adjustments in accumulated OCI were a gain of $0.1 million, $0.3 million and $0.2 million as of June 30, 2013 and 2014 and September 30, 2013, respectively, and a loss of $2.1 million as of September 30, 2014, and primarily relate to translation of U.S. dollar-denominated bank accounts from Nexvet Australia’s Australian dollar functional currency to U.S. dollars.

Foreign currency transactions are translated into the functional currency using the current exchange rate. For assets and liabilities, the exchange rate at the balance sheet date is used. For revenue and expenses and gains and losses, a weighted-average exchange rate for the period is used to translate those elements. The reporting currency of these consolidated financial statements is U.S. dollars. Losses from foreign currency translation for fiscal years 2013 and 2014 and the three months ended September 30, 2013 were nil, $0.4 million and $30,000, respectively, and gain from foreign currency translation for the three months ended September 30, 2014 was $2.0 million. These losses and gain relate to a translation of U.S. dollar-denominated bank accounts into the Company’s Australian dollar functional currency and are included in other income (expense).

Under U.S. GAAP, there is no offset of these two exchange-related items within the consolidated statements of operations and comprehensive loss. Net loss and associated calculations are impacted by this treatment.

Warrants

The Company’s liabilities primarily consist of warrants that were issued to investors and financial advisors in connection with private placements of the Company’s securities in May 2014. The warrants permit the holders to purchase ordinary shares at exercise prices of $8.625 and $7.50 per share on or before May 2019. Because the warrants may be net exercised and are exercisable in U.S. dollars, and the functional currency of Nexvet Australia, the original issuer of the warrants, is Australian dollars, they were classified as a liability as of June 30, 2014 and were reclassified as shareholders’ equity in September 2014 following the Irish Reorganization (in which the original warrants were exchanged for warrants issued by the Company) and the change in the functional currency of the Company to U.S. dollars.

 

 

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Warrants recorded as liabilities ($5.4 million as of June 30, 2014) are valued at fair value using the binomial option-pricing model. The expected term used in the model has been adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions and behavioral considerations. At each balance sheet date, the outstanding warrants are revalued to their current fair value, with the difference in fair value recorded in the consolidated statements of operations and comprehensive loss.

Warrants are classified within Level 3 of the fair value hierarchy wherein fair value is estimated using significant unobservable inputs. The significant assumptions used in estimating the fair value of the warrants include the estimated fair value of the underlying shares, exercise price, volatility of the shares underlying the warrant and the expected term of the warrant. The fair value of the underlying ordinary shares was estimated by reference to the price per share paid by investors for the Company’s Series B preference shares in May 2014. The fair values of the warrants were estimated using the following assumptions:

 

    

June 30,
2014

Fair value per ordinary share

   $6.35

Risk free interest rate

   1.7%

Expected term (in years)

   4 years

Expected volatility

   75%

Expected dividend yield

   Nil

There were no warrants issued during fiscal year 2013. There were warrants to purchase 1,766,998 ordinary shares issued during fiscal year 2014 and no warrants issued during the three months ended September 30, 2014.

The Company reclassified the warrants to shareholders’ (deficit) equity in September 2014 following the Irish Reorganization and the change in the Company’s functional currency to U.S. dollars.

Income Taxes

The Company has historically filed income tax returns in Australia and has not been required to file income tax returns in any other jurisdiction.

The Company applies ASC Topic 740, Income Taxes, which establishes financial accounting and reporting requirements for the effects of income taxes that result from the Company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities on their respective tax bases, and operating losses and tax loss carry forwards. Deferred tax assets and liabilities are measured using enacted statutory tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date.

When the Company determines that it is more likely than not that some portion or all of the deferred tax assets will not be realized in the future, the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that the Company determines is more likely than not to be realized.

License and Collaboration Agreement Revenue Recognition

License and collaboration revenue was $0.2 million for fiscal year 2013 and was nil for each of fiscal year 2014 and the three months ended September 30, 2013 and 2014. Future revenue under a license and collaboration agreement is expected to consist of fees for services, royalties for product sales or payments when specific milestones are met and match underlying activities occurring during the term of the arrangement.

 

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In fiscal year 2013, the Company entered into a license and collaboration agreement with a third party for the research and development of animal health products in Japan. The terms of the agreement include non-refundable signing and license fees, development milestone payments, the potential for manufacturing and supply services and royalties on any product sales derived from the collaboration. The Company analyzed this arrangement to determine whether the deliverables, which included license and performance obligations such as research and steering committee services, can be separated or whether these must be accounted for as a single unit of accounting. The Company recognizes license payments as revenue upon delivery of the license only if the license has stand-alone value and there are no undelivered performance obligations related to the license. During fiscal year 2013, the Company recorded one up-front payment totaling $0.2 million in association with a license and collaboration agreement, since the license was transferred to the counter-party and had stand-alone value.

If the license is considered not to have stand-alone value, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations would be recognized as revenue over the estimated period of when the performance obligations are performed. When the Company determines that an arrangement should be accounted for as a single unit of accounting, it determines the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a proportional performance or straight-line method. The Company recognizes revenue using the proportional performance method when the level of effort required to complete its performance obligations under an arrangement can be reasonably estimated, and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measurement of performance. If the Company cannot reasonably estimate the level of effort to complete its performance obligations under an arrangement, then revenue under the arrangement would be recognized on a straight-line basis over the period the Company is expected to complete its performance obligations.

The Company’s license and collaboration agreement entitles it to additional payments upon the achievement of performance-based milestones. Milestones that involve substantial effort on the Company’s part are considered “substantive milestones.” A substantive milestone is included in the Company’s revenue model when the milestone is achieved. Revenue recognized under this model is limited to the amount of cash received or to which the Company is entitled. To date, no milestone payments have been received, since proof-of-concept has not yet been achieved.

Royalty revenue is recognized upon the sale of the related products, provided the Company has no remaining performance obligations under the arrangement.

Research and Development Expense

Research and development costs are expensed as incurred and consist primarily of (i) payroll and related expense for all employees engaged in scientific research and development functions, including wages, related benefits, and share-based compensation, (ii) fees for regulatory, professional and other consultants and (iii) development costs, including costs of drug discovery, safety, and proof-of-concept and pivotal safety and efficacy studies, development of biological materials, and service providers. The Company is currently pursuing its NV-01, NV-02 and NV-08 lead product candidates and typically uses its employee and infrastructure resources across multiple development programs. The Company tracks outsourced development costs by lead product candidates but does not allocate personnel or other internal costs related to development to specific product candidates.

General and Administrative Expense

General and administrative expense consists primarily of non-research and development-related payroll and related expense for employees, consultants and directors, including wages, related benefits and share-based compensation. General and administrative expense also includes professional and consulting fees for legal, accounting, tax services and other general business services, as well other expenses such as travel, rent and facilities costs.

 

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Other Income (Expense)

Nexvet Australia is eligible under the AusIndustry research and development tax incentive program to obtain a cash amount from the ATO. The tax incentive is available to Nexvet Australia on the basis of specific criteria with which Nexvet Australia must comply. Although the tax incentive is administered through the ATO, the Company has accounted for the tax incentive outside the scope of ASC Topic 740, Income Taxes, as an income tax benefit since Nexvet Australia meets the applicable requirements to participate in the program and the incentive is not linked to Nexvet Australia’s income tax liability and can be realized regardless of whether Nexvet Australia has generated taxable income. Research and development incentive income is recognized when the research and development activities have been undertaken and the Company has completed its assessment of whether such activities meet the relevant qualifying criteria.

The Company recognizes government grant income at the fair value of the grant when it is received and all substantive conditions have been satisfied. When the grant relates to an expense item, it is recognized as income over the periods necessary to match the grant on a systematic basis to the costs that it is intended to compensate.

Exchange (loss) gain consists primarily of gains or losses due to foreign exchange translation, primarily reflecting changes in Australian and U.S. foreign exchange rates. Under U.S. GAAP, these losses relate to a translation of U.S. dollar-denominated bank accounts into Nexvet Australia’s Australian dollar functional currency and represent a non-cash item.

Comprehensive Loss

Comprehensive loss is defined as the total change in shareholders’ deficit during the period other than from transactions with shareholders, which for the Company, includes net change in foreign currency translation adjustments.

Share-Based Compensation

The Company’s share-based compensation plan (see Note 12) provides for the grant of share options, restricted share units and other share-based awards. The fair value of share options is determined as of the date of grant using the binomial option-pricing model. This method incorporates the fair value of the Company’s ordinary shares at the date of each grant and various assumptions such as the risk-free interest rate, expected volatility based on the historic volatility of peer companies, expected dividend yield, and expected term of the share option. Restricted share units are valued at the fair value of the underlying ordinary shares as of the date of grant. To date, the Company has granted options to purchase ordinary shares with an exercise price of their nominal value of $0.125 per ordinary share and restricted share units to acquire ordinary shares with a conversion price of the nominal value of $0.125 per ordinary share on the date of grant. The Company classifies share-based compensation expense in the statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified.

Equity instruments issued to non-employees, including consultants, are accounted for in accordance with Financial Accounting Standards Board (“FASB”) guidance. All transactions in which services are the consideration received for the issuance of equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. The measurement date of the fair value of the equity instrument issued is the earlier of the date on which the counterparty’s performance is complete or the date on which it is probable that performance will occur.

For transactions where the fair value of the equity instrument issued to non-employees is the more reliable measurement and a measurement date has not been reached, the fair value is re-measured at each balance sheet date using the binomial option-pricing model. Compensation expense for these share-based awards is recognized over the term of the consulting agreement or until the award is approved and settled. All such services were provided in fiscal year 2014 or 2015.

 

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Segment Data

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is a clinical stage biopharmaceutical company focusing on developing therapies for companion animals. As of June 30, 2014 and September 30, 2014, all major assets were held in Australia.

Recently Adopted Accounting Pronouncements

The Company has early adopted the provisions of ASU 2014-10, Elimination of Certain Financial Requirements, Including an Amendment to Variable Interest Entities Guidance Topic in Topic 810, Consolidation, starting in fiscal year 2014. In June 2014, the FASB issued guidance removing the definition of a development stage entity from the Master Glossary of the ASC, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. This guidance also eliminates an exception provided to development stage entities in ASC Topic 810, Consolidation, for determining whether an entity is a variable interest entity on the basis of the amount of the investment equity that is at risk. On adoption, the Company was not required to present or disclose any information required by ASC Topic 915, Development Stage Entities.

Recently Issued Accounting Pronouncements

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers. This guidance requires an entity to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about:

 

    Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations).

 

    Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations.

 

    Certain assets—assets recognized from the costs to obtain or fulfill a contract.

This guidance will be effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. The Company is currently evaluating the impact that this guidance will have on the Company’s consolidated results of operations, financial position and cash flows.

In June 2014, the FASB issued ASU 2014-12, Compensation—Stock Compensation. This guidance requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. A reporting entity should apply the existing guidance in ASC Topic 718, Compensation-Stock Compensation, as it relates to awards with performance conditions that affect vesting to account for such awards. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. If the performance target becomes probable of being achieved before the end of the requisite service period, the remaining unrecognized compensation cost should be recognized prospectively over the remaining requisite service period. The total amount of compensation cost

 

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recognized during and after the requisite service period should reflect the number of awards that are expected to vest and should be adjusted to reflect those awards that ultimately vest. The requisite service period ends when the employee can cease rendering service and still be eligible to vest in the award if the performance target is achieved. This guidance will be effective for annual reporting periods beginning after December 15, 2015. The Company is currently evaluating the impact that this guidance will have on the Company’s consolidated results of operations, financial position and cash flows.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40). This guidance defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures. Under the guidance, management is required to evaluate, for each annual and interim reporting period, whether it is probable that the entity will not be able to meet its obligations as they become due within one year after the date that the financial statements are issued or are available to be issued. When management identifies substantial doubt about the entity’s ability to continue as a going concern, additional disclosures are required. This guidance will be effective for annual reporting periods beginning after December 15, 2016. The Company does not expect the adoption of this guidance to have a material impact on the Company’s financial condition, results of operations or cash flows.

3.    Property, Plant and Equipment

Property, plant and equipment, net consisted of the following as of the dates indicated:

 

    

Useful Lives

   June 30,     September 30,
2014
 
        2013     2014    
                (unaudited)  
     (in years)    (in thousands)  

Computer equipment

   3-7    $ 3      $ 68      $ 78   

Other equipment

   4      21        43        40   

Research and development equipment

   5-10      26        199        354   

Office equipment

   5-20      8        100        92   

Leasehold improvements

   5      —          162        150   

Less: Accumulated depreciation and amortization

        (11     (58     (88
     

 

 

   

 

 

   

 

 

 

Property, plant and equipment, net

      $ 47      $ 514      $ 626  
     

 

 

   

 

 

   

 

 

 

Depreciation expense was $10,000, $45,000, $4,000 and $29,000 for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively. Amortization expense was nil, $11,000, nil and $8,000 for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively.

4.    Intangible Assets

Intangible assets, net consisted of the following as of the dates indicated:

 

     Useful Lives    June 30,      September 30,
2014
 
        2013      2014     
                        (unaudited)  
     (in years)    (in thousands)  

Computer software

   1-3    $ —         $ 2       $ 2   

Less: Accumulated amortization

        —           —           —     
     

 

 

    

 

 

    

 

 

 

Intangible assets, net

      $ —         $ 2       $ 2   
     

 

 

    

 

 

    

 

 

 

Intangible assets will be fully amortized over their useful lives.

 

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5.    Accrued Expenses

Accrued expenses consisted of the following as of the dates indicated:

 

     June 30,      September 30,
2014
 
     2013      2014     
                   (unaudited)  
     (in thousands)  

Accrued payroll and related expenses

   $ 73       $ 502       $ 397   

Accrued professional fees

     83         355         581   

Accrued research and development costs

     396         1,442         1,203   
  

 

 

    

 

 

    

 

 

 

Accrued expenses

   $ 552       $ 2,299       $ 2,181   
  

 

 

    

 

 

    

 

 

 

6.    Lease Incentive Liability

Lease incentive liability consisted of the following as of the dates indicated:

 

     June 30,      September 30,
2014
 
     2013      2014     
                   (unaudited)  
     (in thousands)  

Current

   $ —         $ 28       $ 26   
  

 

 

    

 

 

    

 

 

 

Non-Current

   $ —         $ 103       $ 89   
  

 

 

    

 

 

    

 

 

 

In June 2014, a build-out incentive was recorded based on the agreement with the landlord to reimburse the Company for the build-out of the Company’s Melbourne, Australia office space. The Company expects to offset such amounts within rental expense over the lease term.

7.    Warrants

 

     June 30,      September 30,
2014
 
     2013      2014     
                   (unaudited)  
     (in thousands)  

Warrants

   $ —         $ 5,435       $ —     
  

 

 

    

 

 

    

 

 

 

In May 2014, the Company issued warrants to purchase 1,574,998 ordinary shares to purchasers of its Series B preference shares with an exercise price of $8.625 per share. In addition, the Company issued warrants to purchase 192,000 ordinary shares to financial advisors with an exercise price of $7.50 per share.

All warrants have a five year contractual life, are exercisable in U.S. dollars and are revalued to fair value at each balance sheet date using the appropriate exchange rate.

 

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8.    Convertible Preference Shares

The Company has issued Series A investment preference shares (“SIRPS Preference Shares”) and Series B convertible preference shares (“Series B Preference Shares”) (collectively, the “Preference Shares”). The Company’s Memorandum and Articles of Association authorize 12,000,000 Preference Shares with a nominal value of $0.125 per Preference Share.

Preference Shares consisted of the following as of June 30, 2013 and 2014 and September 30, 2014 (unaudited):

 

June 30, 2013

   Preference
Shares
Issued and
Outstanding
     Liquidation
Preference
     Carrying
Value
 
            (in thousands)  

SIRPS preference shares

     792,117       $ 7,194       $ 3,597   
  

 

 

    

 

 

    

 

 

 

 

June 30, 2014

   Preference
Shares
Issued and
Outstanding
     Liquidation
Preference
     Carrying
Value
 
            (in thousands)  

SIRPS preference shares

     1,737,132       $ 16,353       $ 8,177   

Series B preference shares

     4,200,006         51,298         25,649   
  

 

 

    

 

 

    

 

 

 
     5,937,138       $ 67,651       $ 33,826   
  

 

 

    

 

 

    

 

 

 

 

September 30, 2014

   Preference
Shares
Issued and
Outstanding
     Liquidation
Preference
     Carrying
Value
 
            (in thousands)  

SIRPS preference shares

     1,737,132       $ 16,353       $ 8,177   

Series B preference shares

     4,200,006         51,298         25,649   
  

 

 

    

 

 

    

 

 

 
     5,937,138       $ 67,651      $ 33,826  
  

 

 

    

 

 

    

 

 

 

Following changes to redemption criteria of the Preference Shares in August 2014, the Preference Shares have been reclassified into shareholders’ equity.

Voting Rights

Each Preference Share is entitled to the number of votes equal to the number of ordinary shares into which the Preference Share could be converted as of the applicable record date. Holders of Preference Shares have the same rights to receive notices to vote at general meetings of the Company as if they were holders of ordinary shares.

Dividends

Subject to preferences that may be attributable to any then outstanding Preference Shares, the holders of such Preference Shares are entitled to receive dividends, if any, as may be declared by the Company’s board of directors out of legally available funds.

Liquidation Preference

In the event of any liquidation or winding up of the Company, whether voluntary or involuntary, that does not follow a trade sale (being a sale of the main operating subsidiaries, all or a substantial part of the

 

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Company’s business, or all or substantially all of the assets of the Company) (each, a “Liquidating Event”), each holder of Preference Shares then outstanding shall be paid a liquidation preference per share, prior and in preference to any distribution of any of the assets or surplus funds of the Company to the holders of ordinary shares. The liquidation preference of each SIRPS Preference Share equals the issue price of each share multiplied by two plus any declared but unpaid dividends in respect of that SIRPS Preference Share. The liquidation preference for each Series B Preference Share is equal to its issue price multiplied by two, plus eight percent of its issue price per annum, compounded quarterly (such amount only payable and accumulating starting from October 1, 2015), plus any declared but unpaid dividends with respect to the Series B Preference Shares. If, upon the occurrence of a Liquidating Event, the assets and funds thus distributed among the holders of the Preference Shares are insufficient to permit the payment to such holders of the full liquidation preference, then the entire assets and funds to the Company legally available for distribution shall be distributed pro rata among the holders of the then outstanding Preference Shares on an equal priority, pari passu basis, according to their respective liquidation preferences.

After payment to the holders of the Preference Shares of the liquidation preference, the entire remaining assets and funds of the Company legally available for distribution, if any, shall be distributed among the holders of the ordinary shares with the Preference Shares participating pro rata with the ordinary shareholders on an as-converted basis.

A liquidation or winding up of the Company shall be deemed to be occasioned by, or to include the Company’s sale of its main operating subsidiaries, all or a substantial part of the business or all or substantially all of its assets, the appointment of a receiver, manager, administrator, trustee or similar official over the Company or any of its assets, the Company’s suspension of payment of its debts generally or inability to pay its debts when they become due, or other insolvency events.

Conversion

Holders of Preference Shares may at any time in their discretion convert all or part of their Preference Shares into ordinary shares by written notice to the Company specifying the number of shares to be converted.

The Company must convert the SIRPS Preference Shares at the applicable conversion ratio, which is determined by dividing the issue price for the SIRPS Preference Share by the conversion price. The conversion price for a SIRPS Preference Share means the issue price for that SIRPS Preference Share subject to anti-dilution adjustments.

The Company must convert the Series B Preference Shares at the applicable conversion ratio, which is determined by dividing the Series B Preference Share conversion amount by the conversion price. The conversion price equals the issue price for the Series B Preference Share as subject to anti-dilution adjustments. The Series B Preference Share conversion amount equals the issue price, plus eight percent of the issue price per annum, compounded quarterly (such amount only payable and accumulating starting from October 1, 2015) plus any accrued but unpaid dividends with respect to the Series B Preference Shares.

Each SIRPS Preference Share will automatically be converted into ordinary shares on: (i) completion of an initial public offering; (ii) completion of the sale of all of the shares in the Company, including a trade sale; (iii) a return of capital by the Company; or (iv) a transfer or exchange of all or substantially all of the assets of the Company, except for a license of intellectual property rights.

Each Series B Preference Share will automatically be converted into ordinary shares: (i) on completion of a qualifying initial public offering (which is an underwritten initial public offering on the Nasdaq Stock Market which results in gross proceeds to the Company of at least $40.0 million and priced at a price per share of not less than two times the then applicable Series B Preference Share conversion price); (ii) on completion of an initial public offering that is not a qualifying initial public offering if such initial public offering is approved by

 

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holders of not less than 50.1% of the Series B Preference Shares; (iii) on the completion of the sale of all of the shares in the Company where the holders of Series B Preference Shares would receive an amount not less than the Series B liquidation preference; or (iv) if approved by holders representing 75% of the Series B Preference Shares.

Redemption Rights

Since August 2014, there have been no redemption rights afforded to the holders of the Preference Shares. Accordingly, due to the lack of redemption features, such amounts have been reclassified from mezzanine to shareholders’ (deficit) equity. Prior to August 2014, upon certain insolvency and other events, the holders of the Preference Shares could require its redemption. Therefore, the Preference Shares were classified outside of shareholders’ deficit in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities.

Split or Reconstruction

If the capital in the Company is subject to a split, reconstruction or any other event that increases the total share capital, the Company must make adjustment to the conversion ratio, the conversion price or the numbers of Preference Shares to give full effect to the event while maintaining parity between the holders of the Preferred Shares and other shareholders of the Company.

Registration Rights

If the Company undertakes a qualifying initial public offering or other initial public offering in the United States, each holder of Series B Preference Shares will have the right to enter into an agreement with the Company that would grant the holder of the Series B Preference Shares registration rights.

9.    Ordinary Shares

The Company’s Memorandum and Articles of Association authorize 20,000,000 ordinary shares with a $0.125 nominal value per ordinary share. As of June 30, 2013 and 2014, there were 1,264,386 and 1,268,810 ordinary shares outstanding, respectively, which included 264,386 and 254,680 ordinary shares subject to limited recourse loans, respectively. As of September 30, 2013 and 2014, there were 1,264,386 and 1,142,858 ordinary shares outstanding, respectively, which included 264,386 and nil ordinary shares subject to limited recourse loans, respectively. The terms, rights, preferences and privileges of the ordinary shares are as follows:

Voting Rights

Each holder of ordinary shares is entitled to one vote for each ordinary share held on all matters submitted to a vote of the shareholders, including the election of directors. The Company’s Memorandum and Articles of Association do not provide for cumulative voting rights.

Dividends

Subject to preferences that may be attributable to any then outstanding Preference Shares, the holders of the Company’s outstanding ordinary shares are entitled to receive dividends, if any, as may be declared by the Company’s board of directors out of legally available funds.

Liquidation

In the event of the Company’s liquidation, dissolution or winding up, holders of ordinary shares will be entitled to share ratably in the net assets legally available for distribution to shareholders after the payment of all the Company’s debts and other liabilities, subject to satisfaction of the liquidation preferences granted to the holders of any outstanding Preference Shares.

 

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Rights and Preference

Before issuing shares or options to any person, the Company must offer to issue them to existing holders. Otherwise, holders of the Company’s ordinary shares have no preemptive, conversion or subscription rights, and there is no redemption or other related provisions attributable to ordinary shares. The rights, preferences and privileges of the holder of ordinary shares are subject to, and may be adversely affected by, the rights of the holders of shares of any series of Preference Shares that may be issued.

10.    Fair Value Measurement

Assets and liabilities carried at fair value on a recurring basis as of June 30, 2013 and 2014 and September 30, 2014, including financial instruments which the Company accounts for under the fair value option, are summarized in the following tables.

 

June 30, 2013

   Level 1      Level 2      Level 3      Assets/
Liabilities at
Fair Value
 
     (in thousands)  

Assets

           

Cash

   $ 483       $ —         $ —         $ 483   

June 30, 2014

                           

Assets

           

Cash

   $ 30,041       $ —         $ —         $ 30,041   

Liabilities

           

Warrants

     —           —           5,435         5,435   

September 30, 2014 (unaudited)

                           

Assets

           

Cash

   $ 26,388       $ —         $ —         $ 26,388   
  

 

 

    

 

 

    

 

 

    

 

 

 

During fiscal years 2013 and 2014 and the three months ended September 30, 2014, there were no transfers between the levels.

The following table present a reconciliation of all assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) as of June 30, 2013 and 2014 and September 30, 2014 (unaudited), including net realized and unrealized gains (losses) included in earnings and accumulated OCI.

 

Warrants (in thousands)

      

Balance as of June 30, 2012

   $ —     

Issuances

     —     
  

 

 

 

Balance as of June 30, 2013

     —     

Issuances

     5,435   
  

 

 

 

Balance as of June 30, 2014

     5,435   

Reclassification into shareholders’ equity

     (5,435
  

 

 

 

Balance September 30, 2014

   $ —     
  

 

 

 

The following table present information about significant unobservable inputs related to the Company’s material categories of Level 3 assets and liabilities as of June 30, 2014.

 

Financial

Instruments

  

Fair Value

    

Valuation Technique

  

Significant Unobservable
Input

  

Range of Inputs

     (in thousands)                 

Warrants

   $ 5,435       Binomial option-pricing model    Volatility    70-80%
         Expected term    4 years

 

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The warrants were reclassified as shareholders’ equity in September 2014 following the Irish Reorganization and the change in the functional currency of Nexvet Biopharma public limited company to U.S. dollars.

Sensitivity of Fair Value Measures to Changes in Unobservable Inputs

The volatility assumption is representative of the level of uncertainty expected in the movements of the Company’s share price over the expected term of the warrant. A significant increase in volatility would increase the fair value of the warrants while a significant decrease in volatility would decrease the fair value of the warrants.

The highest value of a warrant instrument is attained if it is assumed to be held to expiry. Due to risk aversion, wealth diversification and the lack of marketability, warrant holders occasionally exercise prior to expiry. Based on the market value approach adopted for the valuation of the warrants, it is assumed that the warrants will be held on average for four years. An increase in the expected term of the warrants by one year would increase the fair value of the warrants by $0.5 million, or 10%, while similarly a decrease by one year would decrease the fair value of the warrants by $0.7 million, or 12%.

11.    Net Loss Per Share and Pro Forma Net Loss Per Share

The calculation of net loss per participating securities (“EPS”) for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014 is presented below. For more information on the calculation of EPS, see Note 2.

 

     Year Ended June 30,     Three Months Ended
September 30,
 
             2013                     2014             2013     2014  
                 (unaudited)  
    

(in thousands, except share and per share amounts)

 

Net loss (in thousands)

   $ (3,241   $ (6,710   $ (1,016   $ (2,297
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average ordinary shares issued and outstanding—basic and diluted

        894,794        1,000,872        1,000,000        1,078,166   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per ordinary share—basic and diluted

   $ (3.62   $ (6.70   $ (1.02   $ (2.13
  

 

 

   

 

 

   

 

 

   

 

 

 

The following ordinary share equivalents were excluded from the calculation of diluted net loss per share for the periods ended on the dates indicated because including them would have an anti-dilutive effect:

 

     Year Ended June 30,      Three Months Ended
September 30,
 
             2013                      2014              2013      2014  
                   (unaudited)  

Preference shares

     792,117         5,937,138         1,112,805         5,937,138   

Share-based awards

     —           245,020         —           225,904   

Warrants

     —           1,766,998         —           1,766,998   

Shares subject to limited recourse loans (see Note 12)

     264,386         254,680         264,386         —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

       1,056,503           8,203,836           1,377,191           7,930,040   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Unaudited pro forma net loss per share is calculated as follows:

 

     Year Ended
June 30,
2014
    Three Months Ended
September 30,

2014
 
    

(unaudited)

 

Net loss (in thousands)

   $ (6,710   $ (2,297
  

 

 

   

 

 

 

Weighted-average ordinary shares outstanding

     1,000,872        1,078,166   

Adjustment for conversion of convertible preference shares

     2,241,132        5,937,155   
  

 

 

   

 

 

 

Pro forma weighted-average ordinary shares outstanding, basic and diluted

     3,242,004        7,015,321   
  

 

 

   

 

 

 

Pro forma net loss per share attributable to ordinary shareholders, basic and diluted

   $ (2.07   $ (0.33
  

 

 

   

 

 

 

Unaudited pro forma basic and diluted net loss per share for fiscal year 2014 and for the three months ended September 30, 2014 is computed using the weighted-average number of ordinary shares outstanding after giving effect to the conversion of all convertible preference shares into ordinary shares as if such conversion had occurred at the beginning of the period presented, or the date of original issuance, if later. Outstanding share options, restricted share units and warrants were excluded from the calculation of pro forma net loss per share because including them would have had an anti-dilutive effect.

12.    Share-Based Awards

As permitted by Australian law, the Company’s board of directors has historically granted share options and restricted share units with an exercise or conversion price, as applicable, of nil to recipients in Australia. Contemporaneously with these awards and based upon information available at the time of grant, the Company’s board of directors, with the assistance of management, also determined the fair value of the shares underlying these share options for financial reporting purposes. To determine the best estimate of the fair value of the Company’s ordinary shares at each grant date, the Company’s board of directors considered numerous factors, including contemporaneous third-party valuations, current business conditions and projections, risks inherent to the development of the Company’s research and development programs, including the status of pivotal safety and efficacy studies for its lead product candidates, the Company’s financial condition, the Company’s need for future financing to fund its research and development efforts and the commercialization of its lead product candidates, and other relevant factors.

2012 Employee Share Option Plan

In August 2012, the Company’s board of directors adopted the Company’s Employee Share Option Plan (the “2012 Plan”). Pursuant to the 2012 Plan, the Company issued 264,386 ordinary shares at $4.20 per share to employees (including executive officers), consultants and each member of the Company’s board of directors who could purchase such ordinary shares with an interest-free, limited recourse loan payable to the Company. These limited recourse loans were not collateralized and were not recourse to the assets of the borrower, except to the extent of the shares issued. Because the loans were the sole consideration for the shares issued, the Company accounted for these arrangements as share options since the substance is similar to the grant of an option, with a deemed exercise price equal to the loan amount. The fair value of the notional share options was expensed in fiscal year 2013 when vested with a corresponding credit to additional paid-in capital.

The limited recourse loans were repayable within 30 days of the termination of service to the Company of the employee, director or consultant. Failure to pay back the loan within that time frame would have resulted in relinquishing of those shares by the shareholder. The balance of loans outstanding as of June 30, 2013 and 2014 and September 30, 2013 and 2014 was $1.0 million, $1.0 million, $1.0 million and nil, respectively. As discussed in Note 2, the Company does not recognize a separate receivable for limited recourse loans.

 

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The 2012 Plan is no longer in use. Between June 30, 2014 and September 30, 2014, all of the limited recourse loans were repaid in cash or satisfied by the repurchase by the Company of certain ordinary shares issued subject to such loans.

2013 Long Term Incentive Plan

In September 2013, the Company’s board of directors approved a long-term incentive plan for its employees (including executive officers), directors and consultants pursuant to which in November 2013 the Company issued share options to purchase 215,799 ordinary shares and restricted share units to acquire 29,214 ordinary shares to employees, directors and consultants. The underlying ordinary shares had a fair value of $5.15 per share, but the awards had an exercise or conversion price, as applicable, of nil, as permitted under Australian law. Because Irish law requires the payment to an issuer of at least the nominal value of shares in order to acquire such shares from the issuer, any options or restricted share units with a nil exercise or conversion price became exercisable or convertible, as applicable, at their nominal value in August 2014 in anticipation of the Irish Exchange. This nominal value became $0.10 per ordinary share in September 2014 in connection with the Irish Exchange and was revised to $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014. In September 2014, the Company also issued share options to purchase 16,800 ordinary shares and restricted share units to acquire 21,240 ordinary shares to employees, directors and consultants. The underlying ordinary shares had a fair value of $6.35 per ordinary share, but the awards had an exercise or conversion price of the nominal value of $0.10 per ordinary share, which nominal value became $0.125 per ordinary share in connection with the four-for five share consolidation in November 2014. Except for share options and restricted share units held by directors (which vest in November 2014), share options and restricted share units held by employees and consultants vest in three equal tranches in November 2014, November 2015 and November 2016. The Company revised this plan in September 2014 and refers to this plan as its “2013 Plan.”

Share Awards to Consultants or Advisors for Services Provided

In December 2012, the Company entered into an agreement with Robert Gearing under which the Company agreed to pay to him a commission for arranging certain research and development services. The Company issued Mr. Gearing 6,250 ordinary shares in fiscal year 2013 and 4,424 ordinary shares in fiscal year 2014. The ordinary shares had an aggregate value of $48,000 and the Company recognized share-based compensation expense of $26,000, $22,000, nil and $2,000 in fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively.

In November 2013, the Company entered into an agreement with a financial advisor for the provision of certain financial services. Pursuant to the agreement, the financial advisor elected to receive payment of fees in ordinary shares. In November 2013, the Company issued 8,849 SIRPS Preference Shares at $5.18 per share to the financial advisor.

Related Party Transactions

In May 2012, David Gearing, a co-founder of the Company and its Chief Scientific Officer, loaned the Company $0.2 million, accruing interest at 15% per annum. In February 2013, the Company repaid the loan together with $21,000 in accrued interest.

Dr. Andrew Gearing is a former director, a co-founder of the Company and a brother of David Gearing, a co-founder of the Company and its Chief Scientific Officer. Dr. Andrew Gearing serves on the board of directors of Biocomm Squared Pty Ltd. In August 2010 and August 2013, the Company entered into consulting agreements with Biocomm Squared Pty Ltd for research and development support services. These agreements were superseded by a new consulting agreement in December 2013, which was amended in April 2014. In addition, the Company entered into an agreement with Biocomm Squared Pty Ltd in November 2011 for

 

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assistance in obtaining partnering arrangements with Japanese entities. The Company recorded research and development expense of $0.1 million, $0.2 million, $31,000 and $39,000 in fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, related to these agreements. As of June 30, 2013 and 2014 and September 30, 2013 and 2014, there was $8,000, $23,000, $12,000 and $19,000 payable to Biocomm Squared Pty Ltd, respectively.

Ridge Biotechnology Consulting, LLC is owned and operated by Dr. Robert Gearing, the brother of David Gearing, a co-founder of the Company and its Chief Scientific Officer. In October 2010, the Company entered into a consulting agreement with Ridge Biotechnology Consulting, LLC for the provision of services to the Company. The agreement was superseded by agreements entered into in April 2011 and April 2012, and a new consulting agreement with Ridge Biotechnology Consulting, LLC was entered into in January 2014. The Company recorded general and administrative expense of $51,000, $0.1 million, $9,000 and $52,000 in fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, related to these agreements. As of June 30, 2013 and 2014 and September 30, 2013 and 2014, there was $9,000, $19,000, $5,400 and nil payable to Ridge Biotechnology Consulting, LLC, respectively. Dr. Robert Gearing was also a party to a 2012 agreement with the Company pursuant to which the Company issued Dr. Gearing 6,250 ordinary shares in fiscal year 2013 and 4,424 ordinary shares in fiscal year 2014, with an aggregate value of $48,000, for arranging certain research and development services.

Peter Howard is a former director of the Company. In July 2011, the Company entered into a consultancy agreement with Mr. Howard for financial advisory services. The Company recorded expense of nil, $30,000, $8,000 and $29,000 in fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, related to this agreement.

Dr. Paul Wood is a former director of the Company. In May 2013, the Company entered into a consultancy agreement with Dr. Wood for consulting services. The Company recorded expense of $8,000, $23,000, $14,000 and $3,000 in fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively, related to this agreement.

13.    Valuation of Share Awards

The fair value of each share option is estimated on the date of grant using the binomial option-pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected share volatility based on the historical volatility of its publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s share options has been determined utilizing the “simplified” method as the Company has insufficient historical experience for share options overall, rendering existing historical experience irrelevant to expectations for current grants. The risk-free interest rate is determined by reference to the appropriate reserve bank yield in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The fair value of the underlying ordinary shares considered the price per share paid by investors in the Company’s private financings, including the Series B Preference Shares in May 2014. The fair value of the share options was estimated using the following assumptions:

 

     Year Ended June 30,   

Three Months Ended

September 30, 2014

     2013    2014   

Fair value per ordinary share

   $4.20    $5.15    $6.35

Risk free interest rate

   2.7%    4.0%    1.7%

Expected term (in years)

   5 years    5-10 years    5 years

Expected volatility

   80%    80%    75%

Expected dividend yield

   nil    nil    nil

 

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The following table summarizes share option activity for fiscal years 2013 and 2014 and the three months ended September 30, 2014 (unaudited):

 

    Shares
Issuable
Under
Options
    Weighted-
Average
Exercise
Price
    Weighted-
Average
Remaining
Contractual
Term

(in years)
        Aggregate   
Intrinsic
Value

(in thousands)
 

Outstanding as of June 30, 2012

       

Granted

    264,386 (1)    $ 4.20        5      $ 708   

Exercised

    —          —          —          —     

Expired or forfeited

    —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of June 30, 2013

    264,386        4.20        5        708   

Granted

    215,799        0.125        4.75        1,115   

Exercised

    —          —          —          —     

Ordinary shares no longer subject to limited recourse loans

    (9,706 )(1)      4.20        5        (26

Expired or forfeited

    —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of June 30, 2014

    470,479      $ 2.33        5      $ 1,797   
 

 

 

   

 

 

   

 

 

   

 

 

 

Granted

    161,869      $ 5.70       5      $ 1,026  

Exercised

    (19,115     0.125        5        (2

Ordinary shares no longer subject to limited recourse loans

    (109,611 )(1)      4.20        5        (460

Repurchased

    (145,069 )(1)      6.35        5        (222

Expired or forfeited

    —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of September 30, 2014

    358,553      $ 2.64       5      $ 2,139  
 

 

 

   

 

 

   

 

 

   

 

 

 

Options vested and expected to vest, as of June 30, 2013

    —        $ —         
 

 

 

   

 

 

     

Options vested and expected to vest, as of June 30, 2014

    6,195      $ 0.125       
 

 

 

   

 

 

     

Options vested and expected to vest, as of September 30, 2014

    147,769      $ 6.24       
 

 

 

   

 

 

     

 

  (1) Reflects ordinary shares issued subject to limited recourse loans. See Note 12.

The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s ordinary shares for those share options that had exercise prices lower than the fair value of the Company’s ordinary shares.

 

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In addition to the share options described above, the Company has granted restricted share units to its directors, employees and consultants. Restricted share units are valued at the fair value of the underlying ordinary shares as of the date of grant. The fair value of the ordinary shares issuable upon conversion of restricted share units considered the price per share paid by investors in the Company’s private financings, including the SIRPS Preference Shares in July 2013. The ordinary shares subject to the restricted share units are generally issued when they vest. The table below presents the Company’s restricted share unit activity for fiscal years 2013 and 2014 and the three months ended September 30, 2014 (unaudited):

 

    Number of
Restricted
Share Units
    Weighted
Average
Grant Date
Fair Value
    Weighted
Average
Remaining
Contractual
Term

(in years)
    Aggregate
Intrinsic
Value

(in thousands)
 

Outstanding as of June 30, 2012

       

Granted

    —        $ —          —        $ —     

Converted

    —          —          —           —     

Forfeited

    —           —           —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of June 30, 2013

    —          —          —          —     

Granted

    29,214        5.15        2.4        151   

Converted

    —          —          —          —     

Forfeited

    —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of June 30, 2014

    29,214        5.15        2.4        151   
 

 

 

   

 

 

   

 

 

   

 

 

 

Granted

    21,240        6.35          135  

Converted

    —          —          —          —     

Forfeited

    —          —          —          —     
 

 

 

   

 

 

   

 

 

   

 

 

 

Outstanding as of September 30, 2014

    50,454      $ 5.66        2.1      $ 286   
 

 

 

   

 

 

   

 

 

   

 

 

 

Converted and expected to convert, as of June 30, 2013

    —        $ —         
 

 

 

   

 

 

     

Converted and expected to convert, as of June 30, 2014

    —        $ —         
 

 

 

   

 

 

     

Converted and expected to convert, as of September 30, 2014

    2,140      $ 6.35       
 

 

 

   

 

 

     

As of June 30, 2014 and September 30, 2014, the Company had approximately $0.1 million and $0.2 million, respectively, of unrecognized compensation expense related to unvested restricted share units, which is expected to be recognized over a weighted average period of 2.4 years and 2.3 years, respectively.

Share-Based Compensation

The Company recognizes share-based compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment will be recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to share-based compensation expense in future periods.

 

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The Company recorded share-based compensation expense related to share options and restricted share units for the fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014 as follows:

 

     Year Ended
June 30,
    

Three Months Ended
September 30,

 
    

2013

    

2014

    

2013

    

2014

 
                   (unaudited)  
    

(in thousands)

 

Research and development

   $ 298       $ 74       $ —        $ 42  

General and administrative

     412         224         —           153   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 710       $ 298         $—        $ 195  
  

 

 

    

 

 

    

 

 

    

 

 

 

The Company had an aggregate of $1.0 million and $1.0 million, respectively, of unrecognized share-based compensation expense for share options and restricted share units outstanding as of June 30, 2014 and September 30, 2014, which is expected to be recognized over an estimated period of 2.4 years and 2.3 years, respectively, for share options and restricted share units under the 2013 Plan.

14.    Commitments and Contingencies

Indemnities and Guarantees

The Company has made certain indemnities and guarantees, under which it may be required to make payments to a guaranteed or indemnified party, in relation to certain transactions. The Company indemnifies its officers and directors to the maximum extent permitted under the laws of the State of Victoria, Australia. The duration of these indemnities and guarantees varies and, in certain cases, is indefinite. These indemnities and guarantees do not provide for any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not been obligated to make any payments for these obligations and no liabilities have been recorded for these indemnities and guarantees in the accompanying balance sheets.

Operating Lease

The Company entered into a lease for its office in Melbourne, Australia commencing December 2013 for a period of five years. As of June 30, 2014 and September 30, 2014 commitments totaled $0.5 million and $0.4 million, respectively. There were no rental commitments as of June 30, 2013 or September 30, 2013. Rent expense was $22,000, $0.1 million, $20,000 and $24,000 for fiscal years 2013 and 2014 and the three months ended September 30, 2013 and 2014, respectively. Included in rent expense is a build-out incentive of $11,000. A portion of the incentive paid by the landlord is to be repaid by the Company if the lease is early terminated, determined by the unexpired term of the lease over the original 60-month lease term. There are no escalation clauses in the lease agreement.

In connection with the development of animal biopharmaceuticals the Company has open contracts with suppliers for goods and services of $1.7 million and $1.5 million as of June 30, 2014 and September 30, 2014, respectively. As of June 30, 2014, future payments under these non-cancellable operating leases and non-cancellable purchase obligations were as follows:

 

     Total      Less than
1 Year
     1-3
Years
     3-5
Years
     After 5
Years
 
     (in thousands)  

Operating leases

   $ 475       $ 97       $ 205       $ 173       $ —     

Purchase obligations

     1,670         1,670         —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 2,145       $ 1,767       $ 205       $ 173       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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As of September 30, 2014, future payments under these non-cancellable operating leases and purchase obligations were as follows:

     Total      Less than
1 Year
     1-3
Years
     3-5
Years
     After 5
Years
 
     (unaudited)  
     (in thousands)  

Operating leases

   $ 443       $ 96       $ 204       $ 143       $ —     

Purchase obligations

     1,483         1,483         —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 1,926      $ 1,579      $ 204      $ 143      $ —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

15.    Income Taxes

There is no provision for income taxes because the Company has historically incurred operating losses and maintains a full valuation allowance against its net deferred tax assets. The reported amount of income tax expense differs from the amount that would result from applying domestic federal statutory tax rates to pretax losses primarily because of changes in valuation allowance. In all periods presented, all revenue was earned in Australia.

A reconciliation of the statutory income tax rate to the Company’s effective income tax rate is as follows:

 

     Year Ended June 30,     Three Months
Ended
September 30,
 
       2013         2014       2013     2014  
                 (unaudited)  
     (in thousands)  

Federal statutory income tax rate

   $ 972      $ 1,988      $ 305      $ 696   

Research and development

     (415     (914     (146     (300

Non-deductible expenses

     (281     (70     —          (88

Changes in deferred tax asset valuation allowance

     (276     (1,004     (159     (308
  

 

 

   

 

 

   

 

 

   

 

 

 

Effective income tax rate

   $ —        $ —        $ —        $ —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net deferred tax assets as of June 30, 2013 and 2014 and September 30, 2014 consisted of the following:

 

     June 30,     September 30,
2014
 
     2013     2014    
                 (unaudited)  
    

(in thousands)

 

Tax loss carry forwards

   $ 1,079      $ 4,196      $ 6,566   

Accrued expenses

     129        503        518   
  

 

 

   

 

 

   

 

 

 

Total deferred tax assets

     1,208        4,699        7,084   

Valuation allowance

     (1,208     (4,699     (7,084
  

 

 

   

 

 

   

 

 

 

Net deferred tax assets

   $ —        $ —        $ —     
  

 

 

   

 

 

   

 

 

 

As of June 30, 2014 and September 30, 2014, the Company had total deferred tax assets of $4.7 million and $7.1 million, respectively. Management has evaluated the factors bearing upon the reliability of its deferred tax assets, which consist principally of tax loss carry forwards for Australian income tax purposes of $4.2 million and $6.6 million, respectively. Management concluded that uncertainty of realizing any tax benefits as of June 30, 2014 and September 30, 2014, a full valuation allowance was necessary to offset its net deferred tax assets due to the Company’s lack of taxable income prospects for the foreseeable future.

Utilization of tax loss carry forwards is subject to potential limitation as a consequence of the Australian loss recoupment rules and future ownership changes, future capital raisings or ongoing changes in the Company’s business. Given the change of ownership that occurred in September 2014 (see Note 16), the

 

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Australian tax authorities could argue that there has been a change in the Company’s underlying business in Australia, which may result in these tax losses never being recoverable. Should this occur, future Australian taxable profits would be taxed at the full corporate rate, which is currently 30%. Depending on the actual amount of any limitation on the Company’s ability to use its tax loss carry forwards, a significant portion of its future taxable income could be taxable.

Changes in the valuation allowance for deferred tax assets during fiscal year 2014 and the three months ended September 30, 2014 were as follows:

 

    

June 30, 2014

    

September 30, 2014

 
            (unaudited)  
     (in thousands)  

Valuation allowance as of beginning of year

   $ 1,208       $ 4,699   

Increases recorded to income tax provision

     3,491         2,385   
  

 

 

    

 

 

 

Valuation allowance as of end of year

   $ 4,699       $ 7,084   
  

 

 

    

 

 

 

The Company has not recorded any amounts for unrecognized tax benefits as of June 30, 2013 or 2014 or September 30, 2013 or 2014. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2011 to the present. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision.

16.    Subsequent Events

The Company evaluated subsequent events through December 30, 2014, which is the date the unaudited interim financial statements were available to be issued.

In August 2014, the Company completed a one-for-four share consolidation, and in November 2014, the Company completed a four-for-five share consolidation. All share and per share figures have been adjusted to reflect these consolidations. The adjustments exclude, as an immaterial amount, 32 shares outstanding following the November 2014 four-for-five share consolidation, which represent certain shares that would have become fractional shares in the consolidation and new issuances to prevent any fractional shares as a result of the consolidation, all of which shares are being held in trust pending their redemption or sale.

In August 2014, the board of directors approved a reincorporation of the Company from Australia to Ireland pursuant to a transaction in which all of the holders of ordinary shares, Preference Shares, restricted share units and options and warrants to purchase ordinary shares of Nexvet Australia would exchange their holdings for equivalent ordinary shares, Preference Shares, restricted share units or options or warrants to purchase ordinary shares, as applicable, of Nexvet Biopharma Limited, a newly-formed Irish private company, which was re-registered as a public limited company in September 2014. In September 2014, Nexvet Biopharma public limited company became the parent company of Nexvet Australia pursuant to the Irish Reorganization. The change in ownership of Nexvet Australia may result in loss of the ability to utilize tax loss carry forwards of $6.2 million subject to the application of the Australian loss recoupment rules.

Following the Irish Reorganization, for financial reporting purposes the historical consolidated financial statements of Nexvet Australia became the historical consolidated financial statements of Nexvet Biopharma public company limited and its subsidiaries as a continuation of the predecessor. The capital structure presented is that of Nexvet Biopharma public limited company.

The Company entered into a master collaboration, supply and distribution agreement, and a specific distribution agreement for NV-01, with Virbac S.A., an animal health pharmaceutical company, in November

 

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2014. No consideration was exchanged on execution. Pursuant to these agreements, the Company appointed Virbac as its sole and exclusive distributor of NV-01 and any other products for which it enters into a specific distribution agreement with Virbac in the veterinary field worldwide except for the United States and Canada (and for NV-08, also except for Japan, South Korea, Taiwan, the Philippines, Malaysia, Singapore, the People’s Republic of China, Indonesia, Thailand, India, Vietnam and Myanmar, because of pre-existing distribution rights). Virbac must provide clinical, regulatory, marketing and sales input via a joint steering committee, advise the Company in the drafting of regulatory submissions in the countries within the applicable territory, sell the Company’s products, meet or exceed minimum annual net sales obligations for each product, manage local complaints and transfer drug safety data, not apply for the registration of any trademark that is the same as or similar to any of the Company’s trademarks and launch the product within a specified time period after marketing authorization. Virbac may terminate these agreements if, among other things, the Company does not timely obtain a marketing authorization for NV-01 in Europe, there is a material failure to comply with the target product profiles for NV-01, there is a material deviation from a development plan for NV-01 or the distribution of all products covered by these agreements is prevented in certain important countries specified in these agreements as a result of a potential infringement of a third party’s intellectual property rights. In the future, the Company may be entitled to certain milestone payments for its research and development work for its products, as well as fees based on Virbac’s net sales of the product reduced by specified amounts intended to reflect certain costs of goods and costs of selling, each as provided in the agreements.

 

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LOGO

 


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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13. Other Expenses of Issuance and Distribution.

The following table indicates the expenses, other than the underwriting discount, to be incurred in connection with the offering described in this registration statement all of which will be paid by Nexvet Biopharma public limited company (the “Registrant”). All of the amounts are estimated except for the SEC registration fee, the FINRA filing fee and the Nasdaq listing fee.

 

    

Amount to

be paid

SEC registration fee

   $6,972

Printing and mailing

   *

FINRA filing fee

   9,500

Nasdaq listing fee

   *

Legal fees and expenses

   *

Accounting fees and expenses

   *

Transfer agent and registrar

   *

Miscellaneous

   *
  

 

Total

   *

 

* To be completed by amendment.

 

Item 14. Indemnification of Directors and Officers.

The Registrant’s memorandum and articles of association contain indemnification for the benefit of the Registrant’s directors and executive officers to the fullest extent permitted by Irish law. However, as to the Registrant’s directors and company secretary, this indemnity is limited by the Irish Companies Acts, which prescribe that an advance commitment to indemnify only permits a company to pay the costs or discharge the liability of a director or company secretary where judgment is given in favor of the director or company secretary in any civil or criminal action in respect of such costs or liability, or where an Irish court grants relief because the director or company secretary acted honestly and reasonably and ought fairly to be excused. Any provision whereby an Irish company seeks to commit in advance to indemnify its directors or company secretary over and above the limitations imposed by the Irish Companies Acts will be void, whether contained in its articles of association or any contract between the Registrant and the director or company secretary. This restriction does not apply to the Registrant’s executive officers who are not directors, the company secretary or other persons who would be considered “officers” within the meaning of the Irish Companies Acts.

The Registrant is permitted under its articles of association and the Irish Companies Acts to purchase directors’ and officers’ liability insurance, as well as other types of insurance, for its directors, officers, employees and agents.

The Registrant has entered into indemnification agreements with each of its directors and officers. These indemnification agreements may subject to the provisions of the Irish Companies Acts require the Registrant, among other things, to indemnify its directors and officers for some expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by a director or officer in any action or proceeding arising out of his or her service as one of its directors or officers, or any of its subsidiaries or any other company or enterprise to which the person provides services at its request.

Reference is made to Item 17 of the Registrant’s undertakings with respect to liabilities arising under the Securities Act of 1933, as amended (the “Securities Act”). Reference is also made to the form of underwriting

 

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agreement filed as Exhibit 1.1 to this registration statement for the indemnification agreements between the Registrant and the underwriters.

 

Item 15. Recent Sales of Unregistered Securities

The following list sets forth information regarding all securities sold by Nexvet Australia Pty Ltd, formerly known as Nexvet Biopharma Pty Ltd (“Nexvet Australia”), and the Registrant since July 1, 2011, after giving effect to the one-for-four share consolidation that occurred in August 2014 and the four-for-five share consolidation that occurred in November 2014:

Issuances by Nexvet Australia

1.    From August 2010 through January 2012, Nexvet Australia issued $1.5 million in an aggregate amount of convertible notes to nine investors without any general solicitation or advertising. The convertible notes converted into 534,545 ordinary shares upon the closing of the SIRPS preference share offering in September 2012.

2.    In September 2012 and November 2012, Nexvet Australia issued an aggregate of 250,000 SIRPS preference shares in two equal tranches, to one investor without any general solicitation or advertising, at a price per share of $4.19 for gross proceeds of $1.0 million. In June 2013, the investor transferred 12,500 and 237,500 of its SIRPS preference shares to two investors. In addition, in November 2012 and December 2012, Nexvet Australia issued an aggregate of 248,199 SIRPS preference shares to four investors without any general solicitation or advertising, at a price per share of $4.23 for gross proceeds of $1.0 million.

3.    In May 2013, Nexvet Australia issued an aggregate of 264,386 ordinary shares, without any general solicitation or advertising, to then-existing employees, directors and consultants under the 2012 Employee Share Option Plan at a price per share of $4.20 for gross proceeds of $1.0 million payable by limited recourse loans. Of the shares issued under the 2012 Employee Share Option Plan, 4,424 ordinary shares were issued to a consultant as compensation for services for an aggregate value of $26,000.

4.    From March 2013 to December 2013, Nexvet Australia issued, without any general solicitation or advertising, an aggregate of 1,230,083 SIRPS preference shares at a weighted-average price per share of $5.15 to 25 investors for gross proceeds of $6.3 million. In addition, in November 2013 Nexvet Australia issued 8,849 SIRPS preference shares to an entity for professional services rendered in connection with the financing.

5.    In April 2014, Nexvet Australia issued 4,424 ordinary shares, without any general solicitation or advertising, to a consultant as compensation for services for an aggregate of $22,000, or $4.97 per ordinary share.

6.    In April and May 2014, Nexvet Australia issued, without any general solicitation or advertising, an aggregate of 4,200,006 Series B preference shares at a price per share of $7.50 and an aggregate of 1,574,998 warrants to purchase ordinary shares with an exercise price of $8.625 per ordinary share to 27 investors for gross proceeds of $31.5 million. In addition, Nexvet Australia issued warrants to purchase 192,000 ordinary shares to advisors with an exercise price of $7.50 per ordinary share.

7.    From July 1, 2011 to August 2014, Nexvet Australia issued share options to purchase 215,799 ordinary shares at a nil exercise price and restricted share units to acquire 29,214 ordinary shares at a nil conversion price to then-existing employees, directors and consultants under its 2013 Long Term Incentive Plan, without any general solicitation or advertising. In August 2014, Nexvet Australia, the share option holders and the restricted share unit holders agreed to revise the exercise or conversion price, as applicable, to the nominal value per ordinary share.

8.    From July 1, 2011 to August 2014, Nexvet Australia issued an aggregate of 19,115 ordinary shares, without any general solicitation or advertising, to then-existing employees, directors and consultants upon the

 

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exercise of share options issued under its 2013 Long Term Incentive Plan at a nil exercise price, as permitted by Australian law, for aggregate cash consideration of nil.

The offers and sales of the securities described in paragraphs 1 through 8 were not registered under the Securities Act in reliance on, and in compliance with, Regulation S as issuances to non-U.S. investors outside the United States, Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D promulgated thereunder. All persons acquiring these securities were either accredited investors (as defined in Rule 501 of Regulation D) or non-U.S. persons (as defined in Rule 902 of Regulation S).

The offers and sales of the securities described in paragraphs 3, 7 and 8 were deemed to be exempt from registration under the Securities Act in reliance on Rule 701 as transactions under compensatory benefit plans and contracts relating to compensation.

Issuances by the Registrant

1.    In August 2014, the Registrant issued one ordinary share at a price per share of the nominal value of $0.10 per ordinary share (which nominal value became $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014) in connection with the formation of the Registrant, without any general solicitation or advertising.

2.    In September 2014, pursuant to share exchange agreements, the Registrant allotted 1,142,858 ordinary shares, 1,737,132 SIRPS preference shares and 4,200,006 Series B preference shares to shareholders of Nexvet Australia in exchange for 100% of the issued and outstanding capital shares of Nexvet Australia. In addition, in connection with the share exchange agreements, the Registrant issued warrants to purchase 1,574,998 ordinary shares of the Registrant’s ordinary shares with an exercise price of $8.625 per ordinary share and warrants to purchase 192,000 of the Registrant’s ordinary shares with an exercise price of $7.50 per ordinary share in exchange for the equivalent warrants issued by Nexvet Australia. In connection with the share exchange agreements, the Registrant also issued share options to purchase 470,479 of the Registrant’s ordinary shares with an exercise price of the nominal value of $0.10 per ordinary share and restricted share units to acquire 29,215 of the Registrant’s ordinary shares with a conversion price of the nominal value of $0.10 per ordinary share under its 2013 Long Term Incentive Plan in exchange for the equivalent share options and restricted share units issued by Nexvet Australia. Such exercise or conversion price, as applicable, was revised to the nominal value of $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

3.    In August 2014, Nexvet Australia repurchased 145,069 ordinary shares subject to limited recourse loans from then-existing employees, directors and consultants. As consideration for such repurchase, Nexvet Australia forgave the remaining loan amounts, aggregating to $0.9 million, and, in September 2014, the Registrant issued share options to purchase 145,069 ordinary shares at an exercise price of $6.35 per ordinary share to such employees, directors and consultants, without any general solicitation or advertising.

4.    From September to October 2014, the Registrant issued share options to purchase an aggregate of 158,592 ordinary shares at an exercise price of the nominal value of $0.10 per ordinary share and restricted share units to acquire 37,667 ordinary shares at a conversion price of the nominal value of $0.10 per ordinary share to then-existing employees and directors under its 2013 Long Term Incentive Plan, without any general solicitation or advertising. Such exercise or conversion price, as applicable, was revised to the nominal value of $0.125 per ordinary share in connection with the four-for-five share consolidation in November 2014.

5.    In November 2014, the Registrant issued one ordinary share, two SIRPS preference shares and three Series B preference shares, each at a price per share of $8.00, in connection with the four-for-five share consolidation, without any general solicitation or advertising.

 

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6.    In October and November 2014, the Registrant issued an aggregate of 16,009 ordinary shares, without any general solicitation or advertising, to then-existing employees, directors and consultants upon the conversion of restricted share units issued under its 2013 Long Term Incentive Plan at a conversion price per share of $0.125, for aggregate consideration of $2,001.

7.    In November 2014, the Registrant issued an aggregate of 73,825 ordinary shares, without any general solicitation or advertising, to then-existing employees, directors and consultants upon the exercise of share options issued under its 2013 Long Term Incentive Plan at an exercise price per share of $0.125, for aggregate consideration of $9,228.

The offers and sales of securities described in paragraphs 1 through 7 were not registered under the Securities Act in reliance on, and in compliance with, Regulation S as issuances to non-U.S. investors outside the United States, Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D promulgated thereunder. All persons acquiring these securities were either accredited investors (as defined in Rule 501 of Regulation D) or non-U.S. persons (as defined in Rule 902 of Regulation S).

The offers and sales of the securities described in paragraphs 4, 6 and 7 were deemed to be exempt from registration under the Securities Act in reliance on Rule 701 as transactions under compensatory benefit plans and contracts relating to compensation.

 

Item 16. Exhibits and Financial Statement Schedules.

(a)    See the Exhibit Index on the page immediately preceding the exhibits for a list of exhibits filed as part of this registration statement on Form S-1, which Exhibit Index is incorporated herein by reference.

(b)    Financial Statement Schedules: All schedules have been omitted because they are not required or are not applicable or the required information is shown in the Registrant’s consolidated financial statements or related notes.

 

Item 17. Undertakings

(a)    The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

(b)    The undersigned Registrant hereby undertakes that:

 

  (1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

 

  (2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers, and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. In the event that a claim

 

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for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Melbourne, Australia, on December 30, 2014.

 

Nexvet Biopharma public limited company

By:   /s/ Mark Heffernan
  Name: Mark Heffernan, Ph.D.
  Title:   Chief Executive Officer

POWER OF ATTORNEY

We, the undersigned directors and officers of Nexvet Biopharma public limited company, hereby severally constitute and appoint Mark Heffernan, Ph.D. and Damian Lismore, and both or any one of them, our true and lawful attorneys-in-fact and agents, with full power of substitution and re-substitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign any and all amendments (including post-effective amendments) to this registration statement, and any registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing necessary or desirable to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that each of said attorneys-in-fact or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed below by the following persons in the capacities and on the dates indicated below.

 

Signature

 

Title

 

Date

/s/ Mark Heffernan

Mark Heffernan, Ph.D.

 

Chief Executive Officer and Director

(Principal Executive Officer)

  December 30, 2014

/s/ Damian Lismore

Damian Lismore

 

Chief Financial Officer (Principal

Financial Officer and Principal

Accounting Officer)

  December 30, 2014

/s/ Chris Brown

Chris Brown

  Chairman of the Board   December 30, 2014

/s/ Ashraf Hanna

Ashraf Hanna, Ph.D., M.D.

  Director   December 30, 2014

/s/ Cormac Kilty

Cormac Kilty, Ph.D.

  Director   December 30, 2014

/s/ Joseph McCracken

Joseph McCracken, DVM

  Director   December 30, 2014

 

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Signature

 

Title

 

Date

/s/ John Payne

John Payne

  Director   December 30, 2014

/s/ Graeme Wald

Graeme Wald, Ph.D.

  Director   December 30, 2014

 

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INDEX TO EXHIBITS

 

Exhibit
Number

  

Description of Exhibits

  1.1*    Form of Underwriting Agreement.
  3.1    Form of Memorandum and Articles of Association, to become effective upon completion of this offering.
  3.2    Memorandum and Articles of Association, as currently in effect.
  4.1*    Form of Share Certificate.
  4.2    Shareholders Agreement, dated September 4, 2014, by and between the Registrant and the parties listed on Schedule 9 thereto, as amended.
  4.3    Form of Warrant to Purchase Ordinary Shares.
  5.1*    Opinion of ByrneWallace regarding the legality of the securities being registered.
  8.1*    Tax Opinion of DLA Piper LLP (US).
  8.2*    Tax Opinion of Ernst & Young Business Advisors.
10.1†    Agreement, dated December 21, 2012, by and between Nexvet Australia and Lonza Sales AG.
10.2†    Amendment No. 1 to Agreement, dated May 13, 2013, by and between Nexvet Australia and Lonza Sales AG.
10.3†    Amendment No. 2 to Agreement, dated June 17, 2013, by and between Nexvet Australia and Lonza Sales AG.
10.4†    Amendment No. 3 to Agreement, dated June 9, 2014, by and between Nexvet Australia and Lonza Sales AG.
10.5†    Amendment No. 6 to Agreement, dated September 4, 2014, by and between Nexvet Australia and Lonza Sales AG.
10.6†    Amendment No. 8 to Agreement, dated October 10, 2014, by and between Nexvet Australia and Lonza Sales AG.
10.7†    License Agreement, dated December 21, 2012, by and between Nexvet Australia and Lonza Sales AG.
10.8†    Agreement, dated December 16, 2013, by and between Nexvet Australia and Lonza Sales AG.
10.9†    Amendment No. 1 to Agreement, dated June 17, 2014, by and between Nexvet Australia and Lonza Sales AG.
10.10†    Amendment No. 2 to Agreement, dated October 10, 2014, by and between Nexvet Australia and Lonza Sales AG.
10.11†    License Agreement, dated December 16, 2013, by and between Nexvet Australia and Lonza Sales AG.
10.12†    Master Collaboration, Supply and Distribution Agreement, dated November 24, 2014, by and between Nexvet Ireland Limited and Virbac S.A.
10.13†    Specific Distribution Agreement for NV-01 Product, dated November 24, 2014, by and between Nexvet Ireland Limited and Virbac S.A.
10.14+    Employment Agreement, dated December 22, 2014, by and between the Registrant and Mark Heffernan, Ph.D.
10.15+    Employment Agreement, dated December 22, 2014, by and between the Registrant and David Gearing, Ph.D.
10.16+    Employment Agreement, dated December 22, 2014, by and between the Registrant and Damian Lismore.
10.17+    2013 Long Term Incentive Plan.


Table of Contents

Exhibit
Number

  

Description of Exhibits

10.18+    2014 Equity Incentive Plan.
10.19    Form of Deed of Indemnity, Insurance and Access entered into or to be entered into by directors and officers.
16.1    Letter from Ernst & Young to the Securities and Exchange Commission dated September 5, 2014.
21.1    List of subsidiaries of the Registrant.
23.1*    Consent of ByrneWallace (included in Exhibit 5.1).
23.2    Consent of PricewaterhouseCoopers, independent registered public accounting firm.
24.1    Power of Attorney (included in the signature page).
99.1    Consent of Rajiv Patel to be named as a director nominee.

 

+ Indicates management compensation plan.
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment pursuant to Rule 406 under the Securities Act of 1933, as amended.
* To be filed by amendment.
EX-3.1 2 d775834dex31.htm EX-3.1 EX-3.1

EXHIBIT 3.1

COMPANIES ACTS, 1963 TO 2013

A PUBLIC COMPANY LIMITED BY SHARES

MEMORANDUM

AND

ARTICLES OF ASSOCIATION

OF

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

(Amended by Special Resolution on 17 November 2014)


COMPANIES ACTS, 1963 TO 2013

A PUBLIC COMPANY LIMITED BY SHARES

MEMORANDUM OF ASSOCIATION

OF

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

 

1. The name of the Company is: Nexvet Biopharma public limited company.

 

2. The Company is to be a public limited company.

 

3. The objects for which the Company is established are:

 

  (a) To carry on the business of a holding company and to co-ordinate the active management of the Company’s investments, the administration, finances and activities of any subsidiary companies or associated companies, to do all lawful acts and things whatever that are necessary or convenient in carrying on the business of such a holding company and in particular to carry on in all its branches the business of a management service company, to act as managers and to direct or coordinate the management of other companies or of the business, property and estates of any company or person and to undertake and carry out all such services (including commercial, marketing, technical and information technology services and other services related to this activity) in connection therewith as may be deemed expedient by the Company’s board of directors and to exercise its power as a shareholder of other companies.

 

  (b) To carry on all or any of the businesses of manufacturers, buyers, sellers, and distributing agents of and dealers in all kinds of patent, pharmaceutical, medicinal, veterinary and animal health, and medicated preparations, patent medicines, drugs, herbs, and of and in pharmaceutical, medicinal, veterinary and animal health, proprietary and industrial preparations, compounds, and articles of all kinds; and to manufacture, make up, prepare, buy, sell, and deal in all articles, substances, and things commonly or conveniently used in or for making up, preparing, or packing any of the products in which the Company is authorised to deal, or which may be required by customers of or persons having dealings with the Company.

 

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  (c) To invest in pharmaceutical, veterinary and animal health and related assets, including, amongst other items, investment in pharmaceutical and/or veterinary and animal health companies, products, businesses, divisions, technologies, devices, sales force and other marketing capabilities, development projects and related activities, licences, intellectual and similar property rights, premises and equipment, royalty rights and all other assets needed to operate a pharmaceuticals and/or veterinary and animal health business and to hold, sell or deal with such investments and generally to purchase, take on lease or in exchange or otherwise acquire any real and personal property and rights or privileges.

 

  (d) To establish, maintain and operate laboratories for the purpose of carrying on chemical, physical and other research in medicine, and animal health, chemistry, industry or other unrelated or related fields.

 

  (e) To develop and turn to account any land acquired by the Company or in which it is interested and in particular by laying out and preparing the same for building proposes, constructing, altering, pulling down, decorating, maintaining, fitting up and improving buildings and conveniences, and by planting, paving, draining, farming, cultivating, letting on building lease or building agreement and by advancing money to and entering into contracts and arrangements of all kinds with builders, tenants and others.

 

  (f) To acquire and hold shares and stocks of any class or description, debentures, debenture stock, bonds, bills, mortgages, obligations, investments and securities of all descriptions and of any kind issued or guaranteed by any company, corporation or undertaking of whatever nature and wheresoever constituted or carrying on business or issued or guaranteed by any government, state, dominion, colony, sovereign ruler, commissioners, trust, public; municipal, local or other authority or body of whatsoever nature and wheresoever situated and investments, securities and property of all descriptions and of any kind, including real and chattel real estates, mortgages, reversions, assurance policies, contingencies and choses in action.

 

  (g) To remunerate by cash payments or allotment of shares or securities of the Company credited as fully paid up or otherwise any person or company for services rendered or to be rendered to the Company or any parent or subsidiary body corporate whether in the conduct or management of its business, or in placing or assisting to place or guaranteeing the placing of any of the shares of the Company’s capital, or any debentures or other securities of the Company or in or about the formation or promotion of the Company.

 

  (h) To purchase for investment, property of any tenure and any interest therein, and to make advances upon the security of land or other similar property or any interest therein.

 

  (i) To acquire by purchase, exchange, lease, fee farm grant or otherwise, either for an estate in fee simple or for any less estate or other estate or interest, whether immediate or reversionary and whether vested or contingent, any lands, tenements or hereditaments of any tenure, whether subject or not to any charges or encumbrances, and to hold, farm, work and manage and to let, sublet, mortgage or charge land and buildings of any kind, reversions, interests, annuities, life policies, and any other property real or personal, movable or immovable, either absolutely or conditionally, and either subject or not to any mortgage, charge, ground rent or other rents or encumbrances.

 

3


  (j) To erect or secure the erection of buildings of any kind with a view of occupying or letting them and to enter into any contracts or leases and to grant any licences necessary to effect the same.

 

  (k) To maintain and improve any lands, tenements or hereditaments acquired by the Company or in which the Company is interested, in particular by decorating, maintaining, furnishing, fitting up and improving houses, shops, flats, maisonettes and other buildings and to enter into contracts and arrangements of all kinds with tenants and others.

 

  (l) To sell, exchange, mortgage (with or without power of sale), assign, turn to account or otherwise dispose of and generally deal with the whole or any part of the property, shares, stocks, securities, estates, rights or undertakings of the Company, real, chattels real or personal, movable or immovable, either in whole or in part, upon whatever terms and whatever consideration the Company shall think fit.

 

  (m) To take part in the management, supervision, or control of the business or operations of any company or undertaking, and for that purpose to appoint and remunerate any directors, accountants, or other experts or agents to act as consultants, supervisors and agents of other companies or undertakings and to provide managerial, advisory, technical, design, purchasing and selling services.

 

  (n) To make, draw, accept, endorse, negotiate, issue, execute, discount and otherwise deal with bills of exchange, promissory notes, letters of credit, circular notes, and other negotiable or transferable instruments.

 

  (o) To redeem, purchase, or otherwise acquire in any manner permitted by law and on such terms and in such manner as the Company may think fit any shares in the Company’s capital, which shall include the acquisition of any fully paid shares in the capital of the Company otherwise than for valuable consideration.

 

  (p) To guarantee, support or secure whether by personal covenant or by mortgaging or charging all or any part of the undertaking, property and assets (present and future) and uncalled capital of the Company or by both such methods the performance of the obligations of, and the repayment or payment of the principal amounts of and the premiums, interest and dividends on any security of any person, firm or company including (without prejudice to the generality of the foregoing) any company which is for the time being the Company’s holding company or subsidiary as defined by Section 155 of the Companies Act 1963 or another subsidiary as defined by the said Section of the Company’s holding company or otherwise associated with the Company in business notwithstanding the fact that the Company may not receive any consideration, advantage or benefit, direct or indirect from entering into such guarantee or other arrangement or transaction contemplated herein.

 

  (q) To lend the funds of the Company with or without security and at interest or free of interest and on such terms and conditions as the directors shall from time to time determine.

 

4


  (r) To raise or borrow or secure the payment of money in such manner and on such terms as the directors may deem expedient whether or not by the issue of bonds, debentures or debenture stock, perpetual or redeemable, or by mortgage, charge, lien or pledge upon the whole or any part of the undertaking, property, assets and rights of the Company, present or future, including its uncalled capital and generally in any other manner as the directors shall from time to time determine and to enter into or issue interest and currency hedging and swap agreements, forward rate agreements, interest and currency futures or options and other forms of financial instruments, and to purchase, redeem or pay off any of the foregoing and to guarantee the liabilities of the Company or any other person, and any debentures, debenture stock or other securities may be issued at a discount, premium or otherwise, and with any special privileges as to redemption, surrender, transfer, drawings, allotments of shares; attending and voting at general meetings of the Company, appointment of directors and otherwise.

 

  (s) To accumulate capital for any of the purposes of the Company, and to appropriate any of the Company’s assets to specific purposes, either conditionally or unconditionally, and to admit any class or section of those who have any dealings with the Company to any share in the profits thereof or in the profits of any particular branch of the Company’s business or to any other special rights, privileges, advantages or benefits.

 

  (t) To reduce the share capital of the Company in any manner permitted by law.

 

  (u) To make gifts or grant bonuses to officers or other persons who are or have been in the employment of the Company and to allow any such persons to have the use and enjoyment of such property, chattels or other assets belonging to the Company upon such terms as the Company shall think fit.

 

  (v) To establish and maintain or procure the establishment and maintenance of any pension or superannuation fund (whether contributory or otherwise) for the benefit of and to give or procure the giving of donations, gratuities, pensions, annuities, allowances, emoluments or charitable aid to any persons who are or were at any time in the employment or service of the Company or any of its predecessors in business, or of any company which is a subsidiary of the Company or who may be or have been directors or officers of the Company, or of any such other company as aforesaid, or any persons in whose welfare the Company or any such other company as aforesaid may be interested and the wives, widows, children, relatives and dependants of any such persons and to make payments towards insurance and assurance and to form and contribute to provident and benefit funds for the benefit of such persons and to remunerate any person, firm or company rendering services to the Company, whether by cash payment, gratuities, pensions, annuities, allowances, emoluments or by the allotment of shares or securities of the Company credited as paid up in full or in part or otherwise.

 

  (w) To employ experts to investigate and examine into the conditions, prospects, value, character and circumstances of any business concerns, undertakings, assets, property or rights.

 

5


  (x) To insure the life of any person who may, in the opinion of the Company, be of value to the Company, as having or holding for the Company interests, goodwill, or influence or otherwise and to pay the premiums on such insurance.

 

  (y) To distribute either upon a distribution of assets or division of profits among the members of the Company in bind any property of the Company, and in particular any shares, debentures or securities of other companies belonging to the Company or of which the Company may have the power of disposing.

 

  (z) To give, whether directly or indirectly, and whether by means of a loan, guarantee, the provision of security or otherwise, any financial assistance for the purpose of or in connection with a purchase or subscription made or to be made by any person of or for any shares in the Company, or, where the Company is a subsidiary company, in its holding company.

 

  (aa) To do and carry out all or any of the foregoing objects in any part of the world and either as principals, agents, contractors, trustees or otherwise, and either by or through agents, trustees or otherwise and either alone or in partnership or in conjunction with any other company, firm or person, provided that nothing herein contained shall empower the Company to carry on the businesses of insurance.

 

  (bb) To apply for, purchase or otherwise acquire, manage, license and/or protect any patents, brevets d’invention, licences, trade marks, industrial designs, know-how, concessions and other forms of intellectual property rights and the like conferring any exclusive or non-exclusive or limited or contingent rights to use, or any secret or other information as to any invention or process of the Company, or the acquisition of which may seem calculated directly or indirectly to benefit the Company, and to use, exercise, develop, or grant licences in respect of, or otherwise turn to account the property, rights or information so acquired.

 

  (cc) To enter into partnership or into any arrangement for sharing profits, union of interests, co-operation, joint venture, reciprocal concession or otherwise with any person or company carrying on or engaged in or about to carry on or engage in any business or transaction which the Company is authorised to carry on or engage in or any business or transaction capable of being conducted so as directly or indirectly to benefit the Company.

 

  (dd) To acquire and undertake the whole or any part of the undertaking, business, property and liabilities of any person or company carrying on any business which the Company is authorised to carry on or which is capable of being conducted so as to benefit the Company directly or indirectly or which is possessed of assets suitable for the purposes of the Company.

 

  (ee) To adopt such means of making known the Company and its products and services as may seem expedient.

 

  (ff) To acquire and carry on any business carried on by a subsidiary or a holding company of the Company or another subsidiary of a holding company of the Company.

 

6


  (gg) To promote any company or companies for the purpose of acquiring all or any of the property and liabilities of this Company or for any other purpose which may seem directly or indirectly calculated to benefit this Company.

 

  (hh) To amalgamate with, merge with or otherwise become part of or associated with any other company or association in any manner permitted by law.

 

  (ii) To purchase or otherwise acquire the entire issued share capital of Nexvet Biopharma Pty Ltd and warrants, options and other rights to acquire share capital in Nexvet Biopharma Pty Ltd in consideration for shares, debentures, debenture stock securities, options, warrants and other rights to or over shares to be issued or granted by the Company to the shareholders, option holders and warrant holders of Nexvet Biopharma Pty Ltd on such terms and in such amounts as the directors shall determine.

 

  (jj) To do and carry out all such other things, except the issuing of policies of insurance, as may be deemed by the Company capable of being conveniently carried on in connection with the above objects or any of them or calculated to enhance the value of or render profitable any of the Company’s properties or rights.

And it is hereby declared that the word “company” in this clause, except where used in reference to this Company, shall be deemed to include any person, partnership or other body of persons whether incorporated or not incorporated and whether domiciled in the State or elsewhere and that the objects of the Company as specified in each of the foregoing paragraphs of this clause shall be separate and distinct objects and shall not be in anywise limited or restricted by reference to or inference from the terns of any other paragraph or the name of the Company.

 

4. The liability of each member is limited to the amount from time to time unpaid on such member’s shares.

 

5. The authorised share capital of the Company is €40,000 divided into 400 euro deferred shares of €100 each, and US$12,600,000 divided into 100,000,000 ordinary shares of US$0.125 each and 10,000,000 undesignated preferred shares of US$0.01 each.

 

6. The shares forming the capital, increased or reduced, may be increased or reduced and be divided into such classes and issued with any special rights, privileges and conditions or with such qualifications as regards preference, dividend, capital, voting or other special incidents, and be held upon such terms as may be attached thereto or as may from time to time be provided by the original or any substituted or amended articles of association and regulations of the Company for the time being, but so that where shares are issued with any preferential or special rights attached thereto such rights shall not be alterable otherwise than pursuant to the provisions of the Company’s articles of association for the time being.

 

7. Capitalised terms that are not defined in this memorandum of association bear the same meaning as those given in the articles of association of the Company.

 

7


COMPANIES ACTS 1963 TO 2013

A PUBLIC COMPANY LIMITED BY SHARES

ARTICLES OF ASSOCIATION

OF

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

(Amended and restated by Special Resolution dated 17 November 2014)

PRELIMINARY

 

1. The regulations contained in Table A in the First Schedule to the 1963 Act shall not apply to the Company.

 

2.     

 

  2.1 In these Articles:

 

“1963 Act”

   means the Companies Act 1963.

“1983 Act”

   means the Companies (Amendment) Act 1983.

“1990 Act”

   means the Companies Act 1990.

“Address”

   Includes any number or address used for the purposes of communication by way of electronic mail or other electronic communication.

“Adoption Date”

   means the date of adoption of these Articles.
“Articles” or “Articles of Association”    means these articles of association of the Company, as amended from time to time by Special Resolution.

“Assistant Secretary”

   means any person appointed by the Directors from time to time to assist the Secretary.

“Auditors”

   means the persons for the time being performing the duties of auditors of the Company.

“Board”

   means the board of directors for the time being of the Company.

“clear days”

   means, in relation to a period of notice, that period excluding the day when the notice is given or deemed to be given and the day for which it is given or on which it is to take effect.


“Companies Acts”    means the Companies Acts 1963-2013 and every statutory modification, replacement and re-enactment thereof for the time being in force.
“Company”    means the above-named company.
“Court”    means the Irish High Court.
“Directors”    means the directors for the time being of the Company.
“dividend”    includes interim dividends and bonus dividends.
electronic communication”    shall have the meaning given to those words in the Electronic Commerce Act 2000.
electronic signature”    shall have the meaning given to those words in the Electronic Commerce Act 2000.
“Exchange”    means any securities exchange or other system on which the Shares of the Company may be listed or otherwise authorised for trading from time to time.
“Exchange Act”    means the Securities Exchange Act of 1934 of the United States of America.
“Member”    means a person who has agreed to become a Member of the Company and whose name is entered in the Register of Members as a registered holder of Shares.
“Memorandum”    means the memorandum of association of the Company as amended from time to time by Special Resolution.
“month”    means a calendar month.
“Ordinary Resolution”    means an ordinary resolution of the Company’s Members within the meaning of section 141 of the 1963 Act.
“paid-up”    means paid-up as to the nominal value and any premium payable in respect of the issue of any Shares and includes credited as paid-up.
“Redeemable Shares”    means redeemable shares in accordance with section 206 of the 1990 Act.
“Register of Members” or “Register”    means the register of Members of the Company maintained by or on behalf of the Company, in accordance with the Companies Acts and includes (except where otherwise stated) any duplicate Register of Members.

 

2


“registered office”    means the registered office for the time being of the Company.
“Seal”    means the common seal of the Company and includes every duplicate seal, every official seal and every securities seal.
“Secretary”    means the person appointed by the Board to perform any or all of the duties of secretary of the Company and includes a joint secretary, an Assistant Secretary and any person appointed by the Board to perform the duties of secretary of the Company.
“Share”    means a share in the capital of the Company.
“Special Resolution”    means a special resolution of the Company’s Members within the meaning of section 141 of the 1963 Act.

 

  2.2 In the Articles:

 

  (a) words importing the singular number include the plural number and vice-versa;

 

  (b) words importing the feminine gender include the masculine gender and vice-versa;

 

  (c) words importing persons include any company, partnership or other body of persons, whether corporate or not, any trust and any government, governmental body or agency or public authority, whether of Ireland or elsewhere;

 

  (d) “written” and “in writing” include all modes of representing or reproducing words in visible form, including electronic communication;

 

  (e) references to a company include any body corporate or other legal entity, whether incorporated or established in Ireland or elsewhere;

 

  (f) references to provisions of any law or regulation shall be construed as references to those provisions as amended, modified, re-enacted or replaced from time to time;

 

  (g) any phrase introduced by the terms “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms;

 

  (h) reference to “officer” or “officers” in these Articles means any executive that has been designated by the Company as an “officer” and, for the avoidance of doubt, shall not have the meaning given to such term in the 1963 Act and any such officers shall not constitute officers of the Company within the meaning of Section 2(1) of the 1963 Act;

 

  (i) headings are inserted for reference only and shall be ignored in construing these Articles;

 

3


  (j) references to US$, USD, $ or dollars shall mean United States dollars, the lawful currency of the United States of America and references to €, euro, or EUR shall mean the euro, the lawful currency of Ireland; and

 

  (k) save as otherwise expressly provided in these Articles, where a provision of these Articles covers substantially the same subject matter as an optional provision of the Companies Acts, the section of the Companies Acts shall be deemed not to apply to the Company and, for the avoidance of doubt, these Articles shall be deemed to have effect and prevail over the terms of such optional provision of the Companies Acts which would otherwise apply.

SHARE CAPITAL; ISSUE OF SHARES

 

3. The authorised share capital of the Company is €40,000 divided into 400 euro deferred shares of €100 each, and US$12,600,000 divided into 100,000,000 ordinary shares of US$0.125 each and 10,000,000 undesignated preferred shares of US$0.01 each.

 

4. Subject to the provisions of these Articles relating to new Shares, the Shares shall be at the disposal of the Directors, and they may (subject to the provisions of the Companies Acts) allot, grant options over or otherwise dispose of them to such persons, on such terms and conditions and at such times as they may consider to be in the best interests of the Company and its Members, but so that no Share shall be issued at a discount save in accordance with sections 26(5) and 28 of the 1983 Act, and so that, in the case of Shares offered to the public for subscription, the amount payable on application on each Share shall not be less than one-quarter of the nominal amount of the Share and the whole of any premium thereon. To the extent permitted by the Companies Acts, Shares may also be allotted by a committee of the Directors or by any other person where such committee or person is so authorised by the Directors.

 

5. Subject to any requirement to obtain the approval of Members under any laws, regulations or the rules of any Exchange, the Board is authorised, from time to time, in its discretion, to grant such persons, for such periods and upon such terms as the Board deems advisable, options to purchase or subscribe for any number of Shares of any class or classes or of any series of any class as the Board may deem advisable, and to cause warrants or other appropriate instruments evidencing such options to be issued.

 

6.     

 

  6.1 The Directors are, for the purposes of section 20 of the 1983 Act, generally and unconditionally authorised to exercise all powers of the Company to allot and issue relevant securities (as defined by the said section 20) up to the amount of Company’s authorised but unissued share capital as at the date of adoption of these Articles and to allot and issue any Shares purchased or redeemed by or on behalf of the Company pursuant to the provisions of Part XI of the 1990 Act and held as treasury shares and this authority shall expire five years from the date of adoption of these Articles, save that the Company may before such expiry make an offer or agreement which would or might require relevant securities to be allotted after such expiry and the Directors may allot relevant securities in pursuance of such offer or agreement as if the authority conferred hereby had not expired;

 

  6.2

The Directors are hereby empowered pursuant to sections 23 and 24(1) of the 1983 Act to allot equity securities within the meaning of the said section 23 for cash pursuant to the authority conferred by Article 6.1 as if section 23(1) of the said 1983

 

4


  Act did not apply to any such allotment. The Company may before the expiry of such authority make an offer or agreement which would or might require equity securities to be allotted after such expiry and the Directors may allot equity securities in pursuance of such an offer or agreement as if the power conferred by Article 6.1 had not expired.

 

  6.3 The Company may issue share warrants to bearer pursuant to section 88 of the 1963 Act.

 

7. Without prejudice to any special rights previously conferred on the holders of any existing Shares or class of Shares or to the authority conferred on the Directors pursuant to Article 12 to issue the preferred shares, any Share in the Company may be issued with such preferred or deferred or other special rights or such restrictions, whether in regard to dividend, voting, return of capital or otherwise, as the Company may from time to time by Ordinary Resolution determine.

 

8. The Company may pay commission to any person in consideration of any person subscribing or agreeing to subscribe, whether absolutely or conditionally, for the Shares in the Company or procuring or agreeing to procure subscriptions, whether absolute or conditional, for any Shares in the Company on such terms and, subject to the provisions of the Companies Acts and to such conditions as the Directors may determine, including by paying cash or allotting and issuing fully or partly paid Shares or any combination of the two. The Company may also on any issue of Shares pay such brokerage as may be lawful.

ORDINARY SHARES

 

9. The holder of an ordinary share shall be:

 

  9.1 entitled to dividends on a pro rata basis in accordance with the relevant provisions of these Articles;

 

  9.2 entitled to participate pro rata in the total assets of the Company in the event of the Company’s winding up; and

 

  9.3 entitled, subject to the right of the Company to set record dates for the purpose of determining the identity of Members entitled to notice of and/or vote at a general meeting, to attend general meetings of the Company and shall be entitled to one vote for each ordinary share registered in his name in the Register of Members, both in accordance with the relevant provisions of these Articles.

The rights attaching to the ordinary shares may be subject to the terms of issue of any series or class of preferred share allotted by the Directors from time to time in accordance with Article 12.

 

10. An ordinary share shall be deemed to be a Redeemable Share on, and from the time of, the existence or creation of an agreement, transaction or trade between the Company (including any agent or broker acting on behalf of the Company) and any person (who may or may not be a Member) pursuant to which the Company acquires or will acquire ordinary shares, or an interest in ordinary shares, from the relevant person. In these circumstances, the acquisition of such Shares by the Company, save where acquired for nil consideration in accordance with the Companies Acts, shall constitute the redemption of a Redeemable

 

5


Share in accordance with Part XI of the 1990 Act. A resolution of the Board shall be passed to deem any ordinary share a Redeemable Share (and no resolution of the Members, whether special or otherwise, shall be required).

 

11. All ordinary shares shall rank pari passu with each other in all respects.

PREFERRED SHARES

 

12.     

 

12.1 The Directors are authorised to issue all or any of the authorised but unissued preferred shares from time to time in one or more classes or series, and to fix for each such class or series such voting powers (full or limited or without voting powers), designations, preferences and relative, participating, optional or other special rights and qualifications, limitations or restrictions thereof as are stated and expressed, or in any resolution or resolutions providing for the issue of such class or series adopted by the Board as hereinafter provided, including and subject to the Memorandum and Articles and applicable law, the authority to provide that any such class or series may be:

 

  (a) redeemable at the option of the Company, or the Members, or both, with the manner of the redemption to be set by the Board, and redeemable at such time or times, including upon a fixed date, and at such price or prices;

 

  (b) entitled to receive dividends (which may be cumulative or non-cumulative) at such rates, on such conditions at such times and in respect of such dividend periods (the “Dividend Periods”), and payable in preference to, or in such relation to, the dividends payable on any other class or classes of Shares or any other series;

 

  (c) entitled to such rights upon the dissolution of, or upon any distribution of the assets of, the Company; or

 

  (d) convertible into, or exchangeable for, Shares of any other class or classes of Shares, or of any other series of the same or any other class or classes of Shares, of the Company at such price or prices or at such rates of exchange and with such adjustments as the Directors determine,

which rights and restrictions may be as stated in such resolution or resolutions of the Directors as determined by them in accordance with this Article 12. The Board may at any time before the allotment of any preferred share by further resolution in any way amend the designations, preferences, rights, qualifications, limitations or restrictions, or vary or revoke the designations of such preferred shares.

 

12.2 Notwithstanding the fixing of the number of preferred shares constituting a particular series upon the issuance thereof, the Board at any time thereafter may authorise the issuance of additional preferred shares of the same series subject always to the Companies Acts, the Memorandum and these Articles.

 

12.3 The rights conferred upon a Member holding any pre-existing Shares in the share capital of the Company shall be deemed not to be varied by the creation, issue and allotment of preferred shares in accordance with this Article 12.

 

6


12.4 No dividend shall be declared and set apart for payment on any series of preferred shares in respect of any Dividend Period unless there shall likewise be or have been paid, or declared and set apart for payment, on all preferred shares of each other series entitled to cumulative dividends at the time outstanding that rank senior or equally as to dividends with the series in question, dividends rateably in accordance with the sums which would be payable on the said preferred shares through the end of the last preceding Dividend Period if all dividends were declared and paid in full.

 

12.5 If, upon the winding up of the Company, the assets of the Company distributable among the holders of any one or more series of preferred shares which (i) are entitled to a preference over the holders of the ordinary shares upon such winding up, and (ii) rank equally in connection with any such distribution, shall be insufficient to pay in full the preferential amount to which the holders of such preferred shares shall be entitled, then such assets, or the proceeds thereof, shall be distributed among the holders of each such series of the preferred shares rateably in accordance with the sums which would be payable on such distribution if all sums payable were discharged in full.

EURO DEFERRED SHARES

 

13. The holders of the euro deferred shares shall not be entitled to receive any dividend or distribution and shall not be entitled to receive notice of, nor to attend, speak or vote at any general meeting of the Company. On a return of assets, whether on liquidation or otherwise, the euro deferred shares shall entitle the holder thereof only to the repayment of the amounts paid up on such Shares after repayment of the capital paid up on the ordinary shares plus the payment of $5,000,000 on each of the ordinary shares and the holders of the euro deferred shares (as such) shall not be entitled to any further participation in the assets or profits of the Company.

 

13A. If the holders of 75% or more of the shares of the Company in issue for the time being wish to sell and transfer all (but not some only) of their shares to a purchaser (the “Buyer”), the holders of the euro deferred shares shall sell and transfer (the “Sale and Transfer”) all of the euro deferred shares to the Buyer (or as the Buyer directs) in consideration only for the amount of capital paid up in respect of each of the euro deferred shares (the “Consideration”). If the holders of the euro deferred shares default in the Sale and Transfer to the Buyer (or as the Buyer directs), the holders of the euro deferred shares hereby irrevocably appoint one of the directors of the Company, or any other person who is appointed by the directors of the Company for the purpose as the duly appointed attorney of the holders of the euro deferred shares, with full power to execute, complete and deliver in the name of and on behalf of the holders of the euro deferred shares all such documentation as is required for the Sale and Transfer. Subject to the relevant transfer being properly stamped (where applicable), the Company shall cause the Buyer to be registered as the holder of the euro deferred shares, but the Buyer is not responsible for what is done with any Consideration paid. Entitlement to the euro deferred shares is not affected by any irregularity or invalidity in the sale and transfer procedure. The Company may give a good receipt for the Consideration, shall hold the Consideration in trust for the holders of the euro deferred shares and may issue share certificates for the euro deferred shares to the Buyer (or as the Buyer directs).

 

13B. Any portion of the euro deferred shares which have not been already called up shall not be capable of being called up except in the event and for the purposes of the Company being wound up, and thereupon that portion of the euro deferred shares shall not be capable of being called up except in the event and for the purposes aforesaid.

 

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14. The special resolution passed on the Adoption Date adopting these Articles shall be deemed to confer irrevocable authority on the Company at any time after the Adoption Date:

 

  14.1 to acquire all or any of the fully paid euro deferred shares otherwise than for valuable consideration in accordance with Section 41(2) of the 1983 Act and without obtaining the sanction of the holders thereof;

 

  14.2 to appoint any person to execute on behalf of the holders of the euro deferred shares remaining in issue (if any) a transfer thereof and/or an agreement to transfer the same otherwise than for valuable consideration to the Company or to such other person as the Company may nominate;

 

  14.3 to cancel any acquired euro deferred shares; and

 

  14.4 pending such acquisition and/or transfer and/or cancellation to retain the certificate (if any) for such euro deferred shares.

 

15. In accordance with Section 43(3) of the 1983 Act the Company shall, not later than three years after any acquisition by it of any euro deferred shares as aforesaid, cancel such Shares (except those which, or any interest of the Company in which, it shall have previously disposed of) and reduce the amount of the share capital by the nominal value of the Shares so cancelled and the Directors may take such steps as are requisite to enable the Company to carry out its obligations under that subsection without complying with Sections 72 and 73 of the 1963 Act including passing resolutions in accordance with Section 43(5) of the 1983 Act.

 

16. Neither the acquisition by the Company otherwise than for valuable consideration of all or any of the euro deferred shares nor the redemption thereof nor the cancellation thereof by the Company in accordance with Articles 14 and 15 shall constitute a variation or abrogation of the rights or privileges attached to the euro deferred shares, and accordingly the euro deferred shares or any of them may be so acquired, redeemed and cancelled without any such consent or sanction on the part of the holders thereof. The rights conferred upon the holders of the euro deferred shares shall not be deemed to be varied or abrogated by the creation of further Shares ranking in priority thereto or pari passu therewith.

ISSUE OF WARRANTS

 

17. The Board may issue warrants to subscribe for any class of Shares or other securities of the Company on such terms as it may from time to time determine.

CERTIFICATES FOR SHARES

 

18. Unless otherwise provided for by the Board or the rights attaching to or by the terms of issue of any particular Shares, or to the extent required by any Exchange, depository, or any operator of any clearance or settlement system, no person whose name is entered as a Member in the Register of Members shall be entitled to receive a share certificate for all Shares of each class held by him (nor on transferring a part of holding, to a certificate for the balance).

 

19.

Any share certificate, if issued, shall specify the number of Shares in respect of which it is issued and the amount paid thereon or the fact that they are fully paid, as the case may be, and may otherwise be in such form as shall be determined by the Board. Such certificates may be under Seal. All certificates for Shares shall be consecutively numbered or otherwise

 

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  identified and shall specify the Shares to which they relate. The name and address of the person to whom the Shares represented thereby are issued, with the number of Shares and date of issue, shall be entered in the Register of Members of the Company. All certificates surrendered to the Company for transfer shall be cancelled and no new certificate shall be issued until the former certificate for a like number of Shares shall have been surrendered and cancelled. The Board may authorise certificates to be issued with the Seal and authorised signature(s) affixed by some method or system of mechanical process. In respect of a Share or Shares held jointly by several persons, the Company shall not be bound to issue a certificate or certificates to each such person, and the issue and delivery of a certificate or certificates to one of several joint holders shall be sufficient delivery to all such holders.

 

20. If a share certificate is defaced, worn out, lost or destroyed, it may be renewed on such terms (if any) as to evidence and indemnity and on the payment of such expenses reasonably incurred by the Company in investigating such evidence, as the Board may prescribe, and, in the case of defacement or wearing out, upon delivery of the old certificate.

REGISTER OF MEMBERS

 

21. The Company shall maintain or cause to be maintained a Register of its Members in accordance with the Companies Acts.

 

22. If the Board considers it necessary or appropriate, the Company may establish and maintain a duplicate Register or Registers of Members at such location or locations within or outside Ireland as the Board thinks fit. The original Register of Members shall be treated as the Register of Members for the purposes of these Articles and the Companies Acts.

 

23. The Company, or any agent(s) appointed by it to maintain the duplicate Register of Members in accordance with these Articles, shall as soon as practicable and on a regular basis record or procure the recording in the original Register of Members all transfers of Shares effected on any duplicate Register of Members and shall at all times maintain the original Register of Members in such manner as to show at all times the Members for the time being and the Shares respectively held by them, in all respects in accordance with the Companies Acts.

 

24. The Company shall not be bound to register more than four persons as joint holders of any Share. If any Share shall stand in the names of two or more persons, the person first named in the Register of Members shall be deemed the sole holder thereof as regards service of notices and, subject to the provisions of these Articles, all or any other matters connected with the Company.

TRANSFER OF SHARES

 

25. All transfers of Shares shall be effected by an instrument of transfer in the usual form or such other form as the Board may approve. All instruments of transfer must be left at the registered office or at such other place as the Board may appoint and all such instruments of transfer shall be retained by the Company.

 

26.     

 

  26.1

The instrument of transfer shall be executed by or on behalf of the transferor. The instrument of transfer of any Share shall be in writing and shall be executed with a manual signature or facsimile signature (which may be machine imprinted or

 

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  otherwise) by or on behalf of the transferor provided that in the case of execution by facsimile signature by or on behalf of a transferor, the Board shall have previously been provided with a list of specimen signatures of the authorised signatories of such transferor and the Board shall be reasonably satisfied that such facsimile signature corresponds to one of those specimen signatures. The instrument of transfer need not be signed by the transferee except to the extent required by the Companies Acts.

 

  26.2 The instrument of transfer of any Share may be executed for and on behalf of the transferor by any Director, the Secretary or an Assistant Secretary on behalf of the Company, and the Company shall be deemed to have been irrevocably appointed agent for the transferor of such Share or Shares with full power to execute, complete and deliver in the name of and on behalf of the transferor of such Share or Shares all such transfers of Shares held by the Members in the share capital of the Company. Any document which records the name of the transferor, the name of the transferee, the class and number of Shares agreed to be transferred, details of the total consideration payable and the date of the agreement to transfer the Shares, shall, once executed by the transferor or any Director or the Secretary or Assistant Secretary on behalf of the Company as agent for the transferor, be deemed to be a proper instrument of transfer for the purposes of section 81 of the 1963 Act. The transferor shall be deemed to remain the holder of the Share until the name of the transferee is entered on the Register in respect thereof, and neither the title of the transferee nor the title of the transferor shall be affected by any irregularity or invalidity in the proceedings in reference to the sale should the Directors so determine.

 

  26.3 The Company, at its absolute discretion and insofar as the Companies Acts or any other applicable law permits, may, or may procure that a subsidiary of the Company shall, pay Irish stamp duty arising on a transfer of Shares on behalf of the transferee of such Shares of the Company. If stamp duty resulting from the transfer of Shares in the Company which would otherwise be payable by the transferee is paid by the Company or any subsidiary of the Company on behalf of the transferee, then in those circumstances, the Company shall, on its behalf or on behalf of its subsidiary (as the case may be), be entitled to (i) seek reimbursement of the stamp duty from the transferee, (ii) set-off the stamp duty against any dividends payable to the transferee of those Shares and (iii) to claim a first and permanent lien on the Shares on which stamp duty has been paid by the Company or its subsidiary for the amount of stamp duty paid. The Company’s lien shall extend to all dividends paid on those Shares.

 

  26.4 Notwithstanding the provisions of these Articles and subject to any regulations made under section 239 of the 1990 Act, title to any Shares in the Company may also be evidenced and transferred without a written instrument in accordance with section 239 of the 1990 Act or any regulations made thereunder. The Directors shall have power to permit any class of Shares to be held in uncertificated form and to implement any arrangements they think fit for such evidencing and transfer which accord with such regulations and in particular shall, where appropriate, be entitled to disapply or modify all or part of the provisions in these Articles with respect to the requirement for written instruments of transfer and share certificates (if any), in order to give effect to such regulations.

 

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27. The Board may in its absolute discretion and without assigning any reason for its decision, decline to register any transfer of any Share which is not a fully paid Share. The Board may also, in its absolute discretion, and without assigning any reason, refuse to register a transfer of any Share unless:

 

  27.1 the instrument of transfer is fully and properly completed and lodged with the Company accompanied by the certificate for the Shares (if any) to which it relates (which shall upon registration of the transfer be cancelled) and such other evidence as the Board may reasonably require to show the right of the transferor to make the transfer;

 

  27.2 the instrument of transfer is in respect of only one class of Shares;

 

  27.3 a registration statement under the Securities Act of 1933 of the United States of America is in effect with respect to such transfer or such transfer is exempt from registration and, if requested by the Board, a written opinion from counsel reasonably acceptable to the Board is obtained to the effect that such transfer is exempt from registration;

 

  27.4 the instrument of transfer is properly stamped (in circumstances where stamping is required). For the purposes of these Articles, the Company is entitled to assume that the instrument of transfer is chargeable with stamp duty unless the transferor or transferee can demonstrate that it is not chargeable;

 

  27.5 in the case of a transfer to joint holders, the number of joint holders to which the Share is to be transferred does not exceed four;

 

  27.6 it is satisfied, acting reasonably, that all applicable consents, authorisations, permissions or approvals of any governmental body or agency in Ireland or any other applicable jurisdiction required to be obtained under relevant law prior to such transfer have been obtained; and

 

  27.7 it is satisfied, acting reasonably, that the transfer would not violate the terms of any agreement to which the Company (or any of its subsidiaries) and the transferor are party or subject.

 

28. If the Board shall refuse to register a transfer of any Share, it shall, within two (2) months after the date on which the transfer was lodged with the Company, send to each of the transferor and the transferee notice of such refusal.

 

29. The Company shall not be obligated to make any transfer to an infant or to a person in respect of whom an order has been made by a competent court or official on the grounds that he is or may be suffering from mental disorder or is otherwise incapable of managing his affairs or under other legal disability.

 

30. Upon every transfer of Shares the certificate (if any) held by the transferor shall be given up to be cancelled, and shall forthwith be cancelled accordingly, and subject to Article 18 a new certificate may be issued without charge to the transferee in respect of the Shares transferred to him, and if any of the Shares included in the certificate so given up shall be retained by the transferor, a new certificate in respect thereof may be issued to him without charge. The Company shall also retain the instrument(s) of transfer.

 

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REDEMPTION AND REPURCHASE OF SHARES

 

31. Subject to the provisions of Part XI of the 1990 Act and the other provisions of these Articles, the Company may:

 

  31.1 pursuant to section 207 of the 1990 Act, issue any Shares of the Company which are to be redeemed or are liable to be redeemed at the option of the Company or the Member on such terms and in such manner as (i) are set out in these Articles or (ii) may be determined by the Company in general meeting (by Special Resolution) on the recommendation of the Directors;

 

  31.2 redeem Shares of the Company on such terms as may be contained in, or be determined pursuant to the provisions of, these Articles. Subject as aforesaid, the Company may cancel any Shares so redeemed or may hold them as treasury shares and re-issue such treasury shares as Shares of any class or classes or cancel them;

 

  31.3 subject to or in accordance with the provisions of the Companies Acts and without prejudice to any relevant special rights attached to any class of Shares, pursuant to section 211 of the 1990 Act, purchase any of its own Shares (including any Redeemable Shares and without any obligation to purchase on any pro rata basis as between Members or Members of the same class) and may cancel any Shares so purchased or hold them as treasury (as defined by section 209 of the 1990 Act) and may reissue any such Shares as Shares of any class or classes or cancel them; or

 

  31.4 pursuant to section 210 of the 1990 Act, by way of resolution of the Board, convert any of its Shares into Redeemable Shares provided that the total number of Shares which shall be redeemable pursuant to this authority shall not exceed the limit in section 210(4) of the 1990 Act. No resolution of Members, whether special or otherwise, shall be required to be passed to convert any of the Shares into Redeemable Shares.

 

32. The Company may make a payment in respect of the redemption or purchase of its own Shares in any manner permitted by the Companies Acts.

 

33. The holder of the Shares being purchased shall be bound to deliver up to the Company at its registered office or such other place as the Board shall specify, the certificate(s) (if any) thereof for cancellation and thereupon the Company shall pay to him the purchase or redemption monies or consideration in respect thereof.

VARIATION OF RIGHTS OF SHARES

 

34. If at any time the share capital of the Company is divided into different classes of Shares, the rights attached to any class (unless otherwise provided by the terms of issue of the Shares of that class) may be varied or abrogated with the consent in writing of the holders of three-quarters of all the votes of the issued Shares of that class, or with the sanction of a Special Resolution passed at a general meeting of the holders of the Shares of that class.

 

35. The provisions of these Articles relating to general meetings of the Company shall apply mutatis mutandis to every such general meeting of the holders of one class of Shares except that the necessary quorum shall be one or more persons holding or representing by proxy at least one-half of the issued Shares of the class.

 

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36. The rights conferred upon the holders of the Shares of any class issued with preferred or other rights shall not, unless otherwise expressly provided by the terms of issue of the Shares of that class, be deemed to be varied by (i) the creation or issue of further Shares ranking pari passu therewith; (ii) a purchase or redemption by the Company of its own Shares; or (iii) the creation or issue for value (as determined by the Board) of further Shares ranking as regards participation in the profits or assets of the Company or otherwise in priority to them.

LIEN ON SHARES

 

37. The Company shall have a first and paramount lien on every Share (not being a fully paid Share) for all monies (whether presently payable or not) payable at a fixed time or called in respect of that Share. The Directors, at any time, may declare any Share to be wholly or in part exempt from the provisions of this Article. The Company’s lien on a Share shall extend to all monies payable in respect of it. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as Articles 37 to 41 are dis-applied.

 

38. The Company may sell in such manner as the Directors determine any Share on which the Company has a lien if a sum in respect of which the lien exists is presently payable and is not paid within 14 clear days after notice demanding payment, and stating that if the notice is not complied with the Share may be sold, has been given to the holder of the Share or to the person entitled to it by reason of the death or bankruptcy of the holder.

 

39. To give effect to a sale, the Directors may authorise some person to execute an instrument of transfer of the Share sold to, or in accordance with the directions of, the transferee. The transferee shall be entered in the Register as the holder of the Share comprised in any such transfer and he shall not be bound to see to the application of the purchase monies nor shall his title to the Share be affected by any irregularity in or invalidity of the proceedings in reference to the sale, and after the name of the transferee has been entered in the Register, the remedy of any person aggrieved by the sale shall be in damages only and against the Company exclusively.

 

40. The net proceeds of the sale, after payment of the costs, shall be applied in payment of so much of the sum for which the lien exists as is presently payable and any residue (upon surrender to the Company for cancellation of the certificate for the Shares sold and subject to a like lien for any monies not presently payable as existed upon the Shares before the sale) shall be paid to the person entitled to the Shares at the date of the sale.

 

41. Whenever any law for the time being of any country, state or place imposes or purports to impose any immediate or future or possible liability upon the Company to make any payment or empowers any government or taxing authority or government official to require the Company to make any payment in respect of any Shares registered in the Register as held either jointly or solely by any Members or in respect of any dividends, bonuses or other monies due or payable or accruing due or which may become due or payable to such Member by the Company on or in respect of any Shares registered as mentioned above or for or on account or in respect of any Member and whether in consequence of:

 

  41.1 the death of such Member;

 

  41.2 the non-payment of any income tax or other tax by such Member;

 

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  41.3 the non-payment of any estate, probate, succession, death, stamp or other duty by the executor or administrator of such Member or by or out of his estate; or

 

  41.4 any other act or thing;

in every such case (except to the extent that the rights conferred upon holders of any class of Shares render the Company liable to make additional payments in respect of sums withheld on account of the foregoing):

 

  41.5 the Company shall be fully indemnified by such Member or his executor or administrator from all liability;

 

  41.6 the Company shall have a lien upon all dividends and other monies payable in respect of the Shares registered in the Register as held either jointly or solely by such Member for all monies paid or payable by the Company as referred to above in respect of such Shares or in respect of any dividends or other monies thereon or for or on account or in respect of such Member under or in consequence of any such law, together with interest at the rate of 15% per annum (or such other rate as the Board may determine) thereon from the date of payment to date of repayment, and the Company may deduct or set off against such dividends or other monies so payable any monies paid or payable by the Company as referred to above together with interest at the same rate;

 

  41.7 the Company may recover as a debt due from such Member or his executor or administrator (wherever constituted) any monies paid by the Company under or in consequence of any such law and interest thereon at the rate and for the period referred to above in excess of any dividends or other monies then due or payable by the Company; and

 

  41.8 the Company may if any such money is paid or payable by it under any such law as referred to above refuse to register a transfer of any Shares by any such Member or his executor or administrator until such money and interest is set off or deducted as referred to above or in the case that it exceeds the amount of any such dividends or other monies then due or payable by the Company, until such excess is paid to the Company.

Subject to the rights conferred upon the holders of any class of Shares, nothing in this Article 41 will prejudice or affect any right or remedy which any law may confer or purport to confer on the Company. As between the Company and every such Member as referred to above (and, his executor, administrator and estate, wherever constituted), any right or remedy which such law shall confer or purport to confer on the Company shall be enforceable by the Company.

CALLS ON SHARES

 

42. Subject to the terms of allotment, the Directors may make calls upon the Members in respect of any monies unpaid on their Shares including Shares where the conditions of allotment provide for payment at fixed times and each Member (subject to receiving at least 14 clear days’ notice specifying when and where payment is to be made) shall pay to the Company as required by the notice the amount called on his Shares. A call may be required to be paid by instalments. A call may be revoked before receipt by the Company of a sum due thereunder, in whole or in part and payment of a call may be postponed in whole or in part. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as Articles 42 to 49 are dis-applied.

 

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43. A call shall be deemed to have been made at the time when the resolution of the Directors authorising the call was passed.

 

44. A person on whom a call is made shall (in addition to a transferee) remain liable notwithstanding the subsequent transfer of the Share in respect of which the call is made.

 

45. The joint holders of a Share shall be jointly and severally liable to pay all calls in respect thereof.

 

46. If a call remains unpaid after it has become due and payable, the person from whom it is due and payable shall pay interest on the amount unpaid from the day it became due until it is paid at the rate fixed by the terms of allotment of the Share or in the notice of the call or, if no rate is fixed, at the appropriate rate (as defined by the Companies Acts) but the Directors may waive payment of the interest wholly or in part.

 

47. An amount payable in respect of a Share on allotment or at any fixed date, whether in respect of nominal value by way of premium, shall be deemed to be a call and if it is not paid the provisions of these Articles shall apply as if that amount had become due and payable by virtue of a call.

 

48. Subject to the terms of allotment, the Directors may make arrangements on the issue of Shares for a difference between the holders in the amounts and times of payment of calls on their Shares.

 

49. The Directors may, if they think fit, receive from any Member willing to advance the same all or any part of the monies uncalled and unpaid upon any Shares held by him, and upon all or any of the monies so advanced may pay (until the same would, but for such advance, become payable) interest at such rate as may be agreed upon between the Directors and the Member paying such sum in advance.

FORFEITURE

 

50. If a Member fails to pay any call or instalment of a call on the day appointed for payment thereof, the Directors, at any time thereafter during such times as any part of the call or instalment remains unpaid, may serve a notice on him requiring payment of so much of the call or instalment as is unpaid together with any interest which may have accrued. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as Articles 50 to 58 are dis-applied.

 

51. The notice shall state a further day (not earlier than the expiration of 14 clear days from the date of service of the notice) on or before which the payment required by the notice is to be made, and shall state that in the event of non-payment at or before the time appointed the Shares in respect of which the call was made will be liable to be forfeited.

 

52. If the requirements of any such notice as aforesaid are not complied with then, at any time thereafter before the payment required by the notice has been made, any Shares in respect of which the notice has been given may be forfeited by a resolution of the Directors to that effect. The forfeiture shall include all dividends or other monies payable in respect of the forfeited Shares and not paid before forfeiture. The Directors may accept a surrender of any Share liable to be forfeited hereunder.

 

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53. On the trial or hearing of any action for the recovery of any money due for any call it shall be sufficient to prove that the name of the Member sued is entered in the Register as the holder, or one of the holders, of the Shares in respect of which such debt accrued, that the resolution making the call is duly recorded in the minute book and that notice of such call was duly given to the Member sued, in pursuance of these Articles, and it shall not be necessary to prove the appointment of the Directors who made such call nor any other matters whatsoever, but the proof of the matters aforesaid shall be conclusive evidence of the debt.

 

54. A forfeited Share may be sold or otherwise disposed of on such terms and in such manner as the Directors think fit and at any time before a sale or disposition the forfeiture may be cancelled on such terms as the Directors think fit. Where for the purposes of its disposal such a Share is to be transferred to any person, the Directors may authorise some person to execute an instrument of transfer of the Share to that person. The Company may receive the consideration, if any, given for the Share on any sale or disposition thereof and may execute a transfer of the Share in favour of the person to whom the Share is sold or disposed of and thereupon he shall be registered as the holder of the Share and shall not be bound to see to the application of the purchase money, if any, nor shall his title to the Share be affected by any irregularity or invalidity in the proceedings in reference to the forfeiture, sale or disposal of the Share.

 

55. A person whose Shares have been forfeited shall cease to be a Member in respect of the forfeited Shares, but nevertheless shall remain liable to pay to the Company all monies which, at the date of forfeiture, were payable by him to the Company in respect of the Shares, without any deduction or allowance for the value of the Shares at the time of forfeiture but his liability shall cease if and when the Company shall have received payment in full of all such monies in respect of the Shares.

 

56. A statutory declaration or affidavit that the declarant is a Director or the Secretary of the Company, and that a Share in the Company has been duly forfeited on the date stated in the declaration, shall be conclusive evidence of the facts therein stated as against all persons claiming to be entitled to the Share.

 

57. The provisions of these Articles as to forfeiture shall apply in the case of non-payment of any sum which, by the terms of issue of a Share, becomes payable at a fixed time, whether on account of the nominal value of the Share or by way of premium, as if the same had been payable by virtue of a call duly made and notified.

 

58. The Directors may accept the surrender of any Share which the Directors have resolved to have been forfeited upon such terms and conditions as may be agreed and, subject to any such terms and conditions, a surrendered Share shall be treated as if it has been forfeited.

NON-RECOGNITION OF TRUSTS

 

59. The Company shall not be obligated to recognise any person as holding any Share upon any trust (except as is otherwise provided in these Articles or to the extent required by law) and the Company shall not be bound by or be compelled in any way to recognise (even when having notice thereof) any equitable, contingent, future, or partial interest in any Share, or any interest in any fractional part of a Share, or (except only as is otherwise provided by these Articles or the Companies Acts) any other rights in respect of any Share except an absolute right to the entirety thereof in the registered holder. This shall not preclude the Company from requiring the Members or a transferee of Shares to furnish to the Company with information as to the beneficial ownership of any Share when such information is reasonably required by the Company.

 

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TRANSMISSION OF SHARES

 

60. In case of the death of a Member, the survivor or survivors where the deceased was a joint holder, and the legal personal representatives of the deceased where he was a sole holder, shall be the only persons recognised by the Company as having any title to his interest in the Shares, but nothing herein contained shall release the estate of any such deceased holder from any liability in respect of any Shares which had been held by him solely or jointly with other persons. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as Articles 60 to 64 are dis-applied.

 

61. Any person becoming entitled to a Share in consequence of the death or bankruptcy or liquidation or dissolution of a Member (or in any other way than by transfer) may, upon such evidence being produced as may from time to time be required by the Board and subject as hereinafter provided, elect either to be registered himself as holder of the Share or to make such transfer of the Share to such other person nominated by him and to have such person registered as the transferee thereof, but the Board shall, in either case, have the same right to decline or suspend registration as they would have had in the case of a transfer of the Share by that Member before his death or bankruptcy as the case may be.

 

62. If the person so becoming entitled shall elect to be registered himself as holder, he shall deliver or send to the Company a notice in writing signed by him stating that he so elects.

 

63. Subject to Article 62, a person becoming entitled to a Share by reason of the death or bankruptcy or liquidation or dissolution of the holder (or in any other case than by transfer) shall be entitled to the same dividends and other advantages to which he would be entitled if he were the registered holder of the Share, except that he shall not, before being registered as a Member in respect of the Share, be entitled in respect of it to exercise any right conferred by Membership in relation to meetings of the Company provided however that the Board may at any time give notice requiring any such person to elect either to be registered himself or to transfer the Share and if the notice is not complied with within 90 days the Board may thereafter withhold payment of all dividends, bonuses or other monies payable in respect of the Share until the requirements of the notice have been complied with.

 

64. The Board may at any time give notice requiring a person entitled by transmission to a Share to elect either to be registered himself or to transfer the Share and if the notice is not complied with within 60 days the Board may withhold payment of all dividends and other monies payable in respect of the Share until the requirements of the notice have been complied with.

AMENDMENT OF MEMORANDUM OF ASSOCIATION;

CHANGE OF LOCATION OF REGISTERED OFFICE; AND

ALTERATION OF CAPITAL

 

65. The Company may by Ordinary Resolution:

 

  65.1 divide its share capital into several classes and attach to them respectively any preferential, deferred, qualified or special rights, privileges or conditions;

 

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  65.2 increase the authorised share capital by such sum to be divided into Shares of such nominal value, as such Ordinary Resolution shall prescribe;

 

  65.3 consolidate and divide all or any of its share capital into Shares of larger amount than its existing Shares;

 

  65.4 by subdivision of its existing Shares or any of them divide the whole or any part of its share capital into Shares of smaller nominal value than is fixed by the Memorandum subject to section 68(1)(d) of the 1963 Act, so, however, that in the sub-division the proportion between the amount paid and the amount, if any, unpaid on each reduced Share shall be the same as it was in the case of the Share from which the reduced Share is derived;

 

  65.5 cancel any Shares that at the date of the passing of the relevant Ordinary Resolution have not been taken or agreed to be taken by any person; and

 

  65.6 subject to applicable law, change the currency denomination of its share capital.

 

66. Subject to the provisions of the Companies Acts, the Company may:

 

  66.1 by Special Resolution change its name, alter or add to the Memorandum with respect to any objects, powers or other matters specified therein or alter or add to these Articles;

 

  66.2 by Special Resolution reduce its issued share capital and any capital redemption reserve fund or any share premium account. In relation to such reductions, the Company may by Special Resolution determine the terms upon which the reduction is to be effected, including in the case of a reduction of part only of any class of Shares, those Shares to be affected; and

 

  66.3 by resolution of the Directors change the location of its registered office.

 

67. Whenever as a result of an alteration or reorganisation of the share capital of the Company any Members would become entitled to fractions of a Share, the Directors may, on behalf of those Members, sell the Shares representing the fractions for the best price reasonably obtainable to any person and distribute the proceeds of sale in due proportion among those Members, and the Directors may authorise any person to execute an instrument of transfer of the Shares to, or in accordance with the directions of, the purchaser. The transferee shall not be bound to see to the application of the purchase money nor shall his title to the Shares be affected by any irregularity in or invalidity of the proceedings in reference to the sale.

CLOSING REGISTER OF MEMBERS OR FIXING RECORD DATE

 

68. For the purpose of determining Members entitled to notice of or to vote at any meeting of Members or any adjournment thereof, or Members entitled to receive payment of any dividend, or in order to make a determination of Members for any other proper purpose, the Board may provide, subject to the requirements of section 121 of the 1963 Act, that the Register of Members shall be closed for transfers at such times and for such periods, not exceeding in the whole 30 days in each year. If the Register of Members shall be so closed for the purpose of determining Members entitled to notice of or to vote at a meeting of Members such Register of Members shall be so closed for at least 5 days immediately preceding such meeting and the record date for such determination shall be the date of the closure of the Register of Members.

 

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69. In lieu of, or apart from, closing the Register of Members, the Board may fix in advance a date as the record date (a) for any such determination of Members entitled to notice of or to vote at a meeting of the Members, which record date shall not be more than 90 days nor less than 10 days before the date of such meeting, and (b) for the purpose of determining the Members entitled to receive payment of any dividend, or in order to make a determination of Members for any other proper purpose, which record date shall not be more than 90 days prior to the date of payment of such dividend or the taking of any action to which such determination of Members is relevant. The record date shall not precede the date upon which the resolution fixing the record date is adopted by the Directors.

 

70. If the Register of Members is not so closed and no record date is fixed for the determination of Members entitled to notice of or to vote at a meeting of Members or Members entitled to receive payment of a dividend, the date immediately preceding the date on which notice of the meeting is deemed given under these Articles or the date on which the resolution of the Directors declaring such dividend is adopted, as the case may be, shall be the record date for such determination of Members. When a determination of Members entitled to vote at any meeting of Members has been made as provided in these Articles, such determination shall apply to any adjournment thereof; provided, however, that the Directors may fix a new record date of the adjourned meeting, if they think fit.

GENERAL MEETINGS

 

71. The Board shall convene and the Company shall hold annual general meetings in accordance with the requirements of the Companies Acts.

 

72. The Board may, whenever it thinks fit, and shall, on the requisition in writing of Members holding such number of Shares as is prescribed by, and made in accordance with, section 132 of the 1963 Act, convene a general meeting in the manner required by the Companies Acts. All general meetings other than annual general meetings shall be called extraordinary general meetings. Where any optional provision of the Companies Acts confers rights on the members of a company to convene a general meeting without first directing the board of directors of the company to convene a general meeting and expresses such rights to apply save where a company’s articles of association or constitution provides otherwise, such rights shall not apply to the Members of the Company.

 

73. The Company shall in each year hold a general meeting as its annual general meeting in addition to any other meeting in that year, and shall specify the meeting as such in the notices calling it. Not more than fifteen months shall elapse between the date of one annual general meeting of the Company and that of the next. Subject to section 140 of the 1963 Act, all general meetings may be held outside of Ireland.

 

74. Each general meeting shall be held at such time and place as specified in the notice of meeting.

 

75. The Board may, in its absolute discretion, authorise the Secretary to postpone any general meeting called in accordance with the provisions of these Articles (other than a meeting requisitioned under Article 72 of these Articles or the postponement of which would be contrary to the Companies Acts, law or a court order pursuant to the Companies Acts) if the Board considers that, for any reason, it is impractical or unreasonable to hold the general meeting, provided that notice of postponement is given to each Member before the time for such meeting. Fresh notice of the date, time and place for the postponed meeting shall be given to each Member in accordance with the provisions of these Articles.

 

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NOTICE OF GENERAL MEETINGS

 

76. Subject to the provisions of the Companies Acts allowing a general meeting to be called by shorter notice, an annual general meeting, and an extraordinary general meeting called for the passing of a Special Resolution, shall be called by at least 21 clear days’ notice and all other extraordinary general meetings shall be called by at least 14 clear days’ notice. Such notice shall state the date, time, place of the meeting and, in the case of an extraordinary general meeting, the general nature of the business to be considered. Every notice shall be exclusive of the day on which it is given or deemed to be given and of the day for which it is given and shall specify such other details as are required by applicable law or the relevant code, rules and regulations applicable to the listing of the Shares on the Exchange.

 

77. A general meeting of the Company shall, whether or not the notice specified in this Article has been given and whether or not the provisions of the Articles regarding general meetings have been complied with, be deemed to have been duly convened if applicable law so permits and it is so agreed by the Auditors and by all the Members entitled to attend and vote thereat or by their proxies.

 

78. The notice convening an annual general meeting shall specify the meeting as such, and the notice convening a meeting to pass a Special Resolution shall specify the intention to propose the resolution as a Special Resolution. Notice of every general meeting shall be given in any manner permitted by these Articles to all Members other than such as, under the provisions hereof or the terms of issue of the Shares they hold, those who are not entitled to receive such notice from the Company.

 

79. There shall appear with reasonable prominence in every notice of general meetings of the Company a statement that a Member entitled to attend and vote is entitled to appoint one or more proxies to attend and vote instead of him and that a proxy need not be a Member of the Company.

 

80. The accidental omission to give notice of a general meeting to, or the non-receipt of notice of a meeting by any person entitled to receive notice shall not invalidate the proceedings of that meeting.

 

81. In cases where instruments of proxy are sent out with notices, the accidental omission to send such instrument of proxy to, or the non-receipt of such instrument of proxy by, any person entitled to receive notice shall not invalidate any resolution passed or any proceeding at any such meeting. A Member present, either in person or by proxy, at any general meeting of the Company or of the holders of any class of Shares in the Company, will be deemed to have received notice of that meeting and, where required, of the purpose for which it was called.

PROCEEDINGS AT GENERAL MEETINGS

 

82. All business shall be deemed special that is transacted at an extraordinary general meeting, and also all that is transacted at an annual general meeting, with the exception of declaring a dividend, the consideration of the accounts, balance sheets and the reports of the Directors and Auditors, the election of Directors, the review by the members of the Company’s affairs (to the extent required by the Companies Acts), the re-appointment of the retiring Auditors and the fixing of the remuneration of the Auditors.

 

83. No business shall be transacted at any general meeting unless a quorum is present. One or more Members present in person or by proxy holding not less than a majority of the issued and outstanding Shares of the Company entitled to vote at the meeting in question shall be a quorum.

 

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84. If within 1 hour from the time appointed for the meeting a quorum is not present, the meeting, if convened upon the requisition of Members, shall be dissolved and in any other case it shall stand adjourned to the same day in the next week at the same time and place or to such other time or such other place as the Board may determine and if at the adjourned meeting a quorum is not present within 1 hour from the time appointed for the meeting the Members present shall be a quorum.

 

85. If the Board wishes to make this facility available to Members for a specific or all general meetings of the Company, a Member may participate in any general meeting of the Company, by means of a telephone, video, electronic or similar communication equipment by way of which all persons participating in such meeting can communicate with each other simultaneously and instantaneously and such participation shall be deemed to constitute presence in person at the meeting.

 

86. Each Director and the Auditors shall be entitled to attend and speak at any general meeting of the Company.

 

87. The Chairman, if any, of the Board shall preside as Chairman at every general meeting of the Company, or if there is no such Chairman, or if he shall not be present within 1 hour after the time appointed for the holding of the meeting, or is unwilling to act, the Directors present shall elect one of their number to be Chairman of the meeting or if all of the Directors present decline to take the chair, then the Members present shall choose one of their own number to be Chairman of the meeting. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 87 are dis-applied.

 

88. The Chairman may, with the consent of any general meeting duly constituted hereunder, and shall if so directed by the meeting, adjourn the meeting from time to time and from place to place, but no business shall be transacted at any adjourned meeting other than the business left unfinished, or which might have been transacted, at the meeting from which the adjournment took place. When a general meeting is adjourned for 30 days or more, notice of the adjourned meeting shall be given as in the case of an original meeting; save as aforesaid it shall not be necessary to give any notice of an adjournment or of the business to be transacted at an adjourned general meeting.

89.

 

  89.1 Subject to the Companies Acts, a resolution may only be put to a vote at a general meeting of the Company or of any class of Members if:

 

  (a) it is proposed by or at the direction of the Board; or

 

  (b) it is proposed at the direction of the Court; or

 

  (c) it is proposed on the requisition in writing of such number of Members as is prescribed by, and is made in accordance with, section 132 of the 1963 Act;

 

  (d) it is proposed pursuant to, and in accordance with the procedures and requirements of, Articles 97 or 98; or

 

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  (e) the Chairman of the meeting in his absolute discretion decides that the resolution may properly be regarded as within the scope of the meeting.

 

  89.2 No amendment may be made to a resolution, at or before the time when it is put to a vote, unless the Chairman of the meeting in his absolute discretion decides that the amendment or the amended resolution may properly be put to a vote at that meeting.

 

  89.3 If the Chairman of the meeting rules a resolution or an amendment to a resolution admissible or out of order (as the case may be), the proceedings of the meeting or on the resolution in question shall not be invalidated by any error in his ruling. Any ruling by the Chairman of the meeting in relation to a resolution or an amendment to a resolution shall be final and conclusive.

 

90. Except where a greater majority is required by the Companies Acts or these Articles, any question proposed for a decision of the Members at any general meeting of the Company or a decision of any class of Members at a separate meeting of any class of Shares shall be decided by an Ordinary Resolution.

 

91. At any general meeting a resolution put to the vote of the meeting shall be decided on a poll. The Board or the Chairman may determine the manner in which the poll is to be taken and the manner in which the votes are to be counted.

 

92. A poll demanded on the election of the Chairman or on a question of adjournment shall be taken forthwith. A poll demanded on any other question shall be taken at such time, not being more than 10 days from the date of the meeting or adjourned meeting at which the vote was taken, as the Chairman of the meeting directs, and any business other than that on which a poll has been demanded may be proceeded with pending the taking of the poll.

 

93. No notice need be given of a poll not taken immediately. The result of the poll shall be deemed to be the resolution of the general meeting at which the poll was demanded. On a poll a Member entitled to more than one vote need not use all his votes or cast all the votes he uses in the same way.

 

94. If authorised by the Board, any vote taken by written ballot may be satisfied by a ballot submitted by electronic or telephonic transmission, provided that any such electronic or telephonic submission must either set forth or be submitted with information from which it can be determined that the electronic submission has been authorised by the Member or proxy.

 

95. The Board may, and at any general meeting, the chairman of such meeting may make such arrangement and impose any requirement or restriction it or he considers appropriate to ensure the security of a general meeting including requirements for evidence of identity to be produced by those attending the meeting, the searching of personal property and the restriction of items that may be taken into the meeting place. The Board and, at any general meeting, the chairman of such meeting are entitled to refuse entry to a person who refuses to comply with such arrangements, requirements or restrictions.

 

96.

Subject to section 141 of the 1963 Act, a resolution in writing signed by all of the Members for the time being entitled to attend and vote on such resolution at a general meeting (or being bodies corporate by their duly authorised representatives) shall be as valid and effective for all purposes as if the resolution had been passed at a general meeting of the Company duly convened and held, and may consist of several documents in like form each

 

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  signed by one or more persons, and if described as a special resolution shall be deemed to be a special resolution within the meaning of the 1963 Act. Any such resolution shall be served on the Company.

NOMINATIONS OF DIRECTORS

 

97. Nominations of persons for election to the Board (other than Directors to be nominated by any series of preferred shares, voting separately as a class) at a general meeting may only be made (a) pursuant to the Company’s notice of meeting pursuant to Article 71 at the recommendation of the Board, (b) by or at the direction of the Board or any authorised committee thereof or (c) by any Member who (i) complies with the notice procedures set forth in Articles 98 or 99, as applicable, (ii) was a Member at the time such notice is delivered to the Secretary and on the record date for the determination of Members entitled to vote at such general meeting and (iii) is present at the relevant general meeting, either in person or by proxy, to present his nomination, provided, however, that Members shall only be entitled to nominate persons for election to the Board at annual general meetings or at general meetings called specifically for the purpose of electing Directors.

 

98. For nominations of persons for election to the Board (other than Directors to be nominated by any series of preferred shares, voting separately as a class) to be properly brought before an annual general meeting by a Member, such annual general meeting must have been called for the purpose of, among other things, electing directors and such Member must have given timely notice thereof in writing to the Secretary. To be timely, a Member’s notice shall be delivered to the Secretary at the registered office of the Company, or such other address as the Secretary may designate, not less than 90 days nor more than 150 days prior to the first anniversary of the date the Company’s proxy statement was first released to Members in connection with the prior year’s annual general meeting; provided, however, that in the event the date of the annual general meeting is changed by more than 30 days from the first anniversary date of the prior year’s annual general meeting, notice by the Member to be timely must be so delivered not earlier than the 150th day prior to such annual general meeting and not later than the later of the 90th day prior to such annual general meeting or the 10th day following the day on which public announcement of the date of such meeting is first made. Such Member’s notice shall set forth (a) as to each person whom the Member proposes to nominate for election or re-election as a director, all information relating to such person that is required to be disclosed in solicitations of proxies for election of directors in an election contest, or is otherwise required, in each case pursuant to Regulation 14A under the Exchange Act, or any successor provisions thereto, including such person’s written consent to being named in the proxy statement as a nominee and to serving as a Director of the Company if elected and (b) as to the Member giving the notice (i) the name and address of such Member, as they appear on the Register of Members, (ii) the class and number of Shares that are owned beneficially and/or of record by such Member, (iii) a representation that the Member is a registered holder of Shares entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to propose such nomination and (iv) a statement as to whether the Member intends or is part of a group that intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Company’s outstanding share capital required to approve or elect the nominee and/or (y) otherwise to solicit proxies from Members in support of such nomination. The Board may require any proposed nominee to furnish such other information as it may reasonably require to determine the eligibility of such proposed nominee to serve as a director of the Company, including such evidence satisfactory to the Board that such nominee has no interests that would limit such nominee’s ability to fulfil his duties as a Director.

 

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99. For nominations of persons for election to the Board (other than directors to be nominated by any series of preferred shares, voting separately as a class) to be properly brought before a general meeting called for the purpose of the election of directors, other than an annual general meeting by a Member, such Member must have given timely notice thereof in writing to the Secretary. To be timely, a Member’s notice shall be delivered to the Secretary at the registered office of the Company or such other address as the Secretary may designate, not earlier than the 150th day prior to such general meeting and not later of the 90th day prior to such general meeting or the 10th day following the day on which public announcement is first made of the date of the general meeting and of the nominees proposed by the Board to be elected at such meeting. Such Member’s notice shall set forth the same information as is required by provisions (a) and (b) of Article 98.

 

100. Subject to the Companies Acts, unless otherwise provided by the terms of any series of preferred shares or any agreement among Members or other agreement approved by the Board, only persons who are nominated in accordance with the procedures set forth in Articles 98 and 99 shall be eligible to serve as Directors of the Company. If the Chairman of a general meeting determines that a proposed nomination was not made in compliance with Articles 98 and 99, he shall declare to the meeting that nomination is defective and such defective nomination shall be disregarded. Notwithstanding the foregoing provisions of these Articles, if the Member (or a qualified representative of the Member) does not appear at the general meeting to present his nomination, such nomination shall be disregarded.

VOTES OF MEMBERS

 

101. Subject to any rights or restrictions for the time being attached to any class or classes of Shares, every Member of record present in person or by proxy shall have one vote for each Share registered in his name in the Register of Members.

 

102. In the case of joint holders of record the vote of the senior holder who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other joint holders, and for this purpose seniority shall be determined by the order in which the names stand in the Register of Members.

 

103. A Member of unsound mind, or in respect of whom an order has been made by any court, having jurisdiction in lunacy, may vote by his committee, receiver, curator bonis, or other person in the nature of a committee, receiver or curator bonis appointed by that court, and any such committee, receiver, curator bonis or other persons may vote by proxy. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 103 are dis-applied.

 

104. No Member shall be entitled to vote at any general meeting unless he is registered as a Member on the record date for such meeting.

 

105. No objection shall be raised to the qualification of any voter except at the general meeting or adjourned general meeting at which the vote objected to is given or tendered and every vote not disallowed at such general meeting shall be valid for all purposes. Any such objection made in due time shall be referred to the Chairman of the general meeting whose decision shall be final and conclusive.

 

106. Votes may be given either personally or by proxy. A Member may appoint more than one proxy or the same proxy under one or more instruments to attend and vote at a meeting and may appoint a proxy to vote both in favour of and against the same resolution in such proportion as specified in the instrument appointing the proxy.

 

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PROXIES AND CORPORATE REPRESENTATIVES

 

107.

 

  107.1 Every Member entitled to attend and vote at a general meeting may appoint a proxy to attend, speak and vote on his behalf and may appoint more than one proxy to attend, speak and vote at the same meeting. The appointment of a proxy or corporate representative shall be in such form and may be accepted by the Company at such place and at such time as the Board or the Secretary shall from time to time determine, subject to applicable requirements of the Companies Acts, the United States Securities and Exchange Commission and the Exchange on which the Shares are listed. No such instrument appointing a proxy or corporate representative shall be voted or acted upon after 2 years from its date.

 

  107.2 Without limiting the foregoing, the Directors may from time to time permit appointments of a proxy to be made by means of an electronic or internet communication or facility and may in a similar manner permit supplements to, or amendments or revocations of, any such electronic or internet communication or facility to be made. For the avoidance of doubt, such appointments of proxy made by electronic or internet communication (as permitted by the Board) will be deemed to be deposited at the place specified for such purpose once received by the Company. The Directors may in addition prescribe the method of determining the time at which any such electronic or internet communication or facility is to be treated as deposited at the place specified for such purpose. The Directors may treat any such electronic or internet communication or facility which purports to be or is expressed to be sent on behalf of a Member as sufficient evidence of the authority of the person sending that instruction to send it on behalf of that Member.

 

108. Any body corporate which is a Member of the Company may authorise such person as it thinks fit to act as its representative at any meeting of the Company or of any class of Members of the Company and the person so authorised shall be entitled to exercise the same powers on behalf of the body corporate which he represents as that body corporate could exercise if it were an individual Member of the Company. The Company may require evidence from the body corporate of the due authorisation of such person to act as the representative of the relevant body corporate.

 

109. An appointment of proxy relating to more than one meeting (including any adjournment thereof) having once been received by the Company for the purposes of any meeting shall not require to be delivered, deposited or received again by the Company for the purposes of any subsequent meeting to which it relates.

 

110. Receipt by the Company of an appointment of proxy in respect of a meeting shall not preclude a Member from attending and voting at the meeting or at any adjournment thereof which attendance and voting will automatically cancel any proxy previously submitted.

 

111. An appointment proxy shall be valid, unless the contrary is stated therein, as well for any adjournment of the meeting as for the meeting to which it relates.

 

112.

 

  112.1

A vote given in accordance with the terms of an appointment of proxy or a resolution authorising a representative to act on behalf of a body corporate shall be valid notwithstanding the death or insanity of the principal, or the revocation of the

 

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  appointment of proxy or of the authority under which the proxy was appointed or of the resolution authorising the representative to act or transfer of the Share in respect of which the proxy was appointed or the authorisation of the representative to act was given, provided that no direction in writing (whether in electronic form or otherwise) of such death, insanity, revocation or transfer shall have been received by the Company at the Office, at least 1 hour before the commencement of the meeting or adjourned meeting at which the appointment of proxy is used or at which the representative acts; PROVIDED, HOWEVER, that where such direction is given in electronic form it shall have been received by the Company at least 24 hours (or such lesser time as the Directors may specify) before the commencement of the meeting.

 

  112.2 The Directors may send, at the expense of the Company, by post, electronic mail or otherwise, to the Members forms for the appointment of a proxy (with or without stamped envelopes for their return) for use at any general meeting or at any class meeting, either in blank or nominating any one or more of the Directors or any other persons in the alternative.

DIRECTORS

 

113. The Board may determine the size of the Board from time to time at its absolute discretion.

 

114. The remuneration to be paid to the Directors shall be such remuneration as the Directors shall determine. The Directors shall also be entitled to be paid their travelling, hotel and other expenses properly incurred by them in going to, attending and returning from meetings of the Directors, or any committee of the Directors, or general meetings of the Company, or otherwise in connection with the business of the Company, or to receive a fixed allowance in respect thereof as may be determined by the Board from time to time, or a combination partly of one such method and partly the other. The amount, rate and bases of the remuneration or expenses to be paid to the Directors shall not require approval or ratification by the Members. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 114 are dis-applied.

 

115. The Board may approve additional remuneration to any Director undertaking any special work or services for, or undertaking any special mission on behalf of, the Company other than his ordinary routine work as a Director. Any fees paid to a Director who is also counsel or solicitor to the Company, or otherwise serves it in a professional capacity shall be in addition to his remuneration as a Director. The amount, rate and bases of the remuneration or expenses to be paid to the Directors shall not require approval or ratification by the Members. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 115 are dis-applied.

DIRECTORS’ AND OFFICERS’ INTERESTS

 

116.

A Director or an officer of the Company who is in any way, whether directly or indirectly, interested in a contract, transaction or arrangement or proposed contract, transaction or arrangement with the Company shall, in accordance with section 194 of the 1963 Act, declare the nature of his interest at the first opportunity either (a) at a meeting of the Board at which the question of entering into the contract, transaction or arrangement is first taken into consideration, if the Director or officer of the Company knows this interest then exists, or in any other case, at the first meeting of the Board after learning that he is or has become

 

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  so interested or (b) by providing a general notice to the Directors declaring that he is a director or an officer of, or has an interest in, a person and is to be regarded as interested in any transaction or arrangement made with that person, and after giving such general notice it shall not be necessary to give special notice relating to any particular transaction.

 

117. A Director may hold any other office or place of profit under the Company (other than the office of its Auditors) in conjunction with his office of Director for such period and on such terms as to remuneration and otherwise as the Board may determine.

 

118. A Director may act by himself or his firm in a professional capacity for the Company (other than as its Auditors) and he or his firm shall be entitled to remuneration for professional services as if he were not a Director.

 

119. A Director may be or become a director, managing director, joint managing director, deputy managing director, executive director, manager or other officer or Member of any other company or otherwise interested in any company promoted by the Company or in which the Company may be interested as shareholder or otherwise, and no such Director shall be accountable to the Company for any remuneration or other benefits received by him as a director, managing director, joint managing director, deputy managing director, executive director, manager or other officer or Member of such other company; provided that he has declared the nature of his position with, or interest in, such company to the Board in accordance with Article 116.

 

120. No person shall be disqualified from the office of Director or from being an officer of the Company or prevented by such office from contracting with the Company, either as vendor, purchaser or otherwise, nor shall any such contract or any contract or transaction entered into by or on behalf of the Company in which any Director or officer of the Company shall be in any way interested be or be liable to be avoided, nor shall any Director or officer of the Company so contracting or being so interested be liable to account to the Company for any profit realised by any such contract or transaction by reason of such Director or officer of the Company holding office or of the fiduciary relation thereby established; provided that:

 

  120.1 he has declared the nature of his interest in such contract or transaction to the Board in accordance with Article 116; and

 

  120.2 the contract or transaction is approved by a majority of the disinterested Directors, notwithstanding the fact that the disinterested Directors may represent less than a quorum.

 

121. A Director may be counted in determining the presence of a quorum at a meeting of the Board which authorises or approves the contract, transaction or arrangement in which he is interested and he shall be at liberty to vote in respect of any contract, transaction or arrangement in which he is interested, provided that the nature of the interest of any Director in any such contract or transaction shall be disclosed by him in accordance with Article 116, at or prior to its consideration and any vote thereon.

 

122. For the purposes of Article 116:-

 

  122.1 a general notice given to the Directors that a Director is to be regarded as having an interest of the nature and extent specified in the notice in any transaction or arrangement in which a specified person or class of persons is interested shall be deemed to be a disclosure that the Director has an interest in any such transaction of the nature and extent so specified;

 

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  122.2 an interest of which a Director has no knowledge and of which it is unreasonable to expect him to have knowledge shall not be treated as an interest of his; and

 

  122.3 a copy of every declaration made and notice given under Article 116 shall be entered within 3 days after the making or giving thereof in a book kept for this purpose. Such book shall be open for inspection without charge by any Director, Secretary, the Auditors or Member of the Company at the Registered Office and shall be produced at every general meeting of the Company and at any meeting of the Directors if any Director so requests in sufficient time to enable the book to be available at the meeting.

POWERS AND DUTIES OF DIRECTORS

 

123. The business of the Company shall be managed by the Directors, who may pay all expenses incurred in promoting and registering the Company and may exercise all such powers of the Company as are not, by the Companies Acts or by these Articles, required to be exercised by the Company in general meeting, subject, nevertheless, to any of these Articles and to the provisions of the Companies Acts. No resolution made by the Company in general meeting shall invalidate any prior act of the Directors that would have been valid if that resolution had not been made.

 

124. The Board shall have the power to appoint and remove executives in such terms as the Board sees fit and to give such titles and responsibilities to those executives as it sees fit.

 

125. The Company may exercise the powers conferred by Section 41 of the 1963 Act with regard to having an official seal for use abroad and such powers shall be vested in the Directors.

 

126. Subject as otherwise provided with these Articles, the Directors may exercise the voting powers conferred by shares of any other company held or owned by the Company in such manner in all respects as they think fit and in particular they may exercise their voting powers in favour of any resolution appointing the Directors or any of them as directors or officers of such other company or providing for the payment of remuneration or pensions to the directors or officers of such other company.

 

127. All cheques, promissory notes, drafts, bills of exchange and other negotiable instruments and all receipts for money paid to the Company shall be signed, drawn, accepted, endorsed or otherwise executed, as the case may be, by such person or persons and in such manner as the Directors shall from time to time by resolution determine.

 

128. The Directors may from time to time authorise such person or persons as they see fit to perform all acts, including without prejudice to the foregoing, to effect a transfer of any shares, bonds, or other evidences of indebtedness or obligations, subscription rights, warrants, and other securities in another body corporate in which the Company holds an interest and to issue the necessary powers of attorney for the same; and each such person is authorised on behalf of the Company to vote such securities, to appoint proxies with respect thereto, and to execute consents, waivers and releases with respect thereto, or to cause any such action to be taken.

 

129. The Board may exercise all powers of the Company to borrow money and to mortgage or charge its undertaking, property and uncalled capital or any part thereof and to issue debentures, debenture stock, mortgages, bonds or such other securities whether outright or as security for any debt, liability or obligation of the Company or of any third party.

 

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130. The Directors may procure the establishment and maintenance of or participate in, or contribute to any non-contributory or contributory pension or superannuation fund, scheme or arrangement or life assurance scheme or arrangement for the benefit of, and pay, provide for or procure the grant of donations, gratuities, pensions, allowances, benefits or emoluments to any persons (including Directors or other officers) who are or shall have been at any time in the employment or service of the Company or of any company which is or was a subsidiary of the Company or of the predecessor in business of the Company or any such subsidiary or holding company and the wives, widows, families, relatives or dependants of any such persons. The Directors may also procure the establishment and subsidy of or subscription to and support of any institutions, associations, clubs, funds or trusts calculated to be for the benefit of any such persons as aforesaid or otherwise to advance the interests and well being of the Company or of any such other company as aforesaid or its Members, and payments for or towards the issuance of any such persons as aforesaid and subscriptions or guarantees of money for charitable or benevolent objects or for any exhibition or for any public, general or useful object. Notwithstanding the foregoing, any Director shall be entitled to retain any benefit received by him under this Article, subject only, where the Companies Acts require, to disclosure to the Members and the approval of the Company in a general meeting.

 

131. The Board may from time to time provide for the management of the affairs of the Company in such manner as it shall think fit and the specific delegation provisions contained in the Articles shall not limit the general powers conferred by these Articles.

MINUTES

 

132. The Board shall cause minutes to be made in books kept for the purpose of all appointments of officers made by the Board, all resolutions and proceedings at meetings of the Company or the holders of any class of Shares, of the Directors and of committees of Directors, including the names of the Directors present at each meeting. The original signed minutes shall be retained by the Company in Ireland.

DELEGATION OF THE BOARD’S POWERS

 

133. The Board may delegate any of its powers (with power to sub-delegate) to any committee consisting of one or more Directors. The Board may also delegate to any Director such of its powers as it considers desirable to be exercised by him. Any such delegation may be made subject to any conditions the Board may impose, and either collaterally with or to the exclusion of its own powers and may be revoked or altered. Subject to any such conditions, the proceedings of a committee of the Board shall be governed by the Articles regulating the proceedings of Directors, so far as they are capable of applying.

 

134. The Board may by power of attorney or otherwise appoint any person to be the agent of the Company on such conditions as the Board may determine, provided that the delegation is not to the exclusion of its own powers and may be revoked by the Board at any time.

 

135. The Board may by power of attorney or otherwise appoint any company, firm, person or body of persons, whether nominated directly or indirectly by the Board, to be the attorney or authorised signatory of the Company for such purpose and with such powers, authorities and discretions (not exceeding those vested in or exercisable by the Board under these Articles) and for such period and subject to such conditions as they may think fit, and any such powers of attorney or other appointment may contain such provisions for the protection and convenience of persons dealing with any such attorneys or authorised signatories as the Board may think fit and may also authorise any such attorney or authorised signatory to delegate all or any of the powers, authorities and discretions vested in him.

 

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EXECUTIVE OFFICERS

 

136. The Company shall have a chairman, who shall be a Director and shall be elected by the Board. In addition to the chairman, the Directors and the Secretary, the Company may have such officers as the Board may from time to time determine.

PROCEEDINGS OF DIRECTORS

 

137. Except as otherwise provided by these Articles, the Directors shall meet together for the despatch of business, convening, adjourning and otherwise regulating their meetings and procedures as they think fit. Questions arising at any meeting shall be decided by a majority of votes of the Directors present at a meeting at which there is a quorum. Each Director shall have one vote.

 

138. Regular meetings of the Board may be held at such times and places as may be provided for in resolutions adopted by the Board. No additional notice of a regularly scheduled meeting of the Board shall be required.

 

139. A Director may, and the Secretary on the requisition of a Director shall, at any time summon a meeting of the Directors by at least 24 hours’ notice in writing to every Director which notice shall set forth the general nature of the business to be considered unless notice is waived by all the Directors either at, before or after the meeting is held and provided further if notice is given in person, by telephone, cable, telex, telecopy or email the same shall be deemed to have been given on the day it is delivered to the Directors or transmitting organisation as the case may be. The accidental omission to give notice of a meeting of the Directors to, or the non-receipt of notice of a meeting by any person entitled to receive notice shall not invalidate the proceedings of that meeting. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 139 are dis-applied.

 

140. The quorum necessary for the transaction of the business of the Board may be fixed by the Board and unless so fixed shall be a majority of the Directors in office. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 140 are dis-applied.

 

141. The continuing Directors may act notwithstanding any vacancy in their body, but if and so long as their number is reduced below the number fixed by or pursuant to these Articles as the necessary quorum of Directors, the continuing Directors or Director may act for the purpose of increasing the number of Directors to that number, or of summoning a general meeting of the Company, but for no other purpose. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 141 are dis-applied.

 

142. The Directors may elect a Chairman of their Board and determine the period for which he is to hold office; but if no such Chairman is elected, or if at any meeting the Chairman is not present within five (5) minutes after the time appointed for holding the same, the Directors present may choose one of their number to be a Chairman of the meeting.

 

143. All acts done by any meeting of the Directors or of a committee of Directors shall, notwithstanding that it be afterwards discovered that there was some defect in the appointment of any Director, or that they or any of them were disqualified, be as valid as if every such person had been duly appointed and qualified to be a Director.

 

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144. Members of the Board or of any committee thereof may participate in a meeting of the Board or of such committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other and participation in a meeting pursuant to this provision shall constitute presence in person at such meeting. Unless otherwise determined by the Directors the meeting shall be deemed to be held at the place where the Chairman is at the start of the meeting. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 144 are dis-applied.

 

145. A resolution in writing (in one or more counterparts), signed by all the Directors for the time being or all the members of a committee of Directors shall be as valid and effectual as if it had been passed at a meeting of the Directors or committee as the case may be duly convened and held.

RESIGNATION AND DISQUALIFICATION OF DIRECTORS

 

146. The office of a Director shall be vacated:

 

  146.1 if he resigns his office, on the date on which notice of his resignation is delivered to the Registered Office or tendered at a meeting of the Board or on such later date as may be specified in such notice; or

 

  146.2 on his being prohibited by law from being a Director; or

 

  146.3 on his ceasing to be a Director by virtue of any provision of the Companies Acts.

 

147. The Company may, by Ordinary Resolution, of which extended notice has been given in accordance with section 142 of the 1963 Act, remove any Director before the expiration of his period of office notwithstanding anything in these Articles or in any agreement between the Company and such Director. Such removal shall be without prejudice to any claim such Director may have for damages for breach of any contract of service between him and the Company.

APPOINTMENT OF DIRECTORS

 

148.

The Directors shall be divided into two classes, designated Class I and Class II. The initial division of the Board into classes shall be made by the decision of the affirmative vote of a majority of the Directors in office and each class need not be of equal size or number. The term of the initial Class I directors shall terminate on the date of the 2015 annual general meeting, and the term of the initial Class II directors shall terminate on the date of the 2016 annual general meeting. At each annual general meeting of Members beginning in 2015, successors to the class of directors whose term expires at that annual general meeting shall be elected for a two-year term. Save as otherwise permitted in these Articles, Directors will be elected by way of Ordinary Resolution of the Company in general meeting. If the number of Directors is changed, any increase or decrease shall be apportioned among the classes so as to maintain the number of Directors in each class as nearly equal as possible or as the Chairman of the Board may otherwise direct. In no case will a decrease in the number of Directors shorten the term of any incumbent Director. A Director shall hold office until the annual general meeting for the year in which his term expires and until his successor shall be elected and shall qualify, subject, however, to prior death, resignation, retirement,

 

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  disqualification or removal from office. Any vacancy on the Board, including a vacancy that results from an increase in the number of directors or from the death, resignation, retirement, disqualification or removal of a Director, shall be deemed a casual vacancy. Subject to the terms of any one or more classes or series of preferred shares, any casual vacancy shall only be filled by decision of a majority of the Board then in office, provided that a quorum is present. Any Director of any class elected to fill a vacancy resulting from an increase in the number of Directors of such class shall hold office for a term that shall coincide with the remaining term of that class. Any Director elected to fill a vacancy not resulting from an increase in the number of Directors shall have the same remaining term as that of his predecessor. A Director retiring at a meeting shall retain office until the close or adjournment of the meeting. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as Articles 148 to 151 are dis-applied.

 

149. During any vacancy in the Board, the remaining Directors shall have full power to act as the Board. If, at any general meeting of the Company, the number of Directors is reduced below the minimum prescribed by the Board in accordance with Article 113 due to the failure of any persons nominated to be Directors to be elected, then in those circumstances, the nominee or nominees who receive the highest number of votes in favour of election shall be elected in order to maintain the prescribed minimum number of Directors and each such Director shall remain a Director (subject to the provisions of the Companies Acts and these Articles) only until the conclusion of the next annual general meeting of the Company unless such Director is elected by the Members during such meeting.

 

150. The Company may by Ordinary Resolution appoint any person to be a Director.

 

151. Alternate Directors:

 

  151.1 Any Director may appoint by writing under his hand any person (including another Director) to be his alternate provided always that no such appointment of a person other than a Director as an alternate shall be operative unless and until such appointment shall have been approved by resolution of the Directors.

 

  151.2 An alternate Director shall be entitled, subject to his giving to the Company an address, to receive notices of all meetings of the Directors and of all meetings of committees of Directors of which his appointor is a member, to attend and vote at any such meeting at which the Director appointing him is not personally present and in the absence of his appointor to exercise all the powers, rights, duties and authorities of his appointor as a Director (other than the right to appoint an alternate hereunder).

 

  151.3 Save as otherwise provided in these Articles, an alternate Director shall be deemed for all purposes to be a Director and shall alone be responsible for his own acts and defaults and he shall not be deemed to be the agent of the Director appointing him. The remuneration of any such alternate Director shall be payable out of the remuneration paid to the Director appointing him and shall consist of such portion of the last mentioned remuneration as shall be agreed between the alternate and the Director appointing him.

 

  151.4

A Director may revoke at any time the appointment of any alternate appointed by him. If a Director shall die or cease to hold the office of Director the appointment of his alternate shall thereupon cease and determine but if a Director retires by rotation or otherwise but is reappointed or deemed to have been reappointed at the

 

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  meeting at which he retires, any appointment of an alternate Director made by him which was in force immediately prior to his retirement shall continue after his re-appointment.

 

  151.5 Any appointment or revocation pursuant to this Article 151 may be sent by delivery, post, cable, telegram, telex, telefax, electronic mail or any other means of communication approved by the Directors and may bear a printed or facsimile signature of the Director making such appointment or revocation or in any other manner approved by the Directors.

SECRETARY

 

152. The Secretary shall be appointed by the Board at such remuneration (if any) and on such terms as it may think fit and any Secretary so appointed may be removed by the Board.

 

153. The duties of the Secretary shall be those prescribed by the Companies Acts, together with such other duties as shall from time to time be prescribed by the Board, and in any case, shall include the making and keeping of records of the votes, doings and proceedings of all meetings of the Members and the Board of the Company, and committees, and the authentication of records of the Company.

 

154. A provision of the Companies Acts or these Articles requiring or authorising a thing to be done by or to a Director and the Secretary shall not be satisfied by its being done by or to the same person acting both as Director and as, or in the place of, the Secretary.

SEAL

 

155. The Company may, if the Board so determines, have a Seal (including any official seals kept pursuant to the Companies Acts) which shall only be used by the authority of the Board or of a committee of the Board authorised by the Board in that regard and every instrument to which the Seal has been affixed shall be signed by any person who shall be either a Director or the Secretary or Assistant Secretary or some other person authorised by the Board, either generally or specifically, for the purpose. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 155 are dis-applied.

 

156. The Company may have for use in any place or places outside Ireland, an official seal or seals each of which shall be a duplicate of the common seal of the Company except for the addition on its face of the name of the territory, district or place not situate in Ireland where it is to be used. The Company may also have a securities seal for use in sealing documents creating or evidencing securities issued by the Company which shall be a duplicate of the common seal of the Company except for the addition on its face of the word “Securities”. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 156 are dis-applied.

DIVIDENDS, DISTRIBUTIONS AND RESERVES

 

157. The Company in general meeting may declare dividends, but no dividends shall exceed the amount recommended by the Directors.

 

158. Subject to the Companies Acts, the Board may from time to time declare dividends (including interim dividends) and distributions on Shares of the Company outstanding and authorise payment of the same out of the funds of the Company lawfully available therefore and in any currency chosen at its discretion.

 

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159. The Board may, before declaring any dividends or distributions, set aside such sums as they think proper as a reserve or reserves which shall at the discretion of the Directors, be applicable for any purpose of the Company and pending such application may, at the like discretion, be employed in the business of the Company. The Directors may also, without placing the same to reserve, carry forward any profits which they may think it prudent not to divide.

 

160. No dividend, interim dividend or distribution shall be paid otherwise than in accordance with the provisions of Part IV of the 1983 Act.

 

161. Subject to the rights of persons, if any, entitled to Shares with special rights as to dividends or distributions, if dividends or distributions are to be declared on a class of Shares they shall be declared and paid according to the amounts paid or credited as paid on the Shares of such class outstanding on the record date for such dividend or distribution as determined in accordance with these Articles.

 

162. The Directors may deduct from any dividend payable to any Member all sums of money (if any) immediately payable by him to the Company in relation to the Shares of the Company.

 

163. The Board or any general meeting declaring a dividend (upon the recommendation of the Board), may direct that any dividend or distribution be paid wholly or partly by the distribution of specific assets and in particular of paid up Shares, debentures, or debenture stock of any other company or in any one or more of such ways and where any difficulty arises in regard to such distribution, the Board may settle the same as they think expedient and in particular may issue fractional certificates and fix the value for distribution of such specific assets or any part thereof and may determine that cash payments shall be made to any Members upon the footing of the value so fixed in order to adjust the rights of all Members and may vest any such specific assets in trustees as may seem expedient to the Board.

 

164. Any dividend, distribution, interest or other monies payable in cash in respect of Shares may be paid by cheque or warrant sent through the post, or sent by any electronic or other means of payment, directed to the registered address of the holder or, in the case of joint holders, to the holder who is first named on the Register of Members or to such person and to such address as such holder or joint holders may in writing direct. Every such cheque or warrant, electronic or other payment shall be made payable to the order of the person to whom it is sent and payment of the cheque or warrant shall be a good discharge to the Company. Any one of two or more joint holders may give effectual receipts for any dividends, bonuses, or other monies payable in respect of the Share held by them as joint holders. Any such dividend or other distribution may also be paid by any other method (including payment in a currency other than US$, electronic funds transfer, direct debit, bank transfer or by means of a relevant system) which the Directors consider appropriate and any Member who elects for such method of payment shall be deemed to have accepted all of the risks inherent therein. The debiting of the Company’s account in respect of the relevant amount shall be evidence of good discharge of the Company’s obligations in respect of any payment made by any such methods.

 

165. No dividend or distribution shall bear interest against the Company.

 

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166. If the Directors so resolve, any dividend which has remained unclaimed for six years from the date of its declaration shall be forfeited and cease to remain owing by the Company. The payment by the Directors of any unclaimed dividend or other monies payable in respect of a Share into a separate account shall not constitute the Company a trustee in respect thereof.

CAPITALISATION

 

167. Without prejudice to any powers conferred on the Directors as aforesaid, and subject to the Directors’ authority to issue and allot Shares under Articles 6 and 7, the Directors may:

 

  167.1 resolve to capitalise an amount standing to the credit of reserves (including a share premium account, capital redemption reserve and profit and loss account), whether or not available for distribution;

 

  167.2 appropriate the sum resolved to be capitalised to the Members in proportion to the nominal amount of Shares held by them respectively and apply that sum on their behalf in or towards paying up in full unissued Shares or debentures of a nominal amount equal to that sum, and allot the Shares or debentures, credited as fully paid, to the Members (or as the Board of may direct) in those proportions, or partly in one way and partly in the other, but the share premium account, the capital redemption reserve and profits that are not available for distribution may, for the purposes of this Article 167, only be applied in paying up unissued Shares to be allotted to Members credited as fully paid;

 

  167.3 make any arrangements it thinks fit to resolve a difficulty arising in the distribution of a capitalised reserve and in particular where Shares or debentures become distributable in fractions the Board may deal with the fractions as it thinks fit;

 

  167.4 authorise a person to enter (on behalf of all the Members concerned) into an agreement with the Company providing for the allotment to the Members respectively, credited as fully paid, of Shares or debentures to which they may be entitled on the capitalisation and any such agreement made under this authority being effective and binding on all those Members;

 

  167.5 generally do all acts and things required to give effect to the resolution; and

 

  167.6 any such capitalisation will not require approval or ratification by the Members. The terms of any optional provisions of the Companies Acts or any optional replacement enactment covering substantially the same subject matter as this Article 167 are dis-applied.

ACCOUNTS

 

168. The Directors shall cause to be kept proper books of account, whether in the form of documents, electronic form or otherwise, that:

 

  168.1 correctly record and explain the transactions of the Company;

 

  168.2 will at any time enable the financial position of the Company to be determined with reasonable accuracy;

 

  168.3 will enable the Directors to ensure that any balance sheet, profit and loss account or income and expenditure account of the Company complies with the requirements of the Companies Acts;

 

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  168.4 will record all sums of money received and expended by the Company and the matters in respect of which the receipt or expenditure takes place, all sales and purchases of goods by the Company and the assets and liabilities of the Company; and

 

  168.5 will enable the accounts of the Company to be readily and properly audited.

 

169. Books of account shall be kept on a continuous and consistent basis and entries therein shall be made in a timely manner and be consistent from year to year. The Company may send by post, electronic mail or any other means of electronic communication a summary financial statement to its Members or persons nominated by any Member. The Company may meet, but shall be under no obligation to meet, any request from any of its Members to be sent additional copies of its full report and accounts or summary financial statement or other communications with its Members.

 

170. The books of account shall be kept at the registered office of the Company or, subject to the provisions of the Companies Acts, at such other place as the Directors think fit and shall be open at all reasonable times to the inspection of the Directors.

 

171. Proper books shall not be deemed to be kept as required by Articles 168 to 170, if there are not kept such books of account as are necessary to give a true and fair view of the state of the Company’s affairs and to explain its transactions.

 

172. In accordance with the provisions of the Companies Acts, the Board may from time to time cause to be prepared and to be laid before the Company in general meeting profit and loss accounts, balance sheets, group accounts (if any) and such other reports and accounts as may be required by law.

 

173. A copy of every balance sheet (including every document required by law to be annexed thereto) which is to be laid before the annual general meeting of the Company together with a copy of the Directors’ report and Auditors’ report shall be sent by post, electronic mail or any other means of communication (electronic or otherwise), not less than 21 clear days before the date of the annual general meeting, to every person entitled under the provisions of the Companies Acts to receive them; provided that in the case of those documents sent by electronic mail or any other means of electronic communication, such documents shall be sent with the consent of the recipient, to the Address of the recipient notified to the Company by the recipient for such purposes.

AUDIT

 

174. Auditors shall be appointed and their duties regulated in accordance with Sections 160 to 163 of the 1963 Act or any statutory amendment thereof, any other applicable law and such requirements not inconsistent with the Companies Acts as the Board may from time to time determine.

 

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NOTICES

 

175. Any notice to be given, served, sent or delivered pursuant to these Articles shall be in writing (whether in electronic form or otherwise).

 

  175.1 A notice or document to be given, served, sent or delivered in pursuance of these Articles may be given to, served on or delivered to any Member by the Company:

 

  (a) by handing same to him or his authorised agent;

 

  (b) by leaving the same at his registered address;

 

  (c) by sending the same by the post in a pre-paid cover addressed to him at his registered address; or

 

  (d) by sending, with the consent of the Member to the extent required by law and applicable listing rules (including those relating to NASDAQ), the same by means of electronic mail or other means of electronic communication approved by the Directors, to the Address of the Member notified to the Company by the Member for such purpose (or if not so notified, then to the Address of the Member last known to the Company). For the avoidance of doubt, a notice or document may be sent by electronic means to the maximum extent permitted by any default provisions of the Companies Acts notwithstanding Article 2.2(k).

 

  175.2 For the purposes of these Articles and the Companies Acts, a document shall be deemed to have been sent to a Member if a notice is given, served, sent or delivered to the Member and the notice specifies the website or hotlink or other electronic link at or through which the Member may obtain a copy of the relevant document.

 

  175.3 Where a notice or document is given, served or delivered pursuant to sub-paragraph 175.1(a) or 175.1(b) of this Article, the giving, service or delivery thereof shall be deemed to have been effected at the time the same was handed to the Member or his authorised agent, or left at his registered address (as the case may be).

 

  175.4 Where a notice or document is given, served or delivered pursuant to sub-paragraph 175.1(c) of this Article, the giving, service or delivery thereof shall be deemed to have been effected at the expiration of 24 hours after the cover containing it was posted. In proving service or delivery it shall be sufficient to prove that such cover was properly addressed, stamped and posted.

 

  175.5 Where a notice or document is given, served or delivered pursuant to sub-paragraph 175.1(d) of this Article, the giving, service or delivery thereof shall be deemed to have been effected at the expiration of 48 hours after despatch.

 

  175.6 Every legal personal representative, committee, receiver, curator bonis or other legal curator, assignee in bankruptcy, examiner or liquidator of a Member shall be bound by a notice given as aforesaid if sent to the last registered address of such Member, or, in the event of notice given or delivered pursuant to sub-paragraph 175.1(d), if sent to the address notified by the Company by the Member for such purpose notwithstanding that the Company may have notice of the death, lunacy, bankruptcy, liquidation or disability of such Member.

 

  175.7 Notwithstanding anything contained in this Article, the Company shall not be obliged to take account of or make any investigations as to the existence of any suspension or curtailment of postal services within or in relation to all or any part of any jurisdiction.

 

  175.8

Any requirement in these Articles for the consent of a Member in regard to the receipt by such Member of electronic mail or other means of electronic communications approved by the Directors, including the receipt of the Company’s

 

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  audited accounts and the directors’ and auditor’s reports thereon, shall be deemed to have been satisfied where the Company has written to the Member informing him of its intention to use electronic communications for such purposes and the Member has not, within four weeks of the issue of such notice, served an objection in writing on the Company to such proposal. Where a Member has given, or is deemed to have given, his consent to the receipt by such Member of electronic mail or other means of electronic communications approved by the Directors, he may revoke such consent at any time by requesting the Company to communicate with him in documented form; provided, however, that such revocation shall not take effect until 5 days after written notice of the revocation is received by the Company.

 

  175.9 Without prejudice to the provisions of sub-paragraphs 175.1(a) and 175.1(b) of this Article, if at any time by reason of the suspension or curtailment of postal services in any territory, the Company is unable effectively to convene a general meeting by notices sent through the post, a general meeting may be convened by a public announcement (as defined below) and such notice shall be deemed to have been duly served on all Members entitled thereto at noon (New York time) on the day on which the said public announcement is made. In any such case the Company shall put a full copy of the notice of the general meeting on its website. A “public announcement” shall mean disclosure in a press release reported by a financial news service or in a document publicly filed by the Company with the U.S. Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Exchange Act and the rules and regulations promulgated thereunder.

 

176. Notice may be given by the Company to the joint Members of a Share by giving the notice to the joint Member whose name stands first in the Register in respect of the Share and notice so given shall be sufficient notice to all the joint Members.

 

177.

 

  177.1 Every person who becomes entitled to a Share shall before his name is entered in the Register in respect of the Share, be bound by any notice in respect of that Share which has been duly given to a person from whom he derives his title.

 

  177.2 A notice may be given by the Company to the persons entitled to a Share in consequence of the death or bankruptcy of a Member by sending or delivering it, in any manner authorised by these Articles for the giving of notice to a Member, addressed to them at the address, if any, supplied by them for that purpose. Until such an address has been supplied, a notice may be given in any manner in which it might have been given if the death or bankruptcy had not occurred.

 

178. The signature (whether electronic signature, an advanced electronic signature or otherwise) to any notice to be given by the Company may be written (in electronic form or otherwise) or printed.

 

179. A Member present, either in person or by proxy, at any meeting of the Company or the Members of any class of Shares in the Company shall be deemed to have received notice of the meeting and, where requisite, of the purposes for which it was called.

 

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UNTRACED HOLDERS

 

180.

 

  180.1 The Company shall be entitled to sell at the best price reasonably obtainable any Share or stock of a Member or any Share or stock to which a person is entitled by transmission if and provided that:

 

  (a) for a period of six years (not less than three dividends having been declared and paid) no cheque or warrant sent by the Company through the post in a prepaid letter addressed to the Member or to the person entitled by transmission to the Share or stock at his address on the Register or other the last known address given by the Member or the person entitled by transmission to which cheques and warrants are to be sent has been cashed and no communication has been received by the Company from the Member or the person entitled by transmission; and

 

  (b) at the expiration of the said period of six years the Company has given notice by advertisement in a leading Dublin newspaper and a newspaper circulating in the area in which the address referred to in paragraph (a) of this Article is located of its intention to sell such Share or stock; and

 

  (c) the Company has not during the further period of three months after the date of the advertisement and prior to the exercise of the power of sale received any communication from the Member or person entitled by transmission.

 

  180.2 To give effect to any such sale the Company may appoint any person to execute as transferor an instrument of transfer of such Share or stock and such instrument of transfer shall be as effective as if it had been executed by the Member or person entitled by transmission to such Share or stock. The Company shall account to the Member or other person entitled to such Share or stock for the net proceeds of such sale by carrying all monies in respect thereof to a separate account which shall be a permanent debt of the Company and the Company shall be deemed to be a debtor and not a trustee in respect thereof for such Member or other person. Monies carried to such separate account may either be employed in the business of the Company or invested in such investments (other than Shares of the Company or its holding company if any) as the Directors may from time to time think fit.

DESTRUCTION OF DOCUMENTS

 

181. The Company may destroy:

 

  181.1 any dividend mandate or any variation or cancellation thereof or any notification of change of name or address, at any time after the expiry of two years from the date such mandate variation, cancellation or notification was recorded by the Company;

 

  181.2 any instrument of transfer of Shares which has been registered, at any time after the expiry of six years from the date of registration; and

 

  181.3 any other document on the basis of which any entry in the Register was made, at any time after the expiry of six years from the date an entry in the Register was first made in respect of it;

 

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  181.4 and it shall be presumed conclusively in favour of the Company that every share certificate (if any) so destroyed was a valid certificate duly and properly sealed and that every instrument of transfer so destroyed was a valid and effective instrument duly and properly registered and that every other document destroyed hereunder was a valid and effective document in accordance with the recorded particulars thereof in the books or records of the Company provided always that:

 

  (a) the foregoing provisions of this Article shall apply only to the destruction of a document in good faith and without express notice to the Company that the preservation of such document was relevant to a claim;

 

  (b) nothing contained in this Article shall be construed as imposing upon the Company any liability in respect of the destruction of any such document earlier than as aforesaid or in any case where the conditions of proviso (a) above are not fulfilled; and

 

  (c) references in this Article to the destruction of any document include references to its disposal in any manner.

WINDING UP

 

182. If the Company shall be wound up and the assets available for distribution among the Members as such shall be insufficient to repay the whole of the paid up or credited as paid up share capital, such assets shall be distributed so that, as nearly as may be, the losses shall be borne by the Members in proportion to the capital paid up or credited as paid up at the commencement of the winding up on the Shares held by them respectively. And if in a winding up the assets available for distribution among the Members shall be more than sufficient to repay the whole of the share capital paid up or credited as paid up at the commencement of the winding up, the excess shall be distributed among the Members in proportion to the capital at the commencement of the winding up paid up or credited as paid up on the said Shares held by them respectively. Provided that this Article shall not affect the rights of the Members holding Shares issued upon special terms and conditions.

 

  182.1 In case of a sale by the liquidator under Section 260 of the 1963 Act, the liquidator may by the contract of sale agree so as to bind all the Members for the allotment to the Members directly of the proceeds of sale in proportion to their respective interests in the Company and may further by the contract limit a time at the expiration of which obligations or Shares not accepted or required to be sold shall be deemed to have been irrevocably refused and be at the disposal of the Company, but so that nothing herein contained shall be taken to diminish, prejudice or affect the rights of dissenting Members conferred by the said Section.

 

  182.2 The power of sale of the liquidator shall include a power to sell wholly or partially for debentures, debenture stock, or other obligations of another company, either then already constituted or about to be constituted for the purpose of carrying out the sale.

 

183.

If the Company is wound up, the liquidator, with the sanction of a Special Resolution and any other sanction required by the Companies Acts, may divide among the Members in specie or kind the whole or any part of the assets of the Company (whether they shall consist of property of the same kind or not), and, for such purpose, may value any assets and determine how the division shall be carried out as between the Members or different classes of Members. The liquidator, with the like sanction, may vest the whole or any part of

 

40


  such assets in trustees upon such trusts for the benefit of the contributories as, with the like sanction, he determines, but so that no Member shall be compelled to accept any assets upon which there is a liability.

INDEMNITY

 

184.

 

  184.1 Subject to the provisions of and so far as may be admitted by the Companies Acts, every Director and Secretary shall be entitled to be indemnified by the Company against all costs, charges, losses, expenses and liabilities incurred by him in the execution and discharge of his duties or in relation thereto including any liability incurred by him in defending any proceedings, civil or criminal, which relate to anything done or omitted or alleged to have been done or omitted by him as a Director, Secretary, officer or employee of the Company and in which judgement is given in his favour (or the proceedings are otherwise disposed of without any finding or admission of any material breach of duty on his part) or in which he is acquitted or in connection with any application under any statute for relief from liability in respect of any such act or omission in which relief is granted to him by the Court.

 

  184.2 As far as permissible under the Companies Acts, the Company shall indemnify any current or former executive of the Company (excluding any Directors or Secretary) or any person who is serving or has served at the request of the Company as a director, executive or trustee of another company, joint venture, trust or other enterprise against expenses, including attorneys’ fees, judgments, fines, and amounts paid in settlement actually and reasonably incurred by him in connection with any threatened, pending, or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, other than an action by or in the right of the Company, to which he or he was, is, or is threatened to be made a party by reason of the fact that he or he is or was such a director, executive or trustee, provided always that the indemnity contained in this Article 184.2 shall not extend to any matter which would render it void pursuant to the Companies Acts.

 

  184.3 As far as permissible under the Companies Acts, in the case of any threatened, pending or completed action, suit or proceeding by or in the right of the Company, the Company shall indemnify each person indicated in Article 184.2 of this Article against expenses, including attorneys’ fees, actually and reasonably incurred in connection with the defence or the settlement thereof, except no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable for fraud or dishonesty in the performance of his duty to the Company unless and only to the extent that the Court or the court in which such action or suit was brought shall determine upon application that despite the adjudication of liability, but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses as the court shall deem proper.

 

  184.4 As far as permissible under the Companies Acts, expenses, including attorneys’ fees, incurred in defending any action, suit or proceeding referred to in Articles 184.2 and 184.3 of this Article may be paid by the Company in advance of the final disposition of such action, suit or proceeding as authorised by the Board in the specific case upon receipt of an undertaking by or on behalf of the director, executive or trustee, or other indemnitee to repay such amount, unless it shall ultimately be determined that he is entitled to be indemnified by the Company as authorised by these Articles.

 

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  184.5 It being the policy of the Company that indemnification of the persons specified in this Article shall be made to the fullest extent permitted by law, the indemnification provided by this Article shall not be deemed exclusive (a) of any other rights to which those seeking indemnification or advancement of expenses may be entitled under the Memorandum, Articles, any agreement, any insurance purchased by the Company, any vote of Members or disinterested directors, or pursuant to the direction (however embodied) of any court of competent jurisdiction, or otherwise, both as to action in his official capacity and as to action in another capacity while holding such office, or (b) of the power of the Company to indemnify any person who is or was an employee or agent of the Company or of another company, joint venture, trust or other enterprise which he or he is serving or has served at the request of the Company, to the same extent and in the same situations and subject to the same determinations as are hereinabove set forth with respect to a director, executive or trustee. As used in this paragraph (b), references to the “Company” include all constituent companies in a consolidation or merger in which the Company or a predecessor to the Company by consolidation or merger was involved. The indemnification provided by this Article shall continue as to a person who has ceased to be a director, executive or trustee and shall inure to the benefit of the heirs, executors, and administrators of such a person.

 

  184.6 The Directors shall have power to purchase and maintain for any Director, the Secretary or other officers or employees of the Company insurance against any such liability as referred to in Section 200 of the 1963 Act.

 

  184.7 The Company may additionally indemnify any employee or agent of the Company or any director, executive, employee or agent of any of its subsidiaries to the fullest extent permitted by law.

FINANCIAL YEAR

 

185. The financial year of the Company shall be as prescribed by the Board from time to time.

SHAREHOLDER RIGHTS PLAN

 

186. Subject to applicable law, the Directors are hereby expressly authorised to adopt any shareholder rights plan (a “Rights Plan”), upon such terms and conditions as the Directors deem expedient and in the best interests of the Company, including where the Directors are of the opinion that a Rights Plan could grant them additional time to gather relevant information or pursue strategies in response to or anticipation of, or could prevent, a potential change of control of the Company or accumulation of shares in the Company or interests therein.

 

187. The Directors may exercise any power of the Company to grant rights (including approving the execution of any documents relating to the grant of such rights) to subscribe for ordinary shares or preferred shares in the share capital of the Company (“Rights”) in accordance with the terms of a Rights Plan.

 

42


188. For the purposes of effecting an exchange of Rights for ordinary shares or preferred shares in the share capital of the Company (an “Exchange”), the Directors may:

 

  188.1 resolve to capitalise an amount standing to the credit of the reserves of the Company (including, but not limited to, the share premium account, capital redemption reserve and profit and loss account), whether or not available for distribution, being an amount equal to the nominal value of the ordinary shares or preferred shares which are to be exchanged for the Rights; and

 

  188.2 apply that sum in paying up in full ordinary shares or preferred shares and allot such shares, credited as fully paid, to those holders of Rights who are entitled to them under an Exchange effected pursuant to the terms of a Rights Plan.

 

189. The common law duties of the Directors to the Company are hereby deemed amended and modified such that the adoption of a Rights Plan and any actions taken thereunder by the Directors (if so approved by the Directors) shall be deemed to constitute an action in the best interests of the Company in all circumstances, and any such action shall be deemed to be immediately confirmed, approved and ratified.

 

43

EX-3.2 3 d775834dex32.htm EX-3.2 EX-3.2

EXHIBIT 3.2

COMPANIES ACTS, 1963 TO 2013

A PUBLIC COMPANY LIMITED BY SHARES

MEMORANDUM OF ASSOCIATION

OF

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

(As amended by Special Resolution dated 17 November 2014)

 

1. The name of the Company is Nexvet Biopharma public limited company (the “Company”).

 

2. The Company is to be a public limited company.

 

3. The objects of the Company are:

 

  (a) To purchase or otherwise acquire the entire issued share capital of Nexvet Biopharma Pty Ltd and warrants, options and other rights to acquire share capital in Nexvet Biopharma Pty Ltd in consideration for shares, debentures, debenture stock securities, options, warrants and other rights to or over shares to be issued or granted by the Company to the shareholders, option holders and warrant holders of Nexvet Biopharma Pty Ltd on such terms and in such amounts as the directors shall determine.

 

  (b) To carry on business as a holding and investment company and to carry on all related activities to the aforementioned business, including to hold and actively manage the Company’s investments and all subsidiaries and associates, including any company which is for the time being the Company’s holding or subsidiary company as defined by Section 155 of the Companies Act, 1963 or another subsidiary as defined by the said Section of the Company’s holding company or otherwise associated with the company in business, including the supply of administrative, financial, commercial, marketing, technical and information technology services and any other services related to this activity.

 

  (c) To undertake, carry on and execute all kinds of financial, commercial, trading, manufacturing and other operations and any other business which may seem to be capable of being conveniently carried on in connection with any of these objects, or calculated directly or indirectly to enhance the value of or facilitate the realisation of or render profitable, any of the Company’s property or rights.

 

  (d) To acquire by purchase, lease, sub-lease, exchange, hire or licence or otherwise, and hold for any estate or interest, and to take options over any lands, buildings, water, wells, streams, easements, rights, privileges, concessions, machinery, plant, stock-in-trade and any real, personal, heritable, or movable property of any kind which may appear to be necessary or convenient for the Company’s business or for developing or utilising any of the Company’s property.

 

  (e) To build, construct, maintain, alter, enlarge, pull down and remove or replace any buildings, offices, factories, mills, works, wharves, roads, railways, tramways, machinery, engines, walls, fences, banks, dams, sluices, or watercourses, and to clear sites for the same, or to join with any person, firm or company in doing any of the things aforesaid, and to work, manage and control the same, or join with others in so doing.

 

  (f) To apply for, purchase or by other means acquire, manage, licence and protect, prolong and renew, in any part of the world, any intellectual property, including patents, patent rights, brevets d’invention, licenses, protections and concessions which may appear likely to be advantageous or useful to the Company, and to use and turn to account and to manufacture under, or grant rights or privileges in respect of the same, and to expend money in experimenting upon testing, and in improving or seeking to improve any patents, inventions or rights which the Company may acquire or propose to acquire.


  (g) To acquire and undertake the whole or any part of the business, goodwill and assets of any person, firm or company carrying on or proposing to carry on any of the businesses which this Company is authorised to carry on, and as part of the consideration for such acquisition to undertake all or any of the liabilities of such person, firm or company, or to acquire an interest in, amalgamate with, or enter into any arrangement for sharing profits, or for co-operation, or for limiting competition, or for mutual assistance with any such person, firm or company, and to give or accept by way of consideration for any of the acts or things aforesaid or property acquired, any shares, debentures, debenture stock or securities that may be agreed upon, and to hold and retain or sell, mortgage and deal with any shares, debentures, debenture stock or securities so received.

 

  (h) To manage, supervise and control, or to take part in the management, supervision or control of, any company or undertaking in which the Company is interested by reason of shareholding or otherwise, and for that purpose to appoint and remunerate any directors, accountants or other experts or agents.

 

  (i) To improve, manage, cultivate, develop, exchange, let on lease or otherwise, mortgage, charge, sell, dispose of, turn to account, grant rights and privileges in respect of, or otherwise deal with all or any part of the property and rights of the Company.

 

  (j) To invest and deal with the moneys of the Company not immediately required in such shares and upon such securities and in such manner as may from time to time be determined.

 

  (k) To lend and advance money or give credit to any persons, firms or companies and to guarantee, grant indemnities in respect of, support or secure, whether by personal covenant or by mortgaging or charging all or any part of the undertaking, property and assets (present and future), goodwill and uncalled capital of the Company or by both such methods, the performance of the contracts or obligations of and the repayment or payment of the principal amounts of any premiums, interest and dividends on any securities of any person, firm or company, including (without prejudice to the generality of the foregoing) any company which is for the time being the Company’s holding company as defined by Section 155 of the Companies Act, 1963 or another subsidiary as defined by the said Section of the Company’s holding company or otherwise associated with the company in business notwithstanding the fact that the Company may not receive any consideration, advantage or benefit, direct or indirect from entering into such guarantee or other arrangement or transaction contemplated therein.

 

  (l) To borrow or raise money in such manner as the Company shall think fit, and in particular by the issue of debentures or debenture stock (perpetual or otherwise), and to secure the repayment of any money borrowed, raised or owing by mortgage, charge or lien upon the whole or any part of the Company’s property or assets (whether present or future), including its uncalled capital, and also by a similar mortgage, charge or lien to secure and guarantee the performance by the company of any obligation or liability it may undertake.

 

  (m) To draw, make, accept, endorse, discount, execute and issue promissory notes, bills of exchange, bills of lading, warrants, debentures and other negotiable or transferable instruments.

 

  (n)

To apply for, promote and obtain any Act of the Oireachtas, provisional order or licence of the appropriate Minister, or other authority for enabling the Company to carry any of its objects into effect, or for effecting any modification of the Company’s constitution, or

 

2


  for any other purpose which may seem expedient, and to oppose any proceedings or applications which may seem calculated, directly or indirectly, to prejudice the Company’s interests.

 

  (o) To enter into any arrangements with any governments or authorities (supreme, municipal, local or otherwise), or any corporations, companies or persons that may seem conducive to the attainment of the Company’s objects, or any of them, and to obtain from any such government, authority, corporation, company or person any charters, contracts, decrees, rights, privileges and concessions which the Company may think desirable, and to carry out, exercise and comply with any such charters, contracts, decrees, rights, privileges and concessions.

 

  (p) To purchase or otherwise acquire for cash or by the issue of shares or debentures or debenture stock, or partly for cash, and partly for shares or debentures or debenture stock, and to sell, lease, let, sublet, exchange, dispose, surrender, let on rent, share of profit, royalty or otherwise, grant options over, mortgage, charge, convert, turn to account, dispose of and otherwise deal with (whether for good or valuable consideration or otherwise) real and personal property and rights of all kinds, and in particular mortgages, debentures, produce, concessions, options, contracts, patents, annuities, licenses, stocks, shares, bonds, policies, book debts, business concerns, goodwill and undertakings and claims, privileges and choses in action of all kinds.

 

  (q) To act as agents or brokers and as trustees for any person, firm or company, and to undertake and perform sub-contracts, and also to act in any of the businesses of the Company through or by means of agents, brokers, subcontractors or others.

 

  (r) To remunerate any person, firm or company rendering services to this Company, either by cash payment or by the allotment to him or them of shares or securities of the Company credited as paid up in full or in part or otherwise as may be thought expedient.

 

  (s) To pay all or any expenses incurred in connection with the promotion, formation and incorporation of the Company, or to contract with any person, firm or company to pay the same and to pay commissions to brokers and others for underwriting, placing, selling or guaranteeing the subscription of any shares, debentures, debenture stock or securities of this Company.

 

  (t) To establish and maintain or procure the establishment and maintenance of any non-contributory or contributory pension or superannuation funds for the benefit of and give or procure the giving of donations, gratuities, pensions, allowances, or emoluments to any persons who are or were at any time in the employment or service of the Company, or of any company which is for the time being the Company’s holding or subsidiary company as defined by Section 155 of the Companies Act 1963 or otherwise associated with the Company in business or who are or were at any time directors or officers of the Company or of any such other company as aforesaid and the wives, widows, families and dependants of any such persons and also to establish and subsidise or subscribe to any institutions, associations, clubs or funds calculated to be for the benefit of or to advance the interests and well-being of the Company or of any such other company as aforesaid or of any such persons as aforesaid and to make payments for or towards the insurance of any such persons as aforesaid and to subscribe or guarantee money for charitable or benevolent objects or for any exhibition or for any public, general or useful object and to do any of the matters aforesaid either alone or in conjunction with any such other company as aforesaid.

 

  (u) To secure or guarantee by mortgage, charge or otherwise the performance and discharge of any contract, obligation or liability of a Company or of any person or corporation with whom or which the Company has dealings or having a business or undertaking in which the Company is concerned or interested whether directly or indirectly.

 

3


  (v) To promote or concur in promoting any other company for the purpose of acquiring the whole or any part of the business or property and undertaking any of the liabilities of this Company, or of undertaking any business or operations which may appear likely to assist or benefit this Company or to enhance the value of any property or business of this Company, and to place or guarantee the placing of, underwrite, subscribe for or otherwise acquire all or any part of the shares or securities of any such company as aforesaid.

 

  (w) To undertake and execute any trusts the undertaking whereof may seem desirable, whether gratuitously or otherwise.

 

  (x) To sell or otherwise dispose of the whole or any part of the business or property of the Company, either together or in portions, for such consideration as the Company may think fit, and in particular for shares, debentures or securities of any company purchasing the same.

 

  (y) To distribute among the members of the Company in kind any property of the Company, and in particular any shares, debentures or securities of other companies belonging to this Company, or of which this Company may have the power of disposing.

 

  (z) To procure the Company to be registered or recognised in any member State of the European Union and any foreign country or place.

 

  (aa) To redeem, purchase, or otherwise acquire in any manner permitted by law and on such terms and in such manner as the Company may think fit any shares in the Company’s capital, which shall include the acquisition of any fully paid shares in the capital of the Company otherwise than for valuable consideration.

 

  (bb) To do and carry out all or any of the foregoing objects in any part of the world and either as principals, agents, contractors, trustees or otherwise, and either by or through agents, trustees or otherwise and either alone or in partnership or in conjunction with any other company, firm or person, provided that nothing herein contained shall empower the Company to carry on the businesses of insurance.

It is hereby expressly declared that each sub-clause of this Clause shall be construed independently of the other sub-clauses hereof, and that none of the objects mentioned in any sub-clause shall be deemed to be merely subsidiary to the objects mentioned in any other sub-clause.

Provided always that the provisions of this Clause shall be subject to the Company obtaining, where necessary, for the purpose of carrying any of its objects into effect, such licence, permit or authority as may be required by law.

 

4. The liability of the members is limited.

 

5. The Share Capital of the Company is €40,000.00 divided into 400 Euro Deferred Shares of €100 each, and US$4,000,000 divided into 20,000,000 Ordinary Shares of US$0.125 each, 4,000,000 SIRPS Shares of US$0.125 each, and 8,000,000 Series B Preferred Shares of US$0.125 each with power to increase or decrease the share capital. The capital may be divided into different classes of shares with any preferential, deferred or special rights or privileges attached thereto, and from time to time the Company’s regulations may be varied so far as may be necessary to give effect to any such preference, restriction or other term.

 

4


We, as the subscribers wish to be formed into a Company according to this Memorandum of Association, and we agree to take the number of shares in the capital of the Company opposite our names.

 

Name, Address

  

Number of shares

  

Signature and Date

Geraldine Farrell

1 Dundonald Avenue

Malvern East

Victoria

3145 Australia

   1 Ordinary Share of USD$0.10 each   

     

Dated:

29.07.14

Mark Heffernan

6 Volum Street

Manifold Heights

Victoria

3218

Australia

   1 Ordinary Share of USD$0.10 each   

     

Dated:

29.07.14

Total

   2 Ordinary Shares of USD$0.10 each   

Witness

       

Signature and Date

Name & Address:

 

Melissa Postma

20/311 Royal Pde

Parkville

Vic

3052

Australia

     

     

Dated:

29.07.14

Occupation:

Assistant

     

 

5


COMPANIES ACTS, 1963 TO 2013

A PUBLIC COMPANY LIMITED BY SHARES

ARTICLES OF ASSOCIATION

OF

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

(As amended by Special Resolution dated 17 November 2014)

Preliminary

 

1. The Regulations in Table A, Part I and Part II, first schedule to the Companies Act, 1963 (the Act) will not apply to this Company.

 

A Management of the Company

Company managed by the Directors

 

2. The directors manage the Company. It must do so in accordance with the Companies Acts and lawful resolutions of the Company. A director is not required to own shares in the Company.

Directors to appoint Company Secretary

 

3. The directors must appoint a secretary in accordance with the Companies Acts on the conditions they think fit and the directors may remove any secretary so appointed from office. The directors may appoint one or more of a joint secretary and an assistant secretary in accordance with the Companies Acts on the conditions they think fit and the directors may remove any joint secretary and assistant secretary so appointed from office.

 

3A. Anything which is, by the Companies Acts required or authorised to be done by or to the secretary may be done by or to a joint secretary or may, if the office is vacant or there is for any other reason no secretary or joint secretary capable of acting, be done by or to an assistant secretary or acting secretary or, if there is no assistant secretary or acting secretary capable of acting by or to an officer of the Company authorised generally or specially in that behalf by the directors: provided that any provision of the Companies Acts or these Articles requiring or authorising a thing to be done by or to a director and the secretary shall not be satisfied by its being so done by or to the same person acting both as a director and as, or in place of, the secretary.

Powers of directors

 

4. The directors have the power and duty to manage and control the business and affairs of the Company. They may exercise all the Company’s powers, except those that are required to be exercised by the Company in general meeting. The following are among the specific powers they have:

 

  (a) to borrow or raise money;

 

  (b) to secure the payment of any money in anyway, including by mortgage, debenture or charge on all the Company’s assets and undertakings, present and future.

Directors may confer powers on a person

 

5. The directors may confer on a person (including a director) the power to do specified things on behalf of the Company, whether by power of attorney or not. They may confer on that person a power of sub-delegation. The entrusting of a power to a person does not exclude its exercise by the directors themselves.

 

6


Number of directors

 

6. There must be at least two directors of the Company and not more than 10. The Company may alter the minimum number of directors by passing an ordinary resolution. If the number of directors falls below the minimum set by the Company, they must not act as directors until the number is increased to the minimum, except:

 

  (a) to increase the number of directors to the minimum:

 

  (b) to convene a general meeting of the Company.

Appointment and removal of directors

 

7. The members may appoint a director, remove a director, or do both, by passing an ordinary resolution. The directors may appoint a director either to fill a casual vacancy or to add to their number.

Retirement of directors

 

8. A director may retire from office by giving written notice to the Company at its registered office. The resignation is effective at the time stated in the notice, provided it is after the time the notice was given. If not, the notice is effective immediately it is given.

Office of director becomes vacant

 

9. A director automatically ceases to be a director if any of the following applies:

 

  (a) the director is prohibited from being a director or ceases to be a director or is removed from being a director by the Companies Acts or by an order made under it;

 

  (b) the director becomes insolvent or makes a composition or arrangement with his or her creditors or a class of them;

 

  (c) the director becomes of unsound mind or a person who is, or whose estate is, liable to be dealt with in any way under any law relating to mental health;

 

  (d) the director is absent from meetings of directors for 6 consecutive months without special leave from the directors, and the directors consequently declare his or her office vacant;

 

  (e) the director fails to pay a call on his or her shares in the Company for at least a month after the call was made — or a longer period allowed by the directors.

Alternate directors

 

10. A director may appoint a person to act in his or her place as an alternate for any period the director thinks fit. The appointment must be in writing and must first be approved by a majority of the other directors. The managing director may not appoint an alternate managing director. An alternate does not have to own shares in the Company. An alternate may not be an alternate for more than one director.

Powers of alternate directors

 

11. In the absence of the appointing director, his or her alternate has all the rights, and may exercise all the powers of, the director (including voting at meetings) on the same conditions as the appointing director. The exercise of rights and powers has the same effect as if the appointing director had exercised them. However, the alternate director is not the appointing director’s agent and is personally responsible to the Company for his or her conduct.

Notice of meetings

 

12. An alternate is entitled to receive notices of meetings of directors.

 

7


Resignation of alternate director

 

13. An alternate may resign by giving the Company written notice at its registered office. The resignation takes effect immediately the notice is given.

Termination or suspension of appointment of alternate director

 

14. An appointing director may immediately terminate the appointment of his or her alternate or suspend the appointment, by giving the Company written notice at the registered office. The other directors may immediately terminate the appointment of an alternate, or suspend that appointment, by passing a resolution at a meeting of directors after giving the appointing director reasonable written notice. The appointment of an alternate terminates automatically if the appointing director ceases to be a director, or if anything happens in respect of the alternate which, if it happened to the appointing director, would result in that director ceasing to hold office.

Appointment of managing director

 

15. The directors may appoint one or more of them to be the Company’s managing director for the period and on the terms (including terms as to salary and fees) they think fit. If the managing director is unable to act in that office, the directors may appoint a person to act temporarily as managing director. If more than one managing director has been appointed at a particular time, they hold office jointly.

Resignation etc of managing director

 

16. The clauses in these Articles that apply in relation to the resignation, disqualification and removal of a director apply to the managing director with any necessary qualifications. The directors may remove the managing director from office, but only in accordance with the Company’s contract of employment with that person.

Managing director ceasing to hold office

 

17. The managing director automatically ceases to hold office when he or she ceases to be a director.

Powers of managing director

 

18. The managing director has the powers entrusted to him or her by the directors. The directors may withdraw or vary any power entrusted to the managing director. The entrusting of a power to the managing director does not exclude its exercise by the directors themselves.

Remuneration of directors

 

19. The directors are entitled to be paid directors’ fees set by the directors. The directors may set different amounts for different directors. If they don’t, each director’s fee must be the same as each other director’s fee. The directors’ fees must not be more in aggregate than the maximum amount approved by the Company in general meeting. Directors’ fees accrue daily.

Expenses

 

20. In addition to their fees, directors are entitled to be paid or reimbursed for all travelling and other expenses they properly incur in relation to exercising their powers and performing their duties in relation to:

 

  (a) a meeting of directors;

 

  (b) a meeting of a committee of directors; a general meeting of the Company;

 

  (c) or the business or affairs of the Company.

 

8


Conflict of interests

 

21. A director is entitled to hold another office with the Company, or to be remunerated for other work (including professional work) by the Company, despite being a director. This does not apply in relation to the office or work of auditor. A director is not disqualified from office by reason of entering into a contract or arrangement with the Company or having an interest in a contract or arrangement with the Company, nor is any such contract or arrangement void or liable to be avoided. A director does not have to account to the Company for any profit arising from a contract or arrangement with the Company merely because of being a director and having a fiduciary duty to the Company.

Disclosure of an interest

 

22. A director must disclose an interest in any contract or arrangement with the Company as required by the Companies Acts.

General notice of an interest

 

23. A director may give a general notice to the Company at its registered office that he or she is an officer or member of a specified corporation or firm, or has an interest in it in some other way. The notice must set out the nature and extent of the director’s interest. The notice is effective on all subsequent occasions as a disclosure of the director’s interest in a matter involving the Company and that corporation or firm, but only if the director’s interest at the time of first consideration of the matter is no greater than as stated in the general notice.

Effect of disclosure by a director

 

24. If a director complies with the Companies Acts and these Articles in relation to disclosing an interest:

 

  (a) the director may vote on whether the Company enters into the contract or arrangement;

 

  (b) the contract or arrangement may be entered into;

 

  (c) the director may participate in the execution of the contract; and the director may vote on matters involving the contract.

 

B. MEETINGS OF DIRECTORS

Directors may regulate meetings

 

25. The directors may regulate their meetings in the way they think fit.

Holding meetings

 

26. A director may convene a meeting of directors at any time. The Company secretary must convene a meeting if requested by a director to do so. The convenor convenes a meeting by giving written or oral notice of it to all directors.

Failure to give notice

 

27. The resolutions passed at a meeting of directors for which notice was not given to all directors, and actions taken to implement those resolutions, are nonetheless valid if each director who was not given notice later agrees to waive the receipt of that notice.

Quorum

 

28. No business may be transacted at any time during a meeting of directors unless a quorum is present. Until the directors decide otherwise, the quorum for a meeting of directors is any 2 directors. The quorum must be present throughout a meeting. An alternate director who is not also a director may be counted in the quorum if the appointing director is not present.

 

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Chair

 

29. The directors may elect one of them to be chair for a specified period. If a meeting of directors is held and no chair has been appointed, or the usual chair is not present within 30 minutes after the scheduled starting time or is unwilling to chair the meeting, the directors present must elect one of them to chair that meeting.

Meetings of directors in different places

 

30. With the consent of all directors notified orally or in writing to the Company secretary, a meeting of directors may be convened at different venues, provided the technology used gives the directors at each venue a reasonable opportunity to participate in the meeting.

Each director must be able (directly or by means of telephonic, video or other electronic communication) to speak to each of the other directors and to be heard by each of the other directors. If there is a failure in the technology which deprives any director of a reasonable opportunity of participating in the meeting, the chair must adjourn the meeting until the failure is rectified. If the failure is not rectified within one hour, the chair must adjourn the meeting to a date and time when the chair believes all directors will be able to participate.

A meeting held in this way is deemed to take place at the place where the chairman of the meeting is physically present.

Director’s consent to meeting of directors in different places

 

31. A director who consents to a meeting of directors being held even though all directors are not in the same place may withdraw that consent 48 hours before the meeting is due to be held. In that case, the meeting may not be held.

Departure from a meeting of directors in different places

 

32. A director who wishes to leave a meeting of directors being held even though all directors are not in the same place must obtain the express consent of the chair. A director who fails to do so is conclusively presumed present throughout the meeting for the purposes of the quorum for that meeting.

Voting and resolutions at a meeting

 

33. At a meeting of directors:

 

  (a) each director who is present has one vote;

 

  (b) an alternate director who is also a director has one vote as director and one vote for each appointing director who is absent from the meeting and by whom he or she has been appointed as an alternate; and

 

  (c) the chair has a casting as well as a deliberative vote.

A resolution is passed at a meeting of directors if a majority of the votes cast is in favour of it.

Resolutions by circular

 

34. The directors may pass a resolution by circular without holding a meeting. Reasonable notice of the resolution must be given to all directors. The resolution must be signed by all directors entitled to vote on it and must state that they are in favour of it. The resolution is valid from the time the last director signs it and is taken to have been passed at that time. Different directors may sign different documents provided they are identical. Faxed documents are acceptable. The resolution must be noted in the minutes of the meetings of directors.

Minutes of meetings

 

35. The directors must keep minutes of meetings in accordance with the Companies Acts.

 

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They must record each of the following:

 

  (a) all appointments of officers made by the directors;

 

  (b) the names of directors and alternate directors present at each meeting of directors and of any committee of the directors;

 

  (c) all orders, resolutions and proceedings of meetings of directors and of any committee of the directors;

 

  (d) any matter that the Companies Acts require to be recorded in the books of the Company. This includes declarations and notices of interest made and given by a director.

The chair of the meeting or of the next meeting must sign the minutes as a true and correct record of the meeting. The original signed minutes shall be retained by the Company in Ireland. That person’s signing of the minutes is sufficient evidence of anything recorded and of the regularity of what was done at the meeting.

Committees of directors

 

36. The directors may delegate any of their powers to a committee of directors they specify. The directors may revoke a delegation. A committee must comply with any conditions on the exercise of its powers that the directors set. A power properly exercised by a committee is exercised by the directors. The clauses that apply in relation to the proceedings of a meeting of directors apply in relation to meetings of a committee of directors (except a committee of one).

Minutes of meetings of committees

 

37. The rules applying to the minutes of meetings of directors and their signing apply, with any necessary changes, to the minutes of meetings of a committee. If a committee consists of only one director, a minute signed by that director recording a decision by him or her as that committee is a minute of that committee.

Validation of acts of directors

 

38. Any act done at a meeting of directors or of a committee of directors, or by any person acting as director or by a person claiming to act under a power of attorney executed by the Company, is valid even if it is later discovered that there was a defect in the person’s appointment or continuance in office, or that the person was disqualified from voting or not entitled to vote.

Execution of documents

 

39. In addition to any other way in which the Company may execute a document, it may do so by 2 directors signing it, or by one director and a secretary (including, for the avoidance of doubt, a joint secretary, assistant secretary or acting secretary as may be applicable) of the Company signing it.

Company seal

 

40. The Company shall have a company seal (the terms “company seal”, “seal” and “common seal” shall be interchangeable and shall have the same meaning). The seal shall be used only by the authority of the directors or of a committee of directors authorised by the directors in that behalf and every instrument to which the seal shall be affixed shall be signed by a director (or by some other person appointed by the directors for that purpose) and shall be counter-signed by the secretary (including, for the avoidance of doubt, a joint secretary, assistant secretary or acting secretary as may be applicable) or by a second director or by some other person appointed by the directors for that purpose. The expression “director” in this context shall include any alternate director appointed under these Articles.

 

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41. The directors may exercise the powers conferred on the Company by section 41 of the Act with regard to having an official seal for use in any territory, district or place not situate in the state and such powers shall be vested in the directors and every instrument to which the official seal shall be affixed shall be signed by a director (or by some other person appointed by the directors for that purpose) and shall be counter-signed by the secretary (including, for the avoidance of doubt, a joint secretary, assistant secretary or acting secretary as may be applicable) or by a second director or by some other person appointed by the directors for that purpose. The expression “director” in this context shall include any alternate director appointed under these Articles.

 

C. GENERAL MEETINGS OF THE COMPANY CONVENING A GENERAL MEETING

 

42. General meetings of the Company shall be held in the state unless (i) the directors resolve to hold a general meeting outside the state; or (ii) the members pass a special resolution to hold a general meeting outside the state.

 

43. (1) Subject to paragraph (2) below, the Company shall in each year hold a general meeting as its annual general meeting in addition to any other meeting in that year, and shall specify the meeting as such in the notices calling it; and not more than 15 months shall elapse between the date of one annual general meeting of the Company and that of the next.

(2) So long as the Company holds its first annual general meeting within 18 months of its incorporation, it need not hold it in the year of its incorporation or in the year following. Subject to article 42, the annual general meeting shall be held at such time and place as the directors shall appoint.

 

44. All general meetings other than annual general meetings shall be called extraordinary general meetings.

 

45. The directors may, whenever they think fit, convene an extraordinary general meeting, and extraordinary general meetings shall also be convened on such requisition, or in default, may be convened by such requisitionists, as provided by section 132 of the Act.

Notice of meetings

 

46. Subject to sections 133 and 141 of the Act, an annual general meeting and a meeting called for the passing of a special resolution shall be called by 21 days’ notice in writing at the least and a meeting of the Company (other than an annual general meeting or a meeting for the passing of a special resolution) shall be called by 14 days’ notice in writing at the least. The notice shall be exclusive of the day on which it is served or deemed to be served and of the day for which it is given and shall specify the day, the place and the hour of the meeting and, in the case of special business, the general nature of that business and shall be given in manner authorised by these regulations to such persons as are under the regulations of the Company entitled to receive such notices from the Company.

The accidental omission to give notice of a meeting to, or the non-receipt of notice of a meeting by, any person entitled to receive notice shall not invalidate the proceedings at the meeting.

Quorum

 

47. No business may be transacted at any time during a general meeting unless a quorum is present. The quorum for a general meeting is 2 members who are present in person or by proxy, who are entitled to vote. A representative of a corporation member (entitled to vote) who is an individual may also being counted towards the quorum. The Company shall have a minimum of 7 members.

 

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  47.1 In the case of a meeting convened by a member or members, if a quorum is not present within 30 minutes after the time appointed for a general meeting to be held the meeting shall be dissolved.

 

  47.2 In the case of a meeting convened by the directors, if a quorum is not present within 30 minutes after the time appointed for a general meeting to be held, it automatically stands adjourned to the same day of the following week at the time and venue the directors notify to the members in writing. If a quorum is not present within 30 minutes after the time appointed for the adjourned meeting, the members present shall be a quorum.

Chair

 

48. The chair of meetings of directors is also the chair of a general meeting. If there is no chair, or the chair is unwilling to act as chair, or the chair is not present within 30 minutes after the time appointed for the general meeting to be held, the directors may choose another director to be chair of the meeting. If the directors fail to do so, or all directors present decline to be chair, the members who are present may choose one of them to be chair of the meeting.

Chair’s rulings final

 

49. The chair’s rulings on any matter relating to the order of business, procedure and conduct of the general meeting are final. No motion of dissent from a ruling will be accepted.

Adjournment

 

50. The chair may postpone a general meeting whether or not validly convened. The chair may adjourn a general meeting from time to time and from place to place. The only business that may be transacted at an adjourned meeting is the business stated in the notice concerning the original meeting. If a meeting is postponed or adjourned, the directors must try to notify in writing each person entitled to receive notice of the fact of its postponement or adjournment. In the case of an adjournment, the notice must state the new time and venue for the meeting. An accidental failure to give notice to a person, or the non-receipt by that person of the notice, does not affect the validity of the postponement or adjournment of the meeting.

 

51. On the request or on the decision of a majority of members present and entitled to vote the chair must adjourn a general meeting, or any business, motion, resolution, question, debate, discussion or poll. The adjournment of any business, motion, resolution, question, debate, discussion or poll may be until later in the meeting or to an adjourned meeting in accordance with the decision or request and does not affect the conduct of any other business that remains to be conducted at the meeting.

Adjourned meetings

 

52. No notice has to be given of an adjourned meeting or the business to be transacted at it unless the adjournment is for at least 30 days. In that case, the notice requirements relating to the original meeting apply. No business may be transacted at an adjourned meeting except the business from the meeting adjourned. A resolution passed at an adjourned meeting is passed on the day of that adjourned meeting.

Voting rights

 

53. Subject to any rights or restrictions attached at the relevant time to a class or classes of shares, each member of the Company, or each member of a class of members, who is entitled to attend and vote may attend a meeting of the Company, or of the class of members. An individual member may vote personally or by proxy. A corporation member may do so by a representative who is an individual. No person who is not a member of the Company, or a member of the class of members, or a proxy of that member — or, in the case of a corporation member, a representative of that member — may vote at a meeting of members or of a class of members.

 

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Votes

 

54. On a show of hands, each member present at a meeting of members or of a class of members who is entitled to vote has one vote. On a poll, each member present at a meeting of members or of a class of members who is entitled to vote has one vote for every fully paid up share held.

Votes by joint holders

 

55. Any joint holder of shares may vote at a general meeting. However, if more than one vote is cast, the only one that will be counted is that of the joint holder whose name appears first on the register of members of the Company.

Members not entitled to vote: general

 

56. A member who is a minor or who is of unsound mind or who is, or whose estate is, liable to be dealt with in any way under any law relating to mental health may vote by the person or body who has the management or guardianship of the person or his or her estate. That person or body may vote by proxy or by representative, but only after giving the directors satisfactory proof of the right to do so under this clause.

Members not entitled to vote: amount unpaid

 

57. A member is not entitled to be present or to vote at a general meeting unless all calls and other amounts payable at the time of the meeting in respect of shares held by the member have been paid in full.

Objection to vote

 

58. A challenge to a person’s entitlement to vote at a general meeting or to the validity of a vote made at that meeting may only be raised at that meeting. If a vote is allowed by the chair, it is valid for all purposes.

Method of voting

 

59. A resolution at a general meeting is to be decided on a show of hands unless a poll is demanded by any of the following:

 

  (a) the chair of the meeting;

 

  (b) by not less than five members having the right to vote at the meeting;

 

  (c) by a member or members representing not less than one-tenth of the total voting rights of all the members having the right to vote at the meeting;

 

  (d) by a member or members holding shares in the Company conferring a right to vote at the meeting, being shares on which an aggregate sum has been paid up equal to not less than one-tenth of the total sum paid up on all the shares conferring that right.

Chair to declare proxies before taking vote

 

60. Before taking a vote on a resolution at a general meeting, the chair must inform the meeting whether any proxy votes have been received and how any proxy votes are to be cast

Declaration of result of a vote on a show of hands

 

61. A declaration by the chair of a general meeting of the result of a vote on a show of hands and a subsequent entry into the minutes of that meeting confirming that result that is signed by the chair of that meeting or the next general meeting, is by itself conclusive evidence of the declared result.

 

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When a poll may be demanded

 

62. A poll may be demanded before a vote on a resolution is taken, before the result of a vote on a show of hands is declared, or immediately after the result is declared.

Demand may be withdrawn

 

63. A demand for a poll may be withdrawn at any time before the poll is taken.

Taking of poll

 

64. If a poll is demanded, it must be taken in accordance with the directions of the chair. However, if the poll concerns the election of a chair or the adjournment of the meeting, it must be taken immediately. A delayed poll does not affect the transaction of other business. The result of the poll is the resolution of the meeting on that question.

Chair’s votes

 

65. The chair of a general meeting is not entitled to a casting vote in the case of an equality of votes on a show of hands or a poll.

Right of non-members to attend general meeting

 

66. The chair may invite any person who is not a member to attend and address a general meeting, including a director, auditor or Company secretary. The Company’s auditors are entitled to attend at and receive notice of all general meetings.

Resolutions by circular

 

67. The members may pass a resolution by circular without holding a general meeting. The resolution must be signed by all members entitled to vote on it and must state that they are in favour of it. If there are joint holders of shares entitled to vote on the resolution, each must sign it. The resolution is valid from the time the last member signs it and is taken to have been passed at that time. Different members may sign different documents provided they are identical. Faxed documents are acceptable. The resolution must be recorded in the minutes of the Company’s meetings. The above does not apply to either of the following resolutions: (a) a resolution to remove a director or appoint a director in place of a director who has been removed; and (b) a resolution to remove an auditor under the Companies Acts.

Proxies

 

68. A member who is entitled to vote at a general meeting or a meeting of a class of members may appoint a proxy.

Appointment of proxy

 

69. The instrument appointing a proxy shall be in writing under the hand of the appointer or of his attorney duly authorised in writing, or, if the appointer is a body corporate, either under seal or under the hand of an officer or attorney duly authorised. A proxy need not be a member of the Company.

An appointment for a meeting is valid for an adjournment of that meeting.

Form of proxy

 

70. The following form may be used for the appointment of a proxy.

 

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PROXY FORM

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

Meeting

 

Place:

 

Date:

 

Time:

 

I/We [insert name and address of member/members] am/are a member/members of [insert company name]. I appoint the following person/persons as my proxy/proxies to vote on my/our behalf at the specified meeting and any adjournment.

 

Name of Office of Proxy

 

Address

 
 

I/We appoint the following alternate person/persons to vote on my/our behalf at that meeting and any adjournment if a person I/We have appointed proxy is/are unable to act.

 

Name of Proxy

 

Name of Alternate

 

Address of Alternate

   
   

[Include any instructions concerning voting in favour of or against particular resolutions]

Signature/Signatures of member/members

[insert name of member/members appointing proxy]

Dated:

 

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Revocation of appointment

 

71. A member who has appointed a proxy may revoke the appointment at any time by giving the Company written notice. An appointment is not revoked by the member attending and taking part in a general meeting. However, if the member votes on a resolution, the proxy or other person appointed to exercise a member’s voting rights is unable to vote.

Lodgement of proxies

 

72. The instrument appointing a proxy and the power of attorney or other authority, if any, under which it is signed, or a notarially certified copy of that power or authority shall be deposited at the registered office or at such other place within the state as is specified for that purpose in the notice convening the meeting, before the time for holding the meeting or adjourned meeting at which the person named in the instrument proposes to vote, or, in the case of a poll, before the time appointed for the taking of the poll, and, in default, the instrument of proxy shall not be treated as valid. Faxed documents are acceptable. The deposit of any documentation noted above shall not be required more than 48 hours before the time for holding the meeting or adjourned meeting or before the time appointed for the taking of the poll, as the case may be.

Rights of proxies etc

 

73. A proxy or other person appointed to exercise a member’s voting rights has the same rights as the member to speak and vote at a general meeting. Those rights are suspended while the member is personally present at the meeting. The proxy or other person must vote on a resolution in accordance with any direction in the appointment.

 

  73.1 If there is no direction, and the person is separately entitled to vote on the resolution, the person may vote on it for the member as he or she thinks fit.

 

  73.2 If there is no direction, and the person is not separately entitled to vote on the resolution, he or she must abstain from voting on it.

 

  73.3 A proxy or other person appointed to exercise a member’s voting rights may demand or join in a demand for a poll.

Votes by proxy etc remain valid

 

74. A vote by proxy or other authority is valid despite any of the following:

 

  (a) the death of the member or the member ceasing to have mental capacity;

 

  (b) the bankruptcy or liquidation of the member;

 

  (c) the revocation of the proxy or other authority;

 

  (d) the transfer of the share in respect of which the vote was cast.

This does not apply if the Company receives notice of the relevant fact at its registered office before the commencement of the meeting (or adjourned meeting) at which the vote is to be cast.

Proxy of joint holders

 

75. The vote of a proxy appointed by all the joint holders of a share is to be counted to the exclusion of a vote by any other proxy of any of the joint holders.

Chair may require evidence

 

76. The chair of a general meeting may require a person acting as a proxy for a member to establish that he or she is the person named in the lodged proxy. If the person cannot do so, he or she may be excluded from voting as proxy for the member.

 

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Meetings of members of a class of shares

 

77. The rules applying to general meetings of the Company apply with any necessary modification to meetings of members holding a class of shares, unless a matter is dealt with specifically by the rules for meetings of class members.

 

D. Shares in the company

Power to issue shares

 

78. Without prejudice to any special rights previously conferred on the holders of any existing shares or class of shares, any share in the Company may be issued with such preferred, deferred or other special rights or such restrictions, whether in regard to dividend, voting, return of capital or otherwise, as the Company may from time to time by ordinary resolution determine.

 

79. If at any time the share capital is divided into different classes of shares, the rights attached to any class may, whether or not the Company is being wound up, be varied or abrogated with the consent in writing of the holders of three-fourths of the issued shares of that class, or with the sanction of a special resolution passed at a separate general meeting of the holders of the shares of the class. In the latter case, the quorum for the meeting is members holding 25% of the issued shares of the relevant class. Any member holding shares of the class may demand a poll.

 

80. The rights conferred upon the holders of the shares of any class issued with preferred or other rights shall not, unless otherwise expressly provided by the terms of issue of the shares of that class, be deemed to be varied by the creation or issue of further shares ranking pari passu therewith.

 

81. Subject to the provisions of these regulations relating to new shares, the shares shall be at the disposal of the directors, and they may (subject to the provisions of the Companies Acts, 1963 to 2013 relating to authority, pre-emption or otherwise) allot, grant options over or otherwise dispose of them to such persons, on such terms and conditions and at such times as they may consider to be in the best interests of the Company and its shareholders, but so that no share shall be issued at a discount and so that, in the case of shares offered to the public for subscription by a public limited company, the amount payable on application on each share shall not be less than one-quarter of the nominal amount of the share and the whole of any premium thereon.

 

82. The directors may issue or allot shares as fully paid or partly paid, or as payment for property acquired by, or services rendered to (an undertaking to perform future services shall not be accepted), the Company. They may differentiate between holders, including holders of the same class of shares, in relation to amount of calls or the timing of calls that are to be paid.

 

83. The authorised share capital of the Company is €40,000.00 divided into 400 Euro Deferred Shares of €100 each, and US$4,000,000 divided into 20,000,000 Ordinary Shares of US$0.125 each, 4,000,000 SIRPS Shares of US$0.125 each, and 8,000,000 Series B Preferred Shares of US$0.125 each.

 

84.

The directors of the Company are, for the purposes of section 20 of the Companies (Amendment) Act, 1983 (as amended) (the “1983 Act”) generally and unconditionally authorised to exercise all powers of the Company to allot and issue relevant securities (as defined by the said section 20) up to the amount of Company’s authorised but unissued share capital as at the date of adoption of these Articles and to allot and issue any shares purchased or redeemed by or on behalf of the Company pursuant to the provisions of Part XI of the Companies Act, 1990 (as amended) (the “1990 Act”) and held as treasury shares and this authority shall expire five years from the date of adoption of these Articles, save that the Company may before such expiry make an offer or agreement which would or might require

 

18


  relevant securities to be allotted after such expiry and the directors of the Company may allot relevant securities in pursuance of such offer or agreement as if the authority conferred hereby had not expired.

 

84A. The directors of the Company are hereby empowered pursuant to sections 23 and 24(1) of the 1983 Act to allot equity securities within the meaning of the said section 23 for cash pursuant to the authority conferred by Article 84 as if section 23(1) of the said 1983 Act did not apply to any such allotment. The Company may before the expiry of such authority make an offer or agreement which would or might require equity securities to be allotted after such expiry and the directors of the Company may allot equity securities in pursuance of such an offer or agreement as if the power conferred by Article 84 had not expired.

 

85. Subject to the provisions of the Companies Acts, the Company may purchase or otherwise acquire, on such terms and in such manner as it thinks fit, any shares in the capital of the Company, which shall include the acquisition of any fully paid shares in the capital of the Company otherwise than for valuable consideration.

 

86. Any share of a deceased member may be transferred by his executor or administrator to the widow or widower, child or grandchild of such deceased member.

 

87. Without prejudice to any special rights previously conferred on the holders of existing shares, any share (including shares which the Company shall have power to issue under Section 207 of the 1990 Act or otherwise) may be issued with such preferred, deferred or other special rights, or such restrictions whether in regard to dividend, voting, return of share capital or otherwise, as the Company may from time to time determine, and any share may be issued on the terms that it is, or at the option of the Company is liable to be, redeemed. Subject to the provisions of the 1990 Act, the redemption of such shares may be effected on such terms and in such manner as the directors may from time to time determine.

 

88. The directors may impose conditions dealing with preferred, deferred, qualified guaranteed and other special rights, privileges, conditions, restrictions or limitations in regard to dividend, return of capital, distribution of assets, voting or otherwise.

 

89. Subject to article 84, the directors may grant options to call on the Company to issue shares.

 

90. The directors must not issue any bearer shares or stock, or convert any shares into stock.

Euro Deferred Shares

 

90A. The holders of the Euro Deferred Shares shall not be entitled to receive any dividend or distribution and shall not be entitled to receive notice of, nor to attend, speak or vote at any general meeting of the Company. On a return of assets, whether on liquidation or otherwise, the Euro Deferred Shares shall entitle the holder thereof only to the repayment of the amounts paid up on such shares after repayment of the capital paid up on the Ordinary Shares plus the payment of US$5,000,000 on each of the Ordinary Shares and the holders of the Euro Deferred Shares (as such) shall not be entitled to any further participation in the assets or profits of the Company.

 

90B.

If the holders of 75% or more of the shares of the Company in issue for the time being wish to sell and transfer all (but not some only) of their shares to a purchaser (the “Buyer”), the holders of the Euro Deferred Shares shall sell and transfer (the “Sale and Transfer”) all of the Euro Deferred Shares to the Buyer (or as the Buyer directs) in consideration only for the amount of capital paid up in respect of each of the Euro Deferred Shares (the “Consideration”). If the holders of the Euro Deferred Shares default in the Sale and Transfer to the Buyer (or as the Buyer directs), the holders of the Euro Deferred Shares hereby irrevocably appoint one of the directors of the Company, or any other person who is appointed by the directors of the Company for the purpose as the duly appointed attorney of the holders of the Euro Deferred Shares, with full power to execute, complete and deliver in the name of and on behalf of the

 

19


  holders of the Euro Deferred Shares all such documentation as is required for the Sale and Transfer. Subject to the relevant transfer being properly stamped (where applicable), the Company shall cause the Buyer to be registered as the holder of the Euro Deferred Shares, but the Buyer is not responsible for what is done with any Consideration paid. Entitlement to the Euro Deferred Shares is not affected by any irregularity or invalidity in the sale and transfer procedure. The Company may give a good receipt for the Consideration, shall hold the Consideration in trust for the holders of the Euro Deferred Shares and may issue share certificates for the Euro Deferred Shares to the Buyer (or as the Buyer directs).

Shares that may be issued

 

91. The shares issued by the directors must be of a class described in the Schedule or otherwise authorised by these Articles.

Issue price

 

92. The directors determine the price of any shares they issue.

Preference shares

 

93. Subject to the Companies Acts, the directors may issue preference shares. However, the directors may only issue preference shares if rights with respect to any of the following that are to be attached to the preference shares are either set out in these Articles or have been approved by special resolution of the Company:

 

  (a) repayment of capital;

 

  (b) participation in surplus assets and profits;

 

  (c) cumulative and non-cumulative dividends;

 

  (d) voting; and

 

  (e) priority of payment of capital and dividends in relation to other shares or the Company’s property.

Commission and brokerage

 

94. The Company may pay commission or brokerage as allowed by the Companies Acts. It may do so by paying cash, allotting shares, or both.

Share certificates

 

95. The Company must issue share certificates to holders of shares. They must be in the form laid down by the directors and in accordance with any requirements in the Companies Acts. Each member is entitled to one share certificate, free of charge, for all the shares registered in his or her name. Joint holders of shares are entitled to only one certificate between them.

If a share certificate produced to the directors is worn out or defaced, the directors may order it to be cancelled. On cancellation, they may issue a replacement after being paid a fee set by them. If a share certificate is lost or destroyed, the directors must issue a replacement to the person entitled to the shares after being paid a fee set by the directors.

Calls on shares

 

96. The directors may at any time make a call, including a call by instalments, in respect of an amount unpaid on the shares of members. This does not apply if it was a condition of their issue that the shares were payable at or after fixed times. A call is made when the directors pass a resolution making it. The directors may adjourn or revoke a call.

 

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Notice of a call

 

97. The Company must give at least 14 days’ written notice to each member who holds a share in respect of which a call is made. An accidental failure to give notice or the failure of a member to receive it does not affect the validity of the call.

Fixed payment dates to be dates of calls

 

98. An amount which, by the terms of issue of a share, becomes payable on allotment or at or after a fixed or defined time, is treated as being subject to a call at that time, without notice being required.

Liability for a call

 

99. After receiving notice of a call, a member must comply with it. Joint holders are jointly and severally liable.

Interest on unpaid calls

 

100. If a sum called in respect of a share is not paid before or on the day appointed for payment thereof, the person from whom the sum is due shall pay interest on the sum from the day appointed for payment thereof to the time of actual payment at such rate, not exceeding 5 per cent. per annum, as the directors may determine, but the directors shall be at liberty to waive payment of such interest wholly or in part.

Proceedings

 

101. If a call is not paid on time, the directors may proceed to recover the amount, plus any interest and expenses. The exercise of that right does not affect any right of the Company to forfeit the relevant shares. In any proceedings, it is sufficient and conclusive to prove that:

 

  (a) the defendant’s name is entered in the register of members as a holder of the shares in respect of which the call was made;

 

  (b) the resolution making the call is recorded in the Company’s minute book; and

 

  (c) notice of the call was given to the member; or that the terms on which the shares were issued required payment at or after the relevant fixed or defined time.

Nothing else has to be proved.

Prepayment of calls

 

102. The directors may accept payment of an amount unpaid on a share without a call having been made in respect of any part of it. The directors may authorise the Company to pay interest on that amount, at the rate set by the directors (such rate not to exceed 5 per cent. per annum), from the time it is paid until the time the amount would have become due under a call. The directors may at any time repay any part of a prepaid amount. They must give the member at least one month’s notice of an intention to repay a prepaid amount.

Forfeiture of shares

 

103. If a member does not pay a call on time, the directors may serve a forfeiture notice on the member requiring payment of the relevant amount, plus interest and expenses. The notice must state:

 

  (a) a date and time (no earlier than 14 days after the date the notice is served) on or before which payment of the outstanding amount is required, and the place where payment is to be made; and

 

  (b) that if payment is not made as required, the shares will be liable to forfeiture.

 

21


If the member does not comply, the directors may forfeit the shares, including unpaid dividends declared in respect of them. The directors may at any time annul a forfeiture of shares.

Notice that forfeiture has taken place

 

104. If a share is forfeited, the directors must enter the forfeiture and its date in the register of members of the Company. The Company must give notice of the forfeiture to the member (or members) in whose name the share was registered. Failure to comply with this clause does not invalidate the forfeiture.

Consequences of forfeiture

 

105. A person whose shares have been forfeited ceases at the time of forfeiture to be a member in respect of those shares. He or she has no claim against the Company in respect of the forfeited shares, but remains liable to pay the Company the amount outstanding in respect of them at the date of forfeiture. If the directors think fit, the person must also pay interest on the outstanding amount, at the rate set by the directors (such rate not to exceed 5 per cent. per annum), from the time of the forfeiture until the outstanding amount is paid. The directors are not under an obligation to enforce the person’s obligations.

Evidence of forfeiture

 

106. A statement in writing by a director or the Company secretary that a particular share has been forfeited on a particular date is conclusive evidence of that fact against any person claiming to be entitled to it.

Disposal of forfeited shares

 

107. Subject to the requirements of the Companies Acts, the Company may sell or dispose in some other way of a forfeited share as the directors think fit, on receipt of any consideration for the disposal, the Company may transfer the share to the person to whom it was sold or disposed of. That person is then to be registered as the holder of the share, but is not responsible for seeing to what is done with any consideration paid. Entitlement to the share is not affected by any irregularity or invalidity in the forfeiture and disposal procedure.

Balance belongs to former member

 

108. Any balance of the proceeds of sale after payment to the Company of the amount outstanding for the share belongs to the person who last held the forfeited share.

Company has a lien on shares in respect of amounts payable

 

109. The Company has a first and paramount lien on each share registered (solely or jointly) in the name of a member, and on the proceeds of sale of that share, for all money that is outstanding on it, including an amount the Company may be required to pay in respect of it. The lien extends to dividends declared and other entitlements in respect of the share. Unless the directors decide otherwise, the registration of a transfer of a share waives the Company’s existing lien in respect of it. The directors may exempt a share from the Company’s lien.

Company’s indemnity and lien in respect of certain liabilities etc

 

110. If, under the law of Ireland or any other jurisdiction, a liability is imposed on the Company, or the Company is required to make a payment in respect of any shares registered in the Company’s Share Register or in respect of any dividends or other amounts which are or may become accrued or payable to a member in respect of those shares, then the Company is entitled to be indemnified against that liability or requirement by the holder of those shares. In addition:

 

  (a) The Company has a lien on the shares and the dividends or other amounts for the amount of the liability or requirement, plus interest on that amount, at the rate set by the directors (such rate not to exceed 5 per cent. per annum), from the time the Company pays the amount of the liability or requirement until the time the member indemnifies the Company. The directors may waive payment of the interest;

 

22


  (b) The Company may deduct from any amount payable by it to the member the amount due by the member under the indemnity.

This does not affect any other right the Company may have in respect of its payment of the liability or requirement.

Suspension of a member’s rights

 

111. While the Company holds a lien over shares in respect of an amount which has not been paid on time, the relevant member may not exercise any rights as a member in respect of those shares.

Enforcement of a lien

 

112. The Company may enforce a lien in respect of an amount that has not been paid on time by selling the shares in the way the directors think fit. The Company must give the member or other person entitled to the shares at least 14 days’ written notice, stating the amount due and demanding payment of it.

Completion of sale under a lien

 

113. Subject to the requirements of the Companies Acts, the directors may authorise a person to effect the transfer to the purchaser of shares which have been sold under the Company’s lien over them. The purchaser is entitled to be registered as the holder of the shares and is not responsible for seeing to what is done with the consideration paid. The purchaser’s entitlement to the shares is not affected by any irregularity or invalidity in connection with the sale. The purchaser is not under any obligation to pay any amount in respect of the shares except the purchase price and any other amount agreed with the Company.

Proceeds of sale under lien

 

114. Proceeds received by the Company from the sale of shares under a lien are to be applied towards payment of the amount in respect of which the lien existed and any expenses of the Company in enforcing the lien. Any balance must be paid to the person entitled to the shares before they were sold under the lien. However, the Company may retain any amount that has become payable since the sale in relation to something that occurred before the sale.

Transfer of shares

 

115. Subject to any agreement to the contrary between the members, a person may transfer shares to another person by a document in the usual or common form or in some other form approved by the directors, signed by both the transferor and the transferee. The transferor remains holder of the shares until the transfer is registered.

Registration of transfer

 

116. For a transfer to be registered, the following documents must be lodged at the Company’s registered office:

 

  (a) the instrument of transfer;

 

  (b) the share certificate (if there is one) or evidence satisfactory to the directors of its loss or destruction;

 

  (c) any other information the directors require to establish the transferor’s right to transfer the beneficial ownership in the shares.

No fee is payable in respect of a transfer.

 

23


Refusal to register

 

117. The directors may refuse to register a transfer for any reason they think fit. The Company must give written notice to the person who lodged the transfer within 7 days after a refusal to register a transfer. Except in the case of suspected fraud they must return the transfer to that person.

Suspension of transfers

 

118. The directors may suspend registration of transfers for a specified period at any time provided the total period of suspension in a calendar year is no more than 30 days.

Transmission of shares on the death of a member

 

119. On the death of a member, a surviving joint holder or the personal representative of a deceased sole holder are the only persons who have any title to the deceased’s shares. The estate of a deceased holder remains liable for any liability in respect of the shares held, solely or jointly, at his or her death.

Election by a person entitled

 

120. The directors may require any person who becomes entitled to shares on the death or bankruptcy of a member or under any law relating to mental health to elect either to become registered as the holder of the shares or to nominate another person in whose name the shares are to be registered. If the person elects to become registered, he or she must give the Company a notice to that effect. If the person elects to nominate another person to be registered, he or she must transfer the shares to the other person.

Entitlement before registration

 

121. A person entitled to be registered as the holder of shares is entitled to receive any dividend or other payment payable in respect of the relevant shares that the member would have been entitled to if he or she had not died. However, that person must first give the directors any information they properly require. The person is not entitled to any other rights until he or she becomes registered as the holder of the shares.

Incapacity etc of member

 

122. If a member becomes incapacitated or his or her person or assets becomes liable to be dealt with in any way under a law that relates to incapacity, the person who becomes legally entitled to manage the member’s estate may exercise any rights that the member would have been able to exercise but for the incapacity. However, the person must first give the directors any information they properly require.

 

E. Capital and profits of the company

Alteration of capital of the Company

 

123. The Company may alter its capital by passing the requisite resolution required by the Companies Acts to that effect in general meeting. It may do so in any of the following ways, provided it does not infringe article 79:

 

  (a) by converting any of its shares into larger or smaller numbers, in which case, any amount unpaid on them is to be divided equally among the replacement shares;

 

  (b) by cancelling any shares which are unissued;

 

  (c) by converting a class of shares into another class.

 

24


Reserving profits

 

124. The directors may at any time set aside an amount out of the profits of the Company as a reserve. A reserve is to be applied, at the directors’ discretion, to any of the purposes for which profits may properly be applied, including the running of the Company and investment.

Carrying forward profits

 

125. The directors may carry forward any profits rather than reserving them or distributing them through dividends.

Capitalising profits

 

126. The Company in general meeting may upon the recommendation of the directors resolve that any sum for the time being standing to the credit of any of the Company’s reserves (including any capital redemption reserve fund or share premium account) or to the credit of profit and loss account be capitalised and applied on behalf of the members who would have been entitled to receive the same if the same had been distributed by way of dividend and in the same proportions either in or towards paying up amounts for the time being unpaid on any shares held by them respectively or in paying up in full unissued shares or debentures of the Company of a nominal amount equal to the sum capitalised (such shares or debentures to be allotted and distributed credited as fully paid up to and amongst such holders in the proportions aforesaid) or partly in one way and partly in another, so however, that the only purpose for which sums standing to the credit of the capital redemption reserve fund or the share premium account shall be applied shall be those permitted by sections 62 and 64 of the Act.

 

127. The Company in general meeting may on the recommendation of the directors resolve that it is desirable to capitalise any part of the amount for the time being standing to the credit of any of the Company’s reserve accounts or to the credit of the profit and loss account which is not available for distribution by applying such sum in paying up in full unissued shares to be allotted as fully paid bonus shares to those members of the Company who would have been entitled to that sum if it were, distributed by way of dividend (and in the same proportions), and the directors shall give effect to such resolution.

 

128. Whenever a resolution is passed in pursuance of article 126 or 127, the directors shall make all appropriations and applications of the undivided profits resolved to be capitalised thereby and all allotments and issues of fully paid shares or debentures, if any, and generally shall do all acts and things required to give effect thereto with full power to the directors to make such provision as they shall think fit for the case of shares or debentures becoming distributable in fractions (and, in particular, without prejudice to the generality of the foregoing, to sell the shares or debentures represented by such fractions and distribute the net proceeds of such sale amongst the members otherwise entitled to such fractions in due proportions) and also to authorise any person to enter on behalf of all the members concerned into an agreement with the Company providing for the allotment to them respectively credited as fully paid up of any further shares or debentures to which they may become entitled on such capitalisation or, as the case may require, for the payment up by the application thereto of their respective proportions of the profits resolved to be capitalised of the amounts remaining unpaid on their existing shares and any agreement made under such authority shall be effective and binding on all such members.

Distribution of capital

 

129. If there is more than one class of shares on issue, the directors may distribute capital to one class of shares to the exclusion of another class, or to one class of shares at a different rate from that to another class of shares.

 

25


Declaration of dividends

 

130. Subject to the Companies Acts and any special rights or restrictions applicable to any shares the directors may declare and pay dividends on shares that appear to them to be justified in light of the profits made by the Company. If there is more than one class of shares on issue, the directors may declare and pay a dividend on one class of shares to the exclusion of another class, and may declare and pay a dividend on one class of shares at a different rate from that on another class of shares.

Apportioning dividends

 

131. Dividends are to be credited or paid in respect of particular shares according to the amounts paid or credited on them. Amounts paid before a call has been made are to be ignored. If the amount paid or credited on a share changed during the relevant period, the dividend on that share will be credited or paid proportionally to the amounts paid or credited on the share for the relevant portions of that period. If a share is issued on the basis that it will rank for dividends as from a particular date, it will rank from that date.

Deductions from dividends

 

132. The directors may deduct from a dividend an amount up to the amount owed by the member to the Company on account of the relevant shares, whether on account of calls or otherwise, and may use that amount towards satisfaction of the member’s debt.

Dividends payable in kind

 

133. The directors may direct that any part of a dividend is to be paid by the issue of shares or a distribution of specific assets, including fully paid shares in another Company. The directors may deal as they think fit with any difficulty in relation to the distribution of specific assets. They may do any of the following:

 

  (a) fix the value of a specific asset or part of it;

 

  (b) decide that cash payments may be made on the basis of their valuation;

 

  (c) vest any cash or specific assets in trustees on trust for all members entitled to a dividend.

No interest payable

 

134. No interest is payable by the Company on any dividend declared by the directors.

Method of payment of dividends

 

135. The Company may pay a dividend or other money that is payable in cash by:

 

  (a) drawing a cheque for the amount payable to the member or paying the amount into a bank account in the name of the member;

 

  (b) paying the amount by cheque or in cash to a third person, as directed by the member;

 

  (c) satisfying any amount owed by the member to a third person, as directed by the member; or

 

  (d) applying any part of the amount towards satisfaction of money owing by the member to the Company on any account.

An amount paid by cheque is to be paid either personally or by post to the member’s address as contained in the Company’s register of members.

Unclaimed dividends

 

136. Until a dividend is claimed, the Company may use it for the Company’s benefit in accordance with the Companies Acts.

 

26


F. MISCELLANEOUS

Records to be kept

 

137. The directors shall cause proper books of account to be kept relating to- (a) all sums of money received and expended by the Company and the matters in respect of which the receipt and expenditure takes place; and (b) all sales and purchases of goods by the Company; and (c) the assets and liabilities of the Company. Proper books shall not be deemed to be kept if there are not kept such books of account as are necessary to give a true and fair view of the state of the Company’s affairs and to explain its transactions.

 

138. The books of account shall be kept at the office or, subject to section 147 of the Act, at such other place as the directors think fit, and shall at all reasonable times be open to the inspection of the directors.

 

139. The directors shall from time to time determine whether and to what extent and at what times and places and under what conditions or regulations the accounts and books of the Company or any of them shall be open to the inspection of members, not being directors, and no member (not being a director) shall have any right of inspecting any account or book or document of the Company except as conferred by statute or authorised by the directors or by the Company in general meeting.

 

140. The directors shall from time to time, in accordance with sections 148, 150, 157 and 158 of the Act cause to be prepared and to be laid before the annual general meeting of the Company such profit and loss accounts, balance sheets, group accounts and reports as are required by those sections to be prepared and laid before the annual general meeting of the Company.

 

141. A copy of every balance sheet (including every document required by law to be annexed thereto) which is to be laid before the annual general meeting of the Company together with a copy of the directors’ report and auditors’ report shall, not less than 21 days before the date of the annual general meeting be sent to every person entitled under the provisions of the Companies Act’s to receive them.

Register of charges

 

142. The Company must observe the Companies Acts with respect to the keeping of information relating to all mortgages and charges specifically affecting the Company’s property. A register of all mortgages and charges specifically affecting the Company’s property shall be maintained on behalf of the Company.

Confidential information

 

143. Subject to the Companies Acts, a member who is not a director is not entitled to require or receive from the directors or the Company any information concerning the business, trading or customers of the Company, or any trade secret, secret process, or other confidential information belonging to or used by the Company.

Notices

 

144. The Company may give a notice to a member in any of the following ways:

 

  (a) by serving it on the member personally;

 

  (b) by posting it to the member or leaving it at the member’s address shown in the register of members, or at a replacement address for giving notices supplied to it by the member;

 

  (c) by faxing it or sending it electronically to the fax number or electronic address supplied by the member to the Company for the giving of notices.

 

27


Time of service

 

145. A notice is to be treated as received in accordance with the following:

 

  (a) if it is sent by post in the state, on the next business day after pre-paid posting;

 

  (b) if it is sent by post to an address outside the state, in the ordinary course of prepaid mail;

 

  (c) if it is faxed or sent electronically, on the business day after it is sent.

Notice to a person entitled on the death etc of a member

 

146. The Company may give a notice to a person who becomes entitled to shares on the death or bankruptcy of a member or under any law relating to mental health in accordance with the following:

 

  (a) by serving it on the person personally;

 

  (b) by posting it to the person at the address supplied to it by that person;

 

  (c) by giving it in any other way in which it might have been given if the member had not died or become bankrupt or subject to any law relating to mental health.

Notice to joint holders

 

147. A notice to joint holders is given if the notice is given to the holder first named in the register of members as joint holder.

Notice of a general meeting

 

148. Notice of a general meeting must be given to each of the following:

 

  (a) each member;

 

  (b) each director;

 

  (c) the auditor of the Company;

 

  (d) each person entitled to shares because of the death or bankruptcy of a member or under any law relating to mental health.

Persons not entitled to notice

 

149. A person who does not have an address in the register of members and who has not supplied an address or number for the giving of notices is not entitled to be given notice.

Winding up of the Company

 

150. If, on the winding up of the Company, the assets are more or less than sufficient to repay the whole of the issued capital of the Company, the assets must be distributed so that the profit is made or the loss is borne by members proportionally to the capital which was paid up or which ought to have been paid up on their shares at the commencement of the winding up. Amounts paid in advance of a call are to be ignored.

Distribution of the Company assets

 

151. If the Company is wound up, the liquidator may, on a special resolution of the Company divide any part of the assets among members. The liquidator may do any one or more of the following:

 

  (a) set what he or she regards as fair values on those assets;

 

  (b) decide on the division between different members or classes of members;

 

  (c) vest any assets in trustees on trust for the benefit of members as the liquidator thinks fit, but not so that a member would be forced to accept a share or security on which there is any liability.

 

28


Remuneration in relation to winding up etc

 

152. No remuneration may be paid to a director or liquidator from the proceeds of the sale or realisation of the Company’s property or undertaking, except with the approval of the Company in general meeting.

 

G. INDEMNITY FOR OFFICERS ETC INDEMNITY

 

153. Every director, managing director, agent, auditor, secretary and other officer for the time being of the Company shall be indemnified out of the assets of the Company against any liability incurred by him in defending any proceedings, whether civil or criminal, in relation to his acts while acting in such office, in which judgement is given in his favour or in which he is acquitted or in connection with any application under section 391 of the Act in which relief is granted to him by the court.

Payment for an insurance policy

 

154. To the extent permitted by the Companies Acts, the Company may, at the directors’ discretion, enter into and pay for a policy of insurance insuring a director, managing director, agent, auditor, secretary and other officer (and former director, former managing director, former agent, former auditor, former secretary and other former officer) against any liability incurred as an officer, agent or employee of the Company. However, this does not apply in relation to a liability arising out of or in connection with conduct involving a wilful breach of duty in relation to the Company.

Interrelationship between indemnity and policy

 

155. Every director, managing director, agent, auditor, secretary and other officer who is entitled to an indemnity under the insurance policy entered into by the Company is not entitled to an indemnity from the Company, except to the extent that the policy does not fully indemnify him or her.

Indemnity continues

 

156. An indemnity given by the Company under article 153 continues to apply after any change to or deletion of that clause, but only in relation to acts and omissions before the change or deletion.

 

H. DEFINITIONS

Definitions

 

157. The terms used throughout these Articles listed below shall have the meanings ascribed to them below.

Articles means these articles of association of the Company as may be amended from time to time.

Companies Acts means the Companies Acts 1963 to 2005 and Parts 2 and 3 of the Investment Funds, Companies and Miscellaneous Provisions Act 2006, the Companies (Amendment) Act 2009, the Companies (Miscellaneous Provisions) Act 2009, the Companies (Amendment) Act 2012 and the Companies (Miscellaneous Provisions) Act 2013, including all Acts of the Oireachtas and statutory instruments which are to be read as one with, or construed or read together as one with, the Companies Acts, and every statutory modification, consolidation or re-enactment thereof for the time being in force (or, where the context so admits or requires, any one or more of such Acts).

Writing or writing or written includes writing in an electronic form where applicable.

US$ means the official currency of the United States.

€ or Euro means the official currency of the European Union.

 

29


Schedule

Classes of shares:

- Ordinary Shares of US$0.125 each

- SIRPS Shares of US$0.125 each

- Series B Preferred Shares of US$0.125 each

- Euro Deferred Shares of €100 each

 

30


We, the several persons whose names, addresses and descriptions are subscribed, wish to be formed into a Company in pursuance of these Articles of Association, and we agree to take the number of shares in the capital of the Company set out opposite our respective names.

 

Name, Address

  

Number of shares

  

Signature and Date

Geraldine Farrell

1 Dundonald Avenue

Malvern East

Victoria

3145 Australia

   1 Ordinary Share of USD$0.10 each   

     

Dated:

29.07.14

Mark Heffernan

6 Volum Street

Manifold Heights

Victoria

3218

Australia

   1 Ordinary Share of USD$0.10 each   

     

Dated:

29.07.14

Total

   2 Ordinary Shares of USD$0.10 each   

Witness

       

Signature and Date

Name & Address:

 

Melissa Postma

20/311 Royal Pde

Parkville

Vic

3052

Australia

     

     

Dated:

29.07.14

Occupation:

Assistant

     

 

31

EX-4.2 4 d775834dex42.htm EX-4.2 EX-4.2

Exhibit 4.2

Shareholders agreement

Relating to Nexvet Biopharma Limited

Nexvet Biopharma Limited (Company)

The parties specified in Schedule 9 (Shareholders)


Shareholders agreement

 

Details

     6   

Agreed terms

     7   

1.

 

Defined terms & interpretation

     7   

1.1

 

Defined terms

     7   

1.2

 

Interpretation

     14   

1.3

 

Headings

     14   

1.4

 

New classes of Preference Shares

     15   

2.

 

Not Used

     15   

3.

 

Objectives

     15   

4.

 

Board of Directors

     15   

5.

 

Structure of the Company and the basic duties of the parties

     15   

5.1

 

Company’s corporate structure

     15   

5.2

 

Exercise of voting rights

     15   

6.

 

Powers of decision

     16   

6.1

 

Decisions requiring Special Majority Approval

     16   

6.2

 

Other consents required

     16   

6.3

 

Subsidiaries

     16   

7.

 

Business Plan

     16   

8.

 

Financial and other reporting

     16   

8.1

 

Reports

     16   

8.2

 

Confidentiality

     16   

9.

 

Accounts and records

     16   

9.1

 

Regulatory requirements

     16   

9.2

 

Audit of records

     16   

9.3

 

Right to review

     17   

9.4

 

Disclosure of information

     17   

10.

 

Disclosure by Directors

     17   

11.

 

Dividend policy

     17   

12.

 

Employee Share Option Plan

     17   

12.1

 

Terms of ESOP

     17   

13.

 

Issue of Equity Securities

     17   

14.

 

Sale of Shares – pre-emption

     19   

14.1

 

Restriction

     19   

14.2

 

Pre-emption Offer

     20   

14.3

 

Contents of Transfer Notice

     20   

14.4

 

Acceptance of offer

     20   

14.5

 

Failure to respond

     20   

14.6

 

Allocation of Sale Securities to Shareholders

     20   

14.7

 

Allocation of unallocated Sale Securities

     20   

 

2


14.8

 

Obligation to transfer

     21   

14.9

 

Completion

     21   

14.10

 

Permitted transfers

     21   

14.11

 

Substantial transfer

     21   

14.12

 

Deed of Accession

     22   

14.13

 

Refusal to transfer

     22   

15.

 

Third party offers

     22   

15.1

 

Drag along

     22   

15.2

 

Notice to Remaining Shareholders

     22   

15.3

 

Execution on behalf of Remaining Shareholder

     22   

15.4

 

Tag along – Shareholders

     23   

15.5

 

Preference Shareholder election

     23   

15.6

 

Sale completion

     23   

15.7

 

Tag along – Preference Shareholder sale

     23   

15.8

 

Failure to give Offer Notice or purchase a Preference Shareholder’s Equity Securities

     23   

16.

 

No changes in control

     24   

16.1

 

Restriction

     24   

16.2

 

Mandatory Transfer

     24   

16.3

 

Agreed purchase price

     24   

16.4

 

Independent valuation

     24   

16.5

 

Provision of independent valuation

     24   

16.6

 

Clause 14 suspended

     24   

17.

 

Exit

     24   

17.1

 

Financial Adviser

     24   

17.2

 

Pre-Exit Restructure

     25   

17.3

 

Endeavours to Exit

     25   

17.4

 

Obligations

     25   

17.5

 

Co-operation

     25   

17.6

 

Transfer right suspended

     25   

17.7

 

Escrow

     25   

17.8

 

No warranties

     26   

17.9

 

Sale of Share Capital or Trade Sale

     26   

17.10

 

Attorney

     26   

17.11

 

Qualifying IPO

     26   

17.12

 

Non-Qualifying IPO

     26   

18.

 

Default

     27   

18.1

 

Events of default

     27   

18.2

 

Consequence of default

     27   

18.3

 

Agreed purchase price

     27   

18.4

 

Independent valuation

     27   

18.5

 

Provision of independent valuation

     27   

18.6

 

Other remedies

     27   

18.7

 

Clause 14 suspended

     27   

19.

 

Representations

     28   

19.1

 

General representations

     28   

19.2

 

Disclaimers

     28   

20.

 

Limitation of liability of Fund Trustee

     28   

20.1

 

Fund Trustee

     28   

 

3


21.

 

Confidentiality and announcements

     29   

21.1

 

Confidentiality obligations

     29   

21.2

 

Announcements

     30   

21.3

 

Exceptions

     30   

22.

 

Restraint

     30   

22.1

 

Definitions

     30   

22.2

 

Prohibited activities

     31   

22.3

 

Duration of prohibition

     31   

22.4

 

Geographic application of prohibition

     31   

22.5

 

Interpretation

     31   

22.6

 

Exceptions

     32   

22.7

 

Acknowledgments

     32   

23.

 

Not used

     32   

24.

 

Acknowledgments regarding Preference Shareholders

     32   

24.1

 

Acknowledgments

     32   

25.

 

Termination

     33   

25.1

 

Automatic termination

     33   

25.2

 

Accrued rights

     33   

26.

 

Not Used

     33   

27.

 

Notices

     33   

27.1

 

Service of notices

     33   

27.2

 

Effective on receipt

     33   

28.

 

Agreement is paramount

     33   

29.

 

Miscellaneous

     34   

29.1

 

Alterations

     34   

29.2

 

Approvals and consents

     34   

29.3

 

Assignment

     34   

29.4

 

Costs

     34   

29.5

 

Survival

     34   

29.6

 

Counterparts

     34   

29.7

 

No merger

     34   

29.8

 

Entire agreement

     34   

29.9

 

Further action

     34   

29.10

 

Severability

     34   

29.11

 

Waiver

     34   

29.12

 

Relationship

     35   

29.13

 

Governing law and jurisdiction

     35   

Schedule 1 – Issued share capital

     36   

Schedule 2 – Board (clause 4)

     37   

Schedule 3 – Powers of decision (clause 6)

     41   

Schedule 4 – Terms of SIRPS

     44   

Schedule 5 – Financial and other reporting (clause 8)

     48   

 

4


Schedule 6 – Deed of Accession – clauses 13.8 and 14.12

     49   

Schedule 7– Independent valuation (clauses 16.4 and 18.3)

     50   

Schedule 8 – Terms of Series B Preferred Shares

     52   

Schedule 9 – Shareholders

     58   

Signing page

     60   

 

5


Details

Date                       4 September 2014

Parties

 

Name    Nexvet Biopharma Limited (Registered Number 547923)
Short form name    Company
Notice details    88 Harcourt Street
   Dublin 2
   Ireland
   Facsimile 353 1 6915010
   For the attention of the Company Secretary

 

Name    The parties set out in Schedule 9
Short form name    Shareholders
Notice details    As set out in Schedule 9

Background

 

A The Company was incorporated on 14 August 2014.

 

B The issued share capital of the Company immediately prior to the date of this agreement is set out in Schedule 1.

 

C The Company will be managed and controlled in accordance with the terms of this agreement.

 

6


Agreed terms

 

1. Defined terms & interpretation

 

1.1 Defined terms

In this document:

Accounting Standards means:

 

  (a) accounting standards approved under the Companies Acts and their requirements about the preparation and contents of accounts; and

 

  (b) generally accepted accounting principles, policies, practices and procedures in Ireland.

Affiliate in relation to a Shareholder means:

 

  (a) a Connected Person of the Shareholder or a company in which the Shareholder beneficially owns not less than 50% of the shares;

 

  (b) a trust (whether a unit trust, investment trust or other form of trust) of which the Shareholder is the beneficiary;

 

  (c) a limited partnership whose general partner is a Connected Person of the Shareholder; (d) a general partnership all of whose general partners are Connected Persons of the Shareholder;

 

  (e) a trust (whether a unit trust, investment trust or other form of trust) of which a Connected Person of the Shareholder is the responsible entity, trustee, manager or investment adviser of the trust;

 

  (f) where the Shareholder is a limited partnership, general partnership or a trust, any custodian of all or any of the assets of that limited partnership, general partnership or trust;

 

  (g) where the Shareholder is an individual, the spouse, former spouse, mother, father, brother, sister or child over the age of 18 of the Shareholder; or

 

  (h) in respect of a Fund Trustee, its affiliates being:

 

  (i) the Investment Manager;

 

  (ii) a company, fund, trust, managed investment scheme or partnership that is managed or advised by the Investment Manager or in which the Investment Manager holds a beneficial interest;

 

  (iii) a company, fund, trust, managed investment scheme or partnership in which:

 

  (A) the Fund Trustee;

 

  (B) a shareholder in the Fund Trustee; or

 

  (C) any Connected Person of the persons referred to in paragraphs (a) and (b) above,

are a significant investor (holding an interest in excess of 30%); or

 

  (iv) any custodian of the above.

Board means the board of directors of the Company as constituted from time to time.

 

7


Board Meeting means a meeting of the Board (or any committee of the Board) duly convened and held in accordance with this agreement and the Constitution.

Business means the business conducted by the Group from time to time as approved by the Board, including the discovery, development and commercialisation of biopharmaceutical products, such as companion animal (dog, cat, horse) monoclonal antibodies and therapeutic proteins, any products in any species derived from the patented PETisationTM platform technology, and any diagnostics products for use in animals.

Business Day means:

 

  (a) for receiving a notice under clause 27, a day that is not a Saturday, Sunday, public holiday or bank holiday in the place where the notice is received; and

 

  (b) for all other purposes, a day that is not a Saturday, Sunday, bank holiday or public holiday in Ireland.

Business Hours means from 9.00am to 5.00pm on a Business Day.

Business Plan means the business plan or project plan current as approved by the Board from time to time for the conduct of the Business as approved in accordance with this agreement.

Buyer means a Shareholder who accepts an offer of Equity Securities under clause 14 and is allocated Equity Securities as a result of the acceptance of that offer.

Change of Control means:

 

  (a) in relation to a Shareholder, the person who Controls the Shareholder at the date when the person first becomes a Shareholder subsequently stops having Control; and

 

  (b) in relation to the Company, the Shareholder who Controls the Company at the date of this agreement subsequently stops having Control.

Chief Executive Officer means the chief executive officer of the Group from time to time.

Claim means a claim, notice, demand, action, proceeding, litigation, investigation, judgment, damage, loss, cost, expense or liability however arising, whether present, unascertained, immediate, future or contingent, whether based in contract, tort or statute and whether involving a party to this agreement or third party.

Class means a class of Equity Securities having attached to them identical rights, privileges, limitations and conditions.

Companies Acts means the Companies Acts 1963 – 2013, as may be amended from time to time.

Competitor means any person or entity which conducts a similar activity to, or is competitive with the Business.

Confidential Information of a party (the Disclosing Party) means, in respect of another party (the Recipient), any or all information and data of any nature, whether existing before or after the date of this agreement:

 

  (a) disclosed by the Disclosing Party to the Recipient in connection with this agreement;

 

  (b) concerning the contents of the Transaction Documents or any transaction undertaken under the Transaction Documents; or

 

  (c) obtained by the Recipient where the Recipient knows or suspects, or ought reasonably to have known or suspected, that the information was obtained, whether directly or indirectly, from the Disclosing Party and the Disclosing Party would treat such information as confidential,

 

8


whether before or after the date of this agreement, but excludes information:

 

  (d) the Recipient creates (whether alone or jointly with any third person) independently of the Disclosing Party;

 

  (e) rightfully received by the Recipient from a third party without a duty of confidentiality; or

 

  (f) that is a matter of public knowledge (otherwise than as a result of a breach of confidentiality by the Recipient or any of its permitted disclosees).

Connected Person means, in respect of a person, any corporation, company, partnership, joint venture or other entity which Controls, is Controlled by, or is under common Control with the first person as the case may be.

Constitution means the Company’s memorandum of association and articles of association from time to time.

Control means:

 

  (a) of a company by a person:

 

  (i) the person determines the composition of the board of directors of the company or has the capacity to do so;

 

  (ii) the board of directors of the company is accustomed to act in accordance with the instructions, directions or wishes of the person; or

 

  (iii) the person holds or owns (alone or with its associates or Connected Persons):

 

  (A) the majority of the issued shares of the company;

 

  (B) the majority of the issued shares of the ultimate holding company of the company; or

 

  (C) the majority of any securities or other rights granted by the company entitling holders to distributions based on the profits, earnings or net liquidation proceeds of the company; and

 

  (b) of a trust by a person:

 

  (i) the composition of the board of directors of any trustee company of the trust is determined by the person or the person has the capacity to do so;

 

  (ii) the board of directors of any trustee company of the trust is accustomed to act in accordance with the instructions, directions or wishes of the person; or

 

  (iii) the person holds or owns (alone or with its associates or Connected Persons):

 

  (A) the majority of the issued shares of any trustee company of the trust;

 

  (B) the majority of the issued shares of the ultimate holding company of any trustee company of the trust; or

 

  (C) the majority of the units, securities or other rights granted by the trust which entitling holders to distributions from the trust.

Deed of Accession means a deed of accession in the form of Schedule 6.

Director means a director of the Company from time to time.

Eligible Employee means an Employee (or a nominee which that Employee Controls) whom the Board determines is to receive an offer under an ESOP.

 

9


Employee means:

 

  (a) an individual whom the Board determines to be in the full-time or part-time employment of the Company or another body corporate in the Group (including any employee on parental leave, long service leave or other special leave as approved by the Board);

 

  (b) an individual or entity providing services (including a Director) to the Company or another body corporate in the Group whom the Board determines to be an Employee for the purposes of the ESOP;

 

  (c) an individual who was involved in the creation of the Company or whom the Board determines to be an Employee for the purposes of the ESOP.

Encumber means to mortgage, pledge, charge, assign as security or otherwise encumber.

Equity Securities means Ordinary Shares, Preference Shares and any other shares, options, convertible notes, warrants or other securities convertible into Shares.

ESOP means an Employee incentive arrangement as approved by the Board from time to time.

Excluded Issue means an issue of Equity Securities referred to in clause 13.9.

Exit Event means the first to occur of:

 

  (a) the date on which Equity Securities are allotted or transferred under a disclosure document, prospectus (or other relevant offer document) lodged with the U.S. Securities and Exchange Commission or Australian Securities and Investments Commission (or other relevant regulatory body) in relation to an IPO;

 

  (b) the date on which an agreement for the sale of the Share Capital is completed; and

 

  (c) the date on which, following a Trade Sale and following the passing of a resolution of Shareholders to approve the distribution and payment to Shareholders of the proceeds of sale that are available for distribution or payment to Shareholders, whether in a winding up, by return of capital, share buy-back or otherwise, a determination is made of the amount that will be paid to Shareholders.

Farallon Investors means any investment funds and accounts managed by Farallon Capital Management, L.L.C. and any permitted assigns of these funds and accounts.

Farallon Director means a Director appointed in accordance with paragraph 1.8 of Schedule 2.

Financial Year means 12 months from 1 July to 30 June each year (or such other dates as the Board approves).

Fund means in respect of a Fund Trustee, the investment fund for which it holds Shares.

Fund Trustee means (i) a Shareholder which enters into this agreement as trustee, custodian, sub-custodian or nominee of a Fund and (ii) any Farallon Investors provided that (ii) does not apply in relation to clause 20.

Group means the Company and all its Subsidiaries from time to time.

Group Company means any one of the Company or a Subsidiary.

Holding Company means any holding company of the Company from time to time, and for the avoidance of doubt, may be a company incorporated outside Ireland.

Independent Valuer means a person appointed to value Equity Securities under clause 16 or 18.

Insolvency Event means, in relation to a person:

 

  (a) a receiver, examiner, liquidator, trustee or similar official is appointed over any of the assets or undertaking of the person;

 

10


  (b) the person suspends payment of its debts generally;

 

  (c) the person is or becomes unable to pay its debts when they are due or is unable to pay its debts within the meaning of the Companies Acts or the Personal Insolvency Act 2013 (or analogous legislation in the place of incorporation or residence of the entity);

 

  (d) the person enters into or resolves to enter into any arrangement, composition or compromise with, or assignment for the benefit of, its creditors or any class of them;

 

  (e) an application or order is made for the winding up or dissolution of, or the appointment of a provisional liquidator, to the person or a resolution is passed or steps are taken to pass a resolution for the winding up or dissolution of the person otherwise than for the purpose of an amalgamation or reconstruction that has the prior consent of Shareholders; or

 

  (f) an examiner is appointed under the Companies Acts (or analogous legislation in the place of incorporation or residence of the person).

Investment Manager means in respect of a Fund, the investment manager of that Fund from time to time.

IPO means an initial public offering of Ordinary Shares or ordinary shares in the capital of any Subsidiary that is made under a prospectus or other disclosure document that states that the Company or Subsidiary has or will apply for admission of the Company or any Subsidiary to the official list of the Stock Exchange.

Liquidation Event means

 

  (a) any liquidation or winding up of the Company that does not follow a Trade Sale (including following a liquidation notice issued under paragraph 4 of schedule 4 or 8); or

 

  (b) if the Company suffers an Insolvency Event.

Month means calendar month.

OFML means One Funds Management Limited ACN 117 797 403 as trustee for the Asia Pacific Healthcare Fund II.

Ordinary Shares means ordinary shares in the capital of the Company having the rights set out in the Constitution.

Permitted Transfer means a transfer of Equity Securities permitted under clause 14.10.

Preference Shareholder means a person who holds Preference Shares.

Preference Shares means preference shares, including SIRPS and Series B Preferred Shares, issued to Shareholders in accordance with the terms of this agreement, details of which are set out in a schedule to this agreement including a schedule incorporated by operation of clause 1.4 on or after the date of this agreement.

Preference Shareholding Percentage means in relation to a Preference Shareholder, a fraction expressed as a percentage, the numerator of which is the total number of Preference Share held by the Preference Shareholder and the denominator of which is the total number of Preference Shares (including the Preference Shares held by that Preference Shareholder):

 

  (a) on issue; or

 

  (b) where the reference requires an apportionment between a number of Preference Shareholders, held by those Preference Shareholders,

in each case on a fully diluted basis and assuming all Preference Shares are converted to Ordinary Shares.

 

11


Proceeds on an Exit Event or Proceeds means:

 

  (a) on a Trade Sale or IPO, the total amount available for distribution to Shareholders, whether that amount is distributed in a winding up on a return of capital, by share buy back, by dividend or other distribution, after payments to creditors (including Shareholders in respect of loans made by them to the Company);

 

  (b) on a sale of the Share Capital, the total purchase price after repayment of loans made by Shareholders to the Company; or

 

  (c) on a winding up that does not follow a Trade Sale, the amount available for distribution to Shareholders after payments to creditors (including Shareholders in respect of loans made by them to the Company).

Qualifying IPO means an underwritten IPO on NASDAQ of Ordinary Shares which:

 

  (a) results in gross proceeds to the Company of at least $40 million; and

 

  (b) is priced at a price per share not less than 2 times the then applicable Series B Conversion Price,

unless varied in accordance with clause 17.11.

Reorganisation Event means:

 

  (a) a bonus issue of Shares;

 

  (b) a sub-division or consolidation of Shares; or

 

  (c) another reorganisation or reconstruction of share capital where the Company neither pays nor receives cash.

Restructure has the meaning given in clause 17.2.

Sale Price means the price referred to in clause 14.3(b).

Series B Conversion Price has the meaning given to ‘Conversion Price’ in Schedule 8.

Series B Preferred Shares means preference shares issued to Shareholders in accordance with the terms of this agreement with the attached rights set out in Schedule 4 of this agreement.

Series B Director means a Director appointed in accordance with paragraph 1.1(a)(iv) of Schedule 2.

Series B Shareholder means a Shareholder who holds Series B Preferred Shares.

Share Capital means all of the Shares on issue.

Share means a share in the capital of the Company.

Shareholder means a person who holds a Share and is a party to this agreement and includes a Preference Shareholder.

Shareholder Group means, in relation to a Shareholder:

 

  (a) if none of a Shareholder’s Affiliates are also other Shareholders, the Shareholder alone; or

 

  (b) if two or more Shareholders are Affiliates of each other, those Shareholders together.

Shareholding Percentage means in relation to a Shareholder, a fraction expressed as a percentage, the numerator of which is the total number of Equity Securities held by the Shareholder and the denominator of which is the total number of Equity Securities (including the Equity Securities held by that Shareholder):

 

  (a) on issue; or

 

12


  (b) where the reference requires an apportionment between a number of Shareholders, held by those Shareholders,

in each case on a fully diluted basis and assuming all Equity Securities are converted to Ordinary Shares.

SIRPS means preference shares issued to Shareholders in accordance with the terms of this agreement with the attached rights set out in Schedule 4 of this agreement.

SIRPS Director means a Director appointed in accordance with paragraph 1.1(a)(ii) of Schedule 2.

SIRPS Shareholder means a Shareholder who holds SIRPS.

Special Majority Approval means:

 

  (a) in the case of a vote, resolution or consent of Directors, one passed or given by a majority of Directors and including at least one SIRPS Director;

 

  (b) in the case of a vote, resolution or consent of Shareholders, one passed or given by Shareholders holding 75% of the Shares on issue (calculated on the basis and assumption that all Preference Shares have been converted into Ordinary Shares); or

 

  (c) in the case of a vote, resolution or consent of a class or group of Shareholders, one passed or given by Shareholders holding 75% of the Shares on issue of that class or held by that group.

Stock Exchange means NASDAQ, ASX Limited or another internationally recognised stock exchange in a developed country approved by the Board.

Subsidiary means any subsidiary of the Company at any time.

Tavistock Investor means Boxer Capital L.L.C. and any permitted assigns of that entity.

Trade Sale means a sale of:

 

  (a) the main operating Subsidiaries;

 

  (b) all or a substantial part of the Business; or

 

  (c) all or substantially all of the assets of the Company or the Group.

Transaction Documents means:

 

  (a) this agreement; (b) the Constitution; and

 

  (c) any other agreement or document that the parties agree is a Transaction Document.

Transfer means to sell, assign, transfer, convey or otherwise dispose of a legal or beneficial interest.

Warrants means:

 

  (a) the 1,968,764 warrants issued to subscribers in conjunction with the Series B Preferred Shares; and

 

  (b) the 240,000 warrants issued to advisers in conjunction with issue of the Series B Preferred Shares.

 

13


1.2 Interpretation

In this agreement, unless the context otherwise requires:

 

  (a) the singular includes the plural and vice versa, and a gender includes other genders;

 

  (b) another grammatical form of a defined word or expression has a corresponding meanings;

 

  (c) a reference to a clause, paragraph, schedule or annexure is to a clause or paragraph of, or schedule or annexure to, this agreement, and a reference to this agreement includes any schedules and annexures;

 

  (d) a reference to a document or instrument includes the document or instrument as novated, altered, supplemented or replaced from time to time;

 

  (e) a reference to $ is a reference to US currency;

 

  (f) a reference to time is to Irish time;

 

  (g) a reference to party to this agreement, and a reference to a party to a document includes the party’s executors, administrators, successors and permitted assigns and substitutes;

 

  (h) a reference to a person includes a natural person, partnership, body corporate, association, governmental or local authority or agency or other entity;

 

  (i) a reference to a statute, ordinance, code or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of them;

 

  (j) a word or expression defined in the Companies Acts has the meaning given to it in the Companies Acts;

 

  (k) the meaning of general words is not limited by specific examples introduced by including, for example or similar expressions;

 

  (l) any agreement, representation, warranty or indemnity by two or more parties (including where two or more persons are included in the same defined term) binds them jointly and severally;

 

  (m) any agreement, representation, warranty or indemnity in favour of two or more parties (including where two or more persons are included in the same defined term) is for the benefit of them jointly and severally;

 

  (n) a rule of construction does not apply to the disadvantage of a party because the party was responsible for the preparation of this agreement or any part of it;

 

  (o) if a day on or by which an obligation must be performed or an event must occur is not a Business Day, the obligation must be performed of the event must occur on or by the next Business Day;

 

  (p) a reference to the Company includes each Subsidiary from time to time and all rights and obligations of the parties apply to each Subsidiary as if a reference to the Company is also to the Subsidiary; and

 

  (q) if any calculation relating to the issue or transfer of Equity Securities results in a number that is, or includes, a fraction, the fraction is rounded down to the nearest whole number.

 

1.3 Headings

Headings are for ease of reference only and do not affect interpretation.

 

14


1.4 New classes of Preference Shares

Subject to the Companies Acts and the rights of existing holders of Preference Shares under this agreement, the terms of issue of new classes of Preference Shares issued after the date of this agreement may include additional or different applicable terms of issue to existing classes of Preference Shares. The written terms of issue of any new class of Preference Share will automatically form a new schedule to this agreement on each occasion that a new class of Preference Shares is issued with terms that differ from any existing class of Preference Shares.

 

2. Not Used

 

3. Objectives

The objectives of the Group are to:

 

  (a) carry on the Business;

 

  (b) develop and expand the Business in accordance with the Business Plan; and

 

  (c) maximise the value of the Group.

 

4. Board of Directors

Each Shareholder must exercise its rights as a holder of Shares to ensure that:

 

  (a) the composition of the Board and the procedures for meetings of the Board are as set out in Schedule 2; and

 

  (b) subject to clause 6, the Board will exercise a supervisory role over the chief executive officer of the Company.

 

5. Structure of the Company and the basic duties of the parties

 

5.1 Company’s corporate structure

The Company will conduct the Business as a private or public company limited by shares, subject to variation approved in accordance with Part 2 of Schedule 3.

 

5.2 Exercise of voting rights

Each of the Shareholders must exercise its voting rights and powers of control in relation to the Company in such a way as to promote the purposes of this document. This includes doing each of the following:

 

  (a) ensuring that any Director appointed by it and its other representatives will support and vote for any reasonable proposal put forward at a meeting of the Board or a meeting of Shareholders of the Company which is appropriate for the proper development and conduct of the Business;

 

  (b) ensuring that all employees, representatives, and other persons under its direct or indirect control do nothing to hinder or prevent the Company from carrying on the Business in a proper and business-like way; and

 

  (c) doing its best to promote the Business and the interests of the Company.

 

15


6. Powers of decision

 

6.1 Decisions requiring Special Majority Approval

The Company must not do, or commit to do, any of the things listed in:

 

  (a) Part 1 of Schedule 3 without the Special Majority Approval of Directors;

 

  (b) Part 2 of Schedule 3 without the Special Majority Approval of Shareholders; or

 

  (c) Part 3 of Schedule 3 without the Special Majority Approval of Series B Shareholders.

 

6.2 Other consents required

Clause 6.1 is without prejudice to any other consent or approval required under the Companies Acts or the Constitution for any matter requiring the Special Majority Approval of Directors or Shareholders.

 

6.3 Subsidiaries

If the Company has any Subsidiaries, then this clause 6 and Schedule 3 will apply to each Subsidiary so that the Company shall procure that no Subsidiary may take any action specified in Schedule 3 without the Company having obtained Special Majority Approval of Directors or Shareholders (as the case may be) as required for that action.

 

7. Business Plan

Subject to any other provision of this agreement, each Shareholder must exercise its rights as a holder of Shares to ensure the Company conducts the Business in accordance with the Business Plan, until another Business Plan is approved and adopted in accordance with this agreement.

 

8. Financial and other reporting

 

8.1 Reports

The Company must provide:

 

  (a) the financial reports and information listed in Schedule 5 at the times specified in Schedule 5 to each Director and each Shareholder who holds 15% or more of the Shares in the Company (Substantial Shareholder); and

 

  (b) any other reports and information reasonably required by a Substantial Shareholder (at the cost of the Substantial Shareholder making the request except if all Shareholders agree that the Company will pay the cost), in a form that is satisfactory to the Substantial Shareholder on reasonable grounds.

 

8.2 Confidentiality

Any information provided by the Company under clause 8.1 is provided subject to clause 21.

 

9. Accounts and records

 

9.1 Regulatory requirements

The Company must ensure that its records and accounting books:

 

  (a) reflect the Accounting Standards consistently applied; and

 

  (b) are otherwise maintained in accordance with any requirement of the Board.

 

9.2 Audit of records

 

  (a) The Company must arrange an independent audit of the Company’s accounts and records by an auditor for each Financial Year. The Company must pay for the cost of the independent audit.

 

16


  (b) The requirement for the Company to arrange an independent audit (as outlined in clause 9.2(a)) may be waived with the Special Majority Approval of the Board, subject always to compliance with the Companies Acts.

 

9.3 Right to review

Subject to clause 21, after giving at least two Business Days’ notice to the Company, each Shareholder may, during Business Hours through an accountant, agent, consultant or employee of the Shareholder:

 

  (a) inspect, and take photocopies using the Company’s and the Group’s facilities of, all the books, accounts and financial records of the Company; and

 

  (b) have full access to the Company’s and the Group’s facilities,

for the purpose of auditing or valuing the Company or the Group or any other reasonable purpose.

The relevant Shareholder must pay any costs of the auditor, valuer or any other person incurred in connection with the audit or valuation.

 

9.4 Disclosure of information

A Shareholder may only disclose any information obtained under clause 9.3 in accordance with clause 21.

 

10. Disclosure by Directors

Subject at all times to the duties of each Director and clause 21, a Director may disclose any information (confidential or otherwise) obtained in their capacity as a Director, to the Shareholder that appointed the Director.

 

11. Dividend policy

Subject to Special Majority Approval of the Series B Shareholders, the Board by Special Majority Approval will determine the dividend and distribution policy of the Company having regard to the Business Plan.

 

12. Employee Share Option Plan

 

12.1 Terms of ESOP

The terms of the ESOP must be approved by Special Majority Approval of Directors.

 

12.2 Capacity after issue of Series B Shares

After the initial issue of the Series B Preferred Shares, the Company may issue Equity Securities to Eligible Employees (or their nominees) which on conversion would constitute no more than 300,000 Ordinary Shares, or such greater number approved by Special Majority Approval of the Series B Shareholders.

 

13. Issue of Equity Securities

 

13.1 No obligation

A Shareholder is not obliged to subscribe for Equity Securities under this clause 13.

 

17


13.2 Right of first refusal

Subject to clause 13.9, if the Board resolves to make an issue of Equity Securities, it must offer those Equity Securities first to all Shareholders in their respective Shareholding Percentages on an as converted basis (Preference Offer).

 

13.3 Subscription Notice

The Board must make the Preference Offer by notice in writing to the Shareholders (Subscription Notice) stating:

 

  (a) the total number of Equity Securities available for subscription (Subscription Securities);

 

  (b) the number of Subscription Securities that Shareholder is entitled to;

 

  (c) the type of Equity Securities being offered; and

 

  (d) the terms of issue of the Equity Securities.

 

13.4 Response to Preference Offer

Within 10 Business Days after receiving the Preference Offer (Subscription Response Period), each Shareholder may give written notice (Subscription Election) to the Board stating:

 

  (a) whether it accepts part, or all of the Equity Securities contained in its Preference Offer; and

 

  (b) if it wants to subscribe for a greater number of Equity Securities than the number in its Preference Offer, that it offers to subscribe for a specified number of those Equity Securities not subscribed for by other Shareholders under their Preference Offers.

 

13.5 Failure to respond

If a Shareholder does not give a Subscription Election to the Board within the Subscription Response Period, the Shareholder is taken to have rejected the Preference Offer.

 

13.6 Allocation of Equity Securities

Where the aggregate number of Equity Securities which are accepted under Subscription Elections exceeds or is equal to the aggregate number of Subscription Securities, after the expiry of not less than 10 Business Days after the expiry of the Subscription Response Period, the Board must:

 

  (a) upon receipt of payment, allot and issue to the Shareholder any Equity Securities accepted under clause 13.4; and

 

  (b) second, upon receipt of payment, allot and issue to Shareholders any additional Equity Securities applied for under clause 13.4(b) first to Preference Shareholders according to their respective Preference Shareholding Percentage and then to other Shareholders according to their respective Shareholding Percentage. However, no Shareholder may be allotted and issued more Equity Securities than the number it applied for.

 

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13.7 Shortfall

Where the aggregate number of Equity Securities which are accepted under Subscription Elections is less than the aggregate number of Subscription Securities (Shortfall), the Company:

 

  (a) may offer and allot and issue on terms no more favourable than those specified in the Subscription Notice any remaining Equity Securities under the Shortfall for a period of 180 days from the date of expiry of the Subscription Response Period to such persons as the Board in its discretion determines (which may for clarity include Shareholders or any other persons other than a Competitor); or

 

  (b) may determine not to issue all the Equity Securities initially contemplated.

 

13.8 Deed of Accession

The Board may only allot or issue any Equity Securities to a person that is not a Shareholder if the person has executed, and delivered to the Company, a Deed of Accession.

 

13.9 Excluded Issue

Clause 13 (except clause 13.8 and this clause 13.9) does not apply to:

 

  (a) an issue of Ordinary Shares in an IPO;

 

  (b) an issue of Ordinary Shares on conversion of Preference Shares;

 

  (c) an issue of Shares under a Reorganisation Event;

 

  (d) an issue of Equity Securities pursuant to an ESOP in accordance with clause 12;

 

  (e) an issue of Equity Securities to strategic partners, advisers or in connection with the acquisition of a company, assets or technology, in each case as approved Special Majority Approval of the Board;

 

  (f) the issue of Series B Preferred Shares as payment of dividends in accordance with the terms of issue of the Series B Preferred Shares;

 

  (g) an issue of Ordinary Shares on exercise of Warrants; or

 

  (h) an issue of Equity Securities under a Restructure.

 

14. Sale of Shares – pre-emption

 

14.1 Restriction

 

  (a) A Shareholder (Intending Seller) must not sell, transfer or otherwise dispose of any legal, beneficial or other interest or Encumber any of its Equity Securities (Disposal) at any time prior to 30 June 2016 except:

 

  (i) following an Exit Event; or

 

  (ii) to the extent permitted by clause 14.10 (permitted transfers); or

 

  (iii) with the prior written consent of holders holding not less than 50.1% of the SIRPS and Series B Preferred Shares (on an as converted basis).

 

  (b) Without limiting clause 14.1(a), a Shareholder must not:

 

  (i) Transfer any of its Equity Securities, except in accordance with clauses 14, 15, 16, 17 or 18; or

 

  (ii) Encumber any of its Equity Securities.

 

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14.2 Pre-emption Offer

 

  (a) An Intending Seller of Equity Securities (Sale Securities) must give an irrevocable written offer (Transfer Notice) to each Shareholder offering to sell the Sale Securities to Shareholders in their respective Shareholding Percentages on an as converted basis but excluding the Intending Seller.

 

  (b) The Sale Securities must be all, and may not be part, of the Equity Securities held by the Intending Seller.

 

14.3 Contents of Transfer Notice

 

  Any Transfer Notice must state all of the matters set out below:

 

  (a) the number of Sale Securities that the Shareholder is entitled to purchase;

 

  (b) the sale price of the Sale Securities which must be in cash (Sale Price);

 

  (c) the time (being not less than 20 Business Days nor more than 30 Business Days) within which the offer, if not accepted in accordance with clause 14.4, will be deemed to be declined; and

 

  (d) that if the Shareholder wishes to purchase Sale Securities in excess of their entitlement, they must, when accepting the offer, state the number of excess Sale Securities that they wish to purchase.

 

14.4 Acceptance of offer

Each acceptance must be in writing (Acceptance Notice) and state all of the following:

 

  (a) whether it accepts in full all of Equity Securities contained in its Transfer Notice; and

 

  (b) the number of excess Sale Securities that the Shareholder wish to purchase (if any).

 

14.5 Failure to respond

If within the period specified in the Transfer Notice a Shareholder does not give an Acceptance Notice to the Intending Seller of its acceptance or rejection of the Transfer Notice, the Shareholder is taken to have rejected the Transfer Notice.

 

14.6 Allocation of Sale Securities to Shareholders

Where the aggregate number of Sale Securities which are the subject of Transfer Notices exceeds or is equal to the aggregate number of Sale Securities which are accepted under the Acceptance Notices:

 

  (a) If all Shareholders do not claim their full entitlement, the unclaimed Sale Securities must first be used to satisfy any requests for excess Sale Securities made by the accepting Shareholders.

 

  (b) If there are insufficient unclaimed Sale Securities to satisfy all such requests, the unclaimed Sale Securities must be allocated to the Shareholders in their respective Shareholding Percentage on an as converted basis. However, no accepting Shareholders may be allocated more excess Sale Securities than the number requested by that accepting Shareholder.

 

14.7 Allocation of unallocated Sale Securities

Where the aggregate number of Sale Securities which are accepted under Acceptance Notices is less than the aggregate number of Sale Securities (Shortfall), the Intending Seller is not obliged to transfer any Sale Securities in respect of the Acceptance Notices and:

 

  (a) the Intending Seller may for a period of up to 30 days from expiry of the time period under clause 14.3(c), offer those Sale Securities to any third party (other than a Competitor); or

 

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  (b) subject to Special Majority Approval of the Board, the Company may buy back and cancel those Sale Securities in accordance with the requirements of the Companies Acts in which event the Intending Seller acknowledges and agrees that it must do everything required to approve such proposal and nothing which may defeat it.

 

14.8 Obligation to transfer

 

  (a) Each Buyer is bound to purchase the Sale Securities that the Buyer has agreed to purchase.

 

  (b) The Intending Seller is bound to transfer the Sale Securities to each Buyer upon payment of the Sale Price, subject to deduction and payment to the Company of any amount to which the Company is entitled under any lien on the Sale Securities.

 

14.9 Completion

 

  (a) Each Buyer must pay the Sale Price for the allocated Sale Securities in cleared funds.

 

  (b) In return, the Intending Seller must deliver the signed transfers and relevant certificate (if any) to the Board.

 

14.10 Permitted transfers

Equity Securities may be disposed free of the restrictions in this clause 14 by any Shareholder to any of the following permitted transferees:

 

  (a) a Transfer by a Shareholder under an offer for sale of Shares in conjunction with an IPO;

 

  (b) an Affiliate of that Shareholder;

 

  (c) a trustee of any trust that in the opinion of the Board is principally for the benefit of the Shareholder (which may include an employee, trust, family trust or related superannuation fund);

 

  (d) a beneficiary on trust for whom the Preference Shareholder is stated to be holding Shares in this agreement or another fund managed by the Preference Shareholder;

 

  (e) a custodian of the Shareholder;

 

  (f) a Transfer in accordance with clause 14.11; or

 

  (g) a Transfer pursuant to a Restructure.

However, if the transferee ceases to satisfy the criteria that resulted in it being a permitted transferee, the transferee, on receiving a request by any party, must promptly re-transfer the Equity Securities to the original Shareholder.

 

14.11 Substantial transfer

A Shareholder may Transfer Series B Preferred Shares with an original issue price of not less than $2,000,000 to a transferee which:

 

  (a) is a “QIB” in the U.S. or a “professional investor” in Australia;

 

  (b) is not a Competitor; and

 

  (c) warrants as to those facts to the Company and the Shareholder,

free of the restrictions in this clause 14.

 

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Solely for purposes of this paragraph, the original issue price of a Series B Preferred Share is deemed to be $6.00 per share (and is determined without regard to any deemed issue price for the warrants issued in connection with the Series B Preferred Shares).

 

14.12 Deed of Accession

A Transfer of Equity Securities to a person that is not a Shareholder is void and of no effect unless and until the proposed transferee has executed, and delivered to the Company, a Deed of Accession.

 

14.13 Refusal to transfer

The Company may refuse to register a Transfer of Equity Securities if to do so would cause the Company to be in breach of any law.

 

15. Third party offers

 

15.1 Drag along

If a person acting at arm’s length and who is not an Affiliate of any Shareholder (Offeror):

 

  (a) offers, agrees or contracts to acquire Equity Securities for a cash amount with no collateral benefit passing to any Shareholder except under the terms of the offer (Offer);

 

  (b) the Offeror (at its election) extends the Offer to all other Shareholders (Remaining Shareholders), with all necessary changes, on the same terms and at the same price (determined on the basis that all Preference Shares are converted to Ordinary Shares);

 

  (c) if the Offer is made:

 

  (i) prior to or on 30 June 2016, the Offer is approved by the Company by Special Majority Approval; and

 

  (ii) after 30 June 2016, the Offer is approved by the Company by simple majority approval; and

 

  (d) the Offer is approved by Special Majority Approval of the Series B Shareholders,

all Shareholders must accept the Offer on those terms.

 

15.2 Notice to Remaining Shareholders

If the Offer is extended as set out in clause 15.1(b) and if within 20 Business Days of making that Offer the Remaining Shareholders have not accepted it, the Board must give written notice to the Remaining Shareholders requiring each of them to do so. On giving the notice both of the following will apply to the Remaining Shareholders:

 

  (a) they are deemed to have accepted the Offer in respect of all their Equity Securities in accordance with the terms of the Offer; and

 

  (b) they must deliver up to the Offeror a signed transfer of their Equity Securities and the relevant certificates.

 

15.3 Execution on behalf of Remaining Shareholder

If any Remaining Shareholder has not, within 10 Business Days of becoming required to do so, signed a transfer in respect of their Equity Securities in favour of the Offeror when required to do so, the Board is entitled to and must authorise and instruct any person it thinks fit to execute the necessary transfers on that Remaining Shareholder’s behalf. On receipt by the Company of the purchase moneys payable for the Equity Securities, it must deliver these transfers to the Offeror (or its agents).

 

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15.4 Tag along – Shareholders

 

  (a) If a Shareholder (other than a Preference Shareholder) receives and wishes to accept an Offer (Offeree) and the Offeror does not extend the Offer to the Preference Shareholders within 15 Business Days of making the Offer, the Offeree must use all reasonable endeavours to procure that the Offeror gives a written notice (Offer Notice) to the Preference Shareholders which must specify all the following:

 

  (i) the number of Equity Securities which the Offeree proposes to sell (which may be all or part of that Shareholder’s Equity Securities) and the proportion those Equity Securities represent of the Offeree’s holding in the Company, on the basis all Equity Securities are converted to Ordinary Shares (Sale Percentage);

 

  (ii) the cash price payable for each Security;

 

  (iii) any other terms of the proposed sale.

 

  (b) Clause 15.4(a) does not apply to a Permitted Transfer.

 

15.5 Preference Shareholder election

If an Offer Notice is given under clause 15.4, within 10 Business Days following receipt of the Offer Notice, any Preference Shareholder can by written notice require the Offeree to procure that an equal Sale Percentage of that Preference Shareholder’s Equity Securities are purchased by the Offeror (Tag Along Notice) at the same price determined on the basis that all Preference Shares are converted to Ordinary Shares and otherwise on the same terms specified in the Offer Notice.

 

15.6 Sale completion

If a Preference Shareholder gives a Tag Along Notice under clause 15.5, the Offeree must procure the simultaneous sale of that Preference Shareholder’s Equity Securities on the terms and conditions referred to in the Offer Notice given under clause 15.4. For such purpose, the Preference Shareholder must immediately deliver to the Offeree the certificates in respect of its Equity Securities which are to be sold together with a duly executed share transfer form to effect the transfer.

 

15.7 Tag along – Preference Shareholder sale

 

  (a) If Preference Shareholders receive and wish to accept an Offer to sell more than two thirds of the issued Preference Shares (Offeree) and the aggregate Shareholding Percentage of all other Shareholders, excluding Preference Shares, is less than 10% of the Share Capital (calculated on the basis that all Equity Securities are converted to Ordinary Shares) (Remaining Shareholders), and the Offeror does not extend the Offer to the Remaining Shareholders within 10 Business Days of making the Offer to the Offeree, the Offeree must use all reasonable endeavours to procure that the Offeror gives a written notice (Offer Notice) to the Remaining Shareholders which must specify all of the matters in clause 15.4(a) and follow the process in clauses 15.5 and 15.6 with ‘Preference Shareholder’ replaced by ‘Remaining Shareholder’, and otherwise mutatis mutandis.

 

  (b) Clause 15.7(a) does not apply to a Permitted Transfer.

 

15.8 Failure to give Offer Notice or purchase a Preference Shareholder’s Equity Securities

If the Offeree cannot procure the Offeror:

 

  (a) to give an Offer Notice to the Preference Shareholders in accordance with clause 15.4 within 10 Business Days of receipt of the Offer;

 

  (b) to give the Offer Notice in accordance with clause 15.7 within 10 Business Days of receipt of the Offer; or

 

23


  (c) to purchase a Preference Shareholder’s Equity Securities in accordance with clause 15.6 (following that Preference Shareholder giving a Tag Along Notice),

then the Offeree must not accept the Offer.

 

16. No changes in control

 

16.1 Restriction

A Change in Control of a Shareholder (other than an Investment Manager, a Farallon Investor or a Tavistock Investor) must not occur without the prior written consent of each other Shareholder, which must not be unreasonably withheld.

 

16.2 Mandatory Transfer

If a Shareholder breaches clause 16.1, the Shareholder (Seller):

 

  (a) must immediately give notice to the Company of the Change of Control; and

 

  (b) if another Shareholder requests (at the Shareholder’s discretion), is taken to have given an irrevocable Transfer Notice under clause 14.2 on the earlier of:

 

  (i) the date it gives notice of the Change in Control to the Company; or

 

  (ii) the date the Company becomes aware that the Change in Control has occurred,

for all Equity Securities held by it (Sale Securities) at a cash price per Equity Security determined in accordance with clause 16.4.

Clause 14 applies with necessary changes to any Transfer under this clause 16.2.

 

16.3 Agreed purchase price

Within 10 Business Days after a Transfer Notice is given or taken to be given under clause 16.2, the Seller and the other Shareholders must try to agree on a purchase price for the Sale Securities. If the Seller and the other Shareholders agree on a purchase price within that time, the purchase price for the Sale Securities is that price.

 

16.4 Independent valuation

If the Seller and the other Shareholders cannot agree on the purchase price for the Sale Securities, the Company must, within 10 Business Days after the period referred to in clause 16.3, comply with Schedule 7 to obtain an independent valuation of the Sale Securities. The cash price per Sale Security is the value of the Sale Security determined by the independent valuation.

 

16.5 Provision of independent valuation

The Company must give each Shareholder a copy of any independent valuation obtained under clause 16.4 as soon as the Company receives it.

 

16.6 Clause 14 suspended

Clause 14 is suspended after a Transfer Notice is taken to be given until the value of the Sale Securities is determined in accordance with clause 16.3 or 16.4.

 

17. Exit

 

17.1 Financial Adviser

The Board, by Special Majority Approval must appoint an investment bank, stockbroker or other qualified person of good standing (Financial Adviser) to act on behalf of the Company and all Shareholders to advise whether the best return would be obtained through an IPO, a sale of the Share Capital or a Trade Sale or any combination; and manage the preparation and implementation of the Exit Event in accordance with this clause 17.

 

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17.2 Pre-Exit Restructure

The Board may, at any time, by Special Majority Approval approve a restructure of the Group for the purposes of facilitating an Exit Event, such that a new Holding Company is established for the Group, in which case the Shareholders must exchange their Shares for shares in the new Holding Company such that their Shareholding Percentages are maintained (Restructure), and the parties must use their reasonable endeavours to ensure that that Restructure occurs at the time and otherwise in accordance with the terms of that resolution.

As part of a Restructure, the Company may novate this agreement to the new Holding Company in accordance with clause 29.3 and this agreement will apply to the new Holding Company on and from that date.

 

17.3 Endeavours to Exit

 

  (a) The Board may, at any time, resolve by Special Majority Approval, to pursue an Exit Event.

 

  (b) If a Qualifying IPO has not occurred by 30 September 2015, the Board must pursue an Exit Event unless the Series B Shareholders have resolved by Special Majority Approval to halt the pursuit of an Exit Event.

 

  (c) While the Board is pursuing an Exit Event, the parties must use their reasonable endeavours to ensure that that Exit Event occurs in accordance with the directions of the Board.

 

17.4 Obligations

While the Company is pursuing an Exit Event or Restructure under this clause 17 (following a resolution under clause 17.2 or 17.3 (as the case may be)), the Company and each Shareholder must do each of the following:

 

  (a) take all action to facilitate the Exit Event or Restructure; and

 

  (b) not take any action or refrain from taking action which would prevent, hinder or delay the Exit Event or Restructure.

 

17.5 Co-operation

The Company and each Shareholder must do the things required in clause 17.4 to the extent that it is within its, his or her power, and whether in its capacity as a Shareholder, Director or other officer or employee of the Company (as the case may be), however no Shareholder (solely in his, her or its capacity as a shareholder) or Director (solely in his or her capacity as a director) is required to accept liability for any statement, including a forward looking statement contained in any offer document issued in connection with an Exit Event.

 

17.6 Transfer right suspended

While the Company is pursuing an Exit Event or a Restructure under this clause 17, no person may serve a Transfer Notice under clause 14 unless approved by Special Majority Approval of the Board.

 

17.7 Escrow

 

  (a) The Shareholders undertake to comply with any restrictions on the transfer and encumbrance of their Equity Securities that the Financial Adviser determines are appropriate for an IPO conducted in accordance with this clause 17 so long as such restrictions are not longer than 180 days, unless required by regulatory requirements.

 

25


  (b) The Shareholders agree that each Shareholder who holds 1% or more of the fully converted Share Capital will be equally subject to the most stringent restriction in relation to the length of the restriction period and the proportion of Equity Securities subject to the restriction determined appropriate by the Financial Advisor for any Equity Security in accordance with clause 17.7(a).

 

17.8 No warranties

Each party acknowledges that both Shareholders and Preference Shareholders will not be required to give any warranties, indemnities, undertakings or other covenants in respect of an Exit Event or any other transaction involving the Company or Equity Securities, except as to title and ability to deal with those Equity Securities.

 

17.9 Sale of Share Capital or Trade Sale

On the completion of the sale of Share Capital or Trade Sale (as the case may be) under this clause (or otherwise under this agreement) the following must occur:

 

  (a) in the case of a sale of the Share Capital, each Shareholder must deliver to the proposed purchaser title to all of its Equity Securities free from any Security Interest;

 

  (b) the Board will receive on behalf of either all Shareholders or the Company (as the case may be) the aggregate proceeds of the Exit Event;

 

  (c) the Board will deduct and pay from the proceeds of the Exit Event, the fees and expenses of the Financial Adviser, legal adviser, consultants and all other transaction costs;

 

  (d) the Board must account to the Shareholders in accordance with the rights attaching to Shares for the proceeds of the Exit Event after deduction of the fees and costs in clause 17.9(c); and

 

  (e) in the case of a Trade Sale, the Shareholders must, if so requested by the Preference Shareholders, pass all required resolutions at short notice to either conduct a share buyback or members voluntary winding up of the Company so that the balance proceeds of the Trade Sale may be distributed to the Shareholders on the basis set out in this document and the Constitution.

 

17.10 Attorney

Following a resolution under clause 17.2 or 17.3, each Shareholder (except the Preference Shareholders) and the Company severally and irrevocably and unconditionally appoints (for valuable consideration) any two Directors jointly as its agent and attorney with power to complete an Exit Event as contemplated in this clause (including the power for any two Directors together to execute all necessary documentation to complete the sale on behalf of that Shareholder or the Company (as the case may be)).

 

17.11 Qualifying IPO

The parties agree that the Series B Shareholders may by Special Majority Approval, waive or reduce the conditions for a Qualifying IPO, and if they do so, the definition of Qualifying IPO will be amended accordingly.

 

17.12 Non-Qualifying IPO

The Company may not proceed with an IPO which is not a Qualifying IPO unless it is approved by holders of not less than 50.1% of the Series B Preferred Shares.

 

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18. Default

 

18.1 Events of default

An event of default occurs in relation to a Shareholder if:

 

  (a) the Shareholder breaches this agreement and:

 

  (i) does not remedy the breach within 20 Business Days after receiving a notice of the breach from a party requesting the breach to be remedied; or

 

  (ii) the breach is incapable of being remedied; or

 

  (b) an Insolvency Event occurs in relation to the Shareholder.

 

18.2 Consequence of default

If an event of default occurs in relation to a Shareholder (Defaulting Party), at the election of a party by giving notice to all parties:

 

  (a) all rights attaching to Equity Securities held by the Defaulting Party are suspended until the default is remedied (and, if the default is not capable of remedy, are suspended indefinitely); or

 

  (b) the Defaulting Party is taken to have given an irrevocable Transfer Notice under clause 14.2 on the date on which the event of default occurred, in respect of all Equity Securities held by it (Sale Securities) at a cash price per Sale Security determined in accordance with clause 18.3. Clause 14 applies mutatis mutandis to the transfer.

 

18.3 Agreed purchase price

Within 10 Business Days after a Transfer Notice is given or taken to be given under clause 18.2, the Defaulting Party and the other Shareholders must try to agree on a purchase price for the Sale Securities. If the Defaulting Party and the other Shareholders agree on a purchase price within that time, the purchase price for the Sale Securities is that price.

 

18.4 Independent valuation

If the Defaulting Party and the other Shareholders cannot agree on the purchase price for the Sale Securities, the Company must, within 10 Business Days after the period referred to in clause 18.3, comply with Schedule 7 to obtain an independent valuation of the Sale Securities. The cash price per Sale Security is the value of the Sale Security determined by the independent valuation.

 

18.5 Provision of independent valuation

The Company must give the Defaulting Party and each other Shareholder a copy of the independent valuation as soon as the Company receives it.

 

18.6 Other remedies

Clause 18.2 is in addition to and not to the exclusion of any other right or remedy the other parties may have against a Defaulting Party.

 

18.7 Clause 14 suspended

Clause 14 is suspended after a Transfer Notice is taken to be given until the value of the Sale Securities is determined in accordance with clause 18.3 or 18.4.

 

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19. Representations

 

19.1 General representations

Each party represents to each other party that as at the date of this agreement:

 

  (a) that party is a body corporate duly incorporated and validly existing under the law of the country or jurisdiction of its incorporation or registration;

 

  (b) that party has the corporate or statutory power to own its assets and perform any business activity as contemplated at any time by the Transaction Documents;

 

  (c) the execution or performance of each of the Transaction Documents by that party will constitute legal, valid and binding obligations of it, enforceable in accordance with the terms of the relevant Transaction Document;

 

  (d) the execution or performance of any of the Transaction Documents by that party does not contravene any provision of:

 

  (i) the constitutional documents of that party or any legislation, rules or other document constituting that party or governing its activities;

 

  (ii) any agreement entered into by that party or any instrument to which it is a party or which is binding on it or any of its assets;

 

  (iii) any legislation or rule of law or regulation, authorisation, consent or any order or decree of any governmental authority; or

 

  (iv) any governmental consent relating to that party or its assets; and

 

  (e) the execution or performance of any of the Transaction Documents by that party will not result in the creation or imposition of any encumbrance or restriction of any nature on any of its assets; and

 

  (f) that party has full power and authority and has procured all consents for, and taken all necessary corporate action to authorise, the execution and performance by that party of the Transaction Documents.

 

19.2 Disclaimers

Each party acknowledges and agrees that:

 

  (a) it has relied upon its own inquiries in relation to any fact relating to this agreement and not upon any representation made by or on behalf of any other party, except where expressly specified in a Transaction Document;

 

  (b) any representation or other provision which might otherwise be implied by law into this agreement is excluded to the fullest extent permitted by law; and

 

  (c) it releases each other party from any liability or legal action which it might otherwise have against that other party resulting from any representation or other provision which is not expressly specified in the Transaction Documents.

 

20. Limitation of liability of Fund Trustee

 

20.1 Fund Trustee

 

  (a) A Fund Trustee is bound by this agreement only in its capacity as trustee, custodian, subcustodian or nominee of its Fund and in no other capacity, unless otherwise specifically stated in this agreement.

 

  (b) Subject to clause 20.1(e), the rights of other parties and the Fund under or in respect of this agreement and the other Transaction Documents (whether express or implied by applicable law or otherwise) are not exercisable against the relevant Fund Trustee other than in its capacity as trustee, custodian, subcustodian or nominee of the Fund.

 

28


  (c) Subject to clause 20.1(e), but despite any other provision of this agreement, the Fund Trustee is not liable to pay or satisfy, and the Fund nor any party is entitled to enforce against the Fund Trustee, any damages suffered by or amounts owing to the party or the Fund, which result from a breach or non-performance of an obligation, representation or warranty (whether express, implied by law or otherwise) of the Fund Trustee under or in respect of this agreement or the other Transaction Documents (including in relation to any conduct, omission or transaction in relation to this agreement or the other Transaction Documents) except to the extent the Fund Trustee is entitled to be indemnified (whether from the Fund for which the Fund Trustee holds its units or shares, by way of insurance or otherwise) and is actually indemnified in its capacity as trustee, custodian, subcustodian or nominee of the Fund in respect of that obligation, representation or warranty and those damages and amounts are recoverable by the Fund Trustee under that indemnity.

 

  (d) Subject to clause 20.1(e), if a party does not recover all damages suffered and amounts owing to it as a result of a breach or non-performance of any obligation of the Fund Trustee under or in respect of this agreement or the other Transaction Documents (whether express or implied by applicable law or otherwise), the party may not seek to recover the shortfall by applying to have the Fund Trustee wound up.

 

  (e) The limitations in clause 20.1(b) to 20.1(d):

 

  (i) do not apply to the extent that those damages or amounts owing are not able to be satisfied because the entitlement of the Fund Trustee to be indemnified in its capacity as trustee, custodian, subcustodian or nominee of the Fund is reduced as a result of:

 

  (A) any negligence, wilful default, fraud or dishonesty or other act or omission by the Fund Trustee or any other trustee, responsible entity, custodian, subcustodian or nominee of the fund for which the Fund Trustee holds the units or shares; or

 

  (B) any waiver, relinquishment or surrender by the Fund Trustee or any other trustee, responsible entity, custodian, subcustodian or nominee of the fund for which the Fund Trustee holds the units or shares, of any right of indemnity under the terms of appointment of the Fund Trustee relating to the fund for which the Fund Trustee holds the units or shares in respect of those damages or amounts; and

 

  (ii) do not limit the rights of the Fund Trustee under this agreement or the other Transaction Documents unless expressly specified otherwise.

 

  (f) No attorney, agent, receiver or receiver and manager appointed in accordance with this agreement has authority to act on behalf of the Fund Trustee in a way which exposes the Fund Trustee to any personal liability, and no act or omission of any such person will be considered negligence, wilful default, fraud or dishonesty of the Fund Trustee for the purpose of clause 20.1(e)(i)(A).

 

21. Confidentiality and announcements

 

21.1 Confidentiality obligations

Each party must:

 

  (a) use the Confidential Information only for the purposes of the Business or to make decisions regarding its investment in the Company;

 

29


  (b) keep the Confidential Information confidential and not disclose it or allow it to be disclosed to a third party except:

 

  (i) with the prior written approval of the other parties;

 

  (ii) in accordance with paragraph 9 of Schedule 2; or

 

  (iii) to officers, employees and consultants or advisers of the party (or its Connected Persons) who have a need to know (and only to the extent that each has a need to know) and are aware that the Confidential Information must be kept confidential; and

 

  (c) take or cause to be taken reasonable precautions necessary to maintain the secrecy and confidentiality of the Confidential Information.

 

21.2 Announcements

No announcement, press release or other communication of any kind relating to the negotiations of the parties or the subject matter or terms of this agreement must be made or authorised by or on behalf of the Company without the prior written approval of each affected party unless that announcement, press release or communication is required to be made by law or any order of any court, tribunal, authority or regulatory body.

 

21.3 Exceptions

The obligations of confidentiality under this agreement do not extend to information (whether before or after this agreement is executed):

 

  (a) disclosed to a party, but at the time of disclosure is rightfully known to or in the possession or control of the party and not subject to an obligation of confidentiality on the party;

 

  (b) that is public knowledge (except because of a breach of this agreement or any other obligation of confidence);

 

  (c) required or requested to be disclosed by law, rule, regulation or any order of any court, tribunal, authority or regulatory body or in connection with the enforcement of this agreement or by the rules of a Stock Exchange; or

 

  (d) a Shareholder wishes to disclose to an adviser of the Shareholder if the disclosure is made on a confidential basis.

 

22. Restraint

 

22.1 Definitions

In this clause 22:

 

  (a) engage in means to carry on, participate in, provide finance or services, or otherwise be directly or indirectly involved as a shareholder, unitholder, director, consultant, adviser, contractor, principal, agent, manager, employee, beneficiary, partner, associate, trustee or financier.

 

  (b) a reference to the Business is to the Business as at the date when the relevant Shareholder stops being a Shareholder.

 

  (c) Restricted Business means activity which directly competes in the research and development of canine, equine or feline therapeutic monoclonal antibodies.

 

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22.2 Prohibited activities

Each Shareholder (other than a Fund Trustee) undertakes to the Company and each other Shareholder that it will not:

 

  (a) engage in a business or an activity that is a Restricted Business;

 

  (b) solicit, canvass, approach or accept an approach from a person who was at any time during the 12 months ending on the date when the Shareholder stops being a Shareholder, a client or customer of the Group with a view to obtaining their custom in a business or an activity that is a Restricted Business;

 

  (c) induce or attempt to induce any suppliers to the Group to cease to supply, or restrict or vary the terms of supply, to the Group;

 

  (d) interfere with the relationship between the Group and its customers, employees or suppliers;

 

  (e) induce or help to induce an employee of the Group to leave their employment;

 

  (f) make use of or (except as required by law or any competent regulatory body) disclose or divulge to any third party any information of a secret or confidential nature relating to the business or affairs of the Group;

 

  (g) challenge the Group’s ownership, entitlements, rights or use of any intellectual property used, owned or licensed by the Group at the date the Shareholder stops being a Shareholder;

 

  (h) use or (to the extent the Shareholder may do so) allow the use (except by the Group) of any intellectual property which the Group has the exclusive right to use, own or license at the date the Shareholder stops being a Shareholder.

 

22.3 Duration of prohibition

The undertakings in clause 22 begin when the Shareholder becomes a Shareholder, and end:

 

  (a) on the second anniversary of the date when the Shareholder stops being a Shareholder;

 

  (b) on the first anniversary of the date when the Shareholder stops being a Shareholder; and

 

  (c) 6 months after the date when the Shareholder stops being a Shareholder.

 

22.4 Geographic application of prohibition

The undertakings in clause 22.2 apply only if the activity prohibited by clause 22.2 occurs within:

 

  (a) the world;

 

  (b) Australia, New Zealand, North America, Europe, Japan, Singapore, Israel, United Arab Emirates, India and China;

 

  (c) Australia, New Zealand, North America and Europe;

 

  (d) Australia, New Zealand and North America;

 

  (e) Australia, New Zealand; and

 

  (f) Australia.

 

22.5 Interpretation

Clauses 22.2, 22.3 and 22.4 have effect together as if they consisted of separate provisions, each being severable from the other. Each separate provision results from combining each undertaking in clause 22.2, with each period in clause 22.3, and combining each of those combinations with each area in clause 22.4. If any of those separate provisions is invalid or unenforceable for any reason, the invalidity or unenforceability does not affect the validity or enforceability of any of the other separate provisions or other combinations of the separate provisions of clauses 22.2, 22.3 and 22.4.

 

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22.6 Exceptions

 

  (a) This clause 22 does not restrict a Shareholder from:

 

  (i) undertaking further academic teaching and non-commercial internal research;

 

  (ii) performing any employment (or consulting) agreement with the Group;

 

  (iii) holding 5% or less of the shares of a company listed on a Stock Exchange;

 

  (iv) holding Equity Securities in the Company; or

 

  (v) recruiting a person through a recruitment agency (except if the agency targets employees of the Group) or in a response to a newspaper, web page or other public employment advertisement.

 

  (b) This clause 22 does not restrict a Preference Shareholder from doing anything contemplated in clause 24.1.

 

22.7 Acknowledgments

Each Shareholder acknowledges that:

 

  (a) all the prohibitions and restrictions in this clause 22 are reasonable in the circumstances and necessary to protect the goodwill of the Business;

 

  (b) damages are not an adequate remedy if the Shareholder breaches this clause 22; and

 

  (c) the Company or another Shareholder may apply for injunctive relief if:

 

  (i) the Shareholder breaches or threatens to breach this clause 22; or

 

  (ii) the Company or the other Shareholder believes the Shareholder is likely to breach this clause 22.

 

23. Not used

 

24. Acknowledgments regarding Preference Shareholders

 

24.1 Acknowledgments

Notwithstanding any other provision of this agreement, the parties acknowledge and agree that a Preference Shareholder and its Affiliates:

 

  (a) may invest funds in companies or other entities that may compete with the Company; and

 

  (b) may have obligations in respect of its shareholdings in such competing companies or entities in which funds managed by the Preference Shareholder have been invested or will be invested; and

 

  (c) will not be obliged to vote in favour of a resolution if the matter or decision the subject of the resolution would adversely impact on such shareholdings or cause the Preference Shareholder to breach the obligations referred to in clause 24.1(b)

provided that in attending and voting at Board meetings, the Director nominees of the Preference Shareholder comply with sections 191 and 195 of the Companies Acts as if the Company was regulated by those sections.

 

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In this clause 24 the definition of “Affiliate” is amended so that in (a) “50%” is replaced by “5%” and in (h)(iii) “30%” is replaced by “5%”.

 

25. Termination

 

25.1 Automatic termination

Subject to clause 25.2, this agreement terminates automatically:

 

  (a) if all parties agree;

 

  (b) for a Shareholder, when it stops holding, directly or indirectly, any Shares, at which time the Shareholder has no further rights or obligations under this agreement;

 

  (c) when the Company is wound up by an order of a Court;

 

  (d) on the day the shares offered in an IPO are allotted or transferred (or both); or

 

  (e) on the day an agreement to sell all of the Shares is completed.

 

25.2 Accrued rights

 

  (a) Termination of this agreement is without prejudice to any accrued rights of the parties.

 

  (b) If on termination there remains any Series B Preferred Shares on issue, Schedule 8 will remain in force until no more Series B Preferred Shares remain on issue.

 

26. Not Used

 

27. Notices

 

27.1 Service of notices

A notice, demand, consent or communication under this agreement (Notice) must be:

 

  (a) in writing and in English directed to the recipient’s address for Notices specified in the Details, as varied by any notice; and

 

  (b) hand delivered or sent by pre-paid post or facsimile to that address.

 

27.2 Effective on receipt

A Notice given in accordance with clause 27.1 takes effect when received (or at a later time specified in it), and is taken to be received:

 

  (a) if hand delivered, on delivery;

 

  (b) if sent by prepaid post, two Business Days after the date of posting (or seven Business Days after the date of posting if posted to or from outside Ireland);

 

  (c) if sent by facsimile, when the sender’s facsimile system generates a message confirming successful transmission of the notice in entirety unless, within eight Business Hours after the transmission, the recipient informs the sender that it has not received the entire notice,

but if the delivery, receipt or transmission is not on a Business Day or after 5.00pm on a Business Day, the notice is taken to be received at 9.00am on the Business Day after that delivery, receipt or transmission.

 

28. Agreement is paramount

This agreement prevails over any inconsistent clause in the Constitution. The Shareholders must amend the Constitution to remove the inconsistency as soon as they become aware of it.

 

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29. Miscellaneous

 

29.1 Alterations

Except as set out in clause 17.11, this agreement may only be altered with the written consent of both Shareholders holding at least 75% of the Ordinary Shares on issue and Preference Shareholders holding at least 75% of the Preference Shares on issue.

 

29.2 Approvals and consents

Except where this agreement expressly states otherwise, a party may, in its discretion, give conditionally or unconditionally or withhold any approval or consent under this agreement.

 

29.3 Assignment

 

  (a) Subject to this clause 29.3, a party may only assign this agreement or a right under this agreement with the prior written consent of each other party.

 

  (b) A Fund Trustee may assign a right or obligation under this agreement to an Affiliate without the consent of the other parties.

 

  (c) The Company may novate this agreement to a new Holding Company as part of a Restructure without the consent of the other parties.

 

29.4 Costs

Each party must pay its own costs of negotiating and executing this agreement and any instrument or document executed to give effect to this agreement.

 

29.5 Survival

Any indemnity and any obligation of confidentiality under this agreement is independent and survives termination of this agreement. Any other provision by its nature intended to survive termination of this agreement survives termination of this agreement.

 

29.6 Counterparts

This agreement may be executed in counterparts. All executed counterparts constitute one document.

 

29.7 No merger

The rights and obligations of the parties under this agreement do not merge on completion of any transaction contemplated by this agreement.

 

29.8 Entire agreement

This agreement, together with the other Transaction Documents, constitutes the entire agreement between the parties in connection with its subject matter and supersedes all previous agreements.

 

29.9 Further action

Each party must do, at its own expense, everything reasonably necessary (including executing documents) to give full effect to this agreement and transactions contemplated by it.

 

29.10 Severability

Part or all of a provision of this agreement that is illegal or unenforceable may be severed from this agreement and the remaining parts of the provision or provisions of this agreement continue in force.

 

29.11 Waiver

A party does not waive a right, power or remedy if it fails to exercise or delays in exercising the right, power or remedy. A single or partial exercise of a right, power or remedy does not prevent another or further exercise of that or another right, power or remedy. A waiver of a right, power or remedy must be in writing and signed by the party giving the waiver.

 

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29.12 Relationship

Unless expressly stated, this agreement does not create a relationship of employment, trust, agency or partnership between the parties.

 

29.13 Governing law and jurisdiction

This agreement is governed by the law of Ireland and each party irrevocably and unconditionally submits to the non-exclusive jurisdiction of the courts of Ireland.

 

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Schedule 1 – Issued share capital

Issued capital

 

Type of shares on issue

   Number of
shares on
issue
 

Ordinary

     1,609,922   

SIRPS

     2,171,427   

Series B Preferred Shares

     5,250,016   

TOTAL

     9,031,365   

Issued options/warrants

 

Type of options/warrants on issue

   Number of
options/
warrants
on issue
 

Options under LTI Plan

     282,380   

Warrants (held by shareholders)

     1,968,764   

Warrants (held by advisers)

     240,000   

TOTAL

     2,491,144   

 

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Schedule 2 – Board (clause 4)

 

1. Board composition

 

1.1 Subject to Special Majority Approval of the Directors to the contrary, the maximum number of Directors (excluding alternate Directors) at any one time is 8.

In preparation for a Qualifying IPO, the parties agree that they should take reasonable steps to change the composition of the Board so that the Board’s composition is more aligned with that expected of a company undertaking a Qualifying IPO. This may include the identification of suitable recommended candidates by the Board to replace existing Directors nominated in accordance with the below. Further, to the extent necessary, this paragraph 1.1 must be amended to accommodate such changes.

 

  (a) In the meantime, the Board must include:

 

  (i) an independent chairman;

 

  (ii) subject to paragraph 1.2 and 1.6, up to two Directors appointed by holders of SIRPS (SIRPS Director);

 

  (iii) subject to paragraph 1.3 and 1.6, up to two Directors appointed by the ordinary shareholders (Founder Directors);

 

  (iv) subject to paragraph 1.7, up to one Director appointed by Series B Shareholders (Series B Director);

 

  (v) if required by paragraph 1.8, a Farallon Director; and

 

  (vi) a chief executive officer approved by the Board.

 

  (b) Each Shareholder (whether alone or jointly with any other Shareholder) may remove and replace any Director appointed by it.

 

  (c) Each Shareholder (whether alone or jointly with any other Shareholder) must give the Company notice of each appointment and removal of a Director under paragraphs (a) to (b). Any appointment or removal takes effect at the time the notice is given to the Company.

 

  (d) If a Shareholder loses its right to appoint a Director under this paragraph 1, the Shareholder must ensure any Director appointed by it (whether alone or jointly with any other Shareholder) is immediately removed.

 

  (e) A Director may appoint an alternate Director to act as Director in his or her absence.

 

1.2 Subject to paragraph 1.6, SIRPS Shareholders may by resolution passed by SIRPS Shareholders who hold more than 60% of the SIRPS on issue replace a SIRPS Director with a new nominee as the new SIRPS Director on the board of the Company.

 

1.3 Subject to paragraph 1.6, Ordinary Shareholders may by resolution passed by Ordinary Shareholders who hold more than 60% of the Ordinary Shares on issue replace a Founder Director with a new nominee as the new Founder Director on the board of the Company.

 

1.4 A Director may appoint an alternate Director to act as Director in his or her absence.

 

1.5 A Shareholder which, together with its Affiliates, has a Shareholding Percentage of 10% or greater is entitled to appoint (and remove and replace) an observer to attend Board meetings. The Company has no obligation to pay any fee to the observer and will pay the reasonable costs and expenses of any observer associated with the observer participating in meetings of the Board (except that the Company will not pay travel costs of an observer who can reasonably attend the meeting by telephone or video conference). The observer:

 

  (a) is entitled to receive all information that a Director is entitled to receive and will be subject to the same obligations of confidentiality as the Director;

 

37


  (b) will be entitled to convey all information obtained by him in his capacity as an observer to his appointing Shareholder without restriction, provided that any person to whom such information is conveyed will be subject to the same obligations of confidentiality as the observer; and

 

  (c) will be entitled to participate in any Board meetings to the same extent as a director, but is not entitled to vote.

 

1.6 OFML, while it holds more than:

 

  (a) 25% of the SIRPS on issue, is entitled to nominate and appoint a SIRPS Director and the SIRPS Shareholders may not exercise their rights under paragraph 1.2 in respect of that director; and

 

  (b) 10% of the ordinary shares on issue, is entitled to nominate and appoint an additional (i.e. third) Founder Director, and the Ordinary Shareholders may not exercise their rights under paragraph 1.3 in respect of that director.

 

1.7 Series B Shareholders may by resolution passed by Series B Shareholders who hold more than 60% of the Series B Preferred Shares on issue replace a Series B Director with a new nominee as the new Series B Director on the Board.

 

1.8 If a Qualifying IPO has not occurred by 30 September 2015, the Farallon Investors shall be entitled to appoint a Farallon Director.

 

2. Voting

 

2.1 Subject to any other provision in this agreement, at a Board meeting, decisions must be decided by simple majority vote.

 

2.2 At a Board meeting, the chairman does not have a casting vote in addition to any deliberative vote he or she has.

 

3. Quorum

 

3.1 The quorum for a Board meeting is four (4) Directors, including at least one SIRPS Director.

 

3.2 If a quorum for a Board meeting in accordance with paragraph 3.1 is not present within 30 minutes after the time appointed for the Board meeting, the meeting stands adjourned to the same time and place two Business Days later. At the reconvened meeting (and any further reconvened meetings), the quorum is two (2), comprising of any two (2) Directors.

 

3.3 Directors do not have to be physically be present in the same place and may attend Board meetings using any technology that allows each Director to hear proceedings and be heard by the other Directors. The Company shall facilitate the attendance of meetings by telephone or video conference. A board meeting held in this way is deemed to take place at the place where the chairman of the meeting is physically present.

 

3.4 A Director must not fail to attend a meeting of Directors for the purpose of attempting to prevent a quorum being present. Accordingly, each party must use its reasonable efforts to appoint an alternate Director if it is reasonable to presume that the non-attendance of that Director would result in a quorum failing to be present at the Board meeting.

 

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4. Frequency of board meetings

A Board meeting must be held regularly and not less than 8 times in each Financial Year, except if all Shareholders agree otherwise.

 

5. Time and location of meetings

As far as practicable each Board meeting must be held on the same day and week of the Month and be held at the same location.

 

6. Notice

Written notice of a Board meeting must be given to all Directors at least 5 Business Days before the Board meeting, except if all Directors agree otherwise.

 

7. Board papers

A notice of a Board meeting must include:

 

  (a) an agenda;

 

  (b) a copy of all papers to be considered at that meeting; and

 

  (c) any other standing reports or other information required by the Board.

Meeting minutes shall be prepared in respect of all Board meetings documenting the matters discussed and agreed upon at the meeting. The minutes shall be signed and retained by the Company in Ireland.

 

8. Resolutions

At a Board meeting the Board may only resolve matters specifically referred to in the agenda issued for the meeting, except if all Directors (whether or not present at the meeting) resolve otherwise.

 

9. Nominee Directors

The parties acknowledge that some Directors are nominees of one or more of the Shareholders or otherwise are investment managers for the beneficial owners of a Shareholder or a similar interested party (Interested Party). Accordingly, the parties agree that those Directors may report all matters concerning the Company and any deliberations of the Board to the Shareholders who nominated their appointment and/or the relevant Interested Party and that those Directors may take advice and obtain instructions from the Shareholders and/or the relevant Interested Party who appointed them to the Board, provided that the person to whom the information is disclosed is under confidentiality obligations in respect of such information which are no less onerous than to those set out in this agreement.

 

10. Conflicts of interest

 

  (a) Subject to paragraph 10(c), a Director or Shareholder may be counted in forming a quorum for a Board meeting or a Shareholders’ meeting, as the case may be, to be held to consider any matter notwithstanding any actual, apparent or potential conflict of interest. The entitlement or otherwise of that Director or Shareholder to vote at that meeting will be determined in accordance with the Companies Acts and the Constitution.

 

  (b) The Shareholders and Preference Shareholders covenant with each other, to the extent reasonably possible, to minimise any potential conflict of interest in the operations of the Company. In particular, the Shareholders and Preference Shareholders agree all commercial dealings between the Company or any subsidiary of the Company and themselves or their Affiliates shall be on arm’s length terms.

 

39


  (c) The Investment Manager may provide interim management services as well as business development, company development and fund raising services to the Company. Any services to be provided by the Investment Manager to the Company will be provided on a transparent basis and on arm’s length terms and will be subject to Special Majority Approval of the Board.

 

11. Directors’ remuneration

 

11.1 Directors’ expenses and travel costs

Subject to a resolution of the Board by Special Majority Approval to the contrary, the Company shall pay the reasonable cost of travel in accordance with the Company’s policy in effect at such time, accommodation and other expenses properly incurred by the non-executive Directors (and in accordance with the Company’s policy concerning travel) in relation to their travel to, attendance at, and return from each Board meeting. The Company shall pay costs and expenses incurred by the non-executive Directors in respect of other travel related to the Business of the Company as determined by the Board from time to time.

Where the Company pays costs and expenses incurred by a non-executive Directors in respect of travel or other costs relating to the business of the Company, the Company shall deduct payroll tax (i.e. PAYE/ USC and social security) as appropriate from those payments and remit the tax deducted over to the Irish tax authorities as may be required by the Company pursuant to their obligations under the Irish Taxes Consolidation Act 1997.

 

11.2 D & O Policy

 

  (a) Subject to paragraph 11.2(b) and the terms of any deed of insurance indemnity and access entered into under clause 12, the Company agrees to maintain a D&O Policy in respect of each Director and Officer and to pay the premiums in respect of that D&O Policy.

 

  (b) Nothing in paragraph 11.2(a) constitutes an agreement by the Company to pay a premium which it is prohibited from paying under the Companies Acts or otherwise.

 

  (c) The insurer under the D&O Policy will be subject to approval by the Board. In addition, the amount and terms of the D&O Policy will be subject to approval by the Board.

 

  (d) The amount and terms of the D&O Policy must be reasonably consistent with those which would be secured by a prudent and competent operator of a business similar to the Company.

 

12. Deed of indemnity and access

The Company will grant to each of the Directors and Officers, and to each alternate Director, a deed of insurance, access and indemnity in a form to be agreed from time to time. All Shareholders’ consent to the execution by the Company of a deed of insurance, access and indemnity in favour of present and future Directors and Officers.

 

13. Chief Executive Officer

Subject to the terms of the chief executive officers formal employment contract, the Board may appoint or terminate the appointment of a Chief Executive Officer, such appointment or termination to be approved by a Special Majority Approval of Directors. If the appointment of the Chief Executive Officer is terminated, and if the outgoing Chief Executive Officer is a Director and/or Officer, he or she will be required to immediately resign as a Director and/or Officer, unless the outgoing Chief Executive Officer will otherwise continue as a Director and/or Officer as a nominee of a party under paragraph 1.1 of this Schedule.

 

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Schedule 3 – Powers of decision (clause 6)

 

Part 1

The Company must not do any of the things listed in Part 1 of this Schedule without the Special Majority Approval of the Directors:

 

1. (Chairperson and senior management) Appoint or remove the chairperson of the Company, chief executive officer, chief scientific officer, chief operating officer or chief financial officer or materially change their role or responsibilities. Other than as approved in the Business Plan, any amendments to the employment terms of any of the Chief Executive Officer, chief operating officer, chief financial officer or any executive Director.

 

2. (Power to appoint directors of other corporation) Appoint or remove a director of a corporation that the Company has the power to appoint or remove.

 

3. (Committees of Directors) Appoint, dissolve or alter the composition of any committee of the Board.

 

4. (Remuneration of Directors) Increase the remuneration payable to Directors, except in accordance with the Business Plan.

 

5. (Bonuses) Pay any executive, profit or other bonus to a Director, Increase the remuneration payable to Directors, except in accordance with the Business Plan.

 

6. (Employee Shares) Issue or grant shares or options under an employee share plan, employee share option scheme or employee share purchase scheme or other arrangement referred to in paragraph 7 below.

 

7. (Acquisitions) Acquire securities in another entity by a Group Company.

 

8. (Acquisitions and disposals) Acquire or dispose of a company or business (except the Business), except in accordance with the Business Plan.

 

9. (Assets) Licence, acquire or dispose of an asset or assets (either tangible or intangible) having a value of $50,000 or more (including, but not limited to, patents and other intellectual property), except in accordance with the Business Plan.

 

10. (Finance and operating leases) Enter into a finance or operating lease with a cost of $20,000 or more per annum, except in accordance with the Business Plan.

 

11. (Listing) Apply to a Stock Exchange for a listing or for quotation of any Shares at any time within five years after the Commencement Date.

 

12. (Loans) Make a loan or provide credit or other financial accommodation to a person, except in accordance with the Business Plan.

 

13. (Encumbrances) Encumber an asset or undertaking, except in accordance with the Business Plan.

 

14. (Contracts) Enter into, terminate, amend, vary, assign, novate, enforce or waive a right under, a contract which is greater than $50,000 in value, except in accordance with the Business Plan save for the events detailed in paragraph 9.

 

15. (Disputes) Commence, conduct or settle any dispute or litigation or arbitration (including with a tax authority) except debt collection in the ordinary course of business.

 

16. (Related party transactions) Enter into a contract or other arrangement with a Director or an associate of a Director.

 

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17. (Dividends) Set or change the dividend or distribution policy of the Company, or declare, make or pay a dividend or another distribution.

 

18. (Partnerships and joint ventures) Enter into, amend or vary a partnership or joint venture.

 

19. (Insurance) Amend or vary the insurance cover over the Company or the Business or any key man insurance policy.

 

20. (Winding up) Take a step to dissolve or wind up the Company.

 

21. (Auditor) Appoint or remove the Company’s auditor.

 

22. (Accounting Standards and principles) Materially alter the Accounting Standards or principles previously adopted by the Company for the preparation or presentation of any individual or consolidated financial statements, except if required by law.

 

23. (Balance date) Change the balance date or alter the accounting period of the Company.

 

24. (Financial assistance) Provide a loan or other financial assistance to a Director or his or her associates or vary the terms of any loan or other financial assistance previously provided to a Director or his or her associates.

 

25. (Equity Securities) Issue or allot or grant a right to issue or allot Equity Securities.

 

26. (Employee Share Plans) Adopt or amend the terms of ESOP or any other employee share plan, employee share option scheme or employee share purchase scheme or any other arrangement that may give employees of the Company or other approved persons the right or entitlement to acquire any Equity Securities.

 

27. (Capital expenditure) Incur capital expenditure of more than $40,000 in a Financial Year, except in accordance with the Business Plan.

 

28. (Borrowing) Borrow, or accept any financial accommodation of, $50,000 or more, except in accordance with the Business Plan.

 

29. (Business Plan and budgets) Adopt or vary a Business Plan or milestones or another operating, capital or cash budget or business financial plan.

 

30. (Guarantee) Give or enter into a guarantee, letter of comfort or performance bond, except in accordance with the Business Plan.

 

31. (Key employees/personnel) Appointment or dismissal of any key Company employees or personnel and any changes to the terms of their engagement or remuneration packages.

 

32. (New Directors) Appoint a Director (except in accordance with Schedule 2) or change the authorised number of Directors.

 

33. (Reorganisation Event) Undertake or undergo a Reorganisation Event or buy back any Shares.

 

34. (Trade sale or licence) During the period ending on 17 August 2017, licence, sublicense or effect a sale of the patent or other material assets of the Company (other than by way of a Trade Sale in accordance with clause 17).

Part 2

The Company must not do any of the things listed in Part 2 of this Schedule without the Special Majority Approval of the Shareholders:

 

1. (Constitution) Amend the Constitution.

 

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2. (Scale of operations) The Company must not cease carrying on, or materially alter the scale of operations of, the Business or commence any business or operational activity except the Business (except in accordance with clause 17).

 

Part 3

The Company must not do any of the things listed in Part 3 of this Schedule without the Special Majority Approval of the Series B Shareholders:

 

1. (Trade sale) Any sale, merger or consolidation of the Company or a sale or transfer of substantially all of the assets of the Company or any other Trade Sale (as defined in clause 1.1) following which the Series B Shareholders would not receive the Series B Liquidation Preference.

 

2. (Licence) Any licence or sublicense of substantially all of the assets of the Company.

 

3. (Series B Shares) Change any terms of the Series B Preferred Shares.

 

4. (Priority Shares) Create (by reclassification or otherwise) any class of Shares with rights which are equal or in priority to those of the Series B Preferred Shares.

 

5. (Redemption) Redeem any Shares.

 

6. (Borrowings) Borrow, or accept any financial accommodation of, (which, for the avoidance of doubt, does not include leases) $50,000 or more.

 

7. (Related party transactions) Enter into a contract or other arrangement with a Director, Shareholder or an Affiliate of a Director or Shareholder, except where such arrangements apply to Directors solely in their role as Director or a person solely in respect of their employment.

 

8. (Repurchase) Repurchase of any Shares.

 

9. (Return of Capital) Return any capital on any Shares.

 

10. (Dividends) Declare, make or pay a dividend or another distribution other than in respect of the Series B Preferred Shares.

 

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Schedule 4 – Terms of SIRPS

 

1. Defined terms

In this Schedule 4:

Conversion Price for a given SIRPS means the Issue Price for that SIRPS, subject to adjustment in accordance with paragraph 10.

Issue Price for a given SIRPS means the issue price for that SIRPS.

SIRPS Liquidation Preference in respect of each SIRPS, means:

 

  (a) the Issue Price of the SIRPS multiplied by 2; plus

 

  (b) any declared but unpaid dividends in respect of that SIRPS.

 

2. Dividends

Each SIRPS will confer on its holder the right to receive dividends. Dividends will be calculated on the assumption that each SIRPS has been converted into Ordinary Shares on the basis set out in paragraph 6 below.

 

3. Voting rights

 

  (a) On a show of hands each SIRPS Shareholder has one vote.

 

  (b) On a poll every SIRPS Shareholder has a number of votes equal to the number of Ordinary Shares into which the SIRPS held by that Shareholder are, at the time of the meeting or resolution in question, convertible (with fractions being rounded down to the nearest whole number).

 

  (c) Each SIRPS Shareholder has the same rights to receive notices and to vote at general meetings of the Company as if they were holders of ordinary shares.

 

4. Breach of a Transaction Document

If the Company materially breaches a Transaction Document which breach remains unremedied for a period of 20 days from the date of a written notice delivered by holders of a majority of the SIRPS, and holders of a majority of the SIRPS deliver to the Company a liquidation notice, the Company and the Shareholders shall take such steps as may be required to promptly commence and process the liquidation or winding up of the Company including the passing of such resolutions as may be required to liquidate or wind up.

 

5. Liquidation preference

 

5.1 If there is a Liquidation Event, the Shareholders must be paid as follows:

 

  (a) First, each SIRPS holder shall be entitled to receive:

 

  (i) pari passu with the holders of Series B Preferred Shares; and

 

  (ii) prior to and in preference to other Shares,

the SIRPS Liquidation Preference for each SIRPS held by that Shareholder; and

 

44


  (b) Secondly, after full payment of the SIRPS Liquidation Preference, the remaining assets of the Company will be distributed rateably amongst the Shares including the SIRPS on an as converted basis.

 

5.2 For the avoidance of doubt, and without prejudice to paragraph 5.1 of this Schedule 4, if the Proceeds following a Liquidation Event are paid to the Shareholders or the Company in instalments or the payment of the Proceeds or a portion of the Proceeds is otherwise deferred, a holder of an Ordinary Share is not entitled to any distribution or payment until each SIRPS

Shareholder has received the SIRPS Liquidation Preference for each SIRPS held by that Shareholder immediately prior to the Liquidation Event.

 

6. SIRPS holders’ entitlement

A SIRPS Shareholder is entitled to receive a dividend or the SIRPS Liquidation Preference if that Shareholder is recorded in the share register on the day determined for payment by the Board (and not otherwise).

 

7. Conversion Ratio

The number of Shares into which each SIRPS may be converted will be determined by dividing the Issue Price for the relevant SIRPS by the Conversion Price (Conversion Ratio). The Conversion Ratio will be adjusted each time an adjustment is made to the Conversion Price as provided in paragraph 10 below.

 

8. Conversion

 

  (a) The SIRPS holders may at any time in their discretion convert all or part of their SIRPS into Ordinary Shares by written notice to the Company specifying the number of SIRPS to be converted and tendering the relevant certificate.

 

  (b) Within 5 Business Days of receiving a notice under paragraph 8(a), the Company must:

 

  (i) convert the SIRPS as requested at the Conversion Ratio applicable on the date the notice was given; and

 

  (ii) issue the Shares to that holder and record that issue and holding in the Company’s share register.

 

  (c) The directors of the Company may convert SIRPS in accordance with this paragraph by any method authorised by law.

 

9. Automatic Conversion

 

  (a) The SIRPS will be automatically converted into Ordinary Shares on:

 

  (i) completion of an IPO;

 

  (ii) completion of the sale of the Share Capital (including a Trade Sale);

 

  (iii) a return of capital by the Company; or

 

  (iv) a transfer or exchange of all or substantially all of the assets of the Company (save for a licence of intellectual property rights).

 

45


10. Anti-dilution protection

 

  (a) If at any time after the issue of any SIRPS the Company issues Equity Securities (except under an ESOP in accordance with clause 12 of this agreement) at an issue price per Equity Security less than the then current Conversion Price of those SIRPS immediately prior to the new issue then the Conversion Price of those SIRPS must be adjusted to be equal to the NCP as calculated in the formula below. The Conversion Ratio of those relevant SIRPS will also be re-calculated on the basis that the Conversion Price is the NCP.

 

   NCP = CP x       A +   B      
         CP      
         A + C      

Where

 

  NCP New Conversion Price

 

  CP Conversion Price in effect immediately prior to issuance of securities causing the dilutive adjustment.

 

  A Number of Ordinary Shares deemed to be outstanding immediately prior to new issuance of securities causing the dilutive adjustment (includes all outstanding Ordinary Shares, all outstanding preference shares on an as converted basis; but does not include any convertible securities converting into this round of financing or any outstanding options on an as exercised basis).

 

  B Aggregate consideration received by the Company for the Equity Securities causing the dilutive adjustment.

 

  C Number of Equity Securities to be issued (on an as converted basis) causing the dilutive adjustment.

 

  (b) The adjustment in paragraph 10(a) above shall not apply:

 

  (i) where Equity Securities are issued on conversion of SIRPS or Series B Preferred Shares to Ordinary Shares;

 

  (ii) on the exercise of Warrants;

 

  (iii) on a Restructure or Reorganisation Event; or

 

  (iv) on any additional Equity Securities issued as a result of a Conversion Price adjustment under paragraph 10(a).

 

  (c) For avoidance of doubt the parties agree that:

 

  (i) the Conversion Ratio is not subject to adjustment if the Company issues Equity Securities at an issue price, conversion or exercise price for an amount equal to or higher than the SIRPS price per Share; and

 

  (ii) the above formula is to be applied to each SIRPS Shareholder’ holding of SIRPS on a an individual basis and separately in respect of each parcel of SIRPS held by that individual which have a different Conversion Price.

 

  (d) The adjustment in paragraph 10 (a) above shall not reduce the Conversion Price lower than the par value (if any) of the Ordinary Shares.

 

46


11. Split or reconstruction

If the capital of the Company is subject to a Reorganisation Event which is not adjusted for pursuant to paragraph 10(a), then the Board must make adjustments to the Conversion Ratio, Conversion Price and/or the number of SIRPS on issue (both increasing or decreasing) which in the opinion of the Board are reasonably necessary to give full effect to the Reorganisation Event while maintaining parity between the holders of the SIRPS and other shareholders in the Company and such adjustments will constitute an amendment to these terms.

 

47


Schedule 5 – Financial and other reporting (clause 8)

 

1. (Monthly) At the same time, and in the same format, as delivered to the Board, unaudited management accounts for the preceding Month.

 

2. (Annual) Within 45 Business Days after the end of each Financial Year, audited financial statements (including consolidated profit and loss accounts, balance sheets and cash flow statements) in respect of the Financial Year.

 

3. (Minutes) At the same time as they are provided to the Directors but within 10 Business Days after each meeting:

 

  (a) minutes of all Board meetings; and

 

  (b) minutes of all Shareholder meetings.

 

4. (Offer information) As soon as the Company receives an offer to buy:

 

  (a) Shares;

 

  (b) an interest in a Subsidiary;

 

  (c) all or a substantial part of the Business; or

 

  (d) all or substantially all of the assets of the Company, full details of the offer.

 

5. (Board papers) At the same time as they are provided to the Directors, a copy of all Board papers provided to the Directors in connection with a Board meeting.

 

48


Schedule 6 – Deed of Accession – clauses 13.8 and 14.12

Deed poll of accession

Date

By [full name of acceding party] of [address] (Acceding Party)

Background

This deed poll is supplemental to a shareholders agreement dated [#] August 2014 between Nexvet Biopharma Limited and others (Shareholders Agreement).

Terms

 

1. The Acceding Party confirms that it has been supplied with a copy of the Shareholders Agreement.

 

2. The Acceding Party covenants with all present parties to the Shareholders Agreement (whether original or by accession) to observe, perform and be bound by all the terms of the Shareholders Agreement to the intent and effect that the Acceding Party is deemed with effect from the date on which the Acceding Party is registered as a Shareholder of the Company to be a party to the Shareholders Agreement.

 

3. The Acceding Party’s address for the purposes of the Shareholders Agreement is, until substituted in accordance with the Shareholders agreement:

 

4. [address]

 

5. Clause 29.13 of the Shareholders Agreement applies to this deed poll.

EXECUTED as a deed.

[insert appropriate execution clauses]

 

49


Schedule 7 – Independent valuation (clauses 16.4 and 18.3)

 

1. Application of schedule

This Schedule applies if an independent valuation of any Equity Securities (Sale Securities) is required under clauses 16 or 18.

 

2. Defined terms

In Schedule 7:

Fair Value means:

 

  (a) the dollar figure given by the Independent Valuer; or

 

  (b) if the Independent Valuer gives a range of figures, the mid point in the range of fair market valuations determined by the Independent Valuer in accordance with this Schedule.

Independent Valuer means the person appointed to value the Sale Securities under paragraph 3.

 

3. Appointment of Independent Valuer

The Board must:

 

  (a) appoint, by Special Majority Approval, an independent chartered accountant or independent expert or an investment bank of good standing; or

 

  (b) if the Board fails to agree on an appointment, request the President of the Institute of Chartered Accountants in Ireland to appoint a member of at least five years standing,

to determine the Fair Value of the Sale Securities, in which case the purchase price for the Sale Securities is the Fair Value amount as certified by the Independent Valuer.

 

4. Valuation

The Board must instruct the Independent Valuer to determine a range of fair market values for the Sale Securities having regard to all normal share valuation factors as are considered relevant to the Independent Valuer, including the following assumptions:

 

  (a) there is a willing but not anxious buyer and a willing and anxious seller;

 

  (b) a reasonable time is available in which to obtain a sale of the Sale Securities being valued in the open market (and for that purpose 30 days is a reasonable time); and

 

  (c) the Sale Securities are subject to the restrictions set out in this agreement;

 

  (d) the Sale Securities represent a minority holding and are therefore not entitled to participate in a control premium;

 

  (e) the Sale Securities will not give the buyer effective control;

 

  (f) paragraphs (c), (d) and (e) imply a discount to a valuation undertaken on a whole of Company basis.

 

50


5. Period of determination

The Board must use its best endeavours to ensure that the Independent Valuer determines the value of the Sale Securities as soon as practicable but within 20 Business Days after receiving instructions from the Board.

 

6. Role of Independent Valuer

The Independent Valuer acts as an expert and not as an arbitrator.

 

7. Independent Valuer’s decision

The Independent Valuer’s determination is final and binding on all parties to the transaction.

 

8. Costs

The Company must pay the reasonable costs and expenses of the Independent Valuer.

 

9. Access to information

The Board must ensure:

 

  (a) the Independent Valuer has access at all reasonable times to the accounting records and other records of the Group; and

 

  (b) the officers of the Group give any information or explanations required by the Independent Valuer to value the Sale Securities.

 

51


Schedule 8 – Terms of Series B Preferred Shares

 

1. Defined terms

In this Schedule 8:

Conversion Price for a given Series B Preferred Share means the Issue Price for that Series B Preferred Share, subject to adjustment in accordance with paragraph 10.

Issue Price for a given Series B Preferred Share means the issue price for that Series B Preferred Share.

Series B Conversion Amount in respect of each Series B Preferred Share, means:

 

  (a) the Issue Price; plus

 

  (b) 8% of the Issue Price per annum, compounded quarterly, such amount only accumulating starting from 1 October 2015; plus

 

  (c) any accrued but unpaid dividends in respect of that Series B Preferred Share.

Series B Liquidation Preference in respect of each Series B Preferred Share, means:

 

  (a) the Issue Price multiplied by 2; plus

 

  (b) 8% of the Issue Price per annum, compounded quarterly, such amount only payable and accumulating starting from 1 October 2015; plus

 

  (c) any accrued but unpaid dividends in respect of that Series B Preferred Share.

 

2. Dividends

Each Series B Preferred Share will confer on its holder the right to receive dividends declared on Ordinary Shares calculated on the assumption that each Series B Preferred Share has been converted into Ordinary Shares on the basis set out in paragraph 6 below.

 

3. Voting rights

 

  (a) On a show of hands each Series B Shareholder has one vote.

 

  (b) On a poll every Series B Shareholder has a number of votes equal to the number of Ordinary Shares into which the Series B Preferred Shares held by that Shareholder are, at the time of the meeting or resolution in question, convertible into (with fractions being rounded down to the nearest whole number).

 

  (c) Each Series B Shareholder has the same rights to receive notices and to vote at general meetings of the Company as if it was a holder of Ordinary Shares.

 

4. Breach of a Transaction Document

If the Company materially breaches a Transaction Document which breach remains unremedied for a period of 20 days from the date of a written notice delivered by holders of a majority of the Series B Preferred Shares, and holders of a majority of the Series B Preferred Shares deliver to the Company a liquidation notice, the Company and the Shareholders shall take such steps as may be required to promptly commence and process the liquidation or winding up of the Company including the passing of such resolutions as may be required to liquidate or wind up.

 

52


5. Liquidation preference

 

5.1 If there is a Liquidation Event, the Shareholders must be paid as follows:

 

  (a) First, each Series B Shareholder shall be entitled to receive:

 

  (i) pari passu with the holders of SIRPS; and

 

  (ii) prior to and in preference to other Shares,

the Series B Liquidation Preference for each Series B Preferred Share held by that Shareholder; and

 

  (b) Secondly, after full payment of the Series B Liquidation Preference, the remaining assets of the Company will be distributed rateably amongst the Shares including the Series B Preferred Shares on an as converted basis.

 

5.2 For the avoidance of doubt, and without prejudice to paragraph 5.1 of this Schedule 4, if the Proceeds following a Liquidation Event are paid to the Shareholders or the Company in instalments or the payment of the Proceeds or a portion of the Proceeds is otherwise deferred, a holder of an Ordinary Share is not entitled to any distribution or payment until each Series B

Shareholder has received the Series B Liquidation Preference for each Series B Preferred Share held by that Shareholder immediately prior to the Liquidation Event.

 

6. Series B Shareholders’ entitlement

A Series B Shareholder is entitled to receive a dividend or the Series B Liquidation Preference if that Shareholder is recorded in the share register on the day determined for payment by the Board (and not otherwise).

 

7. Conversion Ratio

The number of Shares into which each Series B Preferred Share may be converted will be determined by dividing the Series B Conversion Amount by the Conversion Price (Conversion Ratio). The Conversion Ratio will be adjusted each time an adjustment is made to the Conversion Price as provided in paragraph 10 below.

 

8. Conversion

 

  (a) The Series B Shareholders may at any time in their discretion convert all or part of their Series B Preferred Shares into Ordinary Shares by written notice to the Company specifying the number of Series B Preferred Shares to be converted and tendering the relevant certificate.

 

  (b) Within 5 Business Days of receiving a notice under paragraph 8(a), the Company must:

 

  (i) convert the Series B Preferred Shares as requested at the Conversion Ratio applicable on the date the notice was given; and

 

  (ii) issue the Ordinary Shares to that holder and record that issue and holding in the Company’s share register.

 

  (c) The Directors may convert Series B Preferred Shares in accordance with this paragraph by any method authorised by law.

 

53


9. Automatic Conversion

The Series B Preferred Shares will be automatically converted into Ordinary Shares:

 

  (a) on completion of a Qualifying IPO or an IPO which is not a Qualifying IPO but which is approved by holders of not less than 50.1% of the Series B Preferred Shares;

 

  (b) on completion of the sale of all of the Share Capital where the Series B Shareholders would receive an amount not less than the Series B Liquidation Preference in respect of their holding of Series B Preferred Shares; or

 

  (c) if approved by Special Majority Approval of the Series B Shareholders.

 

10. Anti-dilution protection

 

  (a) If at any time after the issue of any Series B Preferred Shares the Company issues Equity Securities (except under an ESOP in accordance with clause 12 of this agreement) at an issue price per Equity Security less than the then current Conversion Price of those Series B Preferred Shares immediately prior to the new issue, then the Conversion Price of those Series B Preferred Shares must be adjusted to be equal to the NCP as calculated in the formula below. The Conversion Ratio of those relevant Series B Preferred Shares will also be re-calculated on the basis that the Conversion Price is the NCP.

 

   NCP = CP x       A +   B      
         CP      
         A + C      

Where

 

  NCP New Conversion Price

 

  CP Conversion Price in effect immediately prior to issuance of securities causing the dilutive adjustment.

 

  A Number of Ordinary Shares deemed to be outstanding immediately prior to new issuance of securities causing the dilutive adjustment (includes all outstanding Ordinary Shares, all outstanding preference shares on an as converted basis; but does not include any convertible securities converting into this round of financing or any outstanding options on an as exercised basis).

 

  B Aggregate consideration received by the Company for the Equity Securities causing the dilutive adjustment.

 

  C Number of Equity Securities to be issued (on an as converted basis) causing the dilutive adjustment.

 

  (b) The adjustment in paragraph 10(a) above shall not apply:

 

  (i) where Equity Securities are issued on conversion of SIRPS or Series B Preferred Shares to Ordinary Shares;

 

  (ii) on the exercise of Warrants;

 

  (iii) on a Restructure or Reorganisation Event; or

 

  (iv) on any additional Equity Securities issued as a result of a Conversion Price adjustment under paragraph 10(a).

 

54


  (c) For avoidance of doubt the parties agree that:

 

  (i) the Conversion Ratio is not subject to adjustment if the Company issues Equity Securities at an issue price, conversion or exercise price for an amount equal to or higher than the Series B Preferred Shares Conversion Price per Share; and

 

  (ii) the above formula is to be applied to each Series B Shareholder’s holding of Series B Preferred Shares on an individual basis and separately in respect of each parcel of Series B Preferred Shares held by that individual which have a different Conversion Price.

 

  (d) The adjustment in paragraph 10(a) above shall not reduce the Conversion Price lower than the par value (if any) of the Ordinary Shares.

 

11. Split or reconstruction

If the capital of the Company is subject to a Reorganisation Event which is not adjusted for pursuant to paragraph 10(a), then the Board must make adjustments to the Conversion Ratio, Conversion Price and/or the number of Series B Preferred Shares on issue (both increasing or decreasing) which in the opinion of the Board are reasonably necessary to give full effect to the Reorganisation Event while maintaining parity between the holders of the Series B Preferred Shares and other shareholders in the Company and such adjustments will constitute an amendment to these terms.

 

12. Registration rights

If the Company undertakes a Qualifying IPO or other IPO in the United States, each Series B Shareholder shall have the right to enter into an agreement with the Company granting the Series B Shareholder the registration rights described below.

 

Registrable Securities:   

All ordinary shares of the Company held from time to time by any Investor (including, without limitation, all ordinary shares acquired or to be acquired upon the exchange or conversion of such Investor’s Series B Shares) are referred to in this Schedule as “Registrable Securities.”

 

Long-Form Registration

Rights:

  

Beginning 180 days after the Company’s initial public offering, holders of Registrable Securities (“Electing Holders”) may require the Company to file a registration statement on Form S-1 (or any successor long-form registration statement) for the sale by the Electing Holders of Registrable Securities (each, a “Long-Form Registration”); provided, however, that to exercise Long-Form Registration rights hereunder, the Registrable Securities beneficially owned by the Electing Holders must represent at least 10% of the outstanding ordinary shares of the Company.

 

If the Electing Holders so instruct the Company, the sale of Registrable Securities pursuant to a Long-Form Registration will be conducted as a firm commitment underwritten offering, by one or more underwriters to be selected by the Company with the consent of the Electing Holders.

 

Holders of Registrable Securities that were not Electing Holders will be notified of any exercise of Long-Form Registration rights hereunder and will have pro rata rights to include their Registrable Securities in the registration statement and, if applicable, the underwritten offering.

 

The Electing Holders shall have the right to require two Long-Form Registrations.

 

 

55


  

Subject to customary blackouts and, as applicable, underwriter cutbacks. The Company will not be obligated to effect more than one Long-Form Registration in any six (6) month period.

 

Shelf Registration:   

The Company will use its commercially reasonable efforts to qualify to register securities on Form S-3 (or any successor short-form registration statement) within a reasonable period of time after a form S-3 is eligible to be registered. From and after the time that the Company is so qualified, the holders of Registrable Securities (“Shelf Electing Holders”) may require the Company to have declared effective the registration of their Registrable Securities on such short-form registration statement for the sale of Registrable Securities (each, a “Shelf Registration”); provided, however, that to exercise Shelf Registration rights hereunder, the Registrable Securities beneficially owned by the Shelf Electing Holders must represent at least 5% of the outstanding ordinary shares of the Company.

 

Holders of Registrable Securities that were not Shelf Electing Holders will be notified of any exercise of Shelf Registration rights hereunder and will have pro rata rights to have their Registrable Securities registered for resale in the registration statement relating thereto.

 

The Electing Holders shall have the right (a) to require an unlimited number of Shelf Registrations and (b) to request any Shelf Registration to be conducted as a firm commitment underwritten offering, by one or more underwriters to be selected by the Company with the consent of the Electing Holders.

 

Subject to customary blackouts and, as applicable, underwriter cutbacks.

 

Piggyback Registration:   

The Electing Holders shall be entitled to customary “piggyback” registration rights on all registrations or listings of Company equity securities (whether such registrations or listings are for the benefit of the Company or another selling security holder), except for registrations relating solely to employee benefit plans or a Rule 145 (or its successor rule under the Securities Act) transaction.

 

Subject to customary underwriter cutbacks.

 

Listing:   

If and whenever the holders of Registrable Securities require registration pursuant to this Schedule, the Company will use its commercially reasonable efforts to cause such Registrable Securities to be listed on the Company’s primary national securities exchange (or, if the Company does not have such a primary exchange, on such national securities exchange as may be selected by the Company with the consent of the Electing Holders).

 

Inclusion of Other

Securities:

  

The Company will not include in any Long-Form Registration or Shelf Registration any securities which are not Registrable Securities (other than primary securities to be issued by the Company), without the prior written consent of the Electing Holders.

 

Expenses of Registration:   

All expenses of registration and/or listing contemplated hereby (excluding underwriting commissions and discounts) shall be borne by the Company. Selling holders of Registrable Securities shall be responsible for any applicable underwriting commissions and discounts.

 

 

56


  

The Company will pay for the fees of one counsel to the selling holders (to be selected by the Electing Holders).

 

Termination of Rights:   

All registration and/or listing rights hereunder shall terminate with respect to an Electing Holder when all of such Electing Holder’s Registrable Securities are freely saleable without restriction and without registration under applicable securities laws without any volume limitations (i.e. assuming filing of Form 144, all of such Electing Holder’s Registrable Securities would be available for sale in one transaction pursuant to Rule 144 promulgated under the Securities Act).

 

Indemnification:   

The Company and the holders of Registrable Securities shall have customary indemnification rights/obligations in connection with any such securities registration and/or listing.

 

Lock-Up Obligations in

Connection with

Underwritten Offerings:

  

In connection with any underwritten offering of Registrable Securities, to the extent requested by the underwriters for such offering, each participating Electing Holder will be obligated to agree to customary lock-up restrictions; provided, however, that (a) such lock-up may not exceed 180 calendar days with respect to an initial public offering or 90 calendar days with respect to any other offering, (b) each officer and director of the Company and each holder of more than 5% of the outstanding ordinary shares of the Company also agrees to such lock-up restrictions and (c) the Company also agrees to such lock-up restrictions in respect of primary offerings.

 

 

57


Schedule 9 – Shareholders

 

Shareholder name

Bushranger Funding, LLC
Akubra Investors, LLC
Ute Holdings, LLC
Adage Capital Partners LP
Foresite Capital Fund II
Boxer Capital, LLC
One Funds Management Limited as trustee for Asia Pacific Healthcare Fund II
Irrus Investments Nominee Limited
Gearing Family Pty Ltd as trustee for the Gearing Family Trust
David and Julie Gearing as trustees for the Gearing Family Superannuation Fund
Mark Andrew Heffernan & Patricia Louise Heffernan as trustees for the M&T Heffernan Family Trust
AustralianSuper Pty Ltd as trustee for AustralianSuper
Target Venture Nominees Limited
Aurum Nominees Limited
Cormac & Anne Kilty
Michael Kilty
Ruth-Anne Kilty
Hibbs Nominees Pty Ltd as trustee for the Hibbs Superannuation Fund
Robert Patrick Gearing
Andrew John Hubert Gearing as trustee for the Gearing Family Trust
Kevin Johnson
Michael Burke
Tsutomu Mori as trustee for the Mori Family Trust
Left Wheel Design Pty Ltd as trustee for the Alp Retirement Fund

 

58


Shareholder name

Simon Coghlan as trustee for the Simon J Coghlan No. 2 Family Trust
Dr Paul Wood and Mrs Veronica Wood as trustees for the Wood Family Superannuation Fund
Dr Paul Wood and Mrs Veronica Wood as trustees for the P & V Wood Family Trust
Labyrinth (VIC) Pty Ltd
Cthulhu Ventures LLC
Bertie Weitkamp and Gillian Emond as trustees for Aussie Superannuation Fund
Fortus Funds Investments Pty Ltd
Peter Howard
Lopi Investments Pty Ltd as trustee for Argie Bargie Superannation Fund
Joakim Rodin
Monash Investment Holdings Pty Ltd
Khatabundah Pty Ltd as trustee for The Gibson Family Trust
Andrew O’Brien
Balalaika Pty Ltd as trustee for Elanden Family Trust no. 1
Elsing Pty Ltd
Elena Virtue
Thomas Petrakos
Graham Frank Mitchell
Paul Tontodonati
John Cox
Geraldine Therese Farrell

 

59


Signing page

EXECUTED as a DEED.

Given under the Common Seal of

Nexvet Biopharma Limited

which was affixed hereto and

this Deed was delivered:

 

/s/ Cormac G. Kilty

   

/s/ Colin Sainsbury

Signature of director     Signature of company secretary

CORMAC G. KILTY

   

COLIN SAINSBURY

Name of director (print)    

Name of company secretary (print)

For and on behalf of ByrneWallace Corporate Secretaries Limited

Date: 29 August 2014

Signed and Delivered as a Deed by each of:

 

Bushranger Funding, LLC

Akubra Investors, LLC

Ute Holdings, LLC

By:   Farallon Capital Management, L.L.C., their Manager
By:  

/s/ Rajiv Patel

  Name: Rajiv Patel
  Title: Managing Member

Date: 27 August 2014

 

 

Shareholders agreement | page 60


Signed and Delivered as a Deed by Adage Capital Partners, LP by:    
Adage Capital Partners, GP, LLC, its General Partner    

/s/ Dan Lehan

    Signature of General Partner
   

Dan Lehan

    Name of General Partner (print)
Adage Capital Advisors, LLC, its Managing Member    
   

/s/ Dan Lehan

    Signature of Managing Member
   

Dan Lehan

    Name of Managing Member (print)
Date: 25 August 2014    
Signed and Delivered as a Deed by Foresite Capital Fund II, LP by:    

Dennis D. Ryan, CFO of Foresite Capital

Management II, LLC, General Partner of

Foresite Capital Fund II, LP

   

/s/ Dennis D. Ryan

    Signature of Dennis D. Ryan
   
Date: 19 August 2014    
Signed and Delivered as a Deed by Boxer Capital LLC by:    
   

/s/ Aaron Davis

    Signature of Aaron Davis
   

Managing Director

    Title of Aaron Davis
Date:     28 August 2014    

 

 

Shareholders agreement | page 61


Executed by One Funds Management Ltd ACN 117 797 403 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for Asia Pacific Healthcare Fund II    

/s/ Justin Kurt Epstein

   

/s/ Frank John Tearle

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

JUSTIN KURT EPSTEIN

   

FRANK JOHN TEARLE

Name (please print)     Name (please print)
Date: 2 SEPTEMBER 2014    

Signed and Delivered as a Deed by the directors

of Irrus Investments Nominee Limited (Company Number: 496708) in the presence of:

   

/s/ Michael Ryan

   

/s/ Aidan O’Driscoll

Signature of director     Signature of director

MICHAEL RYAN

   

AIDAN O’DRISCOLL

Name of director (print)     Name of director
Date: 19th August 2014    

 

 

Shareholders agreement | page 62


Executed by Gearing Family Pty Ltd ACN 140 067 812 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Gearing Family Trust:    

/s/ David Gearing

   

/s/ Julie Gearing

Signature of director     Signature of director/company secretary
    * delete whichever is not applicable

DAVID GEARING

   

JULIE GEARING

Name of director (print)     Name of director/company secretary (print)
Date: 19 August 2014    
Signed and Delivered as a Deed by David Gearing as trustee for the Gearing Family Superannuation Fund in the presence of:    

/s/ Peter Gearing

   

/s/ David Gearing

Signature of witness     Signature of David Gearing

PETER GEARING

   
Name of witness (print)    
Date: 19 August 2014    

 

 

Shareholders agreement | page 63


Signed and Delivered as a Deed by Julie Gearing as trustee for the Gearing Family Superannuation Fund in the presence of:    

/s/ Peter Gearing

   

/s/ Julie Gearing

Signature of witness     Signature of Julie Gearing

PETER GEARING

   
Name of witness (print)    
Date: 19 August 2014    
Signed and Delivered as a Deed by Mark Andrew Heffernan as trustee for the M&T Heffernan Family Trust in the presence of:    

/s/ Graham Mckenzie

   

/s/ Mark Andrew Heffernan

Signature of witness     Signature of Mark Andrew Heffernan

Graham Mckenzie

   
Name of witness (print)    
Date: 23 August 2014    

 

 

Shareholders agreement | page 64


Signed and Delivered as a Deed by Patricia Louise Heffernan as trustee for the M&T Heffernan Family Trust in the presence of:    

/s/ Graham Mckenzie

   

/s/ Patricia Louise Heffernan

Signature of witness     Signature of Patricia Louise Heffernan

Graham Mckenzie

   
Name of witness (print)    
Date: 23 August 2014    
Signed on behalf of BCP2 Pty Ltd as attorney and manager of Australian Super Pty Ltd as trustee for AustralianSuper:    

/s/ Stephen Thompson

   

/s/ Chris Nave

Signature     Signature

Stephen Thompson

   

Chris Nave

Name (print)     Name (print)
Date: 31 August 2014    
Signed and Delivered as a Deed by the directors for and on behalf of Target Ventures Nominees Limited (Company Number: 460883) in the presence of:    

/s/ Neil Keenan

   

/s/ Peter Wiley

Signature of director     Signature of director/company secretary
    * delete whichever is not applicable

NEIL KEENAN

   

PETER WILEY

Name of director (print)     Name of director/company secretary (print)
Date: 29 August 2014    

 

 

Shareholders agreement | page 65


Signed and Delivered as a Deed by the directors for and on behalf of Aurum Nominees Limited (Company Number: 123762) in the presence of:    

/s/ Paul Cullinane

   

/s/ Darren Murray

Signature of authorised signatory     Signature of authorised signatory

PAUL CULLINANE

   

DARREN MURRAY

Name of signatory (print)     Name of signatory (print)
Date: 28 August 2014    
Signed and Delivered as a Deed by Cormac Kilty in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Farrell

Signature of witness     Signature of Geraldine Farrell, Donor for & on behalf of Cormac Kilty pursuant to a power of attorney dated 19 August 2014

ELENA VIRTUE

   
Name of witness (print)    
Date: 22 August 2014    

 

 

Shareholders agreement | page 66


Signed and Delivered as a Deed by Anne Kilty in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Farrell

Signature of witness     Signature of Geraldine Farrell, Donor for and on behalf of Anne Kilty pursuant to a power of attorney dated 19 August 2014

Elena Virtue

   
Name of witness (print)    
Date: 22 August 2014    
Signed and Delivered as a Deed by Michael Kilty in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Farrell

Signature of witness     Signature of Geraldine Farrell, Donor for and on behalf of Michael Kilty pursuant to a power of attorney dated 19 August 2014

Elena Virtue

   
Name of witness (print)    
Date: 22 August 2014    

 

 

Shareholders agreement | page 67


Signed and Delivered as a Deed by Ruth-Anne Kilty in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Farrell

Signature of witness    

Signature of Geraldine Farrell, Donor for and on behalf of Ruth-Anne Kilty pursuant to a power of attorney dated

19 August 2014

Elena Virtue

   
Name of witness (print)    
Date: 22 August 2014    
Executed by Hibbs Nominees Pty Ltd ACN 093 883 535 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Hibbs Superannuation Fund:    
   

/s/ Michael Hibbs

    Signature of sole director
   

MICHAEL HIBBS

    Name of director (print)
Date: 28 August 2014    

 

 

Shareholders agreement | page 68


Signed and Delivered as a Deed by Robert Patrick Gearing in the presence of:    

/s/ Heather G.Shilling

   

/s/ Robert Patrick Gearing

Signature of witness     Signature of Robert Patrick Gearing

Heather G.Shilling

   
Name of witness (print)    
Date: 21 August 2014    
Signed and Delivered as a Deed by Andrew John Hubert Gearing as trustee for the Gearing Family Trust in the presence of:    

/s/ Elena Virtue

   

/s/ Andrew John Hubert Gearing

Signature of witness     Signature of Andrew John Hubert Gearing

Elena Virtue

   
Name of witness (print)    
Date: 20 August 2014    

 

 

Shareholders agreement | page 69


Signed and Delivered as a Deed by Kevin Johnson in the presence of:    

/s/ H. Denton

   

/s/ Kevin Johnson

Signature of witness     Signature of Kevin Johnson

Mrs. H. Denton

   
Name of witness (print)    
Date: 19 August 2014    
Signed and Delivered as a Deed by Michael Burke in the presence of:    

/s/ Lorraine Walsh

   

/s/ Michael Burke

Signature of witness     Signature of Michael Burke

LORRAINE WALSH

   
Name of witness (print)    
Date: 27 August 2014    

 

 

Shareholders agreement | page 70


Signed and Delivered as a Deed by Tsutomu Mori as trustee for the Tsutomu Mori Family Trust in the presence of:    

/s/ Geraldine Farrell

   

/s/ Tsutomu Mori

Signature of witness     Signature of Tsutomu Mori

Geraldine Farrell

   
Name of witness (print)    
Date: 20 August 2014    
Executed by Left Wheel Design Pty Ltd ACN 006 119 302 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Alp Retirement Fund:    

/s/ Aileen Alp

   

/s/ Christopher Alp

Signature of director    

Signature of director/company secretary

* delete whichever is not applicable

Aileen Alp

   

CHRISTOPHER ALP

Name of director (print)     Name of director/company secretary (print)
Date: 26 August 2014    

 

 

Shareholders agreement | page 71


Signed and Delivered as a Deed by Simon Coghlan as trustee for the Simon J Coghlan No 2 Family Trust in the presence of:    

/s/ Gorgi Coghlan

   

/s/ Simon Coghlan

Signature of witness     Signature of Simon Coghlan

Gorgi Coghlan

   
Name of witness (print)    
Date: 23 August 2014    
Signed and Delivered as a Deed by Paul Wood as trustee for the Wood Family Superannuation Fund in the presence of:    

/s/ Geraldine Farrell

   

/s/ Paul Wood

Signature of witness     Signature of Paul Wood

Geraldine Farrell

   
Name of witness (print)    
Date: 27 August 2014    

 

 

Shareholders agreement | page 72


Signed and Delivered as a Deed by Veronica Wood as trustee for the Wood Family Superannuation Fund in the presence of:    

/s/ Geraldine Farrell

   

/s/ Veronica Wood

Signature of witness     Signature of Veronica Wood

Geraldine Farrell

   
Name of witness (print)    
Date: 27 August 2014    
Signed and Delivered as a Deed by Paul Wood as trustee for the P & V Wood Family Trust in the presence of:    
   

/s/ Paul Wood

/s/ Geraldine Farrell

    Signature of Paul Wood
Signature of witness    

Geraldine Farrell

   
Name of witness (print)    
Date: 27 August 2014    

 

 

Shareholders agreement | page 73


Signed and Delivered as a Deed by Veronica Wood as trustee for the P & V Wood Family Trust in the presence of:    
   

/s/ Veronica Wood

/s/ Geraldine Farrell

    Signature of Veronica Wood
Signature of witness    

Geraldine Farrell

   
Name of witness (print)    
Date: 27 August 2014    
Executed by Labyrinth (VIC) Pty Ltd ACN 109 759 604 in accordance with section 127 of the Australian Corporations Act 2001 (Cth):    
   

/s/ Stuart Newland

    Signature of sole director
   

STUART NEWLAND

    Name of director (print)
Date: 24th August 2014    
Signed and Delivered as a Deed by Chulthu Ventures LLC:    
   

/s/ James Babcock

    Signature of director
   

JAMES BABCOCK

    Name of director or company secretary
Date: 20 August 2014    

 

 

Shareholders agreement | page 74


Signed and Delivered as a Deed by Bertie Weitkamp as trustee for Aussie Superannuation Fund in the presence of:    

/s/ Sue Asteyno

   

/s/ Bertie Weitkamp

Signature of witness     Signature of Bertie Weitkamp

Sue Asteyno

   
Name of witness (print)    
Date: 25 August 2014    
Signed and Delivered as a Deed by Gillian Emond as trustee for Aussie Superannuation Fund in the presence of:    

/s/ Sue Asteyno

   

/s/ Gillian Emond

Signature of witness     Signature of Gillian Emond

Sue Asteyno

   
Name of witness (print)    
Date: 25 August 2014    

 

 

Shareholders agreement | page 75


Executed by Fortus Funds Investments Pty    

Ltd ACN 146 211 912 in accordance with

section 127 of the Australian Corporations Act

   
2001 (Cth):    
   

/s/ Peter T Howard

    Signature of sole director
   

PETER T HOWARD

    Name of director (print)
Date: 21 August 2014    
Signed and Delivered as a Deed by Peter    
Howard in the presence of:    

/s/ Victoria Howard

   

/s/ Peter Howard

Signature of witness     Signature of Peter Howard

VICTORIA HOWARD

   
Name of witness (print)    
Date: 21 August 2014    

 

 

Shareholders agreement | page 76


Executed by Lopi Investments Pty Ltd ACN 146 010 120 in accordance with section 127 of the Corporations Act 2001 (Cth) as trustee for the Argie Bargie Superannuation Fund:    
   

/s/ Angel F. Lopez

    Signature of sole director
   

ANGEL F. LOPEZ

    Name of director (print)
Date: 20 August 2014    
Signed and Delivered as a Deed by Joakim Rodin in the presence of:    

/s/ Elena Virtue

   

/s/ Joakim Rodin

Signature of witness     Signature of Joakim Rodin

Elena Virtue

   
Name of witness (print)    
Date: 26 August 2014    

 

 

Shareholders agreement | page 77


Executed as a deed by Monash Investment Holdings Pty Ltd ACN 099 844 818 by an authorised officer in the presence of:    
   

/s/ David M. Pitt

    Signature of officer

/s/ Joan Hutchings

   

DAVID M. PITT

Signature of witness     Name of officer (print)

JOAN HUTCHINGS

   

DIRECTOR

Name of witness (print)     Office held
Date: 26th August 2014    
Executed by Khatabundah Pty Ltd ACN 131 919 054 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for The Gibson Family Trust    

/s/ Jayne Gibson

   

/s/ Matthew Gibson

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

Jayne Gibson

   

Matthew Gibson

Name of director     Name of director or company secretary
Date: 23 August 2014    

 

 

Shareholders agreement | page 78


Signed and Delivered as a Deed by Andrew O’Brien in the presence of:    

/s/ Michael J. O’Brien

   

/s/ Andrew O’Brien

Signature of witness     Signature of Andrew O’Brien

MICHAEL J. O’BRIEN

   
Name of witness (print)    
Date: 26 August 2014    
Executed by Balalaika Pty Ltd ACN 106 083 925 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for Elanden Family Trust no. 1    

/s/ L. Mandie

   

/s/ N. Mandie

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

L. MANDIE

   

N. MANDIE

Name of director     Name of director or company secretary
Date: 22 August 2014    

 

 

Shareholders agreement | page 79


Executed by Elsing Pty Ltd ACN 095 146 731 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth):    

/s/ Christopher N. Brown

   

/s/ Jocelyn F Brown

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

CHRISTOPHER N. BROWN

   

JOCELYN F BROWN

Name of director     Name of director or company secretary
Date: 25 August 2014    
Signed and Delivered as a Deed by Elena Virtue in the presence of:    

/s/ Regan Engelhardt

   

/s/ Elena Virtue

Signature of witness     Signature of Elena Virtue

Regan Engelhardt

   
Name of witness (print)    
Date: 20 August 2014    

 

 

Shareholders agreement | page 80


Signed and Delivered as a Deed by Thomas Petrakos in the presence of:    

/s/ Geraldine Farrell

   

/s/ Thomas Petrakos

Signature of witness     Signature of Thomas Petrakos

Geraldine Farrell

   
Name of witness (print)    
Date: 26th August 2014    
Signed and Delivered as a Deed by Graham Frank Mitchell in the presence of:    

/s/ Elena Virtue

   

/s/ Graham Frank Mitchell

Signature of witness     Signature of Graham Frank Mitchell

Elena Virtue

   
Name of witness (print)    
Date: 25 August 2014    

 

 

Shareholders agreement | page 81


Signed and Delivered as a Deed by Paul Tontodonati in the presence of:    

/s/ Thomas Petrakos

   

/s/ Paul Tontodonati

Signature of witness     Signature of Paul Tontodonati

THOMAS PETRAKOS

   
Name of witness (print)    
Date: 26th August 2014    
Signed and Delivered as a Deed by John Cox in the presence of:    

/s/ Elena Virtue

   

/s/ John Cox

Signature of witness     Signature of John Cox

Elena Virtue

   
Name of witness (print)    
Date: 20th August 2014    

 

 

Shareholders agreement | page 82


Signed and Delivered as a Deed by Geraldine Therese Farrell in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Therese Farrell

Signature of witness     Signature of Geraldine Therese Farrell

Elena Virtue

   
Name of witness (print)    
Date: 1 September 2014    

 

 

Shareholders agreement | page 83


Deed of Variation

Shareholders Agreement

Nexvet Biopharma public limited company (Company)

The parties set out in Schedule 1 (Existing Shareholders)


Deed of Variation

 

Details        3   
Agreed terms      4   
1.   Defined terms & interpretation      4   
2.   Operation      5   
3.   Variations to the Shareholders Agreement      5   
4.   Miscellaneous      5   
Schedule 1 – Existing Shareholders      8   
Schedule 2 – Amendments to Shareholders Agreement      10   
Signing page      12   


Details

 

Date

   14 November 2014
Parties   
Name    Nexvet Biopharma public limited company (company number 547923) (Company)
Notice details    88 Harcourt Street, Dublin 2, Ireland
Name    The parties set out in Part 1 of Schedule 1 (Existing Shareholders)
Notice details    As set out in Schedule 1

Background

 

A The Company and the Existing Shareholders are parties to the Shareholders Agreement.

 

B The parties wish to amend the Shareholders Agreement in accordance with this deed.

 

3


Agreed terms

 

1. Defined terms & interpretation

 

1.1 Capitalised words

Capitalised words used but not defined in this deed shall have the meaning given to them in the Shareholders Agreement.

 

1.2 Defined terms

The following words and expressions shall have the following meanings where used in this deed, unless the context otherwise requires:

Shareholders Agreement means the shareholders agreement between the Company and the Existing Shareholders dated 4 September 2014.

Variation Approval means the written approval of Shareholders holding at least 75% of:

 

  (a) the Ordinary Shares on issue; and

 

  (b) the Preference Shares on issue.

Variation Date means the date Variation Approval is obtained, being the date that the last Shareholder required to give effect to Variation Approval executes this deed.

 

1.3 Interpretation

In this deed, except where the context otherwise requires:

 

  (a) the singular includes the plural and vice versa, and a gender includes other genders;

 

  (b) another grammatical form of a defined word or expression has a corresponding meaning;

 

  (c) a reference to a clause, paragraph, schedule or annexure is to a clause or paragraph of, or schedule or annexure to, this deed, and a reference to this deed includes any schedule or annexure;

 

  (d) a reference to a document or instrument includes the document or instrument as novated, altered, supplemented or replaced from time to time;

 

  (e) a reference to US$, $US, dollar or $ is to currency of the United States;

 

  (f) a reference to time is to Dublin, Ireland time;

 

  (g) a reference to a party is to a party to this deed, and a reference to a party to a document includes the party’s executors, administrators, successors and permitted assigns and substitutes;

 

  (h) a reference to a person includes a natural person, partnership, body corporate, association, governmental or local authority or agency or other entity;

 

  (i) a reference to a statute, ordinance, code or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of them;

 

  (j) a word or expression defined in the Companies Acts 1963 to 2013 (as amended) has the meaning given to it in Companies Acts 1963 to 2013 (as amended);

 

4


  (k) the meaning of general words is not limited by specific examples introduced by including, for example or similar expressions;

 

  (l) a rule of construction does not apply to the disadvantage of a party because the party was responsible for the preparation of this deed or any part of it; and

 

  (m) if a day on or by which an obligation must be performed or an event must occur is not a Business Day, the obligation must be performed or the event must occur on or by the next Business Day.

 

1.4 Headings

Headings are for ease of reference only and do not affect interpretation.

 

2. Operation

 

2.1 Acknowledgement

The parties acknowledge that under clause 29.1 of the Shareholders Agreement, the Shareholders Agreement may be varied with approval of Shareholders holding at least 75% of:

 

  (a) the Ordinary Shares on issue; and

 

  (b) the Preference Shares on issue;

 

2.2 Effectiveness

Subject to Variation Approval being obtained to vary the Shareholders Agreement in accordance with this deed, the parties agree that the variations to the Shareholders Agreement set out in clause 3 shall have effect on and from the Variation Date.

 

2.3 Consent

The parties agree that entry into this deed by a Shareholder constitutes written consent of that Shareholder for the Variation Approval and all approvals noted in clause 2.1.

 

3. Variations to the Shareholders Agreement

The parties agree to vary the Shareholders Agreement as set out in Schedule 2.

 

4. Miscellaneous

 

4.1 Governing law and jurisdiction

This deed will be governed by the law of Ireland. The parties submit to the non-exclusive jurisdiction of its courts and courts of appeal from them. The parties will not object to the exercise of jurisdiction of those courts on any basis.

 

4.2 Costs

Except as otherwise set out in this deed, each party must pay its own costs and expenses in relation to preparing, negotiating, executing and completing this deed and any document related to this deed.

 

4.3 Execution of separate documents

This deed is properly executed if each party executes either this document or an identical document. In the latter case, this deed takes effect when the separately executed documents are exchanged between the parties.

 

5


4.4 Variation

No variation of this deed will be of any force or effect unless it is in writing and signed by each party to this deed.

 

4.5 Waivers

 

  (a) A waiver of any right, power or remedy under this deed must be in writing signed by the party granting it. A waiver is only effective in relation to the particular obligation or breach in respect of which it is given. It is not to be taken as an implied waiver of any other obligation or breach or as an implied waiver of that obligation or breach in relation to any other occasion.

 

  (b) The fact that a party fails to do, or delays in doing, something the party is entitled to do under this deed does not amount to a waiver.

 

5. Limitation of liability of fund trustee

 

5.1 In respect of any party who has entered into this deed as a trustee, custodian, subcustodian or nominee (Fund Trustee) of a fund (Fund), the party is bound by this deed only in its capacity as Fund Trustee and in no other capacity, unless otherwise specifically stated in this deed.

 

5.2 Subject to clause 5.5, the rights of other parties and the Fund under or in respect of this deed (whether express or implied by applicable law or otherwise) are not exercisable against the relevant Fund Trustee other than in its capacity as Fund Trustee.

 

5.3 Subject to clause 5.5, but despite any other provision of this deed, the Fund Trustee is not liable to pay or satisfy, and the Fund nor any party is entitled to enforce against the Fund Trustee, any damages suffered by or amounts owing to the party or the Fund, which result from a breach or non-performance of an obligation, representation or warranty (whether express, implied by law or otherwise) of the Fund Trustee under or in respect of this deed (including in relation to any conduct, omission or transaction in relation to this deed) except to the extent the Fund Trustee is entitled to be indemnified (whether from the Fund for which the Fund Trustee holds its units or shares, by way of insurance or otherwise) and is actually indemnified in its capacity as Fund Trustee in respect of that obligation, representation or warranty and those damages and amounts are recoverable by the Fund Trustee under that indemnity.

 

5.4 Subject to clause 5.5, if a party does not recover all damages suffered and amounts owing to it as a result of a breach or non-performance of any obligation of the Fund Trustee under or in respect of this deed (whether express or implied by applicable law or otherwise), the party may not seek to recover the shortfall by applying to have the Fund Trustee wound up.

 

5.5 The limitations in clauses 5.2 to 5.4:

 

  (a) do not apply to the extent that those damages or amounts owing are not able to be satisfied because the entitlement of the Fund Trustee to be indemnified in its capacity as Fund Trustee is reduced as a result of:

 

  (i) any negligence, wilful default, fraud or dishonesty or other act or omission by the Fund Trustee or any other trustee, responsible entity, custodian, subcustodian or nominee of the Fund; or

 

  (ii) any waiver, relinquishment or surrender by the Fund Trustee or any other trustee, responsible entity, custodian, subcustodian or nominee of the Fund, of any right of indemnity under the terms of appointment of the Fund Trustee relating to the Fund in respect of those damages or amounts; and

 

  (b) do not limit the rights of the Fund Trustee under this deed unless expressly specified otherwise.

 

6


5.6 No attorney, agent, receiver or receiver and manager appointed in accordance with this deed has authority to act on behalf of the Fund Trustee in a way which exposes the Fund Trustee to any personal liability, and no act or omission of any such person will be considered negligence, wilful default, fraud or dishonesty of the Fund Trustee for the purpose of clause 5.5(a).

 

7


Schedule 1 – Existing Shareholders

 

Shareholder name

Bushranger Funding, LLC

Akubra Investors, LLC

Ute Holdings, LLC

Adage Capital Partners LP

Foresite Capital Fund II

Boxer Capital, LLC

One Funds Management Limited as trustee for Asia Pacific Healthcare Fund II

Irrus Investments Nominee Limited

Gearing Family Pty Ltd as trustee for the Gearing Family Trust

DJGearing Pty Ltd as trustee for the Gearing Family Superannuation Fund

Mark Andrew Heffernan & Patricia Louise Heffernan as trustees for the M&T Heffernan Family Trust

Mark Andrew Heffernan

AustralianSuper Pty Ltd as trustee for AustralianSuper

Target Venture Nominees Limited

Aurum Nominees Limited

Cormac & Anne Kilty

Michael Kilty

Ruth-Anne Kilty

Hibbs Nominees Pty Ltd as trustee for the Hibbs Superannuation Fund

Robert Patrick Gearing

Andrew John Hubert Gearing as trustee for the Gearing Family Trust

Kevin Johnson

Michael Burke

Tsutomu Mori as trustee for the Mori Family Trust

Left Wheel Design Pty Ltd as trustee for the Alp Retirement Fund

Simon Coghlan as trustee for the Simon J Coghlan No. 2 Family Trust

Dr Paul Wood and Mrs Veronica Wood as trustees for the Wood Family Superannuation Fund

 

8


Shareholder name

Dr Paul Wood and Mrs Veronica Wood as trustees for the P & V Wood Family Trust

Labyrinth (VIC) Pty Ltd

Cthulhu Ventures LLC

Bertie Weitkamp and Gillian Emond as trustees for Aussie Superannuation Fund

Fortus Funds Investments Pty Ltd

Peter Howard

Lopi Investments Pty Ltd as trustee for Argie Bargie Superannation Fund

Joakim Rodin

Monash Investment Holdings Pty Ltd

Khatabundah Pty Ltd as trustee for The Gibson Family Trust

Andrew O’Brien

Balalaika Pty Ltd as trustee for Elanden Family Trust no. 1

Elsing Pty Ltd

Elena Virtue

Thomas Petrakos

Graham Frank Mitchell

Paul Tontodonati

John Cox

Geraldine Therese Farrell

Blueprint Life Science Group LLC

 

9


Schedule 2 – Amendments to Shareholders Agreement

 

1. The ‘Background’ is amended by deleting Paragraph B and redenominating Paragraph C as Paragraph B.

 

2. In clause 1.1, the definition of ‘Warrants’ is amended by:

 

  (a) deleting the number ‘1,968,764’;

 

  (b) deleting the number ‘240,000’.

 

3. Clause 12.2 is amended by inserting the words ‘(or such number determined by the Board to reflect the effect of any Reorganisation Event)’ after the number ‘300,000’.

 

4. Clause 14.11 is amended by inserting the words ‘(or such amount determined by the Board to reflect the effect of any Reorganisation Event)’ after the words ‘$6.00 per share’.

 

5. Schedule 1 is amended by deleting it in its entirety and replacing it with the following:

‘Schedule 1 – NOT USED’

 

6. Paragraph 1.1 of Schedule 2 is amended by deleting the first two paragraphs and paragraph 1.1(a) and replacing them with:

 

  ‘1.1 Subject to Special Majority Approval of the Directors to the contrary, the maximum number of Directors (excluding alternate Directors) at any one time is 9.

In preparation for a Qualifying IPO, the parties agree that they should take reasonable steps to change the composition of the Board so that the Board’s composition is more aligned with that expected of a company undertaking a Qualifying IPO. This may include the identification of suitable recommended candidates by the Board to replace existing Directors nominated in accordance with the below. Further, to the extent necessary, this paragraph 1.1 must be amended to accommodate such changes.

 

  (a) In the meantime, the Board must include :

 

  (i) an independent chairman;

 

  (ii) an independent non-executive director (only after a new independent chairman is appointed after 25 October 2014);

 

  (iii) subject to paragraph 1.2 and 1.6, up to two Directors appointed by holders of SIRPS (SIRPS Director);

 

  (iv) subject to paragraph 1.3 and 1.6, up to two Directors appointed by the ordinary shareholders (Founder Directors);

 

  (v) subject to paragraph 1.7, up to one Director appointed by Series B Shareholders (Series B Director);

 

  (vi) if required by paragraph 1.8, a Farallon Director; and

 

  (vii) a chief executive officer approved by the Board.’

The remaining subparagraphs (b), (c), (d) and (e) of paragraph 1.1 remain unamended.

 

10


7. Item 7 of Part 3 of Schedule 3 is amended by inserting the following words at the end of the sentence:

‘or a Shareholder solely in respect of a matter affecting Equity Securities which they hold’.

 

11


Signing page

 

EXECUTED AND DELIVERED AS A DEED by the parties on the date set out at the top of page 1.

Given under the Common Seal of

Nexvet Biopharma Public Limited Company

which was affixed hereto and

this Deed was delivered:

 

/s/ Mark Heffernan

   

/s/ Damian Lismore

Signature of director     Signature of company secretary

Mark Heffernan

   

Damian Lismore

Name of director (print)     Name of company secretary (print)

Date: 14 November 2014

Signed and Delivered as a Deed by each of:

Bushranger Funding, LLC

Akubra Investors, LLC

Ute Holdings, LLC

 

By:   Farallon Capital Management, L.L.C., their Manager

 

By:  

/s/ Rajiv A. Patel

  Name: Rajiv A. Patel
  Title: Managing Member
Date:   12 November 2014

 

 

Deed of Variation | page 12


Signed and Delivered as a Deed by Adage Capital Partners, LP by:    
   

/s/ Dan Lehan

Adage Capital Partners, GP, LLC, its General Partner     Signature of General Partner
   

Dan Lehan

    Name of General Partner (print)

Adage Capital Advisors, LLC, its Managing Member

 

   

/s/ Dan Lehan

    Signature of Managing Member
   

Dan Lehan

    Name of Managing Member (print)

Date: Oct. 30 2014

 

Signed and Delivered as a Deed by Foresite Capital Fund II, LP by:    
   

/s/ Dennis D. Ryan

Dennis D. Ryan, CFO of Foresite Capital Management II, LLC, General Partner of Foresite Capital Fund II, LP     Signature of Dennis D. Ryan

Date: 10-30 2014

 

Signed and Delivered as a Deed by Boxer Capital LLC by:    
   

/s/ Aaron Davis

    Signature of Aaron Davis
   

Managing Director

    Title of Aaron Davis

Date: 11/12/2014

 

 

Deed of Variation | page 13


Executed by One Funds Management Ltd

ACN 117 797 403 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for Asia Pacific Healthcare Fund II

   

/s/ Justin Kurt Epstein

   

/s/ Frank Tearle

Signature of director

    Signature of director or company secretary*
*delete whichever does not apply

Justin Kurt Epstein

   

Frank John Tearle

Name (please print)     Name (please print)

Date: 14 November 2014

 

Signed and Delivered as a Deed by the directors

of Irrus Investments Nominee Limited (Company Number: 496708) in the presence of:

   

/s/ Michael Ryan

   

/s/ Aidan O’Driscoll

Signature of director    

Signature of director

Michael Ryan

   

Aidan O’Driscoll

Name of director (print)     Name of director/company secretary (print)

Date: November 6 2014

 

 

Deed of Variation | page 14


Executed by Gearing Family Pty Ltd ACN 140 067 812 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Gearing Family Trust:      

/s/ David Gearing

     

/s/ Julie Gearing

Signature of director      

Signature of director

David Gearing

     

Julie Gearing

Name of director (print)       Name of director (print)

Date: 13 November 2014

 

Executed by DJGearing Pty Ltd ACN 167 147 533 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Gearing Family Superannuation Fund:      

/s/ David Gearing

     

/s/ Julie Gearing

Signature of director      

Signature of director

David Gearing

     

Julie Gearing

Name of director (print)       Name of director (print)

Date: 13 November 2014

 

 

Deed of Variation | page 15


Signed and Delivered as a Deed by Mark Andrew Heffernan as trustee for the M&T Heffernan Family Trust in the presence of:    

/s/ D. Agnew

   

/s/ Mark Heffernan

Signature of witness     Signature of Mark Andrew Heffernan

Denise Agnew

   
Name of witness (print)    

Date: 12 November 2014

 

Signed and Delivered as a Deed by Patricia Louise Heffernan as trustee for the M&T Heffernan Family Trust in the presence of:    

/s/ D. Agnew

   

/s/ Patricia Heffernan

Signature of witness     Signature of Patricia Louise Heffernan

Denise Agnew

   
Name of witness (print)    

Date: 12 November 2014

 

 

Deed of Variation | page 16


Signed and Delivered as a Deed by Mark Andrew Heffernan in the presence of:    

/s/ D. Agnew

   

/s/ Mark Heffernan

Signature of witness     Signature of Mark Andrew Heffernan

Denise Agnew

   
Name of witness (print)    

Date: 12 November 2014

 

Signed on behalf of BCP2 Pty Ltd as attorney and manager of AustralianSuper Pty Ltd as trustee for AustralianSuper:    

/s/ Chris Nave

   

/s/ Stephen Thompson

Signature     Signature

Chris Nave

   

H. Stephen Thompson

Name (print)     Name (print)

Date: 14th November 2014

 

 

Deed of Variation | page 17


Signed and Delivered as a Deed by the directors for and on behalf of Target Ventures Nominees Limited (Company Number: 460883) in the presence of:    

/s/ Peter Wiley

   

/s/ Neil Keenan

Signature of director    

Signature of director

Peter Wiley

   

Neil Keenan

Name of director (print)     Name of director

Date: 12 Nov. 2014

 

Signed and Delivered as a Deed by the directors for and on behalf of Aurum Nominees Limited (Company Number: 123762) in the presence of:    

/s/ Darren Murray

   

/s/ James Sheeran

Signature of authorised signatory     Signature of authorised signatory

Darren Murray

   

James Sheeran

Name of signatory (print)     Name of signatory (print)

Date: 12 November 2014

 

 

Deed of Variation | page 18


Signed and Delivered as a Deed by Cormac Kilty in the presence of:    

/s/ Anne Kilty

   

/s/ Cormac Kilty

Signature of witness     Signature of Cormac Kilty

Anne Kilty

   
Name of witness (print)    

Date: 2/11/2014

 

Signed and Delivered as a Deed by Anne Kilty in the presence of:    

/s/ Cormac Kilty

   

/s/ Anne Kilty

Signature of witness     Signature of Anne Kilty

Cormac Kilty

   
Name of witness (print)    

Date: 2nd Nov. 2014

 

 

Deed of Variation | page 19


Signed and Delivered as a Deed by Michael Kilty in the presence of:    

/s/ Cormac Kilty

   

/s/ Michael Kilty

Signature of witness     Signature of Michael Kilty

Cormac Kilty

   
Name of witness (print)    

Date: 2nd November 2014

 

Signed and Delivered as a Deed by Ruth-Anne Kilty in the presence of:    

/s/ Michael Kilty

   

/s/ Ruth-Anne Kilty

Signature of witness     Signature of Ruth-Anne Kilty

Michael Kilty

   
Name of witness (print)    

Date: 2nd November 2014

 

 

Deed of Variation | page 20


Executed by Hibbs Nominees Pty Ltd ACN 093 883 535 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Hibbs Superannuation Fund:    
   

/s/ Michael Hibbs

    Signature of sole director
   

Michael Hibbs

    Name of director (print)

Date: 10/11/2014

 

Signed and Delivered as a Deed by Robert Patrick Gearing in the presence of:    

/s/ Heather G. Schilling

   

/s/ Robert Patrick Gearing

Signature of witness     Signature of Robert Patrick Gearing

Heather G. Schilling

   
Name of witness (print)    

Date: Nov. 2 2014

 

 

Deed of Variation | page 21


Signed and Delivered as a Deed by Andrew John Hubert Gearing as trustee for the Gearing Family Trust in the presence of:    

/s/ Elena Virtue

   

/s/ Andrew John Hubert Gearing

Signature of witness     Signature of Andrew John Hubert Gearing

Elena Virtue

   
Name of witness (print)    

Date: 6 Nov. 2014

 

Signed and Delivered as a Deed by Kevin Johnson in the presence of:    

/s/ Nicola Mallard

   

/s/ Kevin Johnson

Signature of witness     Signature of Kevin Johnson

/s/ Nicola Mallard

   
Name of witness (print)    

Date: 1 Nov. 2014

 

 

Deed of Variation | page 22


Signed and Delivered as a Deed by Michael Burke in the presence of:    

/s/ Lorraine Walsh

   

/s/ Michael Burke

Signature of witness     Signature of Michael Burke

Lorainne Walsh

   
Name of witness (print)    

Date: 10/11/2014

 

Signed and Delivered as a Deed by Tsutomu Mori as trustee for the Mori Family Trust in the presence of:    

/s/ Elena Virtue

   

/s/ Tsutomu Mori

Signature of witness     Signature of Tsutomu Mori

Elena Virtue

   
Name of witness (print)    

Date: 31 Oct. 2014

 

 

Deed of Variation | page 23


Executed by Left Wheel Design Pty Ltd ACN 006 119 302 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Alp Retirement Fund:    
   

/s/ Christopher Alp

   

Signature of director/company secretary

* delete whichever is not applicable

   

Christopher Alp

    Name of director/company secretary (print)

Date: 11/11/2014

 

Signed and Delivered as a Deed by Simon Coghlan as trustee for the Simon J Coghlan No 2 Family Trust in the presence of:    

/s/ Gorgi Coughlan

   

/s/ Simon Coghlan

Signature of witness     Signature of Simon Coghlan

Gorgi Coughlan

   
Name of witness (print)    

Date: 3rd November 2014

 

 

Deed of Variation | page 24


Signed and Delivered as a Deed by Paul Wood as trustee for the Wood Family Superannuation Fund in the presence of:    

/s/ Geraldine Farrell

   

/s/ Paul Wood

Signature of witness     Signature of Paul Wood

Geraldine Farrell

   
Name of witness (print)    

Date: 11/11/2014

 

Signed and Delivered as a Deed by Veronica Wood as trustee for the Wood Family Superannuation Fund in the presence of:    

/s/ Geraldine Farrell

   

/s/ Veronica Wood

Signature of witness     Signature of Veronica Wood

Geraldine Farrell

   
Name of witness (print)    

Date: 11/11/2014

 

 

Deed of Variation | page 25


Signed and Delivered as a Deed by Paul Wood as trustee for the P & V Wood Family Trust in the presence of:    

/s/ Geraldine Farrell

   

/s/ Paul Wood

Signature of witness     Signature of Paul Wood

Geraldine Farrell

   
Name of witness (print)    

Date: 11/11/2014

 

Signed and Delivered as a Deed by Veronica Wood as trustee for the P & V Wood Family Trust in the presence of:    

/s/ Geraldine Farrell

   

/s/ Veronica Wood

Signature of witness     Signature of Veronica Wood

Geraldine Farrell

   
Name of witness (print)    

Date: 11/11/2014

 

 

Deed of Variation | page 26


Executed by Labyrinth (VIC) Pty Ltd ACN 109 759 604 in accordance with section 127 of the Australian Corporations Act 2001 (Cth):    
   

/s/ Stuart Newland

    Signature of sole director
   

Stuart Newland

    Name of director (print)

Date: 3rd November 2014

 

Signed and Delivered as a Deed by Chulthu Ventures LLC:    
   

/s/ James Babcock

    Signature of director
   

James Babcock

    Name of director or company secretary

Date: Nov. 4th 2014

 

Signed and Delivered as a Deed by Bertie Weitkamp as trustee for Aussie Superannuation Fund in the presence of:    

/s/ Roger Langley

   

/s/ Bertie Weitkamp

Signature of witness     Signature of Bertie Weitkamp

Roger Langley

   
Name of witness (print)    

Date: 11/11/2014

 

 

Deed of Variation | page 27


Signed and Delivered as a Deed by Gillian Emond as trustee for Aussie Superannuation Fund in the presence of:    

/s/ Roger Langley

   

/s/ Gillian Emond

Signature of witness     Signature of Gillian Emond

Roger Langley

   
Name of witness (print)    

Date: 11/11/2014

 

Executed by Fortus Funds Investments Pty Ltd ACN 146 211 912 in accordance with section 127 of the Australian Corporations Act 2001 (Cth):    
   

/s/ Peter T. Howard

    Signature of sole director
   

Peter T. Howard

    Name of director (print)

Date: 14 November 2014

 

 

Deed of Variation | page 28


Signed and Delivered as a Deed by Peter Howard in the presence of:    

/s/ Geraldine Farrell

   

/s/ Peter Howard

Signature of witness     Signature of Peter Howard

Geraldine Farrell

   
Name of witness (print)    

Date: 14 November 2014

 

Executed by Lopi Investments Pty Ltd ACN 146 010 120 in accordance with section 127 of the Australian Corporations Act 2001 (Cth) as trustee for the Argie Bargie Superannuation Fund:    
   

/s/ Angel F. Lopez

    Signature of sole director
   

Angel F. Lopez

    Name of director (print)

Date: November 10th, 2014

 

 

Deed of Variation | page 29


Signed and Delivered as a Deed by Joakim Rodin in the presence of:    

/s/ Elena Virtue

   

/s/ Joakim Rodin

Signature of witness     Signature of Joakim Rodin

Elena Virtue

   
Name of witness (print)    

Date: 12/11/2014

 

Executed as a deed by Monash Investment Holdings Pty Ltd ACN 099 844 818 by an authorised officer in the presence of:    

/s/ Rhonda May Hinds

    Signature of officer

/s/ Michael Fenaughty

   

Rhonda May Hinds

Signature of witness     Name of officer (print)

Michael Fenaughty

   

Company Secretary

Name of witness (print)     Office held

Date: 14 November 2014

 

 

Deed of Variation | page 30


Executed by Khatabundah Pty Ltd ACN 131 919 054 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for The Gibson Family Trust    

/s/ Jayne Gibson

   

/s/ Matthew Gibson

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

Jayne Gibson

   

Matthew Gibson

Name of director     Name of director or company secretary

Date: 10/11/2014

 

Signed and Delivered as a Deed by Andrew O’Brien in the presence of:    

/s/ Cathryn McArthur

   

/s/ Andrew O’Brien

Signature of witness     Signature of Andrew O’Brien

Cathryn McArthur

   
Name of witness (print)    

Date: 4 November 2014

 

 

Deed of Variation | page 31


Executed by Balalaika Pty Ltd ACN 106 083 925 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth) as trustee for Elanden Family Trust no. 1    

/s/ M. Mandie

   

/s/ L. Mandie

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

M. Mandie

   

L. Mandie

Name of director     Name of director or company secretary

Date: 2/11/2014

 

Executed by Elsing Pty Ltd ACN 095 146 731 in accordance with section 127(1) of the Australian Corporations Act 2001 (Cth):    

/s/ Christopher N. Brown

   

/s/ Jocelyn Frances Brown

Signature of director     Signature of director or company secretary*
    *delete whichever does not apply

Christopher N. Brown

   

Jocelyn Frances Brown

Name of director     Name of director or company secretary

Date: 10 Nov. 2014

 

 

Deed of Variation | page 32


Signed and Delivered as a Deed by Elena Virtue in the presence of:    

/s/ D. Agnew

   

/s/ Elena Virtue

Signature of witness     Signature of Elena Virtue

Denise Agnew

   
Name of witness (print)    

Date: 31 October 2014

 

Signed and Delivered as a Deed by Thomas Petrakos in the presence of:    

/s/ Paul Tontodonati

   

/s/ Thomas Petrakos

Signature of witness     Signature of Thomas Petrakos

Paul Tontodonati

   
Name of witness (print)    

Date: 12/11/2014

 

 

Deed of Variation | page 33


Signed and Delivered as a Deed by Graham Frank Mitchell in the presence of:    

/s/ Lorraine Ryan

   

/s/ Graham Frank Mitchell

Signature of witness     Signature of Graham Frank Mitchell

Lorraine Ryan

   
Name of witness (print)    

Date: 11/11/2014

 

Signed and Delivered as a Deed by Paul Tontodonati in the presence of:    

/s/ Thomas Petrakos

   

/s/ Paul Tontodonati

Signature of witness     Signature of Paul Tontodonati

Thomas Petrakos

   
Name of witness (print)    

Date: 12/11/2014

 

 

Deed of Variation | page 34


Signed and Delivered as a Deed by John Cox in the presence of:    

/s/ Elena Virtue

   

/s/ John Cox

Signature of witness     Signature of John Cox

Elena Virtue

   
Name of witness (print)    

Date: 5 Nov. 2014

 

Signed and Delivered as a Deed by Geraldine Therese Farrell in the presence of:    

/s/ Elena Virtue

   

/s/ Geraldine Therese Farrell

Signature of witness     Signature of Geraldine Therese Farrell

Elena Virtue

   
Name of witness (print)    

Date: 14 November 2014

 

 

Deed of Variation | page 35


Signed and Delivered as a Deed by Blueprint Life Science Group, LLC by:    
   

/s/ Hershel Berry

    Signature of Hershel Berry
   

Managing Director

    Title of Hershel Berry

Date: November 7, 2014

 

 

Deed of Variation | page 36

EX-4.3 5 d775834dex43.htm EX-4.3 EX-4.3

Exhibit 4.3

NEXVET BIOPHARMA LIMITED (Company)

(Company No. 547923)

Warrant terms of issue

 

1. DEFINITIONS

Terms not defined in the warrant have the same meaning as given in the Shareholders Agreement relating to the Company (Shareholders Agreement).

 

2. ENTITLEMENT

 

2.1 Each warrant entitles the holder to subscribe for 1 fully paid Ordinary Share in the capital of the Company, subject to adjustment under these terms.

 

2.2 The holder has no right to, or interest in, a share unless and until it is issued to the holder on exercise of the warrant.

 

3. ISSUE PRICE

No amount is payable on issue of the warrant.

 

4. EXERCISE PRICE

 

  (a) The exercise price of each warrant is USD8.625, subject to adjustment under these terms (Exercise Price). Notwithstanding any clause of these terms, the Exercise Price shall not be adjusted such that it is less than the par value (if any) of the ordinary shares of the Company. If an adjustment would result in the Exercise Price becoming less than the par value of the ordinary shares of the Company, the Exercise Price shall equal the par value.

 

  (b) Notwithstanding any other provision in these terms, if (i) the Ordinary Shares of the Company are listed on a Stock Exchange and (ii) the fair market value of 1 fully paid Ordinary Share in the capital of the Company (Exercise Share) is greater than the Exercise Price (at the date of calculation set out below), in lieu of exercising the warrant by payment of cash, the holder may elect to receive shares equal to the value (as determined below) of the warrant (or the portion of it being cancelled) by surrender of the warrant at the principal office of the Company together with a written exercise notice (in the form attached at schedule 1) in which event the Company must issue to the holder a number of Exercise Shares computed using the following formula:

X = Y (A-B) / A

Where:

X = the number of Exercise Shares to be issued to the holder

Y = the number of Exercise Shares purchasable under the warrant or, if only a portion of the warrant is being exercised, that portion of the warrant is being exercised, that portion of the warrant being cancelled (at the date of such calculation)

 

1


A = the fair market value of one Exercise Share (at the date of such calculation)

B = Exercise Price (as adjusted to the date of such calculation).

For purposes of the above calculation, the fair market value of one Exercise Share will be the product of (i) the average of the closing bid and asked prices of the Company’s Ordinary Shares quoted in the “Over-The-Counter Market Summary” or the last reported sale price of the Company’s Ordinary Shares or the closing price quoted on the NASDAQ Global Market or on such other Stock Exchange on which the Ordinary Shares are listed, whichever is applicable, as published in the Western Edition of The Wall Street Journal for the five trading days prior to the determination of the fair market value and (ii) the number of shares into which each Exercise Share is convertible at the time of such exercise. Notwithstanding the foregoing, in the event that the warrant is exercised under this clause 4(b) in connection with the Company’s initial public offering of its Ordinary Shares on the NASDAQ Global Market, the fair market value per share of each Exercise Share will be the product of (i) the per share offering price to the public of the Company’s initial public offering and (ii) the number of Ordinary Shares into which each such Exercise Share is convertible at the time of such exercise.

In the event that the initial public offering occurs on any exchange other than the NASDAQ Global Market, the Company and the holder will negotiate in good faith equivalent provisions in light of the applicable rules of the relevant exchange.

If the holder elects to use the process set out in this clause 4(b), the holder must pay to the Company an amount equal to the par value (if any) of the Exercise Shares to be issued to the holder and the Company is not obliged to issue the Exercise Shares to the holder until the holder has paid this amount.

 

  (c) Prior to the IPO of the Company, if at any time after the issue of the warrant the Company issues Equity Securities (except under an ESOP in accordance with clause 12 of the Shareholders Agreement) at an issue price per Equity Security less than the then current Exercise Price of those warrants immediately prior to the new issue, then the Exercise Price of those warrants must be adjusted to be equal to the NCP as calculated in the formula below.

 

   NCP = CP x       A +   B      
         CP      
         A + C      

Where:

NCP = New Exercise Price

CP = Exercise Price in effect immediately prior to issuance of securities causing the dilutive adjustment.

A = Number of Ordinary Shares deemed to be outstanding immediately prior to new issuance of securities causing the dilutive adjustment (includes all outstanding Ordinary Shares, all outstanding preference shares on an as converted basis; but does not include any convertible securities converting into this round of financing or any outstanding options on an as exercised basis).

B = Aggregate consideration received by the Company for the Equity Securities causing the dilutive adjustment.

 

2


C = Number of Equity Securities to be issued (on an as converted basis) causing the dilutive adjustment.

The adjustment in this clause 4(c) shall not apply:

 

  (a) where Equity Securities are issued on conversion of SIRPS or Series B Preferred Shares to Ordinary Shares;

 

  (b) on the exercise of Warrants; or

 

  (c) on a Restructure or Reorganisation Event.

 

5. EXERCISE PERIOD

The exercise period for a warrant (Exercise Period) commences on the date of issue of the warrant (Issue Date) and expires at 5.00pm Dublin time on the Expiry Date (as set out in the warrant certificate).

A warrant not exercised before the expiry of the Exercise Period automatically expires.

A warrant may be exercised at any time during the Exercise Period.

 

6. CERTIFICATE

The Company must give each holder a certificate stating:

 

  (a) the number of warrants issued to the holder;

 

  (b) the Exercise Price;

 

  (c) the Issue Date; and

 

  (d) the Expiry Date.

 

7. TRANSFERABILITY

 

  (a) Prior to a Qualifying IPO, each warrant (and any interest in it) may not be transferred, except:

 

  (i) as part of the sale of the whole of the issued capital of the Company;

 

  (ii) to any Fund managed by the Investment Manager of the holder; or

 

  (iii) to a Related Body Corporate or Affiliate.

 

  (b) If a Qualifying IPO does not occur by April 15, 2015, in addition to clause 7(a) above, each warrant (and any interest in it) may be transferred as part of any transaction relating to the whole of the issued capital of the Company which includes at least:

 

  (i) USD2,000,000 of the original issue price for the Series B Preferred Shares; or

 

  (ii) 100,000 warrants.

Solely for purposes of clause 7(b), the original issue price of a Series B Preferred Share is deemed to be USD6.00 per share (and is determined without regard to any deemed issue price for the warrants issued in connection with the Series B Shares).

 

3


  (c) After a Qualifying IPO, each warrant may be freely transferred and will be recognised by the Company.

 

  (d) Any unauthorised transfer will not be recognised by the Company.

 

8. DRAG ALONG

If a sale of the whole of the issued capital of the Company to a third party (Offeror) is approved by holders of not less than 75% of the Series B Preferred Shares on issue, then the holder must either:

 

  (a) transfer their warrants to the Offeror as part of the sale for a net price equal to the offer price less the Exercise Price; or

 

  (b) exercise their warrants and transfer their Ordinary Shares to the Offeror as part of the sale.

 

9. PARTICIPATION RIGHTS, BONUS ISSUES, RIGHTS ISSUES AND REORGANISATIONS

 

9.1 Participation

A holder is not entitled to participate in any new issue to existing shareholders of securities in the Company unless they have exercised their warrants before the record date for determining entitlements to the new issue of securities and participate as a result of holding shares.

 

9.2 Notice of new issue

The Company must give a holder 5 business days’ notice of:

 

  (a) the proposed terms of the issue or offer proposed under clause 9.1; and

 

  (b) the right to exercise their warrants under clause 9.1.

 

9.3 Bonus issues

If the Company makes a bonus issue of shares or other securities to shareholders (except an issue in lieu of dividends or by way of dividend reinvestment) and no share has been issued in respect of the warrant before the record date for determining entitlements to the issue, then the number of underlying shares over which the warrant is exercisable is increased by the number of shares which the holder would have received if the holder had exercised the warrant before the record date for determining entitlements to the issue.

 

9.4 Reorganisation

If there is a reorganisation (including consolidation, sub-division, reduction or return) of the share capital of the Company, then the rights of the holder (including the number of warrants to which each holder is entitled to on exercise and the Exercise Price) is changed to the extent necessary to comply with the listing rules of ASX, NASDAQ or any other applicable Stock Exchange or the Companies Acts applying to a reorganisation of capital at the time of the reorganisation irrespective of whether or not the ASX Listing Rules apply to the Company.

 

4


9.5 Calculations and adjustments

Any calculations or adjustments which are required to be made under this clause 9 will be made by the Board and will, in the absence of bad faith, manifest error or a question of law, be final and conclusive and binding on the Company and the holder.

 

9.6 Notice of change

The Company must within two weeks give to the holder notice of any change under this clause 9 to the Exercise Price or the number of shares which the holder is entitled to subscribe for on exercise of a warrant.

 

9.7 Restructure of the Group

 

  (a) If at any time the warrants remain outstanding, the Board approves a restructure of the Company group such that the Company is no longer the holding company in the group, then the Board may, by notice in writing, require that the holder exchange their warrants for similar securities in a new holding company of the Company group.

 

  (b) If the Board delivers a notice under paragraph (a), each holder must, in a timely manner, do all things reasonably requested by the Board, including signing all documents, delivering all documents (including warrant certificates), voting all securities, accepting such new securities, forfeiting all rights and releasing all persons, to effect the restructure of the Company group.

 

9.8 IPO

If:

 

  (a) the Board approves an IPO of the Company; and

 

  (b) not less than 200,000 warrants remain outstanding at that time

then the Board must to the extent reasonably practicable to do so and subject to the advice of the relevant underwriters and other financial advisers to the Company and the relevant rules of the applicable stock exchange ensure the warrants will be listed as part of the undertaking of that IPO.

 

9.9 No breach

Notwithstanding anything in this clause 9, the Company shall not be required to take any action which would be in breach of any applicable law, regulation or applicable listing rules.

 

9.10 Amendment

If the Company undertakes any corporate action under this clause 9 which results in an adjustment to the Exercise Price or the number of shares over which the warrant is exercisable, then these Terms will be amended accordingly to allow for consequential amendments which in the opinion of the Board are reasonably necessary to give full effect to the corporate action while maintaining parity between the holders of the warrants and other shareholders in the Company.

 

5


10. METHOD OF EXERCISE OF WARRANTS

 

10.1 Method and payment

To exercise warrants, the holder must give the Board:

 

  (a) a written exercise notice (in the form attached at schedule 1) specifying the number of warrants being exercised;

 

  (b) payment of the Exercise Price for the warrants the subject of the exercise notice by way of bank cheque or by other means of payment approved by the Company;

 

  (c) an executed deed of accession to the shareholders agreement (if not already a party), unless the Board agrees otherwise; and

 

  (d) the certificate for the warrants.

 

10.2 Exercise all or some warrants

 

  (a) A holder may only exercise warrants in multiples of 100 unless the holder exercises all warrants held by the holder.

 

  (b) Warrants will be deemed to have been exercised on the date the exercise notice is lodged with the Board.

 

  (c) An exercise notice is irrevocable, unless the Board agrees otherwise.

 

10.3 Certificates

If a holder exercises less than the total number of warrants registered in the holder’s name:

 

  (a) the holder must surrender their warrant certificate; and

 

  (b) the Company must cancel the warrant certificate and issue the holder a new warrant certificate or holding statement stating the remaining number of warrants held by the holder.

 

10.4 Issue of shares

Subject to clause 10.5, within 10 business days after the holder delivers everything required by clause 10.1, the Company must issue the holder the number of fully paid Ordinary Shares in the capital of the Company specified in the application.

Any fraction of an ordinary share which arises on exercise will not be issued and the number of Ordinary Shares will be rounded down to the nearest whole number.

 

10.5 Refusal to exercise

The Company may refuse to accept an exercise of a warrant if to do so would:

 

  (a) contravene the Company’s Memorandum and Articles of Association (the M&A), the Companies Acts 1963 to 2013 or any other applicable law or listing rules; or

 

  (b) cause the Company to have to produce any offering document or make filings with any regulatory authority in order to comply with any applicable, where the Board believes that to do so would place an unreasonable burden on the Company.

 

6


11. RANKING OF SHARES ISSUED

Subject to the M&A, all shares issued on the exercise of warrants rank in all respects (including rights relating to dividends) pari passu with the existing Ordinary Shares of the Company at the date of issue of those shares. The holder agrees to be bound by the M&A and accept the shares issued on exercise of warrants on this basis.

 

12. GOVERNING LAW

These terms and the rights and obligations of holders are governed by the laws of Ireland. Each participant irrevocably and unconditionally submits to the non-exclusive jurisdiction of the courts of Ireland.

 

7


Schedule 1 - Exercise Notice

NEXVET BIOPHARMA LIMITED

Exercise Notice – Warrants

 

To: The Company Secretary

Nexvet Biopharma Limited

I/we wish to exercise                          warrants issued on [date] as follows:

         (i) with an initial exercise price of USD8.625 per warrant (as may be adjusted pursuant to the terms of the warrants) and attach a cheque for / have deposited with the Company (delete whichever is not applicable) funds for the exercise of the warrants; or

         (ii) pursuant to the terms of the net exercise provisions set forth in clause 4(b) of the warrants and attach a cheque for / have deposited with the Company (delete whichever is not applicable) funds for the par value of the Exercise Shares to be issued.

I/we attach the warrant certificate in respect of these warrants.

 

Dated:    

 

Signed:    

 

Name:    

 

Title:    

 

8

EX-10.1 6 d775834dex101.htm EX-10.1 EX-10.1

Exhibit 10.1

AGREEMENT

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD


CONFIDENTIAL

 

THIS AGREEMENT is made the 21st day of December 2012

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD of 9 Meaden Street, Southbank 3006, Victoria, Australia, (“Customer”).

WHEREAS:

 

A. Customer is the proprietor of the antibody known as NV-01; and

 

B. Lonza and its Affiliates has the expertise in the evaluation and production of monoclonal antibodies for therapeutic use; and

 

C. Customer wishes to contract Lonza for Services relating to the antibody as described in this Agreement; and

 

D. Lonza is prepared to perform such Services for Customer on the terms and conditions set out herein.

NOW IT IS AGREED AS FOLLOWS:

 

1. Definitions and Interpretation

The following terms shall have the following meanings unless the context requires otherwise:

 

“Affiliate”

means any Company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant party to this Agreement. “Control” means the ownership of more than fifty per cent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the party in question;

 

“Agreement”

means this agreement incorporating the Schedules as amended or varied from time to time by written agreement of the parties;

 

“Batch”

means the total Product obtained from one fermentation and associated purification using the Process and carried out in accordance with cGMP;

 

“Cell Line”

means the cell line, particulars of which are set out in Schedule 1;

 

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CONFIDENTIAL

 

 

“cGMP”

means current good manufacturing practices and general biologics products standards as promulgated under the European Commission Directives 2001/83/EC, as amended, and Directive 2003/94/EC; the U.S. Federal Food, Drug and Cosmetic Act found in Title 21 of the U.S. Code of Federal Regulations (CFR), including but not limited to Parts 210, 211 and Parts 11, 301 et seq., 600 to 610, the European Commission Guidelines of Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 2003/94/EC (Eudralex – Volume 4);

 

“cGMP Product”

means Product which is required under Schedule 2 to be manufactured in accordance with cGMP;

 

“Customer Information”

means:

 

  (i) all technical and other information;

 

  (ii) information that comprise modifications to the Process that make the Process suitable or more effective and/or efficient (including improvements in yield and purity) for the expression, purification and production of canine and other non-human mammalian antibodies)

 

  to the extent that (i) and (ii) are not known to Lonza or in the public domain from time to time and are supplied by Customer to Lonza and includes the Customer Patent Rights, Customer Materials and ideas and information;

 

“Customer Materials”

means the Materials supplied by Customer to Lonza (if any) and identified as such by Schedule 1 hereto;

 

“Customer Patent Rights”

means all patents and patent applications of any kind throughout the world that claim the Product or the Cell Line or the Customer Materials or uses thereof in the life sciences or are otherwise owned by the Customer and are necessary or useful in performance of the Services excluding in all cases the Lonza Patent Rights;

 

“Deliver”, “Delivered” or “Delivery”

has the meaning given to it in Clause 4:

 

3


CONFIDENTIAL

 

 

“External Laboratories”

means any third party instructed by Lonza, with Customer’s consent, to conduct activities required to complete the Services, including but not limited to, third parties that synthesise DNA or perform tests on the Cell Line, Product or materials derived therefrom;

 

“GS”

means the glutamine synthetase expression system of which Lonza is the proprietor;

 

“GS Licence”

means a licence granted by Lonza in respect of the use of GS;

 

“Initial Phase”

shall have the meaning set out in clause 2.5;

 

“Lonza Know-How”

means all technical and other information relating directly or indirectly to the Process and/or the performance of the Services known to Lonza or its Affiliates from time to time other than confidential Customer Information and information in the public domain;

 

“Lonza Patent Rights”

means all patents and patent applications of any kind throughout the world relating to the Process which from time to time Lonza or one of its Affiliates is the owner of or is entitled to use;

 

“Pilot Batch”

means the small scale volume of the Product which is produced as a result of the operation of the Process (but not in accordance with cGMP);

 

“Price”

means the price specified in Schedule 3 for the Services;

 

“Process”

means Lonza’s process for the development and production of the Product from the Cell Line, including any improvements or modifications thereto from time to time, all of which excludes Customer Information;

 

“Product”

means all or any part of the product manufactured under this Agreement using the Process (including any sample thereof), particulars of which are set out in Schedule 1 and includes all derivatives thereof;

 

“Quality Agreement”

means the quality agreement entered into by the Parties after the Effective Date and which refers to this Agreement, substantially in the form and substance set out in Schedule 4;

 

4


CONFIDENTIAL

 

 

“Services”

means all or any part of the services the subject of this Agreement performed by Lonza (including, without limitation, cell culture evaluation, purification evaluation, master, working and extended cell bank creation, and sample and bulk production) particulars of which are set out in Schedule 2;

 

“Specification”

means the specification for the cGMP Product, particulars of which are set out in Schedule 1;

 

“Steering Committee”

shall have the meaning set out in Clause 14.2;

 

“Technical Project Team”

shall have the meaning set out in Clause 14.1;

 

“Terms of Payment”

means the terms of payment specified in Schedule 3;

 

“Territory”

means UK, EU, USA, Japan and Australia;

 

“Testing Summary”

shall have the meaning set out in Clause 2.4 and as modified in accordance with Clause 2.5.

References to the singular number include the plural and vice versa, references to Clauses and Schedules are references to clauses and schedules to this Agreement.

 

2. Provision of the Services

 

2.1 Lonza shall diligently carry out the Services as provided in Schedule 2 and shall use reasonable efforts to achieve the estimated timescales set out in that Schedule (“Time Schedule”).

 

2.2 For the purpose of ensuring as much as reasonably practical compliance with the Time Schedule, the parties shall actively monitor Lonza’s adherence to the Time Schedule through the Steering Committee and the parties’ respective technical program team. Each technical program team shall comprise at least one representative from each party, each of which shall be knowledgeable in the manner in which the Services are performed. The parties envisage that during each of the Cell Line and Purification stages, they will convene meetings (whether in person or by conference call) of the technical program team at least once every week, or as otherwise agreed between the parties. If at or in advance of any such meeting one party notifies the other of an expected, foreseeable or actual delay of the Time Schedule, the parties shall discuss and analyse such delay and shall together resolve how to best minimize such delay and how to avoid any such or similar delay being repeated.

 

2.3 Each of the stages of work shall, in accordance with and as set out in Schedule 2, include preparation of written documentation setting out the processes and procedures to be carried out in that stage of work. Completion of each stage shall occur in accordance with the terms of Schedule 2 and the details of the applicable stage or sub-stage.

 

5


CONFIDENTIAL

 

 

 

2.4 Lonza shall manufacture Pilot Batches in accordance with the project plan. It is understood and acknowledged that the first three (3) Pilot Batches will not meet cGMP or Specification or any specification, quantity or quality obligations and Lonza gives no warranty in this regard. Notwithstanding the foregoing in this Section 2.4 and subject always to the unpredictable nature of the biological processes involved, Lonza will perform the project plan in a professional manner, and in doing so, will adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically).

 

2.5 Following completion of the first three (3) Pilot Batches where there has been no material change in the process or procedure (for the avoidance of doubt this may be after any number of Pilot Batches for which the process or procedures have been changed) (the “Initial Phase”) the parties shall, based on the scientific data generated as part of such first three (3) Pilot Batches where there has been no material change in the process or procedure, agree in writing on the parameters (including permitted margins of error) and specifications of a testing summary (the “Testing Summary”). For the avoidance of doubt there shall be no obligation on Lonza to agree to anything which would require Lonza to perform services outside the capabilities of the Process and/or facilities as demonstrated by the scientific data generated from the Initial Phase. Any Pilot Batch made after the Initial Phase shall be tested and released against a certificate of testing which will relate to such Testing Summary. Customer shall pay to Lonza the applicable Price for all Pilot Batches conducted in the Initial Phase (including for the avoidance of doubt, those Pilot Batches before the first three Pilot Batches for which there was no material change in the process or procedure, as well as the first three Pilot Batches for which there was no material change in the process or procedure). Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such non compliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

 

2.6 If required by Customer, Lonza shall manufacture cGMP Product to meet the Specification provided that there shall be no such obligation to meet the Specification in respect of the first three (3) Batches of cGMP Product manufactured or in respect of the first cGMP Batch manufactured following any change in the Process agreed to or requested by Customer.

 

2.7 Owing to the unpredictable nature of the biological processes involved in the Services but subject to Clauses 2.1, 2.2 and 2.4, the timescales set down for the performance of the Services (including without limitation the dates for production and Delivery of Product) and the quantities of Product for Delivery set out in Schedule 2 are estimated only.

 

2.8 Subject to Lonza’s obligations under Clauses 2.1, 2.4, 2.5, 2.6, 2.9, 2.10 and 2.11, Customer shall not be entitled to cancel any unfulfilled part of the Services or to refuse to accept the Services on grounds of late performance, late delivery or failure to produce the estimated quantities of Product for Delivery. Lonza shall not be liable for any loss, damage, costs or expenses of any nature, whether direct or consequential, occasioned by:

 

     (a)    any delay in performance or Delivery howsoever caused; or

 

     (b)    any failure to produce the estimated quantities of Product for Delivery,

 

6


CONFIDENTIAL

 

 

     except that and notwithstanding anything to the contrary in this Agreement, Customer shall not be under any obligation to accept the Services or any Product generated from performance of the Services if such Product does not comply with the Testing Summary and also if such failure resulted from Lonza’s failure to: (i) follow the project plan procedures, or (ii) perform the project plan in a professional manner, or (iii) adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically), subject always to the unpredictable nature of the biological processes involved in the Services.

 

2.9 Lonza shall comply with the International Committee for Harmonisation regulatory requirements from time to time applicable to the Services as set out in Schedule 2.

 

2.10 Lonza hereby undertakes not to use the Cell Line, Customer Materials or Customer Information (or any part thereof) for any purpose other than the performance of the Services under this Agreement.

 

2.11 Lonza shall:

 

  (a) at all times use all reasonable endeavours to keep the Cell Line and/or Customer Materials secure and safe from loss and damage in such manner as Lonza stores its own material of similar nature;

 

  (b) not part with possession of the Cell Line and/or Customer Materials or the Product, save for the purpose of activities at the External Laboratories or as otherwise authorised in writing by Customer; and

 

  (c) obtain the consent of Customer before appointing an External Laboratory to perform any of the Services and procure that all External Laboratories are subject to obligations of confidence substantially in the form of those obligations of confidence imposed on Lonza under this Agreement.

 

2.12 Lonza shall provide Customer with consolidated the Batch records, and shall provide Customer with access to the complete Batch records at Lonza’s Slough Facility (at a time and date agreed between the Parties).

 

2.13 The Parties shall enter into the Quality Agreement as soon as reasonably possible after the Effective Date. Responsibility for quality assurance and quality control of Product shall be allocated between the Parties as set forth in the Quality Agreement.

 

2.14 Where the Cell Line uses GS, Customer acknowledges that it will require a GS Licence from Lonza prior to in vivo clinical studies or any other commercial use or sale of the Product.

 

3. Customer Obligations

 

3.1 Immediately following the date of the Agreement Customer shall supply to Lonza Customer Information, together with full details of any hazards relating to the Cell Line and/or Customer Materials, their storage and use. On review and approval by Lonza’s safety committee of this Customer Information, the Cell Line and/or Customer Materials shall be provided to Lonza at Lonza’s request. Property in the Cell Line and/or Customer Materials and/or Customer Information supplied to Lonza shall remain vested in Customer.

 

7


CONFIDENTIAL

 

 

 

3.2 Customer shall pay the Price set out in Schedule 3 for provision of the Services together with any additional costs and expenses that fall due under this Agreement in accordance with the Terms of Payment.

 

3.3 Customer hereby grants Lonza the non-exclusive right to use the Cell Line, Customer Materials, Customer Patent Rights and Customer Information for the purpose of this Agreement.

 

3.4 Customer shall obtain and maintain product liability insurance with a reputable and solvent insurance provider in the amount of at least US$10,000,000 per event or linked events. Customer shall supply Lonza with a copy of insurance policy on reasonable request and Customer shall not terminate or amend (other than amending to increase the level of cover) such policy without prior written notice to Lonza.

 

4. Delivery, Transportation of Product and Customer Tests

 

4.1 Product shall be Delivered EXW (ex-works) Lonza’s premises in Slough, UK (as defined by Incoterms 2000) which means (a) when Lonza places Product at the disposal of Customer at Lonza’s premises not cleared for export and not loaded onto any collecting vehicle and (b) risk and title to Product pass to Customer at such time (“Deliver,” “Delivery,” or “Delivered,” as appropriate). Subject to Clause 4.2, Lonza shall deliver to Customer the Certificate of Analysis not later than the date of Delivery. Transportation of Product, whether or not under any arrangements made by Lonza on behalf of Customer, shall be made at the sole risk and expense of Customer.

 

4.2 At Customer’s express written request, Lonza will Deliver Product to Customer prior to delivery of the Certificate of Analysis. In the absence of such a request, Lonza will Deliver Product to Customer with a Certificate of Analysis. Such request shall be accompanied by Customer’s written acknowledgement that the Product has been Delivered without the transmittal to Customer of a Certificate of Analysis, that accordingly the Product cannot be administered until transmittal of the Certificate of Analysis, and that Customer nevertheless accepts full risk of loss, title and ownership of the Product. The Delivery of Product in quarantine shall be subject to such testing requirements as Lonza may reasonably require, and the sixty (60) day period referred to in Clause 4.8 shall run from Delivery in quarantine of the Product to Customer.

 

4.3 Unless otherwise agreed by both parties in writing, Lonza shall package and label Product for Delivery in accordance with its standard operating procedures. It shall be the responsibility of Customer to inform Lonza in writing in advance of any special packaging and labelling requirements for Product. All additional costs and expenses of whatever nature incurred by Lonza in complying with such special requirements shall be charged to Customer in addition to the Price.

 

4.4 If requested in writing by Customer, Lonza will (acting as agent for Customer) arrange for insurance of Product whilst held by Lonza after Delivery (awaiting transportation) for a maximum of fourteen (14) days on terms equivalent to those under which Lonza insures product prior to Delivery. All additional costs and expenses of whatever nature incurred by Lonza in arranging such insurance shall be charged to Customer in addition to the Price.

 

8


CONFIDENTIAL

 

 

4.5 If requested in writing by Customer, Lonza will (acting as agent of Customer for such purpose) arrange the transportation of Product from Lonza’s premises to the destination indicated by Customer together with insurance cover for Product in transit at its invoiced value. All additional costs and expenses of whatever nature incurred by Lonza in arranging such transportation and insurance shall be charged to Customer in addition to the Price. Transportation of Product shall be at the sole risk of Customer who shall be deemed to have full knowledge of the carrier’s terms and conditions of carriage. The Customer shall, as appropriate, observe, perform and be subject to the carriage terms in relation to the transportation of the Product.

 

4.6 Where Lonza has made arrangements for the transportation of Product, Customer shall diligently examine the Product as soon as practicable after receipt. Notice of all claims (time being of the essence) arising out of:

 

  (a) visible damage to or total or partial loss of Product in transit shall be given in writing to Lonza and the carrier within three (3) working days of receipt by Customer; or

 

  (b) Delivery shall be given in writing to Lonza within ten (10) days after the date of Lonza’s despatch notice.

 

4.7 Customer shall make damaged Product and associated packaging materials available for inspection and shall comply with the requirements of any insurance policy covering the Product notified by Lonza to Customer. Lonza shall offer Customer all reasonable assistance (at the cost and expense of Customer) in pursuing any claims arising out of the transportation of Product.

 

4.8 Promptly following receipt of Product (whether from a Pilot Batch after the Initial Phase or cGMP Product) or any sample thereof, Customer may carry out any of the tests outlined or referred to in the Testing Summary set out in Schedule 1. Subject to Clause 2, if such tests show that the Product does not comply with the Testing Summary (in respect of product from a Pilot Batch after the Initial Phase) or the Specification (in respect of cGMP Product), Customer shall give Lonza written notice thereof within sixty (60) days from the date of Delivery and shall return such Product to Lonza’s premises for further testing. In the absence of such written notice Product shall be deemed to have been accepted by Customer as meeting the Testing Summary or Specification (as applicable). Subject to Clause 2.4, if Customer has reasonably demonstrated to Lonza that Product returned to Lonza fails to meet Testing Summary or Specification (as applicable) and that such failure is due to Lonza’s failure to: (i) follow the project plan procedures, or (ii) perform the project plan in a professional manner, or (iii) adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically), Lonza shall at Customer’s discretion refund that part of the Price that relates to the production of such Product or replace such Product at its own cost and expense. In the event Customer requires Lonza to replace such Product, Lonza shall use reasonable endeavours to do so with the minimum delay having regard to its commitments to third parties in the timing of such replacement. For the avoidance of doubt, if the reason that the Product fails to meet the Testing Summary or Specification (as applicable) is due to a scientific or technical or other reason beyond Lonza’s reasonable control, Lonza shall not have any obligations to replace or refund under this Clause 4.8.

 

9


CONFIDENTIAL

 

 

4.9 Upon Customer giving to Lonza written notice in accordance with Section 4.8, Customer shall thereby automatically become entitled to access and inspect (pursuant to the provisions of this Clause 4.9) Lonza’s laboratory notebooks and all other records relating to performance of the Services (“Records”). Lonza shall keep complete and accurate Records for a period of 7 years for Product, each considered separately and Customer shall have the right to have such records examined during that time. Upon two (2) weeks prior written notice from Customer, Lonza shall permit a person appointed by Customer as Customer’s authorized representative to have access to Lonza’s Slough site during normal business hours to examine the Records, provided that at all times during such inspection a Lonza employee accompanies the person appointed by Customer. Customer shall bear the full cost of such inspection.

 

4.10 Subject to Clause 2, if there is any dispute concerning whether Product returned to Lonza fails to meet the Testing Summary of Specification (as applicable) or whether such failure is due (in whole or in part) to acts or omissions of Customer or any third party after Delivery, such dispute shall be referred for decision to an independent expert (acting as an expert and not as an arbitrator) to be appointed by agreement between Lonza and Customer or, in the absence of agreement by the President for the time being of the Association of the British Pharmaceutical Industry. The costs of such independent expert shall be borne equally between Lonza and Customer. The decision of such independent expert shall be in writing and, save for manifest error on the face of the decision, shall be binding on both Lonza and Customer.

 

4.11 The provisions of Clauses 4.8 and 4.9 shall be the sole remedy available to Customer in respect of Product that fails to meet Testing Summary or Specification.

 

5. Price and Terms of Payment

 

5.1 Unless otherwise indicated in writing by Lonza, all prices and charges are exclusive of Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by Customer (other than taxes on Lonza’s income). All invoices are strictly net and payment must be made within thirty (30) days of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature.

 

5.2 In the case of cGMP production, Customer shall pay a handling charge of fifteen percent (15%) on the costs of all raw materials (excluding resins), plus freight, taxes and insurance.

 

5.3 In default of payment on due date:

 

  (a) interest shall accrue on any amount overdue at the rate of four per cent (4%) above the base lending rate from time to time of National Westminster Bank pic, interest to accrue on a day to day basis both before and after judgment; and

 

  (b) Lonza shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Services or to treat this Agreement as repudiated on not less than ten (10) days’ prior notice in writing to Customer given at any time thereafter.

 

10


CONFIDENTIAL

 

 

6. Intellectual Property

 

6.1 Neither party will, as a result of this Agreement, acquire any right, title, or interest in any intellectual property that the other party owns or controls as of the Effective Date of this Agreement, or that the other party obtains ownership or control of separate and apart from the performance of the Services under this Agreement. Lonza shall retain all rights to and in the Process (but subject to Customer’s ownership of the Customer Information), Lonza Patent Rights and Lonza Know-How. Notwithstanding anything to the contrary in this Agreement but subject to the preceding two sentences, Customer shall, at all times (both during the term of this Agreement and thereafter) retain all rights in and to the Product (subject to the terms of the GS Licence). Customer shall retain all intellectual property rights of any nature whatsoever subsisting in:

 

  (i) the composition of matter of the Product and the composition of matter of all fragments, including epitopes thereof and all primers and probes corresponding thereto; and

 

  (ii) the use in life science applications of all of the composition described in paragraph (i) of this Section 6.1;

 

  (iii) Customer Information; and

 

  (iv) results from experiments conducted (provided that the experiments themselves that comprise part of the Process shall belong to Lonza) with, and the results of research and development carried out under this Agreement with, the use of any of the biological materials identified in paragraph (i) of this Section 6.1.

 

6.2 Lonza shall own all right, title and interest in “New General Application Intellectual Property,” which as used in this Agreement means intellectual property that Lonza and/or its Affiliates, contractors or agents develops, conceives, invents, reduces to practice or makes in the course of performance of the Services and that: (i) arises from or relates to the Process, Lonza Patent Rights or Lonza Know-How and/or the development or manufacture of biological or chemical products (other than the Product); and (ii) is severable from Customer Patents Rights and from Customer Information and does not reveal or disclose Customer Information or Customer Materials. If Lonza makes use of Customer Information that comprises new ideas and reduces these to practice, Nexvet hereby grants Lonza and its Affiliates a non-exclusive, world-wide, fully paid-up, irrevocable and transferable licence to use those new ideas for research purposes only. If Lonza wishes to make use of such new ideas for anything other than research purposes, the provision of clause 6.6 shall apply.

 

6.3

Except for and not including the New General Application Intellectual Property, Customer shall own all right, title, and interest in any and all intellectual property that Lonza and/or its Affiliates conceives, invents, reduces to practice, develops or makes, solely or jointly with Customer or others, in the course of performance of the Services or as a result of receipt of Customer Information or Customer Materials and (in each case) which is a development or direct derivative of Customer Information or Customer Materials (collectively, the “New

 

11


CONFIDENTIAL

 

  Customer Intellectual Property”). Lonza hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual Property. Lonza shall promptly disclose to Customer in writing all New Customer Intellectual Property. Lonza shall execute, and shall require Lonza’s personnel involved in the performance of the Services to execute, any documents required to confirm Customer’s ownership of the New Customer Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property. Upon Customer’s request and at Customer’s reasonable expense, and at no cost to Lonza, Lonza shall assist Customer as may be necessary to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property. For the avoidance of doubt, the parties agree that the term “New Customer Intellectual Property” shall not under any circumstances be interpreted or defined to include any “New General Application Intellectual Property”.

 

6.4 Lonza hereby grants Customer a non-exclusive, world-wide, fully paid-up, irrevocable and transferable license, with the right to grant and authorize sublicenses, under and to all New General Application Intellectual Property, to the extent such New General Application Intellectual Property is necessary or useful to develop, conduct clinical trials for, formulate, manufacture, test, seek regulatory approval for, market, commercialize, make, have made, use, sell, import, and distribute Product.

 

6.5 Lonza recognises that Customer may wish to transfer the Process to a third party to manufacture the Product, and the Parties agree that the Lonza Know-How and the Lonza Patents contained in the Process may be transferred to a third party (the “Technology Transfer”), on terms and a price to be agreed depending on the scope of the Technology Transfer. Lonza agrees that the maximum sum payable by Customer to Lonza for such Technology Transfer shall be:

 

  (a) £ *** to transfer the Process at any time prior to the commencement of cGMP manufacturing activities; and

 

  (b) £ *** to transfer the Process at any time after the commencement of cGMP manufacturing activities, with the precise amount payable to be determined in advance of such transfer.

 

6.6 If Lonza wishes to use any Customer Information or Customer Materials or Customer Patent Rights for purposes outside this Agreement, the parties shall discuss relevant terms on which Lonza may be granted a licence to do so. If a third party will wish to use any Customer Information or Customer Materials, Nexvet shall enter into a direct contractual arrangement with such third party.

 

7. Warranties and Indemnification

 

7.1 Lonza warranty: Lonza warrants that:

 

  (a) the Services shall be performed in accordance with Clauses 2.1 and 2.2;

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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CONFIDENTIAL

 

 

  (b) at all times throughout the term of this Agreement and subject to 7.1(f), Lonza shall have and maintain all of the approvals and certifications and licenses within the Territory, including all regulatory approvals and certifications and licenses that it is required to have and maintain within the Territory in order to be entitled to lawfully exercise its rights and perform its obligations under this Agreement, including performance of the Services;

 

  (c) unencumbered title (save for any intellectual property rights which may exist) to Product will be conveyed to Customer upon Delivery;

 

  (d) as of the date of this Agreement the Lonza Know How and Lonza Patent Rights are owned by Lonza or Lonza is otherwise entitled to use them for the purposes of providing Services under this Agreement and during the term of this Agreement Lonza shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes;

 

  (e) Lonza has the necessary corporate authorisations to enter into this Agreement;

 

  (f) as of the date of this Agreement to the best of Lonza’s knowledge and belief, the use by Lonza of the Process (excluding any modifications or steps made or developed by Customer, Customer Materials, Customer Information and Customer Patent Rights) and Lonza Patent Rights and Lonza Know How for the performance of the Services as provided herein will not infringe any rights (including without limitation any intellectual or industrial property rights) vested in any third party; and***

 

  (g) Lonza will notify Customer in writing immediately if it receives or is notified of a claim from a third party that the use by Lonza of the Process and/or the Lonza Know How or the Lonza Patent Rights for Services infringes any intellectual property rights vested in such third party.

 

7.2 Customer warranty: Customer warrants that:

 

  (a) Customer has and shall at all times throughout the term of this Agreement have the right to supply the Cell Line, the other Customer Materials and the Customer Information to Lonza and the necessary rights to licence or permit Lonza to use the same for the purpose of the Services;

 

  (b) Customer has the necessary corporate authorisations to enter into this Agreement;

 

  (c) any of the Cell Line, the other Customer Materials, Customer Information and Customer Patent Rights not owned by Customer are licensed to Customer under a licence which will permit their use by Lonza to perform the Services;

 

  (d) not to use any product produced as part of a Pilot Batch in any clinical trial, or to administer it to patients;

 

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CONFIDENTIAL

 

 

  (e) as of the date of this Agreement to the best of Customer’s knowledge and belief, the use by Lonza of the Cell Line, other Customer Materials, Customer Information and Customer Patent Rights for the Services (including without limitation the manufacture of the Product) will not infringe any intellectual property rights of any third party (provided, however, that Lonza shall waive any breach of this warranty which arises if a court of competent jurisdiction determines that the use by Lonza of the Cell Line, other Customer Materials, Customer Information or Customer Patent Rights for the Services infringes the intellectual property rights of a third party, provided that and for so long as Customer actually indemnifies Lonza pursuant to clause 7.5 below); and

 

  (f) Customer will promptly notify Lonza in writing if it receives or is notified of a claim from a third party that the Cell Line, other Customer Materials, Customer Information or the Customer Patent Rights or that the use by Lonza thereof for the provision of the Services infringes any intellectual property rights of such third party.

 

7.3 Disclaimer: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND, EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES AND CONDITIONS, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OR CONDITION OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

7.4 Indemnification by Lonza: Subject to clauses 7.6, 7.7, 7.8, 7.9 and 7.10 below, Lonza shall defend, indemnify and hold harmless each of Customer and its directors, officers, and employees and the successors and assigns of any of the foregoing (each a “Customer Indemnitee”) from and against any loss, damage, costs, claims, liabilities and/or expenses (including court costs and legal fees on a full indemnity basis) that Customer may suffer arising directly out of any breach of the warranties given by Lonza in clause 7.1 above or any claims alleging that Lonza’s sole use of Lonza Know-How (excluding use of Lonza Know-How with Customer Materials or Customer Information) infringes any rights (including without limitation any intellectual property rights) vested in a third party (whether or not Lonza knows or ought to have known the same) provided that there shall be excluded from this indemnity all Customer revenue.

 

7.5 Indemnification by Customer: Subject to clauses 7.6 and 7.7 below, Customer shall defend, indemnify and hold harmless each of (i) Lonza and (ii) its Affiliates and (iii) the directors, officers, and employees of Lonza and/or its Affiliates and (iv) the successors and assigns of any of the foregoing (each of (i), (ii), (iii) and (iv) a “Lonza Indemnitee”) from and against any loss, damage, costs, claims, liabilities and/or expenses of any nature (including court costs and legal fees on a full indemnity basis), that Lonza or a Lonza Indemnitee may suffer arising directly out of any breach of the warranties given by Customer in clause 7.2 above or any claims alleging the use by Lonza or its Affiliates of the Cell Line, the Customer Materials, Customer Patent Rights or the Customer Information infringes any rights (including, without limitation, any intellectual property rights) vested in any third party (whether or not Customer knows or ought to have known about the same) provided that there shall be excluded from this indemnity all Lonza actual or potential revenues other than those which are an integral part of any Price or fees which Customer is obliged to pay to Lonza under this Agreement. Customer shall further indemnify and maintain Lonza and the Lonza Indemnitees promptly indemnified against all claims, actions, costs, losses, damages, expenses (including court costs and legal fees on a full indemnity basis) or other liabilities whatsoever in respect of:

 

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CONFIDENTIAL

 

 

  (a) any product liability in respect of Product (or any product that contains Product), unless such liability is caused by the negligent act or omission of Lonza in the production and/or supply of Product; and

 

  (b) any negligent or wilful act or omission of Customer or any of its Affiliates in relation to the use, processing, storage or sale of the Product.

 

7.6 Indemnification Procedure: If a Lonza Indemnitee or Customer Indemnitee (the “Indemnitee”) intends to claim indemnification under this clause 7, it shall promptly notify the other party (the “Indemnitor”) in writing of such alleged liability. The Indemnitor shall have the right to control the defence thereof with counsel of its choice as long as such counsel is reasonably acceptable to Indemnitee; provided, however, that any Indemnitee shall have the right to retain its own counsel at its own expense, for any reason, including if representation of any Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party reasonably represented by such counsel in such proceeding. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any liability covered by this clause 7. The obligations of this clause 7.6 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve the Indemnitor of any obligation to the Indemnitee under this clause 7. It is understood that only Lonza or Customer may claim indemnity under this clause 7 (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may not directly claim indemnity hereunder.

 

7.7 Subject to Clause 7.9, in no event shall either Party or any and all of its Affiliates have any liability to the other Party or any and all of their Affiliates or Indemnitees pursuant to or in connection with this Agreement or the Services whether in contract, tort, negligence, breach of statutory duty, under any indemnity or otherwise howsoever arising for any incidental, indirect, special, punitive or consequential damages, save that this Clause 7.7 shall not restrict or limit any liability resulting from breach of confidentiality (clause 8), personal injury or death, gross negligence or intentional wrongdoing. It is also acknowledged that any third party claims for which recompense from the other under any indemnity in this Agreement shall be regarded as a direct loss and shall not be limited by this Clause 7.7, even if such third party claim could be considered as a special, incidental, indirect or consequential damages, or punitive damages.

 

7.8

Subject to Clause 7.9, the total aggregate liability of each of the parties and their respective Affiliates to the other and the other party’s Affiliates and Indemnitees pursuant to or in connection with or relation to this Agreement whether in contract, tort, negligence, breach of statutory duty, under any indemnity or otherwise howsoever arising shall in no event exceed

 

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CONFIDENTIAL

 

  and amount equal to *** , save that this Clause 7.8 shall not limit any liability resulting from personal injury or death, fraud, breach of confidentiality (clause 8), gross negligence or intentional wrongdoing or from Customer’s liability under clause 7.5(a). For the avoidance of doubt the limit of liability contained in this Clause 7.8 shall be for the Parties and their Affiliates, there shall not be a separate limit for any Affiliate.

 

7.9 Nothing in this Agreement shall operate to exclude or limit the liability of either Party or their Affiliates for fraud, for death or personal injury caused by its negligence or for any other liability that cannot be excluded or limited as a matter of law.

 

7.10 For the avoidance of doubt the limitations of the liability of Lonza and its Affiliates set out in this Clause 7 shall be shared by Lonza and all of its Affiliates and shall not be construed as a separate limit for each company.

 

8. Confidentiality

 

8.1 Customer acknowledges that Lonza Know-How and Lonza acknowledges that Customer Information with which it is supplied by the other pursuant to the Agreement is supplied, subject to Clause 8.5, in circumstances imparting an obligation of confidence and each agrees to keep such Lonza Know-How or such Customer Information secret and confidential and to respect the other’s proprietary rights therein and not at any time for any reason whatsoever to disclose or permit such Lonza Know-How or such Customer Information to be disclosed to any third party save as expressly provided herein. Lonza may disclose any of Customer’s Confidential Information to Lonza Biologics Plc or Lonza Biologics Porrino SL or to any of Lonza’s other Affiliates provided that (i) in the event that Lonza wishes to make such a disclosure to any of its Affiliates other than Lonza Biologics Plc or Lonza Biologics Porrino SL it shall obtain the prior consent of Nexvet, such consent not to be unreasonably withheld or delayed) and (ii) Lonza shall be responsible for any breaches of confidentiality by such of its Affiliates.

 

8.2 Customer and Lonza shall each procure that all their respective employees, consultants, contractors and persons for whom it is responsible having access to Lonza Know-How or Customer Information shall be subject to the same obligations of confidence as the principals pursuant to Clauses 8.1 and 8.3 and shall be bound by secrecy agreements in support of such obligations.

 

8.3 Lonza and Customer each undertake not to disclose or permit to be disclosed to any third party (including any contractors or consultants not previously approved in writing by Lonza, such approval not to be unreasonably withheld or delayed), or otherwise make use of or permit to be made use of (a) any trade secrets or confidential information relating to the technology, business affairs or finances of the other, any subsidiary, holding company or subsidiary of any such holding company of the other, or of any suppliers, agents, distributors, licensees or other customers of the other which comes into its possession under this Agreement or (b) the commercial terms of this Agreement, except to the extent that the same is required to be disclosed pursuant to subpoena, court order, judicial process or otherwise by law, provided the receiving party provides prompt notice to the disclosing party of such

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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CONFIDENTIAL

 

  requirement in order to give the disclosing party an opportunity to timely seek a protective order or other appropriate judicial relief. In the event the disclosing party is unable to obtain a protective order or other appropriate judicial relief, the receiving party shall disclose only that portion of the disclosing party’s confidential information which is legally required to be disclosed, and ensure that all such confidential information of the disclosing party shall be redacted to the fullest extent permitted by law prior to such disclosure and that the disclosing party shall be given an opportunity to review the confidential information prior to its disclosure.

 

8.4 The obligations of confidence referred to in this Clause 8 shall not extend to any information which:

 

  (a) is or becomes generally available to the public otherwise than by reason of a breach by the receiving party of the provisions of this Clause 8;

 

  (b) is known to the receiving party and is at its free disposal prior to its receipt from the disclosing party;

 

  (c) is subsequently disclosed to the receiving party without being made subject to an obligation of confidence by a third party;

 

  (d) is developed by any servant or agent of the receiving party without access to or use or knowledge of the information by the disclosing party.

 

8.5 Nothing in this Agreement shall prevent Lonza or Customer from making any disclosure under any statutory, regulatory or similar legislative requirement or any court order, subject to the imposition of obligations of secrecy wherever possible in that relation, provided always that information so disclosed shall otherwise remain subject to this Clause 8. Without limiting the foregoing in this clause 8.5, in the event that an applicable regulator requires certain information which is confidential to Lonza and which Customer does not have in its possession, Lonza will, at Customer’s request, send such information to such applicable regulator to the fullest extent required by such regulator and at Lonza’s sole cost and expense.

 

8.6 The parties acknowledges that:

 

  (a) without prejudice to any other rights and remedies that the parties may have, the parties agree that the Lonza Know-How and Customer Information is valuable and that damages may not be an adequate remedy for any breach of the provisions of this clause 8. The parties agree that the relevant party will be entitled without proof of special damage to seek the remedies of an injunction and other equitable relief for any actual or threatened breach by the other party;

 

  (b) save as provided herein Lonza shall not at any time have any right, title, licence or interest in or to Customer Information, Customer Patent Rights or any other intellectual property rights vested in Customer or to which Customer is entitled; and

 

  (c) Customer shall not at any time have any right, title, licence or interest in or to Lonza Know-How, the Lonza Patent Rights or any other intellectual property rights relating to the Process which are vested in Lonza or to which Lonza is otherwise entitled.

 

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CONFIDENTIAL

 

 

 

9. Termination

 

9.1 If it becomes apparent to either Lonza or Customer at any stage in the provision of the Services that it will not be possible to complete the Services for scientific or technical reasons, a sixty (60) day period shall be allowed for good faith discussion and attempts to resolve such problems. If such problems are not resolved within such period, Lonza and Customer shall each have the right to terminate the Agreement forthwith by notice in writing. In the event of such termination, Customer shall pay to Lonza a termination sum calculated by reference to all the Services performed by Lonza prior to such termination (including a pro rata proportion of the Price for any stage of the Services which is in process at the date of termination) and all expenses reasonably incurred by Lonza in giving effect to such termination, including the costs of terminating any irrevocable commitments entered into under the Agreement, such termination sum not to exceed the Price.

 

9.2 Customer may in its sole discretion terminate this Agreement or any individual stages at any time for any reason by giving not less than (thirty) 30 days’ notice in writing to Lonza. In the event of such termination pursuant to this Clause 9.2 and subject to Clauses 9.3 and 9.4 Customer shall pay Lonza a termination sum calculated in accordance with the principles of Clause 9.1 above plus:

 

  (a) in the event notice to terminate Services (or any part thereof) pursuant to this Clause 9.2 is issued to Lonza six (6) months or less before Lonza’s then estimated start date for any stage of those Services which include *** ; or

 

  (b) in the event notice to terminate Services pursuant to this Clause 9.2 is issued to Lonza more than six (6) but not more than twelve (12) months before Lonza’s then estimated start date for any stage of those Services which include *** .

 

9.3 The obligation to make payment under clause 9.2 shall be reduced (retrospectively, and hence Lonza shall make an appropriate refund to Customer) to the extent that Lonza mitigates its loss in this regard (and Lonza shall promptly notify Customer of any such mitigation). This provision shall not entitle Customer to be refunded an amount greater than that paid by Customer to Lonza pursuant to this clause 9 and Lonza shall be entitled to deduct from the amount due to be refunded to Customer its reasonable personnel and associated costs in attempting to mitigate its loss.

 

9.4 For the avoidance of doubt activities relating to cGMP fermentation shall be deemed to commence with the date of removal of the vial of cells from frozen storage for the performance of the fermentation.

 

9.5 The parties may each terminate the Agreement forthwith by notice in writing to the other party upon the occurrence of any of the following events:

 

  (a) if the other commits a material breach of the Agreement (which shall include a breach of the warranties set out in clause 7 above) which in the case of a breach capable of remedy is not remedied within thirty (30) days of the receipt by the other of notice identifying the breach and requiring its remedy; or

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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CONFIDENTIAL

 

 

  (b) if the other ceases for any reason to carry on business or compounds with or convenes a meeting of its creditors or has a receiver or manager appointed in respect of all or any part of its assets or is the subject of an application for an administration order or of any proposal for a voluntary arrangement or enters into liquidation (whether compulsorily or voluntarily) or insolvency, or undergoes any analogous act or proceedings under foreign law.

 

9.6 Upon the termination of the Agreement for whatever reason:

 

  (a) Lonza shall promptly return to Customer all Customer Information and shall dispose of or return to Customer the Customer Materials (and where supplied by Customer the Cell Line) and any materials therefrom, as directed by Customer;

 

  (b) Customer shall promptly return to Lonza all Lonza Know-How it has received from Lonza;

 

  (c) Customer shall not thereafter use or exploit the Lonza Patent Rights or the Lonza Know-How in any way whatsoever;

 

  (d) Lonza and Customer shall do all such acts and things and shall sign and execute all such deeds and documents as the other may reasonably require to evidence compliance with this Clause 9.6.

 

9.7 Termination of this Agreement for whatever reason shall not affect the accrued rights of either Lonza or Customer arising under or out of this Agreement and all provisions which are expressed to survive the Agreement shall remain in full force and effect.

 

9.8 If during the term of or upon expiration or prior termination of this Agreement (but excluding termination by Lonza in accordance with Clause 9.5), Customer notifies Lonza of its wish to obtain a license from Lonza (with the right to sublicense) to utilise the Process, or any part thereof for the production of Product either at its own facility or that of a third party, or any other intellectual property of Lonza or its Affiliates (whether or not patentable) reasonably necessary for the manufacture of the Product, the Parties shall negotiate in good faith the commercially reasonable terms upon which such a license shall be granted and related technology shall be transferred. The Parties agree that prior to the incorporation of any patentable intellectual property the royalty, if any, which would be associated with such patentable intellectual property shall be disclosed to Customer and Customer shall have the option to include or exclude such patentable intellectual property within the Process. In the event that Customer agrees to incorporate any additional patentable intellectual property within the Process then the royalty associated with such patentable intellectual property shall be in addition to any other royalty payable by Customer to Lonza.

 

10. Force Majeure

 

10.1 If Lonza is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and shall give written notice thereof to Customer specifying the matters constituting Force Majeure together with such evidence as Lonza reasonably can give and specifying the period for which it is estimated that such prevention or delay will continue, Lonza shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue.

 

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10.2 The expression “Force Majeure” shall be deemed to include any cause affecting the performance by Lonza of the Agreement arising from or attributable to acts, events, acts of God, omissions or accidents beyond the reasonable control of Lonza.

 

11. Governing Law, Jurisdiction and Enforceability

 

11.1 The construction, validity and performance of the Agreement shall be governed by the laws of England, and Lonza and Customer submit to the non-exclusive jurisdiction of the Courts of England and Wales.

 

11.2 No failure or delay on the part of either Lonza or Customer to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter.

 

11.3 Any disputes relating to issues arising from this Agreement shall, in the absence of resolution within thirty (30) days of the dispute arising, be referred to the Chief Executive Officers of Customer and Lonza, who shall discuss the matter and attempt to resolve it by mutual consent. If the Chief Executive Officers of Customer and Lonza cannot resolve the dispute within thirty (30) days of the matter being referred to them, either party may, by written notice to the other party, invoke the mediation procedure set out in Clause 11.4 below.

 

11.4 If a dispute arises between the parties that the parties cannot resolve pursuant to clause 11.3 above, the parties agree to attempt in good faith to resolve such dispute by mediation administered by the CEDR (Centre for Effective Dispute Resolution) in London. The parties agree that they shall share equally the cost of any mediation fees, and the cost of the mediator. Each party must bear its own attorneys’ fees and associated costs and expenses. The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within sixty (60) days of either party referring the dispute to mediation either party may pursue its rights in a court of law.

 

11.5 Nothing in this Clause 11 shall prevent a party from exercising any right under this Agreement, including the right of termination under clause 9 above.

 

12. Notices

 

12.1 Any notice or other communication to be given under this Agreement shall be delivered personally or sent by facsimile transmission, or if facsimile transmission is not available, by first class pre-paid post addressed as follows:

 

  (a) If to Lonza to: Lonza Sales AG, Muenchensteinerstrasse 38 CH- 4402, Basel, Switzerland,

 

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With a copy to: Lonza Biologics plc

228 Bath Road

Slough

Berkshire SL1 4DX

England

Facsimile: +44 1753 777001

For the attention of: The Head of Legal Services

 

  (b) If to Customer to:

Nexvet Biopharma PTY Ltd,

Meaden Street,

Southbank 3006,

Victoria,

Australia

Facsimile: [                    ]

For the attention of: Mark Heffeman

or to such other destination as either party hereto may hereafter notify to the other in accordance with the provisions of this Clause 12.

 

12.2 All such notices or other communications shall be deemed to have been served as follows:

 

  (a) if delivered personally, at the time of such delivery;

 

  (b) if sent by facsimile, upon receipt of the transmission confirmation slip showing completion of the transmission;

 

  (c) if sent by first class pre-paid post, ten (10) business days (Saturdays, Sundays and Bank or other public holidays excluded) after being placed in the post.

 

13. Illegality

 

13.1 If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of Justice:

 

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  (a) such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement;

 

  (b) the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and

 

  (c) the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rending such provision invalid or unenforceable.

 

14. Governance

 

14.1 Promptly following the Effective Date, Lonza and Customer shall each establish a “Technical Project Team”. Each such Team shall consist of appropriate technical personnel and shall have a designated Project Team Leader.

 

14.2 Promptly following the Effective Date, Lonza and Customer shall establish a “Steering Committee”. The Steering Committee shall be comprised of equal numbers of representatives of each Party.

 

14.3 Without limiting the functions of the Steering Committee set out elsewhere in this Agreement, the role of the Steering Committee shall be to:

14.3.1.    Assess the status of Process in connection with the Services;

14.3.2.    Resolve disputes arising between the Parties under this Agreement, as provided in Clause 14.4;

14.3.3.    Monitor the progress of the Services;

14.3.4.    Monitor and actively address any deviation and/or foreseen or expected deviation from the Time Schedule.

14.3.5.    Plan and assess needs for future supply of Product;

14.3.6.    Discuss and recommend any changes to the Process; and

14.3.7.    Oversee the choice and qualification of vendors supplying Raw Materials;

14.3.8.    Monitor and discuss the prices of Raw Materials.

 

14.4 The Steering Committee shall meet at such times as the Steering Committee determines to resolve issues arising under and to perform its responsibilities under this Agreement, provided that the Steering Committee shall meet not less than six (6) times per calendar year, at such locations or by conference call as shall be agreed between the Parties. Lonza shall arrange for all meetings of the Steering Committee to be duly minuted and copies of the minutes provided to both parties. If any issue to be determined by the Steering Committee is not resolved within thirty (30) days after submission of the relevant issue to the Steering Committee, such issue shall be referred for resolution in accordance with clause 11.3.

 

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14.5 The Steering Committee is not empowered to amend the terms of this Agreement.

 

15. Miscellaneous

 

15.1 Lonza shall be entitled to instruct Lonza Biologics Plc or Lonza Biologics Porrino SL to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations. Subject to the previous sentence and to first obtaining the prior consent of Nexvet (such consent not to be unreasonably withheld or delayed), Lonza shall be entitled to instruct one or more of its Affiliates to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations. Subject thereto, neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement to a successor of that party’s business by reason of merger, sale of all or substantially all of its assets or other form of acquisition.

 

15.2 In the event that Lonza is asked to obtain the services of a third party on behalf of Customer, then Lonza shall not be responsible for the acts and omissions of such third party and in the event of any dispute, Lonza shall use its reasonable endeavours to pass onto Customer whatever remedies it obtains from such third party. For the avoidance of doubt the External Laboratories shall not be a sub-contractor but shall be a third party as referred to in this Clause 15.2.

 

15.3 The obligations of the parties under clauses 2.11,3, 4, 6 (Intellectual Property), 7 (Warranties and Indemnification), 8 (Confidentiality), 9.6 and 9.7 (consequences of termination) and 11 (Governing Law, Jurisdiction and Enforceability) shall survive the termination of this Agreement for any reason.

 

15.4 The text of any press release or other communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of Lonza and Customer.

 

15.5 The Agreement embodies the entire understanding of Lonza and Customer and there are no promises, terms, conditions or obligations, oral or written, expressed on implied, other than those contained in the Agreement. The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between Lonza and Customer relating to the Services.

 

15.6 The parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to this Agreement.

 

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15.7 No variation of or addition to this Agreement or any part thereof shall be effective unless in writing and signed on behalf of both parties. Notwithstanding the above the parties hereby confirm that amendments to the Specification shall be effective if reduced to writing and signed by the quality and/or regulatory representative of both parties, which quality and/or regulatory representative shall be nominated from time to time by each party.

AS WITNESS the hands of the duly authorised representatives of the parties hereto the day and year first above written.

 

NEXVET BIOPHARMA PTY LTD

   LONZA SALES AG

Signature: /s/ Mark Heffernan

 

Printed Name: Mark Heffernan

 

Title: CEO

  

Signature: /s/ Gerry Kennedy

 

Printed Name: Gerry Kennedy

 

Title: Authorised Signatory

  

Signature: /s/ Jeetendra Vaghjiani

 

Printed Name: Jeetendra Vaghjiani

 

Title: Authorised Signatory

 

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SCHEDULE 1

PRODUCT SPECIFICATION

 

“Cell Line”

shall mean the GS-CHO Cell Line, created by Lonza expressing Product.

 

“Product”

shall mean the caninised IgG-A kappa antibody produced by the Cell Line, known as “GS_NV01” that binds to NGF and of which Customer is the proprietor.

Specification and testing summary to be agreed between the parties.

Storage and shipping information

Final Formulation Buffer:

Bottling of Bulk Product:

Primary containers: Nalgene high density polyethylene bottles

Denominations:

The bulk Product will be dispensed into 1L high density polyethylene (HDPE) Nalgene bottles, filling to a tolerance of ± 10% of the nominal volume of the container. Any remaining bulk Product will be dispensed into 125mL HDPE Nalgene bottles, filling to a tolerance of ± 10% of the nominal volume of the container. Any remaining Product will be filled into one container of the smallest size specified. If this is not filled with a tolerance of „b10% of the nominal volume, this will be labelled as a Customer Sample and will not be released for clinical use.

For the calculation of the total fill volume it is assumed that 1g of liquid ~ 1ml.

Product Storage Conditions: Store Product at 5±3°C.

Shipment Temperature: Product shipped at greater than 0°C and below or equal to + 10°C.

Customer samples (removed during the middle of dispensing):

Shipment Temperature: samples shipped at greater than 0°C and below or equal to +10°C.

 

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Testing Summary to be Performed on the 10L runs (Stage 7)

Lonza shall manufacture Product in its pilot facility to evaluate the ability of the Process to produce Product meeting the cGMP Specification. For the pilot runs there shall be no obligation to meet the amounts stated to be target amounts or where the result description is to “report result”.

 

Criterion  

Method (Lonza

SOP Number)

  Target

Characteristics

   

***

   

Identity

   

***

   

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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Criterion  

Method (Lonza

SOP Number)

  Target

Purity

   

***

   

Impurities

   

***

   

 

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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Criterion  

Method (Lonza

SOP Number)

  Target

Safety

   

***

   

 

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

28


CONFIDENTIAL

 

SCHEDULE 2

SERVICES

 

A Supply of Customer Materials and Customer Know How

 

B Assumptions

 

C Activities to be performed by Lonza

***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

29


CONFIDENTIAL

 

 

A Supply of Customer Materials and Customer Know How

Prior to commencement of the Services at Lonza or, if appropriate, prior to the commencement of the relevant Stage of the Services, Customer shall supply Lonza with the following:

 

(i) Sufficient information to allow a risk assessment as required by the “Genetically Modified Organisms (Contained Use) (Amendment)” Regulations 1996 and a safety assessment by Lonza’s Biological Safety Committee

 

(ii) If available, a reference standard sample or suitable reference material (approximately 10mg) of the Product antibody suitable for the purposes intended.

 

B Assumptions

It is assumed that the manufacturing Process will fit the current facility operating conditions and within the Stages below, certain assumptions have been listed. Where during the Services there are indications that there may be a requirement for additional equipment, processing time or other non-standard operability criteria, as listed above, this requirement for additional equipment, processing time or other non-standard operability criteria will be agreed by Lonza and the Customer prior to commencement of the relevant Stage, subject to terms and conditions to be agreed between Lonza and Customer.

 

30


CONFIDENTIAL

 

 

C Activities to be undertaken by Lonza

***

 

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

31


CONFIDENTIAL

 

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

  

Description

  

Price(1)

Stage 1

   ***    £***
      £***3

Stage 2

     
   ***    £***
     

Stage 3

   ***    £***

Stage 4

   ***    £***2

Stage 5

   ***    £***

Stage 6

   ***    £***4 + external laboratory testing charges estimated to be £***

Stage 7

   ***   

£*** plus analysis

£*** * (for Drug Substance)

Notes:

 

* Each individual bioreactor will be priced at this Price if it is completed before 01 July 2014. Any bioreactors completed following this date will be priced at the 2014 Price for such work based on the scope agreed at the time.

 

(1) As described in Clause 4 – “Delivery, Transportation of Product and Customer tests” of the Terms and Conditions, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.

 

(2) This price covers evaluation of the performance of Lonza’s generic assays. If a specific assay has to be developed this would require additional activities at a Price to be agreed.

 

(3) This price is exclusive of the cost of any specialist kits required for this assay.

 

(4) The External Laboratory charges for the tests listed are estimated, for guidance purposes only, to be approximately £ *** for the MCB.

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

32


CONFIDENTIAL

 

 

2. Payment

 

     Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stages 1, 2, 3, 4, 5, and 7.

 

     ***% upon commencement of each Stage or Substage.

 

     ***% upon completion of each Stage or Substage.

 

     Any External Laboratory charges will be invoiced separately.

 

2.2 For Stage 6

 

     ***% upon completion of Stage 6.

 

     External Laboratory charges will be invoiced separately.

Notes: see “1 Price”, above, in this Schedule 3.

cGMP Batch Pricing

Below is Lonza’s batch Price for standard Processes operated within Lonza’s cGMP facilities. If the Process does not fit a standard processing window (slot length) then additional time may be required within the facility and the batch Prices will be updated accordingly. These Prices are valid for Batches commenced between 1st January 2013 until 31st December 2019, subject only to an annual increase based on PPI, with the first increase on 1 January 2014. Lonza reserves the right to increase the prices if there is any exceptional raw material or energy price increases.

 

Scale of Manufacture and site    Batch price excluding raw materials and resins

***

   £***

***

   £***

***

   £***

***

   £***

***

   £***

***

   $***

For prices set out in Pounds Sterling (£), “PPI” shall mean the Producer Price Index as published by the Office for National Statistics or any successor agency issuing such indices. If such index is discontinued and there is no direct successor index, the Steering Committee shall designate an appropriate index that approximates as closely as possible the PPI

For prices set out in US Dollars ($), “PPI” shall mean the Producer Price Index for Pharmaceutical Prescription Preparations, Prescription (“PPI” Series ID PCU 325412325412), as reported by the Bureau of Labor Statistics of the U.S. Department of Labor or, if such index is no longer available, such index by which it is replaced by the Bureau of Labor.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

33


CONFIDENTIAL

 

Schedule 4 – Quality Agreement

To be added to the agreement at a future date.

 

34

EX-10.2 7 d775834dex102.htm EX-10.2 EX-10.2

Exhibit 10.2

 

Confidential   LOGO

AMENDMENT No. 1

TO

the AGREEMENT

dated 21 December 2012

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

Schedule 2

Stage 8 - ***

Schedule 3

Price and Payment

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

THIS AMENDMENT is made the 13th day of May 2013

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, Southbank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lonza entered into an agreement dated 21 December 2012 referring to NV-01, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:


Confidential   LOGO

 

1. Schedule 2 of the Agreement shall be amended to include the following additional stages:

SCHEDULE 2

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 1:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (UK £ Sterling)
Stage 8 - ***    £ ***

Notes:

 

  (1) As described in Clause 4 - “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the Price.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stage 8

***% upon         ***         (line item 8.3.5).     *** .

***% upon completion.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 1 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD   LONZA SALES AG
Signature: /s/ Mark Heffernan   Signature: /s/ John Eley
Printed Name: Mark Heffernan   Printed Name: John Eley
Title: CEO   Title: Senior Legal Counsel
Signature:   Signature: /s/ Nadia Ziefer
Printed Name:   Printed Name: Nadia Zieger
Title:   Title: Legal Counsel
EX-10.3 8 d775834dex103.htm EX-10.3 EX-10.3

Exhibit 10.3

 

Confidential   LOGO

AMENDMENT No. 2

TO

the AGREEMENT

dated 21 December 2012

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

Schedule 2

Stage 1B - ***

Schedule 3

Price and Payment

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

THIS AMENDMENT is made the 17th day of June 2013

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, Southbank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lonza entered into an agreement dated 21 December 2012 referring to NV-01, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:


Confidential   LOGO

 

1. Schedule 2 of the Agreement shall be amended to delete the original optional Stage 1B and replace it with the following Stage.

SCHEDULE 2

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 2:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (UK £ Sterling)
Stage 1B - ***    £*** (1,2)

Notes:

 

  (1) As described in Clause 4 - “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.
  (2) Price for replacement Stage 1B is unchanged from original optional Stage 1B. The additional scope contained within the replacement Stage 1B shall be absorbed by Lonza as agreed at the Joint Steering Committee meeting on 20th May 2013.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

  2.1 For Stage 1B

***% upon commencement.

***% upon completion.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 2 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD    LONZA SALES AG
Signature: /s/ Mark Heffernan    Signature: /s/ Janet White
Printed Name: Mark Heffernan    Printed Name: Janet White
Title: CEO    Title:
Signature:    Signature: /s/ Oliv Brunner
Printed Name:    Printed Name: Oliv Brunner
Title:    Title: Legal Counsel
EX-10.4 9 d775834dex104.htm EX-10.4 EX-10.4

Exhibit 10.4

 

Confidential   LOGO

AMENDMENT No. 3

TO

the AGREEMENT

dated 21 December 2012

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

Schedule 2

Stage 9 – ***

Stage 10 – ***

Stage 11 – ***

Stage 12 – ***

Schedule 3

Price and Payment

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

THIS AMENDMENT is made the 9th day of June 2014

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, Southbank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lanza entered into an agreement dated 21 December 2012 referring to NV-01, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:


Confidential   LOGO

 

1. Schedule 2 of the Agreement shall be amended to include the following Stages 9, 10, 11 and 12.

SCHEDULE 2

***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 3:

 

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (US £ Sterling)  

Stage 9 – ***

   £ * ** 

Stage 10 – ***

   £ * ** 

Stage 11 – ***

   £ * ** 

Stage 12 – ***

   £ * ** 

Notes:

 

  (1) As described in Clause 4 — “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stage 8

£*** upon commencement

£*** upon issue of each interim report (i.e. 3, 6 and 9 months).

£*** upon issue of the final report.

 

2.2 For Stage 10

£*** upon commencement

£*** upon issue of each interim report (i.e. 3, 6 and 12 months).

£*** upon issue of each interim report (i.e. 9, 18 and 24 months).

£*** upon issue of the final report.

 

2.3 For Stage 11

***% on commencement of the stage

***% on completion of the stage

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

2.3 For Stage 12

***% on Completion

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 3 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD     LONZA SALES AG
Signature:   /s/ Mark Heffernan     Signature:   /s/ Sven Frie
Printed Name:   Mark Heffernan     Printed Name:   Sven Frie
Title:   CEO     Title:   Director, Sales & Business Dev.
      Signature:   /s/ Nadia Zieger
      Printed Name:   Nadia Zieger
      Title:   Legal Counsel
EX-10.5 10 d775834dex105.htm EX-10.5 EX-10.5

EXHIBIT 10.5

 

Confidential   LOGO

AMENDMENT No. 6

TO

the AGREEMENT

dated 21 December 2012

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

Schedule 2

Stage 9 – ***

Stage 10 – ***

Schedule 3

Price and Payment

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

THIS AMENDMENT is made the 4th day of September 2014

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, Southbank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lonza entered into an agreement dated 21 December 2012 referring to NV-01, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:


Confidential   LOGO

 

1. Schedule 2 of the Agreement shall be amended to replace Stages 9 and 10 in their entirety with the following Stages.

SCHEDULE 2

***

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 6:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (UK £ Sterling)  

Stage 9 – ***

   £ * ** 

Stage 10 – ***

   £ * ** 

Notes:

 

  (1) As described in Clause 4- “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

  2.1 For Stage 9

£*** upon commencement.

£*** upon issue of each interim report (i.e. 3, 6 months).

£*** upon issue of the 9 month timepoint and the final report.

 

  2.2 For Stage 10

£*** upon commencement.

£*** upon issue of each interim report (i.e. 3, 6 and 12 months).

£*** upon issue of each interim report (i.e. 9, 18 and 24 months).

£*** upon issue of the final report.

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

AS WITNESS WHEREOF the parties have caused this Amendment No. 6 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD     LONZA SALES AG
Signature:       Signature:  
/s/ Mark Heffernan     /s/ Marie Leblanc
Printed Name:   Mark Heffernan     Printed Name:   Marie Leblanc
Title:   Chief Executive Officer     Title:  

Associate Director

Key Account Management

      Signature:  
      /s/ Nadia Zieger
      Printed Name:   Nadia Zieger
      Title:   Senior Legal Counsel
EX-10.6 11 d775834dex106.htm EX-10.6 EX-10.6
Confidential   

 

LOGO

EXHIBIT 10.6

AMENDMENT No. 8

TO

the AGREEMENT

dated 21 December 2012

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

Schedule 2

Stage 7C ***

Schedule 3

Price and Payment

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

 

THIS AMENDMENT is made the 10th day of October 2014

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, South bank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lonza entered into an agreement dated 21 December 2012 referring to NV-01, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.


Confidential    LOGO

 

 

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:

 

1. Schedule 2 of the Agreement shall be amended to add Stage 7C in their entirety as follows.

SCHEDULE 2

***

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 8:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

        Price (UK £
Sterling) (1)

***
 

7C

   Material Supply   
   ***    £    *** 
   ***    £    *** 

Notes:

 

  (1) As described in Clause 4- “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.
  (2) The price will depend upon the number of assays required. This will only be determined during the optimisation work. This will be discussed and agreed between Lonza and the Customer during the work.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stage 7C

***% of material supply price on commencement of the substage

***% of material supply price on completion of purification

***% of QC Testing Price on issue of CoT

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 8 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD   LONZA SALES AG

Signature:

 

/s/ David Gearing

 

Signature:

 

/s/ J. Westedt

Printed Name: David Gearing   Printed Name: Westedt
Title: CSO   Title: Dir. Mrg. Serv.
 

Signature:

 

/s/ Nadia Zieger

  Printed Name:       Nadia Zieger
  Title:       Senior Legal Counsel
EX-10.7 12 d775834dex107.htm EX-10.7 EX-10.7

Exhibit 10.7

CONFIDENTIAL

LICENCE AGREEMENT

between

LONZA SALES AG.

and

NEXVET BIOPHARMA PTY LTD


CONFIDENTIAL

 

INDEX

 

ARTICLE   TITLE   

1.

  Definitions   

2.

  Supply of System and Know-How   

3.

  Ownership of Property and Intellectual Property   

4

  Licences   

5.

  Payments   

6.

  Royalty Procedures   

7.

  Liability and Warranties   

8.

  Confidentiality   

9.

  Intellectual Property Enforcement   

10.

  Term and Termination   

11.

  Assignment   

12.

  Governing Law and Jurisdiction   

13.

  Force Majeure   

14.

  Illegality   

15.

  Miscellaneous   

16.

  Notice   

17.

  Interpretation   
SCHEDULE     

1

  Patent Rights   

 

 

2


CONFIDENTIAL

 

THIS AGREEMENT is made the 21st day of December 2012

BETWEEN

LONZA SALES AG incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as “Lonza”), and

NEXVET BIOPHARMA PTY LTD of 9 Meaden Street, Southbank 3006, Victoria, Australia, (hereinafter referred to as “Licensee”)

WHEREAS

 

A. Lonza is the proprietor of the System and has the right to grant certain Intellectual Property rights in relation thereto (all as hereinafter defined), and

 

B. The Licensee wishes to take a licence under Intellectual Property (as hereinafter defined) of which Lonza is the proprietor to commercially exploit the Product (as hereinafter defined) in the form hereunder.

NOW THEREFORE the parties hereby agree as follows:

 

1. Definitions

 

  1.1 “Affiliate” means any company, corporation, limited liability company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control, directly or indirectly, with the relevant party to this Agreement. “Control” means the ownership of more than fifty percent (50%) of the issued share capital of the party in question or the legal power to direct or cause the direction of the general management and policies of the party in question.

 

  1.2 “Cell Lines” means those cell lines referred to in Clause 2.1.1(b).

 

  1.3 “Combination Product” means any diagnostic or therapeutic product comprising Product and one or more other pharmaceutical active ingredient(s).

 

3


CONFIDENTIAL

 

  1.4 “Competing Contract Manufacturer” shall mean any party who undertakes or performs more than fifty percent (50%) of their business as a third party manufacturer of monoclonal antibodies and/or therapeutic proteins or any product of a similar nature to which this Agreement relates.

 

  1.5 “Effective Date” means the date first above written.

 

  1.6 “First Commercial Sale” means the date of the first sale or other disposal of Product for consideration by the Licensee or its Sublicensee.

 

  1.7 “Intellectual Property” means System Know-How and Patent Rights.

 

  1.8 “Know-How” means technical and other information, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols.

 

  1.9 “Net Selling Price” means

***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

4


CONFIDENTIAL

 

***

 

  1.10 “Patent Rights” means the patents and applications, short particulars of which are set out in Schedule 1 hereto, and all patents and applications thereof of any kind throughout the world whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition, and including any divisions, renewals, continuations, continuations in part, reissues, patent disclosures, improvements and extensions of reissue thereof.

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

5


CONFIDENTIAL

 

  1.11 “Product” means the caninised IgG-A kappa antibody produced by the Cell Line known as NV-01 that binds to NGF and of which Licensee is the proprietor and which is obtained by the expression of any one gene or of any combination of genes by use of the System, or any formulation containing the same.

 

  1.12 “Strategic Partner” means a party with whom Licensee has entered into a contractual relationship, to identify a therapeutic target, collaborate in the performance of research and development of a Product or a product of which the Strategic Partner is the proprietor. In no event may any entity that is primarily a Competing Contract Manufacturer be deemed a Strategic Partner for the purposes of this Agreement.

 

  1.13 “Sublicensee” means a party with whom Licensee has entered into a contractual relationship, under which such party has been granted the right to make or manufacture the Product and to whom Licensee has sub-licenced its rights under this Agreement pursuant to clause 4.3, provided always that the obligations in Clause 4.3 have been satisfied.

 

  1.14 “System” means Lonza’s glutamine synthetase gene expression system consisting of the Cell Lines, the Vectors, and the System Know-How, whether used individually or in combination with each other. For the avoidance of doubt, any gene proprietary to Licensee inserted into the System for the purposes of producing Product does not form part of the System.

 

  1.15 “System Know-How” means Know-How relating directly or indirectly to the System known to Lonza from time to time, of which Lonza is the proprietor.

 

  1.16 “Target Animal Efficacy Study” means the first animal treated in a pivotal efficacy study performed under GCPv with Centre for Veterinary Medicine (CVM) protocol concurrence.

 

  1.17 “Territory” means world-wide.

 

  1.18

“Valid Claim” means a claim within the Patent Rights (including any re-issued and unexpired patents) which has not been held unenforceable or invalid by the decision of a court or other governmental agency of competent jurisdiction

 

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  unappealable or unappealed within the time allowed for appeal and which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise.

 

  1.19 “Vectors” means those vectors referred to in Clause 2.1.1(a).

 

2. Supply of the System and System Know-How

 

  2.1 Unless previously supplied by Lonza under a separate agreement, Lonza shall, if requested by Licensee in writing, arrange for the supply ex-works Lonza’s premises, Slough, Berkshire (Incoterms 2010) to Licensee of the following:

2.1.1    (a)    Vectors

                     ***

            (b)    Cell Lines

                     ***

 

  2.1.2 System Know-How

System Know-How contained as at the date hereinabove in (a) manuals of operating procedures for the System, (b) regulatory information on CD-ROM, (c) Vector nucleotide sequences.

 

  2.1.3 In the event that Licensee requires any additional quantities of the materials referred to in clause 2.1.1, and if Lonza at its sole discretion is willing to supply such additional materials, such supply shall be subject to the payment of an additional fee by Licensee to Lonza in accordance with Lonza’s prices at the time.

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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  2.2 Licensee shall use the System only in the expression of Product by insertion of gene(s) coding for Product(s) into the System, and shall not use, cause the use of or permit to be used the System for any purpose not directly authorised by this Agreement.

 

3. Ownership of Property and Intellectual Property

 

  3.1 It is hereby acknowledged and agreed that as between the parties any and all property and Intellectual Property in the System is vested in Lonza.

 

  3.2 The provisions of this Clause 3 shall survive termination of this Agreement.

 

4. Licences

 

  4.1 Lonza hereby grants to Licensee a world-wide non-exclusive licence (with the right to sublicense, subject to Clause 4.3 below) under the System Know-How and Patent Rights to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory.

 

  4.2 Save as expressly provided by Clause 2.2 above, the Licensee hereby undertakes not to make any modifications or adaptations to the System during the subsistence of this Agreement.

 

  4.3 Subject to the provisions of this Clause 4.3, Licensee shall be entitled to grant a sublicence to the rights granted by Clause 4.1 to any one or more third parties for the purposes of any such third party producing Product for Licensee provided always:

 

  4.3.1 Licensee shall ensure such Sublicensee’s use of the System, the Intellectual Property and the Product is undertaken solely for the purpose of establishing a manufacturing process for Product, or producing Product, for Licensee; and

 

  4.3.2

The Sublicensee shall not, by virtue of this Agreement, be granted any right or licence, either express or implied, under any patent or proprietary right vested in Lonza or otherwise, to use the System, the Intellectual Property or the Product other than for the purposes of

 

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  establishing a manufacturing Process for Product or producing Product for Licensee and Licensee agrees to ensure that such Sublicensee shall not assign, transfer, further sublicense or otherwise make over the benefit or the burden of the rights granted to it pursuant to this Agreement; and

 

  4.3.3 Any Sublicence granted shall be expressly subject and subordinate to the terms of this Agreement, and it shall be Licensee’s responsibility to ensure the strict adherence by any Sublicensee hereunder to the terms and conditions of this Agreement; and

 

  4.3.4 Prior to the grant of any sublicence pursuant to this Clause 4 Licensee shall obtain the written consent of Lonza (such consent not to be unreasonably withheld), to the grant of such sublicence.

 

  4.4 If, on a country-by-country basis, any granted patents that form part of the Patent Rights (including any re-issued patents and unexpired patents), subsequently expire or no longer contain a Valid Claim such Patent Rights shall automatically fall outside the scope of this Agreement and the provisions of Clauses 4.1 to 4.3 shall only apply, with respect to granted patents, to those granted patents which contain a Valid Claim and form part of the Patents Rights for as long as those granted patents remain in force.

 

  4.5 Notwithstanding clause 4.4, on a country-by-country basis, where no Valid Claims within the Patent Rights remain in force, the provisions of Clauses 4.1 to 4.3 shall only apply for as long as the System Know-How remains secret and substantial.

 

  4.6 No licence is granted save as expressly provided herein and no licence in addition thereto shall be deemed to have arisen or be implied by way of estoppel or otherwise. Lonza agrees and acknowledges that, to the extent that they are severable from and do not utilise the System or Intellectual Property, nothing in this Agreement shall be read or construed to granted to it any intellectual property subsisting in the Product or any regulatory approvals that any person attain in respect of the Product, provided that at all time the Intellectual Property, the System and the intellectual property therein shall remain Lonza’s.

 

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5. Payments

 

  5.1 In consideration of the licence granted to Licensee pursuant to Clause 4.1 above, and in consideration for the right to sublicense the rights granted by Clause 4.1 pursuant to Clause 4.3, Licensee shall pay Lonza as follows:

 

  5.1.1 in respect of Product manufactured by Lonza, a royalty of*** percent (***%) of the Net Selling Price;

 

  5.1.2 where Licensee or Licensee’s Strategic Partner manufactures Product:

 

  5.1.2.1 a payment of pounds sterling *** (£***) due annually during the course of this Agreement, and being first payable upon commencement of Target Animal Efficacy Study for registration in US or EU (or equivalent study).

 

  5.1.2.2 a royalty of *** (***%) of the Net Selling Price of such Product manufactured.

 

  5.1.3 where any party other than Lonza, Licensee or Licensee’s Strategic Partner manufactures Product:

 

  5.1.3.1 a payment of pounds sterling *** (£***) per sublicence due annually during the course of such sublicence, and being first payable on the commencement date of the relevant sublicence; and

 

  5.1.3.2 a royalty of *** percent (***%) of the Net Selling Price of such Product manufactured.

 

  5.2 The Licensee’s obligation to pay royalties for Product according to Articles 5.1.1, 5.1.2.2, 5.1.3.2, shall apply country by country until the later of (i) expiry of the last Valid Claim, (ii) the date being ten (10) years from the date of first commercial sale of Product following marketing authorisation of the Product.

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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  5.3 If, on a country-by-country basis, the manufacture and/or sale of the Product are not protected by a Valid Claim within the Patent Rights then in respect of sales in such countries:

 

  (a) the royalties referred to in 5.1.1, 5.1.2.2 and 5.1.3.2 shall be due only in respect of the System Know-How;

 

  (b) the royalties referred to in 5.1.1 and 5.1.2.2 shall be at the rate of *** per cent (***%) of the Net Selling Price;

 

  (c) the royalties referred to in 5.1.3.2 shall be at the rate of ***per cent (***%) of the Net Selling Price.

 

  5.4 The amounts payable under Clauses 5.1.2.1 and 5.1.3.1 shall be halved if, at the time on which payment becomes due and payable under such clauses, the System shall not be protected by a Valid Claim within the Patent Rights.

 

6. Royalty Procedures

 

  6.1 Licensee shall keep true and accurate records and books of account containing all data necessary for the calculation of royalties payable to Lonza. Such records and books of account shall, upon reasonable notice having been given by Lonza (which in no event shall be less than thirty (30) days prior notice), be open at all reasonable times during regular business hours for inspection by independent auditors selected by Lonza and reasonably acceptable to Licensee. Such independent auditors shall agree to maintain the confidentiality of the information and materials disclosed during the audit. Any such audit shall be conducted in a manner that does not interfere unreasonably with the operations of Licensee’s business. Lonza may perform an audit once each calendar year. Each audit shall begin upon the date specified by Lonza and shall be completed as soon as reasonably practicable. Lonza shall pay the costs of the independent auditors conducting such audit, unless the results of the audit reveal an underpayment of 5% or more by Licensee, in which case, Licensee shall pay the reasonable costs of the independent auditors. If an audit concludes that an overpayment or

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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underpayment has occurred during the audited period, such payment shall be remitted by the party responsible for such payment to the other party within thirty (30) days after the date such auditor’s written report identifying the overpayment or underpayment is delivered to the party responsible for such payment.

 

  6.2 Licensee shall prepare a statement in respect of each calendar quarter which shall show for the immediately preceding quarter details of the sales of Product and the royalty due and payable to Lonza thereon.

Such statement shall be submitted to Lonza within thirty (30) days after the end of the calendar quarter to which it relates, together with a remittance for the royalties due to Lonza.

 

  6.3 All sums due under this Agreement:

 

  6.3.1 shall be made in pounds sterling to Lonza. Payments due to Lonza in currencies other than pounds sterling shall first be calculated in the relevant local currency before being calculated at the rate of exchange in effect at the close of business on the day payment is due or made, whichever is earlier, provided always that where payment is made after the date provided therefor herein conversion shall be at the rate in effect at the date of payment if this is more favourable to Lonza. The rate of exchange shall be the mean value of the Pound Spot Rate in London first published in the Financial Times on the day following the day for determining such rates.

 

  6.3.2 are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, and shall be paid by Licensee (other than taxes on Lonza’s income). The parties agree to co-operate in all respects reasonably necessary to take advantage of such double taxation treaties as may be available.

 

  6.4 Where Lonza does not receive payment of any sum by the due date, interest shall accrue thereafter on the sum due and owing to Lonza at the rate of two percent (2%) over the base rate from time to time of National Westminster Bank pic, interest to accrue on a day-to-day basis without prejudice to Lonza’s right to receive payment on the due date.

 

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7. Liability and Warranties

 

  7.1 Lonza gives no representation or warranty that the Patent Rights will be valid nor that the exercise of the rights granted to Licensee hereunder will not infringe other patent rights or intellectual property rights vested in Lonza or any third party.

 

  7.2 Lonza warrants that:

 

  (a) the patents included in the Patent Rights are the only patents that must be licensed from Lonza and/or its Affiliates in order to operate the System; and

 

  (b) it is entitled to grant the rights and licenses contained herein in accordance with the terms and conditions of this Agreement;

 

  (c) as at the date of this Agreement, to Lonza’s reasonable knowledge it has not received any written claims against Lonza alleging that the Intellectual Property infringes the intellectual property rights of any third party.

 

  7.3 the Licensee hereby acknowledges that in order to exploit the rights granted herein the Licensee may require licences under Lonza patent rights other than those herein licensed or under third party patent rights (including those vested in Affiliates of Lonza) that may be infringed by the use by the Licensee of the rights licensed herein and it is hereby agreed that it shall be the Licensee’s responsibility to satisfy itself as to the need for such licences and if necessary to obtain such licences.

 

  7.4 Each Party (“Indemnifying Party”) shall indemnify and hold harmless the other Party (“Indemnified Party”) and its Affiliates, and the officers, employees and agents of the Indemnified Party and its Affiliates at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any contractual, tortious or other claims or proceedings by third parties against Indemnified Party and/or its Affiliates and/or the officers, employees or agents of the Indemnified Party and its Affiliates arising out of the Indemnifying Party’s breach of this Agreement, including breach of representations and warranties, violation of applicable law, negligence or wilful misconduct.

 

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CONFIDENTIAL

 

  7.5 With respect to product liability claims or proceedings, the following shall apply: (a) Except to the extent provided in (b) below, Licensee shall indemnify and hold harmless Lonza and its Affiliates and the officers, employees and agents of Lonza and its Affiliates at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product, and (b) Lonza shall indemnify and hold harmless Licensee and its officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product to the extent such claims or proceedings result from defects in the Cell Lines and Vectors, or from Lonza breach of this Agreement.

 

  7.6 Notice. If a party receives notice of any claim for an indemnity under Clauses 7.4 or 7.5 (an “Indemnifying Claim”), the Indemnified Party shall, as promptly as is reasonably possible, give the Indemnifying Party notice thereof; provided, however, that failure to give such notice promptly shall only relieve the Indemnifying Party of any indemnification obligation hereunder to the extent such failure diminishes the ability of the Indemnifying Party to respond to or to defend the Indemnified Party against such Indemnifying Claim of the Indemnifying Party. The Parties shall consult and cooperate with each other regarding the response to and the defence of any such indemnifying claim and the Indemnifying Party shall assume the defence or represent the interests of the Indemnified Party in respect of such indemnifying claim of the Indemnifying Party, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Indemnified Party and to propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no such settlement shall be made without the written consent of the Indemnified Party, such consent not to be unreasonably withheld. Nothing herein shall prevent the Indemnified Party from retaining its own counsel and participating in its own defence at its own cost and expense.

 

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CONFIDENTIAL

 

  7.7 Any condition or warranty other than those relating to title which might otherwise be implied or incorporated within this Agreement by reason of statute or common law or otherwise is hereby expressly excluded.

 

  7.8 IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR LOSS OF PROFITS, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT. Nothing in this Agreement shall limit or exclude the liability of either party to the other for its fraud, or for death or personal injury arising from its negligence or for any other liability that cannot be limited or excluded as a matter of law.

 

  7.9 The terms of this Clause 7 shall survive expiration or termination of this Agreement for whatever reason.

 

8. Confidentiality

 

  8.1 Licensee expressly acknowledges that the System Know-How and any other Know-How with which it is supplied by Lonza pursuant to this Agreement is supplied in circumstances imparting an obligation of confidence and Licensee agrees to keep such Know How or System Know-How secret and confidential and to respect Lonza’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever to disclose or permit to be disclosed such Know How or System Know-How to any third party other than its Sublicensee hereunder for use in accordance with the terms of this Agreement. Licensee shall procure that only its employees and employees of it Sublicensee hereunder shall have access to the Know How or System Know-How on a need to know basis and that all such employees shall be informed of their secret and confidential nature and shall be subject to the same obligations as Licensee and its Sublicensee hereunder pursuant to this Clause 8.1.

 

  8.2

Licensee hereby undertakes and agrees to keep the System secure and safe from loss, damage, theft, misuse and unauthorised access and shall procure that the System shall be made available only to employees of Licensee and employees of its Sublicensee hereunder on a need to know basis and subject

 

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to the same obligations of confidence as provided in Clause 8.1 hereof, and to use the same for the sole purpose of this Agreement.

 

  8.3 Both parties undertake and agree not to at any time for any reason whatsoever disclose or permit to be disclosed to any third party or otherwise make use of or permit to be made use of any trade secrets or confidential information or materials relating to the business affairs or finances of the other or of any suppliers, agents, distributors, licensees or other customers of the other which comes into their possession pursuant to this Agreement.

 

  8.4 The obligations of confidence referred to in this Clause 8 shall not extend to any information which the receiving party demonstrates:

 

  8.4.1 is or shall become generally available to the public otherwise than by reason of a breach by the recipient party of such information of the provisions of this Clause 8;

 

  8.4.2 is known to the recipient party of such information and is at its free disposal prior to its receipt from the other;

 

  8.4.3 is subsequently disclosed to the recipient party without obligations of confidence by a third party owing no such obligation of confidentiality to the disclosing party; and

 

  8.4.4 Lonza or Licensee may be required to disclose to a government agency for the purpose of any statutory, regulatory or similar legislative requirement applicable to the production of Product or to meet the requirements of any Stock Exchange to which the parties may be subject, but only to the extent such disclosure is required, and subject to obligations of secrecy wherever possible; and

 

  8.4.5 can be demonstrated by competent written evidence as having been independently developed by the recipient of the information in question without access to or use or knowledge of the information of the disclosing party.

 

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  8.5 The obligations of both parties under this Clause 8 shall survive the expiration or termination of this Agreement for whatever reason.

 

9. Intellectual Property Enforcement

 

  9.1 Lonza hereby undertakes and agrees that at its own cost and expense it will:

 

  9.1.1 prosecute or procure prosecution of such of the Patent Rights which are patent applications diligently so as to secure the best commercial advantage obtainable, as determined by Lonza in its commercially reasonable discretion, and will pursue, as determined by Lonza in its commercially reasonable discretion, all necessary actions against any third party that Lonza reasonably believes is infringing, misappropriating or violating any Intellectual Property; and

 

  9.1.2 pay or procure payment of all renewal fees in respect of the Patent Rights valid and subsisting for the full term thereof and in particular will procure such renewal of the registrations thereof as may be necessary from time to time so far as it is reasonable to do so with particular reference to commercial considerations.

 

  9.2 Licensee shall promptly notify Lonza in writing of any infringement or improper or unlawful use of or of any challenge to the validity of the Patent Rights and/or Know-How. Lonza undertakes and agrees to take all such steps and proceedings and to do all other acts and things as may in Lonza’s sole discretion be necessary to restrain any such infringement or improper or unlawful use or to defend such challenge to validity and Licensee shall permit Lonza to have the sole conduct of any such steps and proceedings including the right to settle them whether or not Licensee is a party to them. Licensee shall have the right at its own cost and for its own benefit to initiate, prosecute and control the enforcement of the Patent Rights against infringement by a Third Party in the Territory if all of the following conditions are fulfilled (a) the product manufactured through the infringing activity is a competing product to the Product, (b) Lonza has not granted rights to third parties which prevent Lonza from granting such a right to enforce to Licensee, and (c) Lonza does not initiate proceedings within sixty (60) days of being requested to do so by Licensee.

 

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10. Term and Termination

 

  10.1 Unless terminated earlier in accordance with the provisions of this Clause 10 or Clause 14, this Agreement shall continue in force in each country of the world, until expiry of the last Valid Claim, or for so long as the System Know-How is identified and remains secret and substantial, whichever is later.

 

  10.2 Licensee may terminate this Agreement by giving sixty (60) days notice in writing to Lonza.

 

  10.3 Either Lonza or Licensee may terminate this Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events:

 

  10.3.1 if the other commits a breach of this Agreement which in the case of a breach capable of remedy shall not have been remedied within thirty (30) days of the receipt by the other of a notice identifying the breach and requiring its remedy.

 

  10.3.2 if the other is unable to pay its debts or enters into compulsory or voluntary liquidation (other than for the purpose of effecting a reconstruction or amalgamation in such manner that the company resulting from such reconstruction or amalgamation if a different legal entity shall agree to be bound by and assume the obligations of the relevant party under this Agreement) or compounds with or convenes a meeting of its creditors or has a receiver appointed over all or any part of its assets or takes or suffers any similar action in consequence of a debt, or ceases for any reason to carry on business.

 

  10.4 If at any time during this Agreement Licensee knowingly, directly or indirectly, opposes or assists any third party to oppose the grant of letters patent or any patent application within any of the Patent Rights or disputes or knowingly, directly or indirectly, assists any third party to dispute the validity of any patent within any of the Patent Rights or any of the claims thereof Lonza shall be entitled at any time thereafter to terminate all or any of the licences granted hereunder forthwith by notice to Licensee.

 

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  10.5 If this Agreement is terminated for any reason any and all licences granted hereunder shall terminate with effect from the date of termination and Licensee shall destroy all Vectors, Cell Lines forthwith and shall certify such destruction immediately thereafter in writing to Lonza, provided that Licensee shall be entitled to sell of any Product in its sole discretion remaining in its possession or control at the time that termination becomes effective, provided that such sales shall be completed within six (6) months of the date of expiry or termination of this Agreement and any stocks of Product still remaining shall be destroyed (with an appropriate written certificate of such destruction being immediately sent to Lonza). Licensee shall pay Lonza the royalties in respect of such sales in accordance with Clause 6.

 

  10.6 Termination for whatever reason or expiration of this Agreement shall not affect the accrued rights of the parties arising in any way out of this Agreement as at the date of termination. The right to recover damages against the other and all provisions which are expressed to survive this Agreement shall remain in full force and effect.

 

11. Assignment

 

  11.1 Save as expressly provided by Clause 4, neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement (i) to an Affiliate or (ii) to any 50/50 joint venture company of which Lonza or Licensee, as the case may be, is the beneficial owner of fifty percent (50%) of the issued share capital thereof or (iii) to any company with which that party may merge or (iv) to any company to which that party may transfer its assets and undertaking.

 

  11.2 This Agreement shall be binding upon the successors and assigns of the parties and the name of a party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing herein shall permit any assignment by either party except as expressly provided herein.

 

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12. Governing Law and Jurisdiction

 

  12.1 The validity, construction and performance of this Agreement shall be governed by English law and the parties submit to the non-exclusive jurisdiction of the courts of England and Wales.

 

  12.2 Either party shall have the right to take proceedings in any other jurisdiction for the purposes of enforcing a judgement or order obtained from any court of competent jurisdiction.

 

13. Force Majeure

Neither party shall be in breach of this Agreement if there is any total or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God (including without limitation, fire), act of government or state, war, civil commotion, insurrection, embargo, epidemic, terrorism or earthquake, prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of either party. If either party is unable to perform its duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 13 such party shall give written notice to the other of such inability stating the reason in question. The operation of this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the party relying upon it shall give written notice to the other of this fact. If the reason continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the party not claiming under this Clause 13 shall have the right to terminate this Agreement by giving written notice of such termination to the other party.

 

14. Illegality

 

  14.1 If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of Justice:

 

  (i) such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement;

 

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  (ii) the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and

 

  (iii) the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rending such provision invalid or unenforceable.

 

15. Miscellaneous

 

  15.1 This Agreement embodies and sets forth the entire agreement and understanding of the parties and supersedes all prior oral and written agreements, understanding or arrangements relating to the subject matter of this Agreement. Neither party shall be entitled to rely on any agreement, understanding or arrangement which is not expressly set forth in this Agreement.

 

  15.2 This Agreement shall not be amended, modified, varied or supplemented except in writing signed by duly authorised representatives of the parties.

 

  15.3 No failure or delay on the part of either party hereto to exercise any right or remedy under this Agreement shall be construed or operated as a waiver thereof nor shall any single or partial exercise of any right or remedy under this Agreement preclude the exercise of any other right or remedy or preclude the further exercise of such right or remedy as the case may be. The rights and remedies provided in this Agreement are cumulative and are not exclusive of any rights or remedies provided by law.

 

  15.4 Except as required by law, the text of any press release or other communication to be published by or in the media whether of a scientific nature or otherwise and concerning this Agreement shall require the prior written approval of Lonza and Licensee.

 

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  15.5 Each of the parties hereto shall be responsible for its respective legal and other costs incurred in relation to the preparation of this Agreement.

 

  15.6 The parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999, or by any other statute or common-law principle, by any person who is not a party to this Agreement.

 

16. Notice

 

  16.1 Any notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if sent by e-mail (to the e-mail address set out below) and receipt of such notice is expressly confirmed by the other party or is left at or sent by registered post or by a reputable overnight courier to a party or delivered in person to a party at the address set out below for such party or such other address as the party may from time to time designate by written notice to the other(s):

Address of Lonza

Lonza Sales AG, 228 Bath Road, Slough, Berkshire SL1 4DX

Facsimile: 01753 777001

E-mail: [                    ]

For the attention of the Head of Legal Services

Address of Licensee

Nexvet Biopharma Pty Ltd of 9 Meaden Street, Southbank 3006,

Victoria, Australia

Facsimile: [                    ]

E-mail: mark.heffernan@nexvet.com

For the attention of Mark Heffernan, PhD, CEO

 

  16.2 All such notices and documents shall be in the English language. Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the notice or other document by post or, where the notice or other document is sent by hand, at the time of such delivery. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched.

 

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17. Interpretation

 

  17.1 The headings in this Agreement are inserted only for convenience and shall not affect the construction hereof.

 

  17.2 Where appropriate words denoting a singular number only shall include the plural and vice versa.

 

  17.3 Reference to any statute or statutory provision includes a reference to the statute or statutory provision as from time to time amended, extended or re-enacted.

AS WITNESS the hands of the duly authorised representatives of the parties hereto

 

Signed for and on behalf of

LONZA SALES AG

  

/s/ Gerry Kennedy

Gerry Kenney

Authorised Signatory

 

   TITLE

Signed for and on behalf of

LONZA SALES AG

  

/s/ Jeetendra Vaghjiani

Jeetendra Vaghjiani

Authorised Signatory

 

   TITLE

Signed for and on behalf of

NEXVET BIOPHARMA PTY LTD

  

/s/ Mark Heffernan

Mark Heffernan

CEO

   TITLE

 

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SCHEDULE 1

***

 

Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Priority Application Dates:

   ***

Earliest Publication Date/No:  

   ***

 

Territory   Appl. Date   Patent No.   Expiry Date
***   ***   ***   ***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


CONFIDENTIAL

 

Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Inventors:

   ***

Priority Application Dates:

   ***

Earliest Publication Date/No:  

   ***

 

Territory   Appl. Date   Patent No.   Expiry Date
***   ***   ***   ***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Priority Application Dates:

   ***

Earliest Publication Date/No:  

   ***

 

Territory   Appl. Date   Patent No.   Expiry Date
***   ***   ***   ***

 

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Lonza Ref. No.

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Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Priority Application Dates:

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Earliest Publication

Date/No:  

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Territory   Appl. Date   Patent No.   Expiry Date
***   ***   ***   ***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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EX-10.8 13 d775834dex108.htm EX-10.8 EX-10.8

Exhibit 10.8

CONFIDENTIAL

AGREEMENT

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD


CONFIDENTIAL

 

THIS AGREEMENT is made the 16th day of December 2013

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD of 9 Meaden Street, Southbank 3006, Victoria, Australia , (“Customer”).

WHEREAS:

 

A. Customer is the proprietor of the antibody known as NV-02; and

 

B. Lonza and its Affiliates has the expertise in the evaluation and production of monoclonal antibodies for therapeutic use; and

 

C. Customer wishes to contract Lonza for Services relating to the antibody as described in this Agreement; and

 

D. Lonza is prepared to perform such Services for Customer on the terms and conditions set out herein.

NOW IT IS AGREED AS FOLLOWS:

 

1. Definitions and Interpretation

The following terms shall have the following meanings unless the context requires otherwise:

 

“Affiliate”

means any Company, partnership or other entity which directly or indirectly Controls, is Controlled by or is under common Control with the relevant party to this Agreement. “Control” means the ownership of more than fifty per cent (50%) of the issued share capital or the legal power to direct or cause the direction of the general management and policies of the party in question;

 

“Agreement”

means this agreement incorporating the Schedules as amended or varied from time to time by written agreement of the parties;

 

“Batch”

means the total Product obtained from one fermentation and associated purification using the Process and carried out in accordance with cGMP;

 

“Cell Line”

means the cell line, particulars of which are set out in Schedule 1;

 

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CONFIDENTIAL

 

 

“cGMP”

means current good manufacturing practices and general biologics products standards as promulgated under the European Commission Directives 2001/83/EC, as amended, and Directive 2003/94/EC; the U.S. Federal Food, Drug and Cosmetic Act found in Title 21 of the U.S. Code of Federal Regulations (CFR), including but not limited to Parts 210, 211 and Parts 11, 301 et seq., 600 to 610, the European Commission Guidelines of Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 2003/94/EC (Eudralex – Volume 4);

 

“cGMP Product”

means Product which is required under Schedule 2 to be manufactured in accordance with cGMP;

 

“Customer Information”

means:

 

  (i) all technical and other information;

 

  (ii) information that comprise modifications to the Process that make the Process suitable or more effective and/or efficient (including improvements in yield and purity) for the expression, purification and production of canine and other non-human mammalian antibodies)

 

  to the extent that (i) and (ii) are not known to Lonza or in the public domain from time to time and are supplied by Customer to Lonza and includes the Customer Patent Rights, Customer Materials and ideas and information;

 

“Customer Materials”

means the Materials supplied by Customer to Lonza (if any) and identified as such by Schedule 1 hereto;

 

“Customer Patent Rights”

means all patents and patent applications of any kind throughout the world that claim the Product or the Cell Line or the Customer Materials or uses thereof in the life sciences or are otherwise owned by the Customer and are necessary or useful in performance of the Services excluding in all cases the Lonza Patent Rights;

 

“Deliver”, “Delivered” or “Delivery”

has the meaning given to it in Clause 4;

 

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CONFIDENTIAL

 

 

“External Laboratories”

means any third party instructed by Lonza, with Customer’s consent, to conduct activities required to complete the Services, including but not limited to, third parties that synthesise DNA or perform tests on the Cell Line, Product or materials derived therefrom;

 

“GS”

means the glutamine synthetase expression system of which Lonza is the proprietor;

 

“GS Licence”

means a licence granted by Lonza in respect of the use of GS;
 

 

“Initial Phase”

shall have the meaning set out in clause 2.5;

 

“Lonza Know-How”

means all technical and other information relating directly or indirectly to the Process and/or the performance of the Services known to Lonza or its Affiliates from time to time other than confidential Customer Information and information in the public domain;

 

“Lonza Patent Rights”

means all patents and patent applications of any kind throughout the world relating to the Process which from time to time Lonza or one of its Affiliates is the owner of or is entitled to use;

 

“Pilot Batch”

means the small scale volume of the Product which is produced as a result of the operation of the Process (but not in accordance with cGMP);

 

“Price”

means the price specified in Schedule 3 for the Services;

 

“Process”

means Lonza’s process for the development and production of the Product from the Cell Line, including any improvements or modifications thereto from time to time, all of which excludes Customer Information;

 

“Product”

means all or any part of the product manufactured under this Agreement using the Process (including any sample thereof), particulars of which are set out in Schedule 1 and includes all derivatives thereof;

 

“Quality Agreement”

means the quality agreement entered into by the Parties after the Effective Date and which refers to this Agreement, substantially in the form and substance set out in Schedule 4;

 

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CONFIDENTIAL

 

 

“Services”

means all or any part of the services the subject of this Agreement performed by Lonza (including, without limitation, cell culture evaluation, purification evaluation, master, working and extended cell bank creation, and sample and bulk production) particulars of which are set out in Schedule 2;

 

“Specification”

means the specification for the cGMP Product, particulars of which are set out in Schedule 1;

 

“Steering Committee”

shall have the meaning set out in Clause 14.2;

 

“Technical Project Team”

shall have the meaning set out in Clause 14.1;

 

“Terms of Payment”

means the terms of payment specified in Schedule 3;

 

“Territory”

means UK, EU, USA, Japan and Australia;

 

“Testing Summary”

shall have the meaning set out in Clause 2.4 and as modified in accordance with Clause 2.5;

 

“Veterinary Product Regulations”

shall mean any Australian, US or EU laws, regulations, guidelines, or policies which, from time to time, regulate the development, supply and marketing of veterinary products, including the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products and the US FDA / CVM Guidance for Industry;

 

     References to the singular number include the plural and vice versa, references to Clauses and Schedules are references to clauses and schedules to this Agreement.

 

2. Provision of the Services

 

2.1 Lonza shall diligently carry out the Services as provided in Schedule 2 and shall use reasonable efforts to achieve the estimated timescales set out in that Schedule (“Time Schedule”).

 

2.2 For the purpose of ensuring as much as reasonably practical compliance with the Time Schedule, the parties shall actively monitor Lonza’s adherence to the Time Schedule through the Steering Committee and the parties’ respective technical program team. Each technical program team shall comprise at least one representative from each party, each of which shall be knowledgeable in the manner in which the Services are performed. The parties envisage that during each of the Cell Line and Purification stages, they will convene meetings (whether in person or by conference call) of the technical program team at least once every week, or as otherwise agreed between the parties. If at or in advance of any such meeting one party notifies the other of an expected, foreseeable or actual delay of the Time Schedule, the parties shall discuss and analyse such delay and shall together resolve how to best minimize such delay and how to avoid any such or similar delay being repeated.

 

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CONFIDENTIAL

 

2.3 Each of the stages of work shall, in accordance with and as set out in Schedule 2, include preparation of written documentation setting out the processes and procedures to be carried out in that stage of work. Completion of each stage shall occur in accordance with the terms of Schedule 2 and the details of the applicable stage or sub-stage.

 

2.4 Lonza shall manufacture Pilot Batches in accordance with the project plan. It is understood and acknowledged that the first three (3) Pilot Batches will not meet cGMP or Specification or any specification, quantity or quality obligations and Lonza gives no warranty in this regard. Notwithstanding the foregoing in this Section 2.4 and subject always to the unpredictable nature of the biological processes involved, Lonza will perform the project plan in a professional manner, and in doing so, will adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically).

 

2.5 Following completion of the first three (3) Pilot Batches where there has been no material change in the process or procedure (for the avoidance of doubt this may be after any number of Pilot Batches for which the process or procedures have been changed) (the “Initial Phase”) the parties shall, based on the scientific data generated as part of such first three (3) Pilot Batches where there has been no material change in the process or procedure, agree in writing on the parameters (including permitted margins of error) and specifications of a testing summary (the “Testing Summary”). For the avoidance of doubt there shall be no obligation on Lonza to agree to anything which would require Lonza to perform services outside the capabilities of the Process and/or facilities as demonstrated by the scientific data generated from the Initial Phase. Any Pilot Batch made after the Initial Phase shall be tested and released against a certificate of testing which will relate to such Testing Summary. Customer shall pay to Lonza the applicable Price for all Pilot Batches conducted in the Initial Phase (including for the avoidance of doubt, those Pilot Batches before the first three Pilot Batches for which there was no material change in the process or procedure, as well as the first three Pilot Batches for which there was no material change in the process or procedure). Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such noncompliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

 

2.6 If required by Customer, Lonza shall manufacture cGMP Product to meet the Specification provided that there shall be no such obligation to meet the Specification in respect of the first three (3) Batches of cGMP Product manufactured or in respect of the first cGMP Batch manufactured following any change in the Process agreed to or requested by Customer.

 

2.7 Owing to the unpredictable nature of the biological processes involved in the Services but subject to Clauses 2.1, 2.2 and 2.4, the timescales set down for the performance of the Services (including without limitation the dates for production and Delivery of Product) and the quantities of Product for Delivery set out in Schedule 2 are estimated only.

 

2.8

Subject to Lonza’s obligations under Clauses 2.1, 2.4, 2.5, 2.6, 2.9, 2.10 and 2.11, Customer shall not be entitled to cancel any unfulfilled part of the Services or to

 

6


CONFIDENTIAL

 

     refuse to accept the Services on grounds of late performance, late delivery or failure to produce the estimated quantities of Product for Delivery. Lonza shall not be liable for any loss, damage, costs or expenses of any nature, whether direct or consequential, occasioned by:

 

  (a) any delay in performance or Delivery howsoever caused; or

 

  (b) any failure to produce the estimated quantities of Product for Delivery,

 

     except that and notwithstanding anything to the contrary in this Agreement, Customer shall not be under any obligation to accept the Services or any Product generated from performance of the Services if such Product does not comply with the Testing Summary and also if such failure resulted from Lonza’s failure to: (i) follow the project plan procedures, or (ii) perform the project plan in a professional manner, or (iii) adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically), subject always to the unpredictable nature of the biological processes involved in the Services.

 

2.9 Lonza shall comply with the International Committee for Harmonisation regulatory requirements from time to time applicable to the Services as set out in Schedule 2.

 

2.10 Lonza hereby undertakes not to use the Cell Line, Customer Materials or Customer Information (or any part thereof) for any purpose other than the performance of the Services under this Agreement.

 

2.11 Lonza shall:

 

  (a) at all times use all reasonable endeavours to keep the Cell Line and/or Customer Materials secure and safe from loss and damage in such manner as Lonza stores its own material of similar nature;

 

  (b) not part with possession of the Cell Line and/or Customer Materials or the Product, save for the purpose of activities at the External Laboratories or as otherwise authorised in writing by Customer; and

 

  (c) obtain the consent of Customer before appointing an External Laboratory to perform any of the Services and procure that all External Laboratories are subject to obligations of confidence substantially in the form of those obligations of confidence imposed on Lonza under this Agreement.

 

2.12 Lonza shall provide Customer with consolidated Batch records, and shall provide Customer with access to the complete Batch records at Lonza’s Slough Facility (at a time and date agreed between the Parties).

 

2.13 The Parties shall enter into the Quality Agreement as soon as reasonably possible after the Effective Date. Responsibility for quality assurance and quality control of Product shall be allocated between the Parties as set forth in the Quality Agreement.

 

2.14 Where the Cell Line uses GS, Customer acknowledges that it will require a GS Licence from Lonza prior to in vivo clinical studies or any other commercial use or sale of the Product.

 

2.15

The Parties acknowledge and agree that during the term of the Agreement, there may be requirements under any Veterinary Regulations which will necessitate a

 

7


CONFIDENTIAL

 

change in any of the Process or any of the Services to be provided under this Agreement, the matter will be elevated to the Steering Committee to determine the nature of any such changes in accordance with clause 14.3. The Parties will negotiate in good faith the changes necessary to comply with any Veterinary Regulations (if applicable) and any additional work associated with such changes shall be at Customer’s expense.

 

3. Customer Obligations

 

3.1 Immediately following the date of the Agreement Customer shall supply to Lonza Customer Information, together with full details of any hazards relating to the Cell Line and/or Customer Materials, their storage and use. On review and approval by Lonza’s safety committee of this Customer Information, the Cell Line and/or Customer Materials shall be provided to Lonza at Lonza’s request. Property in the Cell Line and/or Customer Materials and/or Customer Information supplied to Lonza shall remain vested in Customer.

 

3.2 Customer shall pay the Price set out in Schedule 3 for provision of the Services together with any additional costs and expenses that fall due under this Agreement in accordance with the Terms of Payment.

 

3.3 Customer hereby grants Lonza the non-exclusive right to use the Cell Line, Customer Materials, Customer Patent Rights and Customer Information for the purpose of this Agreement.

 

3.4 Customer shall obtain and maintain product liability insurance with a reputable and solvent insurance provider in the amount of at least US$10,000,000 per event or linked events. Customer shall supply Lonza with a copy of insurance policy on reasonable request and Customer shall not terminate or amend (other than amending to increase the level of cover) such policy without prior written notice to Lonza.

 

4. Delivery, Transportation of Product and Customer Tests

 

4.1 Product shall be Delivered EXW (ex-works) Lonza’s premises in Slough, UK (as defined by Incoterms 2010) which means (a) when Lonza places Product at the disposal of Customer at Lonza’s premises, not cleared for export and not loaded onto any collecting vehicle and (b) risk and title to Product pass to Customer at such time (“Deliver,” “Delivery,” or “Delivered,” as appropriate). Lonza shall deliver to Customer the Certificate of Analysis not later than the date of Delivery. Transportation of Product, whether or not under any arrangements made by Lonza on behalf of Customer, shall be made at the sole risk and expense of Customer.

 

4.2 [Not used]

 

4.3 Unless otherwise agreed by both parties in writing, Lonza shall package and label Product for Delivery in accordance with its standard operating procedures. It shall be the responsibility of Customer to inform Lonza in writing in advance of any special packaging and labelling requirements for Product. All additional costs and expenses of whatever nature incurred by Lonza in complying with such special requirements shall be charged to Customer in addition to the Price.

 

4.4

If requested in writing by Customer, Lonza will (acting as agent for Customer) arrange for insurance of Product whilst held by Lonza after Delivery (awaiting transportation) for a maximum of fourteen (14) days on terms equivalent to those

 

8


CONFIDENTIAL

 

  under which Lonza insures product prior to Delivery. All additional costs and expenses of whatever nature incurred by Lonza in arranging such insurance shall be charged to Customer in addition to the Price.

 

4.5 If requested in writing by Customer, Lonza will (acting as agent of Customer for such purpose) arrange the transportation of Product from Lonza’s premises to the destination indicated by Customer together with insurance cover for Product in transit at its invoiced value. All additional costs and expenses of whatever nature incurred by Lonza in arranging such transportation and insurance shall be charged to Customer in addition to the Price. Transportation of Product shall be at the sole risk of Customer who shall be deemed to have full knowledge of the carrier’s terms and conditions of carriage. The Customer shall, as appropriate, observe, perform and be subject to the carriage terms in relation to the transportation of the Product.

 

4.6 Where Lonza has made arrangements for the transportation of Product, Customer shall diligently examine the Product as soon as practicable after receipt. Notice of all claims (time being of the essence) arising out of:

 

  (a) visible damage to or total or partial loss of Product in transit shall be given in writing to Lonza and the carrier within three (3) working days of receipt by Customer; or

 

  (b) Delivery shall be given in writing to Lonza within ten (10) days after the date of Lonza’s despatch notice.

 

4.7 Customer shall make damaged Product and associated packaging materials available for inspection and shall comply with the requirements of any insurance policy covering the Product notified by Lonza to Customer. Lonza shall offer Customer all reasonable assistance (at the cost and expense of Customer) in pursuing any claims arising out of the transportation of Product.

 

4.8 Promptly following receipt of Product (whether from a Pilot Batch after the Initial Phase or cGMP Product) or any sample thereof, Customer may carry out any of the tests outlined or referred to in the Testing Summary set out in Schedule 1. Subject to Clause 2, if such tests show that the Product does not comply with the Testing Summary (in respect of product from a Pilot Batch after the Initial Phase) or the Specification (in respect of cGMP Product), Customer shall give Lonza written notice thereof within sixty (60) days from the date of Delivery and shall return such Product to Lonza’s premises for further testing. In the absence of such written notice Product shall be deemed to have been accepted by Customer as meeting the Testing Summary or Specification (as applicable). Subject to Clause 2.4, if Customer has reasonably demonstrated to Lonza that Product returned to Lonza fails to meet Testing Summary or Specification (as applicable) and that such failure is due to Lonza’s failure to: (i) follow the project plan procedures, or (ii) perform the project plan in a professional manner, or (iii) adhere to the highest standards generally acceptable in the industry (being the industry of manufacturing biologics generally and antibodies specifically), Lonza shall at Customer’s discretion refund that part of the Price that relates to the production of such Product or replace such Product at its own cost and expense. In the event Customer requires Lonza to replace such Product, Lonza shall use reasonable endeavours to do so with the minimum delay having regard to its commitments to third parties in the timing of such replacement. For the avoidance of doubt, if the reason that the Product fails to meet the Testing Summary or Specification (as applicable) is due to a scientific or technical or other reason beyond Lonza’s reasonable control, Lonza shall not have any obligations to replace or refund under this Clause 4.8.

 

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CONFIDENTIAL

 

 

4.9 Upon Customer giving to Lonza written notice in accordance with Section 4.8, Customer shall thereby automatically become entitled to access and inspect (pursuant to the provisions of this Clause 4.9) Lonza’s laboratory notebooks and all other records relating to performance of the Services (“Records”). Lonza shall keep complete and accurate Records for a period of 7 years for Product, each considered separately and Customer shall have the right to have such records examined during that time. Upon two (2) weeks prior written notice from Customer, Lonza shall permit a person appointed by Customer as Customer’s authorized representative to have access to Lonza’s Slough site during normal business hours to examine the Records, provided that at all times during such inspection a Lonza employee accompanies the person appointed by Customer. Customer shall bear the full cost of such inspection.

 

4.10 Subject to Clause 2, if there is any dispute concerning whether Product returned to Lonza fails to meet the Testing Summary of Specification (as applicable) or whether such failure is due (in whole or in part) to acts or omissions of Customer or any third party after Delivery, such dispute shall be referred for decision to an independent expert (acting as an expert and not as an arbitrator) to be appointed by agreement between Lonza and Customer or, in the absence of agreement by the President for the time being of the Association of the British Pharmaceutical Industry. The costs of such independent expert shall be borne equally between Lonza and Customer. The decision of such independent expert shall be in writing and, save for manifest error on the face of the decision, shall be binding on both Lonza and Customer.

 

4.11 The provisions of Clauses 4.8 and 4.9 shall be the sole remedy available to Customer in respect of Product that fails to meet Testing Summary or Specification.

 

5. Price and Terms of Payment

 

5.1 Unless otherwise indicated in writing by Lonza, all prices and charges are exclusive of Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by Customer (other than taxes on Lonza’s income). All invoices are strictly net and payment must be made within thirty (30) days of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature.

 

5.2 In the case of cGMP production, Customer shall pay a handling charge of fifteen percent (15%) on the costs of all raw materials (excluding resins), plus freight, taxes and insurance.

 

5.3 In default of payment on due date:

 

  (a) interest shall accrue on any amount overdue at the rate of two per cent (2%) above the base lending rate from time to time of National Westminster Bank plc, interest to accrue on a day to day basis both before and after judgment; and

 

  (b) Lonza shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Services or to treat this Agreement as repudiated on not less than ten (10) days’ prior notice in writing to Customer given at any time thereafter.

 

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CONFIDENTIAL

 

 

6. Intellectual Property

 

6.1 Neither party will, as a result of this Agreement, acquire any right, title, or interest in any intellectual property that the other party owns or controls as of the Effective Date of this Agreement, or that the other party obtains ownership or control of separate and apart from the performance of the Services under this Agreement. Lonza shall retain all rights to and in the Process (but subject to Customer’s ownership of the Customer Information), Lonza Patent Rights and Lonza Know-How. Notwithstanding anything to the contrary in this Agreement but subject to the preceding two sentences, Customer shall, at all times (both during the term of this Agreement and thereafter) retain all rights in and to the Product (subject to the terms of the GS Licence). Customer shall retain all intellectual property rights of any nature whatsoever subsisting in:

 

  (i) the composition of matter of the Product and the composition of matter of all fragments, including epitopes thereof and all primers and probes corresponding thereto; and

 

  (ii) the use in life science applications of all of the composition described in paragraph (i) of this Section 6.1;

 

  (iii) Customer Information; and

 

  (iv) results from experiments conducted (provided that the experiments themselves that comprise part of the Process shall belong to Lonza) with, and the results of research and development carried out under this Agreement with, the use of any of the biological materials identified in paragraph (i) of this Section 6.1.

 

6.2 Lonza shall own all right, title and interest in “New General Application Intellectual Property,” which as used in this Agreement means intellectual property that Lonza and/or its Affiliates, contractors or agents develops, conceives, invents, reduces to practice or makes in the course of performance of the Services and that: (i) arises from or relates to the Process, Lonza Patent Rights or Lonza Know-How and/or the development or manufacture of biological or chemical products (other than the Product); and (ii) is severable from Customer Patents Rights and from Customer Information and does not reveal or disclose Customer Information or Customer Materials. If Lonza makes use of Customer Information that comprises new ideas and reduces these to practice, Nexvet hereby grants Lonza and its Affiliates a non-exclusive, world-wide, fully paid-up, irrevocable and transferable licence to use those new ideas for research purposes only. If Lonza wishes to make use of such new ideas for anything other than research purposes, the provision of clause 6.6 shall apply.

 

6.3

Except for and not including the New General Application Intellectual Property, Customer shall own all right, title, and interest in any and all intellectual property that Lonza and/or its Affiliates conceives, invents, reduces to practice, develops or makes, solely or jointly with Customer or others, in the course of performance of the Services or as a result of receipt of Customer Information or Customer Materials and (in each case) which is a development or direct derivative of Customer Information or Customer Materials (collectively, the “New Customer Intellectual Property”). Lonza hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual Property. Lonza shall promptly disclose to Customer in writing all New Customer Intellectual Property. Lonza shall execute, and shall require Lonza’s personnel involved in the performance of the Services to execute, any documents

 

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CONFIDENTIAL

 

  required to confirm Customer’s ownership of the New Customer Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property. Upon Customer’s request and at Customer’s reasonable expense, and at no cost to Lonza, Lonza shall assist Customer as may be necessary to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property. For the avoidance of doubt, the parties agree that the term “New Customer Intellectual Property” shall not under any circumstances be interpreted or defined to include any “New General Application Intellectual Property”.

 

6.4 Lonza hereby grants Customer a non-exclusive, world-wide, fully paid-up, irrevocable and transferable licence, with the right to grant and authorize sublicenses, under and to all New General Application Intellectual Property, to the extent such New General Application Intellectual Property is necessary or useful to develop, conduct clinical trials for, formulate, manufacture, test, seek regulatory approval for, market, commercialize, make, have made, use, sell, import, and distribute Product.

 

6.5 Lonza recognises that Customer may wish to transfer the Process to a third party to manufacture the Product, and the Parties agree that the Lonza Know- How and the Lonza Patents contained in the Process may be transferred to a third party (the “Technology Transfer”), on terms and a price to be agreed depending on the scope of the Technology Transfer. Lonza agrees that the maximum sum payable by Customer to Lonza for such Technology Transfer shall be:

 

  (a) £ *** to transfer the Process at any time prior to the commencement of cGMP manufacturing activities; and

 

  (b) £ *** to transfer the Process at any time after the commencement of cGMP manufacturing activities,

with the precise amount payable to be determined in advance of such transfer.

 

6.6 If Lonza wishes to use any Customer Information or Customer Materials or Customer Patent Rights for purposes outside this Agreement, the parties shall discuss relevant terms on which Lonza may be granted a licence to do so. If a third party will wish to use any Customer Information or Customer Materials, Nexvet shall enter into a direct contractual arrangement with such third party.

 

7. Warranties and Indemnification

 

7.1 Lonza warranty: Lonza warrants that:

 

  (a) the Services shall be performed in accordance with Clauses 2.1 and 2.2;

 

  (b) at all times throughout the term of this Agreement and subject to 7.1(f), Lonza shall have and maintain all of the approvals and certifications and licences within the Territory, including all regulatory approvals and certifications and licences that it is required to have and maintain within the Territory in order to be entitled to lawfully exercise its rights and perform its obligations under this Agreement, including performance of the Services;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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CONFIDENTIAL

 

 

  (c) unencumbered title (save for any intellectual property rights which may exist) to Product will be conveyed to Customer upon Delivery;

 

  (d) as of the date of this Agreement the Lonza Know How and Lonza Patent Rights are owned by Lonza or Lonza is otherwise entitled to use them for the purposes of providing Services under this Agreement and during the term of this Agreement Lonza shall not do or cause anything to be done which would adversely affect their ownership or entitlement to use the same for those purposes;

 

  (e) Lonza has the necessary corporate authorisations to enter into this Agreement;

 

  (f) as of the date of this Agreement to the best of Lonza’s knowledge and belief, the use by Lonza of the Process (excluding any modifications or steps made or developed by Customer, Customer Materials, Customer Information and Customer Patent Rights) and Lonza Patent Rights and Lonza Know How for the performance of the Services as provided herein will not infringe any rights (including without limitation any intellectual or industrial property rights) vested in any third party; and

 

  (g) Lonza will notify Customer in writing immediately if it receives or is notified of a claim from a third party that the use by Lonza, it’s Affiliates, contractors or External Laboratories, of the Process and/or the Lonza Know How or the Lonza Patent Rights for Services infringes any intellectual property rights vested in such third party.

 

7.2 Customer warranty: Customer warrants that:

 

  (a) Customer has and shall at all times throughout the term of this Agreement have the right to supply the Cell Line, the other Customer Materials and the Customer Information to Lonza and the necessary rights to license or permit Lonza, its Affiliates, contractors and External Laboratories to use the same for the purpose of the Services;

 

  (b) Customer has the necessary corporate authorisations to enter into this Agreement;

 

  (c) any of the Cell Line, the other Customer Materials, Customer Information and Customer Patent Rights not owned by Customer are licensed to Customer under a licence which will permit their use by Lonza, its Affiliates, contractors and External Laboratories to perform the Services;

 

  (d) not to use any product produced as part of a Pilot Batch in any clinical trial, or to administer it to human patients, acknowledging that product produced as part of a Pilot Batch will be used in feline patients;

 

  (e)

as of the date of this Agreement to the best of Customer’s knowledge and belief, the use by Lonza, its Affiliates, contractors and External Laboratories of the Cell Line, other Customer Materials, Customer Information and Customer Patent Rights for the Services(including without limitation the manufacture of the Product) will not infringe any intellectual property rights of any third party (provided, however, that Lonza shall waive any breach of this warranty which arises if a court of competent jurisdiction determines that the use by Lonza of the Cell Line, other Customer Materials, Customer

 

13


CONFIDENTIAL

 

Information or Customer Patent Rights for the Services infringes the intellectual property rights of a third party, provided that and for so long as Customer actually indemnifies Lonza pursuant to clause 7.5 below); and

 

  (f) Customer will promptly notify Lonza in writing if it receives or is notified of a claim from a third party that the Cell Line, other Customer Materials, Customer Information or the Customer Patent Rights or that the use by Lonza, its Affiliates, contractors and/or External Laboratories thereof for the provision of the Services infringes any intellectual property rights of such third party.

 

7.3 Disclaimer: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND, EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, ALL OTHER WARRANTIES AND CONDITIONS, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OR CONDITION OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

7.4 Indemnification by Lonza: Subject to clauses 7.6, 7.7, 7.8, 7.9 and 7.10 below, Lonza shall defend, indemnify and hold harmless each of (i) Customer and (ii) its Customer’s Affiliates and (iii) the directors, officers, and employees of Customer and / or its Affiliates and (iv) the successors and assigns of any of the foregoing (each of (i), (ii), (iii) and (iv) a “Customer Indemnitee”) from and against any loss, damage, costs, claims, liabilities and/ or expenses (including court costs and legal fees on a full indemnity basis) that Customer or a Customer Indemnitee may suffer arising directly out of any breach of the warranties given by Lonza in clause 7.1 above or any claims alleging that Lonza’s sole use of Lonza Know-How (excluding use of Lonza Know-How with Customer Materials, Customer Patent Rights or Customer Information) infringes any rights (including without limitation any intellectual property rights) vested in a third party (whether or not Lonza knows or ought to have known the same) provided that there shall be excluded from this indemnity all Customer revenue.

 

7.5 Indemnification by Customer: Subject to clauses 7.6 and 7.7 below, Customer shall defend, indemnify and hold harmless each of (i) Lonza and (ii) its Lonza’s Affiliates and (iii) the directors, officers, and employees of Lonza and/or its Affiliates and (iv) the successors and assigns of any of the foregoing (each of (i), (ii), (iii) and (iv) a “Lonza Indemnitee”) from and against any loss, damage, costs, claims, liabilities and/or expenses of any nature (including court costs and legal fees on a full indemnity basis), that Lonza or a Lonza Indemnitee may suffer arising directly out of any breach of the warranties given by Customer in clause 7.2 above or any claims alleging the use by Lonza or its Affiliates, contractors or External Laboratories of the Cell Line, the Customer Materials, Customer Patent Rights or the Customer Information infringes any rights (including, without limitation, any intellectual property rights) vested in any third party (whether or not Customer knows or ought to have known about the same) provided that there shall be excluded from this indemnity all Lonza actual or potential revenues other than those which are an integral part of any Price or fees which Customer is obliged to pay to Lonza under this Agreement. Customer shall further indemnify and maintain Lonza and the Lonza Indemnitees promptly indemnified against all claims, actions, costs, losses, damages, expenses (including court costs and legal fees on a full indemnity basis) or other liabilities whatsoever in respect of:

 

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  (a) any product liability in respect of Product (or any product that contains Product), unless such liability is caused by the negligent act or omission of Lonza in the production and/or supply of Product; and

 

  (b) any negligent or wilful act or omission of Customer or any of its Affiliates in relation to the use, processing, storage or sale of the Product.

 

7.6 Indemnification Procedure: If a Lonza Indemnitee or Customer Indemnitee (the “Indemnitee”) intends to claim indemnification under this clause 7, it shall promptly notify the other party (the “Indemnitor”) in writing of such alleged liability. The Indemnitor shall have the right to control the defence thereof with counsel of its choice as long as such counsel is reasonably acceptable to Indemnitee; provided, however, that any Indemnitee shall have the right to retain its own counsel at its own expense, for any reason, including if representation of any Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party reasonably represented by such counsel in such proceeding. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any liability covered by this clause 7. The obligations of this clause 7.6 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve the Indemnitor of any obligation to the Indemnitee under this clause 7. It is understood that only Lonza or Customer may claim indemnity under this clause 7 (on its own behalf or on behalf of its Indemnitees), and other Indemnitees may not directly claim indemnity hereunder.

 

7.7 Subject to Clause 7.9, in no event shall either Party or any and all of its Affiliates have any liability to the other Party or any and all of their Affiliates or Indemnitees pursuant to or in connection with this Agreement or the Services whether in contract, tort, negligence, breach of statutory duty, under any indemnity or otherwise howsoever arising for any loss of profit, loss of revenue, incidental, indirect, special, punitive or consequential damages, save that this Clause 7.7 shall not restrict or limit any liability resulting from breach of confidentiality (clause 8), personal injury or death (of humans), gross negligence or intentional wrongdoing. It is also acknowledged that any third party claims for which recompense from the other under any indemnity in this Agreement shall be regarded as a direct loss and shall not be limited by this Clause 7.7, even if such third party claim could be considered as a special, incidental, indirect or consequential damages, or punitive damages.

 

7.8 Subject to Clause 7.9, the total aggregate liability of each of the parties and their respective Affiliates to the other and the other party’s Affiliates and Indemnitees pursuant to or in connection with or relation to this Agreement whether in contract, tort, negligence, breach of statutory duty, under any indemnity or otherwise howsoever arising shall not exceed an amount equal to ***, save that this Clause 7.8 shall not limit any liability resulting from personal injury or death (of humans), fraud, breach of confidentiality (clause 8), gross negligence or intentional wrongdoing or from Customer’s liability under clause 7.5(a). For the avoidance of doubt the limit of liability contained in this Clause 7.8 shall be for the Parties and their Affiliates, there shall not be a separate limit for any Affiliate. Nothing in this Clause 7 shall limit or exclude Customer’s obligations to pay invoices, and Customer’s payment of invoices shall not count towards Customer’s limit of liability.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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7.9 Nothing in this Agreement shall operate to exclude or limit the liability of either Party or their Affiliates for fraud, for death or personal injury (of humans) caused by its negligence or for any other liability that cannot be excluded or limited as a matter of law.

 

7.10 For the avoidance of doubt the limitations of the liability of a Party and its Affiliates set out in this Clause 7 shall be shared by that Party and all of its Affiliates and shall not be construed as a separate limit for each company.

 

8. Confidentiality

 

8.1 Customer acknowledges that Lonza Know-How and Lonza acknowledges that Customer Information with which it is supplied by the other pursuant to the Agreement is supplied, subject to Clause 8.5, in circumstances imparting an obligation of confidence and each agrees to keep such Lonza Know-How or such Customer Information secret and confidential and to respect the other’s proprietary rights therein and not at any time for any reason whatsoever to disclose or permit such Lonza Know-How or such Customer Information to be disclosed to any third party save as expressly provided herein. Lonza may disclose any of Customer’s Confidential Information to Lonza Biologics Plc or Lonza Biologics Porrino SL or to any of Lonza’s other Affiliates provided that (i) in the event that Lonza wishes to make such a disclosure to any of its Affiliates other than Lonza Biologics Plc or Lonza Biologics Porrino SL it shall obtain the prior consent of Nexvet, such consent not to be unreasonably withheld or delayed) and (ii) Lonza shall be responsible for any breaches of confidentiality by such of its Affiliates.

 

8.2 Customer and Lonza shall each procure that all their respective employees, consultants, contractors and persons for whom it is responsible having access to Lonza Know-How or Customer Information shall be subject to the same obligations of confidence as the principals pursuant to Clauses 8.1 and 8.3 and shall be bound by secrecy agreements in support of such obligations.

 

8.3 Lonza and Customer each undertake not to disclose or permit to be disclosed to any third party (including any contractors or consultants not previously approved in writing by Lonza, such approval not to be unreasonably withheld or delayed), or otherwise make use of or permit to be made use of (a) any trade secrets or confidential information relating to the technology, business affairs or finances of the other, any subsidiary, holding company or subsidiary of any such holding company of the other, or of any suppliers, agents, distributors, licensees or other customers of the other which comes into its possession under this Agreement or (b) the commercial terms of this Agreement, except to the extent that the same is required to be disclosed pursuant to subpoena, court order, judicial process or otherwise by law, provided the receiving party provides prompt notice to the disclosing party of such requirement in order to give the disclosing party an opportunity to timely seek a protective order or other appropriate judicial relief. In the event the disclosing party is unable to obtain a protective order or other appropriate judicial relief, the receiving party shall disclose only that portion of the disclosing party’s confidential information which is legally required to be disclosed, and ensure that all such confidential information of the disclosing party shall be redacted to the fullest extent permitted by law prior to such disclosure and that the disclosing arty shall be given an opportunity to review the confidential information prior to its disclosure.

 

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8.4 The obligations of confidence referred to in this Clause 8 shall not extend to any information which:

 

  (a) is or becomes generally available to the public otherwise than by reason of a breach by the receiving party of the provisions of this Clause 8;

 

  (b) is known to the receiving party and is at its free disposal prior to its receipt from the disclosing party;

 

  (c) is subsequently disclosed to the receiving party without being made subject to an obligation of confidence by a third party;

 

  (d) is developed by any servant or agent of the receiving party without access to or use or knowledge of the information by the disclosing party.

 

8.5 Nothing in this Agreement shall prevent Lonza or Customer from making any disclosure under any statutory, regulatory or similar legislative requirement or any court order, subject to the imposition of obligations of secrecy wherever possible in that relation, provided always that information so disclosed shall otherwise remain subject to this Clause 8. Without limiting the foregoing in this clause 8.5, in the event that an applicable regulator requires certain information which is confidential to Lonza and which Customer does not have in its possession, Lonza will, at Customer’s request, send such information to such applicable regulator to the fullest extent required by such regulator and at Lonza’s sole cost and expense.

 

8.6 The parties acknowledges that:

 

  (a) without prejudice to any other rights and remedies that the parties may have, the parties agree that the Lonza Know-How and Customer Information is valuable and that damages may not be an adequate remedy for any breach of the provisions of this clause 8. The parties agree that the relevant party will be entitled without proof of special damage to seek the remedies of an injunction and other equitable relief for any actual or threatened breach by the other party;

 

  (b) save as provided herein Lonza shall not at any time have any right, title, licence or interest in or to Customer Information, Customer Patent Rights or any other intellectual property rights vested in Customer or to which Customer is entitled; and

 

  (c) Customer shall not at any time have any right, title, licence or interest in or to Lonza Know-How, the Lonza Patent Rights or any other intellectual property rights relating to the Process which are vested in Lonza or to which Lonza is otherwise entitled.

 

9. Termination

 

9.1

If it becomes apparent to either Lonza or Customer at any stage in the provision of the Services that it will not be possible to complete the Services for scientific or technical reasons, a sixty (60) day period shall be allowed for good faith discussion and attempts to resolve such problems. If such problems are not resolved within such period, Lonza and Customer shall each have the right to terminate the Agreement forthwith by notice in writing. In the event of such termination, Customer shall pay to Lonza a termination sum calculated by reference to all the Services performed by Lonza prior to such termination (including a pro rata proportion of the

 

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Price for any stage of the Services which is in process at the date of termination) and all expenses reasonably incurred by Lonza in giving effect to such termination, including the costs of terminating any irrevocable commitments entered into under the Agreement, such termination sum not to exceed the Price.

 

9.2 Customer may in its sole discretion terminate this Agreement or any individual stages at any time for any reason by giving not less than (thirty) 30 days’ notice in writing to Lonza. In the event of such termination pursuant to this Clause 9.2 and subject to Clauses 9.3 and 9.4 Customer shall pay Lonza a termination sum calculated in accordance with the principles of Clause 9.1 above plus:

 

  (a) in the event notice to terminate Services (or any part thereof) pursuant to this Clause 9.2 is issued to Lonza six (6) months or less before Lonza’s then estimated start date for any stage of those Services which include         *** ; or

 

  (b) in the event notice to terminate Services pursuant to this Clause 9.2 is issued to Lonza more than six (6) but not more than twelve (12) months before Lonza’s then estimated start date for any stage of those Services which include         ***

 

9.3 The obligation to make payment under clause 9.2 shall be reduced (retrospectively, and hence Lonza shall make an appropriate refund to Customer) to the extent that Lonza mitigates its loss in this regard (and Lonza shall promptly notify Customer of any such mitigation). This provision shall not entitle Customer to be refunded an amount greater than that paid by Customer to Lonza pursuant to this clause 9 and Lonza shall be entitled to deduct from the amount due to be refunded to Customer its reasonable personnel and associated costs in attempting to mitigate its loss.

 

9.4 For the avoidance of doubt activities relating to cGMP fermentation shall be deemed to commence with the date of removal of the vial of cells from frozen storage for the performance of the fermentation.

 

9.5 The parties may each terminate the Agreement forthwith by notice in writing to the other party upon the occurrence of any of the following events:

 

  (a) if the other commits a material breach of the Agreement (which shall include a breach of the warranties set out in clause 7 above) which in the case of a breach capable of remedy is not remedied within thirty (30) days of the receipt by the other of notice identifying the breach and requiring its remedy; or

 

  (b) if the other ceases for any reason to carry on business or compounds with or convenes a meeting of its creditors or has a receiver or manager appointed in respect of all or any part of its assets or is the subject of an application for an administration order or of any proposal for a voluntary arrangement or enters into liquidation (whether compulsorily or voluntarily) or insolvency, or undergoes any analogous act or proceedings under foreign law.

 

9.6 Upon the termination of the Agreement for whatever reason:

 

  (a) Lonza shall promptly return to Customer all Customer Information and shall dispose of or return to Customer the Customer Materials (and where supplied by Customer the Cell Line) and any materials therefrom, as directed by Customer;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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  (b) Customer shall promptly return to Lonza all Lonza Know-How it has received from Lonza;

 

  (c) Customer shall not thereafter use or exploit the Lonza Patent Rights or the Lonza Know-How in any way whatsoever;

 

  (d) Lonza and Customer shall do all such acts and things and shall sign and execute all such deeds and documents as the other may reasonably require to evidence compliance with this Clause 9.6.

 

9.7 Termination of this Agreement for whatever reason shall not affect the accrued rights of either Lonza or Customer arising under or out of this Agreement and all provisions which are expressed to survive the Agreement shall remain in full force and effect.

 

9.8 If during the term of or upon expiration or prior termination of this Agreement (but excluding termination by Lonza in accordance with Clause 9.5), Customer notifies Lonza of its wish to obtain a license from Lonza (with the right to sublicense) to utilise the Process, or any part thereof for the production of Product either at its own facility or that of a third party, or any other intellectual property of Lonza or its Affiliates (whether or not patentable) reasonably necessary for the manufacture of the Product, the Parties shall negotiate in good faith the commercially reasonable terms upon which such a license shall be granted and related technology shall be transferred. The Parties agree that prior to the incorporation of any patentable intellectual property the royalty, if any, which would be associated with such patentable intellectual property shall be disclosed to Customer and Customer shall have the option to include or exclude such patentable intellectual property within the Process. In the event that Customer agrees to incorporate any additional patentable intellectual property within the Process then the royalty associated with such patentable intellectual property shall be in addition to any other royalty payable by Customer to Lonza.

 

10. Force Majeure

 

10.1 If Lonza is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and shall give written notice thereof to Customer specifying the matters constituting Force Majeure together with such evidence as Lonza reasonably can give and specifying the period for which it is estimated that such prevention or delay will continue, Lonza shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue.

 

10.2 The expression “Force Majeure” shall be deemed to include any cause affecting the performance by Lonza of the Agreement arising from or attributable to acts, events, acts of God, omissions or accidents beyond the reasonable control of Lonza.

 

11. Governing Law, Jurisdiction and Enforceability

 

11.1 The construction, validity and performance of the Agreement shall be governed by the laws of England, and Lonza and Customer submit to the non-exclusive jurisdiction of the Courts of England and Wales.

 

11.2 No failure or delay on the part of either Lonza or Customer to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter.

 

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11.3 Except for any disputes requiring a Party to seek urgent interlocutory or injunctive relief, any disputes relating to issues arising from this Agreement shall, in the absence of resolution within thirty (30) days of the dispute arising, be referred to senior executives of Customer and Lonza, who shall discuss the matter and attempt to resolve it by mutual consent. If the senior executives of Customer and Lonza cannot resolve the dispute within thirty (30) days of the matter being referred to them, either party may, by written notice to the other party, invoke the mediation procedure set out in Clause 11.4 below.

 

11.4 If a dispute arises between the parties that the parties cannot resolve pursuant to clause 11.3 above, the parties agree to attempt in good faith to resolve such dispute by mediation administered by the CEDR (Centre for Effective Dispute Resolution) in London. The parties agree that they shall share equally the cost of any mediation fees, and the cost of the mediator. Each party must bear its own attorneys’ fees and associated costs and expenses. The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within sixty (60) days of either party referring the dispute to mediation either party may pursue its rights in a court of law.

 

11.5 Nothing in this Clause 11 shall prevent a party from exercising any right under this Agreement, including the right of termination under clause 9 above.

 

12. Notices

 

12.1 Any notice or other communication to be given under this Agreement shall be delivered personally or sent by facsimile transmission, or if facsimile transmission is not available, by first class pre-paid post addressed as follows:

 

  (a) If to Lonza to: Lonza Sales AG, Muenchensteinerstrasse 38 CH-4402, Basel, Switzerland,

With a copy to: Lonza Biologics plc

228 Bath Road

Slough

Berkshire SL1 4DX

England

Facsimile: +44 1753 777001

For the attention of: The Head of Legal Services

 

  (b) If to Customer to:

Nexvet Biopharma Pty Ltd,

Level 39, 385 Bourke Street,

Melbourne 3000,

Victoria,

Australia

Facsimile: +61 3 8459 2102

For the attention of: Mark Heffeman

 

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or to such other destination as either party hereto may hereafter notify to the other in accordance with the provisions of this Clause 12.

 

12.2 All such notices or other communications shall be deemed to have been served as follows:

 

  (a) if delivered personally, at the time of such delivery;

 

  (b) if sent by facsimile, upon receipt of the transmission confirmation slip showing completion of the transmission;

 

  (c) if sent by first class pre-paid post, ten (10) business days (Saturdays, Sundays and Bank or other public holidays excluded) after being placed in the post.

 

13. Illegality

 

13.1 If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of Justice:

 

  (a) such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement;

 

  (b) the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and

 

  (c) the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rending such provision invalid or unenforceable.

 

14. Governance

 

14.1 Promptly following the Effective Date, Lonza and Customer shall each establish a “Technical Project Team”. Each such Team shall consist of appropriate technical personnel and shall have a designated Project Team Leader.

 

14.2 Promptly following the Effective Date, Lonza and Customer shall establish a “Steering Committee”. The Steering Committee shall be comprised of equal numbers of representatives of each Party.

 

14.3 Without limiting the functions of the Steering Committee set out elsewhere in this Agreement, the role of the Steering Committee shall be to:

14.3.1.    Assess the status of Process in connection with the Services;

 

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14.3.2.    Resolve disputes arising between the Parties under this Agreement, as provided in Clause 14.4;

14.3.3.    Monitor the progress of the Services;

14.3.4.    Monitor and actively address any deviation and/or foreseen or expected deviation from the Time Schedule.

14.3.5.    Plan and assess needs for future supply of Product;

14.3.6.    Discuss and recommend any changes to the Process; and

14.3.7.    Oversee the choice and qualification of vendors supplying Raw Materials;

14.3.8.    Monitor and discuss the prices of Raw Materials.

 

14.4 The Steering Committee shall meet at such times as the Steering Committee determines to resolve issues arising under and to perform its responsibilities under this Agreement, provided that the Steering Committee shall meet not less than six (6) times per calendar year, at such locations or by conference call as shall be agreed between the Parties. Lonza shall arrange for all meetings of the Steering Committee to be duly minuted and copies of the minutes provided to both parties. If any issue to be determined by the Steering Committee is not resolved within thirty (30) days after submission of the relevant issue to the Steering Committee, such issue shall be referred for resolution in accordance with clause 11.3.

 

14.5 The Steering Committee is not empowered to amend the terms of this Agreement.

 

15. Miscellaneous

 

15.1 Lonza shall be entitled to instruct Lonza Biologics Plc to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations. Subject to the previous sentence and to first obtaining the prior consent of Nexvet (such consent not to be unreasonably withheld or delayed), Lonza shall be entitled to instruct one or more of its Affiliates to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations. Subject thereto, neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement to a successor of that party’s business by reason of merger, sale of all or substantially all of its assets or other form of acquisition.

 

15.2 In the event that Lonza is asked to obtain the services of a third party on behalf of Customer, then Lonza shall not be responsible for the acts and omissions of such third party and in the event of any dispute, Lonza shall use its reasonable endeavours to pass onto Customer whatever remedies it obtains from such third party. For the avoidance of doubt the External Laboratories shall not be a sub-contractor but shall be a third party as referred to in this Clause 15.2.

 

15.3 The obligations of the parties under clauses 2.11,3, 4, 6 (Intellectual Property), 7 (Warranties and Indemnification), 8 (Confidentiality), 9.6 and 9.7 (consequences of termination) and 11 (Governing Law, Jurisdiction and Enforceability) shall survive the termination of this Agreement for any reason.

 

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15.4 The text of any press release or other communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of Lonza and Customer.

 

15.5 The Agreement embodies the entire understanding of Lonza and Customer and there are no promises, terms, conditions or obligations, oral or written, expressed on implied, other than those contained in the Agreement. The terms of the Agreement shall supersede all previous agreements (if any) which may exist or have existed between Lonza and Customer relating to the Services.

 

15.6 The parties to this Agreement do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to this Agreement.

 

15.7 No variation of or addition to this Agreement or any part thereof shall be effective unless in writing and signed on behalf of both parties. Notwithstanding the above the parties hereby confirm that amendments to the Specification shall be effective if reduced to writing and signed by the quality and/or regulatory representative of both parties, which quality and/or regulatory representative shall be nominated from time to time by each party.

 

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AS WITNESS the hands of the duly authorised representatives of the parties hereto the day and year first above written.

 

NEXVET BIOPHARMA PTY LTD

   LONZA SALES AG

Signature:    /s/ Mark Heffernan

   Signature:    /s/ Sven Frie

Printed Name:    Mark Heffernan

   Printed Name:    Sven Frie

Title:    CEO

   Title:    Director Sales & Business Dev
   Signature:    /s/ C. Allekinger
   Printed Name:    C. Allekinger
   Title:    Legal Counsel

 

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SCHEDULE 1

PRODUCT SPECIFICATION

 

“Cell Line”

   shall mean the GS-CHO Cell Line, created by Lonza expressing Product.

“Product”

   shall mean the IgG kappa antibody produced by the Cell Line, known as “GS_NV02” that binds to cat nerve growth factor and of which Customer is the proprietor.

Specification and testing summary to be agreed between the parties prior to GMP manufacturing.

Tentative storage and shipping information

Final Formulation Buffer:

Bottling of Bulk Product:

Primary containers: Nalgene high density polyethylene bottles

Denominations:

The bulk Product will be dispensed into 1L high density polyethylene (HDPE) Nalgene bottles, filling to a tolerance of ±10% of the nominal volume of the container. Any remaining bulk Product will be dispensed into 125mL HDPE Nalgene bottles, filling to a tolerance of ± 10% of the nominal volume of the container. Any remaining Product will be filled into one container of the smallest size specified. If this is not filled with a tolerance of ±10% of the nominal volume, this will be labelled as a Customer Sample and will not be released for clinical use.

For the calculation of the total fill volume it is assumed that 1g of liquid ~ 1ml.

Product Storage Conditions: Store Product at 5±3°C.

Shipment Temperature: Product shipped at greater than 0°C and below or equal to +10°C.

Customer samples (removed during the middle of dispensing):

Shipment Temperature: samples shipped at greater than 0°C and below or equal to +10°C.

 

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Testing Summary to be Performed on the 10L runs (Stage 8)

Lonza shall manufacture Product in its pilot facility to evaluate the ability of the Process to produce Product meeting the cGMP Specification. For the pilot runs there shall be no obligation to meet the amounts stated to be target amounts or where the result description is to “report result”.

 

Criterion

 

Method (Lonza

SOP Number)

   Target  

Characteristics

      

***

      

Identity

      

***

      

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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Criterion

 

Method (Lonza

SOP Number)

   Target  

Purity

      

***

      

Impurities

      

***

      
1 The applicability of these Lonza generic assays for this Product will be evaluated in Stage 5

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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Criterion

 

Method (Lonza

SOP Number)

   Target  

***

      

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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SCHEDULE 2

SERVICES

 

A. Supply of Customer Materials and Customer Know How

 

B. Assumptions

 

C. Activities to be performed by Lonza

Table of Contents

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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A. Supply of Customer Materials and Customer Know How

Prior to commencement of the Services at Lonza or, if appropriate, prior to the commencement of the relevant Stage of the Services, Customer shall supply Lonza with the following:

 

(i) Sufficient information to allow a risk assessment as required by the “Genetically Modified Organisms (Contained Use) (Amendment)” Regulations 1996 and a safety assessment by Lonza’s Biological Safety Committee.

 

(ii) If available, a reference standard sample or suitable reference material (approximately 10mg) of the Product antibody suitable for the purposes intended.

 

B. Assumptions

It is assumed that the manufacturing Process will fit the current facility operating conditions and within the Stages below, certain assumptions have been listed. Where during the Services there are indications that there may be a requirement for additional equipment, processing time or other non-standard operability criteria, as listed above, this requirement for additional equipment, processing time or other non-standard operability criteria will be agreed by Lonza and the Customer prior to commencement of the relevant Stage, subject to terms and conditions to be agreed between Lonza and Customer.

 

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C. Activities to be undertaken by Lonza

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

  

Description

  

Price(1)

  

***%Discounted Price(1)

Stage 1    ***    £***    £***

Stage 2

   ***    £***    £***

Stage 3

   ***    £***    £***

Stage 4

   ***    £***    £***

Stage 5

   ***    £***(2)    £***(2)
      £***    £***
      £***    £***

Stage 6

   ***    £***    £***

Stage 7

   ***    £*** + external laboratory testing charges estimated to be £***    £*** + external laboratory testing charges estimated to be £***

Stage 8

   ***   

£***

   £***

Stage 8

   ***   

£***

  

£***

Notes:

 

(1) As described in Clause 4 – “Delivery, Transportation of Product and Customer tests” of the Terms and Conditions, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the Price.

 

(2) This Price covers evaluation of the performance of Lonza’s generic assays. If a specific assay has to be developed this would require additional activities at a Price to be agreed.

 

(4) The external Laboratory charges for the tests listed are estimated, for guidance purposes only, to be approximately £*** for the MCB.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

32


CONFIDENTIAL

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stages 1, 2, 3, 4, 6 and 8.

***% upon commencement of each Stage.

***% upon completion of each Stage.

Any External Laboratory charges will be invoiced separately.

 

2.2 For Stage 5A, 5B and 7

***% upon completion of Stage or sub-stage 5A, B and 7.

External Laboratory charges will be invoiced separately.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

33

EX-10.9 14 d775834dex109.htm EX-10.9 EX-10.9

Exhibit 10.9

 

Confidential   LOGO

AMENDMENT No. 1

TO

the AGREEMENT

dated 16 December 2013

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

(NV02)

Schedule 2

9 Stage 9 ***

Schedule 3

Price and Payment

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

THIS AMENDMENT is made the 17 day of June 2014

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of Level 8, 31 Queen Street, Melbourne, 3000, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lanza entered into an agreement dated 16 December 2013 referring to NV-02, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:


Confidential   LOGO

 

1. Schedule 2 of the Agreement shall be amended to include the following Stage 9.

SCHEDULE 2

***

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 9:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (US £ Sterling)  

Stage 9 ***

   £ * **(1) 

Notes:

 

  (1) As described in Clause 4 — “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stage 9

***% upon commencement

***% upon issue of the statement of testing.

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential   LOGO

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 1 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD     LONZA SALES AG
Signature:   /s/ David Gearing     Signature:   /s/ Sven Frie
Printed Name:   David Gearing     Printed Name:   Sven Frie
Title:   Chief Scientific Officer     Title:   Director, Sales & Business Dev.
13 Jun 2014     17-June- 2014
      Signature:   /s/ Nadia Zieger
      Printed Name:   Nadia Zieger
      Title:   Legal Counsel
EX-10.10 15 d775834dex1010.htm EX-10.10 EX-10.10

EXHIBIT 10.10

 

Confidential    LOGO

AMENDMENT No. 2

TO

the AGREEMENT

dated 16 December 2013

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

(NV02)

Schedule

Stage 8 ***

Schedule 3

Price and Payment

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

THIS AMENDMENT is made the 10th day of October 2014

BETWEEN

 

1. LONZA SALES AG, of Muenchensteinerstrasse 38, Ch-4002 Basel, Switzerland (“Lonza”) and

 

2. NEXVET BIOPHARMA PTY LTD, of 9 Meaden Street, South bank, 3006, Victoria, Australia (“Customer”).

WHEREAS

 

A. Customer and Lonza entered into an agreement dated 16 December 2013 referring to NV-02, (the “Agreement”), under which Lonza is required to perform Services relating to the Cell line and Product described.

 

B. Customer would like Lonza to carry out additional activities under the Agreement.

 

C. Lonza is prepared to perform the additional activities.


Confidential    LOGO

 

NOW THEREFORE it is agreed hereby by the parties to amend the Agreement and perform additional services as follows:

 

1. Schedule 2 of the Agreement shall be amended to include as following amended Stage 8.

SCHEDULE 2

***

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

2. Schedule 3 of the Agreement shall be amended by the addition of the following provisions in respect of the additional Stages contained in this Amendment No. 2:

SCHEDULE 3

PRICE AND TERMS OF PAYMENT

 

1. Price

In consideration for Lonza performing the Services as detailed in Schedule 2 Customer shall pay Lonza as follows:

 

Stage

   Price (UK £ Sterling)
***
 

Stage 8 ***

   £ * ** (1) 

Notes:

  (1) As described in Clause 4- “Delivery, Transportation of Product and Customer Tests” of the Agreement, additional costs and expenses incurred by Lonza in arranging insurance and transportation in order to ship samples, Product, and Cell Line shall be charged to Customer in addition to the price.

 

2. Payment

Payment by Customer of the Price for each Stage shall be made against Lonza’s invoices as follows:

 

2.1 For Stage 8

*** upon commencement

*** upon issue of the statement of testing.

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Confidential    LOGO

 

3. Save as herein provided all other terms and conditions of the Agreement shall remain in full force and effect.

AS WITNESS WHEREOF the parties have caused this Amendment No. 2 to be executed by their representatives thereunto duly authorised as of the day and year first written.

 

NEXVET BIOPHARMA PTY LTD     LONZA SALES AG
Signature:     Signature:
/s/ David Gearing     /s/ J. Westedt
Printed Name: David Gearing     Printed Name: Westedt
Title: CSO     Title: Dir. Mrg. Serv.
    Signature:
    /s/ Nadia Zieger
    Printed Name:       Nadia Zieger
    Title:       Senior Legal Counsel
EX-10.11 16 d775834dex1011.htm EX-10.11 EX-10.11

Exhibit 10.11

 

CONFIDENTIAL   LOGO

GS KO LICENCE ROW

LICENSE AGREEMENT

between

LONZA SALES AG

and

NEXVET BIOPHARMA PTY LTD

 

1


CONFIDENTIAL   LOGO

 

INDEX

 

ARTICLE

  

TITLE

  

PAGE

 
  1.    DEFINITIONS      3   
  2.    SUPPLY OF THE SYSTEM, CDACF VERSION 8 SYSTEM AND SYSTEM KNOW-HOW      7   
  3.    OWNERSHIP OF PROPERTY AND INTELLECTUAL PROPERTY      8   
  4.    LICENSES      8   
  5.    PAYMENTS      9   
  6.    ROYALTY PROCEDURES      12   
  7.    LIABILITY AND WARRANTIES      13   
  8.    CONFIDENTIALITY      15   
  9.    INTELLECTUAL PROPERTY ENFORCEMENT      16   
10.    TERM AND TERMINATION      17   
11.    ASSIGNMENT      18   
12.    GOVERNING LAW AND JURISDICTION      18   
13.    FORCE MAJEURE      19   
14.    ILLEGALITY      19   
15.    MISCELLANEOUS      20   
16.    NOTICE      20   
17.    INTERPRETATION      21   
APPENDIX      
1    Patent Rights   
2    CDACF Version 8 Base Powders   
3    CDACF Version 8 Supplements, Media and Feeds   
4    CDACF Version 8 Know-How   

 

2


CONFIDENTIAL   LOGO

 

THIS AGREEMENT is made the 16th day of December 2013

BETWEEN

LONZA SALES AG incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as “Lonza”), and

NEXVET BIOPHARMA PTY LTD of Level 39, 385 Bourke Street, Melbourne 3000, Victoria, Australia, (hereinafter referred to as “Licensee”)

WHEREAS

 

A. Lonza is the proprietor of the System and the CDACF Version 8 System and has the right to grant rights to certain Intellectual Property Rights in relation thereto (all as hereinafter defined), and

 

B. The Licensee wishes to take a licence under such Intellectual Property Rights of which Lonza is the proprietor to commercially exploit the Product (as hereinafter defined) in the form hereunder.

NOW THEREFORE the parties hereby agree as follows:

 

1. Definitions

In this Agreement the following words and phrases shall have the following meanings:

 

  1.1 Affiliate” means any company, corporation, limited liability company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control, directly or indirectly, with the relevant party to this Agreement. “Control” means the ownership of more than fifty percent (50%) of the issued share capital of the party in question or the legal power to direct or cause the direction of the general management and policies of the party in question.

 

  1.2 CDACF Version 8 Base Powders” means the powders set out in Appendix 2.

 

  1.3 CDACF Version 8 Feeds” means the concentrated nutrient solutions used in order to maintain the growth and productivity of mammalian cells, as more fully set out in Appendix 3.

 

  1.4 CDACF Version 8 Media” means the solutions of nutrients used in mammalian cell culture, as more fully set out in Appendix 3.

 

  1.5 CDACF Version 8 Know-How” means any Know-How specifically relating to the CDACF Version 8 Base Powders, CDACF Version 8 Feeds, CDACF Version 8 Media or the CDACF Version 8 Supplements used either in combination or individually, as set out in Appendix 4.

 

3


CONFIDENTIAL   LOGO

 

  1.6 CDACF Version 8 System” means the CDACF Version 8 Base Powders, CDACF Version 8 Feeds, CDACF Version 8 Media, CDACF Version 8 Know-How and the CDACF Version 8 Supplements used either in combination or individually.

 

  1.7 CDACF Version 8 Supplements” means the supplement solutions, as more fully set out in Appendix 3.

 

  1.8 Cell Lines” means those cell lines referred to in Clause 2.1.1.

 

  1.9 Combination Product” means any diagnostic or therapeutic product comprising Product and one or more other pharmaceutically active ingredient(s).

 

  1.10 Competing Contract Manufacturer” shall mean any third party who, together with its affiliates, undertakes or performs more than fifty percent (50%) of their business as a third party manufacturer of monoclonal antibodies and/or therapeutic proteins or any product of a similar nature to which this Agreement relates.

 

  1.10 Confidential Information” means any Know-How and confidential information disclosed by one party to the other in connection with this Agreement including for the avoidance of doubt the terms of this Agreement itself. In the case of Lonza, Confidential Information shall mean System Know-How, CDACF Version 8 System Know-How and all information relating to the System and/or CDACF Version 8 System and any other materials, specifications or information which is provided and/or disclosed by Lonza, its Affiliates and their respective officers, employees, agents and advisors to the Licensee and its officers, employees, agents and advisors, whether directly or indirectly, including, without limitation, all agreements, research databases, trade secrets, Intellectual Property Rights, business and/ or commercial and/ or financial data (including data pertaining to Lonza’s suppliers, agents, distributors and customers), specifications, technical designs, documents and drawings which are related to the System, the CDACF Version 8 System and/or Lonza’s business.

 

  1.11 Effective Date” means the date first above written.

 

  1.12 First Commercial Sale” means the date of the first sale or other disposal of Product for consideration by the Licensee or its Sublicensee.

 

  1.13 Intellectual Property Rights” means all rights, title and interests, vested and/or arising out of any industrial or intellectual property, whether protected at common law or under statute, which includes (without limitation) any rights and interests in copyrights, designs, trademarks, servicemarks, trade-names, technology, business names, logos, commercial symbols, processes, developments, licenses, trade secrets, goodwill, drawings, computer software, formulae, technical information, research data, procedures, designs, Confidential Information and any other knowledge of any nature whatsoever throughout the world whether in existence today or which will come into existence in the future, and including all applications for patents, copyrights, trademarks, trade names, rights to apply and any amendments/modifications or renewals thereto; and all other intellectual property rights.

 

4


CONFIDENTIAL   LOGO

 

  1.14 Know-How” means any technical and other information, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols.

 

  1.15 Losses” means losses, damages, costs and expenses.

 

  1.16 Net Selling Price” means ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

5


CONFIDENTIAL   LOGO

 

***

 

  1.17 Patent Rights (Lonza)” means the patents and applications, short particulars of which are set out in Appendix 1A hereto, and all patents and applications thereof of any kind throughout the world whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition, and including any divisions, renewals, continuations, continuations in part, reissues, patent disclosures, improvements and extensions of reissue thereof.

 

  1.18 Patent Rights (Third Party)” means the patents and applications, short particulars of which are set out in Appendix 1B hereto, and to the extent granted to Lonza by the owners of the Patent Rights (Third Party), all patents and applications thereof of any kind throughout the world whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition, and including any divisions, renewals, continuations, continuations in part, reissues, patent disclosures, improvements and extensions of reissue thereof.

 

  1.19 Product” means the felinised IgG kappa antibody produced by the Cell Line known as NV-02 that binds to NGF and of which Licensee is the proprietor and which is obtained by the expression of any one gene or of any combination of genes by use of the System, or any formulation containing the same.

 

  1.20 Strategic Partner” means a party with whom Licensee has entered into a contractual relationship, to identify a therapeutic target, collaborate in the performance of research and development and/or commercialization of a Product or a product of which the Strategic Partner is the proprietor. In no event may any entity that is primarily a Competing Contract Manufacturer be deemed a Strategic Partner for the purposes of this Agreement.

 

  1.21 Sublicensee” means a party with whom Licensee has entered into a contractual relationship, under which such party has been granted the right to make or manufacture the Product and to whom Licensee has sub-licensed its rights under this Agreement pursuant to clause 4.3, provided always that the obligations in Clause 4.3 have been satisfied.

 

  1.22 System” means Lonza’s glutamine synthetase gene expression system known as GS Xceed™ consisting of the Cell Lines and the Vectors, and the System Know-How, whether used individually or in combination with each other. For the avoidance of doubt, any gene proprietary to Licensee inserted into the System for the purposes of producing Product does not form part of the System.

 

  1.23 System Know-How” means Know-How relating directly or indirectly to the System known to Lonza from time to time, of which Lonza is the proprietor.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

6


CONFIDENTIAL   LOGO

 

  1.24 Target Animal Efficacy Study” means the first animal treated in a pivotal efficacy study performed under GCPv with Centre for Veterinary Medicine (CVM) protocol concurrence.

 

  1.25 Territory” means world-wide.

 

  1.26 Valid Claim” means a claim within the Patent Rights (Lonza) or the Patent Rights (Third Party) (including any re-issued and unexpired patents) which, but for the licence and other rights granted pursuant to Clauses 4.1 and 4.3 hereof, would be infringed by the manufacture, use, sale, offer for sale, exportation or importation of Product by Licensee or its Sublicensees and which also (a) has not been cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, and (b) has not been revoked, held invalid or declared unpatentable or unenforceable in a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, and (c) which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise.

 

  1.27 Vectors” means those vectors referred to in Clause 2.1.1.

 

2. Supply of the System, CDACF Version 8 System and System Know-How

 

2.1 Unless previously supplied by Lonza under a separate agreement, Lonza shall, if requested by Licensee in writing, arrange for the supply ex-works Lonza’s premises, Slough, Berkshire (Incoterms 2010) to Licensee of the following:

 

  2.1.1 Vectors ***

 

  2.1.2 Cell Lines ***

 

  2.1.3 System Know-How

System Know-How contained as at the date hereinabove in (a) manuals of operating procedures for the System, (b) regulatory information in pdf format, and (c) Vector nucleotide sequences.

 

2.2 In the event that Licensee requires any additional quantities of the materials referred to in Clauses 2.1.1 and 2.1.2, and if Lonza at its sole discretion is willing to supply such additional materials, such supply shall be subject to the payment of an additional fee by Licensee to Lonza in accordance with Lonza’s prices at the time.

 

2.3 In relation to the CDACF Version 8 System, Lonza shall following signature of this Agreement (a) provide Licensee with details of how to purchase the CDACF Version 8 Base Powders and CDACF Version 8 Supplements to enable Licensee (and only Licensee) to make CDACF Version 8 Feeds and CDACF Version 8 Media and (b) supply Licensee with the CDACF Version 8 Know-How.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

7


CONFIDENTIAL   LOGO

 

2.4 Licensee shall use the System only in the expression of Product by insertion of gene(s) coding for Product(s) into the System, and shall not use, cause the use of or permit to be used the System for any purpose not directly authorised by this Agreement.

 

2.5 The CDACF Version 8 System may only be used in conjunction with the System and may not be used in conjunction with any other gene expression system or for any other purpose whatsoever.

 

2.6 Lonza shall make available to Licensee, subject to Licensee paying any charge Lonza may (acting reasonably) make available to Licensee updates to the CDACF Version 8 Know-How and/or the System Know-How from time to time.

 

3. Ownership of Property and Intellectual Property

 

3.1 It is hereby acknowledged and agreed that as between the parties any and all property and Intellectual Property Rights in the System and System Know-How is vested in Lonza. Similarly it is hereby acknowledged that as between the parties any and all Intellectual Property Rights in the Product and any gene proprietary to Licensee, or any of its licensors or sublicensees, inserted into the System for the purpose of producing Product, is vested in Licensee, or its applicable licensors and sublicensees.

 

3.2 The provisions of this Clause 3 shall survive termination of this Agreement.

 

4. Licenses

 

4.1 Lonza hereby grants to Licensee:

 

  (a) a world-wide non-exclusive licence under the System Know-How, CDACF Version 8 Know-How, and the Patent Rights (Lonza) (with the right to sublicense, subject to Clause 4.3 below);

 

  (b) a world-wide non-exclusive sublicence under the Patent Rights (Third Party) (with the right to sublicense, subject to Clause 4.3 below);

in each case (a) and (b) to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory (“Commercial Activities”).

 

4.2 Save as expressly provided by Clause 2.4 above, the Licensee hereby undertakes not to make any modifications or adaptations to the System and the CDACF Version 8 System during the subsistence of this Agreement.

 

4.3 Subject to the provisions of this Clause 4.3, Licensee shall be entitled to grant a sublicence to the rights granted by Clause 4.1 to any one or more third parties for the purposes of any such third party producing Product for Licensee provided always:

 

  4.3.1 Licensee shall ensure such Sublicensee’s use of the System, the CDACF Version 8 System, Lonza’s Intellectual Property Rights and the Product is undertaken solely for undertaking Commercial Activities, for or on behalf of Licensee; and

 

8


CONFIDENTIAL   LOGO

 

  4.3.2 The Sublicensee shall not, by virtue of this Agreement, be granted any right or licence, either express or implied, under any patent or proprietary right vested in Lonza or otherwise, to use the System, the CDACF Version 8 System, Lonza’s Intellectual Property Rights or the Product other than for undertaking Commercial Activities for or on behalf of Licensee and Licensee agrees to ensure that such Sublicensee shall not assign, transfer, further sublicense or otherwise make over the benefit or the burden of the rights granted to it pursuant to this Agreement; and

 

  4.3.3 Any sublicence granted shall be expressly subject and subordinate to the terms of this Agreement, and it shall be Licensee’s responsibility to ensure the strict adherence by any Sublicensee hereunder to the terms and conditions of this Agreement; and

 

  4.3.4 Prior to the grant of any sublicence pursuant to this Clause 4 Licensee shall obtain the written consent of Lonza (such consent not to be unreasonably withheld, conditioned or delayed), to the grant of such sublicence.

 

  4.3.5 Licensee shall not sublicense the rights sublicensed to it under the *** patents listed in Appendix 1B to *** or any of its affiliates or its or their successors with affiliate meaning for the purposes of this Clause 4.3.5 any entity controlling, controlled by, or under common control with *** .

 

4.4 If, on a country-by-country basis, any granted patents that form part of the Patent Rights (Lonza) or Patent Rights (Third Party) (including any re-issued patents and unexpired patents), subsequently expire or no longer contain a Valid Claim such Patent Rights shall automatically fall outside the scope of this Agreement and the provisions of Clauses 4.1 to 4.3 shall only apply, with respect to granted patents, to those granted patents which contain a Valid Claim and form part of the Patents Rights (Lonza) or Patent Rights (Third Party) for as long as those granted patents remain in force.

 

4.5 Notwithstanding clause 4.4, on a country-by-country basis, where no Valid Claim remains in force, the provisions of Clauses 4.1 to 4.3 shall only apply for as long as the System Know-How and CDACF Version 8 Know-How (as appropriate) remain secret and substantial.

 

4.6 No licence is granted save as expressly provided herein and no licence in addition thereto shall be deemed to have arisen or be implied by way of estoppel or otherwise.

 

5. Payments

 

5.1 In consideration of the licence granted to Licensee pursuant to Clause 4.1 above, and in consideration for the right to sublicense the rights granted by Clause 4.1 pursuant to Clause 4.3, Licensee shall pay Lonza as follows, subject to the adjustment as set forth in Clause 5.2:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

9


CONFIDENTIAL   LOGO

 

  5.1.1 in respect of Product manufactured by Lonza, a royalty of *** percent (***%) of the-Net Selling-Price;

 

  5.1.2 where Licensee or Licensee’s Strategic Partner manufactures Product:

 

  5.1.2.1 a payment of pounds sterling *** (£***) due annually during the course of this Agreement, and being first payable upon commencement of Target Animal Efficacy Study for registration in US or EU (or equivalent study) and thereafter on each anniversary of such date; and

 

  5.1.2.2 a royalty of *** percent (***%) of the Net Selling Price of such Product manufactured.

 

  5.1.3 where any party other than Lonza, Licensee or Licensee’s Strategic Partner manufactures Product:

 

  5.1.3.1 a payment of pounds sterling *** (£***) per sublicence due annually during the course of such sublicence (irrespective as to the years of manufacture), and being first payable on the commencement date of the relevant sublicence; and

 

  5.1.3.2 a royalty of *** percent (***%) of the-Net Selling Price of such-Product-manufactured.

 

5.2 The Licensee’s obligation to pay royalties for Product according to 5.1.1, 5.1.2.2 and 5.1.3.2 shall apply on a country-by-country basis until the later of (i) expiry of the last Valid Claim or (ii) the date being ten (10) years from the date of the First Commerical Sale of Product following marketing authorisation of the Product. If, on a country-by-country basis, the manufacture and/or sale of the Product are not protected by a Valid Claim (either because no patent or application was ever filed for such territory or the patent or application is no longer of effect) then in respect of sales in such countries:

 

  (a) the royalties referred to in 5.1.1, 5.1.2.2 and 5.1.3.2 shall be due only in respect of the System Know-How;

 

  (b) the royalties referred to in 5.1.1 and 5.1.2.2 shall be at the rate of *** per cent (***%) and *** per cent (***%) respectively of the Net Selling Price;

 

  (c) the royalties referred to in 5.1.3.2 shall be at the rate of *** per cent (***%) of the Net Selling Price.

 

5.3 For the avoidance of doubt the licence to use the CDACF Version 8 System is given in consideration of the obligations incumbent upon the Licensee under the terms of this Agreement but is otherwise royalty-free.

 

5.4 Subject always to Clause 5.5, if, during the term of this Agreement, Licensee is required to take a bona fide royalty-bearing licence under intellectual property rights owned by *** and which are required in order to operate the GS System or the CDACF Version 8 System in order to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory (the “*** Licence”):

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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  (a) Licensee may deduct from royalties due under this Agreement on such Product *** percent (***%) of the royalties actually paid by Licensee to *** , but in no event will the royalties paid to Lonza under this Agreement be less than *** percent (***%) of the amount due pursuant to Clauses 5.1.1, 5.1.2.2 and 5.1.3.2 hereof. This provision will apply only to prospective running royalties payable to *** on the same basis as required by Clause 5 hereof;

 

  (b) with regard to lump-sum license fees, milestone payments and minimum annual royalties in excess of accrued royalties, Licensee may, once the Product is commercialised and offered for sale for use in patients after having been appropriately licensed and approved for such use, deduct from royalties due under this Agreement on such Product *** percent (***%) of such lump-sum license fees, milestone payments and minimum annual royalties in excess of accrued royalties actually paid by Licensee to ***, but in no event will the royalties paid to Lonza under this Agreement be less than *** percent (***%) of the amount due pursuant to Clauses 5.1.1, 5.1.2.2 and 5.1.3.2 hereof.

 

  (c) no credit will be allowed for any amount paid for rights not required to permit Licensee to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory, as provided in this Agreement.

For the avoidance of doubt, Licensee shall not be entitled to recover for the same loss or damage under this Clause and under Clause 7.2A.

 

5.5 Licensee shall not agree any arrangement with *** under which any fees or royalties under any *** Licence are lowered or made more favourable to Licensee as a consequence of any arrangements made with regard to any damages or settlement which Licensee pays to *** and for which Licensee would seek indemnification from Lonza pursuant to Clause 7.2A. If there is any dispute as to whether Licensee has structured any arrangements it has entered into with *** so as to maximise the sums for which Lonza is required to indemnify them under Clause 7.2A and/or reduce the licence fees or other payments which Licensee is required to pay to *** , the matter shall be referred to an independent third party (“Expert”) who shall assess the terms of any settlement and licence arrangement with *** and determine how much of any such settlement and licence arrangement attributable as damages for historic infringement (and therefore the subject of the indemnity from Lonza under Clause 7.2A) and how much is attributable to any new licence arrangements between Licensee and *** , to which the provisions of Clause 5.4(a) and (b) shall apply. The Expert must be a person with an appropriate level of expertise in licensing and / or valuation to be able to determine the dispute, and must be agreed to by the parties, or if not agreed within a reasonable time of the dispute arising, must be appointed by the then President of the Licensing Executives Society of Britain & Ireland. The costs of the Expert shall be shared equally between the parties and the parties agree to be bound by the determination of the Expert save in the event of manifest error.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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6. Royalty Procedures

 

6.1 Licensee shall, and shall ensure that its Sublicensees shall, keep true and accurate records and books of account containing all data necessary for the calculation of royalties payable to Lonza. Such records and books of account shall, upon reasonable notice having been given by Lonza (which in no event shall be less than thirty (30) days prior notice), be open at all reasonable times during regular business hours for inspection by independent auditors selected by Lonza and reasonably acceptable to Licensee. Such independent auditors shall agree to maintain the confidentiality of the information and materials disclosed during the audit. Any such audit shall be conducted in a manner that does not interfere unreasonably with the operations of Licensee’s business. Lonza may perform an audit once each calendar year. Each audit shall begin upon the date specified by Lonza and shall be completed as soon as reasonably practicable. Lonza shall pay the costs of the independent auditors conducting such audit, unless the results of the audit reveal an underpayment of 5% or more by Licensee, in which case, Licensee shall pay the reasonable costs of the independent auditors. If an audit concludes that an overpayment or underpayment has occurred during the audited period, such payment shall be remitted by the party responsible for such payment to the other party within thirty (30) days after the date such auditor’s written report identifying the overpayment or underpayment is delivered to the party responsible for such payment.

 

6.2 Licensee shall prepare a statement in respect of each calendar quarter which shall show for the immediately preceding quarter details of the sales of Product on a country by country basis and the royalty due and payable to Lonza thereon.

Such statement shall be submitted to Lonza within thirty (30) days after the end of the calendar quarter to which it relates, together with a remittance for the royalties due to Lonza.

 

6.3 All sums due under this Agreement:

 

  6.3.1 shall be made in pounds sterling to Lonza. Payments due to Lonza in currencies other than pounds sterling shall first be calculated in the relevant local currency before being calculated at the rate of exchange in effect at the close of business on the day payment is due or made, whichever is earlier, provided always that where payment is made after the date provided therefor herein conversion shall be at the rate in effect at the date of payment if this is more favourable to Lonza. The rate of exchange shall be the mean value of the Pound Spot Rate in London first published in the Financial Times on the day following the day for determining such rates.

 

  6.3.2 are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, and shall be paid by Licensee (other than taxes on Lonza’s income). The parties agree to co-operate in all respects reasonably necessary to take advantage of such double taxation treaties as may be available.

 

6.4 Where Lonza does not receive payment of any sum by the due date, interest shall accrue thereafter on the sum due and owing to Lonza at the rate of two percent (2%) per annum over the base rate from time to time of National Westminster Bank plc, interest to accrue on a day-to-day basis without prejudice to Lonza’s right to receive payment on the due date.

 

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7. Liability and Warranties

 

7.1 Lonza gives no representation or warranty that the Patent Rights (Lonza) or Patent Rights (Third Party) which are patent applications will be granted or if granted will be valid nor that the exercise of the rights granted to Licensee hereunder will not infringe other patent rights or intellectual property rights vested in Lonza or any third party.

 

7.2 Lonza warrants that:

 

  (a) the patents included in the Patent Rights (Lonza) are the only patents that must be licensed from Lonza and/or its Affiliates in order to operate the System;

 

  (b) it is entitled to grant the rights and licences contained herein in accordance with the terms and conditions of this Agreement;

 

  (c) as at the date of this Agreement, to the best of Lonza’s knowledge and belief, the GS System and the CDACF Version 8 System do not infringe the intellectual property rights of any third party, including any *** patents not listed in Appendix 1B ;

 

  (d) as at the date of this Agreement, to the best of Lonza’s knowledge and belief, Lonza is not in breach of any licence with any third party, including, in particular, the licence with *** , pursuant to which Lonza is licensed any of the Patent Rights (Third Party);

 

  (e) as at the date of this Agreement, to the best of Lonza’s knowledge and belief, Lonza is not aware of any facts, matters or circumstances under which Lonza’s rights to the Patent Rights (Third Party) (including the rights to sublicense those rights to the Licensee) will be terminated or withdrawn.

 

7.2A Lonza shall (subject always to Clauses 5.5, 7.6 and 7.8) indemnify and hold harmless each of Licensee and its Affiliates, and their respective officers, employees and agents at all times in respect of any and all:

 

  (i) legal fees which Licensee properly incurs; and

 

  (ii) any damages or other amounts (including legal costs incurred by ***) which Licensee is ordered to pay to *** by a court of competent jurisdiction, or which Licensee properly agrees to pay in settlement with *** (provided that such settlements shall not include any element of lost profits, lost revenue or indirect or consequential losses);

in each case ((i) and (ii)) which arise (and to the extent that they arise) directly from any claim (actual or threatened) by *** against Licensee in relation to US patent number 8377674 that the use in accordance with the terms of this Agreement of the GS System and the CDACF Version 8 System infringes any intellectual property rights of *** . For the avoidance of doubt, Licensee shall not be entitled to recover for the same loss or damage under this Clause and under Clause 5.4.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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7.3 Subject to Clause 5.4, the Licensee hereby acknowledges that in order to exploit the rights granted herein the Licensee may require licences under Lonza patent rights (other than those herein licensed) or under third party patent rights (including those vested in Affiliates of Lonza) that may be infringed by the use by the Licensee of the rights licensed herein and it is hereby agreed that it shall be the Licensee’s responsibility to satisfy itself as to the need for such licences and if necessary to obtain such licences.

 

7.4 Each party (“Indemnifying Party”) shall indemnify and hold harmless the other party and its Affiliates, and their respective officers, employees and agents (each an “Indemnified Party”) at all times in respect of any and all Losses suffered or incurred as a result of any contractual, tortious or other claims or proceedings by third parties (collectively “Third Party Claims”) against Indemnified Party arising out of the Indemnifying Party’s breach of this Agreement, including breach of representations and warranties, violation of applicable law, negligence or wilful misconduct.

 

7.5 With respect to product liability claims or proceedings, the following shall apply: (a) except to the extent provided in (b) below, Licensee shall indemnify and hold harmless Lonza, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury (in each case to humans) relating to the Product, and (b) Lonza shall indemnify and hold harmless Licensee, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury (in each case to humans) relating to the Product to the extent such claims or proceedings result from defects in the Cell Lines and Vectors, or from Lonza’s breach of this Agreement.

 

7.6 Notice. If a party receives notice of any claim for an indemnity under Clauses 7.4 or 7.5 (an “Indemnifying Claim”), the Indemnified Party shall, as promptly as is reasonably possible, give the Indemnifying Party notice thereof; provided, however, that failure to give such notice promptly shall only relieve the Indemnifying Party of any indemnification obligation hereunder to the extent such failure diminishes the ability of the Indemnifying Party to respond to or to defend the Indemnified Party against such Indemnifying Claim of the Indemnifying Party. The parties shall consult and cooperate with each other regarding the response to and the defence of any such indemnifying claim and the Indemnifying Party shall assume the defence or represent the interests of the Indemnified Party in respect of such indemnifying claim of the Indemnifying Party, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Indemnified Party and to propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no such settlement shall be made without the written consent of the Indemnified Party, such consent not to be unreasonably withheld. The Indemnified Party shall not agree any settlement of any such claim without the prior written consent of the Indemnifying Party. Nothing herein shall prevent the Indemnified Party from retaining its own counsel and participating in its own defence at its own cost and expense.

 

7.7 Any condition or warranty other than those relating to title which might otherwise be implied or incorporated within this Agreement by reason of statute or common law or otherwise is hereby expressly excluded.

 

7.8

EXCEPT FOR EITHER PARTY’S BREACH OF CLAUSE 8 HEREOF IN NO EVENT SHALL EITHER PARTY AND/OR THEIR RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY, THEIR AFFILIATES AND/OR THEIR RESPECTIVE OFFICER’S, EMPLOYEES AND AGENTS WITH RESPECT TO ANY SUBJECT

 

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  MATTER OF THIS AGREEMENT WHETHER IN CONTRACT IN TORT IN NEGLIGENCE OR FOR BREACH OF STATUTORY DUTY OR OTHERWISE FOR LOSS OF PROFITS, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES. Nothing in this Agreement shall limit or exclude the liability of either party for its fraud, or for death or personal injury (in each case to humans) arising from its negligence or for any other liability that cannot be limited or excluded as a matter of law.

 

7.9 The terms of this Clause 7 shall survive expiration or termination of this Agreement for whatever reason.

 

8. Confidentiality

 

8.1 Licensee expressly acknowledges that Confidential Information disclosed by Lonza pursuant to this Agreement is supplied in circumstances imparting an obligation of confidence and Licensee agrees to keep such Confidential Information secure, secret and confidential and undertakes to respect Lonza’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever to disclose, cause or permit to be disclosed such Confidential Information to any third party other than its Sublicensee hereunder for use in accordance with the terms of this Agreement. Licensee shall procure that only its employees and employees of its Sublicensee hereunder shall have access to Confidential Information and then only on a need to know basis and that all such employees shall be informed of their secret and confidential nature and shall be subject to the obligations of confidentiality and non-use no less stringent than those set out herein.

 

8.2 Licensee hereby undertakes and agrees to keep the System and the CDACF Version 8 System secure and safe from loss, damage, theft, misuse and unauthorised access and shall procure that the System and the CDACF Version 8 System shall be made available only to employees of Licensee and employees of its Sublicensee hereunder on a need to know basis and subject to the same obligations of confidence as provided in Clause 8.1 hereof, and to use the same for the sole purpose of this Agreement.

 

8.3 Both parties undertake and agree not to at any time for any reason whatsoever disclose or permit to be disclosed to any third party or otherwise make use of or permit to be made use of any trade secrets or confidential information or materials relating to the business affairs or finances of the other or of any suppliers, agents, distributors, licensees or other customers of the other which comes into their possession pursuant to this Agreement.

 

8.4 The obligations of confidence referred to in this Clause 8 shall not extend to any information which the receiving party demonstrates:

 

  8.4.1 is or shall become generally available to the public otherwise than by reason of a breach by the recipient party of such information of the provisions of this Clause 8;

 

  8.4.2 is known to the recipient party of such information and is at its free disposal prior to its receipt from the other;

 

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  8.4.3 is subsequently disclosed to the recipient party without obligations of confidence by a third party owing no such obligation of confidentiality to the disclosing party; or

 

  8.4.4 can be demonstrated by competent written evidence as having been independently developed by the recipient of the information in question without access to or use or knowledge of the information of the disclosing party.

 

8.5 Notwithstanding the foregoing it is acknowledged between the parties that Lonza or Licensee may be required to disclose Confidential Information to a government agency for the purpose of any statutory, regulatory or similar legislative requirement applicable to the production of Product, or to a court of law or to meet the requirements of any Stock Exchange to which the parties may be subject. In such circumstances the disclosing party will inform the other party prior to disclosure being made as to the nature of the required disclosure, shall only make the disclosure to the extent legally required and shall seek to impose obligations of secrecy wherever possible. Notwithstanding such disclosure such Confidential Information shall otherwise remain subject to this Clause 8.

 

8.6 Each party hereto expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided hereunder by a party may cause irreparable harm to the other party (“Non-Breaching Party”) and that money damages may not provide a sufficient remedy to the Non-Breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then in addition to all other remedies available at law or in equity, the Non-Breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the Non-Breaching Party.

 

8.7 The obligations of both parties under this Clause 8 shall survive the expiration or termination of this Agreement for whatever reason.

 

9. Intellectual Property Enforcement

 

9.1 Lonza hereby undertakes and agrees that at its own cost and expense it will:

 

  9.1.1 prosecute or procure prosecution of such of the Patent Rights (Lonza) which are patent applications diligently so as to secure the best commercial advantage obtainable, as determined by Lonza in its commercially reasonable discretion, and will pursue, as determined by Lonza in its commercially reasonable discretion, all necessary actions against any third party that Lonza reasonably believes is infringing, misappropriating or violating any Lonza Intellectual Property Rights; and

 

  9.1.2 pay or procure payment of all renewal fees in respect of the Patent Rights (Lonza) to ensure they are valid and subsisting for the full term thereof and in particular will procure such renewal of the registrations thereof as may be necessary from time to time so far as it is reasonable to do so with particular reference to commercial considerations.

 

9.2

Licensee shall promptly notify Lonza in writing of any infringement or improper or unlawful use of or of any challenge to the validity of the Patent Rights (Lonza) and/or Know-How. Lonza undertakes and agrees to take all such steps and proceedings and to do all other acts and things as may in Lonza’s sole discretion be necessary to

 

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  restrain any such infringement or improper or unlawful use or to defend such challenge to validity and Licensee shall permit Lonza to have the sole conduct of any such steps and proceedings including the right to settle them whether or not Licensee is a party to them. Licensee shall have the right at its own cost and for its own benefit to initiate, prosecute and control the enforcement of the Patent Rights (Lonza) against infringement by a Third Party in the Territory if all of the following conditions are fulfilled (a) the product manufactured through the infringing activity is a competing product to the Product, (b) Lonza has not granted rights to third parties which prevent Lonza from granting such a right to enforce to Licensee, and (c) Lonza does not initiate proceedings within sixty (60) days of being requested to do so by Licensee.

 

9.3 As soon as practicable after Lonza becomes aware, Lonza shall promptly notify Licensee of any allegation that any of the Patent Rights (Third Party) infringe any rights of any third party or of any challenge to the validity of any of the Patent Rights (Third Party). Lonza shall keep Licensee reasonably informed of the outcome of any such allegations and / or challenges, including the extent to which any such allegations or challenges may impact on the ability for the Licensee to continue to be a sublicensee of such rights.

 

10. Term and Termination

 

10.1 Unless terminated earlier in accordance with the provisions of this Clause 10 or Clause 14, this Agreement shall continue in force in each country of the world, until expiry of the last Valid Claim, or for so long as the System Know-How and/or CDACF Version 8 Know-How is identified and remains secret and substantial, whichever is later.

 

10.2 Licensee may terminate this Agreement by giving sixty (60) days’ notice in writing to Lonza.

 

10.3 Either Lonza or Licensee may terminate this Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events:

 

  10.3.1 if the other commits a breach of this Agreement which in the case of a breach capable of remedy shall not have been remedied within thirty (30) days of the receipt by the other of a notice identifying the breach and requiring its remedy.

 

  10.3.2 if the other is unable to pay its debts or enters into compulsory or voluntary liquidation (other than for the purpose of effecting a reconstruction or amalgamation in such manner that the company resulting from such reconstruction or amalgamation if a different legal entity shall agree to be bound by and assume the obligations of the relevant party under this Agreement) or compounds with or convenes a meeting of its creditors or has a receiver or administrator appointed over all or any part of its assets or takes or suffers any similar action in consequence of a debt, or ceases for any reason to carry on business.

 

10.4

If at any time during this Agreement Licensee knowingly, directly or indirectly, opposes or assists any third party to oppose the grant of letters patent or any patent application within any of the Patent Rights (Lonza)=or disputes or knowingly, directly or indirectly, assists any third party to dispute the validity of any patent within any of

 

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  the Patent Rights (Lonza) or any of the claims thereof Lonza shall be entitled at any time thereafter to terminate all or any of the licences granted hereunder forthwith by notice to Licensee.

 

10.5 If this Agreement expires or is terminated for any reason any and all licences granted hereunder shall terminate with effect from the date of termination and Licensee shall destroy all Vectors, Cell Lines forthwith and shall certify such destruction immediately thereafter in writing to Lonza provided that Licensee shall be entitled to sell any Product in its sole discretion remaining in its possession or control at the time that termination becomes effective, provided that such sales shall be completed within six (6) months of the date of expiry or termination of this Agreement and any stocks of Product still remaining shall be destroyed (with an appropriate written certificate of such destruction being immediately sent to Lonza). Licensee shall pay Lonza the royalties in respect of such sales in accordance with Clause 6.

 

10.6 Termination for whatever reason or expiration of this Agreement shall not affect the accrued rights of the parties arising in any way out of this Agreement as at the date of termination. The right to recover damages against the other and all provisions which are expressed to survive this Agreement shall remain in full force and effect.

 

11. Assignment

 

11.1 Save as expressly provided by Clause 4, neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the benefit and/or burden of this Agreement (i) to an Affiliate or (ii) to any joint venture company of which Lonza or Licensee, as the case may be, is the beneficial owner of at least fifty percent (50%) of the issued share capital thereof or (iii) to any company with which that party may merge or (iv) to any company to which that party may transfer its assets and undertaking.

 

11.2 This Agreement shall be binding upon the successors and assigns of the parties and the name of a party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing herein shall permit any assignment by either party except as expressly provided herein.

 

12. Governing Law and Jurisdiction

 

12.1 The validity, construction and performance of this Agreement shall be governed by English law and the parties submit to the non-exclusive jurisdiction of the courts of England and Wales.

 

12.2 Either party shall have the right to take proceedings in any other jurisdiction for the purposes of enforcing a judgement or order obtained from any court of competent jurisdiction. Subject to the remainder of this clause 12, the parties shall have the right to proceed to a suitable jurisdiction for the purpose of enforcing a judgment, award, or order (including without limitation seeking specific performance) and injunctive reliefs.

 

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12.3 Except for any disputes requiring a Party to seek urgent interlocutory or injunctive relief, any disputes relating to issues arising from this Agreement shall, in the absence of resolution within thirty (30) days of the dispute arising, be referred to senior executives of the Licensee and Lonza, who shall discuss the matter and attempt to resolve it by mutual consent. If the senior executives of the Licensee and Lonza cannot resolve the dispute within thirty (30) days of the matter being referred to them, either party may, by written notice to the other party, invoke the mediation procedure set out in clause 12.4 below.

 

12.4 If a dispute arises between the parties that the parties cannot resolve pursuant to clause 12.3 above, the parties agree to attempt in good faith to resolve such dispute by mediation administered by the CEDR (Centre for Effective Dispute Resolution) in London. The parties agree that they shall share equally the cost of any mediation fees, and the cost of the mediator. Each party must bear its owns attorneys’ fees and associated costs and expenses. The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within sixty (60) days of either party referring the dispute to mediation either party may pursue its rights in a court of law.

 

13. Force Majeure

Neither party shall be in breach of this Agreement if there is any total or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God (including without limitation, fire), act of government or state, war, civil commotion, insurrection, embargo, epidemic, terrorism or earthquake, prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of either party. If either party is unable to perform its duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 13 such party shall give written notice to the other of such inability stating the reason in question. The operation of this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the party relying upon it shall give written notice to the other of this fact. If the reason continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the party not claiming under this Clause 13 shall have the right to terminate this Agreement by giving written notice of such termination to the other party.

 

14. Illegality

 

14.1 If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of Justice:

 

  (i) such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the parties and shall be deemed not to be included in this Agreement;

 

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  (ii) the other provisions of this Agreement shall be binding on the parties as if such provision was not included therein; and

 

  (iii) the parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the parties without rendering such provision invalid or unenforceable.

 

15. Miscellaneous

 

15.1 This Agreement embodies and sets forth the entire agreement and understanding of the parties and supersedes all prior oral and written agreements, understandings or arrangements relating to the subject matter of this Agreement. Neither party shall be entitled to rely on any agreement, understanding or arrangement which is not expressly set forth in this Agreement.

 

15.2 This Agreement shall not be amended, modified, varied or supplemented except in writing signed by duly authorised representatives of the parties.

 

15.3 No failure or delay on the part of either party hereto to exercise any right or remedy under this Agreement shall be construed or operated as a waiver thereof nor shall any single or partial exercise of any right or remedy under this Agreement preclude the exercise of any other right or remedy or preclude the further exercise of such right or remedy as the case may be. The rights and remedies provided in this Agreement are cumulative and are not exclusive of any rights or remedies provided by law.

 

15.4 Except as required by law, the text of any press release or other communication to be published by or in the media whether of a scientific nature or otherwise and concerning this Agreement shall require the prior written approval of Lonza and Licensee.

 

15.5 Each of the parties shall be responsible for its respective legal and other costs incurred in relation to the preparation of this Agreement.

 

15.6 The parties do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999, or by any other statute or common-law principle, by any person who is not a party to this Agreement.

 

16. Notice

 

16.1 Any notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if sent by e-mail (to the e-mail address set out below) and receipt of such notice is expressly confirmed by the other party or is-left at or sent by registered post or by a reputable overnight courier to a party or delivered in person to a party at the address set out below for such party or such other address as the party may from time to time designate by written notice to the other(s):

 

  Address of Lonza
  Lonza Sales AG, Muenchensteinerstrasse 38 CH-4402, Basel, Switzerland

 

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With a copy to:   

Lonza Biologics Plc

228 Bath Road, Slough, Berkshire SL1 4DX

Facsimile: 01753 777001

Address of Licensee

Nexvet Biopharma Pty Ltd of Level 39, 385 Bourke Street, Melbourne 3006, Victoria, Australia

E-mail: mark.heffernan@nexvet.com

For the attention of: Mark Heffernan, PhD, CEO

 

16.2 All such notices and documents shall be in the English language. Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the notice or other document by post or, where the notice or other document is sent by hand, at the time of such delivery. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched.

 

17. Interpretation

 

17.1 The headings in this Agreement are inserted only for convenience and shall not affect the construction hereof.

 

17.2 Where appropriate words denoting a singular number only shall include the plural and vice versa.

 

17.3 Reference to any statute or statutory provision includes a reference to the statute or statutory provision as from time to time amended, extended or re-enacted.

 

17.4 References to the recitals, clauses and appendix shall be deemed to be a reference to the recitals, clauses and appendix to this Agreement and shall form an integral part of this Agreement.

 

17.5 Reference in this Agreement to either Lonza or Licensee (as the case may be) shall, unless repugnant to the subject or context thereof, include their respective Affiliates, successors and assigns, save that the obligation to indemnify pursuant to clauses 7.4 shall only be obligations on Lonza and Licensee respectively, and the obligation to indemnify in clause 7.5 shall only be on Licensee. No Affiliates shall be obligated to provide any indemnification.

 

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AS WITNESS the hands of the duly authorized representatives of the parties hereto

 

Signed for and on behalf of

LONZA SALES AG

    By:   /s/ Sven Frie  
     

 

    Name:   Sven Frie  
     

 

    Title:   Director Sales and Business Dev   TITLE
     

 

 

Signed for and on behalf of

LONZA SALES AG

    By:   /s/ Cordula Altekruger  
     

 

    Name:   Cordula Altekruger  
     

 

    Title:   Legal Counsel   TITLE
     

 

 

Signed for and on behalf of

NEXVET BIOPHARMA PTY LTD

    By:   /s/ illegible  
     

 

    Name:    
     

 

    Title:   CEO   TITLE
     

 

 

 

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APPENDIX 1A

PATENT RIGHTS (LONZA)

 

Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Inventors:

   ***

Priority Application Dates:

   ***

Earliest Publication Date/No.:

   ***

 

Territory

 

Appl. Date

 

Patent No.

 

Expiry Date

***

     

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

23


 

 

Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Priority Application Date:

   ***

Earliest Publication Date/No.:

   ***

 

Territory

 

Appl. Date

 

Patent No.

 

Application No.

 

Expiry Date

***

       

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

 


 

 

Lonza Ref. No.

   ***

Subject Matter:

   ***

Title:

   ***

Origin:

   ***

Registered Owner:

   ***

Priority Application Date:

   ***

Earliest Publication Date/No.:

   ***

 

Territory

 

Appl. Date

 

Patent No.

 

Application No.

 

Expiry Date

***

       

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 


Lonza Ref:    ***
Subject Matter:    ***
Title:    ***
Priority Date:    ***
Earliest Publication Date:    ***

 

Territory

 

Appl. Date

 

Patent Application

or* Patent Number

 

Patent Expiry Date

***

     

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


APPENDIX 1B

PATENT RIGHTS (THIRD PARTY)

 

Subject Matter:    ***
Title:    ***
Origin:    ***
Registered Owner:    ***

 

Territory

 

Appl. Date

 

Patent No.

 

Filing No.

 

Expiry Date

***

       

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


*** PATENT PORTFOLIO

***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


*** PATENT PORTFOLIO CONTINUED

 

Title

  

Application Number

  

Date of Filing

***

   ***    ***

***

   ***    ***

***

   ***    ***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


***

 

Subject Matter:    ***
Title:    ***
Origin:    ***
Registered Owner:    ***
European Patent No.    ***
Expiry date:    ***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


APPENDIX 2

CDACF VERSION 8 BASE POWDERS

***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


APPENDIX 3

CDACF VERSION 8 SUPPLEMENTS, MEDIA AND FEEDS

***

 

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


APPENDIX 4

CDACF VERSION 8 KNOW-HOW

***

 

 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EX-10.12 17 d775834dex1012.htm EX-10.12 EX-10.12

Exhibit 10.12

MASTER COLLABORATION, SUPPLY AND DISTRIBUTION AGREEMENT

BETWEEN

VIRBAC, a company organized under the law of FRANCE, with registered office at 1ère avenue 2065 M – L.I.D., 06516, Carros, France - registered under number 417 350 311 RCS at Grasse, France, acting for itself and its Affiliates, herein duly represented by Christian Karst, Member of the Executive Board,

Hereinafter referred to as “VIRBAC”;

AND

NEXVET IRELAND LIMITED, a company organised under the laws of Ireland, with registered office at 88 Harcourt Street, Dublin 2 Ireland, with registered number 550752, represented by Dr Mark Heffernan, Chief Executive Officer and Director, Hereinafter referred to as “NEXVET

NEXVET and VIRBAC are hereafter referred individually as the “Party” and collectively as the “Parties”.

RECITALS

Whereas VIRBAC is a global pharmaceutical company exclusively dedicated to animal health. VIRBAC is engaged in the research, development, manufacture and distribution of veterinary products.

Whereas NEXVET develops and commercialises biological veterinary products.

Whereas VIRBAC has offered to advise NEXVET in the development of Products in the Territory.

Whereas NEXVET has offered to appoint VIRBAC as its exclusive distributor of the Products in the Territory and VIRBAC has accepted such appointment, on the terms and conditions set out in the present agreement.

THEREFORE IT HAS BEEN FURTHER AGREED AS FOLLOWS:

 

1. DEFINITIONS

 

1.1. For the purposes of the present agreement, the following words shall have the following respective meanings:

Agreement means this master collaboration, supply and distribution agreement for Products and all the annexes attached hereto, including the Specific Distribution Agreements entered from time to time pursuant to this master collaboration, supply and distribution agreement for Products.

 

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Affiliates means with respect to either Party any other company directly or indirectly controlling, controlled by or under control with such Party. For the purposes of this definition “control” means owning or controlling, in the aggregate, forty nine percent (49%) or greater of the voting rights.

Asian Territory means Japan, South Korea, Taiwan, the Philippines, Malaysia, Singapore, the Peoples’ Republic of China, Indonesia, Thailand, India, Vietnam and Myanmar.

Commercial Margin means the Net Sales less the Total Cost of Goods less the Cost of Selling.

Competing Products means canine, feline or equine monoclonal antibody targeting the same molecular target (for example, for NV-01: canine monoclonal antibodies targeting NGF).

Cost of Goods means the costs incurred by or on behalf of NEXVET in the production of the Products, including materials, labour and industrial overheads together with all ancillary expenses arising from such production such as duties, custom fees, freight and insurance.

Cost of Selling means the total direct and variable cost of storage, delivery, selling, advertising and promotion of the Product(s) by or on behalf of VIRBAC. These costs include direct and variable distribution, sales and marketing staff expenses (salaries and commissions), internal or external warehousing fees, sales meeting, sales and marketing staff travelling expenses, fees and all other direct and variable operating costs related to distribution, sales and marketing. Notwithstanding the foregoing, for each Product the Cost of Selling in:

 

    Year 1, Year 2 and Year 3 shall be [***] of VIRBAC’s Net Sales of the applicable Product;

 

    Year 4 and Year 5 shall be [***] of VIRBAC’s Net Sales of the applicable Product; and

 

    Year 6 and thereafter shall be [***] of VIRBAC’s Net Sales of the applicable Product.

For each Product “Year 1” shall be a twelve (12) month period starting on the date of the First Commercialization of the Product and subsequent “Years” shall be calculated accordingly.

Confidential Information means information not generally known to the public which gives a Party or a third party some competitive or business advantage or the opportunity of obtaining such an advantage. The Confidential Information may pertain to, among other things: financial, economic, scientific and technical information such as formula, designs, methods, systems, procedures, devices, know-how, computer hardware, computer software, costs, sales as well as facts with respect to the identities, personnel, projects, needs and policies of a Party

Development Plans means the document as defined in Article 10 “Development Plans” agreed between the Parties and included in each Specific Distribution Agreement. A Development Plan template is included in Annex 3.

Excluded Licensed Molecules means those molecules which, as at the date of this Agreement, are the subject of a third party agreement, being:

 

  (a) a canine anti-TNF-a canine p80TNFR-Fc covered and / or claimed in patent number PCT/GB2013/050433 filed on 22 February 2013 and entitled “Tumour necrosis factor receptor fusion proteins and methods of using the same”, including the molecule with the internal research code of NV-08; and

 

  (b) any new canine anti-TNF-a monoclonal antibody derived from the research activities on NEXVET’s canine anti-TNF-a monoclonal antibody with an internal research code of NV-06.

 

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Excluded Territory means:

 

  (a) in relation to the Excluded Licensed Molecules, the Asian Territory; or

 

  (b) a country within the Territory in which NEXVET may license a Pre-Development Candidate to a third party.

Field means veterinary field.

First Commercialization means the first commercial arm’s length bona fide sale of a Product by or on behalf of VIRBAC in a Major Country, excluding the sale or provision of any Products by way of samples or for the purpose of clinical trials.

Force Majeure means any event outside the reasonable control of either party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, lightning, war, revolution, act of terrorism, riot or civil commotion but excluding strikes of the affected party’s own employees.

Freedom To Operate Analysis or FTO Analysis means an analysis obtained from a patent attorney opining on the ability for a Product to be exploited (including manufactured, marketed, distributed and sold) in the Territory without a claim that such exploitation infringes a third party’s patent rights.

GMP means current good manufacturing practices according to rules governing medicinal products in the European Union Volume IV “Good manufacturing practices for medicinal products”(http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm) and other applicable laws, regulations and practices of a similar nature in other jurisdictions within the Territory.

Important Country means [***].

Intellectual Property Rights means all intellectual property rights subsisting anywhere in the world, including:

 

  (a) patents, copyright, rights in circuit layouts, designs, trade and service marks (including goodwill in those marks), domain names and trade names, trade secrets and any right to have confidential information kept confidential; and

 

  (b) any application or right to apply for registration of any of the rights referred to in paragraph (a),

whether or not such rights are registered or capable of being registered.

Joint Steering Committee (or JSC) means the joint steering committee as defined in Article 11 “Joint Steering Committee”.

Major Countries means [***].

Manufacturer means such third party manufacturer(s) of the Products. For each Product, the Manufacturer(s) shall be defined in its Specific Distribution Agreement.

Manufacturing Margin means NEXVET’s [***] margin on the Cost of Goods being the difference between the Purchase Price and the Cost of Goods. However, the Manufacturing Margin shall not exceed NEXVET’s share of the Commercial Margin.

For the sake of clarity and by way of a worked example: if the Purchase Price from NEXVET is [***] and the Cost of Goods is [***], the Manufacturing Margin will be [***].

Manufacturing Site(s) means the site(s) where the Products are manufactured. For each Product the Manufacturing Site(s) shall be defined in its Specific Distribution Agreement.

 

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Marketing Authorization means the sale or /and the import authorisation, marketing authorisation, other governmental licenses, approvals, permits and other authorisations required and which are granted by the authorities to enable the Parties to import, market and sell the Products in the Territory.

Marketing Authorization Holder, MAH or MH means the holder of the Marketing Authorization for a Product, which shall be NEXVET unless agreed otherwise pursuant to the Specific Distribution Agreement.

Net Sales means the invoiced price of Products sold by VIRBAC to third parties less, to the extent identified on the invoice, any costs of packing, insurance, transport, delivery, VAT and any other government taxes, duties or levies, and normal rebates, free goods, trade discounts and other allowances granted and any reimbursements of Products already sold but returned by customers.

New Product means a product that is solely developed and/or owned by NEXVET, or to which NEXVET has exclusive rights, which is (i) a canine, feline or equine monoclonal antibody which has been derived from the PETization technology or (ii) a canine, feline or equine receptor fusion protein, and for either of which a Specific Distribution Agreement has not been entered into by the Parties.

New Product Notice has the meaning given in Article 6.1.

NEXVET Fees means the sums due to NEXVET under this Agreement as described in Article 19.2 (Financial Terms) being NEXVET’s share of the Commercial Margin, which includes the Manufacturing Margin.

NEXVET Know-how means any technical and other information relating to the Products, the New Products or PETization, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, lab and commercial scale fermentation and purification techniques for biologics, assay protocols. It also includes marketing data and knowledge to build and gather a Registration Dossier.

NEXVET Technology means the Patent together with the NEXVET Know-how and all data and any manufacturing process related to the Products owned or controlled by NEXVET.

NV-01 means pharmaceutical canine monoclonal antibody product under its finished form targeting nerve growth factor (NGF) covered by the Patent.

Patent means the patent(s) which are set out in Annex 1 and associated patent applications, including, without limitation, any patents issuing on any such patent applications, as well as any divisionals, continuations, continuations-in-part, substitutions, re-examinations, reissues, renewals, extensions, supplementary protection certificates and the like, and any foreign counterparts of any of the foregoing, all as updated from time to time by NEXVET.

Pharmacovigilance Data Exchange Agreement means the agreement for the exchange of data relating to pharmacovigilance for each Product to be entered into between the Parties which shall be in the form of the template agreement set out in Annex 8 and which shall be annexed to the Specific Distribution Agreement of each Product.

Pre-Development Candidate means a product for which no New Product Notice has been issued by NEXVET.

Products means a product for which the Parties have entered a Specific Distribution Agreement. A list of current Products is set out in Annex 2. This list may be updated from

 

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time to time as new Specific Distribution Agreements are entered into by the Parties in relation to New Products. For clarification, Products are products that are solely owned by NEXVET and any products that are in-licensed by NEXVET from third parties or are developed in conjunction with third parties may not be Products due to contractual obligations owed by NEXVET to such third parties.

Purchase Price means the Ex-Works price paid by VIRBAC to NEXVET for the Products which is equal to the Cost of Goods plus the Manufacturing Margin.

Quality Agreement means the agreement for the quality of each Product to be entered into between the Parties which shall be in the form of the template agreement set out in Annex 4 and which shall be annexed to the Specific Distribution Agreement of each Product.

Quarter means one of the four quarters that make up the financial year, i.e. January, February and March; April, May and June; July, August and September; and October, November and December.

Registration Dossier means any and all information, processes, techniques and data necessary to be submitted or filed with a regulatory authority to obtain Marketing Authorization relating to the Products, including all administrative, technical, scientific, or other data and information (including raw data) as well as Product samples if and to the extent required to be filed or submitted to a regulatory authority within the Territory to obtain a Marketing Authorization.

Specifications means the specifications for each Product as detailed in its Specific Distribution Agreement.

Specific Distribution Agreement means the agreement for the distribution of each Product to be entered into between the Parties which shall be in the form of the template agreement set out in Annex 5.

Target Product Profile means the target product profile of each Product as discussed from time to time through the JSC, agreed between the Parties and referenced in each Specific Distribution Agreement.

Territory means (i) for all Products other than the Excluded Licensed Molecules, worldwide except the USA and Canada; (ii) for any Products that are the Excluded Licensed Molecules, worldwide except the USA, Canada and the Asian Territory.

Total Cost of Goods means the Cost of Goods paid by VIRBAC to NEXVET for the Products plus all ancillary expenses paid by VIRBAC arising from such purchase such as duties, custom fees, freight and insurance.

Trademark means all the trademarks, trademark rights, service trademarks, trade usage, logotypes, domain names, whether registered or not which are owned or licensed by NEXVET and which are used with the Products and which are set out in the applicable Specific Distribution Agreement.

Trade Dress means VIRBAC’s presentation and labelling as the distinctive configuration, colour, format, designs, trademarks and logos incorporated into the packaging and label presentation of any Products, but excludes the Trademarks.

VIRBAC Trademarks means any trademarks, trademark rights, service trademarks, trade usage, logotypes, domain names, whether registered or not, which are owned or licensed by VIRBAC, excluding the Trademarks.

 

1.2. In the case of conflict or ambiguity, the order of precedence for this Agreement and the documents attached to or referred to in this Agreement are as follows:

 

  (i) first Articles 1 to 40 of this Agreement;

 

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  (ii) then second the Annexes to this Agreement; and

 

  (iii) then third the Specific Distribution Agreements entered pursuant to this Agreement.

 

1.3. The headings in this Agreement are inserted for convenience only and shall not affect the interpretation or construction of this Agreement.

 

1.4. Words expressed in the singular shall include the plural and vice versa. Words referring to a particular gender include every gender. References to a person include an individual, company, body corporate, corporation, unincorporated association, firm, partnership or other legal entity.

 

1.5. The words “other”, “including” and “in particular” shall not limit the generality of any preceding words or be construed as being limited to the same class as any preceding words where a wider construction is possible.

 

1.6. References to any statute or statutory provision shall include (i) any subordinate legislation made under it, (ii) any provision which it has modified or re-enacted (whether with or without modification), and (iii) any provision which subsequently supersedes it or re-enacts it (whether with or without modification) whether made before or after the date of this Agreement.

 

2. PURPOSE

 

2.1. VIRBAC shall advise NEXVET in the development of the Products and the New Products in the Territory and in the Field.

 

2.2. Subject to the terms and conditions of this Agreement, NEXVET hereby appoints VIRBAC as its sole and exclusive distributor of the Products in the Field in the Territory for the term of the Agreement and VIRBAC hereby accepts that appointment subject to the terms of this Agreement.

 

2.3. In the Territory, NEXVET shall exclusively supply to VIRBAC and VIRBAC shall purchase exclusively from NEXVET the Products for distribution and sale during the term of this Agreement.

 

2.4. All quantities of Products shall be supplied by NEXVET to VIRBAC in accordance with the terms and conditions of this Agreement, the Specific Distribution Agreement, the Target Product Profile, the Specifications, the Marketing Authorizations and all applicable laws.

 

2.5. NEXVET grants to VIRBAC the right to sell and distribute the Products under NEXVET’s Trademarks in the Territory in the Field, subject to and in accordance with the terms and conditions of this Agreement, the Specifications, the Marketing Authorizations and all applicable laws.

 

2.6. The Parties agree to enter into a Quality Agreement and a Pharmacovigilance Agreement for each Product which shall be in the form of the template Quality Agreement set out in Annex 4 and the template Pharmacovigilance Data Exchange Agreement set out in Annex 8 modified as applicable to reflect the requirements of the relevant Product and attached to each Specific Distribution Agreement.

 

2.7. In accordance with the terms of Article 6 “First option to New Product”, NEXVET grants to VIRBAC a right of first negotiation to enter into a Specific Distribution Agreement to distribute New Products.

 

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3. EXCLUSIVITY

 

3.1. Subject to Article 3.2, during the term of the applicable Specific Distribution Agreement and subject to the other terms of this Agreement, NEXVET is not allowed to distribute the Products by itself or its Affiliates or through any third party in any country within the Territory.

 

3.2. NEXVET is allowed to distribute and sell a Product in the Territory itself only as of the first full calendar year following the [***] anniversary of the First Commercialization of this Product. In this case VIRBAC’s right to exclusively distribute the applicable Product is revoked and it shall become NEXVET’s sole but not exclusive distributor for the applicable Product in the Field and in the Territory.

For the sake of clarity and by way of a worked example: If a Product’s First Commercialization in on [***] then NEXVET shall be allowed to distribute and sell that Product itself as from [***] and VIRBAC shall continue to have a right to distribute the applicable Product from this date in accordance with the terms of this Agreement.

Where NEXVET exercises its rights in accordance with this Article 3.2 to distribute and sell a Product in the Territory itself only, NEXVET shall compensate VIRBAC by paying to VIRBAC for each Product a sum equal to [***] of VIRBAC’s Net Sales for the Product in the Territory for the previous 12 (twelve months). This compensatory payment is in consideration for the losses potentially suffered by VIRBAC and it is VIRBAC’s sole and exclusive remedy for NEXVET exercising its rights under this Article 3.2. This compensatory payment shall be paid within [***] date of invoice.

 

3.3. If NEXVET decides to distribute a Product in the Territory itself only in accordance with Article 3.2 above, NEXVET shall notify VIRBAC at least [***] before distributing this Product and the Parties’ obligations to communicate, under the framework of the JSC, the clinical, regulatory, marketing and sales input for this Product shall immediately cease to apply.

 

3.4. During the term of the applicable Specific Distribution Agreement, if NEXVET distributes a Product in the Territory itself in accordance with Article 3.2 above, NEXVET must only distribute that Product (i) under a different trade dress to the Trade Dress that is used for the Product by VIRBAC, and (ii) under trademarks that shall not be identical with or similar to the Trademarks licensed to VIRBAC by NEXVET and used by VIRBAC in accordance with the applicable Specific Distribution Agreement. For the avoidance of doubt, once a Specific Distribution Agreement expires or is terminated, VIRBAC’s licence to use the Trademarks in relation to that Product also terminates, and NEXVET shall be free to distribute the Product using the Trademarks but with a different trade dress from VIRBAC’s Trade Dress. VIRBAC will remain the owner of the Trade Dress.

 

4. NON COMPETITION

For each Product, VIRBAC is not allowed in the Territory to distribute itself or through a third party a Competing Product in a country where a Marketing Authorization has been obtained for a period of [***] from the First Commercialization of such Product.

For each Product, and for so long as a Specific Distribution Agreement for that Product is in place, NEXVET is not allowed in the Territory to distribute itself or through a third party a Competing Product under a trademark that is identical with or similar to the Trademarks that are licensed to VIRBAC for such Product.

 

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5. LINK BETWEEN THE AGREEMENT AND SUBSEQUENT SPECIFIC DISTRIBUTION AGREEMENT

 

5.1. Each Specific Distribution Agreement subsequently signed between the Parties in application of the Agreement, shall be an integral part of the Agreement and be governed by the Agreement.

 

5.2. The Parties shall use the Specific Distribution Agreement template as attached in Annex 5.

 

5.3. Each Specific Distribution Agreement must be signed by the legal representative of each Party.

 

6. FIRST OPTION TO NEW PRODUCT

 

6.1. The Parties acknowledge and agree that NEXVET has the right to manage its owns business and as such it is free to manage and exploit any Pre-Development Candidates as NEXVET, in its absolute discretion, deems appropriate. For a period of [***] from the date of execution of this Agreement, NEXVET will notify VIRBAC via the JSC if a development candidate should be nominated as a New Product in the Territory (taking into account any Excluded Territory, if applicable, with respect to the development candidate), on the basis that NEXVET (i) has developed a reasonable overview of the proposed target product profile of such development candidate, (ii) has obtained minimum safety and efficacy information from proof of concept studies, (iii) has a realistic estimation of cost of goods of such development candidate and (iv) solely owns or has the exclusive rights to the development candidate.

This [***] period shall automatically expire unless otherwise agreed in writing by the Parties before the expiry date.

 

6.2. VIRBAC has the first option right to negotiate a Specific Distribution Agreement with NEXVET in the Territory for a New Product. VIRBAC has [***] days from the receipt of a New Product Notice to inform NEXVET in writing of its interest in negotiating the distribution of the New Product (a “VIRBAC Notice”).

 

6.3. The Parties have [***] months from the date of the VIRBAC Notice to negotiate a term sheet and [***] using all reasonable endeavours to negotiate and execute the terms and conditions for the Specific Distribution Agreement of the New Product. The timescales set out in this Article 6.3 may be extended by mutual agreement of the Parties in writing.

 

6.4. If the Parties fail to agree the terms and conditions for the Specific Distribution Agreement of a New Product in the agreed timeframes set out in Article 6.3 then VIRBAC shall have no rights in relation to such New Product.

 

7. TERM

 

7.1. The Agreement is deemed to come into force on November 24th, 2014 and shall remain in force for 10 (ten) years from the date of First Commercialization of the first Product (“Initial Term”).

 

7.2. The duration of each Specific Distribution Agreement for each Product shall be set forth in the Specific Distribution Agreement itself. If the term of a Specific Distribution Agreement exceeds the term of this Agreement then the following articles of this Agreement shall survive solely of the purpose of applying to the applicable Specific Distribution Agreement until the expiration or termination of such Specific Distribution Agreement:

Article 1 (Definitions);

Article 2 (Purpose)

 

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Article 3 (Exclusivity)

Article 8 (Responsibilities)

Article 9 (Minimum Annual Net Sales Obligations)

Article 10 (Development Plans)

Article 11 (Joint Steering Committee)

Article 12 (Marketing Authorization)

Article 13 (Manufacturing and Batch Release)

Article 14 (Supply and Delivery)

Article 15 (Defects)

Article 16 (Recall of the Product)

Article 17 (Rolling Forecast and Orders)

Article 18 (Pharmacovigilance)

Article 19 (Financial Terms)

Article 20 (Right of first refusal for Registration Dossier)

Article 21 (Intellectual Property Rights)

Article 21A (Infringement of Nexvet Technology or Trademarks by a third party)

Article 22 (Trademarks and Packaging)

Article 23 (Audits)

Article 24 (Liability - Insurance)

Article 25 (Confidentiality)

Article 26 (Termination and Consequences of Termination)

Article 27 (Remaining Stock)

Article 28 (Notice)

Article 29 (Material Safety data Sheet)

Article 30 (Notification to Anti-Poison Center)

Article 31 (Information)

Article 32 (Force Majeure)

Article 38 (Applicable Law and Jurisdiction)

 

7.3. Unless agreed otherwise in writing by the Parties in advance of the ninth anniversary of the First Commercialization of the First Product, this Agreement shall automatically extend by a period of two (2) years on the expiry of the Initial Term and shall continue to automatically extend on the expiry of each such two (2) year extension periods by additional two (2) year extension periods unless agreed otherwise by the Parties in writing.

 

8. RESPONSIBILITIES

 

8.1. VIRBAC Responsibilities

VIRBAC shall:

 

  (a) provide clinical, regulatory, marketing and sales input via a Joint Steering Committee (JSC). This shall include the provision of annual budgets (i.e. expenses forecasted), marketing strategy, pricing, forecast, demand/orders post-launch and any subsequent country launch plans for the Important Countries.

 

  (b) advise NEXVET in the drafting of regulatory submissions in the countries within the Territory. This advice shall include reviewing and commenting on draft regulatory submissions prepared by NEXVET.

 

  (c) sell the Products according to the terms of the Agreement.

 

  (d) subject to Article 9 “Minimum Annual Net Sales Obligations”, meet or exceed Minimum Annual Obligations for each Product.

 

  (e) Subject to Article 18 “Pharmacovigilance”, VIRBAC shall be responsible for the local management of complaints and shall transfer any data in the timelines defined in Article 18 and the Pharmacovigilance Data Exchange Agreement entered into by the Parties in each Specific Distribution Agreement.

 

  (f) Not itself apply for, or cause or allow any Affiliate or any third party to apply for, or become involved with any application by any other person for the registration of any trademark that is the same as any of the Trademarks, or that is similar to or capable of being confused with any of the Trademarks,

 

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VIRBAC shall use commercially reasonable endeavours to launch the Products within [***] after the issuance of the Marketing Authorization and it shall launch the Products no later than [***] after the issuance of the Marketing Authorization by each national authority.

VIRBAC warrants that VIRBAC’s employees, any VIRBAC Affiliates, and any VIRBAC agents and/or any third party distributors engaged by VIRBAC, shall comply with any applicable laws and regulations in the Territory in relation to such acts, and shall otherwise comply with VIRBAC’s obligations under this Agreement.

 

8.2. NEXVET Responsibilities

NEXVET shall:

 

  (a) file, prosecute and maintain the Patents at its own costs.

 

  (b) conduct and provide to the JSC a Freedom To Operate analysis for the Products in the Territory. This analysis should be performed and updated regularly at the request of the JSC by professional patent attorneys.

 

  (c) execute all pre-clinical and clinical development activities at its owns costs in accordance with Development Plan as agreed between the Parties.

 

  (d) share all development information via the JSC including pre-clinical, clinical development and more generally all information related to the development of the Products worldwide.

 

  (e) register the Registration Dossier at its own costs. NEXVET will be the owner of the Registration Dossier and the holder of the Marketing Authorization.

 

  (f) register, maintain and prosecute at its owns costs the Trademarks,

 

  (g) during the term of any Specific Distribution Agreement, NEXVET shall, notably, refrain from registering, from using itself, or from licensing to other partners, any trademarks that are identical with or similar to any Trademarks which have been licensed to VIRBAC in the Territory under a Specific Distribution Agreement (unless and until that Specific Distribution Agreement expires or is terminated and VIRBAC’s licence to use such Trademarks ceases),

 

  (h) use commercially reasonable endeavours to obtain the Marketing Authorizations for the Products at its own costs in accordance with the Target Product Profile agreed between the Parties.

 

  (i) use commercially reasonable endeavours to maintain the Marketing Authorizations within the Territory and NEXVET shall bear all the costs related to such maintenance (including but not limited to the ongoing stability studies).

 

  (j) supply the Products to VIRBAC in accordance with the terms of this Agreement and the applicable Specific Distribution Agreement.

 

  (k) fund any development candidates which may become New Products.

 

9. MINIMUM ANNUAL NET SALES OBLIGATIONS

 

9.1. The minimum annual net sales obligations for each Product in the entire Territory shall be defined in the relevant Specific Distribution Agreement (“Minimum Annual Net Sales Obligations”).

 

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9.2. If VIRBAC fails to meet the Minimum Annual Net Sales Obligations for a Product during [***], VIRBAC shall have the right, as its exclusive remedy, to pay to NEXVET an amount equal to the difference between the applicable NEXVET Fees which relate to the Minimum Annual Net Sales Obligations of such Product which VIRBAC has failed to achieve and the actual NEXVET Fees paid by VIRBAC for such Product during the [***] in which VIRBAC failed to meet the Minimum Annual Net Sales Obligations (hereinafter the “Amount”).

For the sake of clarity and as example:

For a Product, if Minimum Annual Obligations are not achieved for [***] where:

 

    Minimum NEXVET Fees is [***] for the [***]; and

 

    Actual NEXVET Fees paid by VIRBAC for the [***] is [***];

VIRBAC shall have the right to pay to NEXVET [***].

 

9.3. If VIRBAC has not made the payment referred to in Article 9.2 above to NEXVET within [***] of the issuance of the invoice corresponding to the Amount then NEXVET may terminate the applicable Specific Distribution Agreement on notice to VIRBAC without any obligation to pay compensation of any kind. In such case, NEXVET shall issue a credit note corresponding to the Amount or cancel the applicable invoice. Upon such termination, VIRBAC’s rights to distribute the Product or use any of the Trademarks shall terminate, and NEXVET shall then have the right to distribute the relevant Product in the Territory itself or through a third party, and shall have the right to use the Trademarks in relation to the relevant Product. If VIRBAC does make the payment referred to in Article 9.2 then the applicable Specific Distribution Agreement shall continue subject to its terms and, for the avoidance of doubt, VIRBAC’s obligation to achieve the Minimum Annual Net Sales Obligations shall continue.

 

9.4. VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the full applicable calendar year and the following years in case of:

 

  (a) Co-distribution of the Product in the Territory in accordance with NEXVET’s right in Article 3 (Exclusivity).

 

9.5. Subject to Article 9.6 below:

 

  (1) VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the full applicable calendar year to the extent that its failure to achieve the applicable Minimum Annual Net Sales Obligations is caused by one or more of the causes described below:

 

  (a) NEXVET’s material breach of this Agreement or of the applicable Specific Distribution Agreement, where such material breach directly and materially affects VIRBAC’s ability to achieve the applicable Minimum Annual Net Sales Obligations and where such material breach is not remedied by NEXVET within [***] of receipt of a notification from VIRBAC requiring the remedy of such material breach; or

 

  (b) no delivery of the Products by NEXVET for more than [***] (“No Delivery Period”); or

 

  (c) material modification of the Marketing Authorization for quality, safety or pharmacovigilance issues where such modification is not able to be rectified and such modification negatively impacts the Target Product Profile in an Important Country and in a way that materially limits VIRBAC’s ability to achieve the Minimum Annual Net Sales Obligations.

For the purposes of Article 9.5(1)(b), where the No Delivery Period is spread across [***] then VIRBAC shall have the right to elect which calendar year’s Minimum

 

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Annual Net Sales Obligation it shall be relieved of. VIRBAC shall only be able to elect to obtain relief for [***] Minimum Annual Net Sales Obligations and it shall be required to achieve the Minimum Annual Net Sales in [***]. For the sake of clarity and by way of a worked example:

[***]

 

  (2) VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the applicable [***], on a pro-rata basis, to the extent that its failure to achieve the applicable Minimum Annual Net Sales Obligations is caused by one or more of the causes described below:

 

  (a) an event of Force Majeure which materially limits its ability to achieve the Minimum Annual Net Sales Obligations; or

 

  (b) no delivery of the Products for [***] or less or late delivery of the Products by NEXVET by at least [***] on [***] consecutive orders, with such late deliveries materially limiting VIRBAC’s ability to achieve the Minimum Annual Net Sales Obligations; or

 

  (c) material modification of the Marketing Authorization for quality, safety or pharmacovigilance issues where such modification negatively impacts the Target Product Profile in an Important Country and in a way that materially limits VIRBAC’s ability to achieve the Minimum Annual Net Sales Obligations (provided that such modification is rectified within a period of [***] of the modification);

PROVIDED THAT for Articles 9.5 (2)(a), (2)(b) and 2(c) only, once the issue which has led to VIRBAC obtaining relief from its obligation to achieve the Minimum Annual Net Sales Obligations has been resolved VIRBAC shall again be obligated to achieve the Minimum Annual Net Sales Obligations. In such a case the Minimum Annual Net Sales Obligations will be recalculated by NEXVET and agreed by the JSC on a pro-rata basis to take into account the period during which VIRBAC was relieved of its obligation to achieve the Minimum Annual Net Sales Obligations. This recalculation may take in account [***] Minimum Annual Net Sales Obligations if the events referred to in Articles 9.5 (2)(a), (2)(b) and 2(c) continue across [***].

 

9.6. VIRBAC shall only be able to avail of the relief set out in Article 9.5 if it is in full compliance with its corresponding obligations directly linked to the Minimum Annual Net Sales Obligations in this Agreement.

 

9.7. The Parties shall discuss the reassessment of the Minimum Annual Net Sales Obligations in case of:

 

  (a) the arrival of a Competing Product and/or any new breakthrough product with a different technology for the same indication, or

 

  (b) VIRBAC being prohibited from selling a Product in any Important Country due to:

 

  (i) an inability to obtain, or a loss of, a Marketing Authorization in any Important Country, notwithstanding reasonable efforts by NEXVET to obtain or maintain such Marketing Authorization and through no fault of either Party; or

 

  (ii) a third party having intellectual property rights that would be infringed by the exploitation of the Product in the Important Country (as determined through the conduct of a FTO Analysis) and where NEXVET has not been able to either obtain a licence to such third party rights or to manufacture, package or prepare to sell the Product in a way that does not infringe such third party rights, notwithstanding reasonable efforts to do so; or

 

  (c) a material improvement in the applicable Target Product Profile. If the Target Product Profile is so improved the Parties shall discuss increasing the applicable Minimum Annual Net Sales Obligations.

 

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10. DEVELOPMENT PLANS

 

10.1. Each Specific Distribution Agreement shall include a Development Plan. Each Development Plan shall include separate components describing NEXVET’s proposed development and regulatory activities with the goal of obtaining Marketing Authorizations according to the Target Product Profile agreed between the Parties, in the Territory. The Development Plan shall be in the form of the Development Plan template set out in Annex 3.

 

10.2. Each component of a Development Plan shall also include the proposed timeline for the activities described thereunder.

 

10.3. The Development Plan shall become effective once approved by the JSC and material changes may only be amended thereafter by the JSC.

 

11. JOINT STEERING COMMITTEE

 

11.1. Establishment

Promptly after the signature of the Agreement, VIRBAC and NEXVET shall establish a joint steering committee (the “JSC”) to oversee the development, registration, manufacture, technical support, marketing and sales of the Products in the Field.

 

11.2. Responsibilities

The JSC shall be responsible for:

 

  (i) establishing (either by itself or through project teams), reviewing, sharing all Development Plans for the Territory and approving all Development Plans for the Territory,

 

  (ii) reviewing and monitoring activities under the Development Plans and the progress thereof in the Territory,

 

  (iii) managing the integration and coordination of the development and the manufacturing of the Products in the Territory,

 

  (iv) the choice of the Trademarks,

 

  (v) facilitating access to and ensuring the exchange of information between the Parties related to the Products in the Field in the Territory,

 

  (vi) ensuring that the development of the Products in the Field for the Territory proceed in a coordinated and expeditious manner,

 

  (vii) sharing and reviewing marketing and sales plans for the Territory,

 

  (viii) discussing and agreeing on the technical support and any additional studies (for instance clinical studies) related to such technical support. It is agreed between the Parties that NEXVET shall not unreasonably withhold its agreement to conduct these post-approval studies if such studies are necessary to market and support the Products in the Territory. The Parties shall discuss the sharing of the costs of any such studies,

 

  (ix) discussing and agreeing on the publication plans in relation to any Products and the participation to conferences and conventions for the Territory,

 

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  (x) discussing and agreeing on the life cycle development of the Products (for example new indications, new formulations),

 

  (xi) seeking to resolving disputes between the Parties in accordance with the dispute resolution procedure set in Article 39 “Dispute Resolution Procedure”; and

 

  (xii) defining and agreeing the scope and object of the Freedom to Operate Analysis for each Product and ongoing review of the same.

 

11.3. Membership

The JSC shall be comprised of an equal number of representatives from each of NEXVET and VIRBAC. The exact number of such representatives shall be 3 (three) for each of VIRBAC and NEXVET, or such other number as the Parties may agree. The JSC shall allow attendance of ad hoc members from both parties according to the topics to be addressed during the meetings.

 

11.4. Decision Making

The decisions of the JSC shall be made by unanimous decision of the representatives (for sake of clarity ad hoc members do not participate to the vote). If the JSC fails to reach unanimous consent on a particular matter within [***] after the JSC meeting, either Party may refer such matter to the Chief Executive Officers of each of the Parties for resolution.

Where agreement is not reached, VIRBAC’s Board will have the final say on (i) marketing (excluding decisions related to the Trademarks for which final say shall rest with NEXVET’s CEO), (ii) decisions as to whether or not to launch the Product(s) in a particular country within the Territory where VIRBAC reasonably determines, taking into account the FTO Analysis, that there is a reasonable risk that such launch will infringe a third party’s Intellectual Property Rights (“Third Party Rights Risk”), and (iii) pricing decisions in the Territory. NEXVET CEO will have the final say on Product development, registration and manufacturing decisions.

To the extent that VIRBAC decides not to launch a Product(s) in a particular country within the Territory within [***] after the issuance of the Marketing Authorization by the applicable national authority due to a Third Party Rights Risk VIRBAC shall inform NEXVET of such in writing, the Parties shall meet within [***] of the date of such notice to determine whether the launch is to be delayed for a reasonable period of time (and if so the length of that delay) or shall not take place at all. If VIRBAC decides not to launch the Product(s) at all due to the Third Party Rights Risk or still will not launch the Product(s) after the agreed delay period due to the Third Party Rights Risk, either Party shall have the right to partially terminate the applicable Specific Distribution Agreement on [***] notice in relation to the applicable country and upon such partial termination all of VIRBAC’s rights in respect of the applicable Product in the applicable country shall cease and NEXVET shall be free to market and distribute the Product(s) in that country either itself or through a third party as it determines in its absolute discretion. In such case, NEXVET shall market and distribute the Product in the applicable country under a different trade dress to the Trade Dress that is used for the Product by VIRBAC. NEXVET will however be free to use the Trademarks in relation to the Product in the applicable country. In addition, the Minimum Annual Net Sales Obligations will be recalculated by the Parties and agreed by the JSC to take into account the loss of the applicable country.

Each Party will bear its own costs in relation to the JSC. The JSC should meet four times a year with at least two meetings face-to-face per annum.

 

11.5. NEXVET information sharing through the JSC

Through the JSC, NEXVET shall keep VIRBAC informed of the following:

 

  (i) Development Plans and their progress outside the Territory,

 

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  (ii) The process of the integration and coordination of the development and the manufacturing of Products outside the Territory,

 

  (iii) Information relating to the same or similar Products outside the Territory,

 

  (iv) The progress of marketing and sales plans for the Products outside the Territory,

 

  (v) Information on publication plans, conferences and conventions outside the Territory in relation to the Products.

 

  (vi) The progress made in connection with Trademark protection in the Territory and the risks encountered which can prevent the use of the Trademarks in the Territory by VIRBAC.

Unless indicated otherwise by NEXVET, all such information shall be Confidential Information of NEXVET and Article 25 shall apply to such information.

 

11.6. Through the JSC, VIRBAC shall keep NEXVET informed of the following:

 

  (i) Marketing, launch and annual budget plans for the Product in the Territory,

 

  (ii) Market information on similar technology and/or products to any Products in the Territory in so far as VIRBAC is aware of such,

 

  (iii) Information on inventory holdings by VIRBAC and its distributors for the Product to the extent this information is available,

 

  (iv) Pharmacovigilance issues for the Product(s);

 

  (v) Potential new products and target product profiles that would enhance the collaboration between the Parties.

 

12. MARKETING AUTHORIZATION

 

12.1. NEXVET shall be responsible, at its own expenses, for obtaining and maintaining in its own name the Marketing Authorization and any other governmental or certifying body permits, authorizations and certifications necessary. NEXVET shall be the holder of the Marketing Authorization in the Territory unless agreed otherwise pursuant to each Specific Distribution Agreement.

 

12.2. VIRBAC shall provide reasonable cooperation with NEXVET in obtaining and maintaining the Marketing Authorization in the Territory. All these documents shall be provided in English language. VIRBAC will not invoice NEXVET for any internal costs for this cooperation.

 

12.3. Where additional studies are required for the purpose of obtaining the Marketing Authorization, the cost of said additional studies shall be borne by NEXVET.

 

13. MANUFACTURING AND BATCH RELEASE

 

13.1. Manufacturing

NEXVET shall procure that the Products are manufactured by the Product Manufacturer. Nevertheless, the Products shall be manufactured under NEXVET’s responsibility and liability even when the Manufacturer is not NEXVET. NEXVET shall remain responsible to VIRBAC for the acts of the Manufacturer even though the Manufacturer is a third party.

 

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NEXVET warrants to VIRBAC that:

 

  (1) the Manufacturing Site shall comply with the Product Authorization, GMP or equivalent manufacturing standards and with all applicable laws and, in particular, the Manufacturer shall avoid any contamination with other products and/or active ingredients manufactured by the Manufacturer; and.

 

  (2) the Manufacturer has and shall have full capacity and authority to fulfil the obligations established under the Agreement and, shall have all necessary licenses, permits and consents to manufacture the Product for sale of the Products in any country of the Territory.

NEXVET shall inform the JSC if it proposes to change the Product Manufacturing Site and/or the Product Manufacturer. NEXVET shall provide the JSC with at least [***] written notice of any such changes.

 

13.2. Batch release

NEXVET acts as the manufacturer and the batch releaser of the Products. Quality control proceedings shall be performed in compliance with the Marketing Authorization and all applicable laws.

NEXVET shall send to VIRBAC the following documents with every batch of Product: certificate of analysis and the batch release documentation, at the following address:

VIRBAC

[***]

Both Parties shall ensure or procure that when they are in possession of a batch of Products that such Products are stored in compliance with relevant government requirements and that they shall at all times handle the Products in compliance with the Marketing Authorization.

NEXVET shall ensure that it will keep all the batch documentation of the Products after date of delivery of the Products to VIRBAC in accordance with any applicable regulatory requirements and/or applicable laws.

 

14. SUPPLY AND DELIVERY

 

14.1. NEXVET warrants that the Products shall meet the applicable Product Specification as set in the Specific Distribution Agreement.

 

14.2. All Products shall be delivered subject to and in accordance with the terms of this Agreement and the applicable Specific Distribution Agreement to the exclusion of any other terms either Party may seek to impose on or around the time of delivery. The Specific Distribution Agreements will include delivery details which apply to the applicable Products (such as timeline, minimum order quantity, consequences of late delivery etc.), PROVIDED THAT NEXVET shall set the minimum order quantities for each Product(s).

 

14.3. The Products shall be delivered to VIRBAC with at least [***] of their approved shelf live remaining and in any event with at the minimum [***] of their approved shelf live remaining unless otherwise agreed by the Parties in each Specific Distribution Agreement.

 

14.4. NEXVET shall promptly inform VIRBAC in the event NEXVET cannot, for whatsoever reason, deliver the Product within the agreed delivery date. Time of delivery shall not be of the essence.

 

14.5. VIRBAC storage of the Products: VIRBAC must store the Products in a proper manner in conditions which adequately protect and preserve the Products without any charge to NEXVET and not tamper with any identification upon the Products or their packaging. In particular, VIRBAC shall ensure that it stores and maintains the Products in accordance with the applicable specifications and the Marketing Authorization.

 

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14.6. The penalty in case of late delivery of the Product shall be defined in each Specific Distribution Agreement.

 

14.7. Retention of Title:

 

  (a) Risk in respect of the Products supplied to VIRBAC shall pass to VIRBAC on delivery.

 

  (b) Title to and property in the Products supplied under a Specific Distribution Agreement shall remain vested in NEXVET (even though they have been delivered and risk has passed to VIRBAC) until: the price of the Products has been paid, discharged or satisfied in full whether or not due for payment.

 

  (c) VIRBAC acknowledges that it is in possession of the Products solely as bailee for NEXVET until such time as title in the Products passes to VIRBAC.

 

  (d) Until title to and property in the Products pass to VIRBAC, NEXVET may at any time without prior notice to VIRBAC require VIRBAC to deliver the Products up to NEXVET and NEXVET may repossess and resell the Products if any of the events specified in Article 26.5 as giving rise to a right for NEXVET to terminate this Agreement occurs, or if any sum due to VIRBAC from NEXVET under this Agreement or on any other account or under any other contract is not paid when due;

 

  (e) NEXVET’s rights and remedies set out in this Article 14.7 represent the sole and exclusive remedy of NEXVET and the entire liability and obligation of VIRBAC with respect to this article.

 

15. DEFECTS

 

15.1. Provided the Products present a visible defect, VIRBAC shall inform NEXVET and NEXVET shall, without prejudice of any other indemnities set out in the Agreement, at its own expenses and immediately, take back the defective Products and refund VIRBAC the amounts already paid or to replace the defective Products with other Products immediately.

 

15.2. In the event that Products contain a latent defect, VIRBAC shall notify the existence of such latent defect within [***] of said discovery. If NEXVET disagrees or disputes the written notification from VIRBAC, the Parties shall submit samples of the rejected Products to a mutually acceptable independent laboratory for analysis, whose analysis results on the matter shall be final and binding. The Party found to be in error shall bear the cost of such analysis.

 

15.3. In the event such laboratory shows that the relevant batch does not meet the agreed quality, VIRBAC may reject such batch which NEXVET shall replace with Products to be delivered free of charge and as soon as reasonably applicable or if the Products are already on the market, NEXVET shall replace the Products free of charge, without prejudice of any other indemnities set out in the Agreement.

 

15.4. NEXVET shall not be liable for Products’ failure to comply with the applicable specification in any of the following events:

 

  (a) the defect has arisen because VIRBAC has failed to comply with Article 14.5, or more generally has failed to follow NEXVET’s instructions as to the storage, commissioning, installation, use and maintenance of the Products or (if there are none) good trade practice regarding the same;

 

  (b) VIRBAC alters such Products without the written consent of NEXVET;

 

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  (c) the defect arises as a result of fair wear and tear, wilful damage, negligence, or abnormal storage or working conditions; or

 

  (d) the Products differ from the applicable specification as a result of changes made to ensure they comply with applicable statutory or regulatory requirements.

 

16. RECALL OF THE PRODUCT

 

16.1. VIRBAC shall maintain an efficient distribution system within the Territory and shall establish and maintain a batch tracing and recall system which will enable it to identify, with minimum delay, customers within the Territory who will have been supplied with any particular batch of the Products and to recall such Products. VIRBAC shall provide all reasonable assistance requested by NEXVET in relation to a recall of the Products or a field alert.

 

16.2. In the event that the Authorities require a recall of the Product or if NEXVET believes that a recall of the Products may be necessary or appropriate, NEXVET shall immediately notify VIRBAC. In the latter case (if NEXVET believes a recall is necessary), the two parties shall discuss whether a recall is necessary but NEXVET, as the MAH, with exception of local regulatory requirements, is responsible for the final decision of any recalls or field alert activities and for corresponding communication with health authorities.

 

16.3. VIRBAC shall use its reasonable endeavours to perform and coordinate recalls or field alert activities as required by NEXVET according to Article 16.2 from time to time.

 

16.4. NEXVET shall provide any information reasonably required by VIRBAC relating to recall or field alert activities within [***] of the request, if such information is readily available at NEXVET.

 

17. ROLLING FORECAST AND ORDERS

 

17.1 Rolling forecast

VIRBAC will at least [***] before the end of December of each calendar year notify NEXVET in writing of the estimated rolling forecast for the Products for the following calendar year. Such forecasts are non-binding and will be updated as necessary on a Quarterly basis.

VIRBAC shall use its reasonable endeavours to hold stock(s) of the Products sufficient to meet the total demand of the market in the Territory.

 

17.2 Orders

VIRBAC will place firm purchase orders for the Products by email or fax giving not less than [***] notice prior to the required date of delivery to enable NEXVET to arrange its schedule for production.

In the event that VIRBAC places orders for quantities in excess of its estimated requirements and/or for delivery within a shorter period than [***], NEXVET will use its reasonable endeavours to comply with such request.

All orders will be deemed accepted and binding [***] from receipt of the orders by NEXVET. If orders are not accepted, NEXVET shall indicate in writing the reasons of refusal and, if applicable, the date of the possible delivery of the Products.

 

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18. PHARMACOVIGILANCE

 

18.1 Subject to the provisions of Article 8:

 

  (a) The Parties shall be responsible for the compliance with the pharmacovigilance obligations as defined under local rules in the Territory, and shall comply with a Pharmacovigilance Data Exchange Agreement to be entered into between the Parties in each Specific Distribution Agreement, in a form substantially the same as set out in Annex 8 of this Agreement. By way of assisting and advising NEXVET on the distribution of the Product in the Territory, VIRBAC shall take all reasonable steps to inform NEXVET of any local rules within the Territory that may be applicable with respect to the Product and with which NEXVET may have to comply.

 

  (b) VIRBAC shall be responsible for the local management of complaints and shall transfer any data within [***] of receipt of the first information to NEXVET for serious cases. For the other non-serious cases, VIRBAC shall transfer any data within [***] of receipt of the first information to NEXVET.

 

       NEXVET as the Marketing Authorization Holder shall be responsible for preparing and submitting the reports (expedited and periodic) to the concerned agencies.

 

  (c) Each Party shall provide, within a reasonable deadline or the legal deadline, any information requested by the other Party in order to comply with the local pharmacovigilance obligations in the Territory.

 

  (d) All relevant information relating to pharmacovigilance must be shared between NEXVET and VIRBAC in order to allow the parties to assume their obligations and responsibilities.

 

  (e) NEXVET being the MAH will be responsible for the communication on pharmacovigilance with the authorities.

 

19. FINANCIAL TERMS

 

19.1 Milestone payment

In recognition and consideration of the research and development work conducted by NEXVET, VIRBAC shall pay to NEXVET a milestone payment or payments for each Product (“Milestone Payment”).

The trigger event(s) and the amount of the Milestone Payment shall be defined in each Specific Distribution Agreement for each Product and shall be paid by VIRBAC to NEXVET within [***] of the date of the trigger event(s). For the sake of clarity, a Milestone Payment is paid only once for each trigger event for that Product, unless specified otherwise.

If a Specific Distribution Agreement is terminated before a trigger event(s) occurs then no Milestone Payment will be due for the applicable Product.

 

19.2 NEXVET Fees

 

19.2.1 The NEXVET Fees will be defined in each Specific Distribution Agreement for each Product.

The NEXVET Fees shall be determined based on the share of the Commercial Margin between NEXVET and VIRBAC.

 

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The Parties acknowledge and agree that:

 

  (i) the payment of the NEXVET Fees shall incorporate the deferred payment of the Manufacturing Margin for the Product; and

 

  (ii) the Manufacturing Margin shall not exceed NEXVET’s share of the Commercial Margin.

 

19.2.2 NEXVET shall invoice the Products at the Purchase Price as follows:

 

    an invoice for the Manufacturing Margin whereby the payment of the invoice shall be deferred and included in the Quarterly NEXVET Fee calculation;

 

    an invoice for the Cost of Goods that shall be raised on delivery of the Products.

 

19.2.3 The NEXVET Fees shall be invoiced on a Quarterly basis as follows:

 

  (i) the Manufacturing Margin; and

 

  (ii) the remaining balance of NEXVET’s share of the Commercial Margin.

The NEXVET Fees shall be estimated on a Quarterly basis by VIRBAC based on VIRBAC’s sales, and such estimation shall be provided to NEXVET within [***] from the end of the Quarter. NEXVET shall issue an invoice based on this estimation to VIRBAC.

 

19.2.3 At the end of each calendar year, and in any event by the end of January each year, VIRBAC shall calculate and communicate to NEXVET the exact NEXVET Fees to be paid to NEXVET for the preceding year less amounts already paid by VIRBAC for the 3 (three) first Quarters of the relevant year. NEXVET shall issue the corresponding invoice on receipt of the required information from VIRBAC.

 

19.2.4 For sake of clarity, a financial example is set out in Annex 9.

 

19.3 Purchase Price of the Products

The Purchase Price of the Products shall be Ex-Works Product Manufacturer (Incoterms 2010), unless otherwise mentioned in the Specific Distribution Agreement.

The Purchase Price of each Product shall be disclosed and agreed between the Parties through the JSC and shall be stated in each Specific Distribution Agreement.

During the term of the Agreement, NEXVET shall use its reasonable endeavours to reduce its costs in line with any specified requirements in the Specific Distribution Agreement.

 

19.4 Cost of Selling

VIRBAC shall use the Cost of Selling as defined in Section 1 «Definitions » of the Agreement for the calculation of the Commercial Margin.

 

19.5 Payments

Unless otherwise agreed in this Agreement, all the invoices shall be paid by VIRBAC to NEXVET within [***] from the date of the invoice.

The invoices and payment shall be made to NEXVET in Euros by wire transfer to the bank account specified in any invoice.

The functional currency in the VIRBAC’s group’s foreign subsidiaries is the current local currency. The financial income statements of foreign companies for which the functional currency is not the Euro are converted using the published Banque de France foreign exchange reference monthly average rate. Payments to Nexvet will be calculated on this basis. For the purpose of calculations, the Net Sales will be converted from Euro to USD using the Banque de France’s published foreign exchange reference monthly average rate for the period and compared to the USD Minimum Annual Net Sales Obligations amounts disclosed in the Specific Distribution Agreement.

 

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20. RIGHT OF FIRST REFUSAL FOR REGISTRATION DOSSIER

 

20.1. If NEXVET receives a bona fide proposal from a third party for the assignment of the Registration Dossier for any of the Products, NEXVET shall notify VIRBAC of the receipt of a third party proposal for the assignment of the Registration Dossier, but not the details.

 

20.2. VIRBAC will have a [***] period from the receipt of the notification from NEXVET to make an offer to purchase the Registration Dossier. At the end of that period, NEXVET shall consider all offers and be free to assign the Registration Dossier to whichever entity (being the third party or VIRBAC) to whom NEXVET, in its sole discretion, determines.

 

21. THIRD PARTY INTELLECTUAL PROPERTY RIGHTS INDEMNITY

 

21.1 NEXVET shall hold harmless and fully indemnify VIRBAC, and shall compensate and reimburse VIRBAC, against any damages, expenses and costs awards suffered and/or incurred by VIRBAC in connection with any third party’s claim that its Intellectual Property Rights have been infringed arising out of VIRBAC’s use of the Trademarks in accordance with this Agreement and resulting from the making, offering, putting on the market, marketing, importing, stocking, manufacturing, the distribution of the Products in the Territory in accordance with this Agreement.

 

21.2 VIRBAC shall hold harmless and fully indemnify NEXVET, and shall compensate and reimburse NEXVET, against any damages and costs awards suffered and/or incurred by NEXVET in connection with any third party claim of infringement of that third party’s Intellectual Property Rights arising out of the use of the VIRBAC Trademarks, the Trade Dress and any marketing material used by or on behalf of VIRBAC in relation to the sale, marketing or distribution of the Products, PROVIDED THAT the indemnity shall apply only to such damages and costs arising from any such infringement which relates to the VIRBAC Trademarks, the Trade Dress or VIRBAC’s marketing material.

 

21.3 The party that is seeking to be indemnified under either Article 21.1 or Article 21.2 (each an “Indemnified Party”) agrees to promptly notify the other party (the “Indemnifying Party”) in writing of any claim or allegation by a third party, and to:

 

  21.2.1 make no admission without the Indemnifying Party’s prior written consent (such consent not to be unreasonably withheld);

 

  21.1.2 allow the Indemnifying Party to have sole conduct and control of the defence of any such claim or any related settlement negotiations; and

 

  21.2.3 give the Indemnifying Party all reasonable assistance (at the Indemnifying Party’s cost) with such defence or any related settlement negotiations.

 

21.4 If any claim is made pursuant to Article 21.1 above, or if, in the reasonable opinion of NEXVET, such as claim is likely to be made, NEXVET shall promptly and at its own expense either:

 

  21.4.1 procure such rights as are necessary to enable VIRBAC to continue distributing the Products. In such case, these expenses (such as royalties) should not be taken out of the Commercial Margin that will be shared between VIRBAC and NEXVET and should be borne exclusively by NEXVET; or

 

  21.4.2 modify or replace the infringing part of the Products (without curtailing in any material aspect the Products) so as to avoid the infringement or alleged infringement.

 

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21.5 The foregoing indemnity in Article 21.1 will not apply to any claim that is based upon or arising from (i) any misuse of the Products by VIRBAC without the consent of NEXVET, (ii) any alternation of the Products by VIRBAC, or (iii) VIRBAC’s continued use of the Products subsequent to receipt of notice of any claimed infringement.

 

21.6 Subject to the additional remedy available to VIRBAC under Article 22.1(d) below, this Article 21 represents the sole and exclusive remedy of either Party (as applicable) and the entire liability and obligation of the other Party (as applicable) with respect to infringement or claims of infringement or misappropriation of any third party’s Intellectual Property Rights.

 

21A. INFRINGEMENT OF NEXVET TECHNOLOGY OR TRADEMARKS BY A THIRD PARTY

 

21A.1 Each Party shall promptly give notice in writing to the other if it becomes aware of any infringement or suspected infringement of the Trademarks, the NEXVET Technology or any other Intellectual Property Rights relating to the Products within the Territory.

 

21A.2 NEXVET has the first right, but not the obligation, at NEXVET’s cost and in its sole discretion, to take action in relation to any unauthorised use of any of the NEXVET Technology or the Trademarks. NEXVET will have absolute control over any litigation involving or affecting the NEXVET Technology or the Trademarks. VIRBAC acknowledges and agrees that NEXVET will retain any and all damages or awards arising from any proceedings undertaken pursuant to this Article 21A.2. VIRBAC must provide NEXVET with all reasonable assistance in connection with any action taken by NEXVET under this Article 21A.2 and NEXVET must indemnify VIRBAC from and against all expenses, losses, damaged and costs whatsoever arising directly or indirectly as a result of any action taken under this Article 21A.2.

 

21A.3 If NEXVET does not take action under Article 21A.2 within [***] of being notified of a claim in accordance with Article 21A.1, VIRBAC may, with the prior written consent of NEXVET, take action at VIRBAC’s cost, provided that:

 

  (a) VIRBAC must consult with, and have due regard to the interests of NEXVET;

 

  (b) NEXVET will have the option at any time to direct VIRBAC in relation to the action or to assume control of the action from VIRBAC; and

 

  (c) VIRBAC must not settle or compromise any action without the prior written consent of NEXVET.

VIRBAC will retain any and all damages or awards arising from any proceedings taken under this Article 21A.3. NEXVET will provide VIRBAC with all reasonable assistance in connection with any action taken by VIRBAC under this Article (including being joined to proceedings or allowing proceedings to be instituted in NEXVET’s name if required). VIRBAC must indemnify NEXVET from and against all expenses, losses, damaged and costs whatsoever arising directly or indirectly as a result of any action taken under this Article 21A.3.

 

22. TRADEMARKS AND PACKAGING

 

22.1. Trademark licence

 

  (a) The Products shall be distributed by VIRBAC in the Territory under the Trademarks in accordance with and subject to this Agreement.

 

  (b)

NEXVET grants to VIRBAC an exclusive, revocable, non-transferable licence in the Territory, to use the applicable Trademarks in the promotion, advertisement and sale of the Products only, subject to, and for the duration of, the applicable Specific

 

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  Distribution Agreement. VIRBAC acknowledges and agrees that all rights in the Trademarks shall remain in NEXVET, and that VIRBAC has and will acquire no right in them by virtue of the discharge of its obligations under this Agreement or the applicable Specific Distribution Agreement, except for the right to use the Trademarks as expressly provided in the Specific Distribution Agreement. Any goodwill in any of the Trademarks that is generated by or on behalf of VIRBAC during the term of this Agreement or any Specific Distribution Agreement enures for the benefit of NEXVET.

 

  (c) NEXVET is responsible, at its own costs, in the Territory, to obtain the registration of the Trademarks, to maintain and to police the registered Trademarks. The cost of the Trademark licence is included in the global amount paid by VIRBAC within the framework of this Agreement and VIRBAC shall not pay additional fees for the licence granted by NEXVET to sell the Products under its Trademarks.

 

  (d) NEXVET agrees to reimburse VIRBAC for any direct costs incurred by VIRBAC for the destruction of packaging and re-working of artwork in the event of a final and binding decision that any of the Trademarks infringe the rights of a third party in the Territory.

 

  (e) To the extent that any Trademark is no longer able to be used by VIRBAC due to a final and binding decision that the Trademark infringes the rights of a third party in the Territory, NEXVET will use its reasonable endeavours to provide a replacement Trademark for the Products, in which case all the provisions of this Agreement with respect to the Trademarks will be applied to this new Trademark.

 

22.2. All representations of the Trademarks that VIRBAC intends to use shall be submitted to NEXVET for written approval before use and shall not be used unless such approval is provided by NEXVET in writing within [***] which approval shall not be unreasonably withheld.

 

22.3. VIRBAC shall comply with all rules for the use of the Trademarks issued by NEXVET (including those set out in any branding manual issued by NEXVET) and shall not, without the prior written consent of NEXVET, alter or make any addition to the labelling or packaging of the Products displaying the Trademarks. VIRBAC shall not alter, deface or remove any reference to the Trademarks, any reference to NEXVET or any other name displayed on the Products or their packaging or labelling.

 

22.4. VIRBAC shall not do, or omit to do, anything in its use of the Trademarks that could adversely affect their validity or reputation.

 

22.5. VIRBAC shall immediately on request enter into any further agreements with NEXVET, in a form satisfactory to NEXVET, necessary for the recording, registration or safeguarding of NEXVET’s Trademark rights for the marketing of the Products under the Trademarks.

 

22.6. VIRBAC shall not use the Trademarks as part of the name under which VIRBAC conducts its business, or any connected business, or under which it sells or services any products (except the Products), or in any other way, except as expressly permitted hereunder.

 

22.7. VIRBAC shall not sub-license, assign, transfer, charge, or otherwise encumber the right to use, reference, or designate the Trademarks to any other party, except as otherwise expressly permitted under this Agreement or a Specific Distribution Agreement.

 

22.8. Upon termination of this Agreement or the applicable Specific Distribution Agreement for any reason, VIRBAC will immediately stop using all or any part of the Trademarks, except where permitted to sell remaining stock pursuant to Article 27.

 

22.9.

Trade Dress: NEXVET shall deliver the Products with their primary and secondary packaging in compliance with the Marketing Authorization and in accordance with

 

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  VIRBAC’s graphic arts and packaging Trade Dress directions; provided that graphic arts and packaging Trade Dress meet NEXVET´s instructions over the format, blisters, sizes. In no event shall NEXVET be authorized to make any changes in VIRBAC’s graphic arts and packaging Trade Dress.

 

22.10 NEXVET alone is responsible for the registration, maintenance and protection of any of the Trademarks, marks or designs that relate to the Products, except for any of the VIRBAC Trademarks or the Trade Dress, in which case, VIRBAC is responsible for the registration, maintenance and protection of any Intellectual Property Rights in the VIRBAC Trademarks or the Trade Dress.

 

22.11 Ownership of Trademarks and VIRBAC Trademarks and Trade Dress

 

  (a) NEXVET hereby acknowledges VIRBAC’s ownership of the VIRBAC Trademarks and Trade Dress, whether or not registered, and shall not acquire any rights in respect thereof. NEXVET shall not register or file in its own name or in the name of any other person or company any signs such as trademarks, company names or domain names, consisting of or containing the VIRBAC Trademarks or the name VIRBAC. NEXVET shall not register, use or file any signs being confusingly similar to or containing the VIRBAC Trademarks or the name VIRBAC.

 

  (b) NEXVET undertakes not to infringe, directly or indirectly, or help the infringement of any of the VIRBAC Trademarks and/or Trade Dress. This obligation shall apply within and outside the Territory and shall survive the expiration or termination of this Agreement for any reason whatsoever.

 

  (c) VIRBAC hereby acknowledges NEXVET’s ownership of the Trademarks, whether or not registered, and shall not acquire any rights in respect thereof except for the licensed rights under any Specific Distribution Agreement. VIRBAC shall not register or file in its own name or in the name of any other person or company any signs such as trademarks, company names or domain names, consisting of or containing the Trademarks or the name NEXVET. VIRBAC shall not register, use or file any signs being confusingly similar to or containing the Trademarks or the name NEXVET.

 

  (d) VIRBAC undertakes not to infringe, directly or indirectly, or help the infringement of any Trademarks. This obligation shall apply within and outside the Territory and shall survive the expiration or termination of this Agreement for any reason whatsoever.

 

23. AUDITS

 

23.1. Subject to Article 25, each Party or, at Parties election, its professional advisers or auditors has the right to audit the other Party at its own expenses in order to verify the compliance with the terms of the Agreement including any financial aspects (such as Cost of Goods). In addition and subject to obtaining the consent of the Manufacturer, VIRBAC has the right to inspect the Manufacturer Site(s).

 

23.2. Each Party shall provide at least [***] notice prior to the audit.

 

23.3. During an audit, each Party undertakes to cooperate closely and particularly to provide the other Party or its nominated auditors with all requested elements linked with the audit scope.

 

23.4. In case of assignment of the Agreement to a competitor of VIRBAC, such assignee will not be authorized to audit VIRBAC directly. In such case, the assignee and VIRBAC shall appoint an independent audit firm and such audit firm will be bound by an agreement for the conduct of the audit with VIRBAC and the assignee

 

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24. LIABILITY – INSURANCE

 

24.1 Each Party will maintain insurance coverage in accordance with the present article at all times commencing on the coming into force of this Agreement and continuing during the term of the Agreement. Each Party shall take out all insurance policies with a reputable insurance company, registered in a country member of the European Union, in accordance with their contractual obligations allowing each Party to fully defend their rights. Each of the general liability insurance and the Products liability insurance coverage obtained by each of the Parties shall be not less than [***] per event or series of connected events and per year and either Party shall produce a brokers letter as evidence of its compliance with this obligation on the request of the other Party from time to time.

 

24.2 Limitation of Liability

 

  (i) Subject to Articles 24.2 (ii) and (iii), the total aggregate liability of each Party in respect of any loss or damage (material and/or immaterial) suffered by the other Party and arising out of or in connection with this Agreement, regardless of the form of action whether in contract, tort (including negligence or breach of statutory duty), indemnity, misrepresentation or otherwise in connection with this Agreement shall not exceed:

 

  (a) [***] for Specific Distribution Agreement for NV-01;

 

  (b) [***] per Specific Distribution Agreement for the other Products;

and in any event,

 

  (c) [***] in aggregate for this Agreement and all Specific Distribution Agreements.

 

  (ii) Subject to Article 24.2(iii), neither Party shall be liable to the other Party, in contract, tort (including negligence) or for breach of statutory duty or in any other way for: (a) any loss of goodwill or reputation; or (b) any special or indirect or consequential losses; in any case, whether or not such losses were within the contemplation of any Party at the date of this Agreement, or were suffered or incurred by any party arising out of or in connection with this Agreement.

 

  (iii) Nothing in this Agreement excludes or limits:

 

  (a) either Party’s liability for fraud or fraudulent misrepresentation; or

 

  (b) either Party’s liability for any liability which cannot legally be excluded or limited; or

 

  (c) either Party’s liability arising under Article 21 (Third Party Intellectual Property Indemnity).

 

25. CONFIDENTIALITY

 

25.1. The Parties undertake that they will not, at any time whether during or following the term of this Agreement, divulge, disclose or communicate Confidential Information in any manner to any person or entity other than in compliance with this Article 25.

 

25.2. The Parties shall only disclose Confidential Information to employees, agents, authorised representatives and advisors on a need to know basis and shall in any event remain liable for their employees, agents, authorised representatives and advisors who receive the Confidential Information as well as any other person involved in the execution of the relevant project. Employees shall be bound to respect the same confidentiality duties.

 

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25.3. The restrictions on the use or disclosure of Confidential Information set out in this Article 25 shall not apply:

 

  (i) to any information which a Party can demonstrate by documentation as independently developed by a Party or lawfully received free of restriction from another source having the right to furnish such information.

 

  (ii) after the information has become generally known or available to the public without breach of this Agreement by a Party or its Affiliates

 

  (iii) to any information which at the time of disclosure to a Party was known to such Party or its Affiliates free of restriction and evidenced by documentation in such Party’ s possession

 

  (iv) to the extent that the other Party agrees in writing that the information is free of such restrictions.

 

25.4. Provided that one of the Parties is required to produce the information pursuant to an order issued by a court or regulatory body, this Party shall, prior to such production, immediately notify the other Party of the order to the extent legally permitted.

 

25.5. Nevertheless, if the regulatory body insists for the production of the information, the Parties shall give the information and shall use their reasonable endeavours to obtain protective orders preventing the further disclosure of the information beyond that mandated by the relevant court or regulatory body.

 

25.6. The obligations set out in this Article 25 shall survive the termination or expiry of this Agreement.

 

26. TERMINATION AND CONSEQUENCES OF TERMINATION

 

26.1 Should the Commercial Margin of any Product fail to exceed [***] of Net Sales on a consistent basis for [***] or the Parties agree that the Commercial Margin is likely to fall below [***] of Net Sales on a consistent basis for [***], the Parties agree to meet via the JSC to discuss the issue in order to try and find a way to ensure the Commercial Margin exceeds [***] of Net Sales.

If a solution cannot be agreed by the Parties within [***] of the first meeting of the JSC on the issue then either Party shall have the right to terminate the applicable SDA on [***] written notice period without any obligation to pay any compensation of any kind. If either Party does so terminate the Parties will work together to ensure an orderly termination and to seek to minimise the disruption on the other Party.

 

26.2 Each Party shall have the right to immediately terminate the Agreement in the event that the other Party is in material breach of the Agreement and fails to remedy the material breach within [***] after having received registered letter from the other Party. Termination under this clause is without prejudice to any other remedy to which it may be entitled at law, in equity, or otherwise under this Agreement.

In addition, in case of termination of the Agreement for material breach of NEXVET during the first year following the payment of the last milestone, NEXVET shall fully reimburse to VIRBAC the total amount of the milestone as defined in article “Milestones Payments” of the Agreement and in each Specific Distribution Agreement.

 

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26.3 VIRBAC, without any charge, shall be entitled to terminate the Agreement forthwith at any time during the term of the Agreement, with [***] prior written notice in case of:

 

  (i) NEXVET not obtaining the Marketing Authorization for NV-01 in Europe within [***] of the date of the Specific Distribution Agreement for NV-01; or

 

  (ii) studies performed by or on behalf of NEXVET according to the Development Plan resulting in a material failure to comply at minimum with the Target Product Profile for NV-01; or

 

  (iii) Material deviation from a Development Plan for NV-01 where the agreement of the JSC has not been obtained in advance; or

 

  (iv) If, in the reasonable opinion of VIRBAC after review of the FTO Analysis, the distribution of all Products using NEXVET Technology in the Important Countries is prevented as a result of a potential infringement of a third party’s Intellectual Property Rights and NEXVET is not able to either obtain promptly a licence from the third party, without any cost to VIRBAC, or change the applicable Product so that it does not infringe that third party’s Intellectual Property Rights;

 

26.4 VIRBAC, without any charge, shall be entitled to terminate a Specific Distribution Agreement forthwith at any time during the term of the applicable Specific Distribution Agreement, with [***] prior written notice in case of:

 

  (i) If, in the reasonable opinion of VIRBAC after review of the FTO Analysis, the distribution of the applicable Product in the Important Countries is prevented as a result of a potential infringement of a third party’s Intellectual Property Rights and NEXVET is not able to either obtain promptly a licence from the third party, without any cost to VIRBAC, or change the applicable Product so that it does not infringe that third party’s Intellectual Property Rights; or

 

  (ii) Material deviation from a Development Plan where the agreement of the JSC has not been obtained in advance.

 

26.5 In the following events, VIRBAC and NEXVET shall each have the right to terminate this Agreement by providing a [***] period of notice:

 

  (i) the other Party is unable to pay its debts within the meaning of section 214 of the Companies Act 1963 or is otherwise insolvent;

 

  (ii) the other Party proposes to make or makes any compromise, composition, arrangement or scheme of arrangement with or for the benefit of any of its creditors;

 

  (iii) the other Party passes a resolution that the Party be wound up (except for the purpose of bona-fide solvent reconstruction or amalgamation);

 

  (iv) a receiver, examiner or manager is appointed to, or any distress, execution or other process is levied or enforced or served out upon or against, the other Party or any part of the other Party’s assets, undertaking or revenues; or

 

  (v) a petition is made or proceedings are commenced in relation to any of the events described in above in this Article 26.5 or similar or analogous events or proceedings occur or are taken under the law of any other jurisdiction.

 

26.6. Termination of this Agreement (in whole or in part) shall not affect any rights, remedies, obligations or liabilities of the Parties that have accrued up to the date of termination, including the right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination.

 

26.7. Termination or expiry of this Agreement (in whole or in part) shall not affect any rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination or expiry, including the right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination or expiry.

 

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26.8. Subject to Article 27 (Remaining Stock), if this Agreement terminates (for any reason) or expires then all rights and licences granted in this Agreement shall automatically terminate, unless otherwise agreed in writing in advance by the Parties.

 

26.9. On termination or expiry of this Agreement each of the Parties shall immediately return to the other party (or, if the other party so requests by notice in writing, destroy) all of the other party’s property in its possession at the date of termination, including all of its Confidential Information, together with all copies of such Confidential Information and shall certify that it has done so, and shall make no further use of such Confidential Information.

 

27. REMAINING STOCK

Upon termination for whatsoever reason or expiration of the Agreement, all existing orders shall be honoured and, subject to the terms of Article 19 “Financial Terms” and any financial terms in any Specific Distribution Agreement continuing to apply, VIRBAC shall have the right to sell any remaining inventory of the Product for a limited term agreed between the Parties which shall in any event be at least [***].

 

28. NOTICE

All written notice permitted or required by the provisions of this Agreement (unless otherwise provided) shall be deemed so delivered when actually delivered by hand, Return Receipt Requested, registered post or fax.

All notices shall be addressed as follows:

To NEXVET:

Company Secretary

Nexvet Ireland Limited

[***]

To VIRBAC:

[***]

 

29. MATERIAL SAFETY DATA SHEET

NEXVET shall complete a Material Safety Data Sheet (MSDS) regarding the Products. In this regard, NEXVET commits to complete the document attached in Annex 6 of this Agreement for each Product.

 

30. NOTIFICATION TO “ANTI-POISON CENTER”

To be in compliance with regulations in France regarding Products sold to companies located in France such as VIRBAC, NEXVET commits:

 

    Either to describe the formula of any Product in the MSDS,

 

    or, to send a document to VIRBAC confirming that NEXVET has sent directly the description of the formula of any Product to the following Anti-Poison Center:

[***]

 

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31. INFORMATION

NEXVET shall, at least [***] prior to the first supply of any Products, send to VIRBAC the information required in the form attached in Annex 7 in order for VIRBAC to be able to reference any new Product.

 

32. FORCE MAJEURE

 

32.1. Neither Party to this Agreement shall be liable for failure or delay in the performance of its obligations where such failure or delay is due to an event of Force Majeure.

 

32.2. It is agreed that such Party shall not be held responsible for any default or loss of trade or profit consequent upon such cause provided that the Party so affected shall give prompt written notice to the other Party and shall be excused of performance hereunder to an extent and for the duration of such prevention, restriction or interference.

 

32.3. The Party so affected shall promptly notify the other Party when the cause or causes preventing, restricting or interfering with its performance hereunder have been removed. If a Force Majeure subsists for more than 90 (ninety) successive days, either Party may terminate this Agreement immediately by registered letter to the other Party without creating any liability for damages.

 

32.4. Nevertheless, neither Party shall be relieved of an obligation to make a due to an event of Force Majeure.

 

33. NO RIGHT TO SET-OFF

A Party’s obligation to make any required payments under the Agreement shall not be subject to any right of offset, set-off, deduction or counterclaim.

 

34. INDEPENDENT CONTRACTOR

Each Party declares and acknowledges to be an independent contractor. Nothing herein contained in the Agreement shall be construed so as to create a partnership or joint venture; and neither Party hereto shall be liable for the debts or obligations of the other.

 

35. ASSIGNMENT – SUB-LICENSE

The Agreement will be binding on the successors of either Party.

Both Parties shall have the right to assign this Agreement or any of the Specified Distribution Agreement to any of their Affiliates without prior agreement of the other Party.

 

36. ENTIRE AGREEMENT

The Agreement contains all of the terms and conditions mutually agreed by the Parties hereto with reference to the subject matter hereof.

Any alteration or amendments to the Agreement must be mutually agreed upon and shall only be effective if presented in writing and signed by the authorised representatives of both Parties.

 

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This Agreement constitutes the entire Agreement about the Products in the Territory between the Parties and supersedes any and all prior agreement either written or oral.

Part or all of any provision of this Agreement that is illegal or unenforceable may be severed from this Agreement but the remaining provisions of this Agreement continue in force.

 

37. PRESS RELEASE

The wording of any press release shall be agreed between the Parties prior any communication or publication.

 

38. APPLICABLE LAW AND JURISDICTION

 

38.1. The Agreement and any dispute or non-contractual obligation arising out of, or in connection with, it shall be governed by, and construed in accordance with the laws of Ireland.

 

38.2. Subject to compliance with Article 39, each Party hereby submits to the exclusive jurisdiction of the courts of Ireland over any dispute or non-contractual obligation arising out of or in connection with the Agreement.

 

39. DISPUTE RESOLUTION PROCEDURE

 

39.1. If a dispute arises out of or in connection with this Agreement or any Specific Distribution Agreement or the performance, validity or enforceability of either, then:

 

  (i) either Party may call a meeting of the JSC by giving not less than [***] written notice to the other, and each Party shall procure that an authorised representative attends all such meetings;

 

  (ii) those attending the relevant JSC meeting shall use all reasonable endeavours to resolve the dispute. If the meeting fails to resolve the dispute within [***] of its being referred to it, either Party may refer the dispute to the Member of the Executive Board and/or the Chief Executive Officers of the Parties by notice in writing, who shall co-operate to resolve the dispute as amicably as possible within [***] of the dispute being referred to them;

 

  (iii) if the Member of the Executive Board and/or the Chief Executive Officers fail to resolve the dispute in the allotted time, the Parties may within that period agree in writing to enter into an alternative dispute resolution procedure with the assistance of a mediator agreed by the Parties. Any reference to mediation shall be made in accordance with the procedures of the Centre for Effective Dispute Resolution (“CEDR”). The mediation shall be conducted by a single mediator appointed by the Parties or, if the Parties are unable to agree on the identity of the mediator within [***] after the date of the request that the dispute be resolved by mediation, or if the person appointed is unable or unwilling to act, the mediator shall be appointed by CEDR on the application of either Party. The mediation shall be conducted in English at a venue to be agreed between the parties. Mediation is without prejudice to the rights of the parties in any future proceedings; and

 

  (iv) if the Parties reach a settlement, such settlement shall be reduced to writing and, once signed by a duly authorised representative of each of the Parties, shall be and remain binding on the Parties.

 

39.2. The procedure in this Article 39 shall be binding on the Parties with regard to participation in the mediation but not as to its outcome. All negotiations connected with the dispute shall be conducted in strict confidence and without prejudice to the rights of the parties in any future legal proceedings.

 

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39.3. Except for any party’s right to seek interim or interlocutory relief in the courts pursuant to Article 39.5, no party may commence other legal proceedings under the jurisdiction of the courts or any other form of arbitration until [***] after the appointment of a mediator.

 

39.4. The parties shall bear their own legal costs of complying with Articles 39.1(i) 39.1(iv), but the costs and expenses of mediation shall be borne by the parties equally.

 

39.5. Notwithstanding the provisions of this Article 39, either Party may take proceedings or seek remedies before the courts or any competent authority of any country for interim or interlocutory remedies in relation to any breach of this Agreement or infringement by the other Party of that Party’s intellectual property rights.

 

40. COUNTERPART SIGNATURES

This Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original of this Agreement but all the counterparts shall together constitute the same agreement.

No counterpart shall be effective until each party has executed at least one counterpart.

Annex 1 – Patents

Annex 2 – Products (Target Product Profile and then summary of product characteristic)

Annex 3 – Template for Development Plan

Annex 4 – Template for Quality Agreement

Annex 5 – Template for Specific Distribution Agreement

Annex 6 – Material Safety Data Sheet

Annex 7 – Information

Annex 8 – Pharmacoviligance Data Exchange Agreement (PDEA)

Annex 9 – Financial Example

IN WITNESS OF THE ABOVE the Parties have signed this Agreement on the date written at the head of this Agreement.

 

VIRBAC     NEXVET
/s/ Christian Karst     /s/ Mark Heffernan
NAME:   CHRISTIAN KARST     NAME:   DR MARK HEFFERNAN
TITLE:   MEMBER OF THE EXECUTIVE BOARD     TITLE:   CHIEF EXECUTIVE OFFICER AND DIRECTOR
DATE: 28 November 2014     DATE: 26 November 2014

 

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ANNEX 1 – PATENTS

PCT/GB2012/051002 - Family 1

“Anti-nerve growth factor antibodies and methods of preparing and using the same” – Priority Date: 06 May 2011

 

Country

  

Application No.

(Patent No.)

  

Filing Date

  

Renewal (R)

Expiry Date (E)

Australia

   2012252151    8/5/2012   

•     R: 8/5/2016

•     E: 8/5/2032

Brazil

   BR11203028654.7      

•     R: 8/5/2015

•     E: 8/5/2032

China

   201280033616.8      

•     E: 8/5/2032

Europe

   12723730.3      

•     R: 8/6/2015

•     E: 8/5/2032

Hong Kong

   TBA      

•     E: 8/5/2032

India

   9470/DELNP/2013      

•     E: 8/5/2032

Japan

   2014-509817      

•     E: 8/5/2032

Korea

   10-2013-7032543      

•     E: 8/5/2032

Malaysia

   PI2013702079      

•     E: 8/5/2032

New Zealand

   617446      

•     E: 8/5/2032

Russia

   2013154304      

•     E: 8/5/2032

Singapore

   201308192.2    8/5/2012   

•     E: 8/5/2032

United Kingdom        

   1320045.6      

•     E: 8/5/2032

PCT/GB2012/051008 - Family 4

“Therapeutic canine immunoglobulins and methods of using the same” – Priority Date: 06 May 2011

 

Country

  

Application No.

(Patent No.)

  

Filing Date

  

Renewal (R)

Expiry Date (E)

Australia

   2012252156    8/5/2012   

•     R: 8/5/2016

•     E: 8/5/2032

Brazil

   BR1120130285230      

•     R: 8/5/2015

•     E: 8/5/2032

China

   201280033531.X      

•     E: 8/5/2032

Europe

   12723733.7      

•     R: 8/6/2015

•     E: 8/5/2032

Hong Kong

   14109146.8      

•     E: 8/5/2032

India

   9473/DELNP/2013      

•     E: 8/5/2032

Japan

   2014-509820      

•     E: 8/5/2032

Korea

   10-2013-7032546      

•     E: 8/5/2032

Malaysia

   PI2013702082      

•     E: 8/5/2032

New Zealand

   617450      

•     E: 8/5/2032

 

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Country

  

Application No.

(Patent No.)

  

Filing Date

  

Renewal (R)

Expiry Date (E)

Russia    2013154302      

•     E: 8/5/2032

Singapore

   201308190.6    8/5/2012   

•     E: 8/5/2032

United Kingdom

   1320053.0      

•     E: 8/5/2032

 

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ANNEX 2 - PRODUCTS

2.1 List of Products

1/ Product included in the Agreement:

NV-01

2/ New Products:

In accordance with Article 6 of the Agreement. Right of first negotiation to New Products, owned by NEXVET in the Field and in the Territory.

2.2 Target Product Profile:

2.2.1 Target Product Profile of NV-01:

[***]

UNIT DOSING TABLE

[***]

2.2.2 Target Product Profile of the new Products:

To be added in each Specific Distribution Agreement

2.3 Summary of product characteristics of the Products

To be added in each Specific Distribution Agreement

 

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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


ANNEX 3 – Template for Development Plans

 

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LOGO


Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

Contents [right click on TOC to update headings and page numbers]

 

1    Executive Summary      5   
2    Commercial      6   
   2.1    Summary      6   
      2.1.1    Accessible Population      6   
      2.1.2    Market Size      6   
      2.1.3    Customer Needs      6   
      2.1.4    Future Trends      6   
   2.2    NV-01 Target Product Profile      6   
      2.2.1    Product Definition      6   
      2.2.2    Indications      6   
      2.2.3    Label Highlights      6   
   2.3    Competitor Landscape      6   
      2.3.1    Current Competition      6   
      2.3.2    Potential Future Competitors      6   
   2.4    Competitive Positioning      6   
      2.4.1    NV-01 SWOT Analysis      6   
      2.4.2    Differentiation      6   
      2.4.3    Marketing Strategy      6   
   2.5    COGs and Pricing      6   
      2.5.1    Pricing      6   
      2.5.2    Cost of Goods      6   
3    Intellectual Property      7   
   3.1    Summary of IP Status      7   
   3.2    Current Patents      7   
4    Draft Package Insert      8   
   4.1    Draft US Package Insert      8   
5    Regulatory Strategy      9   
   5.1    Summary      9   
   5.2    North America      9   
      5.2.1    United States      9   
      5.2.2    Canada      9   
   5.3    Europe         9   
   5.4    Japan         9   
   5.5    Australia and New Zealand      9   
   5.6    Other Markets      9   
6    Biopharmaceutical Product Development and Manufacturing      10   
   6.1    Summary      10   
   6.2    Cell Bank      10   
   6.3    Drug Substance (DS)      10   
      6.3.1    Description      10   
      6.3.2    Characterization of DS      10   
      6.3.3    Manufacture of Bulk DS      10   
      6.3.4    Proposed Impurities Analysis      10   
      6.3.5    Reference Standards      10   
      6.3.6    Analytical Methods and Acceptance Criteria      10   
      6.3.7    Risk of canine infectious disease transmission from NV-01 derived from Lonza CHO cells      10   

 

 

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      6.3.8    DS Stability      10   
      6.3.9    Manufacturing Facility      10   
   6.4    Drug Product (DP)      10   
      6.4.1    Description of Drug Product      10   
      6.4.2    Method of Manufacture      10   
      6.4.3    Analytical Methods and Acceptance Criteria      10   
      6.4.4    Stability Testing Program      10   
7    Clinical Development      11   
   7.1    Summary      11   
   7.2    Target Label Claim      11   
   7.3    Completed and Ongoing Studies      11   
   7.4    Mechanism of Action      11   
   7.5    Dosage Characterization      11   
      7.5.1    Dose Justification      11   
      7.5.2    Dose Selection Study (Contingency)      11   
   7.6    Dosing Interval Selection      11   
      7.6.1    Background      11   
      7.6.2    Objective      11   
      7.6.3    Ongoing Study      11   
      7.6.4    Timing      11   
   7.7    Immunogenicity Assay Development and Assessment      11   
   7.8    Route of Administration      11   
      7.8.1    Background      11   
      7.8.2    Objective      11   
      7.8.3    Proposed Study      11   
      7.8.4    Timing      11   
   7.9    Pivotal Pharmacokinetics      12   
      7.9.1    Background      12   
      7.9.2    Objective      12   
      7.9.3    Proposed Study      12   
      7.9.4    Timing      12   
   7.10    Pivotal Clinical Study in Veterinary Patients      12   
      7.10.1    Background      12   
      7.10.2    Objective      12   
      7.10.3    Proposed Study      12   
      7.10.4    Timing      12   
   7.11    Efficacy Protocol Outlines      12   
8    Target Animal Safety      13   
   8.1    Summary      13   
   8.2    Margin of Safety Study      13   
      8.2.1    Background      13   
      8.2.2    Objective      13   
      8.2.3    Proposed Study      13   
      8.2.4    Timing      13   
   8.3    Immunogenicity Study      13   
      8.3.1    Background      13   
      8.3.2    Objective      13   
      8.3.3    Proposed Study      13   

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

      8.3.4    Timing      13   
     8.4      

Safety Observations in Veterinary Patient Study

     13   
     8.5      

Definition of Safe Interval before NSAID Administration

     13   
      8.5.1   

Background

     13   
      8.5.2   

Strategy

     13   
     8.6      

Safety Protocol Outlines

     13   

9

  

 

Toxicology, User and Environmental Safety

     14   
     9.1      

Summary

     14   
     9.2      

Toxicology

     14   
     9.3      

User Safety

     14   
     9.4      

Environmental Safety

     14   

10

  

 

Scientific Disclosure and Publications

     15   
     10.1      

Primary Disclosure

     15   
     10.2      

Publications

     15   
     10.3      

Conferences

     15   

11

  

 

Project Plan and Costs

     16   
     11.1      

Estimated Filing and Approval Dates

     16   
     11.2      

Key Milestones and Timelines

     16   
     11.3      

Budget and Cost Estimates

     16   
     11.4      

Gantt Chart

     16   

 

 

4 of 16


Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

1 Executive Summary

 

 

5 of 16


Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

2 Commercial

 

2.1 Summary

 

2.1.1 Accessible Population

 

2.1.2 Market Size

 

2.1.3 Customer Needs

 

2.1.4 Future Trends

 

2.2 NV-01 Target Product Profile

 

2.2.1 Product Definition

 

2.2.2 Indications

 

2.2.3 Label Highlights

 

2.3 Competitor Landscape

 

2.3.1 Current Competition

 

2.3.2 Potential Future Competitors

 

2.4 Competitive Positioning

 

2.4.1 NV-01 SWOT Analysis

 

2.4.2 Differentiation

 

2.4.3 Marketing Strategy

 

2.5 COGs and Pricing

 

2.5.1 Pricing

 

2.5.2 Cost of Goods

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

3 Intellectual Property

 

3.1 Summary of IP Status

 

3.2 Current Patents

 

 

7 of 16


Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

4 Draft Package Insert

 

4.1 Draft US Package Insert

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

5 Regulatory Strategy

 

5.1 Summary

 

5.2 North America

 

5.2.1 United States

 

5.2.2 Canada

 

5.3 Europe

 

5.4 Japan

 

5.5 Australia and New Zealand

 

5.6 Other Markets

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

6 Biopharmaceutical Product Development and Manufacturing

 

6.1 Summary

 

6.2 Cell Bank

 

6.3 Drug Substance (DS)

 

6.3.1 Description

 

6.3.2 Characterization of DS

 

6.3.3 Manufacture of Bulk DS

 

6.3.4 Proposed Impurities Analysis

 

6.3.5 Reference Standards

 

6.3.6 Analytical Methods and Acceptance Criteria

 

6.3.7 Risk of canine infectious disease transmission from NV-01 derived from Lonza CHO cells.

 

6.3.7.1 Background

 

6.3.7.2 Canine adventitious agent mitigation for NV-01

 

6.3.8 DS Stability

 

6.3.9 Manufacturing Facility

 

6.4 Drug Product (DP)

 

6.4.1 Description of Drug Product

 

6.4.2 Method of Manufacture

 

6.4.3 Analytical Methods and Acceptance Criteria

 

6.4.4 Stability Testing Program

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

7 Clinical Development

 

7.1 Summary

 

7.2 Target Label Claim

 

7.3 Completed and Ongoing Studies

 

7.4 Mechanism of Action

 

7.5 Dosage Characterization

 

7.5.1 Dose Justification

 

7.5.2 Dose Selection Study (Contingency)

 

7.5.2.1 Background

 

7.5.2.2 Objective (Contingency)

 

7.5.2.3 Proposed Study (Contingency)

 

7.5.2.4 Timing

 

7.6 Dosing Interval Selection

 

7.6.1 Background

 

7.6.2 Objective

 

7.6.3 Ongoing Study

 

7.6.4 Timing

 

7.7 Immunogenicity Assay Development and Assessment

 

7.8 Route of Administration

 

7.8.1 Background

 

7.8.2 Objective

 

7.8.3 Proposed Study

 

7.8.4 Timing

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

7.9 Pivotal Pharmacokinetics

 

7.9.1 Background

 

7.9.2 Objective

 

7.9.3 Proposed Study

 

7.9.4 Timing

 

7.10 Pivotal Clinical Study in Veterinary Patients

 

7.10.1 Background

 

7.10.2 Objective

 

7.10.3 Proposed Study

 

7.10.4 Timing

 

7.11 Efficacy Protocol Outlines

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

8 Target Animal Safety

 

8.1 Summary

 

8.2 Margin of Safety Study

 

8.2.1 Background

 

8.2.2 Objective

 

8.2.3 Proposed Study

 

8.2.4 Timing

 

8.3 Immunogenicity Study

 

8.3.1 Background

 

8.3.2 Objective

 

8.3.3 Proposed Study

 

8.3.4 Timing

 

8.4 Safety Observations in Veterinary Patient Study

 

8.5 Definition of Safe Interval before NSAID Administration

 

8.5.1 Background

 

8.5.2 Strategy

 

8.6 Safety Protocol Outlines

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

9 Toxicology, User and Environmental Safety

 

9.1 Summary

 

9.2 Toxicology

 

9.3 User Safety

 

9.4 Environmental Safety

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

10 Scientific Disclosure and Publications

 

10.1 Primary Disclosure

 

10.2 Publications

 

10.3 Conferences

 

 

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Nexvet Biopharma Pty Ltd   Product Development Plan

 

 

 

11 Project Plan and Costs

 

11.1 Estimated Filing and Approval Dates

 

11.2 Key Milestones and Timelines

 

11.3 Budget and Cost Estimates

 

11.4 Gantt Chart

 

 

16 of 16


ANNEX 4 – Template for Quality Agreement

BACKGROUND

The purpose of the quality agreement (hereinafter referred to as the “Quality Agreement”) is to define the terms and conditions to the quality tasks to assure the manufacture and supply of safe Product(s), suitable for pharmaceutical use in order to complete the Supply Agreement.

NOW, THEREFORE in consideration of the mutual agreements hereinafter set forth, the Parties intending to be legally bound hereby agree as follows:

 

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CONTENT:

1. SCOPE AND PURPOSE OF THE AGREEMENT

NEXVET undertakes to carry out the manufacture, packaging, control, release and supply to VIRBAC of the product(s) listed in exhibit 1, hereafter referred to PRODUCTS(s).

VIRBAC undertakes to market, sell and distribute the PRODUCT(s).

NEXVET is the holder of Marketing authorisations of the PRODUCT(s), hereafter referred to as MAH.

NEXVET has adequate premises, equipment, knowledge, experience, competent personnel and manufacturing authorisation to undertake satisfactorily the work ordered by VIRBAC.

This Quality Agreement is set to define responsibilities relative to quality tasks to assure the manufacture and supply of safe PRODUCT(s), suitable for pharmaceutical use.

This Quality Agreement also includes commitments between VIRBAC and NEXVET regarding the provision of information, documents, or samples, and communication and notification rules, related to quality.

Contact persons for good execution of this Quality Agreement are listed in exhibit 3.

2. APPLICABLE GMP STANDARD

NEXVET shall manufacture the PRODUCT(s) in compliance with cGMP.

“Current Good Manufacturing Practices” (cGMP) means all applicable standards relating to the manufacture of the PRODUCT(s) listed in exhibit 1. For the purposes of this agreement, cGMP shall mean the principles defined in the EU Guideline Eudralex Volume 4: Good Manufacturing Practise, Medicinal Products for Human and Veterinary Use promulgated by any European Governmental Authority having jurisdiction over the manufacture of the PRODUCT(s), in the form of laws or guidance documents.

3. RESPONSIBILITIES

Details on division of responsibilities between NEXVET and VIRBAC are presented in exhibit 2.

4. CERTIFICATE OF ANALYSIS / RELEASE

The following documentation is required for batches of PRODUCT shipped to VIRBAC:

 

¨ Certificates of Analysis and Release

The Certificates of Analysis and Release shall be dated and signed by a qualified person of NEXVET’s Quality Unit, or it may be produced by a computer system which provides a degree of control equivalent to that given by a signature.

The Certificate of Analysis must include – as a minimum –

 

¨ Manufacturer’s name and address, incl. telephone number (original manufacturing site),

 

¨ PRODUCT name, pharmaceutical form and SUBSTANCE(s) dosage,

 

¨ Manufacturer’s batch number,

 

¨ Reference to the agreed specification,

 

¨ Test parameters and corresponding specification requirements,

 

¨ Test results (numerical, where applicable) for each chemical, physical or microbiological test performed,

 

¨ Manufacturing date, date of release and expiration of the PRODUCT.

 

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The Certificate of Release states that the subject batch was produced in accordance to the applicable Marketing Authorisation, to the approved manufacturing process, and in compliance with all applicable cGMP requirements as well as this Quality Agreement. The Certificate of release also makes reference to deviations that occurred relating to production or control and to their closure. It also states on batch suitability for shipment to the market.

Certificate of Analysis and Certificate of Release may be issued as separate documents or combined to a single document, as appropriate.

 

¨ Product Samples

NEXVET should provide VIRBAC two samples of finished product of each packaging batch for handling of complaints.

5. CHANGE CONTROL

NEXVET shall have a documented and effective change control system in place.

NEXVET is required to provide advanced notification to VIRBAC of any significant changes to the process, specifications, control, storage, labelling and packaging, equipment, facilities (including introduction of new critical product) and utilities which may have an impact on the quality of the PRODUCT, and/or on regulatory obligations of VIRBAC, and/or on its use by VIRBAC.

Principles:

 

¨ Notification of changes is required for information of VIRBAC.

 

¨ Where the change requires regulatory notification or approval, NEXVET is responsible for the submission of all necessary change notifications to all competent authorities in full compliance with the applicable regulations. NEXVET will inform VIRBAC of the receipt of the necessary acknowledgement of the validity of the notification and, depending on the type of change, the acceptance or approval of the change by the competent authorities.

6. RIGHT TO AUDIT

NEXVET shall allow –upon signature of appropriate confidentiality agreement– VIRBAC or its representatives to carry out on-site audits by appointment. NEXVET shall permit -or obtain allowance from manufacturing sub-contractor where applicable- all reasonable access to the manufacturing, packaging, warehousing and laboratory areas related to the manufacture of the PRODUCT(s), including pertinent documentation. Any such audit shall take place during normal business hours and must not interfere with NEXVET’s manufacturing operations. With exception of critical quality issue, NEXVET and VIRBAC should agree on an audit date within [***] from first request.

The results of the audit and the observation(s) shall be sent to NEXVET by means of a written report within 4 weeks. NEXVET must ensure a satisfactory follow up to the observations made during the audit performed by VIRBAC, and take corrective actions mutually agreed upon by the parties. Answer from NEXVET audit report should be supplied to VIRBAC within 4 weeks.

The audit frequency shall depend upon the results of the previous audit(s) and the quality performance of NEXVET. In the absence of critical quality incidents the frequency shall be not more than once every 3 years. If quality issues arise VIRBAC shall have the right to audit more frequently.

7. AUTHORITY INSPECTIONS

NEXVET is responsible for maintaining valid manufacturing authorisation or licence including the manufacture of the PRODUCT(s). Any change in manufacturing authorisation that impacts the manufacture or supply of PRODUCT(s) should be notified by NEXVET to VIRBAC without delay.

 

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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


8. SUB-CONTRACTING

NEXVET is fully responsible for the quality of the materials or services provided by sub-contractors and for all commitments as agreed upon with this Quality Agreement. This must be assured through quality agreements with the respective sub-contractors and technical delivery specifications.

A list of current sub-contractors related to the manufacture of the PRODUCT(s) is provided in Appendix 4.

Where NEXVET would like to use a new sub-contractor, this list needs to be updated and is subject of the established change control procedure (see section 5).

9. RETENTION OF SAMPLES

NEXVET will store sufficient retention samples of PRODUCT(s) in commercial packaging and of all starting materials suitably packaged, to perform at least two (2) full specification analyses. Samples are to be retained for at least one (1) year after the expiry date of the batch.

NEXVET will make PRODUCT(s) retention samples available to VIRBAC promptly upon VIRBAC’s justified request.

NEXVET shall keep available any retention samples relevant to assessing the quality of the PRODUCT(s) in the event of complaints and/or recall procedures. This requirement shall continue even in case of termination of the supply of PRODUCT(s).

10. RETENTION OF RECORDS / DOCUMENTATION

NEXVET will store the original master batch records, the executed batch records, and all other original documentation that is related to the manufacture of the PRODUCT and that is required to be maintained under cGMPs, protected from destruction and unauthorised access, for at least one (1) year after the expiry date of the batch assigned by NEXVET or for five (5) years after certification of the batch, which ever is the longer.

NEXVET will retain the original manufacturing records for validation batches for the entire term of the marketing authorisation validity.

NEXVET shall keep available any records relevant to assessing the quality of the PRODUCT(s) in the event of complaints and/or recall procedures. This requirement shall continue even in case of termination of the supply of PRODUCT(s).

11. STABILITY

NEXVET will perform on-going stability studies for the PRODUCT(s).

NEXVET is responsible for assigning shelf life to the PRODUCT(s) and for determining suitable storage and shipping conditions, based upon stability studies and marketing authorisation.

12. COMPLAINTS

All complaints related to the PRODUCT(s) reported, regardless of source (e.g., customers, veterinaries, pharmacists, sales representatives, VIRBAC or affiliates) will be handled by VIRBAC and communicated to NEXVET.

VIRBAC will make relevant information and samples of the affected PRODUCT(s) available to assist in the investigation of NEXVET.

NEXVET is responsible for recording and investigating all quality-related complaints on the PRODUCT(s) and will maintain the complete complaint database and complaint files.

NEXVET will complete their investigation and respond to VIRBAC in writing to all complaints within [***] of receipt with formal written report on the complaint detailing identifiable root causes and corrective and preventive actions where applicable.

 

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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


13. RECALL

VIRBAC shall maintain an efficient distribution system within the Territory and shall establish and maintain a batch tracing and recall system which will enable it to identify, with minimum delay, customers within the Territory who will have been supplied with any particular batch of the Products and to recall such Products.

In the event that NEXVET believes that a recall of the PRODUCT(s) may be necessary or appropriate, NEXVET shall immediately notify VIRBAC. The two parties will take joint decisions on the disposition of PRODUCT(s).

NEXVET, as MAH, with exception of local regulatory requirements*, is responsible for the final decision of any recalls or field alert activities and for corresponding communication with health authorities.

VIRBAC is responsible for the performance and the coordination of any recalls or field alert activities.

NEXVET shall provide any information required by VIRBAC relating to recall or field alert activities within [***] of the request, if such information is readily available at NEXVET.

 

* In France, Belgium and Switzerland as applicable, the distributor of the PRODUCT will be responsible for the final decision, communications with authorities and the coordination of any recalls or field alert activities.

14. PRODUCT QUALITY REVIEW

NEXVET shall conduct an annual Product Quality Review (PQR) for the PRODUCT(s), according to the requirements of cGMP.

NEXVET will provide VIRBAC with copies of the relevant information of its PQR of the previous annual period, upon request, within [***].

15. STORAGE AND DISTRIBUTION

NEXVET shall make commercially reasonable efforts to exclude, during packaging, storage, and shipping of the PRODUCT(s), the possibility of deterioration, contamination, or mix-ups with any other material.

NEXVET and VIRBAC shall comply with the following requirements in relation to shipment and distribution of the PRODUCT(s).

 

¨ Compliance with storage conditions stated on the labels

 

¨ Ability to recall PRODUCT from distribution network

 

¨ Quarantine PRODUCT with questionable quality

 

¨ Qualification of hauliers and shipping agents used to transport the PRODUCT(s).

16. STARTING MATERIALS

NEXVET is responsible for GMP certification of Active Pharmaceutical Ingredient suppliers.

17. DEVIATIONS / OOS

NEXVET will notify VIRBAC promptly in the event of any critical deviation(s) that can potentially affect the quality of the PRODUCT(s).

For all confirmed OOS stability test results that indicate that the PRODUCT(s) has (have) failed to remain within specifications, NEXVET will notify VIRBAC promptly.

 

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18. REGULATORY DOCUMENTS

NEXVET shall be responsible for preparation of registration documents related to PRODUCT(s) and submission of such registration documents to any regulatory authority, including maintaining such submissions.

19. PRODUCT RELEASE

NEXVET has the responsibility to perform the release of the PRODUCT(s) prior to shipment.

NEXVET will not ship any PRODUCT(s) to any destination, as identified by the VIRBAC, until the PRODUCT(s) is (are) released for shipment, unless prior written approval has been received from the VIRBAC to perform such a shipment under quarantine.

20. SPECIFICATIONS

Specifications for manufacturing and testing of the PRODUCT(s), intermediates, starting materials and packaging components, as applicable, are detailed in relevant sections of marketing authorisation and/or in supply agreement.

21. RELATED AGREEMENTS

This Quality Agreement supersedes any prior Quality Agreement under the scope of this agreement.

Where any inconsistencies should arise between the supply agreement and this Quality Agreement, the supply agreement will take precedence over the Quality Agreement in all non-quality related matters unless otherwise stated in the supply agreement. The Quality Agreement will take precedence in all quality related matters.

 

VIRBAC
  Quality Assurance Director
Date  

 

Signature  

 

 

NEXVET
  Quality Management Division
Date  

 

Signature  

 

 

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EXHIBIT 1

List of Products

 

Pharmaceutical and dosage form

  

Country

[To be completed.]   

 

42


EXHIBIT 2

Division of Responsibilities

 

A Regulatory Compliance

 

VIRBAC

 

NEXVET

1.   Marketing authorisation holder   [***]   [***]
2.   Supply of marketing authorisation and all necessary documentation for manufacture, control and/or release   [***]   [***]
3.   Adhere to approved registration documentation incl. all described manufacturing and packaging processes and specifications, materials and PRODUCT(s) control testing and specifications (Marketing Authorisation, NDA, as applicable)   [***]   [***]
4.   Maintaining valid manufacturing license(s), as applicable   [***]   [***]
5.   Maintaining site master file, as applicable   [***]   [***]
6.   Approving significant changes   [***]   [***]
7.   Submitting change notifications/applications to authorities   [***]   [***]

B Purchasing and control of materials

 

VIRBAC

 

NEXVET

8.   Setting specification for ACTIVE SUBSTANCE   [***]   [***]
9.   Purchasing ACTIVE SUBSTANCE   [***]   [***]
10.   Qualifying and monitoring ACTIVE SUBSTANCE suppliers   [***]   [***]
11.   Purchasing materials according to specifications   [***]   [***]
12.   Qualifying and monitoring material suppliers   [***]   [***]
13.   Performing an identity check on all incoming materials   [***]   [***]
14.   Testing of incoming materials (incl. ACTIVE SUBSTANCE), as appropriate   [***]   [***]
15.   Taking retention samples of materials (incl. ACTIVE SUBSTANCE)   [***]   [***]
16.   Release of materials (incl. ACTIVE SUBSTANCE) for involvement in production of PRODUCT(s)   [***]   [***]

C Manufacturing and Testing of bulk PRODUCT(s)

 

VIRBAC

 

NEXVET

17.   Setting manufacturing process and specifications for manufacture of bulk PRODUCT(s), incl. IPCs – in accordance with marketing authorisation   [***]   [***]
18.   Generating Master Batch Record (bulk PRODUCT(s))   [***]   [***]
19.   Approving Master Batch Record (bulk PRODUCT(s))   [***]   [***]
20.   Manufacturing bulk PRODUCT(s) according to Master Batch Procedure   [***]   [***]
21.   Generating Batch Production Record (bulk PRODUCT(s))   [***]   [***]
22.   Approving Batch Production Record (bulk PRODUCT(s))   [***]   [***]
23.   Assigning batch numbers   [***]   [***]
24.   Sampling during production of bulk PRODUCT(s)   [***]   [***]

 

43

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


C Manufacturing and Testing of bulk PRODUCT(s)

 

VIRBAC

 

NEXVET

25.   Performing IPCs   [***]   [***]
26.   Investigating OOS results and critical deviations relating to bulk production   [***]   [***]

D Purchasing and Testing of Primary Packaging Material

 

VIRBAC

 

NEXVET

27.   Specifying primary packaging material for PRODUCT   [***]   [***]
28.   Artworks approval for printed components   [***]   [***]
29.   Developing test methods for primary packaging material, if needed   [***]   [***]
30.   Purchasing primary packaging material including labelling   [***]   [***]
31.   Testing and releasing primary packaging material   [***]   [***]
32.   Taking retention samples of primary packaging material   [***]   [***]

E Primary Packaging of PRODUCT(s) (semi-finished PRODUCT)

 

VIRBAC

 

NEXVET

33.   Setting manufacturing process and specifications for primary packaging of PRODUCT(s), incl. IPCs and incl. labelling if applicable – in accordance with marketing authorisation and artworks   [***]   [***]
34.   Generating Master Batch Record (primary packaging of PRODUCT(s))   [***]   [***]
35.   Approving Master Batch Record (primary packaging of PRODUCT(s))   [***]   [***]
36.   Primary packaging of PRODUCT(s) according to Master Batch Procedure   [***]   [***]
37.   Generating Batch Production Record (primary packaging of PRODUCT(s))   [***]   [***]
38.   Approving Batch Production Record (primary packaging of PRODUCT(s))   [***]   [***]
39.   Assigning packaging batch numbers, if applicable   [***]   [***]
40.   Sampling during primary packaging of PRODUCT(s)   [***]   [***]
41.   Performing IPCs   [***]   [***]
42.   Investigating OOS results and critical deviations relating to primary packaging   [***]   [***]

D Purchasing and Testing of Secondary Packaging Material

 

VIRBAC

 

NEXVET

43.   Specifying packaging (II) material for PRODUCT – in accordance with marketing authorisation   [***]   [***]
44.   Artworks approval for printed components   [***]   [***]
45.   Developing test methods for packaging (II) material, if needed   [***]   [***]
46.   Purchasing packaging (II) material including labelling   [***]   [***]
47.   Testing and releasing packaging (II) material   [***]   [***]
48.   Taking retention samples of packaging (II) material   [***]   [***]

 

44

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


F Secondary Packaging and Labelling of PRODUCT(s)

 

VIRBAC

 

NEXVET

49.   Setting manufacturing process and specifications for secondary packaging and labelling of PRODUCT(s), incl. IPCs and labelling – in accordance with marketing authorisation and artworks   [***]   [***]
50.   Generating Master Batch Record (Secondary packaging of PRODUCT(s))   [***]   [***]
51.   Approving Master Batch Record (Secondary packaging of PRODUCT(s))   [***]   [***]
52.   Secondary Packaging and Labelling of PRODUCT(s) according to Master Batch Procedure   [***]   [***]
53.   Generating Batch Production Record (Secondary packaging of PRODUCT(s))   [***]   [***]
54.   Approving Batch Production Record (Secondary packaging of PRODUCT(s))   [***]   [***]
55.   Assigning packaging batch numbers, if applicable   [***]   [***]
56.   Sampling during secondary packaging of PRODUCT(s)   [***]   [***]
57.   Performing IPCs   [***]   [***]
58.   Investigating OOS results and critical deviations relating to packaging operations   [***]   [***]

G Quality Control and release of PRODUCT(s)

 

VIRBAC

 

NEXVET

59.   Setting testing procedures and specifications for PRODUCT(s) – in accordance with marketing authorisation   [***]   [***]
60.   Generating Control Records   [***]   [***]
61.   Approving Control Records   [***]   [***]
62.   QC sampling of PRODUCT(s)   [***]   [***]
63.   Performing quality control on PRODUCT(s)   [***]   [***]
64.   Investigating OOS results and critical deviations   [***]   [***]
65.   Defining amount for retention samples   [***]   [***]
66.   Sampling and storing retention samples, until shipment to CG (if requested)   [***]   [***]
67.   Approving analytical records for the PRODUCT   [***]   [***]
68.   Purchasing / providing of (certified) reference standards   [***]   [***]
69.   Review of production and control records, incl. OOS and deviation reports   [***]   [***]
70.   Release of batch   [***]   [***]

H Storage and Shipment

 

VIRBAC

 

NEXVET

71.   Storing PRODUCT under labelled conditions   [***]   [***]
72.   Qualifying of carrier   [***]   [***]
73.   Preparing PRODUCT for dispatch and loading of vehicles   [***]   [***]
74.   Maintaining storage conditions during transportation   [***]   [***]

 

45

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


I Documents (Generation and Approval)

 

VIRBAC

 

NEXVET

75.   Supply of marketing authorisation and all necessary documentation for manufacture   [***]   [***]
76.   Generating Master Batch Procedures/Records   (ref. to previous tables)
77.   Approving Master Batch Procedures/Records   (ref. to previous tables)
78.   Generating Batch Production and Control Records   (ref. to previous tables)
79.   Approving Batch Production and Control Records   (ref. to previous tables)
80.   Archiving the original documents and providing copies, if requested   [***]   [***]
81.   Providing Certificates of Analysis of materials, if requested   [***]   [***]
82.   Issuing Certificate of Analysis for PRODUCT   [***]   [***]
83.   Issuing reports on full-scale OOS investigations and critical deviations   [***]   [***]
84.   Providing development reports, test procedures, validation documents, etc and other source documents requested by CG   [***]   [***]

J Qualification / Validation

 

VIRBAC

 

NEXVET

85.   Qualifying of equipment, utilities and facilities   [***]   [***]
86.   Preparing and approving equipment and facility qualification protocols and reports used for the PRODUCT(s)   [***]   [***]
87.   Validating the manufacturing process   [***]   [***]
88.   Preparing and approving process validation protocols and reports for the PRODUCT(s)   [***]   [***]
89.   Validating cleaning procedures   [***]   [***]
90.   Preparing and approving cleaning validation approach applicable to the PRODUCT(s)   [***]   [***]
91.   Validating / transferring analytical methods   [***]   [***]
92.   Preparing and approving analytical validation / transferring approach applicable to the PRODUCT(s)   [***]   [***]
93.   Retaining qualification and validation documentation   [***]   [***]
94.   Validating computerised systems   [***]   [***]
95.   Preparing and approving validation protocols and reports for computer validation   [***]   [***]

K Stability Program

 

VIRBAC

 

NEXVET

96.   Preparing and approving protocol for on going stabilities   [***]   [***]
97.   Performing stability on going stabilities   [***]   [***]
98.   Approving stability reports on on-going stabilities   [***]   [***]
99.   Determining shelf life   [***]   [***]

 

46

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


L Product Quality Review

 

VIRBAC

 

NEXVET

100.

  Preparing annual PQR report   [***]   [***]

101.

  Reviewing PQR reports   [***]   [***]

M Complaints and Recall

 

VIRBAC

 

NEXVET

102.

  Receiving complaints from external customers   [***]   [***]

103.

  Forwarding complaints related to PRODUCT to CA   [***]   [***]

104.

  Investigating complaints related to PRODUCT   [***]   [***]

105.

  Implementing corrective actions, if necessary   [***]   [***]

106.

  Responding to external customers   [***]   [***]

107.

  Deciding to initiate recall   [***]   [***]

108.

  Notifying authorities, external customers, or consumers   [***]   [***]

109.

  Clarifying root cause   [***]   [***]

110.

  Storing or disposing returned product   [***]   [***]

[***]

 

N Sub-Contracting

 

VIRBAC

 

NEXVET

111.

  Approving sub-contracting operations   [***]   [***]

112.

  Qualifying sub-contractor   [***]   [***]

113.

  Procuring of sub-contracted products or services   [***]   [***]

114.

  Quality monitoring sub-contracted operation   [***]   [***]

 

47

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Exhibit 3

Persons to whom communication should be addressed

 

    

VIRBAC

  

NEXVET

Quality Assurance    [To be completed.]   

Release of the finished products/

Qualified Person

     
Regulatory Department      

 

48


Exhibit 4

List of agreed third party subcontractors

 

Name

  

Address

  

Approved activity

[To be completed.]

     

 

49


Document Change History Record

 

VERSION NUMBER/

ISSUE DATE

  

Reason for Change

Version 01 / 24 November 2014    Creation

 

50


Annex 5 – Template for Specific Distribution Agreements

SPECIFIC DISTRIBUTION AGREEMENT

THIS SPECIFIC AGREEMENT is made between:

VIRBAC, a company organized under the law of FRANCE, with registered office at 1ère avenue 2065 M – L.I.D., 06516, Carros, France - registered under number 417 350 311 RCS at Grasse, France, acting for itself and its Affiliates, herein duly represented by Christian Karst, Member of the Executive Board,

Hereinafter referred to as “VIRBAC”;

AND

NEXVET IRELAND LIMITED, a company organised under the laws of Ireland, with registered office at 88 Harcourt Street, Dublin 2 Ireland, with registered number 550752, represented by Dr Mark Heffernan, Chief Executive Officer & Director,

Hereinafter referred to as “NEXVET

WHEREAS:

A Master Collaboration, Supply and Distribution Agreement of Product has been entered into between VIRBAC and NEXVET on the November 24th, 2014 (the “Agreement”) whereby NEXVET and VIRBAC have agreed the general terms upon which NEXVET shall provide the Product to VIRBAC and/or its Affiliates.

VIRBAC is willing to purchase                      Product from NEXVET, distribute                      Product and NEXVET is willing to provide such                      Product to VIRBAC, subject to the terms and conditions of the Agreement and this Specific Distribution Agreement.

Article 1. Definitions

                     Product means

 

Article 2. Purpose of this Specific Agreement

2.1 The purpose of this Specific Distribution Agreement is to specify the conditions under which VIRBAC will place orders to NEXVET for the provision of                      Product in accordance with the Target Product Profile defined in Exhibit 1, the Marketing Authorization and the Specification defined in Exhibit 3 and to distribute                      Products in the Territory.

2.2 The provisions of the Agreement not otherwise modified in the Specific Distribution Agreement apply to the Specific Distribution Agreement. To the extent that there is any inconsistency between this Specific Distribution Agreement and the Agreement, the terms of the Agreement shall prevail, unless expressly stated otherwise in this Specific Distribution Agreement.

2.3 Capitalized terms that are not otherwise defined in this Specific Distribution Agreement have the meanings specified in the Agreement.

 

51


Article 3. Development plans

The Development Plan for                      Product shall describe all the proposed development and regulatory activities of NEXVET, including the proposed timelines for such activities, to obtain the Marketing Authorizations in the Territory and according to the Target Product Profile defined in Exhibit 1.

Such Development Plan shall be approved by the JSC and included in Exhibit 2 within [***] of execution of this Specific Distribution Agreement.

 

Article 4. Marketing Authorization

If the Marketing Authorization for                      Product in Europe is not obtained within                      from the date of execution of the Agreement, then VIRBAC has the right to terminate this Specific Distribution Agreement.

 

Article 5. Minimum Annual Net Sales Obligations

 

Article 6. Manufacturing

The Manufacturer(s) and the Manufacturing Site(s) for                      Product shall be defined by NEXVET and included by amendment to this Specific Distribution Agreement no later than [***] prior to the first filing of the Registration Dossier before the Authority in the Territory.

 

Article 7. Supply and Delivery

NEXVET warrants that                      Product shall meet the applicable Specification as set in Exhibit 3. Such Specification shall be included in Exhibit 3 Agreement no later than [***] prior the first filing of the Registration Dossier before the Authority in the Territory.

The                      Product shall be delivered within a maximum of [***] from the date of receipt of VIRBAC’s orders, and, unless agreed otherwise in writing, shall be delivered Ex-Works Incoterms 2010 at the Manufacturing Site.

The minimum order quantity will be set regularly by NEXVET and advised to VIRBAC in writing. The minimum order quantity will initially be set no later than [***] prior to the first filing of the Registration Dossier before the Authority in the Territory.

 

Article 8. Pharmacovigilance

A pharmacovigilance data exchange agreement shall be agreed by the Parties and included in Exhibit 4 no later than [***] prior to the first filing of the Registration Dossier before the Authority in the Territory.

 

Article 9. Financial terms

9.1 Milestone Payment

9.2 NEXVET Fees

9.3 Purchase Price of                      Product

 

52

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Article 10. Term

The Specific Distribution Agreement is deemed to come into force on                      and shall remain in force for 10 (ten) years from the date of First Commercialization of                      Product (“Initial Term”).

The Specific Distribution Agreement shall thereafter automatically be renewed by periods of 2 (two) years, unless a written notice of termination is sent, by registered letter and confirmed by email, by one of the Parties, no later than 6 (six) months prior to the expiration of the Initial Term or any 2 (two) year extension thereof.

 

Article 11. Trademarks

The Trademark(s) for                      Product shall be agreed by the JSC and included by amendment to this Specific Distribution Agreement no later than [***] prior to the first filing of the Registration Dossier before the Authority of                      Product within the Territory.

 

Article 12. Quality Agreement

A Quality Agreement shall be negotiated and agreed between the Parties and included in Exhibit 4 no later than [***] prior to the first filing of the Registration Dossier before the Authority of                      Product in the Territory.

 

Article 13. Material Safety Data Sheet

NEXVET shall complete a Material Safety Data Sheet (MSDS) regarding NV-01 Product. This MSDS shall be included in Exhibit no later than [***] prior to the first filing of the Registration Dossier before the Authority                      Product in the Territory.

 

Article 14. Counterpart Signatures

This Specific Distribution Agreement may be executed in any number of counterparts, each of which when executed shall constitute an original of this Specific Distribution Agreement, but all the counterparts together constitute the same Specific Distribution Agreement. No counterpart shall be effective until each party has executed at least one counterpart.

IN WITNESS OF THE ABOVE the Parties have signed this Specific Distribution Agreement on the date written at the head of this Specific Distribution Agreement.

 

VIRBAC     NEXVET
By:  

 

    By:  

 

Name:  

 

    Name:  

 

Title:  

 

    Title:  

 

Date and place     Date and place

 

53

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Annex 6– Material Safety Data Sheet

 

54


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 1/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
à renseigner / to complete   
matrice – matrice

 

 

LOGO

SAFETY DATA SHEET

(REACH regulation (EC) n°1907/2006 – n°453/2010)

 

 

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

1.1 Product identifier

Product name: matrice

Product code: matrice.

1.2 Relevant identified uses of the substance or mixture and uses advised against

 

Species cibles    N/A
Galenic aspect    N/A
Class    N/A
Medicine    veterinary

1.3 Details of the supplier of the safety data sheet

Registered company name: à renseigner / to complete.

Address: à renseigner / to complete. à renseigner / to complete. à renseigner / to complete.

Telephone: à renseigner / to comple. Fax: à renseigner / to complete.

à renseigner / to complete

1.4 Emergency telephone number: +33 (0)1 45 42 59 59.

Association/Organisation: INRS / ORFILA http://www.centres-antipoison.net.

 

 

SECTION 2: HAZARDS IDENTIFICATION

2.1 Classification of the substance or mixture

In compliance with EC regulation No. 1272/2008 and its amendments.

This mixture does not present a physical hazard. Refer to the recommendations regarding the other products present on the site.

This mixture does not present a health hazard with the exception of possible occupational exposure thresholds (see paragraphs 3 and 8).

This mixture does not present an environmental hazard. No known or foreseeable environmental damage under standard conditions of use.

In compliance with directives 67/548/EEC, 1999/45/EC and their amendments.

This mixture does not present a physical hazard. Refer to the recommendations regarding the other products present on the site.

This mixture does not present a health hazard with the exception of possible occupational exposure thresholds (see paragraphs 3 and 8).

This mixture does not present an environmental hazard. No known or foreseeable environmental damage under standard conditions of use.

2.2 Label elements

In compliance with EC regulation No. 1272/2008 and its amendments.

No labelling requirements for this mixture.

In compliance with directives 67/548/EEC, 1999/45/EC and their amendments.

No labelling requirements for this mixture.

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 2/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
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2.3 Other hazards

No data available.

 

 

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1 Substances

No substances fulfil the criteria set forth in annexe II section A of the REACH regulation (EC) n° 190 7/2006.

3.2 Mixtures

No substances fulfil the criteria set forth in annexe II section A of the REACH regulation (EC) n° 190 7/2006.

 

 

SECTION 4: FIRST AID MEASURES

As a general rule, in case of doubt or if symptoms persist, always call a doctor.

NEVER induce swallowing by an unconscious person.

4.1 Description of first aid measures

In the event of exposure by inhalation:

Transport outdoors, keep the patient warm and in the rest, if the breath is irregular or stopped, to practise the artificial breath. Make nothing absorb by the mouth. If the person is unconscious, to place in position of recovery and call on to a doctor.

In the event of splashes or contact with eyes:

Wash thoroughly with soft, clean water for 15 minutes holding the eyelids open.

If there is any redness, pain or visual impairment, consult an ophthalmologist.

In the event of splashes or contact with skin:

Watch out for any remaining product between skin and clothing, watches, shoes, etc.

In the event of swallowing:

Seek medical attention, showing the label.

Give nothing by the mouth – If the person is unconscious Place her on the highly-rated and call a doctor.

4.2 Most important symptoms and effects, both acute and delayed

No data available.

4.3 Indication of any immediate medical attention and special treatment needed

No data available.

 

 

SECTION 5: FIREFIGHTING MEASURES

Non-flammable.

5.1 Extinguishing media

Suitable methods of extinction

In the event of a fire, use:

– sprayed water or water mist

– foam

– multipurpose ABC powder

– carbon dioxide (CO2)

Unsuitable methods of extinction

In the event of a fire, do not use:

– water jet

5.2 Special hazards arising from the substance or mixture

A fire will often produce a thick black smoke. Exposure to decomposition products may be hazardous to health.

Do not breathe in smoke.

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 3/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
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In the event of a fire, the following may be formed:

– carbon monoxide (CO)

– carbon dioxide (CO2)

5.3 Advice for firefighters

No data available.

 

 

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment and emergency procedures

Consult the safety measures listed under headings 7 and 8.

For fire-fighters

Fire-fighters will be equipped with suitable personal protective equipment (See section 8).

6.2 Environmental precautions

Prevent any material from entering drains or waterways.

6.3 Methods and material for containment and cleaning up

Retrieve the product by mechanical means (sweeping/vacuuming).

6.4 Reference to other sections

No data available.

 

 

SECTION 7: HANDLING AND STORAGE

Requirements relating to storage premises apply to all facilities where the mixture is handled.

7.1 Precautions for safe handling

Always wash hands after handling.

Fire prevention:

Prevent access by unauthorised personnel.

Recommended equipment and procedures:

For personal protection, see section 8.

Observe precautions stated on label and also industrial safety regulations.

Prohibited equipment and procedures:

No smoking, eating or drinking in areas where the mixture is used.

7.2 Conditions for safe storage, including any incompatibilities

No data available.

Storage

 

Temperature    N/A
Keep away    N/A

Packaging

Always keep in packaging made of an identical material to the original.

7.3 Specific end use(s)

No data available.

 

 

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters

No data available.

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 4/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
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8.2 Exposure controls

Personal protection measures, such as personal protective equipment

Pictogram(s) indicating the obligation of wearing personal protective equipment (PPE):

 

LOGO

Use personal protective equipment that is clean and has been properly maintained.

Store personal protective equipment in a clean place, away from the work area.

Never eat, drink or smoke during use. Remove and wash contaminated clothing before re-using. Ensure that there is adequate ventilation, especially in confined areas.

– Eye / face protection

Avoid contact with eyes.

Before handling powders or dust emission, wear mask goggles in accordance with standard EN166.

– Hand protection

Wear suitable protective gloves in the event of prolonged or repeated skin contact.

Type of gloves recommended:

– Natural latex

– Nitrile rubber (butadiene-acrylonitrile copolymer rubber (NBR))

– PVC (polyvinyl chloride)

– Butyl Rubber (Isobutylene-isoprene copolymer)

– Body protection

Work clothing worn by personnel shall be laundered regularly.

After contact with the product, all parts of the body that have been soiled must be washed.

– Respiratory protection

Avoid breathing dust.

Type of FFP mask:

Wear a disposable half-mask dust filter in accordance with standard EN149.

 

 

SECTION 9: SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1 Information on basic physical and chemical properties

General information:

 

Physical state:    Solid.
Color:    N/A

Important health, safety and environmental information

 

pH:    Not relevant.
Boiling point/boiling range:    Not relevant.
Flash point interval:    Not relevant.
Vapour pressure (50°C):    Not relevant.
Density:    Not stated.
Water solubility:    Soluble.
Melting point/melting range:    Not relevant.
Self-ignition temperature:    Not relevant.
Decomposition point/decomposition range:    Not relevant.

9.2 Other information

No data available.

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 5/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
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SECTION 10: STABILITY AND REACTIVITY

10.1 Reactivity

No data available.

10.2 Chemical stability

This mixture is stable under the recommended handling and storage conditions in section 7.

10.3 Possibility of hazardous reactions

No data available.

10.4 Conditions to avoid

Avoid:

– formation of dusts

– frost

Dusts can form an explosive mixture with air.

10.5 Incompatible materials

10.6 Hazardous decomposition products

The thermal decomposition may release/form:

– carbon monoxide (CO)

– carbon dioxide (CO2)

 

 

SECTION 11: TOXICOLOGICAL INFORMATION

11.1 Information on toxicological effects

No data available.

11.1.1 Substances

No toxicological data available for the substances.

11.1.2 Mixture

No toxicological data available for the mixture.

 

 

SECTION 12: ECOLOGICAL INFORMATION

12.1 Toxicity

12.1.1 Substances

No aquatic toxicity data available for the substances.

12.1.2 Mixtures

No aquatic toxicity data available for the mixture.

12.2 Persistence and degradability

No data available.

12.3 Bioaccumulative potential

No data available.

12.4 Mobility in soil

No data available.

12.5 Results of PBT and vPvB assessment

No data available.

12.6 Other adverse effects

No data available.

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


 

SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)    Date: 08/11/2013 Page 6/6
Version: N°2 (18/06/2013)    Revision: N°1 (18/06/2013
à renseigner / to complete   
matrice – matrice

 

 

 

SECTION 13: DISPOSAL CONSIDERATIONS

Proper waste management of the mixture and/or its container must be determined in accordance with Directive 2008/98/EC.

13.1 Waste treatment methods

Do not pour into drains or waterways.

Waste:

Waste management is carried out without endangering human health, without harming the environment and, in particular without risk to water, air, soil, plants or animals.

Recycle or dispose of waste in compliance with current legislation, preferably via a certified collector or company.

Do not contaminate the ground or water with waste, do not dispose of waste into the environment.

Soiled packaging:

Empty container completely. Keep label(s) on container.

Give to a certified disposal contractor.

 

 

SECTION 14: TRANSPORT INFORMATION

Exempt from transport classification and labelling.

Transport product in compliance with provisions of the ADR for road, RID for rail, IMDG for sea and ICAO/IATA for air transport (ADR 2011 – IMDG 2010 – ICAO/IATA 2012).

 

 

SECTION 15: REGULATORY INFORMATION

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture

– Particular provisions:

No data available.

15.2 Chemical safety assessment

No data available.

 

 

SECTION 16: OTHER INFORMATION

Since the user’s working conditions are not known by us, the information supplied on this safety data sheet is based on our current level of knowledge and on national and community regulations.

The mixture must not be used for other uses than those specified in section 1 without having first obtained written handling instructions. It is at all times the responsibility of the user to take all necessary measures to comply with legal requirements and local regulations.

The information in this safety data sheet must be regarded as a description of the safety requirements relating to the mixture and not as a guarantee of the properties thereof.

Abbreviations:

ADR: European agreement concerning the international carriage of dangerous goods by Road.

IMDG: International Maritime Dangerous Goods.

IATA: International Air Transport Association.

ICAO: International Civil Aviation Organisation

RID: Regulations concerning the International carriage of Dangerous goods by rail.

WGK: Wassergefahrdungsklasse (Water Hazard Class).

 

– Made under license of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr –


Annex 7 - Information

 

LOGO

 

55


ANNEX 8: Pharmacovigilance Data Exchange Agreement (PDEA)

1. SCOPE

This document describes the actions, time frames and assigned responsibilities which the Parties will adopt to ensure compliance to regulatory obligations for Pharmacovigilance.

This agreement shall become effective on the date signed by both parties and will supersede all previous pharmacovigilance arrangements as applicable.

The communication language of the data exchange will be English.

2. DEFINITIONS

2.1 Veterinary medicinal product (VMP)

Any active substance (AI) or combination of AI which may be administered to animals with a view to treating or preventing disease in animals, making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals.

2.2 Adverse Event (AE)

An adverse event is any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after use of a veterinary medicinal product (VMP), regardless of whether the product was used as recommended on the Summary of Product Characteristics (SPC) (i.e. on label use or off-label use).

Possible adverse events include:

Ø Adverse Reaction (AR): An adverse reaction (AR) is a reaction to a VMP which is harmful and unintended and occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.

Ø Serious Adverse Reaction (SAR): An adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.

Ø Human Adverse Reaction: A reaction which is noxious and unintended and occurs in a human being following exposure to a VMP.

Ø A Suspected Lack of Expected Efficacy (SLEE): The apparent inability of an authorised VMP to have the expected efficacy in an animal according to the claims of the SPC and following use of the product in accordance with the SPC.

Ø Investigation of the validity of the withdrawal period: Where levels of VMP residues in tissues or food products of treated food producing animals are above the established maximum residue levels while the recommended withdrawal period of the given VMP has been respected.

Ø Potential environmental problems: A situation where animals of non-target species, other animals, human beings or plants are suspected to be adversely affected through exposure to a VMP present in the environment.

Ø Transmission of an infectious agent via a VMP.

2.3 Date of first receipt (DFR)

Calendar date when the first personnel of VIRBAC is notified of the mentioned adverse events.

To be notified in this context means VIRBAC becoming aware of a suspicion of adverse event by any means: written or oral report from a sales representative, phone call or e-mail or paper mail received from a veterinarian, the animal owner or any other health care professional or product vendor, including question or information received on a website or a facebook page managed directly by VIRBAC suggesting that an adverse event occurred in animal or human being.

 

56


2.4 Periodic Safety Update Report (PSUR)

A periodical scientific report on AE that have been reported to the MAH during a specific period.

3. PRODUCTS AND TERRITORY

The obligations described in this PDEA apply to the Product(s) and Territory listed in each Specific Distribution Agreement.

4. RESPONSIBILITIES

All relevant information should be shared between VIRBAC and NEXVET in order to allow the two parties to assume their obligations and responsibilities with regard to safety issues of the Product(s).

4.1 Responsibilities of the SUPPLIER (MAH)

NEXVET must ensure that an appropriate system of pharmacovigilance is in place in order to assure responsibility for the products on the market and to ensure that appropriate regulatory action can be taken, when necessary.

As the Marketing Authorisation Holder (MAH) in the EU/EEA area, NEXVET shall be responsible for the following activities:

Ø Reporting to the concerned National Competent authorities (preparation and submission of PSURs according to the agreed calendar, electronic submission of adverse events) and responses to their requests for information.

Ø Signal detection and continuous monitoring of the Product’s safety profile.

Ø Maintaining the safety related regulatory documentation (SPC) for the Product(s).

Ø Evaluation and communication of changes to the benefit-risk balance of Product(s).

Ø Interaction between safety issues and Product(s) defects.

Ø Identification of AE from the published peer reviewed scientific literature.

4.2 Responsibilities of VIRBAC (DISTRIBUTOR)

As the distributor in the Territory, VIRBAC shall be in charge of the following operations:

Ø Maintenance of a local system of pharmacovigilance, i.e. comprising the necessary resources for the collection and transmission of AE to the SUPPLIER.

Ø Transmission to NEXVET of any request regarding pharmacovigilance issues from the national competent authority. VIRBAC shall provide reasonable assistance to NEXVET to answer questions from the competent authority.

Ø Upon NEXVET’s demand received within a sufficient delay, transmission to NEXVET of sales data to enable the preparation of PSURs

Ø Writing job description detailing their missions for all personnel who may receive or process AE data, including sales representatives and telephone operator. Writing internal business rules or procedures detailing AE management and transmission to NEXVET. Staff receive appropriate training.

Ø Appointment of a Contact Person (CP) in charge of processing and transmission of safety reports. A Deputy of the CP is named in order to maintain the continuity of pharmacovigilance operations in case of the CP’s absence.

Ø Back up procedure in case of absence of the CP described in internal business rule or procedure in order to ensure the continuity of the pharmacovigilance operations.

Ø Identification of AE related to the Product(s) from the nationally-published peer reviewed scientific literature and transmission to NEXVET.

 

57


5. DATA EXCHANGE OF INDIVIDUAL REPORTS

VIRBAC shall be responsible for collecting all AE either received directly from the national competent authority or veterinarians or other health care professionals or any other user of the Product(s), including AE occurring during clinical trials conducted by VIRBAC. Reports will be written in english.

The individual AE reports need to fulfil the four (4) minimum criteria to the reportable:

Ø an identifiable source (e.g. veterinarian, pharmacist, animal owner): name and complete address of the reporter,

Ø animal/human details: breed, age, sex,

Ø suspect product(s): Brand name and authorisation number,

Ø reaction details.

Once at least the four minimal aforementioned information needed to consider a case as reportable are available to VIRBAC, the calculation of the delay to report the case to NEXVET starts.

VIRBAC shall forward to NEXVET reports of serious and human adverse reaction within [***] of DFR to enable their electronic submission by the SUPPLIER to the european database Eudravigilance Veterinary within the legal delay (15 calendar days).

All other adverse event reports shall be forwarded to NEXVET [***] of DFR.

VIRBAC shall ensure active follow-up as necessary about all AE and forward any follow-up information to the SUPPLIER within the same delay, i.e. [***] after reception respectively.

The reporting form given in Appendix 1 of this PDEA shall be completed and transmitted to NEXVET.

6. AUDIT

The Parties agree on the principle that audits might be conducted upon need.

Made in                      in two copies, on                     

 

FOR NEXVET     FOR VIRBAC

 

   

 

 

58

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


APPENDIX 1 of the PDEA

CONTACT DETAILS AND PHARMACOVIGILANCE REPORT FORM

For the SUPPLIER:

 

Name:  
Job Title:   Contact person
Tel.  
E-mail:  
Name:  
Job Title:   Deputy of the contact person
Tel.  
E-mail:  

For VIRBAC:

 

Name:   [***]
Job Title:   [***]
Tel.   [***]
E-mail:   [***]
Address:   [***]
Name:   [***]
Job Title:   [***]
Tel.   [***]
E-mail:   [***]
Address:   [***]

 

59

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


VETERINARY PHARMACOVIGILANCE

Form for reporting suspected adverse events

   
1 - SUBSIDIARY OR COMPANY   2 - ORIGINAL REPORTER
     

Name of sender:

 

Address:

  Name:    
 

 

Address:

   
Case reference:          
Type of report:  ¡  Initial    ¡  Follow-up     Telephone / Fax /Email:    
Date of First info Receipt (DFR):    

¡  Veterinarian    ¡  Physician    ¡   Pharmacist

¡   Owner    ¡  Other:

   
3 - VETERINARIAN / PHARMACIST / PHYSICIAN   4 - ANIMAL OWNER / HUMAN PATIENT
     
Name:       Name:    
     
Address:       Address:    

¡  Identical to original reporter

 

     
   
5 - ANIMAL DATA    
   
N° of animals treated:   N° of animals affected:   N° of animals died:    
   
Animal characteristics (animals affected):   Species:      
   
Breed/production type:             Weight:   Age:    
Sex/physiological status:  ¡  Female    ¡  Male    ¡  Pregnant    ¡   Neutered    ¡  Lactating    ¡  Other:    
State of health at time of treatment:     ¡  Good    ¡  Fair    ¡   Poor    ¡  Critical    ¡  Unknown    
   

Reason(s) for treatment [prevention against what disease and diagnosis]:

 

   
 
6 - PRODUCTS DATA AND TREATMENT DETAILS
 

List of all medications used concurrently and during the previous week:

 

Product(s) trade name (incl. dosage and strength)

Company name

               

Active substance(s)

Pharmaceutical form

               

Batch Number

Expiry date

               

Dose

Frequency of treatment

               

Route

Site of administration

               
Who administered the product(s)?                
Use according label                
Start date of treatment                
Stop date or duration                
Action after reaction (drug withdrawn, dose reduced)?                
Did reaction abate after stopping drug treatment?                
Did reaction reappear after reintroduction?                
Storage details                

 

GEDOQ FOR00352 version 05    DOC APPLICABLE


Confidential – For discussion purpose only

 

 

7 - EVENT DATA (safety issue in animals/lack of expected efficacy/withdrawal period issue/ environmental problem/transmission of infectious agents)

 
Date or time to onset of signs:                                                     Duration of reaction:
 
Describe the sequence of events incl. administration of product(s), all clinical signs, site of reaction, severity, laboratory tests, necropsy results, possible contributing factors (if necessary use extra sheet):
 
Treatment given to address this adverse reaction:    ¡ Yes             ¡ No            Details:
 
Outcome of reaction to date:
     Euthanised       Died      

Under  

treatment  

   With sequelae         Recovered          Unknown  
N° of animals:                           
Date when:                           
 
8 - PREVIOUS EXPOSURE AND EVENT(S) TO PRODUCT(S)
   

Previous exposure to product(s)?

Previous reaction to product(s)?

 

¡ Yes            ¡ No        Which one(s):                        Date:

¡ Yes            ¡ No        Which one(s):                        Date:

    

Description of reaction, treatment given and outcome:

 

 
9 - DETAILS OF SUSPECTED ADVERSE EVENT(S) IN HUMANS
 

Sex:                    Age/date of birth:                     Occupation (with relevance to exposure):

 

Date of exposure:                                                             Date of reaction:

 

Nature and duration of exposure, reaction details (including symptoms and treatment of the reaction) and outcome:

 

Identification of the physician or poison center or pharmacovigilance center if consulted:

 

 
10 - FOR SUBSIDIARY OR COMPANY USE / CAUSALITY ASSESSMENT
 
¡ A (probable)        ¡ B (possible)        ¡ O (unclassified)        ¡ O1 (inconclusive)        ¡ N (unlikely)
 

Reasons for assessment and comments:

 

 

Date:

Name of the original reporter (see section 2 of the document) or the person responsible for completing this form:

Signature (if reporting form printed):

 

¡ Attachments included    ¡ Reports to follow

 

61


Confidential – For discussion purpose only

ANNEX 9 - FINANCIAL EXAMPLE

 

62


Annex 9 – Financial Example

 

 

Nexvet recovers Manufacturing Margin from Commercial Margin

[***]

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EX-10.13 18 d775834dex1013.htm EX-10.13 EX-10.13

Exhibit 10.13

SPECIFIC DISTRIBUTION AGREEMENT FOR NV-01 PRODUCT

THIS SPECIFIC DISTRIBUTION AGREEMENT is made between:

VIRBAC, a company organized under the law of FRANCE, with registered office at 1ère avenue 2065 M – L.I.D., 06516, Carros, France - registered under number 417 350 311 RCS at Grasse, France, acting for itself and its Affiliates, herein duly represented by Christian Karst, Member of the Executive Board,

Hereinafter referred to as “VIRBAC”;

AND

NEXVET IRELAND LIMITED, a company organised under the laws of Ireland, with registered office at 88 Harcourt Street, Dublin 2 Ireland, with registered number 550752, represented by Dr Mark Heffernan, Chief Executive Officer & Director,

Hereinafter referred to as “NEXVET

WHEREAS:

A Master Collaboration, Supply and Distribution Agreement of Product has been entered into between VIRBAC and NEXVET on the November 24th 2014 (the “Agreement”) whereby NEXVET and VIRBAC have agreed the general terms upon which NEXVET shall provide the Product to VIRBAC and/or its Affiliates.

VIRBAC is willing to purchase NV-01 Product from NEXVET, distribute NV-01 Product and NEXVET is willing to provide such NV-01 Product to VIRBAC, subject to the terms and conditions of the Agreement and this Specific Distribution Agreement.

Article 1. Definitions

NV-01 Product means pharmaceutical canine monoclonal antibody product under its finished form targeting nerve growth factor (NGF) covered by the Patent.

Article 2. Purpose of this Specific Agreement

 

2.1 The purpose of this Specific Distribution Agreement is to: (i) specify the conditions under which VIRBAC will place orders to NEXVET for the provision of NV-01 Product in accordance with the Target Product Profile defined in Exhibit 1, the Marketing Authorization and the Specification defined in Exhibit 3 and (ii) for VIRBAC to distribute NV-01 Products in the Territory.

 

2.2

The provisions of the Agreement not otherwise modified in the Specific Distribution Agreement apply to this Specific Distribution Agreement. To the extent that there is

 

1


  any inconsistency between this Specific Distribution Agreement and the Agreement, the terms of the Agreement shall prevail, unless expressly stated otherwise in this Specific Distribution Agreement.

 

2.3 Capitalized terms that are not otherwise defined in this Specific Distribution Agreement have the meanings specified in the Agreement.

 

Article 3. Development Plan

The Development Plan for NV-01 Product shall describe all the proposed development and regulatory activities of NEXVET, including the proposed timelines for such activities, to obtain the Marketing Authorizations in the Territory and according to the Target Product Profile defined in Exhibit 1.

Such Development Plan shall be approved by the JSC and included in Exhibit 2 within [***] of execution of this Specific Distribution Agreement.

 

Article 4. Marketing Authorization

If the Marketing Authorization for NV-01 Product in Europe is not obtained within [***] from the date of execution of the Agreement, then VIRBAC has the right to terminate the Agreement and this Specific Distribution Agreement.

 

Article 5. Minimum Annual Net Sales Obligations

For NV-01 Product, the Minimum Annual Net Sales Obligations for the Territory calculated from the fourth full calendar year following the First Commercialization of NV-01 Product in any one of the Major Countries, are as follows:

In year 4: [***]

In year 5: [***]

In year 6: [***]

In year 7: [***]

In year 8: [***]

In year 9: [***]

In year 10: [***]

The functional currency in the VIRBAC’s group’s foreign subsidiaries is the current local currency. The financial income statements of foreign companies for which the functional currency is not the Euro are converted using the published Banque de France foreign exchange reference monthly average rate. Payments to Nexvet will be calculated on this basis. For the purpose of calculations, the Net Sales will be converted from Euro to USD using the Banque de France’s published foreign exchange reference monthly average rate for the period and compared to the USD Minimum Annual Net Sales Obligations amounts disclosed in the Specific Distribution Agreement.

 

2

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Article 6. Manufacturing

The Manufacturer(s) and the Manufacturing Site(s) for NV-01 Product shall be defined by NEXVET and included by amendment to this Specific Distribution Agreement no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority in the Territory.

 

Article 7. Supply and Delivery

NEXVET warrants that NV-01 Product shall meet the Specification as set out in Exhibit 3. Such Specification shall be included in Exhibit 3 no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority within the Territory.

The NV-01 Product shall be delivered within a maximum of [***] from the date of receipt of VIRBAC’s orders, and, unless agreed otherwise in writing, shall be delivered Ex-Works Incoterms 2010 at the Manufacturing Site.

The minimum quantity per order will be agreed by the Parties in writing no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority in the Territory.

 

Article 8. Pharmacovigilance

A pharmacovigilance data exchange agreement shall be agreed by the Parties and included in Exhibit 4 no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority in the Territory.

 

Article 9. Financial terms

The financial terms for NV-01 Product are as follows:

 

9.1 Milestone Payment

VIRBAC shall pay to NEXVET:

 

(a) [***] when the first Marketing Authorisation for NV-01 is issued in a Major Country; and

 

(b) [***] on the First Commercialization of NV-01.

For the sake of clarity, each of the above milestone payments is only to be paid once. These milestones payments shall be made by VIRBAC to NEXVET in USD.

 

9.2 NEXVET Fees

NEXVET Fees will be equal to [***] for sales of NV-01 Product by VIRBAC and/or its Affiliates in the Territory, and which included the deferred payment of the Manufacturing Margin.

 

3

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


9.3 Purchase Price of NV-01 Product

The Parties agree to discuss and validate the Purchase Price of NV-01 Product through the JSC and to include it by amendment in this Specific Distribution Agreement no later than [***] prior the first filing of the Registration Dossier with the applicable regulatory authority in the Territory.

The Purchase Price of NV-01 Product shall be fairly negotiated and revised by the JSC annually before the end of October taking into consideration the forecasts, the batch(es) size, increase or decrease of raw material costs (based on international prices) and the variation of the manufacturing costs.

The prices, as revised, shall be effective for NV-01 Product to be delivered after January 1st of the following year.

NEXVET shall use its reasonable endeavours to reduce such Purchase Price during the term of the Agreement.

The non-binding target Total Cost of Goods for NV-01 Product shall be below [***] of the Net Sales of NV-01 Product.

 

Article 10. Term

This Specific Distribution Agreement is deemed to come into force on November 24th, 2014 and shall remain in force for 10 (ten) years from the date of First Commercialization of NV-01 Product (“Initial Term”).

The Specific Distribution Agreement shall thereafter automatically be renewed by periods of 2 (two) years, unless a written notice of termination is sent, by registered letter and confirmed by email, by one of the Parties, no later than 6 (six) months prior to the expiration of the Initial Term or any 2 (two) year extension thereof.

Article 11. Trademarks

The Trademark(s) for NV-01 Product shall be agreed by the JSC and included by amendment to this Specific Distribution Agreement no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority of NV-01 Product in the Territory.

Article 12. Quality Agreement

A Quality Agreement shall be negotiated and agreed between the Parties and included in Exhibit 4 no later than [***] prior to the first first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority in the Territory.

 

4

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Article 13. Material Safety Data Sheet

NEXVET shall complete a Material Safety Data Sheet (MSDS) regarding NV-01 Product. This MSDS shall be included in Exhibit 5 no later than [***] prior to the first filing of the Registration Dossier of NV-01 Product with the applicable regulatory authority in the Territory.

Article 14. Counterpart Signatures

This Specific Distribution Agreement may be executed in any number of counterparts, each of which when executed shall constitute an original of this Specific Distribution Agreement, but all the counterparts together constitute the same Specific Distribution Agreement. No counterpart shall be effective until each party has executed at least one counterpart.

IN WITNESS OF THE ABOVE the Parties have signed this Specific Distribution Agreement on the date written at the head of this Specific Distribution Agreement.

 

VIRBAC     NEXVET
By:   /s/ Christian Karst     By:   /s/ Mark Heffernan
Name:   Christian Karst     Name:   Dr Mark Heffernan
Title:   Member of the Executive Board     Title:   Chief Executive Officer and Director
Date and place:  

November 28, 2014

Nice, France

    Date and place:  

26 November 2014

Dublin, Ireland

 

5

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Exhibit 1 – Target product profile for NV-01

[***]

UNIT DOSING TABLE

[***]

 

6

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.


Exhibit 2 – Development Plan for NV-01 Product

[To be completed.]

 

7


Exhibit 3 – Specification for NV-01 Product

[To be completed.]

 

8


Exhibit 4 – Quality Agreement for NV-01 Product

[To be completed.]

 

9


Exhibit 4 – Pharmacovigilance Agreement for NV-01 Product

[To be completed.]

 

10


Exhibit 5 – Material Safety Data Sheet for NV-01 Product

[To be completed.]

 

11


Exhibit 6 – Information for NV-01 Product

[To be completed.]

 

12

EX-10.14 19 d775834dex1014.htm EX-10.14 EX-10.14

Exhibit 10.14

 

LOGO

December 22, 2014

Mark Heffernan

 

  Re: Your employment by Nexvet US, Inc.

Dear Mark:

On behalf of Nexvet US, Inc. (the “Company”), a wholly-owned subsidiary of Nexvet Biopharma plc, a company organized in the Republic of Ireland (the “Parent Company”), I am pleased to confirm your employment with the Company upon the following terms and conditions commencing upon the date (the “Start Date”) of the closing of the IPO (as defined by Section 8) of the Parent Company. Prior to the Start Date, you will continue to be employed by Nexvet Australia Pty Ltd, being a wholly-owned subsidiary of the Parent Company, upon the existing terms and conditions of your employment; provided, however, that Section 8 of this agreement (the “Agreement”) will be effective from the date on which the Parent Company files with the U.S. Securities and Exchange Commission a registration statement on Form S-1 with respect to the IPO (the “Filing Date”). All references to “$” are to United States dollars.

1. Position, Duties and Indemnification. Your position and title will be Chief Executive Officer of the Parent Company, and you will report to the Parent Company’s Board of Directors (the “Parent Board”). In this position, your duties will consist of duties commensurate with your position and title as may be assigned to you from time to time in good faith by the Company or the Parent Board. In addition, you will be elected to, and will serve as a member of, the Parent Board. Further, you will serve as the President and Director of the Company. Your employment with the Company is a full-time position, and in performing your duties you will devote your full business time and commercially reasonable efforts on behalf of the Company and Parent Company. Notwithstanding the foregoing, at any time after the first anniversary of the Start Date (or earlier if agreed with the Parent Board), it is acknowledged and agreed that, with the prior approval of the Parent Board (such approval not to be unreasonably withheld or delayed), you may engage in civic and not-for-profit activities, and serve on the boards of directors or serve as an advisor to non-competitive private or public companies so long as such activities do not materially interfere with the performance of your duties to the Company. You shall serve as the Chief Executive Officer of the Parent Company, with the right to attend all meetings of the Parent Board so long as you remain the Chief Executive Officer of the Company. It is acknowledged and agreed that, with effect from 14 August 2014, you have been a member of the Board of Directors of the Parent Company (as defined below), and the Parent Company shall nominate you for election to serve as member of the Board of Directors of the Parent Company as long as you continue to serve as the Chief Executive Officer of the Parent Company. In addition, you will abide by all Company and Parent Company policies and directives as in effect from time to time, as well as all applicable laws. It is further acknowledged and agreed that the Parent Company has agreed to indemnify you pursuant to a Deed of Indemnity, Insurance and Access dated 3 September 2014, which is in the same form of agreements entered into by the Parent Company and the other Board members of the Parent Company.


Mark Heffernan

December 22, 2014

Page 2

 

2. Base Salary. The Company will pay you a base salary at the annual rate of $450,000.00 ($37,500.00 per month) in accordance with the Company’s standard payroll schedule. This position is an exempt position, which means you are paid for the job and not by the hour. Accordingly, you will not receive overtime pay if you work more than 8 hours in a workday or 40 hours in a workweek. You will be eligible for your first salary review and a comprehensive review of the key elements of your compensation package after the Parent Company achieves a market capitalization, as determined by reference to publicly available Parent Company stock trading data, that exceeds $500,000,000.00, or as the Board of Directors of the Parent Company or the Compensation Committee thereof determines in good faith from time to time, but in any event no later than the second anniversary of your Start Date. Adjustments to your salary or other compensation, if any, will be made by the Parent Board or Compensation Committee in its sole and absolute discretion.

3. Bonus. Your incentive (bonus) compensation, if awarded by the Parent Board or Compensation Committee, will be determined based on achievement by you, and the Parent Company, as relevant, of objectives established by the Parent Board or Compensation Committee. Initial objectives will be established by the Parent Board or Compensation Committee and provided in writing to you within thirty (30) days after your Start Date. Such incentive (bonus) compensation will range on a sliding scale from 0% to 45% of your base salary for the given fiscal year for which such bonus is granted, based upon the achievement by you, and/or the Parent Company, as relevant to the bonus achievement criteria set by the Parent Board, for achieving as relevant, 0% to 100% of your personal objectives, and as relevant to the given fiscal year, the Parent Company’s corporate objectives for the given fiscal year, as determined in good faith by the Parent Board. Notwithstanding the above, your bonus for fiscal year 2015 shall be based upon your base salary for fiscal year 2015, with remuneration payments (including superannuation payments made in Australia on your behalf) made to you in currencies other than US dollars converted to US currency as at the date that those payments were made. The annual incentive bonus compensation will be earned by you if you remain employed on the last day of a given year. Any bonus awarded by the Parent Board will be paid to you in cash no later than ninety (90) days after the end of the fiscal year for which such bonus is earned and will be subject to relevant payroll tax withholdings and deductions. If your employment with the Company terminates as a result of an Involuntary Termination (as defined below), then you will be eligible for a pro-rata bonus, calculated in line with other executives in the Parent Company and in line with reasonable business practice.

4. Place of Work. Your primary place of work will be located in or within 50 miles of San Francisco, California or as the Board may determine from time to time as being in the best interests of the Company and agreed with you, such agreement not to be unreasonably withheld or delayed.

5. Relocation Benefits. In order to assist you in relocating to the San Francisco Bay Area to serve in your position with the Company, the Company will provide you with a one-time relocation allowance of $119,700.00 (the “Relocation Allowance”). Subject to Section 12(b)(iii), the applicable portion(s) of the Relocation Allowance will be paid either directly by the Company for relocation expenses incurred by you or to you as a reimbursement of relocation expenses as soon as practicable following the month in which you have incurred such expenses. The Relocation


Mark Heffernan

December 22, 2014

Page 3

 

Allowance is contingent upon your relocation to the San Francisco Bay Area prior to May 1, 2015 or such other date as agreed by the Board. The Relocation Allowance is intended to cover your costs in connection with such relocation, including, but not limited to, airfare for you and your family, rental car, relocation consultant, temporary housing and the shipping of household and personal effects. You will provide documentary evidence to the Company of the relocation expenses you have incurred in accordance with this Section 5. You agree that if you voluntarily resign from the Company within twelve (12) months after the Start Date, you will repay to the Company all payments made to you under this Section 5 within thirty (30) days after the date of such resignation, except in the case of an Involuntary Termination, as hereinafter defined.

6. Business Expenses. The Company will reimburse you for your commercially reasonable business expenses incurred in connection with your duties, upon presentation by you to the Company of appropriate supporting documentation, and otherwise in accordance with the Company’s applicable policies with respect to such reimbursement and Section 12(b)(iii) below.

7. Paid Time Off and Employee Benefits. On the Start Date, you will be credited with the number of hours of unused annual leave and personal / carer’s leave you have accrued with Nexvet Australia Pty Ltd. Beginning with the next calendar year following the Start Date, you will be provided no less than 200 hours of paid time off (“PTO”) per calendar year of employment with the Company. 1/12th of your annual PTO allowance will accrue each month and a pro rata entitlement will apply for each part month. The Company’s PTO program applies to any absence from work not otherwise covered by a specific time off benefit such as holiday pay. PTO covers all scheduled vacation or personal time off as well as unscheduled time off due to personal illness, emergencies and the like. Your annual PTO allowance will increase to 240 hours after 5 April 2016. Unused PTO carries over from year to year to a maximum of 240 hours. Your usage of PTO will be subject to the Company’s other policies in relation to PTO and, with authorization from the Chairman of the Parent Company, you may take up to 40 hours more time off than you have accrued. In addition, if you have relocated to the San Francisco Bay Region (or such other area as may be determined by the Board as being in the best interests of the Company) in accordance with Section 5, you will be entitled to reimbursement in accordance with Section 12(b)(iii) below of up to $25,000.00 from the Company per Company fiscal year for your expenses for an annual vacation trip for you and your family during the fiscal years ending in 2016, 2017 and 2018. You also will be eligible to participate in the Company’s benefits plans according to the terms and conditions of such benefit plans as in effect from time to time, such as, for example purposes only, group health insurance plans and pension and retirement plans. The Company may implement and change its benefit plans from time to time as determined by the Board.

8. IPO Option.

(a) Grant of Option. As soon as practicable after the pricing of an initial public offering of the Parent Company’s capital stock (the “IPO”) pursuant to a definitive written agreement between the Parent Company and the underwriter(s) engaged by the Parent Company for such IPO, and subject to your continued employment with Nexvet Australia Pty Ltd through such date, the Parent Board will grant to you a nonstatutory stock option (the “IPO Option”) pursuant to the Parent Company’s 2014 Equity Incentive Plan or its successor (the


Mark Heffernan

December 22, 2014

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Plan”) to purchase 100,000 ordinary shares of the Parent Company’s capital stock. Unless otherwise required by applicable law, the exercise price per share subject to the IPO Option (“IPO Option Exercise Price”) will be the greater of $15.00 (as adjusted pro rata to reflect any change in the Parent Company’s capital structure) and the public offering price in the IPO. The IPO Option will vest and become exercisable (i) with respect to 20% thereof upon the closing of the IPO and (ii) with respect to the remaining 80% thereof in 16 substantially equal installments on the last day of each of the 16 consecutive calendar quarters commencing after the closing of the IPO; provided, however that the IPO Option will become 100% vested and exercisable in full as of a date specified by the Parent Board prior to the consummation of a Change in Control (as defined below), provided that your service with the Company has not terminated prior to such date. The IPO option will be subject to the terms and conditions of the appropriate form of option agreement approved by the Parent Board for use under the Plan, which you will be required to execute.

(b) Change in Control Prior to IPO. If a Change in Control (as defined in Section 13) is consummated on or after the Filing Date but prior to the Start Date, and if the Parent Company has not granted the IPO Option to you prior to the consummation of such Change in Control, then, provided that your employment with Nexvet Australia Pty Ltd has not terminated prior to the consummation of the Change in Control, the Parent Company shall pay to you an amount in cash equal to one-third of 1% of the amount that otherwise would be payable to the holders of the capital stock of the Parent Company pursuant to the Change in Control transaction, net of the repayment of the liabilities of the Parent Company not assumed by the acquirer in such transaction and the expenses incurred by the Parent Company in connection with such transaction, but without reduction for the amounts payable to you pursuant to this Section 8(b) and to the Company’s Chief Financial Officer and Chief Scientific Office under similar arrangements. The amount payable to you pursuant to this Section 8(b), if any, will be paid to you at the same time(s) and subject to the same terms and conditions that apply to the payment of transaction consideration to the holders of the capital stock of the Parent Company, and in any event in a manner that complies with the requirements for payment of “transaction-based compensation” within the meaning of United States Treasury Regulation Section 1.409A-3(i)(5)(iv)(A).

(c) Change in Control After IPO. If a Change in Control (as defined in Section 13) is consummated on or after the Start Date, and if the Parent Company has not granted the IPO Option to you prior to the consummation of such Change in Control, then, provided that your employment with the Company has not terminated prior to the consummation of the Change in Control, the Company shall pay to you an amount in cash in a single lump sum within 60 days following the consummation of the Change in Control calculated as (i) minus (ii), where (i) and (ii) are defined as:

(i) 100,000 multiplied by the closing market price of one (1) ordinary share of Parent Company capital stock determined on the date immediately prior to the Change in Control; and

(ii) 100,000 multiplied by the IPO Option Exercise Price (as adjusted pro rata to reflect any change in the Parent Company’s capital structure).


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December 22, 2014

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9. Annual Equity Awards. Subject to the approval of the Parent Board and provided that your employment with the Company has not previously terminated, you will be eligible to be granted an award under the Plan as soon as practicable but no later than 31 August in each fiscal year of the Parent Company commencing after the IPO (the “Annual Equity Award”). Each Annual Equity Award may be any type of award authorized under the Plan and will have an Award Value (as defined below) of up to $1,000,000.00, with the Award Value of any Annual Equity Award determined by the Parent Board in its discretion. For the purposes of this Section, “Award Value” means a value ascribed to an Annual Equity Award by the Parent Board, in its discretion, as of the date of grant of the Annual Equity Award. Each Annual Equity Award may vest on the basis of such service and/or performance or other conditions as may be established by the Parent Board; provided, however that each Annual Equity Award will become 100% vested and exercisable in full (if applicable) as of a date specified by the Parent Board prior to the consummation of a Change in Control (as defined below), provided that your service with the Company has not terminated prior to such date. Each Annual Equity Award will be subject to the terms and conditions of the appropriate form of award agreement approved by the Parent Board for use under the Plan, which you will be required to execute.

10. Employment Relationship. Your employment with the Company is “at will,” and for no specific period of time, and thus either you or the Company may terminate your employment at any time and for any reason, with or without cause upon written notice by the terminating party to the other party. Although your job duties, title, compensation and benefits, as well as the Company’s personnel policies and procedures, may be changed by action of the Board in good faith from time to time during the term of your service of the Company, the “at-will” nature of your employment may only be changed in an express written agreement to such effect signed by you and a duly authorized officer of the Company other than you who has been authorized by the Board to execute such written agreement on behalf of the Company.

11. Termination of Employment. If you voluntarily terminate your employment with the Company at any time for any reason, other than your Resignation for Good Reason (as defined below), you must provide at least three (3) months’ notice and you will be entitled to your base salary then in effect prorated through until your termination date, as well as any accrued but unused vacation and all amounts and benefits earned or incurred pursuant to Section 3, Section 6, Section 7, Section 8 and Section 9 through the last day of your employment (the “Accrued Rights”), and you will not be entitled to any other compensation or benefits from Company.

(a) Termination for Cause, Death, or Disability. If the Company terminates your employment for Cause (as defined below, and as determined in the discretion of the Board) or if your employment with the Company terminates as a result of your death or Disability, as defined below, you will be entitled to your Accrued Rights, and you will not be entitled to any other compensation or benefits from the Company. If the Company offers death or Disability benefits to an executive officer of the Company in the future, you will be entitled to similar death or Disability benefits, so long as such benefits are compliant with Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”).


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December 22, 2014

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(b) Involuntary Termination Other Than In Connection With a Change in Control. If your employment with the Company terminates as a result of an Involuntary Termination (as defined below), then you will be entitled to your Accrued Rights. In addition, you will be entitled to the benefits described in this Section 11(b) (the “Severance Benefits”) provided that you have (i) returned all of the Company’s property in your possession, and (ii) executed and not revoked a full and complete release of all claims against the Company and related persons in the form set forth in Exhibit A hereto (the “Release”), and the Release has become effective in accordance with its terms on or before the 60th day following the date of your termination of employment with the Company. The Severance Benefits consist of:

(i) Continued payment by the Company of your monthly base salary rate (determined by your annual salary rate in effect at the time of your Separation without regard to a reduction that would constitute Good Reason) for a period of six (6) months after your Separation (as defined below) (the “Salary Continuation Benefit”).

(ii) Payment to you by the Company of an aggregate amount, net of required withholding taxes, equal to the product of (A) six (6) and (B) the monthly amount the Company was paying for coverage of you and your eligible dependents, if any, under the Company’s health insurance plans in which you and your eligible dependents, if any, were participants as of the day of your termination of employment (the “Health Benefit”). The aggregate amount of the Health Benefit will be apportioned on the basis of six (6) monthly installments and paid, net of applicable withholding taxes, at the same time and in the same manner as the Company’s payment of the Salary Continuation Benefit.

(iii) If your termination of employment occurs after the first day of a given fiscal year of the Parent Company, and if the Parent Company has not yet granted your Annual Equity Award in the fiscal year that your termination occurs, the Company shall, acting in good faith, pay you an amount of cash (the “Annual Equity Award Benefit”) equal to the product determined by multiplying (A) the greater of (x) the Award Value of the Annual Equity Award that you otherwise would have received for the fiscal year of your termination of employment and (y) the Award Value of the Annual Equity Award granted to you during the immediately preceding fiscal year, by (B) a ratio, the numerator of which equals the number of days elapsed from the beginning of the immediately preceding fiscal year to the date of your termination of employment, and the denominator of which equals the total number of days contained in the current fiscal year.

(iv) Any portions of the IPO Option and Annual Equity Awards granted to you prior to your Separation that remain unvested as of the date of your Separation will become 100% vested and exercisable in full for the remainder of the option term as if your employment had not terminated (if applicable) as of your termination date.


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December 22, 2014

Page 7

 

The Annual Equity Award Benefit will be paid, and the Salary Continuation Benefit and Health Benefit payments will commence, on the next Company payroll date following the effective date of the Release, and the first payment will include any unpaid amounts accrued from the date of your Separation. Notwithstanding the foregoing, to the extent the payment of the Annual Equity Award Benefit, the Salary Continuation Benefit and/or the Health Benefit constitute “deferred compensation” within the meaning of Section 409A of the Code, and if the period beginning on the date of your Separation and ending on the first Company payroll date occurring on or after the date which is sixty (60) days thereafter spans two (2) calendar years, then the payment of the Annual Equity Award Benefit will be made, and the Salary Continuation Benefit and Health Benefit will commence, on the first payroll date occurring on or after the date which is sixty (60) days following your Separation date (provided the other requirements for receipt of such Severance Benefits have been met), subject in each case to the provisions of Section 12(b)(ii) below.

(c) Involuntary Termination In Connection With a Change in Control. If your employment with the Company, the Parent Company or any successor in interest to the Company or Parent Company that has assumed the Company’s or Parent Company’s obligation under this Agreement terminates as a result of an Involuntary Termination immediately prior to, upon, or within twelve (12) months following, a Change in Control, then you will be entitled to your Accrued Rights. In addition, provided that you have (i) returned all of the Company’s property in your possession, and (ii) executed and not revoked the Release and the Release has become effective in accordance with its terms on or before the 60th day following the date of your termination of employment with the Company, you will be entitled to receive the Severance Benefits set forth in Section 11(b), payable at the time(s) and subject to the conditions set forth therein, provided that the Salary Continuation Benefit and the Health Benefit will each be for a period of twelve (12) months (the “Change in Control Severance Benefits”) in lieu of the period for such benefits described in Sections 11(b)(i) and (ii).

12. Tax Matters.

(a) Withholding. All forms of compensation referred to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.

(b) Certain Provisions Respect to Section 409A of the Code.

(i) For purposes of Section 409A of the Code, each installment payment of Salary Continuation Benefit and the Health Benefit is hereby designated as a separate payment.

(ii) If the Company determines that you are a “specified employee” under Section 409A(a)(2)(B)(i) of the Code at the time of your Separation, then (i) the Severance Benefits or Change in Control Severance Benefits, as applicable, to the extent that they are treated as deferred compensation subject to Section 409A of the Code, will commence on the payroll date following the earlier of (A) expiration of the six (6) month period measured from your Separation or (B) the date of your death, and (ii) the installments that otherwise would have been paid prior to such date will be paid in a lump sum when the payment of Severance Benefits or Change in Control Severance Benefits, as applicable, commence.


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December 22, 2014

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(iii) Notwithstanding anything herein to the contrary, the reimbursement of expenses or in-kind benefits provided pursuant to this Agreement will be subject to the following conditions: (i) the expenses eligible for reimbursement or in-kind benefits in one taxable year will not affect the expenses eligible for reimbursement or in-kind benefits in any other taxable year; (ii) the reimbursement of eligible expenses or in-kind benefits will be made promptly, subject to the Company’s applicable policies, but in no event later than the end of the year after the year in which such expense was incurred; and (iii) the right to reimbursement or in-kind benefits will not be subject to liquidation or exchange for another benefit.

(iv) The Company intends that income provided to you pursuant to this Agreement will not be subject to taxation under Section 409A of the Code. The provisions of this Agreement will be interpreted and construed in favor of satisfying any applicable requirements of Section 409A of the Code. However, the Company does not guarantee any particular tax effect for income provided to you pursuant to this Agreement. In any event, except for the Company’s responsibility to withhold applicable income and employment taxes from compensation paid or provided to you, the Company will not be responsible for the payment of any applicable taxes on compensation paid or provided to you pursuant to this Agreement.

(c) Section 280G Excise Tax Matters.

(i) In the event that any payment in the nature of compensation (within the meaning of Section 280G(b)(2) of the Code) to you or for your benefit, paid or payable or distributed or distributable pursuant to the terms of this Agreement, or otherwise in connection with, or arising out of, your employment with the Company (collectively, the “Payments”), would, but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code or any similar or successor provision (the “Excise Tax”), then the Payments shall be either: (1) delivered in full, or (2) delivered as to such lesser extent which would result in no portion of such Payments being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the Excise Tax, results in the receipt by you on an after-tax basis, of the greatest amount of Payments, notwithstanding that all or some portion of such Payments may be taxable under Section 4999 of the Code. Any reduction under this Subsection shall be applied first to Payments that constitute “deferred compensation” (within the meaning of Section 409A of the Code and the regulations thereunder). If there is more than one such Payment, then such reduction shall be applied on a pro rata basis to all such Payments. Notwithstanding the foregoing, if required by the individual, entity or group which will control the Company upon the occurrence of a Change in Control, the Company and you shall take all actions necessary to comply with the stockholder vote requirements necessary to obtain the exemption under Section 280G(b)(5) of the Code and the applicable regulations promulgated thereunder, if available to the Company, for the portion of the Payments that would otherwise be subject to the Excise Tax.

(ii) An initial determination as to whether a reduction in the Payments


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December 22, 2014

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is required pursuant to this Agreement and the amount of such reduction shall be made by the Company. The Company shall provide its determination (the “Determination”), together with detailed supporting calculations and documentation, to you within fifteen (15) days of the Change in Control or the date of your termination of employment, as applicable, or such other time as requested by you (provided you reasonably believe that any of the Payments may be subject to the Excise Tax). If requested by you, the Company shall furnish you, at the Company’s expense, with an opinion reasonably acceptable to you from the Company’s accounting firm (or an accounting firm of equivalent stature reasonably acceptable to you) that there is a reasonable basis for the Determination.

(d) Tax Advice. You are encouraged to obtain your own tax advice regarding your compensation from the Company. You agree that the Company does not have a duty to design its compensation policies in a manner that minimizes your tax liabilities, and you will not make any claim against the Company or the Board related to tax liabilities arising from your compensation.

13. Definitions. The following terms have the meaning set forth below wherever they are used in this Agreement:

Cause” means the occurrence of any of the following:

(a) Your gross negligence, gross misconduct or your refusal to perform your duties and responsibilities to the Company after you have received a written description of such failure and been provided with thirty (30) days to cure such failure, or your material breach of your fiduciary duties to the Company. Any willful act or acts or omission or omissions by you that have a material adverse effect on the Company’s reputation or financial statements will be deemed to be such a breach of your duties and responsibilities to the Company; provided, however, in all such cases, you will have been given a written description of such failure or breach and thirty (30) days to cure the breach.

(b) Your conviction of, or plea of nolo contendere to, a felony, in which case, notwithstanding anything set forth in this Agreement, the Company may immediately terminate your employment for Cause.

(c) Your engagement in acts of embezzlement or material dishonesty; in which case, notwithstanding anything set forth in this Agreement, the Company may immediately terminate your employment for Cause.

Change in Control” means: (a) a merger or consolidation or the sale, or exchange by the stockholders of the Parent Company of all or substantially all of the capital stock of the Parent Company, where the stockholders of the Parent Company immediately before such transaction do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the surviving or acquiring corporation or other surviving or acquiring entity, in substantially the same proportion as before such transaction; (b) any transaction or series of related transactions to which the Parent Company is a party in which in excess of fifty percent (50%) of its voting power is transferred, other than any


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December 22, 2014

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such transfer in which the stockholders of the Parent Company immediately before such transfer obtain or retain, directly or indirectly, more than fifty percent (50%) of the beneficial interest in the voting power of the voting stock or other voting equity of the corporation or other entity to which the voting power of the Parent Company was transferred, or (c) the sale or exchange of all or substantially all of the Parent Company’s assets, other than a sale or transfer to a subsidiary of the Parent Company as defined in Section 424(f) of the Code, in which the stockholders of the Parent Company immediately before such sale or exchange do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the corporation or other entity acquiring the Parent Company’s assets, in substantially the same proportion as before such transaction.

Disability” means “disability” as defined by the long-term disability plan or policy adopted by the Company covering you, and in lieu of such plan or policy, it means a “permanent and total disability” as defined by Section 22(e)(3) of the Code.

Involuntary Termination” means either (a) your Termination Without Cause or (b) your Resignation for Good Reason.

Resignation for Good Reason” means a Separation as a result of your resignation within ninety (90) days after one of the following conditions has come into existence without your consent:

(a) The material breach by the Company of any of its obligations under this Agreement; or

(b) Without your express written consent, a material reduction of your duties, position or responsibilities or your removal from such position and responsibilities, or a reduction in the level of supervisor within the organization to whom you report; or

(c) Without your express written consent, a material reduction in your base salary, unless such reduction is made in connection with a company-wide cost reduction effort; or

(d) The Company’s requirement that you report to a primary work location that is not within the region described in Section 4; or

(e) A material reduction in the kind or level of employee benefits to which you are entitled immediately prior to such reduction with the result that your overall benefits package is significantly reduced such that the reduction constitutes a “material negative change” to your employment relationship (within the meaning of Section 1.409A-1(n)(2) of the United States Federal Treasury Regulations), unless such reduction is made in connection with a company-wide cost reduction effort of similar scope for all similarly situated employees.

A Resignation for Good Reason will not be deemed to have occurred unless you give the Company written notice of the condition within thirty (30) days after the condition comes into existence and the Company fails to remedy the condition within thirty (30) days after receiving your written notice.


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December 22, 2014

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Separation” means a “separation from service,” as defined in Section 409A of the Code and/or the regulations and other guidance issued by the Internal Revenue Service or the Department of Treasury under Section 409A of the Code.

Termination Without Cause” means a Separation as a result of a termination of your employment by the Company without Cause other than for death or Disability.

14. Interpretation, Amendment and Enforcement. Other than the terms of the awarding of options to you pursuant to the Company’s superseded long term incentive plan and the terms of the Employee Incentive Plan which comes into effect at the IPO, and other than the deed of indemnity, insurance and access referred to in Section 1, this Agreement supersedes and replaces any prior agreements, representations or understandings (whether written, oral, implied or otherwise) between you and the Company with respect to the subject matter hereof, and constitutes the complete agreement between you and the Company regarding the subject matter hereof. This Agreement may not be amended or modified except by a written Agreement signed by both you and a duly authorized officer of the Company that explicitly states the intent of both parties hereto to supplement the terms herein. The terms of this Agreement and the resolution of any disputes as to the meaning, effect, performance or validity of this Agreement or arising out of, related to, or in any way connected with, this Agreement, your employment with the Company or any other relationship between you and the Company (the “Disputes”) will be governed by the laws of the State of California, excluding its laws relating to conflicts of law or choice of law. You and the Company submit to the exclusive personal jurisdiction of, and venue in, the U.S. federal and State of California courts located in San Francisco, California in connection with any dispute or any claim related to any dispute between the parties hereto related to or arising from this Agreement.

15. Successors and Assigns. This Agreement is personal to you and may not be assigned by you in whole or in part. Any purported assignment by you will be null and void from the initial date of the purported assignment. The Company may assign this Agreement to any successor or assign (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company. This Agreement will inure to the benefit of the Company and to such successors and assigns.

16. Remedies. In the event of a breach or threatened breach by you of this Agreement, you hereby consent and agree that the Company will be entitled to seek, in addition to other available remedies, a temporary or permanent injunction or other equitable relief against such breach or threatened breach from any court of competent jurisdiction, without the necessity of showing any actual damages or that money damages would not afford an adequate remedy, and without the necessity of posting any bond or other security. The aforementioned equitable relief will be in addition to, not in lieu of, legal remedies, monetary damages or other available forms of relief.

17. Severability. If any provision of this Agreement is held by a court to be invalid, void or unenforceable, the remaining provisions will nevertheless continue in full force and effect without being impaired or invalidated in any way and will be construed in accordance with the purposes and tenor and effect of this Agreement.


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December 22, 2014

Page 12

 

18. Counterparts. This Agreement may be executed in counterparts, each of which will be an original, but both of which together will constitute one instrument.

19. Survival. Upon the expiration or other termination of this Agreement, the respective rights and obligations of the parties hereto will survive such expiration or other termination to the extent necessary to carry out the intentions of the parties under this Agreement

This offer is contingent upon your: 1) signing and providing to the Company the Company’s standard Employee Proprietary Information and Inventions Agreement; and 2) providing the Company with a true and correct copy of appropriate documents establishing your identity and right to work in the United States.

[SIGNATURE PAGE FOLLOWS]


Mark Heffernan

December 22, 2014

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You may accept this offer by signing and dating the enclosed duplicate original of this Agreement and returning it to me by email to chris.brown@gibbshill.com.au not later than 5:00 PM California time on 29 December, 2014.

 

Very truly yours,
NEXVET US, INC.
By:  

/s/ Christopher Nigel Brown

Name: Christopher Nigel Brown
Title:   Director

I HAVE READ AND ACCEPT THIS EMPLOYMENT OFFER AND THE TERMS OF THIS AGREEMENT:

 

/s/ Mark Heffernan

Mark Heffernan
Date signed: 22 December 2014
ACCEPTED AND AGREED TO:
NEXVET BIOPHARMA PLC
By:  

/s/ Joseph McCracken

Name: Joseph McCracken
Title:   Director
By:  

/s/ Christopher Nigel Brown

Name: Christopher Nigel Brown
Title:   Director
EX-10.15 20 d775834dex1015.htm EX-10.15 EX-10.15

Exhibit 10.15

 

LOGO

Employment agreement

Nexvet Australia Pty Ltd

ACN 141 909 131

and

David Gearing


Table of contents

 

1.    Definitions and interpretation      4   
1.1    Definitions      4   
1.2    Interpretation      7   
2.    Position      7   
3.    Status of agreement      7   
3.1    Replacement of Earlier Agreements      7   
3.2    Commencement date and term      8   
4.    Duties and Obligations      8   
4.1    Duties      8   
4.2    Obligations      8   
4.3    Other appointments      8   
4.4    Conflict of interest      9   
4.5    Company policies      9   
4.6    Common law duties      9   
5.    Employment locations      9   
6.    Hours of work      9   
7.    Remuneration      9   
7.1    Total Remuneration Package      9   
7.2    IPO Option Grant      10   
7.3    Annual Equity Award      11   
7.4    Offset      11   
7.5    Expenses      11   
7.6    Superannuation      12   
7.7    Annual review      12   
7.8    Bonus      12   
7.9    Legislative benefits      12   
7.10    Probation Period      12   
8.    Leave      12   
8.1    Annual leave      12   
8.2    Personal/Carer’s leave      13   
8.3    Parental leave      13   
8.4    Long service leave      13   
8.5    Public holidays      13   
9.    Termination of Employment      13   
9.1    Termination by the Company      13   
9.2    Notice period by the Employee      14   
9.3    Payment in lieu of notice      14   
9.4    Garden leave      14   
9.5    Summary dismissal      14   
9.6    Return of Company property      15   
9.7    Accrued entitlements on Termination      15   
9.8    Appointment of Company as attorney on termination of Employment      15   
10.    Confidential Information      15   
10.1    Acknowledgment of Employee      15   
10.2    Obligations of the Employee      15   
10.3    Unauthorised disclosure      16   
10.4    Confidentiality deed      16   


10.5    Survival      16   
11.    Intellectual Property      16   
12.    Moral Rights      17   
13.    Non-Competition      17   
13.1    Obligations of the Employee      17   
13.2    General      18   
13.3    Survival      19   
14.    Suspension      19   
15.    Changes to position, duties, remuneration, or location      19   
16.    Corporations Act      19   
17.    Dispute resolution      19   
17.1    Mediation      19   
17.2    Arbitration      19   
17.3    Location      20   
18.    Assignment      20   
18.1    Successors of Company      20   
18.2    Assignment for reconstruction or amalgamation      20   
18.3    References to Company to be references to assignee      20   
19.    General      20   
19.1    Entire understanding      20   
19.2    No adverse construction      20   
19.3    Further assurances      20   
19.4    No waiver      20   
19.5    Severability      21   
19.6    Consents and approvals      21   
19.7    No variation      21   
19.8    Governing law and jurisdiction      21   
19.9    Counterparts      21   
19.10    Conflicting provisions      21   
19.11    Non merger      21   
Schedule 1 – Employee particulars      23   
Schedule 2 – Employee duties      24   


Employment agreement

Date 22 December 2014

Parties

Nexvet Australia Pty Ltd ACN 141 909 131 of Level 8, 31 Queen Street, Melbourne, 3000 (Company).

and

David Gearing (Employee).

Operative provisions

 

1. Definitions and interpretation

 

1.1 Definitions

In this agreement:

Act means the Fair Work Act 2009 (Cth) as amended or replaced from time to time.

Annual Equity Award has the meaning set out in clause 7.3.

Annual Equity Award Benefit has the meaning set out in clause 9.1(c).

Award Value has the meaning set out in clause 7.3.

Base Salary means the amount specified in Item 4 of Schedule 1.

Business means the business conducted by the Company from time to time, including the discovery, development and commercialisation of biopharmaceutical products, such as companion animal (dog, cat and horse) monoclonal antibodies and therapeutic proteins, any products in any species derived from the patented PETisation™ platform technology, and any diagnostic products for use in animals.

Business Premises means the Company’s premises at which the Employee predominantly works during the Employment, as described in Item 3 of Schedule 1.

Change in Control means (a) a merger or consolidation or the sale, or exchange by the stockholders of the Parent Company of all or substantially all of the capital stock of the Parent Company, where the stockholders of the Parent Company immediately before such transaction do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the surviving or acquiring corporation or other surviving or acquiring entity, in substantially the same proportion as before such transaction; (b) any transaction or series of related transactions to which the Parent Company is a party in which in excess of fifty percent (50%) of its voting power is transferred, other than any such transfer in which the stockholders of the Parent Company immediately before such transfer obtain or retain, directly or indirectly, more than fifty percent (50%) of the beneficial interest in the voting power of the voting stock or other voting equity of the corporation or other entity to which the voting power of the Parent Company was transferred, or (c) the sale or exchange of all or substantially all of the Parent Company’s assets, other than a sale or transfer to a subsidiary of the Parent Company in which the stockholders of the Parent Company immediately before such sale or exchange do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the corporation or other entity acquiring the Parent Company’s assets, in substantially the same proportion as before such transaction.

 

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Commencement Date means the date specified in Item 1 of Schedule 1.

Compensation Committee means the compensation committee established by the Parent Board.

Confidential Information means:

 

  (a) all Information regarding the current Business or future business interests, methodology or affairs of the Company or any Related Entity of the Company;

 

  (b) all other Information belonging or relating to the Company or any Related Entity of the Company;

 

  (c) all Information which the Employee knows, or ought reasonably to be expected to know, is confidential to the Company or any Related Entity of the Company;

but excludes:

 

  (d) any Information which is lawfully already in the public domain, or becomes part of the public domain other than due to the fault of the Employee or any person for whom the Employee is responsible; and

 

  (e) any Information which is required to be disclosed by Law.

Corporations Act means the Corporations Act 2001 (Cth).

Duties means the duties as set out in Schedule 2.

Earlier Agreements means the first employment agreement entered into between the Employee and the Company on or about the 1st September 2010, and the second employment agreement entered into between the Employee and the Company on or about 1 November 2013.

EIP Plan means the 2014 Employee Incentive Plan of the Parent Company which will come into force upon the IPO, or any successor to that plan.

Employment means the employment by the Company of the Employee pursuant to this agreement and the Earlier Agreements.

Filing Date has the meaning set out in clause 3.1.

Indemnity means the separate indemnity agreement that the Parent Company and the Employee will enter into pursuant to clause 3.3.

Industrial Award means any modern award applicable at any time to the Employee’s employment with the Company.

Information means any information, whether oral, graphic, electronic, written or in any other form, including:

 

  (a) forms, memoranda, letters, specifications, processes, procedures, statements, formulae, technology, inventions, trade secrets, research and development information, know how, designs, plans, photographs, microfiche, business records, notes, accounting procedures or financial information, sales and marketing information, names and details of customers, suppliers and agents, employee details, reports, drawings and data; and

 

  (b) copies and extracts made of or from that information and data, whether translated from the original form, recompiled, partially copied, modified, updated or otherwise altered.

Intellectual Property Rights means all present and future intellectual and industrial property rights conferred by statute, at common law or in equity, including (without limitation):

 

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  (a) patents, designs, copyright, rights in circuit layouts, plant breeder’s rights, trade marks, know how, brand names, domain names, inventions, product names, trade secrets, the right to have confidential information kept confidential and other results of intellectual effort in the scientific, technological, bio-technological, industrial, literary or artistic and commercial fields, whether or not registered or capable of registration;

 

  (b) any application or right to apply for registration of any of those rights;

 

  (c) any registration of any of those rights or any registration of any application referred to in paragraph (b); and

 

  (d) all renewals and extensions of these rights.

IPO has the meaning set out in clause 7.2(a).

IPO Option has the meaning set out in clause 7.2(a).

Law means any:

 

  (a) principles of law or equity established by decisions of courts;

 

  (b) statutes, regulations or by-laws of the Commonwealth, a State, a Territory or a Government Agency; and

 

  (c) requirements and approvals (including conditions) of the Commonwealth, a State, a Territory or a Government Agency that have the force of law;

Parent Board means the Board of Directors of Nexvet Biopharma plc.

Parent Company means Nexvet Biopharma plc, a corporation incorporated in the Republic of Ireland.

Probation Period means the period specified in Item 7 of Schedule 1

Related Body Corporate has the meaning given to that term in the Corporations Act.

Related Entity has the meaning given to that term in the Corporations Act.

Restraint Area is each of the following areas separately:

 

  (a) within the State of Victoria;

 

  (b) within Australia;

 

  (c) within Australia and the United States of America;

 

  (d) within Australia, the United States of America, Europe, Japan and China; and

 

  (e) the world.

Restrained Duties means duties the same or similar to those performed by the Employee in the course of the Employment.

Restraint Period is the period referred to in clause 13.1 and is each of the following periods separately:

 

  (a) the Term;

 

  (b) the Term plus 6 months; and

 

  (c) the Term plus 12 months

Start Date means the date of the closing of the IPO (as defined by clause 7.2) of the Parent Company.

Term means the term of this agreement, starting on the Start Date and ending on the Termination Date.

Termination Date or Termination means the date of termination or expiry of this agreement for any reason.

 

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Total Remuneration Package means the remuneration package specified in clause 7.1.

 

1.2 Interpretation

In this agreement, unless the context requires otherwise:

 

  (a) the singular includes the plural and vice versa;

 

  (b) a gender includes the other genders;

 

  (c) the headings are used for convenience only and do not affect the interpretation of this agreement;

 

  (d) other grammatical forms of defined words or expressions have corresponding meanings;

 

  (e) a reference to a document includes the document as modified from time to time and any document replacing it;

 

  (f) the word “person” includes a natural person and any body or entity whether incorporated or not;

 

  (g) the word “month” means calendar month and the word “year” means 12 months;

 

  (h) the words “in writing” include any communication sent by letter, facsimile transmission or email or any other form of communication capable of being read by the recipient;

 

  (i) a reference to a thing includes a part of that thing;

 

  (j) a reference to all or any part of a statute, rule, regulation or ordinance (statute) includes that statute as amended, consolidated, re-enacted or replaced from time to time;

 

  (k) wherever “include” or any form of that word is used, it must be construed as if it were followed by “(without being limited to)”;

 

  (l) money amounts are stated in Australian currency unless otherwise specified; and

 

  (m) a reference to any agency or body, if that agency or body ceases to exist or is reconstituted, renamed or replaced or has its powers or functions removed (defunct body), means the agency or body which performs most closely the functions of the defunct body.

 

2. Position

 

  (a) The Employee is employed by the Company in the position as described in Item 2 of Schedule 1 in accordance with the terms of this agreement.

 

  (b) The Employee reports to the person named in Item 2 of Schedule 1 or any other position as directed by the Company or the Parent Company from time to time.

 

3. Status of agreement

 

3.1 Replacement of Earlier Agreements

The Employee has been employed by the Company since the Commencement Date pursuant to the Earlier Agreements. The parties have agreed that the Earlier Agreements will be replaced by this agreement, with effect on and from the Start Date. The terms of the Employment are accordingly governed by the terms of this agreement as from the Start Date. Prior to the Start Date, the Employee will continue to be employed by the Company upon the existing terms and conditions of his employment, provided however, that clause 7.2 of this agreement will be effective from the date on which the Parent Company files with the U.S. Securities and Exchange Commission a registration statement on Form S-1 with respect to the IPO (Filing Date).

 

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3.2 Commencement date and term

The parties agree that the Employment commenced on the Commencement Date and will continue unless and until terminated in accordance with clause 9.

 

3.3 Indemnity

The Parent Company and the Employee will enter into a separate agreement pursuant to which the Parent Company will indemnify the Employee to the same extent that the Parent Company indemnifies its board members and other most senior executive officers of the Parent Company, the Company or Nexvet US Inc (as applicable).

 

4. Duties and Obligations

 

4.1 Duties

During the Employment, the Employee is to perform the Duties as well as any additional duties required by the Company or the Parent Company from time to time. The duties may be altered by the Company from time to time to reflect changed business conditions.

 

4.2 Obligations

At all times during the Employment, the Employee must:

 

  (a) show the utmost good faith and devote the whole of the Employee’s working time and attention to the business of the Company and, if the Company so directs, to the business of any Related Body Corporate of the Company;

 

  (b) use the Employee’s best endeavours at all times to promote the interests and welfare of the Company and any Related Entity of the Company;

 

  (c) honestly, faithfully and diligently obey and perform all lawful orders and instructions of the Company or the person to whom the Employee reports;

 

  (d) honestly, faithfully and diligently perform the duties and exercise the powers which from time to time may be assigned to the Employee by the Company or by the person to whom the Employee reports;

 

  (e) act in the best interests of the Company and any Related Entity of the Company at all times;

 

  (f) use the Employee’s best endeavours to promote the development, profitability, interests and welfare of the Company and any Related Entity of the Company;

 

  (g) not misuse the Company’s property or services, or allow such misuse by other persons;

 

  (h) as soon as practicable upon becoming aware thereof inform the Company of any act of dishonesty pertaining to the business, property or transactions of the Company on the part of any person which may have come to the Employee’s knowledge; and

 

  (i) keep the terms of the Employee’s remuneration confidential.

 

4.3 Other appointments

 

  (a) During the Employment, the Employee may not take up any other employment or engagement (paid or unpaid) without the prior written consent of the Chief Executive Officer of the Company, such consent not to be unreasonably withheld or delayed.

 

  (b) Without limiting clause 4.3(a), the Employee will not, during the Employment, without the prior written consent of the Company, undertake any appointment, position or work that:

 

  (i) results in the Employee competing with the Company;

 

  (ii) otherwise adversely affects the Company; or

 

  (iii) hinders the Employee’s performance of duties owed to the Company.

 

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4.4 Conflict of interest

 

  (a) The Employee will ensure that there is no conflict between the Company’s interests and the Employee’s personal interests.

 

  (b) The Employee will make full and complete disclosure to the Company of the existence, nature and extent of any conflict or potential conflict of interest that the Employee may have in any manner or capacity whatever with the Employee’s duties or obligations under this agreement.

 

  (c) The Employee must not solicit or accept from any person any remuneration or benefit in excess of the Employee’s official remuneration with the Company for the discharge of the Employee’s duties.

 

  (d) The Employee must immediately report to the Company any remuneration or benefit the Employee receives from another person in connection with the Employment and the Employee must not deal with or otherwise dispose of any such remuneration or benefit without the prior written consent of the Company.

 

  (e) The Employee must avoid any circumstance where a person or persons can improperly influence or receive unduly favourable treatment from the Company.

 

4.5 Company policies

 

  (a) The Employee must comply with all policies and procedures of the Company and the Parent Company.

 

  (b) Notwithstanding clause 4.5(a), the policies and procedures of the Company or the Parent Company:

 

  (i) are for the benefit of the Company and the Parent Company and do not impose any contractual obligations on the Company or the Parent Company; and

 

  (ii) are not incorporated into and do not form part of this agreement.

 

4.6 Common law duties

Nothing in this agreement is intended to limit the Employee’s duties of good faith and fidelity to the Company and Parent Company or any other duties implied at common law.

 

5. Employment locations

The Employee’s primary place of work will be as specified in Item 3 of Schedule 1. However, the Employee may be required to work at other locations as reasonably directed by the Company.

 

6. Hours of work

The Employee is required to work 38 hours per week plus all such reasonable additional hours as required to properly perform their Duties in accordance with this agreement or as directed by the Company.

 

7. Remuneration

 

7.1 Total Remuneration Package

 

  (a) In consideration of the duties provided and to be provided by the Employee, subject to clause 9.7, the Employee will be entitled to the Total Remuneration Package accruing and payable with respect to the period beginning on the Start Date comprising of the Base Salary together with superannuation as provided in clause 7.6. The Employee is also entitled to the Additional Benefits, as described in Item 5 of Schedule 1.

 

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  (b) The Employee will not be entitled to any additional remuneration for any additional hours worked as the Employee’s Total Remuneration Package has been set to compensate the Employee for these additional hours.

 

7.2 IPO Option

 

  (a) Grant of Option

As soon as practicable after the pricing of an initial public offering of the Parent Company’s capital stock (IPO) pursuant to a definitive written agreement between the Parent Company and the underwriter(s) engaged by the Parent Company for such IPO, and subject to the Employee’s continued employment with the Company through such date, the Parent Board will grant to the Employee a nonstatutory stock option (IPO Option) pursuant to the EIP Plan to purchase 100,000 ordinary shares of the Parent Company’s capital stock. Unless otherwise required by applicable law, the exercise price per share subject to the IPO Option (IPO Option Exercise Price) will be the greater of US$15.00 (as adjusted pro rata to reflect any change in the Parent Company’s capital structure) and the public offering price in the IPO. The IPO Option will vest and become exercisable (i) with respect to 20% thereof upon the closing of the IPO and (ii) with respect to the remaining 80% thereof in 16 substantially equal instalments on the last day of each of each of the 16 consecutive calendar quarters commencing after the closing of the IPO; provided, however that the IPO Option will become 100% vested and exercisable in full as of a date specified by the Parent Board prior to the consummation of a Change in Control, provided that the Employee’s service with the Company has not terminated prior to such date. The IPO option will be subject to the terms and conditions of the appropriate form of option agreement approved by the Parent Board for use under the EIP Plan, which the Employee will be required to execute.

 

  (b) Change in Control Prior to IPO

If a Change in Control is consummated on or after the Filing Date but prior to the Start Date, and if the Parent Company has not granted the IPO Option to the Employee prior to the consummation of such Change in Control, then, provided that the Employee’s employment with the Company has not terminated prior to the consummation of the Change in Control, the Parent Company shall pay to the Employee an amount in cash equal to one-third of 1% of the amount that otherwise would be payable to the holders of the capital stock of the Parent Company pursuant to the Change in Control transaction, net of the repayment of the liabilities of the Parent Company not assumed by the acquirer in such transaction and the expenses incurred by the Parent Company in connection with such transaction, but without reduction for the amounts payable to the Employee pursuant to this clause 7.2(b) and to Nexvet US Inc.’s Chief Financial Officer and Chief Executive Officer under similar arrangements. The amount payable to the Employee pursuant to this clause 7.2(b), if any, will be paid to the Employee at the same time(s) and subject to the same terms and conditions that apply to the payment of transaction consideration to the holders of the capital stock of the Parent Company.

 

  (c) Change in Control After IPO.

If a Change in Control is consummated on or after the Start Date, and if the Parent Company has not granted the IPO Option to the Employee prior to the consummation of such Change in Control, then, provided that the Employee’s employment with the Company has not terminated prior to the consummation of the Change in Control, the Company shall pay to the Employee an amount in cash in a single lump sum within 60 days following the consummation of the Change in Control calculated as (i) minus (ii), where (i) and (ii) are defined as:

 

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  (i) 100,000 multiplied by the closing market price of one (1) ordinary share of Parent Company capital stock determined on the date immediately prior to the Change in Control; and

 

  (ii) 100,000 multiplied by the IPO Option Exercise Price (as adjusted pro rata to reflect any change in the Parent Company’s capital structure).

 

7.3 Annual Equity Award

Subject to the approval of the Parent Board, and provided that the Employee’s employment with the Company has not previously terminated, the Employee will be eligible to be granted an award under the EIP Plan as soon as practicable but no later than 31 August in each fiscal year of the Parent Company commencing after the IPO (Annual Equity Award). Each Annual Equity Award may be any type of award authorised under the EIP Plan and will have an Award Value (as defined below) of up to $US300,000 with the Award Value of any Annual Equity Award determined by the Parent Board in its discretion. For the purposes of this Section, “Award Value” means a value ascribed to an Annual Equity Award by the Parent Board, in its discretion, as of the date of grant of the Annual Equity Award. Each Annual Equity Award may vest on the basis of such service and/or performance or other conditions as may be established by the Parent Board; provided, however that each Annual Equity Award will become 100% vested and exercisable in full (if applicable) as of a date specified by the Parent Board prior to the consummation of a Change in Control, provided that the Employee’s service with the Company has not terminated prior to such date. Each Annual Equity Award will be subject to the terms and conditions of the appropriate form of award agreement approved by the Parent Board for use under the EIP Plan, which the Employee will be required to execute.

 

7.4 Offset

 

  (a) To the extent that the Employee’s Total Remuneration Package exceeds the Employee’s entitlements under the Industrial Award or pursuant to the Act at any time, the Employee’s Total Remuneration Package is inclusive of and paid in full satisfaction of all payments and benefits that the Company is legally obliged to provide to the Employee, including any overtime payments or other payments for hours worked in excess of ordinary hours, and including all entitlements the Employee has to payments (including wages, overtime and allowances) under the Industrial Award or pursuant to the Act.

 

  (b) To the extent that the Employee’s Total Remuneration Package exceeds the Employee’s entitlements under the Industrial Award or pursuant to the Act, the Company may (to the fullest extent permitted by law) offset against this amount any future increases in the rates and allowances contained in the Industrial Award or pursuant to the Act.

 

  (c) Notwithstanding this clause or anything else in this agreement, the Industrial Award is not incorporated into and does not form part of this agreement.

 

  (d) Subject to any applicable laws, the Employee hereby authorises the Company to make deductions from any payments owing to the Employee to recover any debt owed by the Employee to the Company (to the fullest extent permitted by law), including as a result of previous over-payment to the Employee.

 

7.5 Expenses

Except as expressly provided for in this agreement, the Employee will be reimbursed for all expenses which are in the Company’s opinion reasonably incurred by the Employee in the course of the Employment, subject to provision of receipts or other documentary evidence to the Company’s satisfaction.

 

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7.6 Superannuation

The Company will in addition to the Base Salary make contributions on the Employee’s behalf to a complying superannuation fund which meets the Company’s statutory obligations under applicable superannuation legislation, currently 9.5%. The contributions will be capped at 9.5% of the maximum superannuation contribution base.

 

7.7 Annual review

The Employee will be eligible for his first salary review and a comprehensive review of the key elements of the Total Remuneration Package after the Parent Company achieves a market capitalisation, as determined by reference to publicly available Parent Company stock trading data, that exceeds US$500,000,000.00 or as the Parent Board determines in good faith from time to time, but in any event no later than the second anniversary of the Start Date. Adjustments to the Base Salary or other compensation, if any, will be made by the Parent Board in its sole and absolute discretion.

 

7.8 Bonus

The Employee’s incentive (bonus) compensation, if awarded by the Parent Board, will be determined based on achievement by the Employee, and the Company, as relevant, of objectives established by the Parent Board. Initial objectives will be established by the Parent Board and provided in writing to the Employee within thirty (30) days after the Start Date. Such incentive (bonus) compensation will range on a sliding scale from 0% to 40% of the Base Salary for the given fiscal year for which such bonus is granted, based upon the achievement by the Employee, and/or the Company, as relevant to the bonus achievement criteria set by the Parent Board, for achieving as relevant, 0% to 100% of the Employee’s personal objectives, and as relevant to the given fiscal year, the Company’s corporate objectives for the given fiscal year, as determined in good faith by the Parent Board. Notwithstanding the above, the Employee’s bonus for fiscal year 2015 shall be based upon the Employee’s Base Salary for fiscal year 2015. The annual incentive bonus compensation will be earned by the Employee if the Employee remains employed on the last day of a given year. Any bonus awarded by the Parent Board will be paid to the Employee in cash no later than ninety (90) days after the end of the fiscal year for which such bonus is earned and will be subject to relevant applicable taxation and statutory deductions. Should the Employment be terminated under clause 9.1 (and not by reason of clause 9.5), the Employee will be eligible for a pro-rata bonus, calculated in line with other executives in the Parent Company and in line with reasonable business practice.

 

7.9 Legislative benefits

The Employee acknowledges that the Total Remuneration Package is (to the extent not prohibited by law) deemed inclusive of an allowance in favour of the Employee for all additional employee benefits and allowances (not otherwise specified in this agreement) required by applicable legislation to be provided by an employer if favour of, or for the benefit of, an employee employed to provide the Duties.

 

7.10 Probation Period

The parties agree that this agreement will be subject to the Probation Period, during which time this agreement may be terminated by the Company with at least one month’s notice or payment in lieu of notice. During the Probation Period, the Employee’s performance will be reviewed and discussed with the Employee. At the expiry of the Probation Period, unless notified otherwise in writing, the Employee will be deemed to be employed by the Company on a permanent basis, on the terms of this agreement.

 

8. Leave

 

8.1 Annual leave

 

  (a) The Employee will be entitled to 4 weeks annual leave for every 12 months service on a pro-rata and cumulative basis in accordance with the Act.

 

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  (b) The Employee will be entitled to one (1) additional week of annual leave in any 12 month service period (calculated on the anniversary date), provided that the employee has already taken or will be taking the 4 weeks of annual leave referred to in paragraph (a) in that 12 month period. If the Employee does not choose to take the additional week’s leave, the additional week will not accrue.

 

  (c) Annual leave is to be taken at a time agreed with the Company or failing agreement as directed by the Company in accordance with the Act.

 

8.2 Personal/Carer’s leave

 

  (a) The Employee will be entitled to 10 days personal/carer’s leave per annum, which includes sick leave, on a pro-rata and cumulative basis, in accordance with the Act.

 

  (b) To claim any period of personal/carer’s leave, the Company may require the Employee to provide a medical certificate from a registered health practitioner or, if that is not reasonably practicable, a statutory declaration from the Employee, in an appropriate form.

 

  (c) Personal/carer’s leave will not be paid out on termination of the Employment.

 

8.3 Parental leave

The Employee will be entitled to unpaid parental leave in accordance with the Act.

 

8.4 Long service leave

The Employee will be entitled to long service leave in accordance with applicable State legislation.

 

8.5 Public holidays

The Employee will be entitled to paid leave on days declared public holidays in accordance with the Act.

 

9. Termination of Employment

 

9.1 Termination by the Company

 

  (a) Subject to clauses 9.3 and 9.5, the Company may terminate the Employment at any time by giving the Employee six (6) months written notice.

 

  (b) The notice in (a) above will be increased to 12 months if the Company terminates the Employment immediately prior to, upon, or within 12 months following a Change in Control.

 

  (c) If the Employment is terminated by the Company under this clause 9.1 (and not by reason of clause 9.5) and such termination occurs after the first day of a given fiscal year of the Parent Company, and if the Parent Company has not yet granted the Employee’s Annual Equity Award in the fiscal year that the Employee’s termination occurs, the Company shall, acting in good faith, pay the Employee an amount of cash (Annual Equity Award Benefit) equal to the product determined by multiplying (A) the greater of (x) the Award Value of the Annual Equity Award that the Employee otherwise would have received for the fiscal year of the Employee’s termination of employment and (y) the Award Value of the Annual Equity Award granted to the Employee during the immediately preceding fiscal year, by (B) a ratio, the numerator of which equals the number of days elapsed from the beginning of the immediately preceding fiscal year to the date of the Employee’s termination of employment, and the denominator of which equals the total number of days contained in the current fiscal year.

 

  (d)

If the Employment is terminated by the Company under this clause 9.1 (and not by reason of clause 9.5) then any portions of the IPO Option and Annual Equity Awards granted to the Employee prior to the termination of Employment that remain

 

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  unvested as of the Termination Date will become 100% vested and exercisable in full for the remainder of the option term as if the Employee’s Employment had not terminated (if applicable) as of the Termination Date.

 

9.2 Notice period by the Employee

 

  (a) The Employment may be terminated by the Employee by giving the Company three (3) months written notice.

 

  (b) If the Employee does not give the Company the period of notice referred to in this clause in writing or the Employee leaves the Employment during the period of notice, the Employee agrees that the Company is entitled to withhold (to the fullest extent permitted by law) from any monies owing to the Employee an amount representing that portion of the Total Remuneration Package the Employee would have earned for the number of weeks or days of the notice period that the Employee did not work.

 

  (c) If the Employment is terminated by the Employee then any portions of the IPO Option and Annual Equity Awards granted to the Employee prior to the termination of Employment that remain unvested as of the Termination Date shall not vest and shall not be exercisable.

 

9.3 Payment in lieu of notice

If notice is given by the Company (under clause 9.1) or the Employee (under clause 9.2) the Company may, in lieu of notice, make payment to the Employee in a sum equal to the Total Remuneration Package the Employee would have earned if the Employee had been given or had given the relevant period of notice.

 

9.4 Garden leave

 

  (a) Following the giving of notice by the Company or the Employee, the Company may for part or all of the notice period at its sole discretion direct the Employee to:

 

  (i) perform alternative duties; or

 

  (ii) perform no duties and not attend for work.

 

  (b) Clause 9.4(a) does not affect the Company’s right to at any time make payment in lieu of part or all of the notice period in accordance with clause 9.3.

 

9.5 Summary dismissal

 

  (a) The Company may terminate the Employment summarily without notice or any payment in lieu of notice to the Employee if the Employee:

 

  (i) commits serious misconduct;

 

  (ii) commits a serious or persistent breach of any material term or condition of this agreement;

 

  (iii) refuses or fails to comply with a lawful and reasonable directive of the Company that is not rectified by the Employee within 30 days of receipt of written notice from the Company;

 

  (iv) engages in any fraudulent or dishonest conduct;

 

  (v) is intoxicated at work to the extent that the Employee cannot perform the Employee’s duties;

 

  (vi) is convicted of, or pleads guilty to, any serious or indictable criminal offence;

 

  (vii) engages in any conduct which brings or may bring the Company into disrepute;

 

  (viii) is prohibited by Law from taking part in the management of the Company;

 

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  (ix) becomes of unsound mind (as determined by 2 independent medical practitioners selected by the Board) or a person whose person or estate is liable to be dealt with in any way under any Law relating to mental health and in either instance is incapable of undertaking their Duties to the full extent required under this agreement (as determined by the Board, excluding the Employee should the Employee be a director of the Company), or

 

  (x) is made bankrupt or enters into any composition or arrangement with or for the benefit of their creditors generally.

 

  (b) If the Employment is terminated by the Company under this clause 9.5, then any portions of the IPO Option and Annual Equity Awards granted to the Employee prior to the termination of Employment that remain unvested as of the Termination Date shall not vest and shall not be exercisable.

 

9.6 Return of Company property

On termination of the Employment, the Employee must as soon as practicable return to the Company all property, materials and items belonging to the Company or any Related Entity of the Company in the Employee’s possession custody or control.

 

9.7 Accrued entitlements on Termination

Any payment by the Company in respect of accrued but unpaid or untaken annual leave or long service leave on termination of the Employment, will be calculated on the basis of the Base Salary.

 

9.8 Appointment of Company as attorney on termination of Employment

The Employee irrevocably appoints the Company as his attorney in his name and on his behalf to sign any documents and do all things necessary or desirable to give effect to the termination of Employment and to any other matter arising from the termination of the Employment.

 

10. Confidential Information

 

10.1 Acknowledgment of Employee

The Employee acknowledges that through the course of the Employment or otherwise, the Employee may obtain access to, or become aware of, Confidential Information which is of commercial value to the Company and which is owned by and will at all times remain the property of the Company or a Related Entity of the Company.

 

10.2 Obligations of the Employee

 

  The Employee must:

 

  (a) only use the Confidential Information for the purposes of performing, and to the extent necessary to perform, the Employee’s duties in the course of employment with the Company;

 

  (b) not memorise, modify, reverse engineer or make copies, notes or records of the Confidential Information for any purpose other than in connection with the performance of the Employee’s duties;

 

  (c) keep in the strictest confidence all Confidential Information and not disclose to any person any Confidential Information without the consent of the Company;

 

  (d) not use, or modify any Confidential Information for the Employee’s own use or benefit or the use or benefit of any third party; and

 

  (e) promptly, at the request of the Company at any time, disclose and deliver up to the Company, all Confidential Information including copies in the Employee’s possession, custody or control.

 

Employment agreement for David Gearing   15


10.3 Unauthorised disclosure

The Employee must take all reasonable precautions to prevent any unauthorised disclosure of Confidential Information, including the following precautions:

 

  (a) the Employee must at all times store all Confidential Information safely and securely;

 

  (b) except with the prior written authority of the Company, the Employee must not remove any Confidential Information from the premises at which it is stored except where it is necessary to do so for the sole purpose of performing their Duties under this agreement;

 

  (c) the Employee must immediately notify the Company in writing of any actual, threatened or suspected unauthorised disclosure of any Confidential Information; and

 

  (d) the Employee must take all reasonable measures to minimise any unauthorised dissemination of any Confidential Information which is in any way related to or resulting from an act or failure to act by the Employee.

 

10.4 Confidentiality deed

The Employee will be requested to enter into a formal deed in the form attached at Annexure A in relation to the Company’s Confidential Information at or about the same time as entering into this agreement.

 

10.5 Survival

The Employee’s obligations under this clause 10 survive the termination of the Employment for any reason.

 

11. Intellectual Property

 

  (a) The Employee hereby assigns to the Company absolutely and beneficially the whole of the Employee’s right, title and interest in the world, whether presently existing or which arises at a date after the date of this agreement in and to all Intellectual Property Rights acquired, developed or created by the Employee:

 

  (i) in the course of their employment with the Company (including pursuant to the Earlier Agreements);

 

  (ii) prior to the date of this agreement or the Earlier Agreements, where the Employee was providing services for the Company or Business (which includes in anticipation of the incorporation of the Company), the shareholders of the Company or for the benefit of any of the Company, its shareholders or the Business;

 

  (iii) which in any way affect, relate to or are connected with the Business; or

 

  (iv) with the use of any of the Company’s or Related Entity’s resources, including the Company’s Related Entity’s computer/s or other information technology equipment, the Company’s Related Entity’s laboratory or other research and development facilities or at the Company’s Related Entity’s premises,

 

  (collectively, the Assigned Intellectual Property Rights).

 

  (b) The Employee hereby agrees and undertakes to promptly disclose to the Company any Assigned Intellectual Property Rights upon acquisition, creation or development.

 

  (c) The Employee acknowledges and agrees that the Company will own all right, title and interest in and to all of the Assigned Intellectual Property Rights immediately upon creation, acquisition or development of the Assigned Intellectual Property Rights.

 

  (d)

The Employee irrevocably agrees to promptly execute all documents, forms and authorisations and do all acts and things that the Company considers to be

 

Employment agreement for David Gearing   16


  necessary or desirable to give effect to this agreement and to absolutely vest in the Company full right, title and interest in and to all of the Assigned Intellectual Property Rights.

 

  (e) At the Company’s request and expense, the Employee undertakes to assist the Company, whether during the course of or subsequent to the termination of the Employment, in connection with any controversy or legal proceeding relating to such Intellectual Property rights and in obtaining domestic or foreign patent or other protection covering the same.

 

  (f) The Employee hereby irrevocably appoints the Company and each of its directors severally as and to be the attorney of the Employee to do anything and execute any document which the Employee is required to do or execute pursuant to or in connection with the assignment of Intellectual Property Rights under this agreement and which the Employee has failed to do or execute. This power of attorney is granted to secure the performance of the Employee’s obligations to the Company in relation to the assignment of Intellectual Property Rights under this agreement.

 

12. Moral Rights

 

  (a) To the extent that the Employee has any moral rights in any work (whether or not currently in existence) created, made, delivered, produced, contributed to or otherwise provided by the Employee to the Company in the course of the Employment (collectively Works), the Employee hereby irrevocably and unconditionally consents, to the fullest extent permitted by law (whether present or future), pursuant to the Copyright Act 1968 (Cth), to the Company, its successors, assignees and licensees, and their licensees, and other persons authorised by any of them:

 

  (i) reproducing, adapting, publishing, performing, exhibiting, communicating or transmitting the Works or any adaptation thereof (or any part of any of the Works or of any such adaptation) anywhere in the world, in whatever form and in whatever circumstances the Company thinks fit including the making of any distortions, additions or alterations to the Works or any adaptation thereof (or any part of the Works or of such adaptation) as so reproduced, adapted, published, performed, exhibited, communicated or transmitted;

 

  (ii) reproducing, adapting, publishing, performing, exhibiting, communicating or transmitting the Works or any adaptation thereof (or any part of any of the Works or of any such adaptation) anywhere in the world without making identification of the Company or the Employee or any other person in relation thereto;

 

  (iii) doing any act or omission that would constitute derogatory treatment of the Works; and

 

  (iv) combining or juxtaposing the Works with anything else,

for any purpose whatsoever, whether such acts or omissions occur before or after the date on which that consent is given.

 

  (b) The Employee warrants that the consent obtained pursuant to this clause will be a genuine consent and complies with the provisions of the Copyright Act 1968 (Cth) and that the Employee has not relied on any statement or representation made by the Company or anyone acting on behalf of the Company.

 

13. Non-Competition

 

13.1 Obligations of the Employee

The Employee must not, in any capacity including on their own account or as a member, shareholder, unit holder, director, partner, joint venturer, employee, trustee, beneficiary, principal, agent, adviser, contractor, consultant, manager, associate, representative or financier or in any other way or by any other means:

 

Employment agreement for David Gearing   17


  (a) during the Restraint Period and in the Restraint Area, perform the Restrained Duties for a business, activity or operation which is the same as, substantially similar to, or competitive with the Business carried on by the Company or any material part of that Business;

 

  (b) during the Restraint Period, solicit, canvas, approach or accept an approach from any person who was at any time during the period commencing 6 months prior to the Termination, a customer or supplier of the Business or the Company, with any purpose of, or having the effect of, obtaining the custom or services of that person in a Restrained Business;

 

  (c) during the Restraint Period, represent itself as being in any way connected with, interested in or associated with the Business or the Company (except as its proprietor before Completion and after Completion as an Employee (where applicable);

 

  (d) during the Restraint Period, solicit, canvas, encourage, or induce, or endeavour to do so, any person who is at Completion, or who was at any time during the period commencing 6 months prior to the Termination, a director, employee, agent, associate, contractor or advisor of the Company, to leave the office, employment or agency of, or association with, the Company;

 

  (e) during the Restraint Period, interfere with the business of the Company or divulge to any person any information concerning the business of the Company or any of its dealings, transactions or affairs; or

 

  (f) during the Restraint Period, interfere to the detriment of the Company with the relationship between the Company and its clients, customers, employees or suppliers.

 

13.2 General

 

  (a) Nothing in this clause 13 prevents the Employee from holding in aggregate less than 5% of the issued shares of a body corporate, or interests in a registered managed investment scheme, included on the official list of a financial market (as defined in the Corporations Act).

 

  (b) Each covenant in this clause, each paragraph of the Restraint Area definition and each paragraph of the Restraint Period definition is a separate and independent covenant by the Employee. They can be combined and each combination is a separate covenant and restriction, although they are cumulative in effect.

 

  (c) For the avoidance of any doubt, if any of the separate and independent covenants or restrictions set out in this clause is or becomes invalid or unenforceable for any reason:

 

  (i) where the offending provision can be read down so as to give it a valid and enforceable operation of a partial nature, it must be read down to the minimum extent necessary to achieve that result;

 

  (ii) in any other case the offending provision must be severed from these terms, in which event the remaining provisions of these terms operate as if the severed provision had not been included; and

 

  (iii) without limiting the above, if the covenant or restriction in question would be valid or enforceable if any activity was deleted or the area or time was reduced, then that provision must be read down by deleting that activity, or reducing that period or area, to the minimum extent necessary to achieve that result.

 

  (d) The Employee acknowledges that each of the restrictions imposed by this clause:

 

Employment agreement for David Gearing   18


  (i) is reasonable in its extent (as to duration, geographical area and restrained conduct) having regard to the interests of each party to this agreement;

 

  (ii) extends no further, in any respect, than is reasonably necessary for the maintenance and protection of the business of the Company and its goodwill; and

 

  (iii) does not unreasonably restrict the Employee’s right to carry on the Employee’s profession or trade.

 

13.3 Survival

The Employee’s obligations under this clause 13 survive the termination of this agreement for any reason.

 

14. Suspension

Where the Company considers it necessary, it may direct the Employee not to attend work but on full pay, whilst it conducts an investigation into any concerns relating to the Employee’s conduct or performance as an employee or for any other reason.

 

15. Changes to position, duties, remuneration, or location

 

  (a) The Employee’s employment with the Company will continue to be subject to the terms of this agreement, unless varied or replaced by an agreement agreed to by both parties in writing, despite any change to the Employee’s position, duties, remuneration or location.

 

  (b) This agreement may only be varied by a document in writing signed by or on behalf of each party.

 

16. Corporations Act

Notwithstanding any provision of this agreement, the Company is not required to pay or provide, or procure the payment or provision of, any monies or benefits to the Employee which do not comply with the provisions of the Corporations Act without the need for the Company to obtain shareholder approval. Any such payments or benefits to be provided to the Employee must be reduced to ensure compliance with this clause and the Corporations Act. In the event that the Company pays or provides any monies or benefits to the Employee in excess of the amount permitted to be paid or provided to the Employee under the Corporations Act without shareholder approval, the Employee must, on receiving written notice from the Company, immediately repay those monies or benefits to the Company.

 

17. Dispute resolution

 

17.1 Mediation

Except in the case of a dispute where one party seeks urgent interlocutory or injunctive relief, any dispute, controversy or claim arising out of or in relation to this agreement or its breach, termination or invalidity (Dispute) will first be the subject of a mediation administered by the Institute of Arbitrators and Mediators Australia (IAMA).

 

17.2 Arbitration

If the Dispute is not resolved within 28 days (or any other period agreed to in writing between the parties) after the appointment of the mediator, the Dispute will be submitted to arbitration, administered by the IAMA. The arbitrator must be agreed between the parties from a panel suggested by the IAMA or, failing agreement, an arbitrator must be appointed by the President of the IAMA or his / her nominee. The arbitrator must not be the same person as the mediator. Subject to the above, the arbitration will be conducted and held in accordance with the laws of Victoria.

 

Employment agreement for David Gearing   19


17.3 Location

Any mediation or arbitration meetings and proceedings must be held in Melbourne, Australia.

 

18. Assignment

 

18.1 Successors of Company

The rights and obligations of the Company under this agreement enure to the benefit of and are binding upon the successors of the Company.

 

18.2 Assignment for reconstruction or amalgamation

With the prior written agreement of the Employee (such agreement not to be unreasonably withheld or delayed), the Company may assign its rights and obligations under this agreement for all or any part of the term of the Employment, to any other company (including a Related Body Corporate) as part of a reconstruction or amalgamation of the Company, provided that the Employee agrees that the other company could reasonably be expected to undertake the financial obligations of the Company under this agreement that remain outstanding as at the date of the assignment.

 

18.3 References to Company to be references to assignee

Following an assignment under clause 18.2, references to this agreement to the Company will be to the Company’s assignee.

 

19. General

 

19.1 Entire understanding

 

  (a) Other than the terms of the awarding of options to you pursuant to the Company’s superseded long term incentive plan and the terms of the EIP Plan, this agreement supersedes all prior communications and agreements between the parties as to the terms and conditions of the Employee’s employment, including the Earlier Agreements, any prior written or verbal undertakings or statements.

 

  (b) Each party acknowledges that, except as expressly stated in this agreement, that party has not relied on any representation, warranty or undertaking of any kind made by or on behalf of another party in relation to the subject matter of this agreement.

 

19.2 No adverse construction

This agreement is not to be construed to the disadvantage of a party because that party was responsible for its preparation.

 

19.3 Further assurances

A party, at its own expense and within a reasonable time of being requested by another party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this agreement.

 

19.4 No waiver

 

  (a) A failure, delay, relaxation or indulgence by a party in exercising any power or right conferred on the party by this agreement does not operate as a waiver of the power or right.

 

  (b) A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this agreement.

 

  (c) A waiver of a breach does not operate as a waiver of any other breach.

 

Employment agreement for David Gearing   20


19.5 Severability

Any provision of this agreement which is invalid in any jurisdiction must in relation to that jurisdiction:

 

  (a) be read down to the minimum extent necessary to achieve its validity, if applicable; and

 

  (b) be severed from this agreement in other case,

without invalidating or affecting the remaining provisions of this agreement or the validity of that provision in any other jurisdiction.

 

19.6 Consents and approvals

Where anything in this agreement depends on the consent or approval of a party then, unless this agreement provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

19.7 No variation

This agreement cannot be amended or varied except in writing signed by the parties.

 

19.8 Governing law and jurisdiction

 

  (a) This agreement is governed by and must be construed in accordance with the governing laws as described in Item 6 of Schedule 1.

 

  (b) The parties submit to the exclusive jurisdiction of the courts of that State (as referred to in clause 19.8(a)) in respect of all matters arising out of or relating to this agreement, its performance or subject matter.

 

19.9 Counterparts

If this agreement consists of a number of signed counterparts, each is an original and all of the counterparts together constitute the same document.

 

19.10 Conflicting provisions

If there is any conflict between the main body of this agreement and any Schedules or annexures comprising it, then the provisions of the main body of this agreement prevail.

 

19.11 Non merger

A term or condition of, or act done in connection with, this agreement does not operate as a merger of any of the rights or remedies of the parties under this agreement and those rights and remedies continue unchanged.

 

Employment agreement for David Gearing   21


Signing page

Executed as an agreement

 

Signed by David Gearing in the presence of:  

)

)

   
     

/s/ David Gearing

                          Signature

 

/s/ Mark Heffernan

Signature of witness

Mark Heffernan

Name of witness

(please print)

 

Executed by Nexvet Australia Pty Ltd ACN

141 909 131 in accordance with section 127(1) of

the Corporations Act 2001 (Cth):

 

)

)

)

)

   

 

/s/ Christopher Nigel Brown

     

/s/ Geraldine T. Farrell

Signature of director       Signature of company secretary*
      *delete whichever does not apply

Christopher Nigel Brown

     

Geraldine T. Farrell

Name (please print)       Name (please print)

 

Employment agreement for David Gearing   22


Schedule 1 – Employee particulars

 

1. Commencement Date

1 September 2010

 

2. Position

Chief Scientific Officer reporting to the Chief Executive Officer of the Parent Company.

 

3. Primary place of work and Business Premises

MIMR – PHI, 27-31 Wright St. Clayton VIC 3168

 

4. Base Salary

Base Salary of US$325,000 gross per annum (inclusive of superannuation) paid monthly in equal instalments on a pro-rata basis; half of which will be paid in arrears and half paid in advance. Each instalment is to be paid in Australian dollars converted in each case at the rate selected by the Parent Company for conversion of US$ to A$ on the relevant date for accounting purposes. The Company will deduct appropriate tax and other statutory deductions from the gross A$ figure and will pay the net salary into the Employee’s nominated bank account.

The Employee may salary package the Base Salary with the consent of the Company and in accordance with law, provided that the total cost to the Company (including fringe benefits tax) must not increase due to the salary packaging arrangement.

 

5. Additional Benefits

The Employee will also be entitled to the following additional benefits:

 

    Mobile phone, lap top computer;

 

6. Governing Law

The laws of Victoria, Australia.

 

7. Probation Period

N/A

 

Employment agreement for David Gearing   23


Schedule 2 – Employee duties

 

    Provide strong scientific leadership and mentoring to a group of highly motivated and ambitious scientists.

 

    Oversee a scientific laboratory its compliance.

 

    Project leader on pre-clinical and clinical development programmes, overseeing all aspects from manufacture/CMC, regulatory, pre-clinical and clinical development.

 

    Oversee an internal team of scientists and development professionals and external consultants on development activities to meet the scientific and clinical corporate objectives.

 

    Manage multiple research projects, and scientific management of Nexvet’s external scientific collaborations.

 

    Personnel and budget accountability for all programmes.

 

    Working with IP consultants and advisors on the Nexvet portfolio and in new IP identification & protection.

 

    Work closely with the CEO and other senior management on key strategic goals

 

    Support business development activities in planning and implementing commercial objectives.

 

    Work closely with key opinion leaders in the review of new opportunities for in and out-licensing.

 

    Develop a scientific and clinical advisory board of experts from new and existing networks.

 

    Working closely with the CEO and other advisors in fundraising activities and due-diligence

 

    Represent Nexvet at key international and national conferences

 

    Draft and oversee publications in peer-reviewed scientific journals.

 

Employment agreement for David Gearing   24
EX-10.16 21 d775834dex1016.htm EX-10.16 EX-10.16

Exhibit 10.16

 

LOGO

December 22, 2014

Damian Lismore

Re: Your employment as Chief Financial Officer of Nexvet US, Inc.

Dear Damian:

On behalf of Nexvet US, Inc. (the “Company”), a wholly-owned subsidiary of Nexvet Biopharma plc, a company organized in the Republic of Ireland (the “Parent Company”), I am pleased to confirm your employment with the Company upon the following terms and conditions commencing upon the date (the “Start Date”) of the closing of the IPO (as defined by Section 8) of the Parent Company. Prior to the Start Date, you will continue to be employed by Nexvet Australia Pty Ltd, being a wholly-owned subsidiary of the Parent Company, upon the existing terms and conditions of your employment; provided, however, that Section 8 of this agreement (the “Agreement”) will be effective from the date on which the Parent Company files with the U.S. Securities and Exchange Commission a registration statement on Form S-1 with respect to the IPO (the “Filing Date”). All references to “$” are to United States dollars.

1. Position, Duties and Indemnification. Your position and title will be Chief Financial Officer of the Company and Parent Company, and you will report to the Parent Company’s Board of Directors (the “Parent Board”). In this position, your duties will consist of duties commensurate with your position and title as may be assigned to you from time to time in good faith by the Company or the Parent Board. Your employment with the Company is a full-time position, and in performing your duties you will devote your full business time and commercially reasonable efforts on behalf of the Company and Parent Company. Notwithstanding the foregoing, at any time after the first anniversary of the Start Date (or earlier if agreed with the Parent Board), it is acknowledged and agreed that, with the prior approval of the Parent Board (such approval not to be unreasonably withheld or delayed), you may engage in civic and not-for-profit activities, and serve on the boards of directors or serve as an advisor to non-competitive private or public companies so long as such activities do not materially interfere with the performance of your duties to the Company and Parent Company. As part of your employment, you may also advise the Parent Board and attend Parent Board meetings upon request for so long as you remain the Chief Financial Officer of the Parent Company. In addition, you will abide by all Company and Parent Company policies and directives as in effect from time to time, as well as all applicable laws. The Parent Company shall indemnify you pursuant to a separate agreement to the same extent that it indemnifies the Parent Board members and other most senior executive officers of the Parent Company.

2. Base Salary. The Company will pay you a base salary at the annual rate of $350,000.00 ($29,166.67 per month) in accordance with the Company’s standard payroll schedule. This position is an exempt position, which means you are paid for the job and not by the hour. Accordingly, you will not receive overtime pay if you work more than 8 hours in a workday or 40 hours in a workweek. You will be eligible for your first salary review and a comprehensive review of the key elements of your compensation package after the Parent Company achieves a market capitalization, as determined by reference to publicly available Parent Company stock trading data,


Damian Lismore

December 22, 2014

Page 2

 

that exceeds $500,000,000.00, or as the Parent Board or the Compensation Committee determines in good faith from time to time, but in any event no later than the second anniversary of your Start Date. Adjustments to your salary or other compensation, if any, will be made by the Parent Board or Compensation Committee in its sole and absolute discretion.

3. Bonus. Your incentive (bonus) compensation, if awarded by the Parent Board or Compensation Committee, will be determined based on achievement by you, and the Company and Parent Company, as relevant, of objectives established by the Parent Board or Compensation Committee. Initial objectives will be established by the Parent Board or Compensation Committee and provided in writing to you within thirty (30) days after your Start Date. Such incentive (bonus) compensation will range on a sliding scale from 0% to 40% of your base salary for the given fiscal year for which such bonus is granted, based upon the achievement by you, and/or the Parent Company, as relevant to the bonus achievement criteria set by the Parent Board or Compensation Committee, for achieving as relevant, 0% to 100% of your personal objectives, and as relevant to the given fiscal year, the Parent Company’s corporate objectives for the given fiscal year, as determined in good faith by the Parent Board. Notwithstanding the above, your bonus for fiscal year 2015 shall be based upon your base salary for fiscal year 2015, with remuneration payments (including superannuation payments made in Australia on your behalf) made to you in currencies other than US dollars converted to US currency as at the date that those payments were made. The annual incentive bonus compensation will be earned by you if you remain employed on the last day of a given year. Any bonus awarded by the Parent Board will be paid to you in cash no later than ninety (90) days after the end of the fiscal year for which such bonus is earned and will be subject to relevant payroll tax withholdings and deductions. If your employment with the Company terminates as a result of an Involuntary Termination (as defined below), then you will be eligible for a pro-rata bonus, calculated in line with other executives in the Parent Company and in line with reasonable business practice.

4. Place of Work. Your primary place of work will be located in or within 50 miles of San Francisco, California or as the Parent Board may determine from time to time as being in the best interests of the Company and agreed with you, such agreement not to be unreasonably withheld or delayed.

5. Relocation Benefits. In order to assist you in relocating to the San Francisco Bay Area to serve in your position with the Company, the Company will provide you with a one-time relocation allowance of $50,700.00 (the “Relocation Allowance”). Subject to Section 12(b)(iii), the applicable portion(s) of the Relocation Allowance will be paid either directly by the Company for relocation expenses incurred by you or to you as a reimbursement of relocation expenses as soon as practicable following the month in which you have incurred such expenses. The Relocation Allowance is contingent upon your relocation to the San Francisco Bay Area prior to May 1, 2015 or such other date as agreed by the Board. The Relocation Allowance is intended to cover your costs in connection with such relocation, including, but not limited to, airfare for you and your family, rental car, relocation consultant, temporary housing and the shipping of household and personal effects. You will provide documentary evidence to the Company of the relocation expenses you have incurred in accordance with this Section 5. You agree that if you voluntarily resign from the Company within twelve (12) months after the Start Date, you will repay to the Company all payments made to you under this Section 5 within thirty (30) days after the date of such resignation, except in the case of an Involuntary Termination, as hereinafter defined.


Damian Lismore

December 22, 2014

Page 3

 

6. Business Expenses. The Company will reimburse you for your commercially reasonable business expenses incurred in connection with your duties, upon presentation by you to the Company of appropriate supporting documentation, and otherwise in accordance with the Company’s applicable policies with respect to such reimbursement and Section 12(b)(iii) below.

7. Paid Time Off and Employee Benefits. On the Start Date, you will be credited with the number of hours of unused annual leave and personal / carer’s leave you have accrued with Nexvet Australia Pty Ltd. Beginning with the next calendar year following the Start Date, you will be provided no less than 200 hours of paid time off (“PTO”) per calendar year of employment with the Company. 1/12th of your annual PTO allowance will accrue each month and a pro rata entitlement will apply for each part month. The Company’s PTO program applies to any absence from work not otherwise covered by a specific time off benefit such as holiday pay. PTO covers all scheduled vacation or personal time off as well as unscheduled time off due to personal illness, emergencies and the like. Your annual PTO allowance will increase to 240 hours after 18 November 2018. Unused PTO carries over from year to year to a maximum of 240 hours. Your usage of PTO will be subject to the Company’s other policies in relation to PTO and, with authorization from the CEO, you may take up to 40 hours more time off than you have accrued. In addition, if you have relocated to the San Francisco Bay Region (or such other area as may be determined by the Board as being in the best interests of the Company) in accordance with Section 5, you will be entitled to reimbursement in accordance with Section 12(b)(iii) below of up to $10,000.00 from the Company per Company fiscal year for your expenses for an annual vacation trip for you and your family during the fiscal years ending in 2016, 2017 and 2018. You also will be eligible to participate in the Company’s benefits plans according to the terms and conditions of such benefit plans as in effect from time to time, such as, for example purposes only, group health insurance plans and pension and retirement plans. The Company may implement and change its benefit plans from time to time as determined by the Board.

8. IPO Option.

(a) Grant of Option. As soon as practicable after the pricing of an initial public offering of the Parent Company’s capital stock (the “IPO”) pursuant to a definitive written agreement between the Parent Company and the underwriter(s) engaged by the Parent Company for such IPO, and subject to your continued employment with Nexvet Australia Pty Ltd through such date, the Parent Board will grant to you a nonstatutory stock option (the “IPO Option”) pursuant to the Parent Company’s 2014 Equity Incentive Plan or its successor (the “Plan”) to purchase 100,000 ordinary shares of the Parent Company’s capital stock. Unless otherwise required by applicable law, the exercise price per share subject to the IPO Option (“IPO Option Exercise Price”) will be the greater of $15.00 (as adjusted pro rata to reflect any change in the Parent Company’s capital structure) and the public offering price in the IPO. The IPO Option will vest and become exercisable (i) with respect to 20% thereof upon the closing of the IPO and (ii) with respect to the remaining 80% thereof in 16 substantially equal installments on the last day of each of the 16 consecutive calendar quarters commencing after the closing of the IPO; provided, however that the IPO Option will become 100% vested and exercisable in full as of a date specified by the Parent Board prior to the consummation of a Change in Control (as defined below), provided that your service with the Company has not terminated prior to such date. The IPO option will be subject to the terms and conditions of the appropriate form of option agreement approved by the Parent Board for use under the Plan, which you will be required to execute.


Damian Lismore

December 22, 2014

Page 4

 

(b) Change in Control Prior to IPO. If a Change in Control (as defined in Section 13) is consummated on or after the Filing Date but prior to the Start Date, and if the Parent Company has not granted the IPO Option to you prior to the consummation of such Change in Control, then, provided that your employment with Nexvet Australia Pty Ltd has not terminated prior to the consummation of the Change in Control, the Parent Company shall pay to you an amount in cash equal to one-third of 1% of the amount that otherwise would be payable to the holders of the capital stock of the Parent Company pursuant to the Change in Control transaction, net of the repayment of the liabilities of the Parent Company not assumed by the acquirer in such transaction and the expenses incurred by the Parent Company in connection with such transaction, but without reduction for the amounts payable to you pursuant to this Section 8(b) and to the Company’s Chief Executive Officer and Chief Scientific Officer under similar arrangements. The amount payable to you pursuant to this Section 8(b), if any, will be paid to you at the same time(s) and subject to the same terms and conditions that apply to the payment of transaction consideration to the holders of the capital stock of the Parent Company, and in any event in a manner that complies with the requirements for payment of “transaction-based compensation” within the meaning of United States Treasury Regulation Section 1.409A-3(i)(5)(iv)(A).

(c) Change in Control After IPO. If a Change in Control (as defined in Section 13) is consummated on or after the Start Date, and if the Parent Company has not granted the IPO Option to you prior to the consummation of such Change in Control, then, provided that your employment with the Company has not terminated prior to the consummation of the Change in Control, the Company shall pay to you an amount in cash in a single lump sum within 60 days following the consummation of the Change in Control calculated as (i) minus (ii), where (i) and (ii) are defined as:

(i) 100,000 multiplied by the closing market price of one (1) ordinary share of Parent Company capital stock determined on the date immediately prior to the Change in Control; and

(ii) 100,000 multiplied by the IPO Option Exercise Price (as adjusted pro rata to reflect any change in the Parent Company’s capital structure).

9. Annual Equity Awards. Subject to the approval of the Parent Board and provided that your employment with the Company has not previously terminated, you will be eligible to be granted an award under the Plan as soon as practicable but no later than 31 August in each fiscal year of the Parent Company commencing after the IPO (the “Annual Equity Award”). Each Annual Equity Award may be any type of award authorized under the Plan and will have an Award Value (as defined below) of up to $400,000.00, with the Award Value of any Annual Equity Award determined by the Parent Board in its discretion. For the purposes of this Section, “Award Value” means a value ascribed to an Annual Equity Award by the Parent Board, in its discretion, as of the date of grant of the Annual Equity Award. Each Annual Equity Award may vest on the basis of such service and/or performance or other conditions as may be established by the Parent Board; provided, however that each Annual Equity Award will become 100% vested and exercisable in full (if applicable) as of a date specified by the Parent Board prior to the consummation of a Change in


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December 22, 2014

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Control (as defined below), provided that your service with the Company has not terminated prior to such date. Each Annual Equity Award will be subject to the terms and conditions of the appropriate form of award agreement approved by the Parent Board for use under the Plan, which you will be required to execute.

10. Employment Relationship. Your employment with the Company is “at will,” and for no specific period of time, and thus either you or the Company may terminate your employment at any time and for any reason, with or without cause upon written notice by the terminating party to the other party. Although your job duties, title, compensation and benefits, as well as the Company’s personnel policies and procedures, may be changed by action of the Board in good faith from time to time during the term of your service of the Company, the “at-will” nature of your employment may only be changed in an express written agreement to such effect signed by you and a duly authorized officer of the Company other than you who has been authorized by the Board to execute such written agreement on behalf of the Company.

11. Termination of Employment. If you voluntarily terminate your employment with the Company at any time for any reason, other than your Resignation for Good Reason (as defined below), you must provide at least three (3) months’ notice and you will be entitled to your base salary then in effect prorated through until your termination date, as well as any accrued but unused vacation and all amounts and benefits earned or incurred pursuant to Section 3, Section 6, Section 7, Section 8 and Section 9 through the last day of your employment (the “Accrued Rights”), and you will not be entitled to any other compensation or benefits from Company.

(a) Termination for Cause, Death, or Disability. If the Company terminates your employment for Cause (as defined below, and as determined in the discretion of the Board) or if your employment with the Company terminates as a result of your death or Disability, as defined below, you will be entitled to your Accrued Rights, and you will not be entitled to any other compensation or benefits from the Company. If the Company offers death or Disability benefits to an executive officer of the Company in the future, you will be entitled to similar death or Disability benefits, so long as such benefits are compliant with Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”).

(b) Involuntary Termination Other Than In Connection With a Change in Control. If your employment with the Company terminates as a result of an Involuntary Termination (as defined below), then you will be entitled to your Accrued Rights. In addition, you will be entitled to the benefits described in this Section 11(b) (the “Severance Benefits”) provided that you have (i) returned all of the Company’s and Parent Company’s property in your possession, and (ii) executed and not revoked a full and complete release of all claims against the Company and related persons in the form set forth in Exhibit A hereto (the “Release”), and the Release has become effective in accordance with its terms on or before the 60th day following the date of your termination of employment with the Company. The Severance Benefits consist of:

(i) Continued payment by the Company of your monthly base salary rate (determined by your annual salary rate in effect at the time of your Separation without regard to a reduction that would constitute Good Reason) for a period of six (6) months after your Separation (as defined below) (the “Salary Continuation Benefit”).


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December 22, 2014

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(ii) Payment to you by the Company of an aggregate amount, net of required withholding taxes, equal to the product of (A) six (6) and (B) the monthly amount the Company was paying for coverage of you and your eligible dependents, if any, under the Company’s health insurance plans in which you and your eligible dependents, if any, were participants as of the day of your termination of employment (the “Health Benefit”). The aggregate amount of the Health Benefit will be apportioned on the basis of six (6) monthly installments and paid, net of applicable withholding taxes, at the same time and in the same manner as the Company’s payment of the Salary Continuation Benefit.

(iii) If your termination of employment occurs after the first day of a given fiscal year of the Parent Company, and if the Parent Company has not yet granted your Annual Equity Award in the fiscal year that your termination occurs, the Company shall, acting in good faith, pay you an amount of cash (the “Annual Equity Award Benefit”) equal to the product determined by multiplying (A) the greater of (x) the Award Value of the Annual Equity Award that you otherwise would have received for the fiscal year of your termination of employment and (y) the Award Value of the Annual Equity Award granted to you during the immediately preceding fiscal year, by (B) a ratio, the numerator of which equals the number of days elapsed from the beginning of the immediately preceding fiscal year to the date of your termination of employment, and the denominator of which equals the total number of days contained in the current fiscal year.

(iv) Any portions of the IPO Option and Annual Equity Awards granted to you prior to your Separation that remain unvested as of the date of your Separation will become 100% vested and exercisable in full for the remainder of the option term as if your employment had not terminated (if applicable) as of your termination date.

The Annual Equity Award Benefit will be paid, and the Salary Continuation Benefit and Health Benefit payments will commence, on the next Company payroll date following the effective date of the Release, and the first payment will include any unpaid amounts accrued from the date of your Separation. Notwithstanding the foregoing, to the extent the payment of the Annual Equity Award Benefit, the Salary Continuation Benefit and/or the Health Benefit constitute “deferred compensation” within the meaning of Section 409A of the Code, and if the period beginning on the date of your Separation and ending on the first Company payroll date occurring on or after the date which is sixty (60) days thereafter spans two (2) calendar years, then the payment of the Annual Equity Award Benefit will be made, and the Salary Continuation Benefit and Health Benefit will commence, on the first payroll date occurring on or after the date which is sixty (60) days following your Separation date (provided the other requirements for receipt of such Severance Benefits have been met), subject in each case to the provisions of Section 12(b)(ii) below.

(c) Involuntary Termination In Connection With a Change in Control. If


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your employment with the Company, the Parent Company or any successor in interest to the Company or Parent Company that has assumed the Company’s or Parent Company’s obligation under this Agreement terminates as a result of an Involuntary Termination immediately prior to, upon, or within twelve (12) months following, a Change in Control, then, you will be entitled to your Accrued Rights. In addition, provided that you have (i) returned all of the Company’s and Parent Company’s property in your possession, and (ii) executed and not revoked the Release and the Release has become effective in accordance with its terms on or before the 60th day following the date of your termination of employment with the Company, you will be entitled to receive the Severance Benefits set forth in Section 11(b), payable at the time(s) and subject to the conditions set forth therein, provided that the Salary Continuation Benefit and the Health Benefit will each be for a period of twelve (12) months (the “Change in Control Severance Benefits”) in lieu of the period for such benefits described in Sections 11(b)(i) and (ii).

12. Tax Matters.

(a) Withholding. All forms of compensation referred to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.

(b) Certain Provisions Respect to Section 409A of the Code.

(i) For purposes of Section 409A of the Code, each installment payment of Salary Continuation Benefit and the Health Benefit is hereby designated as a separate payment.

(ii) If the Company determines that you are a “specified employee” under Section 409A(a)(2)(B)(i) of the Code at the time of your Separation, then (i) the Severance Benefits or Change in Control Severance Benefits, as applicable, to the extent that they are treated as deferred compensation subject to Section 409A of the Code, will commence on the payroll date following the earlier of (A) expiration of the six (6) month period measured from your Separation or (B) the date of your death, and (ii) the installments that otherwise would have been paid prior to such date will be paid in a lump sum when the payment of Severance Benefits or Change in Control Severance Benefits, as applicable, commence.

(iii) Notwithstanding anything herein to the contrary, the reimbursement of expenses or in-kind benefits provided pursuant to this Agreement will be subject to the following conditions: (i) the expenses eligible for reimbursement or in-kind benefits in one taxable year will not affect the expenses eligible for reimbursement or in-kind benefits in any other taxable year; (ii) the reimbursement of eligible expenses or in-kind benefits will be made promptly, subject to the Company’s applicable policies, but in no event later than the end of the year after the year in which such expense was incurred; and (iii) the right to reimbursement or in-kind benefits will not be subject to liquidation or exchange for another benefit.

(iv) The Company intends that income provided to you pursuant to this Agreement will not be subject to taxation under Section 409A of the Code. The provisions of this Agreement will be interpreted and construed in favor of satisfying any applicable requirements of Section 409A of the Code. However, the Company does not guarantee any


Damian Lismore

December 22, 2014

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particular tax effect for income provided to you pursuant to this Agreement. In any event, except for the Company’s responsibility to withhold applicable income and employment taxes from compensation paid or provided to you, the Company will not be responsible for the payment of any applicable taxes on compensation paid or provided to you pursuant to this Agreement.

(c) Section 280G Excise Tax Matters.

(i) In the event that any payment in the nature of compensation (within the meaning of Section 280G(b)(2) of the Code) to you or for your benefit, paid or payable or distributed or distributable pursuant to the terms of this Agreement, or otherwise in connection with, or arising out of, your employment with the Company (collectively, the “Payments”), would, but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code or any similar or successor provision (the “Excise Tax”), then the Payments shall be either: (1) delivered in full, or (2) delivered as to such lesser extent which would result in no portion of such Payments being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income taxes and the Excise Tax, results in the receipt by you on an after-tax basis, of the greatest amount of Payments, notwithstanding that all or some portion of such Payments may be taxable under Section 4999 of the Code. Any reduction under this Subsection shall be applied first to Payments that constitute “deferred compensation” (within the meaning of Section 409A of the Code and the regulations thereunder). If there is more than one such Payment, then such reduction shall be applied on a pro rata basis to all such Payments. Notwithstanding the foregoing, if required by the individual, entity or group which will control the Company upon the occurrence of a Change in Control, the Company and you shall take all actions necessary to comply with the stockholder vote requirements necessary to obtain the exemption under Section 280G(b)(5) of the Code and the applicable regulations promulgated thereunder, if available to the Company, for the portion of the Payments that would otherwise be subject to the Excise Tax.

(ii) An initial determination as to whether a reduction in the Payments is required pursuant to this Agreement and the amount of such reduction shall be made by the Company. The Company shall provide its determination (the “Determination”), together with detailed supporting calculations and documentation, to you within fifteen (15) days of the Change in Control or the date of your termination of employment, as applicable, or such other time as requested by you (provided you reasonably believe that any of the Payments may be subject to the Excise Tax). If requested by you, the Company shall furnish you, at the Company’s expense, with an opinion reasonably acceptable to you from the Company’s accounting firm (or an accounting firm of equivalent stature reasonably acceptable to you) that there is a reasonable basis for the Determination.

(d) Tax Advice. You are encouraged to obtain your own tax advice regarding your compensation from the Company. You agree that the Company does not have a duty to design its compensation policies in a manner that minimizes your tax liabilities, and you will not make any claim against the Company or the Board related to tax liabilities arising from your compensation.


Damian Lismore

December 22, 2014

Page 9

 

13. Definitions. The following terms have the meaning set forth below wherever they are used in this Agreement:

Cause” means the occurrence of any of the following:

(a) Your gross negligence, gross misconduct or your refusal to perform your duties and responsibilities to the Company after you have received a written description of such failure and been provided with thirty (30) days to cure such failure, or your material breach of your fiduciary duties to the Company. Any willful act or acts or omission or omissions by you that have a material adverse effect on the Company’s reputation or financial statements will be deemed to be such a breach of your duties and responsibilities to the Company; provided, however, in all such cases, you will have been given a written description of such failure or breach and thirty (30) days to cure the breach.

(b) Your conviction of, or plea of nolo contendere to, a felony, in which case, notwithstanding anything set forth in this Agreement, the Company may immediately terminate your employment for Cause.

(c) Your engagement in acts of embezzlement or material dishonesty; in which case, notwithstanding anything set forth in this Agreement, the Company may immediately terminate your employment for Cause.

Change in Control” means: (a) a merger or consolidation or the sale, or exchange by the stockholders of the Parent Company of all or substantially all of the capital stock of the Parent Company, where the stockholders of the Parent Company immediately before such transaction do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the surviving or acquiring corporation or other surviving or acquiring entity, in substantially the same proportion as before such transaction; (b) any transaction or series of related transactions to which the Parent Company is a party in which in excess of fifty percent (50%) of its voting power is transferred, other than any such transfer in which the stockholders of the Parent Company immediately before such transfer obtain or retain, directly or indirectly, more than fifty percent (50%) of the beneficial interest in the voting power of the voting stock or other voting equity of the corporation or other entity to which the voting power of the Parent Company was transferred, or (c) the sale or exchange of all or substantially all of the Parent Company’s assets, other than a sale or transfer to a subsidiary of the Parent Company as defined in Section 424(f) of the Code, in which the stockholders of the Parent Company immediately before such sale or exchange do not obtain or retain, directly or indirectly, at least a majority of the beneficial interest in the voting stock or other voting equity of the corporation or other entity acquiring the Parent Company’s assets, in substantially the same proportion as before such transaction.

Disability” means “disability” as defined by the long-term disability plan or policy adopted by the Company covering you, and in lieu of such plan or policy, it means a “permanent and total disability” as defined by Section 22(e)(3) of the Code.

Involuntary Termination” means either (a) your Termination Without Cause or (b) your Resignation for Good Reason.

Resignation for Good Reason” means a Separation as a result of your resignation within ninety (90) days after one of the following conditions has come into existence without your consent:


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December 22, 2014

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(a) The material breach by the Company of any of its obligations under this Agreement; or

(b) Without your express written consent, a material reduction of your duties, position or responsibilities or your removal from such position and responsibilities, or a reduction in the level of supervisor within the organization to whom you report; or

(c) Without your express written consent, a material reduction in your base salary, unless such reduction is made in connection with a company-wide cost reduction effort; or

(d) The Company’s requirement that you report to a primary work location that is not within the region described in Section 4; or

(e) A material reduction in the kind or level of employee benefits to which you are entitled immediately prior to such reduction with the result that your overall benefits package is significantly reduced such that the reduction constitutes a “material negative change” to your employment relationship (within the meaning of Section 1.409A-1(n)(2) of the United States Federal Treasury Regulations), unless such reduction is made in connection with a company-wide cost reduction effort of similar scope for all similarly situated employees.

A Resignation for Good Reason will not be deemed to have occurred unless you give the Company written notice of the condition within thirty (30) days after the condition comes into existence and the Company fails to remedy the condition within thirty (30) days after receiving your written notice.

Separation” means a “separation from service,” as defined in Section 409A of the Code and/or the regulations and other guidance issued by the Internal Revenue Service or the Department of Treasury under Section 409A of the Code.

Termination Without Cause” means a Separation as a result of a termination of your employment by the Company without Cause other than for death or Disability.

14. Interpretation, Amendment and Enforcement. Other than the terms of the awarding of options to you pursuant to the Company’s superseded long term incentive plan and the terms of the Employee Incentive Plan which comes into effect at the IPO, and other than the deed of indemnity to be entered into pursuant to Section 1, this Agreement supersedes and replaces any prior agreements, representations or understandings (whether written, oral, implied or otherwise) between you and the Company with respect to the subject matter hereof, and constitutes the complete agreement between you and the Company regarding the subject matter hereof. This Agreement may not be amended or modified except by a written Agreement signed by both you and a duly authorized officer of the Company that explicitly states the intent of both parties hereto to supplement the terms herein. The terms of this Agreement and the resolution of any disputes as to the meaning, effect, performance or validity of this Agreement or arising out of, related to, or in any way connected with, this Agreement, your employment with the Company or any other relationship between you and the Company (the “Disputes”) will be governed by the laws of the State of California, excluding its laws relating to conflicts of law or choice of law. You and the Company submit to the exclusive personal jurisdiction of, and venue in, the U.S. federal and State of California courts located in San Francisco, California in connection with any dispute or any claim related to any dispute between the parties hereto related to or arising from this Agreement.


Damian Lismore

December 22, 2014

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15. Successors and Assigns. This Agreement is personal to you and may not be assigned by you in whole or in part. Any purported assignment by you will be null and void from the initial date of the purported assignment. The Company may assign this Agreement to any successor or assign (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business or assets of the Company. This Agreement will inure to the benefit of the Company and to such successors and assigns.

16. Remedies. In the event of a breach or threatened breach by you of this Agreement, you hereby consent and agree that the Company will be entitled to seek, in addition to other available remedies, a temporary or permanent injunction or other equitable relief against such breach or threatened breach from any court of competent jurisdiction, without the necessity of showing any actual damages or that money damages would not afford an adequate remedy, and without the necessity of posting any bond or other security. The aforementioned equitable relief will be in addition to, not in lieu of, legal remedies, monetary damages or other available forms of relief.

17. Severability. If any provision of this Agreement is held by a court to be invalid, void or unenforceable, the remaining provisions will nevertheless continue in full force and effect without being impaired or invalidated in any way and will be construed in accordance with the purposes and tenor and effect of this Agreement.

18. Counterparts. This Agreement may be executed in counterparts, each of which will be an original, but both of which together will constitute one instrument.

19. Survival. Upon the expiration or other termination of this Agreement, the respective rights and obligations of the parties hereto will survive such expiration or other termination to the extent necessary to carry out the intentions of the parties under this Agreement.

This offer is contingent upon your: 1) signing and providing to the Company the Company’s standard Employee Proprietary Information and Inventions Agreement; and 2) providing the Company with a true and correct copy of appropriate documents establishing your identity and right to work in the United States.

[SIGNATURE PAGE FOLLOWS]


Damian Lismore

December 22, 2014

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You may accept this offer by signing and dating the enclosed duplicate original of this Agreement and returning it to me by email to chris.brown@gibbshill.com.au not later than 5:00 PM California time on 29 December, 2014.

 

Very truly yours,
NEXVET US, INC.
By:  

/s/ Christopher Nigel Brown

Name:   Christopher Nigel Brown
Title:   Director

I HAVE READ AND ACCEPT THIS EMPLOYMENT OFFER AND THE TERMS OF THIS AGREEMENT:

 

/s/ Damian Lismore

Damian Lismore
Date signed:   22 December 2014
ACCEPTED AND AGREED TO:

NEXVET BIOPHARMA PLC

By:  

/s/ Joseph McCracken

Name:   Joseph McCracken
Title:   Director
By:  

/s/ Christopher Nigel Brown

Name:   Christopher Nigel Brown
Title:   Director
EX-10.17 22 d775834dex1017.htm EX-10.17 EX-10.17

EXHIBIT 10.17

 

DATED 4 September 2014

NEXVET BIOPHARMA PLC (CO NO. 547923)

(“COMPANY”)

(ADOPTED BY THE BOARD ON 18 SEPTEMBER 2014)

LONG TERM INCENTIVE PLAN

RULES


CONTENTS

 

1.

 

INTRODUCTION

     4   
 

Name of Plan

     4   
 

Objects of Plan

     4   
 

Commencement of Plan

     4   
 

Advice

     4   

2.

 

DEFINED TERMS & INTERPRETATION

     4   
 

Defined terms

     4   
 

Interpretation

     8   
 

Primary Instruments

     9   
 

Headings

     9   

3.

 

OPERATION OF THE PLAN

     9   
 

Plan operates in accordance with Rules

     9   
 

Rules binding

     9   

4.

 

PRINCIPAL CONDITIONS

     10   
 

Plan Securities issued only to Employees

     10   
 

Compliance with laws

     10   

5.

 

OFFERS

     10   
 

Board may make Offer

     10   
 

Form of Offer

     10   
 

Offer personal

     11   

6.

 

APPLICATION FOR PLAN SECURITIES

     11   
 

Acceptance of Offer

     11   
 

Application for all or some Plan Securities

     11   
 

Lapse of Offer

     11   

7.

 

GRANT OF PLAN SECURITIES

     11   
 

Acceptance of application and issue

     11   
 

Eligible Employee becomes a Participant

     12   
 

Certificates

     12   
 

Consideration for Plan Securities

     12   
 

Entitlement to underlying Shares

     12   
 

Interest in Shares

     12   
 

Confidentiality

     12   

8.

 

EXERCISE AND VESTING

     12   
 

Vesting dates

     12   
 

Vesting on cessation

     13   


 

Exercise Conditions

     13   
 

Waiver of Exercise Conditions

     13   
 

Notice of an expected Exit Event

     13   
 

Effect of Exit Event Notice

     13   
 

If Exit Event does not occur

     13   
 

Exercise of Option during Exercise Period

     14   
 

Issue of Shares

     14   
 

Shares rank equally

     14   
 

Deed of Accession

     14   

9.

 

LAPSE OF PLAN SECURITIES

     15   
 

Lapse of Plan Securities

     15   
 

Rights cease

     15   

10.

 

DEALINGS WITH PLAN SECURITY

     15   
 

Plan Securities personal

     15   
 

No unauthorised disposal

     16   
 

No transfers

     16   

11.

 

ADJUSTMENTS AND OTHER MATTERS

     16   
 

New issues

     16   
 

Bonus issues

     16   
 

Re-organisation of capital

     16   
 

Winding up

     16   
 

Reorganisation of the Group

     17   
 

IPO

     17   
 

Fractions of Shares

     17   
 

Calculations and adjustments

     17   
 

Notice of change

     18   

12.

 

ADMINISTRATION OF THE PLAN

     18   
 

Powers of Board

     18   
 

Determination

     18   
 

Exercise of powers or discretion

     18   
 

Expenses and costs

     18   
 

Tax

     18   

13.

 

AMENDMENTS

     19   
 

Board may amend

     19   
 

Consent of Participants

     19   

14.

 

RIGHTS OF PARTICIPANTS

     19   


 

No conferred rights

     19   
 

Other schemes

     19   
 

General meetings

     19   

15.

 

NOTICES

     19   

16.

 

GOVERNING LAW

     20   
 

Governing law

     20   


PLAN RULES

 

1. INTRODUCTION

Name of Plan

 

1.1 The Plan is called the Nexvet Long Term Incentive Plan.

Objects of Plan

 

1.2 The objects of the Plan are to:

 

  1.2.1 retain Eligible Employees by providing them with an incentive to remain employed or engaged with the Group in the long term;

 

  1.2.2 recognise the ongoing ability of Eligible Employees and their expected efforts and contribution in the long term to the performance and success of the Group; and

 

  1.2.3 provide Eligible Employees with the opportunity to acquire Plan Securities in the Company in accordance with these Rules,

with the result of aligning interests between the company and Eligible Employees.

Commencement of Plan

 

1.3 The Plan commences on the date determined by the Board.

Advice

 

1.4 The Company is not responsible for the consequences of participation in the Plan by Eligible Employees, who should obtain their own independent advice at their own expense on the financial, taxation and other consequences to them of or relating to participation in the Plan.

 

2. DEFINED TERMS & INTERPRETATION

Defined terms

 

2.1 In these Rules:

“Application Form” means an application for the issue of Plan Securities, in the form approved by the Board from time to time;

“Bad Leaver” means any Participant who ceases to be employed or engaged by a member of the Group and who is not a Good Leaver A or Good Leaver B;

“Board” means the Board of the Company or any committee of the Board to which it has delegated power to administer the Plan, from time to time;

“Business Day” means a day that is not a Saturday, Sunday, public holiday or bank holiday in Dublin, Ireland;

“Companies Acts” means the Companies Acts 1963 – 2013 as may be amended from time to time.

 

4


“Confirmation” means a confirmation from the Company of the terms of Plan Securities issued to the Participant under the Exchange;

“Corporations Act” means the Corporations Act 2001 (Cth);

“Date of Grant” means, with respect to a Plan Security, the date on which the Board grants the Plan Security to an Eligible Employee;

“Date of Issue” means, with respect to a Share issued on exercise of a Plan Security, the date on which the Board issues the Share to the Eligible Employee;

“Eligible Employee” means an Employee whom the Board determines is to receive an Offer or Confirmation under the Plan;

“Employee” means, for the purposes of this Plan:

 

  (a) an individual whom the Board determines to be in the full-time or part-time employment of a body corporate in the Group (including any employee on parental leave, long service leave or other special leave as approved by the Board);

 

  (b) a director of a body corporate in the Group holding a salaried employment or office in a body corporate in the Group;

 

  (c) a director of the Company;

 

  (d) an individual providing services to a body corporate in the Group whom the Board determines to be an Employee for the purposes of the Plan;

 

  (e) an individual whose associate (as defined in section 139GE of the Income Tax Assessment Act 1936 ) provides services to a body corporate in the Group, which individual the Board determines to be an Employee for the purposes of the Plan; or

 

  (f) an individual otherwise in the employment of a body corporate in the Group whom the Board determines to be an Employee for the purposes of the Plan,

but for the avoidance of doubt does not impute an employee/employer relationship for any purpose;

“Exchange” means the transaction pursuant to which the Company acquired all of the issued capital of Nexvet Biopharma Pty Ltd (an Australian registered company) and issued Options and RSUs in exchange for the transfer to the Company of certain options and RSUs issued by Nexvet Biopharma Pty Ltd;

“Exercise Conditions” means the performance, Vesting or other conditions (if any) determined by the Board set out in Rule 8.3 and otherwise specified in an Offer or Confirmation which are, subject to these Rules, required to be satisfied, reached or met before:

 

  (a) an Option can be exercised; or

 

  (b) an RSU automatically converts;

“Exercise Date” means:

 

5


  (a) in respect of an Option:

 

  (i) subject to paragraph (ii), 10 Business Days after the Company receives an Exercise Notice in respect of that Option delivered in accordance with Rule 8.8; or

 

  (ii) the Exit Event Date, if the Company receives an Exercise Notice in respect of that Option delivered as a result of the operation of Rule 8.6; and

 

  (b) in respect of an RSU, 10 Business Days after the later of:

 

  (i) the date the Exercise Conditions are satisfied or waived in full; and

 

  (ii) the date the holder pays the Exercise Price to the Company;

“Exercise Notice” means a notice stating that a Participant wants to exercise the Options the subject of the notice, in the form approved by the Board from time to time;

“Exercise Period” means, in respect of an Option:

 

  (a) the period:

 

  (i) commencing on the date the Exercise Conditions are satisfied or waived in full; and

 

  (ii) ending on the date the Option lapses in accordance with Rule 9.1;

 

  (b) if an Exit Event Notice is delivered, the period prior to the Exit Event Date; or

 

  (c) such other the period designated by the Board;

“Exercise Price” means, in respect of a Plan Security:

 

  (a) the greater of (i) nil and (ii) the par value of Shares; or

 

  (b) such other the price to be paid on the exercise of the Plan Security as determined by the Board and set out in an Offer or Confirmation;

“Exit Event” means the first to occur of:

 

  (a) an agreement for a Trade Sale completing; or

 

  (b) any other circumstance determined by the Board;

“Exit Event Date” has the meaning given to it in Rule 8.5;

“Exit Event Notice” has the meaning given to it in Rule 8.5;

“Good Leaver A” means any Participant who ceases to be employed or engaged by a member of the Group:

 

6


  (a) as a result of the death, illness (including mental illness), serious disability or permanent incapacity through ill health (as determined by the Board, acting reasonably) of the Participant; or

 

  (b) in exceptional circumstances where the Board determines the Participant should be treated as a Good Leaver A;

“Good Leaver B” means any Participant who ceases to be employed or engaged by a member of the Group:

 

  (a) as a result of a breach by the Company of the Participant’s employment contract, constructive dismissal by the Company of the Participant or the Participant being made redundant; or

 

  (b) in exceptional circumstances where the Board determines the Participant should be treated as a Good Leaver B;

“Group” means the Company and its Subsidiaries;

“IPO” means an initial public offering of Shares made under a prospectus or other disclosure document stating that the Company has or will apply, in conjunction with the offering for quotation of the Shares on a stock exchange approved by the Company;

“Legal Personal Representative” means the executor of the will or an administrator of the estate of a deceased person, the trustee of the estate of a person under a legal disability or a person who holds an enduring power of attorney granted by a person;

“M&A” means the memorandum and articles of association of the Company from time to time;

“Nominee” has the meaning given in Rule 5.4;

“Option” means an option granted to a Participant under the Plan to be issued a Share under the Plan;

“Offer” means an invitation to an Eligible Employee to apply for a grant of Plan Securities in accordance with Rule 5.2;

“Offer Period” means, in respect of an Offer, the period of time in which the Offer may be accepted by the Eligible Employee;

“Participant” means, subject to Rule 5.4, a person holding Plan Securities issued under the Plan and includes, if a Participant dies or becomes subject to a legal disability, the Legal Personal Representative of the Participant;

“Participating Subsidiary” means a Subsidiary of the Company which the Board has approved for participation in the Plan;

“Plan” means the Nexvet Long Term Incentive Plan governed by these Rules;

“Plan Securities” means:

 

  (a) Options;

 

  (b) RSUs; or

 

7


  (c) such other securities in the capital of the Company, or securities convertible into the capital of the Company which the Board approves for issue under the Plan, from time to time;

“Related Party” means in respect of:

 

  (a) a body corporate, anyone who is an associate of that body corporate under sections 11 to 15 (inclusive) of the Corporations Act; and

 

  (b) an individual, an Associate of that individual as defined in section 318 of the Income Tax Assessment Act 1936;

“RSU” means a restricted stock unit granted to a Participant under the Plan to be issued a Share under the Plan;

“Rules” means the rules governing the operation of the Plan set out in this document, as amended from time to time;

“Security Interest” means a mortgage, charge, pledge, lien, encumbrance or other third party interest of any nature;

“Share” means a share in the Company;

“Subsidiary” has the meaning given in the Companies Acts;

“Tax” includes any tax, levy, impost, value added tax, GST, deduction, charge, rate, contribution, duty or withholding which is assessed (or deemed to be assessed), levied, imposed or made by any government or any governmental, semi-governmental or judicial entity or authority together with any interest, penalty, fine, charge, fee or other amount assessed (or deemed to be assessed), levied, imposed or made on or in respect of any or all of the foregoing;

“Trade Sale” means an unconditional agreement providing for the sale of:

 

  (a) all main operating Subsidiaries of the Company;

 

  (b) all or substantially all of the equity securities in the Company;

 

  (c) all or substantially all of the assets of the Group; or

 

  (d) such other similar transaction approved by the Board; and

“Vest” means in relation to:

 

  (a) an Option, means the point in time after which the Option becomes freely exercisable by its holder; or

 

  (b) an RSU, means the point in time after which the RSU becomes freely convertible under this Plan,

subject to any other Exercise Conditions which may apply to that Plan Security.

Interpretation

 

2.2 In this document, except where the context otherwise requires:

 

8


  2.2.1 the singular includes the plural and vice versa, and a gender includes other genders;

 

  2.2.2 another grammatical form of a defined word or expression has a corresponding meaning;

 

  2.2.3 a reference to a Rule, paragraph, schedule or annexure is to a Rule or paragraph of, or schedule or annexure to, this document, and a reference to this document includes any schedule or annexure;

 

  2.2.4 a reference to a document or instrument includes the document or instrument as novated, altered, supplemented or replaced from time to time;

 

  2.2.5 a reference to time is to Dublin, Ireland time;

 

  2.2.6 a reference to a person includes a natural person, partnership, body corporate, association, governmental or local authority or agency or other entity;

 

  2.2.7 a reference to a statute, ordinance, code or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of them;

 

  2.2.8 a word or expression defined in the Companies Acts has the meaning given to it in the Companies Acts;

 

  2.2.9 the meaning of general words is not limited by specific examples introduced by including, for example or similar expressions;

 

  2.2.10 a rule of construction does not apply to the disadvantage of a party because the party was responsible for the preparation of this agreement or any part of it; and

 

  2.2.11 if a day on or by which an obligation must be performed or an event must occur is not a Business Day, the obligation must be performed or the event must occur on or by the next Business Day.

Primary Instruments

 

2.3 These Rules are to be interpreted subject to the M&A and the Companies Acts.

Headings

 

2.4 Headings are for ease of reference only and do not affect interpretation.

 

3. OPERATION OF THE PLAN

Plan operates in accordance with Rules

 

3.1 The Plan operates in accordance with these Rules.

Rules binding

 

3.2 These Rules bind the Company, each Participating Subsidiary and each Participant.

 

9


4. PRINCIPAL CONDITIONS

Plan Securities issued only to Employees

 

4.1 A Plan Security may not be issued to a person under the Plan unless the person remains an Employee as at the Date of Grant, or the Board determines otherwise.

Compliance with laws

 

4.2 A:

 

  4.2.1 Plan Security may not be offered or issued to, Vest or be exercised by, an Eligible Employee or Participant; or

 

  4.2.2 Share may not be issued to an Eligible Employee or Participant on exercise of a Plan Security,

if to do so would:

 

  4.2.3 contravene the M&A, the Companies Acts or any applicable law; or

 

  4.2.4 cause the Company to have to produce any offering document or make filings with any regulatory authority in order to comply with any applicable law, where the Board believes that to so would place an unreasonable burden on the Company.

 

5. OFFERS

Board may make Offer

 

5.1 Subject to these Rules, the Board may from time to time make an Offer to any Eligible Employee.

Form of Offer

 

5.2 An Offer must be in writing and state:

 

  5.2.1 the name and address of the Eligible Employee to whom the Offer is made;

 

  5.2.2 the date of the Offer;

 

  5.2.3 the number and type of Plan Securities for which the Eligible Employee may make application;

 

  5.2.4 the proposed Date of Grant of the relevant Plan Securities;

 

  5.2.5 the Offer Period;

 

  5.2.6 the Exercise Conditions (if any) attaching to the relevant Plan Securities; and

 

  5.2.7 any other specific terms and conditions applicable to the Offer; and

otherwise be in the form approved by the Board from time to time.

 

10


Offer personal

 

5.3 Subject to Rule 5.4, each Offer is personal to the Eligible Employee to whom it is made. Only the Eligible Employee to whom an Offer is made may accept the invitation constituted by an Offer and the Company may only issue the Plan Securities referred to the Offer to that Eligible Employee.

 

5.4 An Eligible Employee may nominate a Related Party or such other person approved by the Board to receive the Plan Securities on their behalf (“Nominee”). If an Eligible Employee nominates a Nominee, then the Eligible Employee and the Nominee will be deemed to be jointly a Participant for the purposes of the Plan and these Rules shall be read accordingly.

 

5.5 If, at any time while a Nominee holds Plan Securities, a Nominee is no longer a Related Party of the relevant Eligible Employee or a person approved by the Board, the Nominee must promptly do all things necessary to transfer the Plan Securities to the relevant Eligible Employee, another Related Party of the relevant Eligible Employee or another person approved by the Board. All rights attaching to the Plan Securities are suspended until that transfer takes place.

 

6. APPLICATION FOR PLAN SECURITIES

Acceptance of Offer

 

6.1 An Eligible Employee may accept the invitation constituted by an Offer by giving to the Company duly completed and executed Application Form within the Offer Period.

Application for all or some Plan Securities

 

6.2 An Eligible Employee may, in his or her discretion, accept the invitation constituted by an Offer, in whole or in part, in multiples of 100 Plan Securities or any other multiple approved by Board for the Eligible Employee.

Lapse of Offer

 

6.3 An Offer not accepted in accordance with Rule 6.1 lapses unless the Board determines otherwise.

 

7. GRANT OF PLAN SECURITIES

Acceptance of application and issue

 

7.1 If an Eligible Employee delivers a duly completed and executed Application Form before the expiry of the Offer Period, the Company may, subject to the conditions of the Offer, accept the Application Form and on that acceptance:

 

  7.1.1 grant to the Eligible Employee all of the Plan Securities the subject of the Application Form; and

 

  7.1.2 give the Eligible Employee notice of the Date of Grant of those Plan Securities.

 

7.2 If the Exchange completes, the Company may:

 

  7.2.1 grant to the Eligible Employee the Plan Securities the subject of the Exchange; and

 

11


  7.2.2 give the Eligible Employee notice of the Date of Grant of those Plan Securities; and

 

  7.2.3 deliver the Confirmation to the Eligible Employee.

Eligible Employee becomes a Participant

 

7.3 An Eligible Employee becomes a Participant and is bound by these Rules when the Company grants Plan Securities to the Eligible Employee.

Certificates

 

7.4 Except as otherwise agreed with a Participant, the Company must give to each Participant one or more certificates or a statement setting out:

 

  7.4.1 the number of Plan Securities granted to the Participant;

 

  7.4.2 the Exercise Price of those Plan Securities; and

 

  7.4.3 the Date of Grant of those Plan Securities.

Consideration for Plan Securities

 

7.5 Except pursuant to the Exchange:

 

  7.5.1 the consideration for the grant of Plan Securities to an Eligible Employee is the services expected of an Eligible Employee to or for the benefit of the Group; and

 

  7.5.2 an Eligible Employee does not have to pay money or give other consideration for the grant of a Plan Security.

Entitlement to underlying Shares

 

7.6 Each Plan Security confers on its holder the entitlement to acquire a beneficial interest in a number of Shares, in accordance with and subject to, these Rules.

Interest in Shares

 

7.7 A Participant has no right to a Share the subject of a Plan Security held by the Participant unless and until the Share is issued to that Participant under these Rules.

Confidentiality

 

7.8 A Participant must keep confidential all details of Plan Securities held or offered under these Rules unless permission to disclose details has been given by the Board.

 

8. EXERCISE AND VESTING

Vesting dates

 

8.1 Unless otherwise specified in an Offer or Confirmation and subject to Rules 8.2, 8.4 and 8.6, a Participant’s Plan Securities which have not previously lapsed Vest as follows:

 

  8.1.1 one third on the first anniversary of the Date of Grant;

 

12


  8.1.2 one third on the second anniversary of the Date of Grant; and

 

  8.1.3 one third on the third anniversary of the Date of Grant.

Vesting on cessation

 

8.2 If the Participant is a Good Leaver A or Good Leaver B, the Participant’s Plan Securities Vest on the date the Participant ceases to be employed or engaged by a member of the Group.

Exercise Conditions

 

8.3 Subject to Rules 8.4 and 8.6:

 

  8.3.1 a Participant may not exercise an Option; and

 

  8.3.2 an RSU will not be able to convert,

unless and until:

 

  8.3.3 the Plan Security Vests; and

 

  8.3.4 any other Exercise Conditions specified in the Offer or Confirmation relating to the Plan Security has been satisfied, reached or met.

Waiver of Exercise Conditions

 

8.4 The Board may, at its discretion, by notice to the Participant reduce or waive the Exercise Conditions attaching to a Plan Security in whole or in part at any time and in any particular case.

Notice of an expected Exit Event

 

8.5 At least 10 Business Days before an Exit Event, the Board must give each Participant notice (“Exit Event Notice”) stating the proposed date of the Exit Event (“Exit Event Date”).

Effect of Exit Event Notice

 

8.6 If an Exit Event Notice is delivered:

 

  8.6.1 all outstanding Plan Securities which have not Vested shall Vest on the Exit Event Date, immediately prior the Exit Event;

 

  8.6.2 all Exercise Conditions relating to Plan Securities shall be waived on the Exit Event Date; and

 

  8.6.3 all Participants who hold Options must comply with Rule 8.8 in respect of those Options which they wish to exercise, subject to the Exit Event occurring.

If Exit Event does not occur

 

8.7 If an expected Exit Event prompting an Exit Event Notice does not occur:

 

  8.7.1 the Board must give each Participant notice of the fact as soon as practicable;

 

13


  8.7.2 all Exit Event Notices and Exercise Notices given in response shall be deemed to be null and void and of no effect; and

 

  8.7.3 the Plan Securities survive.

Exercise of Option during Exercise Period

 

8.8 A Participant may exercise an Option at any time during the Exercise Period for the Option by giving the Company:

 

  8.8.1 a duly completed and executed Exercise Notice;

 

  8.8.2 the Exercise Price (if any) for those Options; and

 

  8.8.3 any certificate for those Options.

Conversion of RSUs

 

8.9 A Participant may convert an RSU at any time after the satisfaction of the Exercise Conditions by giving the Company the Exercise Price (if any) for those RSUs.

Issue of Shares

 

8.10 Subject to these Rules, the Company will only issue a Share on exercise of a Plan Security:

 

  8.10.1 on the relevant Exercise Date;

 

  8.10.2 if the Participant has complied with Rule 8.14; and

 

  8.10.3 subject to Rule 4.2.

Shares rank equally

 

8.11 Unless otherwise provided in an Exercise Notice and subject to these Rules, Shares issued on the exercise of a Plan Security rank equally with all existing Shares on and from the Date of Issue in respect of all rights issues, bonus share issues and dividends which have a record date for determining entitlements on or after the Date of Issue. For the avoidance of doubt, no such rights in relation to a Share exist in favour of a Participant prior the Date of Issue.

 

8.12 Each Participant agrees to accept Shares issued to him subject to the M&A and agrees to be bound by the M&A.

 

8.13 Each Participant agrees that the on-sale of Shares issued on the exercise of a Plan Security may be restricted by law in the 12 months immediately following the Date of Issue. The Company may, but is not required to, issue such notices or lodge such documents to enable the on-sale of Shares in the 12 months immediately following the Date of Issue.

Deed of Accession

 

8.14 The Company may refuse to issue any Share to a Participant unless that Participant has signed a deed of accession to any applicable shareholders’ agreement or like document.

 

14


9. LAPSE OF PLAN SECURITIES

Lapse of Plan Securities

 

9.1 A Plan Security lapses on the earlier of:

 

  9.1.1 the Exercise Date;

 

  9.1.2 an Exit Event occurring;

 

  9.1.3 ten years from the Date of Grant or any earlier date determined by the Board and set out in the Offer or Confirmation;

 

  9.1.4 the date the Board determines that the Plan Security should lapse because the Participant (in the Board’s opinion):

 

  9.1.4.1 has breached a material obligation under the Plan or any other staff equity participation arrangement;

 

  9.1.4.2 has been dismissed or removed from office for a reason which entitles a body corporate in the Group to dismiss the Participant without notice;

 

  9.1.4.3 has committed any act of fraud, defalcation or serious misconduct in relation to the affairs of that body corporate (whether or not charged with an offence) or gross dereliction of duty;

 

  9.1.4.4 has become insolvent, declared himself or herself or become bankrupt or entered into administration or does something or has done something which prevents the Participant from or will result in the Participant being unable to properly perform his or her duties; or

 

  9.1.4.5 has done any act which brings a body corporate in the Group into disrepute; or

 

  9.1.5 the date the Participant holding the Plan Security stops being employed by the Company or any Participating Subsidiary and is a Bad Leaver; or

 

  9.1.6 180 days after the date the Participant holding the Plan Security stops being employed by the Company or any Participating Subsidiary and is a Good Leaver B.

Rights cease

 

9.2 If a Plan Security lapses, all rights of a Participant under the Plan in respect of the Plan Security cease.

 

10. DEALINGS WITH PLAN SECURITY

Plan Securities personal

 

10.1 Except where Plan Securities have been transferred under Rule 10.3, Plan Securities held by a Participant are personal to the Participant and may not be exercised by any other person.

 

15


No unauthorised disposal

 

10.2 Except as permitted under Rule 10.3, a Participant must not dispose of or grant any Security Interest over or otherwise deal with Plan Securities or any interest in Plan Securities, and any Security Interest or disposal or dealing will not be recognised in any manner by the Company.

No transfers

 

10.3 Subject to these Rules, a Participant may not dispose or transfer Plan Securities or any interest in Plan Securities without the prior written consent of the Board. Any purported disposal or transfer not in accordance with this Rule 10.3 is void and of no effect.

 

11. ADJUSTMENTS AND OTHER MATTERS

New issues

 

11.1 Participants are not entitled to participate in any new issue of securities in the Company to all existing holders of Shares unless:

 

  11.1.1 they have become entitled to exercise their Plan Securities under the Plan; and

 

  11.1.2 they do so before the record date for the determination of entitlements to the new issue of securities and participate as a result of being holders of Shares.

 

11.2 The Company must give Participants notice of any new issue of securities before the record date for determining entitlements to the new issue.

Bonus issues

 

11.3 If the Company makes a bonus issue of Shares or other securities to all existing holders of Shares (except an issue in lieu or in satisfaction of dividends or by way of dividend reinvestment) and any Plan Security has not been exercised before the record date for determining entitlements to the bonus issue, then the number of underlying Shares over which the Plan Security is exercisable is increased by the number of Shares which the Participant would have received if the Participant had exercised the Plan Security before the record date.

Re-organisation of capital

 

11.4 If there is a reorganisation of capital of the Company, then the rights of a Participant (including the number of Plan Securities to which each Participant is entitled and/or the Exercise Price) are changed to the extent necessary to comply with the listing rules of the Australian Stock Exchange or any other applicable exchange, from time to time, applying to a reorganisation of capital at the time of the reorganisation, whether or not the Company is listed at that time.

Winding up

 

11.5 If a resolution for a members’ voluntary winding up of the Company is proposed (except for the purpose of a reconstruction or amalgamation) the Board may, in its absolute discretion, give written notice to Participants of the proposed resolution. Subject to the Exercise Conditions (or waiver or reduction of them), the Participants may, during the period referred to in the notice, exercise their Plan Securities. However, Plan Securities cannot be exercised under this Rule 11.5 after the period referred to in the notice.

 

16


Reorganisation of the Group

 

11.6 If at any time during which Plan Securities remain outstanding, the Board approves a reorganisation of the Group such that the Company is no longer to be the holding company of the Group, then the Board may require that each Participant exchange their Plan Securities for similar securities in the new holding company of the Group by notice in writing to each Participant.

 

11.7 If the Board delivers a notice under Rule 11.6, each Participant must, in a timely manner, do all things reasonably requested by the Board, including signing all documents, delivering all documents (including any security certificates), voting all securities, accepting such new securities, forfeiting all rights and releasing all persons, to give effect to the reorganisation of the Group.

 

11.8 Each Participant irrevocably appoints any two directors of the Company jointly as its agent and attorney with power to give effect to the reorganisation of the Group as contemplated in Rule 11.6, including the power of any two directors together to execute all necessary documents and deliver and accept all securities required to complete the exchange on behalf of that Participant.

IPO

 

11.9 If the Company undertakes an IPO, each Participant agrees to:

 

  11.9.1 be bound by any applicable escrow or restriction on trading placed on any Plan Securities (and any Shares issued on exercise of any Plan Securities) by the applicable listing rules of the relevant stock exchange on which the Company is admitted to trading; and

 

  11.9.2 execute any documents reasonably required to give effect to such escrow or restriction on trading.

 

11.10 If the Company undertakes an IPO, each Participant agrees that the on-sale of Shares issued on the exercise of a Plan Security may be restricted by law in the period following the IPO.

Fractions of Shares

 

11.11 For the purposes of this Rule 11, if Plan Securities are exercised simultaneously, then the Participant may aggregate the number of Shares or fractions of Shares for which the Participant may subscribe. Fractions in the aggregate number only will be disregarded in determining the total entitlement of a Participant.

Calculations and adjustments

 

11.12 Any calculation or adjustment required under this Rule 11 will be made by the Board and is, in the absence of manifest error, final and conclusive and binding on the Company and the Participant.

 

17


Notice of change

 

11.13 The Company must within a reasonable period give each Participant notice of any change under these Rules to the number of Shares that the Participant will receive on exercise of a Plan Security.

 

12. ADMINISTRATION OF THE PLAN

Powers of Board

 

12.1 The Plan is administered by the Board. The Board has power to:

 

  12.1.1 determine appropriate procedures and make regulations consistent with these Rules for the administration and operation of the Plan;

 

  12.1.2 resolve conclusively all questions of fact or interpretation arising in connection with the Plan;

 

  12.1.3 terminate or suspend the operation of the Plan at any time, if the termination or suspension does not adversely affect or prejudice the rights of Participants holding Plan Securities at that time;

 

  12.1.4 delegate any functions and powers it may consider appropriate, for the efficient administration of the Plan, to any person or persons whom the Board reasonably believes to be capable of performing those functions and exercising those powers;

 

  12.1.5 take and rely upon independent professional or expert advice in or in relation to the exercise of any of their powers or discretions under these Rules; and

 

  12.1.6 administer the Plan in accordance with these Rules as and to the extent provided in these Rules.

Determination

 

12.2 Any power or discretion conferred on the Board by these Rules may be exercised by the Board in the interests or for the benefit of the Company, and the Board is not, in exercising the power or discretion, under any fiduciary or other obligation to any other person.

Exercise of powers or discretion

 

12.3 The Board has absolute discretion in any determination, decision, approval or opinion by it under these Rules.

Expenses and costs

 

12.4 Subject to these Rules, the Company and each Participating Subsidiary must pay any expense, cost and charge incurred in the administration of the Plan in the amounts and proportions as agreed by them.

Tax

 

12.5 Except as required by law, the Company is not responsible for any Tax which may become payable by a Participant in connection with the issue of Shares on the exercise of Plan Securities or any other dealing by a Participant with the Plan Securities or Shares.

 

18


12.6 If the Company is obligated in any jurisdiction to withhold Tax or is secondarily liable for any Tax, then the Company is authorised to deduct such Tax from any payments due to a Participant or to take such steps as appropriate to collect Tax from a Participant (which may include selling Plan Securities or Shares of a Participant).

 

12.7 The Company may be required by law to provide information about a Participant to Tax authorities and each Participant agrees to the Company providing such information.

 

13. AMENDMENTS

Board may amend

 

13.1 Subject to Rule 13.2, the Board may at any time amend these Rules, or waive or modify the application of these Rules in relation to any Participant.

Consent of Participants

 

13.2 If a proposed amendment to these Rules would adversely affect the rights of Participants in respect of any Plan Securities then held by them, the Board must obtain the consent of Participants holding not less than 75% of the Plan Securities affected adversely by the proposed amendment.

 

14. RIGHTS OF PARTICIPANTS

No conferred rights

 

14.1 These Rules:

 

  14.1.1 do not confer on an Employee the right to receive an Offer;

 

  14.1.2 do not confer on a Participant the right to continue as an Employee;

 

  14.1.3 do not affect any right the Company or any Participating Subsidiary may have to terminate the employment of a Participant; and

 

  14.1.4 may not be used to increase damages in any action brought against the Company or any Participating Subsidiary in respect of that termination.

Other schemes

 

14.2 Participation in the Plan does not affect, and is not affected by, participation in any other employee share or option scheme operated by the Company unless the terms of the other scheme provide otherwise.

General meetings

 

14.3 A Participant, as a Participant alone, may not attend or vote at general meetings of holders of Shares.

 

15. NOTICES

 

15.1 Notices may be given by the Company to Participants in any manner as the Board may from time to time determine.

 

19


16. GOVERNING LAW

Governing law

 

16.1 These Rules and the rights and obligations of Participants under the Plan are governed by the law of Ireland and each Participant irrevocably and unconditionally submits to the non-exclusive jurisdiction of the courts of Ireland.

 

20

EX-10.18 23 d775834dex1018.htm EX-10.18 EX-10.18

EXHIBIT 10.18

NEXVET BIOPHARMA PUBLIC LIMITED COMPANY

2014 EQUITY INCENTIVE PLAN


1. Establishment, Purpose and Term of Plan

     1   

1.1 Establishment

     1   

1.2 Purpose

     1   

1.3 Term of Plan

     1   

2. Definitions and Construction

     1   

2.1 Definitions

     1   

2.2 Construction

     8   

3. Administration

     8   

3.1 Administration by the Committee

     8   

3.2 Authority of Officers

     8   

3.3 Administration with Respect to Insiders

     9   

3.4 Committee Complying with Section 162(m)

     9   

3.5 Powers of the Committee

     9   

3.6 Option Repricing

     10   

3.7 Indemnification

     10   

4. Shares Subject to Plan

     10   

4.1 Maximum Number of Shares Issuable

     10   

4.2 Annual Increase in Maximum Number of Shares Issuable

     11   

4.3 Share Counting

     11   

4.4 Adjustments for Changes in Capital Structure

     11   

4.5 Assumption or Substitution of Awards

     12   

5. Eligibility, Participation, Minimum Exercise/Purchase Price, and Incentive Stock Option Limitations

     12   

5.1 Persons Eligible for Awards

     12   

5.2 Participation in the Plan

     12   

5.3 Minimum Exercise Purchase Price

     12   

5.4 Incentive Stock Option Limitations

     12   

6. Share Options

     13   

6.1 Exercise Price

     13   

6.2 Exercisability and Term of Options

     13   

6.3 Payment of Exercise Price

     14   

6.4 Effect of Termination of Service

     15   

6.5 Transferability of Options

     16   

 

-i-


7. Restricted Share Units

     16   

7.1 Grant of Restricted Share Unit Awards

     16   

7.2 Purchase Price

     16   

7.3 Vesting

     17   

7.4 Voting Rights, Dividend Equivalent Rights, and Distributions

     17   

7.5 Effect of Termination of Service

     18   

7.6 Settlement of Restricted Share Unit Awards

     18   

7.7 Nontransferability of Restricted Share Unit Awards

     18   

8. Performance Awards

     18   

8.1 Types of Performance Awards Authorized

     18   

8.2 Initial Value of Performance Shares and Performance Units

     18   

8.3 Establishment of Performance Period, Performance Goals and Performance Award Formula

     19   

8.4 Measurement of Performance Goals

     19   

8.5 Settlement of Performance Awards

     20   

8.6 Voting Rights; Dividend Equivalent Rights and Distributions

     21   

8.7 Effect of Termination of Service

     22   

8.8 Nontransferability of Performance Awards

     22   

9. Cash-Based Awards and Other Share-Based Awards

     23   

9.1 Grant of Cash-Based Awards

     23   

9.2 Grant of Other Share-Based Awards

     23   

9.3 Value of Cash-Based and Other Share-Based Awards

     23   

9.4 Payment or Settlement of Cash-Based Awards and Other Share-Based Awards

     23   

9.5 Voting Rights; Dividend Equivalent Rights and Distributions

     23   

9.6 Effect of Termination of Service

     24   

9.7 Nontransferability of Cash-Based Awards and Other Share-Based Awards

     24   

10. Standard Forms of Award Agreement

     24   

10.1 Award Agreements

     24   

10.2 Authority to Vary Terms

     24   

11. Change in Control

     25   

11.1 Effect of Change in Control on Awards

     25   

11.2 Effect of Change in Control on Nonemployee Director Awards

     26   

11.3 Federal Excise Tax Under Section 4999 of the Code

     26   

 

-ii-


12. Compliance with Applicable Law

     27   

13. Compliance with Section 409A

     28   

13.1 Awards Subject to Section 409A

     28   

13.2 Deferral and/or Distribution Elections

     28   

13.3 Subsequent Elections

     28   

13.4 Payment of Section 409A Deferred Compensation

     29   

14. Tax Withholding

     31   

14.1 Tax Withholding in General

     31   

14.2 Withholding in or Directed Sale of Shares

     31   

15. Amendment, Suspension or Termination of Plan

     32   

16. Miscellaneous Provisions

     32   

16.1 Repurchase Rights

     32   

16.2 Forfeiture Events

     32   

16.3 Provision of Information

     33   

16.4 Rights as Employee, Consultant or Director

     33   

16.5 Rights as a Shareholder

     33   

16.6 Delivery of Title to Shares

     33   

16.7 Fractional Shares

     33   

16.8 Retirement and Welfare Plans

     33   

16.9 Beneficiary Designation

     34   

16.10 Severability

     34   

16.11 No Constraint on Corporate Action

     34   

16.12 Unfunded Obligation

     34   

16.13 No Representations or Covenants with respect to Tax Qualification

     34   

16.14 Choice of Law

     35   

 

-iii-


Nexvet Biopharma Public Limited Company

2014 Equity Incentive Plan

 

  1. ESTABLISHMENT, PURPOSE AND TERM OF PLAN.

1.1 Establishment. The Nexvet Biopharma Public Limited Company 2014 Equity Incentive Plan (the Plan) is hereby established effective as of the day immediately preceding the effective date of the initial registration by the Company of its Shares under Section 12 of the Securities Act (the Effective Date).

1.2 Purpose. The purpose of the Plan is to advance the interests of the Participating Company Group and its shareholders by providing an incentive to attract, retain and reward persons performing services for the Participating Company Group and by motivating such persons to contribute to the growth and profitability of the Participating Company Group. The Plan seeks to achieve this purpose by providing for Awards in the form of Options, Restricted Share Units, Performance Shares, Performance Units, Cash-Based Awards and Other Share-Based Awards.

1.3 Term of Plan. The Plan shall continue in effect until its termination by the Committee; provided, however, that all Awards shall be granted, if at all, within ten (10) years from the Effective Date.

 

  2. DEFINITIONS AND CONSTRUCTION.

2.1 Definitions. Whenever used herein, the following terms shall have their respective meanings set forth below:

(a) Affiliate means (i) a parent entity, other than a Parent Corporation, that directly, or indirectly through one or more intermediary entities, controls the Company or (ii) a subsidiary entity, other than a Subsidiary Corporation, that is controlled by the Company directly or indirectly through one or more intermediary entities. For this purpose, the terms “parent,” “subsidiary,” “control” and “controlled by” shall have the meanings assigned such terms for the purposes of registration of securities on Form S-8 under the Securities Act.

(b) Award means any Option, Restricted Share Unit, Performance Share, Performance Unit, Cash-Based Award, or Other Share-Based Award granted under the Plan.

(c) Award Agreement means a written or electronic agreement between the Company and a Participant setting forth the terms, conditions and restrictions applicable to an Award.

(d) Board means the Board of Directors of the Company.

(e) Cash-Based Award means an Award denominated in cash and granted pursuant to Section 9.


(f) “Cashless Exercise” means a Cashless Exercise as defined in Section 6.3(b)(i).

(g) “Cause” means, unless such term or an equivalent term is otherwise defined by the applicable Award Agreement or other written agreement between a Participant and a Participating Company applicable to an Award, any of the following: (i) the Participant’s theft, dishonesty, willful misconduct, breach of fiduciary duty for personal profit, or falsification of any Participating Company documents or records; (ii) the Participant’s material failure to abide by a Participating Company’s code of conduct or other policies (including, without limitation, policies relating to confidentiality and reasonable workplace conduct); (iii) the Participant’s unauthorized use, misappropriation, destruction or diversion of any tangible or intangible asset or corporate opportunity of a Participating Company (including, without limitation, the Participant’s improper use or disclosure of a Participating Company’s confidential or proprietary information); (iv) any intentional act by the Participant which has a material detrimental effect on a Participating Company’s reputation or business; (v) the Participant’s repeated failure to perform any reasonable assigned duties after written notice from a Participating Company of, and a reasonable opportunity to cure, such failure; (vi) any material breach by the Participant of any employment, service, non-disclosure, non-competition, non-solicitation or other similar agreement between the Participant and a Participating Company, which breach is not cured pursuant to the terms of such agreement; or (vii) the Participant’s conviction (including any plea of guilty or nolo contendere) of any criminal act involving fraud, dishonesty, misappropriation or moral turpitude, or which impairs the Participant’s ability to perform his or her duties with a Participating Company.

(h) “Change in Control” means, unless such term or an equivalent term is otherwise defined by the applicable Award Agreement or other written agreement between the Participant and a Participating Company applicable to an Award, the occurrence of any one or a combination of the following:

(i) any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becomes the “beneficial owner” (as such term is defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing more than fifty percent (50%) of the total Fair Market Value or total combined voting power of the Company’s then-outstanding securities entitled to vote generally in the election of Directors; provided, however, that a Change in Control shall not be deemed to have occurred if such degree of beneficial ownership results from any of the following: (A) an acquisition by any person who on the Effective Date is the beneficial owner of more than fifty percent (50%) of such voting power, (B) any acquisition directly from the Company, including, without limitation, pursuant to or in connection with a public offering of securities, (C) any acquisition by the Company, (D) any acquisition by a trustee or other fiduciary under an employee benefit plan of a Participating Company, or (E) any acquisition by an entity owned directly or indirectly by the shareholders of the Company in substantially the same proportions as their ownership of the voting securities of the Company; or

(ii) an Ownership Change Event or series of related Ownership Change Events (collectively, a “Transaction”) in which the shareholders of the Company immediately before the Transaction do not retain immediately after the Transaction direct or

 

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indirect beneficial ownership of more than fifty percent (50%) of the total combined voting power of the outstanding securities entitled to vote generally in the election of Directors or, in the case of an Ownership Change Event described in Section 2.1(cc)(iii), the entity to which the assets of the Company were transferred (the “Transferee”), as the case may be; or

(iii) a date specified by the Committee following approval by the shareholders of a plan of complete liquidation or dissolution of the Company;

provided, however, that a Change in Control shall be deemed not to include a transaction described in subsections (i) or (ii) of this Section 2.1(h) in which a majority of the members of the board of directors of the continuing, surviving or successor entity, or parent thereof, immediately after such transaction is comprised of Directors who were Directors of the Company immediately preceding the commencement of the actions leading up to the Change in Control (but excluding a director who was elected or nominated in connection with an actual or threatened proxy contest relating to the election of directors of the Company).

For purposes of the preceding sentence, indirect beneficial ownership shall include, without limitation, an interest resulting from ownership of the voting securities of one or more corporations or other business entities which own the Company or the Transferee, as the case may be, either directly or through one or more subsidiary corporations or other business entities. The Committee shall determine whether multiple events described in subsections (i), (ii) and (iii) of this Section 2.1(h) are related and to be treated in the aggregate as a single Change in Control, and its determination shall be final, binding and conclusive.

(i) “Code” means the Internal Revenue Code of 1986, as amended, and any applicable regulations and administrative guidelines promulgated thereunder.

(j) “Committee” means the Compensation Committee of the Board and such other committee or subcommittee of the Board, if any, duly appointed to administer the Plan and having such powers in each instance as shall be specified by the Board. If, at any time, there is no committee of the Board then authorized or properly constituted to administer the Plan, the Board shall exercise all of the powers of the Committee granted herein, and, in any event, the Board may in its discretion exercise any or all of such powers.

(k) “Company” means Nexvet Biopharma Public Limited Company, a corporation incorporated in Ireland, and any successor corporation thereto.

(l) “Consultant” means a person engaged to provide consulting or advisory services (other than as an Employee or a Director) to a Participating Company, provided that the identity of such person, the nature of such services or the entity to which such services are provided would not preclude the Company from offering or selling securities to such person pursuant to the Plan in reliance on registration on Form S-8 under the Securities Act.

(m) “Covered Employee” means, at any time the Plan is subject to Section 162(m), any Employee who is or may reasonably be expected to become a “covered employee” as defined in Section 162(m), or any successor statute, and who is designated, either as an individual Employee or a member of a class of Employees, by the Committee no later than the earlier of (i) the date that is ninety (90) days after the beginning of the Performance Period, or (ii) the date on which twenty-five percent (25%) of the Performance Period has elapsed, as a “Covered Employee” under this Plan for such applicable Performance Period.

 

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(n) “Director” means a member of the Board.

(o) “Disability” means, unless such term or an equivalent term is otherwise defined by the applicable Award Agreement or other written agreement between the Participant and a Participating Company applicable to an Award, the permanent and total disability of the Participant, within the meaning of Section 22(e)(3) of the Code.

(p) “Dividend Equivalent Right” means the right of a Participant, granted at the discretion of the Committee or as otherwise provided by the Plan, to receive a credit for the account of such Participant in an amount equal to the cash dividends paid on one Share for each Share represented by an Award held by such Participant.

(q) “Employee” means any person treated as an employee (including an Officer or a Director who is also treated as an employee) in the records of a Participating Company and, with respect to any Incentive Stock Option granted to such person, who is an employee for purposes of Section 422 of the Code; provided, however, that neither service as a Director nor payment of a Director’s fee shall be sufficient to constitute employment for purposes of the Plan. The Company shall determine in good faith and in the exercise of its discretion whether an individual has become or has ceased to be an Employee and the effective date of such individual’s employment or termination of employment, as the case may be. For purposes of an individual’s rights, if any, under the terms of the Plan as of the time of the Company’s determination of whether or not the individual is an Employee, all such determinations by the Company shall be final, binding and conclusive as to such rights, if any, notwithstanding that the Company or any court of law or governmental agency subsequently makes a contrary determination as to such individual’s status as an Employee.

(r) “Exchange Act” means the Securities Exchange Act of 1934, as amended.

(s) “Fair Market Value” means, as of any date, the value of a Share or other property as determined by the Committee, in its discretion, or by the Company, in its discretion, if such determination is expressly allocated to the Company herein, subject to the following:

(i) Except as otherwise determined by the Committee, if, on such date, the Shares are listed or quoted on a national or regional securities exchange or quotation system, the Fair Market Value of a Share shall be the closing price of a Share as quoted on the national or regional securities exchange or quotation system constituting the primary market for the Shares, as reported in The Wall Street Journal or such other source as the Company deems reliable. If the relevant date does not fall on a day on which the Shares have traded on such securities exchange or quotation system, the date on which the Fair Market Value shall be established shall be the last day on which the Shares were so traded or quoted prior to the relevant date, or such other appropriate day as shall be determined by the Committee, in its discretion.

 

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(ii) Notwithstanding the foregoing, the Committee may, in its discretion, determine the Fair Market Value of a Share on the basis of the opening, closing, or average of the high and low sale prices of a Share on such date or the preceding trading day, the actual sale price of a Share received by a Participant, any other reasonable basis using actual transactions in the Shares as reported on a national or regional securities exchange or quotation system, or on any other basis consistent with the requirements of Section 409A (including, but not limited to, the determination of Fair Market Value based on the average selling price of the Shares during a specified period that is within thirty (30) days before or thirty (30) days after such date, provided that, with respect to the grant of an Option, the commitment to grant such Award based on such valuation method must be irrevocable before the beginning of the specified period). The Committee may vary its method of determination of the Fair Market Value as provided in this Section for different purposes under the Plan to the extent consistent with the requirements of Section 409A.

(iii) If, on such date, the Shares are not listed or quoted on a national or regional securities exchange or quotation system, the Fair Market Value of a Share shall be as determined by the Committee in good faith without regard to any restriction other than a restriction which, by its terms, will never lapse, and in a manner consistent with the requirements of Section 409A.

(t) “Incentive Stock Option” means an Option intended to be (as set forth in the Award Agreement) and which qualifies as an incentive stock option within the meaning of Section 422(b) of the Code.

(u) “Insider” means an Officer, a Director or other person whose transactions in Shares are subject to Section 16 of the Exchange Act.

(v) Net Exercise means a Net Exercise as defined in Section 6.3(b)(iii).

(w) Nonemployee Director means a Director who is not an Employee.

(x) “Nonemployee Director Award” means any Award granted to a Nonemployee Director.

(y) “Nonstatutory Stock Option” means an Option not intended to be (as set forth in the Award Agreement) or which does not qualify as an Incentive Stock Option.

(z) “Officer” means any person designated by the Board as an officer of the Company.

(aa) “Option” means an Incentive Stock Option or a Nonstatutory Stock Option granted pursuant to the Plan.

(bb) “Other Share-Based Award” means an Award denominated in Shares and granted pursuant to Section 9.

 

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(cc) “Ownership Change Event” means the occurrence of any of the following with respect to the Company: (i) the direct or indirect sale or exchange in a single or series of related transactions by the shareholders of the Company of securities of the Company representing more than fifty percent (50%) of the total combined voting power of the Company’s then outstanding securities entitled to vote generally in the election of Directors; (ii) a merger or consolidation in which the Company is a party; or (iii) the sale, exchange, or transfer of all or substantially all of the assets of the Company (other than a sale, exchange or transfer to one or more subsidiaries of the Company).

(dd) “Parent Corporation” means any present or future “parent corporation” of the Company, as defined in Section 424(e) of the Code.

(ee) “Participant” means any eligible person who has been granted one or more Awards.

(ff) “Participating Company” means the Company or any Parent Corporation, Subsidiary Corporation, or Affiliate.

(gg) “Participating Company Group” means, at any point in time, the Company and all other entities collectively which are then Participating Companies.

(hh) “Performance Award” means an Award of Performance Shares or Performance Units.

(ii) “Performance Award Formula” means, for any Performance Award, a formula or table established by the Committee pursuant to Section 8.3 which provides the basis for computing the value of a Performance Award at one or more levels of attainment of the applicable Performance Goal(s) measured as of the end of the applicable Performance Period.

(jj) “Performance-Based Compensation” means compensation under an Award that satisfies the requirements of Section 162(m) for certain performance-based compensation paid to Covered Employees.

(kk) “Performance Goal” means a performance goal established by the Committee pursuant to Section 8.3.

(ll) “Performance Period” means a period established by the Committee pursuant to Section 10.3 at the end of which one or more Performance Goals are to be measured.

(mm) “Performance Share” means a right granted to a Participant pursuant to Section 8 to receive a payment equal to the value of a Performance Share, as determined by the Committee, based upon attainment of applicable Performance Goal(s).

(nn) “Performance Unit” means a right granted to a Participant pursuant to Section 8 to receive a payment equal to the value of a Performance Unit, as determined by the Committee, based upon attainment of applicable Performance Goal(s).

 

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(oo) Restricted Share Unit means a right granted to a Participant pursuant to Section 7 to receive on a future date or the occurrence of a future event a Share or cash in lieu thereof, as determined by the Committee.

(pp) Rule 16b-3 means Rule 16b-3 under the Exchange Act, as amended from time to time, or any successor rule or regulation.

(qq) Section 162(m) means Section 162(m) of the Code.

(rr) Section 409A means Section 409A of the Code.

(ss) Section 409A Deferred Compensation means compensation provided pursuant to an Award that constitutes nonqualified deferred compensation within the meaning of Section 409A.

(tt) Securities Act means the Securities Act of 1933, as amended.

(uu) Service means a Participant’s employment or service with the Participating Company Group, whether as an Employee, a Director or a Consultant. Unless otherwise provided by the Committee, a Participant’s Service shall not be deemed to have terminated merely because of a change in the capacity in which the Participant renders Service or a change in the Participating Company for which the Participant renders Service, provided that there is no interruption or termination of the Participant’s Service. Furthermore, a Participant’s Service shall not be deemed to have been interrupted or terminated if the Participant takes any military leave, sick leave, or other bona fide leave of absence approved by the Company. However, unless otherwise provided by the Committee, if any such leave taken by a Participant exceeds ninety (90) days, then on the ninety-first (91st) day following the commencement of such leave the Participant’s Service shall be deemed to have terminated, unless the Participant’s right to return to Service is guaranteed by statute or contract. Notwithstanding the foregoing, unless otherwise designated by the Company or required by law, an unpaid leave of absence shall not be treated as Service for purposes of determining vesting under the Participant’s Award Agreement. A Participant’s Service shall be deemed to have terminated either upon an actual termination of Service or upon the business entity for which the Participant performs Service ceasing to be a Participating Company. Subject to the foregoing, the Company, in its discretion, shall determine whether the Participant’s Service has terminated and the effective date of and reason for such termination.

(vv) Shares means the ordinary shares of the Company, as adjusted from time to time in accordance with Section 4.4.

(ww) Share Tender Exercise means a Share Tender Exercise as defined in Section 6.3(b)(ii).

(xx) Subsidiary Corporation means any present or future “subsidiary corporation” of the Company, as defined in Section 424(f) of the Code.

(yy) Ten Percent Owner means a Participant who, at the time an Option is granted to the Participant, owns securities possessing more than ten percent (10%) of the total combined voting power of all classes of securities of a Subsidiary Corporation or a Parent Corporation within the meaning of Section 422(b)(6) of the Code.

 

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(zz) Trading Compliance Policy means the written policy of the Company pertaining to the purchase, sale, transfer or other disposition of the Company’s equity securities by Directors, Officers, Employees or other service providers who may possess material, nonpublic information regarding the Company or its securities.

(aaa) Vesting Conditions mean those conditions established in accordance with the Plan prior to the satisfaction of which an Award or shares subject to an Award remain subject to forfeiture or a repurchase option in favor of the Company exercisable for the Participant’s monetary purchase price, if any, for such shares upon the Participant’s termination of Service or failure of a performance condition to be satisfied.

2.2 Construction. Captions and titles contained herein are for convenience only and shall not affect the meaning or interpretation of any provision of the Plan. Except when otherwise indicated by the context, the singular shall include the plural and the plural shall include the singular. Use of the term “or” is not intended to be exclusive, unless the context clearly requires otherwise.

 

  3. ADMINISTRATION.

3.1 Administration by the Committee. The Board has delegated the administration of the Plan to the Committee including the authority to grant one or more Awards without the further approval of the Board. The Plan shall be administered by the Committee. All questions of interpretation of the Plan, of any Award Agreement or of any other form of agreement or other document employed by the Company in the administration of the Plan or of any Award shall be determined by the Committee, and such determinations shall be final, binding and conclusive upon all persons having an interest in the Plan or such Award, unless fraudulent or made in bad faith. Any and all actions, decisions and determinations taken or made by the Committee in the exercise of its discretion pursuant to the Plan or Award Agreement or other agreement thereunder (other than determining questions of interpretation pursuant to the preceding sentence) shall be final, binding and conclusive upon all persons having an interest therein. All expenses incurred in connection with the administration of the Plan shall be paid by the Company.

3.2 Authority of Officers. Any Officer shall have the authority to act on behalf of the Company with respect to any matter, right, obligation, determination or election that is the responsibility of or that is allocated to the Company herein, provided that the Officer has apparent authority with respect to such matter, right, obligation, determination or election. To the extent permitted by applicable law, the Board or the Committee may, in its discretion, delegate to a committee comprised of one or more Officers and/or Directors the authority to grant one or more Awards of Options or Restricted Share Units, without further approval of the Board or the Committee, to any Employee, other than an Employee who, at the time of such grant, is an Insider or a Covered Employee, and to exercise such other powers under the Plan as the Board or the Committee may determine; provided, however, that (a) the Board and/or the Committee shall fix the maximum number of shares subject to Awards that may be granted by

 

8


such Officers and/or Directors, (b) each such Award shall be subject to the terms and conditions of the appropriate standard form of Award Agreement approved by the Board or the Committee and shall conform to the provisions of the Plan, and (c) each such Award shall conform to such other limits and guidelines as may be established from time to time by the Board and/or the Committee.

3.3 Administration with Respect to Insiders. With respect to participation by Insiders in the Plan, at any time that any class of equity security of the Company is registered pursuant to Section 12 of the Exchange Act, the Plan shall be administered in compliance with the requirements, if any, of Rule 16b-3.

3.4 Committee Complying with Section 162(m). If the Company is a “publicly held corporation” within the meaning of Section 162(m), the Board may establish a Committee of “outside directors” within the meaning of Section 162(m) to approve the grant of any Award intended to result in the payment of Performance-Based Compensation.

3.5 Powers of the Committee. In addition to any other powers set forth in the Plan and subject to the provisions of the Plan, the Committee shall have the full and final power and authority, in its discretion:

(a) to determine the persons to whom, and the time or times at which, Awards shall be granted and the number of Shares, units or monetary value to be subject to each Award;

(b) to determine the type of Award granted;

(c) to determine the Fair Market Value of Shares or other property;

(d) to determine whether an Award shall be intended to result in Performance-Based Compensation;

(e) to determine the terms, conditions and restrictions applicable to each Award (which need not be identical) and any shares acquired pursuant thereto, including, without limitation, (i) the exercise or purchase price of shares pursuant to any Award, (ii) the method of payment for shares purchased pursuant to any Award, (iii) the method for satisfaction of any tax withholding obligation arising in connection with any Award, including by the withholding or delivery of Shares, (iv) the timing, terms and conditions of the exercisability or vesting of any Award or any shares acquired pursuant thereto, (v) the Performance Measures, Performance Period, Performance Award Formula and Performance Goals applicable to any Award and the extent to which such Performance Goals have been attained, (vi) the time of expiration of any Award, (vii) the effect of any Participant’s termination of Service on any of the foregoing, and (viii) all other terms, conditions and restrictions applicable to any Award or shares acquired pursuant thereto not inconsistent with the terms of the Plan;

(f) to determine whether an Award will be settled in Shares, cash, other property or in any combination thereof;

(g) to approve one or more forms of Award Agreement;

 

9


(h) to amend, modify, extend, cancel or renew any Award or to waive any restrictions or conditions applicable to any Award or any shares acquired pursuant thereto;

(i) to accelerate, continue, extend or defer the exercisability or vesting of any Award or any shares acquired pursuant thereto, including with respect to the period following a Participant’s termination of Service;

(j) to prescribe, amend or rescind rules, guidelines and policies relating to the Plan, or to adopt sub-plans or supplements to, or alternative versions of, the Plan, including, without limitation, as the Committee deems necessary or desirable to comply with the laws of, or to accommodate the tax policy, accounting principles or custom of, foreign jurisdictions whose residents may be granted Awards; and

(k) to correct any defect, supply any omission or reconcile any inconsistency in the Plan or any Award Agreement and to make all other determinations and take such other actions with respect to the Plan or any Award as the Committee may deem advisable to the extent not inconsistent with the provisions of the Plan or applicable law.

3.6 Option Repricing. The Committee shall have the authority, without additional approval by the shareholders of the Company, to approve a program providing for either (a) the cancellation of outstanding Options having exercise prices per share greater than the then Fair Market Value of a Share (“Underwater Awards”) and the grant in substitution for Underwater Awards of new Options covering the same or a different number of shares but having a lower exercise price per share then on the original grant date, or payments in cash, or (b) the substitution of other Awards for Underwater Awards.

3.7 Indemnification. In addition to such other rights of indemnification as they may have as members of the Board or the Committee or as officers or employees of the Participating Company Group, to the extent permitted by applicable law, members of the Board or the Committee and any officers or employees of the Participating Company Group to whom authority to act for the Board, the Committee or the Company is delegated shall be indemnified by the Company against all reasonable expenses, including attorneys’ fees, actually and necessarily incurred in connection with the defense of any action, suit or proceeding, or in connection with any appeal therein, to which they or any of them may be a party by reason of any action taken or failure to act under or in connection with the Plan, or any right granted hereunder, and against all amounts paid by them in settlement thereof (provided such settlement is approved by independent legal counsel selected by the Company) or paid by them in satisfaction of a judgment in any such action, suit or proceeding, except in relation to matters as to which it shall be adjudged in such action, suit or proceeding that such person is liable for gross negligence, bad faith or intentional misconduct in duties; provided, however, that within sixty (60) days after the institution of such action, suit or proceeding, such person shall offer to the Company, in writing, the opportunity at its own expense to handle and defend the same.

 

  4. SHARES SUBJECT TO PLAN.

4.1 Maximum Number of Shares Issuable. Subject to adjustment as provided in Sections 4.2, 4.3, and 4.4, the maximum aggregate number of Shares that may be

 

10


issued under the Plan shall be equal to 1,280,000 shares and shall consist of authorized but unissued or reacquired Shares or any combination thereof. Notwithstanding the forgoing, and subject to adjustment pursuant to Section 4.4, the maximum aggregate number of Shares that may be subject to issuance at any given time in connection with outstanding Awards granted under the Plan shall not exceed a number equal to ten percent (10%) of the total number of issued and outstanding Shares (calculated on a non-diluted basis). All of the Shares issuable under the Plan, after taking into account any applicable adjustment under Sections 4.2, 4.3, and 4.4 may be issued as Incentive Stock Options.

4.2 Annual Increase in Maximum Number of Shares Issuable. Subject to adjustment as provided in Section 4.4, the maximum aggregate number of Shares that may be issued under the Plan as set forth in Section 4.1 shall be cumulatively increased on July 1, 2015 and on each subsequent July 1 through and including July 1, 2024, by a number of shares (the “Annual Increase”) equal to the smaller of (a) four percent (4%) of the number of Shares of the Company issued and outstanding on the immediately preceding June 30, or (b) an amount determined by the Board.

4.3 Share Counting. If an outstanding Award for any reason expires or is terminated or canceled without having been exercised or settled in full, or if Shares acquired pursuant to an Award subject to forfeiture or repurchase are forfeited or repurchased by the Company for an amount not greater than the Participant’s purchase price, the Shares allocable to the terminated portion of such Award or such forfeited or repurchased Shares shall again be available for issuance under the Plan. Shares shall not be deemed to have been issued pursuant to the Plan with respect to any portion of an Award that is settled in cash. Shares withheld or reacquired by the Company in satisfaction of tax withholding obligations pursuant to Section 14.2 with respect to Options shall not be available for issuance under the Plan, however, shares withheld for such basis on other Awards shall again be available for issuance under the Plan. If the exercise price of an Option is paid by means of a Net Exercise, then the number of Shares available for issuance under the Plan shall be reduced by the gross number of shares subject to the Option exercise. If the exercise price of an Option is paid by tender to the Company, or attestation to the ownership, of Shares owned by the Participant, the number of shares available for issuance under the Plan shall be reduced by the gross number of shares for which the Option is exercised.

4.4 Adjustments for Changes in Capital Structure. Subject to any required action by the shareholders of the Company and the requirements of Sections 409A and 424 of the Code to the extent applicable, in the event of any change in the Shares effected without receipt of consideration by the Company, whether through merger, consolidation, reorganization, reincorporation, recapitalization, reclassification, share dividend, share split, reverse share split, split-up, split-off, spin-off, combination of shares, exchange of shares, or similar change in the capital structure of the Company, or in the event of payment of a dividend or distribution to the shareholders of the Company in a form other than Shares (excepting regular, periodic cash dividends) that has a material effect on the Fair Market Value of Shares, appropriate and proportionate adjustments shall be made in the number and kind of shares subject to the Plan and to any outstanding Awards, the Annual Increase, and in the exercise or purchase price per share under any outstanding Award in order to prevent dilution or enlargement of Participants’ rights under the Plan. For purposes of the foregoing, conversion of any convertible securities of the

 

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Company shall not be treated as “effected without receipt of consideration by the Company.” If a majority of the shares which are of the same class as the shares that are subject to outstanding Awards are exchanged for, converted into, or otherwise become (whether or not pursuant to an Ownership Change Event) shares of another corporation (the New Shares), the Committee may unilaterally amend the outstanding Awards to provide that such Awards are for New Shares. In the event of any such amendment, the number of shares subject to, and the exercise or purchase price per share of, the outstanding Awards shall be adjusted in a fair and equitable manner as determined by the Committee, in its discretion. Any fractional share resulting from an adjustment pursuant to this Section shall be rounded down to the nearest whole number and the exercise or purchase price per share shall be rounded up to the nearest whole cent, and in no event may the exercise or purchase price, if any, under any Award be decreased to an amount less than the nominal value, if any, of the Shares subject to such Award. The Committee in its discretion, may also make such adjustments in the terms of any Award to reflect, or related to, such changes in the capital structure of the Company or distributions as it deems appropriate, including modification of Performance Goals, Performance Award Formulas and Performance Periods. The adjustments determined by the Committee pursuant to this Section shall be final, binding and conclusive. 

4.5 Assumption or Substitution of Awards. The Committee may, without affecting the number of Shares reserved or available hereunder, authorize the issuance or assumption of benefits under this Plan in connection with any merger, consolidation, acquisition of property or Shares, or reorganization upon such terms and conditions as it may deem appropriate, subject to compliance with Section 409A, any other applicable provisions of the Code and/or applicable laws.

 

  5. ELIGIBILITY, PARTICIPATION, MINIMUM EXERCISE/PURCHASE PRICE, AND INCENTIVE STOCK OPTION LIMITATIONS.

5.1 Persons Eligible for Awards. Awards may be granted only to Employees, Consultants and Directors.

5.2 Participation in the Plan. Awards are granted solely at the discretion of the Committee. Eligible persons may be granted more than one Award. However, eligibility in accordance with this Section shall not entitle any person to be granted an Award, or, having been granted an Award, to be granted an additional Award.

5.3 Minimum Exercise/Purchase Price. Notwithstanding anything in this Plan to the contrary, to the extent required by applicable law, the minimum exercise or purchase price for a Share shall, after taking into account any adjustment pursuant to Section 4.4, assumption or substitution pursuant to Section 4.5, or any other provisions in the Plan impacting the exercise or purchase price for a Share not be less than the nominal value of a Share.

5.4 Incentive Stock Option Limitations.

(a) Persons Eligible. An Incentive Stock Option may be granted only to a person who, on the effective date of grant, is an Employee of the Company, a Parent Corporation or a Subsidiary Corporation (each being an ISO-Qualifying Corporation). Any person who is not an Employee of an ISO-Qualifying Corporation on the effective date of the grant of an Option to such person may be granted only a Nonstatutory Stock Option.

 

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(b) Fair Market Value Limitation. To the extent that options designated as Incentive Stock Options (granted under all equity plans of the Participating Company Group, including the Plan) become exercisable by a Participant for the first time during any calendar year for Shares having a Fair Market Value greater than One Hundred Thousand Dollars ($100,000), the portion of such options which exceeds such amount shall be treated as Nonstatutory Stock Options. For purposes of this Section, options designated as Incentive Stock Options shall be taken into account in the order in which they were granted, and the Fair Market Value of Shares shall be determined as of the time the option with respect to such Shares are granted. If the Code is amended to provide for a limitation different from that set forth in this Section, such different limitation shall be deemed incorporated herein effective as of the date and with respect to such Options as required or permitted by such amendment to the Code. If an Option is treated as an Incentive Stock Option in part and as a Nonstatutory Stock Option in part by reason of the limitation set forth in this Section, the Participant may designate which portion of such Option the Participant is exercising. In the absence of such designation, the Participant shall be deemed to have exercised the Incentive Stock Option portion of the Option first. Upon exercise of the Option, shares issued pursuant to each such portion of the Option shall be separately identified.

 

  6. SHARE OPTIONS.

Options shall be evidenced by Award Agreements specifying the number of Shares covered thereby, in such form as the Committee shall establish. Such Award Agreements may incorporate all or any of the terms of the Plan by reference and shall comply with and be subject to the following terms and conditions:

6.1 Exercise Price. The exercise price for each Option shall be established in the discretion of the Committee; provided, however, that (a) the exercise price per share shall be not less than the Fair Market Value of a Share on the effective date of grant of the Option and (b) no Incentive Stock Option granted to a Ten Percent Owner shall have an exercise price per share less than one hundred ten percent (110%) of the Fair Market Value of a Share on the effective date of grant of the Option. Notwithstanding the foregoing, subject to Section 5.3, an Option (whether an Incentive Stock Option or a Nonstatutory Stock Option) may be granted with an exercise price lower than the minimum exercise price set forth above if such Option is granted pursuant to an assumption or substitution for another option in a manner that would qualify under the provisions of Sections 409A or 424(a) of the Code.

6.2 Exercisability and Term of Options. Options shall be exercisable at such time or times, or upon such event or events, and subject to such terms, conditions, performance criteria and restrictions as shall be determined by the Committee and set forth in the Award Agreement evidencing such Option; provided, however, that (a) no Option shall be exercisable after the expiration of seven (7) years after the effective date of grant of such Option, (b) no Incentive Stock Option granted to a Ten Percent Owner shall be exercisable after the expiration of five (5) years after the effective date of grant of such Option and (c) no Option granted to an Employee who is a non-exempt employee for purposes of the Fair Labor Standards

 

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Act of 1938, as amended, shall be first exercisable until at least six (6) months following the date of grant of such Option (except in the event of such Employee’s death, disability or retirement, upon a Change in Control, or as otherwise permitted by the Worker Economic Opportunity Act). Subject to the foregoing, unless otherwise specified by the Committee in the grant of an Option, each Option shall terminate seven (7) years after the effective date of grant of the Option, unless earlier terminated in accordance with its provisions.

6.3 Payment of Exercise Price.

(a) Forms of Consideration Authorized. Except as otherwise provided below, payment of the exercise price for the number of Shares being purchased pursuant to any Option shall be made (i) in cash, by check or in cash equivalent; (ii) if permitted by the Committee and subject to the limitations contained in Section 6.3(b), by means of (1) a Cashless Exercise, (2) a Share Tender Exercise or (3) a Net Exercise; (iii) by such other consideration as may be approved by the Committee from time to time to the extent permitted by applicable law, or (iv) by any combination thereof. The Committee may at any time or from time to time grant Options which do not permit all of the foregoing forms of consideration to be used in payment of the exercise price or which otherwise restrict one or more forms of consideration, taking into account such considerations as it deems advisable, including, without limitation, the permissibility of such provisions under applicable law.

(b) Limitations on Forms of Consideration.

(i) Cashless Exercise. A Cashless Exercise means the delivery of a properly executed notice of exercise together with irrevocable instructions to a broker providing for the assignment to the Company of the proceeds of a sale or loan with respect to some or all of the shares being acquired upon the exercise of the Option (including, without limitation, through an exercise complying with the provisions of Regulation T as promulgated from time to time by the Board of Governors of the Federal Reserve System). The Company reserves, at any and all times, the right, in the Company’s sole and absolute discretion, to establish, decline to approve or terminate any program or procedures for the exercise of Options by means of a Cashless Exercise, including with respect to one or more Participants specified by the Company notwithstanding that such program or procedures may be available to other Participants.

(ii) Share Tender Exercise. A Share Tender Exercise means the delivery of a properly executed exercise notice accompanied by a Participant’s tender to the Company, or attestation to the ownership, in a form acceptable to the Company of whole Shares owned by the Participant having a Fair Market Value that does not exceed the aggregate exercise price for the shares with respect to which the Option is exercised. A Share Tender Exercise shall not be permitted if it would constitute a violation of the provisions of any law, regulation or agreement restricting the redemption of the Company’s Shares. If required by the Company, an Option may not be exercised by tender to the Company, or attestation to the ownership, of Shares unless such shares either have been owned by the Participant for a period of time required by the Company (and not used for another option exercise by attestation during such period) or were not acquired, directly or indirectly, from the Company.

 

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(iii) Net Exercise. A Net Exercise means the delivery of a properly executed exercise notice followed by a procedure pursuant to which (1) the Company will reduce the number of shares otherwise issuable to a Participant upon the exercise of an Option by the largest whole number of shares having a Fair Market Value that does not exceed the aggregate exercise price for the shares with respect to which the Option is exercised, and (2) the Participant shall pay to the Company in cash the remaining balance of such aggregate exercise price not satisfied by such reduction in the number of whole shares to be issued.

(iv) Minimum payment Required. If any of the foregoing exercise methods are implemented, the Company shall establish procedures, if required by applicable law, for the payment of a Share’s nominal value in a form acceptable under applicable law.

6.4 Effect of Termination of Service.

(a) Option Exercisability. Subject to earlier termination of the Option as otherwise provided by this Plan and unless otherwise provided by the Committee, an Option shall terminate immediately upon the Participant’s termination of Service to the extent that it is then unvested and shall be exercisable after the Participant’s termination of Service to the extent it is then vested only during the applicable time period determined in accordance with this Section and thereafter shall terminate.

(i) Disability. If the Participant’s Service terminates because of the Disability of the Participant, the Option, to the extent unexercised and exercisable for vested shares on the date on which the Participant’s Service terminated, may be exercised by the Participant (or the Participant’s guardian or legal representative) at any time prior to the expiration of twelve (12) months (or such longer or shorter period provided by the Award Agreement) after the date on which the Participant’s Service terminated, but in any event no later than the date of expiration of the Option’s term as set forth in the Award Agreement evidencing such Option (the Option Expiration Date).

(ii) Death. If the Participant’s Service terminates because of the death of the Participant, the Option, to the extent unexercised and exercisable for vested shares on the date on which the Participant’s Service terminated, may be exercised by the Participant’s legal representative or other person who acquired the right to exercise the Option by reason of the Participant’s death at any time prior to the expiration of twelve (12) months (or such longer or shorter period provided by the Award Agreement) after the date on which the Participant’s Service terminated, but in any event no later than the Option Expiration Date. The Participant’s Service shall be deemed to have terminated on account of death if the Participant dies within three (3) months (or such longer or shorter period provided by the Award Agreement) after the Participant’s termination of Service.

(iii) Termination for Cause. Notwithstanding any other provision of the Plan to the contrary, if the Participant’s Service is terminated for Cause or if, following the Participant’s termination of Service and during any period in which the Option otherwise would remain exercisable, the Participant engages in any act that would constitute Cause, the Option shall terminate in its entirety and cease to be exercisable immediately upon such termination of Service or act.

 

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(iv) Other Termination of Service. If the Participant’s Service terminates for any reason, except Disability, death or Cause, the Option, to the extent unexercised and exercisable for vested shares on the date on which the Participant’s Service terminated, may be exercised by the Participant at any time prior to the expiration of three (3) months (or such longer or shorter period provided by the Award Agreement) after the date on which the Participant’s Service terminated, but in any event no later than the Option Expiration Date.

(b) Extension if Exercise Prevented by Law. Notwithstanding the foregoing, other than termination of Service for Cause, if the exercise of an Option within the applicable time periods set forth in Section 6.4(a) is prevented by the provisions of Section 14 below, the Option shall remain exercisable until the later of (i) thirty (30) days after the date such exercise first would no longer be prevented by such provisions or (ii) the end of the applicable time period under Section 6.4(a), but in any event no later than the Option Expiration Date.

6.5 Transferability of Options. During the lifetime of the Participant, an Option shall be exercisable only by the Participant or the Participant’s guardian or legal representative. An Option shall not be subject in any manner to anticipation, alienation, sale, exchange, transfer, assignment, pledge, encumbrance, or garnishment by creditors of the Participant or the Participant’s beneficiary, except transfer by will or by the laws of descent and distribution. Notwithstanding the foregoing, to the extent permitted by the Committee, in its discretion, and set forth in the Award Agreement evidencing such Option, a Nonstatutory Stock Option shall be assignable or transferable subject to the applicable limitations, if any, described in the General Instructions to Form S-8 under the Securities Act. An Incentive Stock shall not be assignable or transferable.

 

  7. RESTRICTED SHARE UNITS.

Restricted Share Unit Awards shall be evidenced by Award Agreements specifying the number of Restricted Share Units subject to the Award, in such form as the Committee shall establish. Such Award Agreements may incorporate all or any of the terms of the Plan by reference and shall comply with and be subject to the following terms and conditions:

7.1 Grant of Restricted Share Unit Awards. Restricted Share Unit Awards may be granted upon such conditions as the Committee shall determine, including, without limitation, upon the attainment of one or more Performance Goals described in Section 8.4. If either the grant of a Restricted Share Unit Award or the Vesting Conditions with respect to such Award is to be contingent upon the attainment of one or more Performance Goals, the Committee shall follow procedures substantially equivalent to those set forth in Sections 8.3 through 8.5(a).

7.2 Purchase Price. No monetary payment (other than applicable tax withholding, if any) shall be required as a condition of receiving a Restricted Share Unit Award,

 

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the consideration for which shall be services actually rendered to a Participating Company or for its benefit. Notwithstanding the foregoing, if required by applicable law, the Participant shall furnish consideration having a value not less than the required minimum payment for the Shares issued upon settlement of the Restricted Share Unit Award in such form as may be required and/or permitted under applicable law.

7.3 Vesting. Restricted Share Unit Awards may (but need not) be made subject to Vesting Conditions based upon the satisfaction of such Service requirements, conditions, restrictions or performance criteria, including, without limitation, Performance Goals as described in Section 8.4, as shall be established by the Committee and set forth in the Award Agreement evidencing such Award. The Committee, in its discretion, may provide in any Award Agreement evidencing a Restricted Share Unit Award that, if the satisfaction of Vesting Conditions with respect to any shares subject to the Award would otherwise occur on a day on which the sale of such shares would violate the provisions of the Trading Compliance Policy, then the satisfaction of the Vesting Conditions automatically shall be determined on the first to occur of (a) the next trading day on which the sale of such shares would not violate the Trading Compliance Policy; and (b) the last day of the calendar year in which the original vesting date occurred.

7.4 Voting Rights, Dividend Equivalent Rights, and Distributions. Participants shall have no voting rights with respect to Shares represented by Restricted Share Units until the date of the issuance of such shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company). However, the Committee, in its discretion, may provide in the Award Agreement evidencing any Restricted Share Unit Award that the Participant shall be entitled to Dividend Equivalent Rights with respect to the payment of cash dividends on Shares during the period beginning on the date such Award is granted and ending, with respect to each share subject to the Award, on the earlier of the date the Award is settled or the date on which it is terminated. Dividend Equivalent Rights, if any, shall be paid by crediting the Participant with a cash amount or with additional whole Restricted Share Units as of the date of payment of such cash dividends on Shares, as determined by the Committee. The number of additional Restricted Share Units (rounded down to the nearest whole number), if any, to be credited shall be determined by dividing (a) the amount of cash dividends paid on the dividend payment date with respect to the number of Shares represented by the Restricted Share Units previously credited to the Participant by (b) the Fair Market Value per Share on such date. Unless otherwise determined by the Committee and provided by the Award Agreement, such cash amount or additional Restricted Share Units shall be subject to the same terms and conditions and shall be settled in the same manner and at the same time as the Restricted Share Units originally subject to the Restricted Share Unit Award. In the event of a dividend or distribution paid in Shares or other property or any other adjustment made upon a change in the capital structure of the Company as described in Section 4.4, appropriate adjustments shall be made in the Participant’s Restricted Share Unit Award so that it represents the right to receive upon settlement any and all new, substituted or additional securities or other property (other than regular, periodic cash dividends) to which the Participant would be entitled by reason of the Shares issuable upon settlement of the Award, and all such new, substituted or additional securities or other property shall be immediately subject to the same Vesting Conditions as are applicable to the Award.

 

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7.5 Effect of Termination of Service. Unless otherwise provided by the Committee and set forth in the Award Agreement evidencing a Restricted Share Unit Award, if a Participant’s Service terminates for any reason, whether voluntary or involuntary (including the Participant’s death or disability), then the Participant shall forfeit to the Company any Restricted Share Units pursuant to the Award which remain subject to Vesting Conditions as of the date of the Participant’s termination of Service.

7.6 Settlement of Restricted Share Unit Awards. The Company shall issue to a Participant on the date on which Restricted Share Units subject to the Participant’s Restricted Share Unit Award vest or on such other date determined by the Committee in compliance with Section 409A, if applicable, and set forth in the Award Agreement one (1) Share (and/or any other new, substituted or additional securities or other property pursuant to an adjustment described in Section 7.4) for each Restricted Share Unit then becoming vested or otherwise to be settled on such date, subject to the withholding of applicable taxes, if any. If permitted by the Committee, the Participant may elect, consistent with the requirements of Section 409A, to defer receipt of all or any portion of the Shares or other property otherwise issuable to the Participant pursuant to this Section, and such deferred issuance date(s) and amount(s) elected by the Participant shall be set forth in the Award Agreement. Notwithstanding the foregoing, the Committee, in its discretion, may provide for settlement of any Restricted Share Unit Award by payment to the Participant in cash of an amount equal to the Fair Market Value on the payment date of the Shares or other property otherwise issuable to the Participant pursuant to this Section.

7.7 Nontransferability of Restricted Share Unit Awards. The right to receive shares pursuant to a Restricted Share Unit Award shall not be subject in any manner to anticipation, alienation, sale, exchange, transfer, assignment, pledge, encumbrance, or garnishment by creditors of the Participant or the Participant’s beneficiary, except transfer by will or by the laws of descent and distribution. All rights with respect to a Restricted Share Unit Award granted to a Participant hereunder shall be exercisable during his or her lifetime only by such Participant or the Participant’s guardian or legal representative.

 

  8. PERFORMANCE AWARDS.

Performance Awards shall be evidenced by Award Agreements in such form as the Committee shall establish. Such Award Agreements may incorporate all or any of the terms of the Plan by reference and shall comply with and be subject to the following terms and conditions:

8.1 Types of Performance Awards Authorized. Performance Awards may be granted in the form of either Performance Shares or Performance Units. Each Award Agreement evidencing a Performance Award shall specify the number of Performance Shares or Performance Units subject thereto, the Performance Award Formula, the Performance Goal(s) and Performance Period applicable to the Award, and the other terms, conditions and restrictions of the Award.

8.2 Initial Value of Performance Shares and Performance Units. Unless otherwise provided by the Committee in granting a Performance Award, each Performance Share

 

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shall have an initial monetary value equal to the Fair Market Value of one (1) Share, subject to adjustment as provided in Section 4.4, on the effective date of grant of the Performance Share, and each Performance Unit shall have an initial monetary value established by the Committee at the time of grant. The final value payable to the Participant in settlement of a Performance Award determined on the basis of the applicable Performance Award Formula will depend on the extent to which Performance Goals established by the Committee are attained within the applicable Performance Period established by the Committee.

8.3 Establishment of Performance Period, Performance Goals and Performance Award Formula. In granting each Performance Award, the Committee shall establish in writing the applicable Performance Period, Performance Award Formula and one or more Performance Goals which, when measured at the end of the Performance Period, shall determine on the basis of the Performance Award Formula the final value of the Performance Award to be paid to the Participant. Unless otherwise permitted in compliance with the requirements under Section 162(m) with respect to each Performance Award intended to result in the payment of Performance-Based Compensation, the Committee shall establish the Performance Goal(s) and Performance Award Formula applicable to each Performance Award no later than the earlier of (a) the date ninety (90) days after the commencement of the applicable Performance Period or (b) the date on which 25% of the Performance Period has elapsed, and, in any event, at a time when the outcome of the Performance Goals remains substantially uncertain. Once established, the Performance Goals and Performance Award Formula applicable to a Performance Award intended to result in the payment of Performance-Based Compensation to a Covered Employee shall not be changed during the Performance Period. The Company shall notify each Participant granted a Performance Award of the terms of such Award, including the Performance Period, Performance Goal(s) and Performance Award Formula.

8.4 Measurement of Performance Goals. Performance Goals shall be established by the Committee on the basis of targets to be attained (Performance Targets) with respect to one or more measures of business or financial performance (each, a Performance Measure), subject to the following:

(a) Performance Measures. Performance Measures shall be calculated in accordance with the Company’s financial statements, or, if such measures are not reported in the Company’s financial statements, they shall be calculated in accordance with generally accepted accounting principles, a method used generally in the Company’s industry, or in accordance with a methodology established by the Committee prior to the grant of the Performance Award. As specified by the Committee, Performance Measures shall be calculated with respect to the Company and each Subsidiary Corporation consolidated therewith for financial reporting purposes, one or more Subsidiary Corporations or such division or other business unit of any of them selected by the Committee. Unless otherwise determined by the Committee prior to the grant of the Performance Award, the Performance Measures applicable to the Performance Award shall be calculated prior to the accrual of expense for any Performance Award for the same Performance Period and excluding the effect (whether positive or negative) on the Performance Measures of any change in accounting standards or any extraordinary, unusual or nonrecurring item, as determined by the Committee, occurring after the establishment of the Performance Goals applicable to the Performance Award. Each such adjustment, if any, shall be made solely for the purpose of providing a consistent basis from period to period for the

 

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calculation of Performance Measures in order to prevent the dilution or enlargement of the Participant’s rights with respect to a Performance Award. Performance Measures may be based upon one or more of the following, as determined by the Committee: (i) revenue; (ii) sales; (iii) expenses; (iv) operating income; (v) gross margin; (vi) operating margin; (vii) earnings before any one or more of: share-based compensation expense, interest, taxes, depreciation and amortization; (viii) pre-tax profit; (ix) net operating income; (x) net income; (xi) economic value added; (xii) free cash flow; (xiii) operating cash flow; (xiv) balance of cash, cash equivalents and marketable securities; (xv) Share price; (xvi) earnings per share; (xvii) return on shareholder equity; (xviii) return on capital; (xix) return on assets; (xx) return on investment; (xxi) total shareholder return; (xxii) employee satisfaction; (xxiii) employee retention; (xxiv) market share; (xxv) customer satisfaction; (xxvi) product development; (xxvii) research and development expenses; (xxviii) completion of an identified special project; and (xxix) completion of a joint venture or other corporate transaction.

(b) Performance Targets. Performance Targets may include a minimum, maximum, target level and intermediate levels of performance, with the final value of a Performance Award determined under the applicable Performance Award Formula by the Performance Target level attained during the applicable Performance Period. A Performance Target may be stated as an absolute value, an increase or decrease in a value, or as a value determined relative to an index, budget or other standard selected by the Committee.

8.5 Settlement of Performance Awards.

(a) Determination of Final Value. As soon as practicable following the completion of the Performance Period applicable to a Performance Award, the Committee shall certify in writing the extent to which the applicable Performance Goals have been attained and the resulting final value of the Award earned by the Participant and to be paid upon its settlement in accordance with the applicable Performance Award Formula.

(b) Discretionary Adjustment of Award Formula. In its discretion, the Committee may, either at the time it grants a Performance Award or at any time thereafter, provide for the positive or negative adjustment of the Performance Award Formula applicable to a Performance Award granted to any Participant who is not a Covered Employee to reflect such Participant’s individual performance in his or her position with the Company or such other factors as the Committee may determine. If permitted under a Covered Employee’s Award Agreement, the Committee shall have the discretion, on the basis of such criteria as may be established by the Committee, to reduce some or all of the value of the Performance Award that would otherwise be paid to the Covered Employee upon its settlement notwithstanding the attainment of any Performance Goal and the resulting value of the Performance Award determined in accordance with the Performance Award Formula. No such reduction may result in an increase in the amount payable upon settlement of another Participant’s Performance Award that is intended to result in Performance-Based Compensation.

(c) Effect of Leaves of Absence. Unless otherwise required by law or a Participant’s Award Agreement, payment of the final value, if any, of a Performance Award held by a Participant who has taken in excess of thirty (30) days in unpaid leaves of absence during a Performance Period shall be prorated on the basis of the number of days of the Participant’s Service during the Performance Period during which the Participant was not on an unpaid leave of absence.

 

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(d) Notice to Participants. As soon as practicable following the Committee’s determination and certification in accordance with Sections 8.5(a) and (b), the Company shall notify each Participant of the determination of the Committee.

(e) Payment in Settlement of Performance Awards. As soon as practicable following the Committee’s determination and certification in accordance with Sections 8.5(a) and (b), but in any event within the Short-Term Deferral Period described in Section 13.1 (except as otherwise provided below or consistent with the requirements of Section 409A), payment shall be made to each eligible Participant (or such Participant’s legal representative or other person who acquired the right to receive such payment by reason of the Participant’s death) of the final value of the Participant’s Performance Award. Payment of such amount shall be made in cash, Shares, or a combination thereof as determined by the Committee. Unless otherwise provided in the Award Agreement evidencing a Performance Award, payment shall be made in a lump sum. If permitted by the Committee, the Participant may elect, consistent with the requirements of Section 409A, to defer receipt of all or any portion of the payment to be made to the Participant pursuant to this Section, and such deferred payment date(s) elected by the Participant shall be set forth in the Award Agreement. If any payment is to be made on a deferred basis, the Committee may, but shall not be obligated to, provide for the payment during the deferral period of Dividend Equivalent Rights or interest.

(f) Provisions Applicable to Payment in Shares. If payment is to be made in Shares, the number of such shares shall be determined by dividing the final value of the Performance Award by the Fair Market Value of a Share determined by the method specified in the Award Agreement. Shares issued in payment of any Performance Award may be fully vested and freely transferable shares or may be Shares subject to Vesting Conditions.

8.6 Voting Rights; Dividend Equivalent Rights and Distributions. Participants shall have no voting rights with respect to Shares represented by Performance Share Awards until the date of the issuance of such shares, if any (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company). However, the Committee, in its discretion, may provide in the Award Agreement evidencing any Performance Share Award that the Participant shall be entitled to Dividend Equivalent Rights with respect to the payment of cash dividends on Shares during the period beginning on the date the Award is granted and ending, with respect to each share subject to the Award, on the earlier of the date on which the Performance Shares are settled or the date on which they are forfeited. Such Dividend Equivalent Rights, if any, shall be credited to the Participant either in cash or in the form of additional whole Performance Shares as of the date of payment of such cash dividends on Shares, as determined by the Committee. The number of additional Performance Shares (rounded down to the nearest whole number), if any, to be so credited shall be determined by dividing (a) the amount of cash dividends paid on the dividend payment date with respect to the number of Shares represented by the Performance Shares previously credited to the Participant by (b) the Fair Market Value per Share on such date. Dividend Equivalent Rights may be paid currently or may be accumulated and paid to the extent that Performance Shares become nonforfeitable, as determined by the Committee. Settlement of Dividend Equivalent

 

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Rights may be made in cash, Shares, or a combination thereof as determined by the Committee, and may be paid on the same basis as settlement of the related Performance Share as provided in Section 8.5. Dividend Equivalent Rights shall not be paid with respect to Performance Units. In the event of a dividend or distribution paid in Shares or other property or any other adjustment made upon a change in the capital structure of the Company as described in Section 4.4, appropriate adjustments shall be made in the Participant’s Performance Share Award so that it represents the right to receive upon settlement any and all new, substituted or additional securities or other property (other than regular, periodic cash dividends) to which the Participant would be entitled by reason of the Shares issuable upon settlement of the Performance Share Award, and all such new, substituted or additional securities or other property shall be immediately subject to the same Performance Goals as are applicable to the Award.

8.7 Effect of Termination of Service. Unless otherwise provided by the Committee and set forth in the Award Agreement evidencing a Performance Award, the effect of a Participant’s termination of Service on the Performance Award shall be as follows:

(a) Death or Disability. If the Participant’s Service terminates because of the death or Disability of the Participant before the completion of the Performance Period applicable to the Performance Award, the final value of the Participant’s Performance Award shall be determined by the extent to which the applicable Performance Goals have been attained with respect to the entire Performance Period and shall be prorated based on the number of months of the Participant’s Service during the Performance Period. Payment shall be made following the end of the Performance Period in any manner permitted by Section 8.5.

(b) Other Termination of Service. If the Participant’s Service terminates for any reason except death or Disability before the completion of the Performance Period applicable to the Performance Award, such Award shall be forfeited in its entirety; provided, however, that in the event of an involuntary termination of the Participant’s Service, the Committee, in its discretion, may waive the automatic forfeiture of all or any portion of any such Award and determine the final value of the Performance Award in the manner provided by Section 8.7(a). Payment of any amount pursuant to this Section shall be made following the end of the Performance Period in any manner permitted by Section 8.5.

8.8 Nontransferability of Performance Awards. Prior to settlement in accordance with the provisions of the Plan, no Performance Award shall be subject in any manner to anticipation, alienation, sale, exchange, transfer, assignment, pledge, encumbrance, or garnishment by creditors of the Participant or the Participant’s beneficiary, except transfer by will or by the laws of descent and distribution. All rights with respect to a Performance Award granted to a Participant hereunder shall be exercisable during his or her lifetime only by such Participant or the Participant’s guardian or legal representative.

 

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  9. CASH-BASED AWARDS AND OTHER SHARE-BASED AWARDS.

Cash-Based Awards and Other Share-Based Awards shall be evidenced by Award Agreements in such form as the Committee shall establish. Such Award Agreements may incorporate all or any of the terms of the Plan by reference and shall comply with and be subject to the following terms and conditions:

9.1 Grant of Cash-Based Awards. Subject to the provisions of the Plan, the Committee, at any time and from time to time, may grant Cash-Based Awards to Participants in such amounts and upon such terms and conditions, including the achievement of performance criteria, as the Committee may determine.

9.2 Grant of Other Share-Based Awards. The Committee may grant other types of equity-based or equity-related Awards not otherwise described by the terms of this Plan (including the grant or offer for sale of unrestricted securities, share-equivalent units, stock appreciation units, securities or debentures convertible into Shares or other forms determined by the Committee) in such amounts and subject to such terms and conditions as the Committee shall determine. Other Share-Based Awards may be made available as a form of payment in the settlement of other Awards or as payment in lieu of compensation to which a Participant is otherwise entitled. Other Share-Based Awards may involve the transfer of actual Shares to Participants, or payment in cash or otherwise of amounts based on the value of Shares and may include, without limitation, Awards designed to comply with or take advantage of the applicable local laws.

9.3 Value of Cash-Based and Other Share-Based Awards. Each Cash-Based Award shall specify a monetary payment amount or payment range as determined by the Committee. Each Other Share-Based Award shall be expressed in terms of Shares or units based on such Shares, as determined by the Committee. The Committee may require the satisfaction of such Service requirements, conditions, restrictions or performance criteria, including, without limitation, Performance Goals as described in Section 8.4, as shall be established by the Committee and set forth in the Award Agreement evidencing such Award. If the Committee exercises its discretion to establish performance criteria, the final value of Cash-Based Awards or Other Share-Based Awards that will be paid to the Participant will depend on the extent to which the performance criteria are met. The establishment of performance criteria with respect to the grant or vesting of any Cash-Based Award or Other Share-Based Award intended to result in Performance-Based Compensation shall follow procedures substantially equivalent to those applicable to Performance Awards set forth in Section 8.

9.4 Payment or Settlement of Cash-Based Awards and Other Share-Based Awards. Payment or settlement, if any, with respect to a Cash-Based Award or an Other Share-Based Award shall be made in accordance with the terms of the Award, in cash, Shares or other securities or any combination thereof as the Committee determines. The determination and certification of the final value with respect to any Cash-Based Award or Other Share-Based Award intended to result in Performance-Based Compensation shall comply with the requirements applicable to Performance Awards set forth in Section 8. To the extent applicable, payment or settlement with respect to each Cash-Based Award and Other Share-Based Award shall be made in compliance with the requirements of Section 409A.

9.5 Voting Rights; Dividend Equivalent Rights and Distributions. Participants shall have no voting rights with respect to Shares represented by Other Share-Based Awards until the date of the issuance of such Shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company), if any, in settlement of such Award. However, the Committee, in its discretion, may provide in the Award Agreement evidencing any Other Share-Based Award that the Participant shall be entitled to

 

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Dividend Equivalent Rights with respect to the payment of cash dividends on Shares during the period beginning on the date such Award is granted and ending, with respect to each Share subject to the Award, on the earlier of the date the Award is settled or the date on which it is terminated. Such Dividend Equivalent Rights, if any, shall be paid in accordance with the provisions set forth in Section 7.4. Dividend Equivalent Rights shall not be granted with respect to Cash-Based Awards. In the event of a dividend or distribution paid in Shares or other property or any other adjustment made upon a change in the capital structure of the Company as described in Section 4.4, appropriate adjustments shall be made in the Participant’s Other Share-Based Award so that it represents the right to receive upon settlement any and all new, substituted or additional securities or other property (other than regular, periodic cash dividends) to which the Participant would be entitled by reason of the Shares issuable upon settlement of such Award, and all such new, substituted or additional securities or other property shall be immediately subject to the same Vesting Conditions and performance criteria, if any, as are applicable to the Award.

9.6 Effect of Termination of Service. Each Award Agreement evidencing a Cash-Based Award or Other Share-Based Award shall set forth the extent to which the Participant shall have the right to retain such Award following termination of the Participant’s Service. Such provisions shall be determined in the discretion of the Committee, need not be uniform among all Cash-Based Awards or Other Share-Based Awards, and may reflect distinctions based on the reasons for termination, subject to the requirements of Section 409A, if applicable.

9.7 Nontransferability of Cash-Based Awards and Other Share-Based Awards. Prior to the payment or settlement of a Cash-Based Award or Other Share-Based Award, the Award shall not be subject in any manner to anticipation, alienation, sale, exchange, transfer, assignment, pledge, encumbrance, or garnishment by creditors of the Participant or the Participant’s beneficiary, except transfer by will or by the laws of descent and distribution. The Committee may impose such additional restrictions on any Shares issued in settlement of Cash-Based Awards and Other Share-Based Awards as it may deem advisable, including, without limitation, minimum holding period requirements, restrictions under applicable federal securities laws, under the requirements of any stock exchange or market upon which such Shares are then listed and/or traded, or under any state securities laws or foreign law applicable to such Shares.

 

  10. STANDARD FORMS OF AWARD AGREEMENT.

10.1 Award Agreements. Each Award shall comply with and be subject to the terms and conditions set forth in the appropriate form of Award Agreement approved by the Committee and as amended from time to time. No Award or purported Award shall be a valid and binding obligation of the Company unless evidenced by a fully executed Award Agreement, which execution may be evidenced by electronic means.

10.2 Authority to Vary Terms. The Committee shall have the authority from time to time to vary the terms of any standard form of Award Agreement either in connection with the grant or amendment of an individual Award or in connection with the authorization of a new standard form or forms; provided, however, that the terms and conditions of any such new, revised or amended standard form or forms of Award Agreement are not inconsistent with the terms of the Plan.

 

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  11. CHANGE IN CONTROL.

11.1 Effect of Change in Control on Awards. Subject to the requirements and limitations of Section 409A, if applicable, the Committee may provide for any one or more of the following:

(a) Accelerated Vesting. In its discretion, the Committee may provide in the grant of any Award or at any other time may take action it deems appropriate to provide for acceleration of the exercisability, settlement, and/or vesting in connection with a Change in Control of each or any outstanding Award or portion thereof and shares acquired pursuant thereto upon such conditions, including termination of the Participant’s Service prior to, upon, or following the Change in Control, and to such extent as the Committee determines. Further, unless otherwise provided by the applicable Award Agreement or determined by the Committee and subject to Section 13.4(f), in the event that the Acquiror (as defined below) elects not to assume, continue or substitute for, in accordance with Section 11.1(b), any portion of an Award outstanding immediately prior to the Change in Control, the exercisability and/or vesting of such portion of the Award held by a Participant whose Service has not terminated prior to the Change in Control shall be accelerated in full effective as of a date prior to, but conditioned upon, the consummation of the Change in Control as determined by the Committee.

(b) Assumption, Continuation or Substitution. In the event of a Change in Control, the surviving, continuing, successor, or purchasing corporation or other business entity or parent thereof, as the case may be (the Acquiror), may, without the consent of any Participant, assume, substitute for, or continue the Company’s rights and obligations under each or any Award or portion thereof outstanding immediately prior to the Change in Control or substitute for each or any such outstanding Award or portion thereof a substantially equivalent award with respect to the Acquiror’s shares, as applicable. For purposes of this Section, if so determined by the Committee in its discretion, an Award denominated in Shares shall be deemed assumed if, following the Change in Control, the Award confers the right to receive, subject to the terms and conditions of the Plan and the applicable Award Agreement, for each Share subject to the Award immediately prior to the Change in Control, the consideration (whether shares, cash, other securities or property or a combination thereof) to which a holder of a Share on the effective date of the Change in Control was entitled (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding Shares); provided, however, that if such consideration is not solely common stock of the Acquiror, the Committee may, with the consent of the Acquiror, provide for the consideration to be received upon the exercise or settlement of the Award, for each Share subject to the Award, to consist solely of common stock of the Acquiror equal in Fair Market Value to the per share consideration received by holders of Shares pursuant to the Change in Control. Any Award or portion thereof which is neither assumed or continued by the Acquiror in connection with the Change in Control nor exercised or settled as of the time of consummation of the Change in Control shall terminate and cease to be outstanding effective as of the time of consummation of the Change in Control.

 

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(c) Cash-Out of Outstanding Share-Based Awards. The Committee may, in its discretion and without the consent of any Participant, determine that, upon the occurrence of a Change in Control, each or any Award denominated in Shares or portion thereof outstanding immediately prior to the Change in Control and not previously exercised or settled shall be canceled in exchange for a payment with respect to each vested share (and each unvested share, if so determined by the Committee) of Shares subject to such canceled Award in (i) cash, (ii) Shares or of a corporation or other business entity a party to the Change in Control, or (iii) other property which, in any such case, shall be in an amount having a Fair Market Value equal to the Fair Market Value of the consideration to be paid per Share in the Change in Control, reduced (but not below zero) by the exercise or purchase price per share, if any, under such Award. In the event such determination is made by the Committee, an Award having an exercise or purchase price per share equal to or greater than the Fair Market Value of the consideration to be paid per Share in the Change in Control may be canceled without payment of consideration to the holder thereof. Payment pursuant to this Section (reduced by applicable withholding taxes, if any) shall be made to Participants in respect of the vested portions of their canceled Awards as soon as practicable following the date of the Change in Control and in respect of the unvested portions of their canceled Awards in accordance with the vesting schedules applicable to such Awards.

11.2 Effect of Change in Control on Nonemployee Director Awards.

Subject to the requirements and limitations of Section 409A, if applicable, including as provided by Section 13.4(f), in the event of a Change in Control, each outstanding Nonemployee Director Award shall become immediately exercisable and vested in full and, except to the extent assumed, continued or substituted for pursuant to Section 11.1(b), shall be settled effective immediately prior to the time of consummation of the Change in Control.

11.3 Federal Excise Tax Under Section 4999 of the Code.

(a) Excess Parachute Payment. If any acceleration of vesting pursuant to an Award and any other payment or benefit received or to be received by a Participant would subject the Participant to any excise tax pursuant to Section 4999 of the Code due to the characterization of such acceleration of vesting, payment or benefit as an “excess parachute payment” under Section 280G of the Code, or if such actions would result in the loss of a corporate tax deduction under Section 280G, then, provided such election would not subject the Participant to taxation under Section 409A, the Participant shall elect to reduce the amount of any acceleration of vesting called for under the Award in order to avoid such characterization. Unless the Participant is subject to a written agreement between the Participant and a Participating Company governing the order of reduction, to the extent amounts are to be reduced, then payments shall be accomplished by reducing or eliminating severance payments that the Participant may become entitled to, then reducing or eliminating cash bonus payments, then by the reduction, or elimination of equity awards which are valued in full for purposes of Section 280G of the Code, then the reduction or elimination of accelerated vesting or settlement of other equity awards and finally the reduction or elimination of other compensatory payments. Such reductions shall first come from each category to the extent such amounts constitute Section 409A Deferred Compensation and with respect to any category in which there are multiple awards or grants, in reverse chronological order (i.e. with the most recent grant or award reduced or eliminated first).

 

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(b) Determination by Independent Accountants. To aid the Participant in making any election called for under Section 11.3(a), no later than the date of the occurrence of any event that might reasonably be anticipated to result in an “excess parachute payment” to the Participant as described in Section 11.3(a), the Company shall request a determination in writing by the professional firm engaged by the Company for general tax purposes, or, if the tax firm so engaged by the Company is serving as accountant or auditor for the Acquiror, the Company will appoint a nationally recognized tax firm to make the determinations required by this Section. (the “Tax Firm”). As soon as practicable thereafter, the Tax Firm shall determine and report to the Company and the Participant the amount of such acceleration of vesting, payments and benefits which would produce the greatest after-tax benefit to the Participant. For the purposes of such determination, the Tax Firm may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. The Company and the Participant shall furnish to the Tax Firm such information and documents as the Tax Firm may reasonably request in order to make its required determination. The Company shall bear all fees and expenses the Tax Firm charge in connection with its services contemplated by this Section.

 

  12. COMPLIANCE WITH APPLICABLE LAW.

The grant of Awards and the issuance of Shares or other property pursuant to any Award shall be subject to compliance with all requirements of all applicable securities and other applicable laws rules and regulations, approvals by government agencies as may be required or as the Company deems necessary or advisable, and the requirements of any stock exchange or market system upon which the Shares may then be listed. In addition, no Award may be exercised or shares issued pursuant to an Award unless (a) a registration statement under the Securities Act shall at the time of such exercise or issuance be in effect with respect to the shares issuable pursuant to the Award, or (b) in the opinion of legal counsel to the Company, the shares issuable pursuant to the Award may be issued in accordance with the terms of an applicable exemption from the registration requirements of the Securities Act. The inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Company’s legal counsel to be necessary to the lawful issuance and sale of any shares under the Plan shall relieve the Company of any liability in respect of the failure to issue or sell such shares as to which such requisite authority shall not have been obtained. As a condition to issuance of any Shares, the Company may require the Participant to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.

 

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  13. COMPLIANCE WITH SECTION 409A.

13.1 Awards Subject to Section 409A. With respect to Awards granted to Participants who are, or become, subject to taxation under the Code, the Company intends that Awards granted pursuant to the Plan shall either be exempt from or comply with Section 409A, and the Plan shall be so construed. The provisions of this Section 13 shall apply to any Award or portion thereof that constitutes or provides for payment of Section 409A Deferred Compensation. Such Awards may include, without limitation:

(a) An Option that includes any feature for the deferral of compensation other than the deferral of recognition of income until the later of (i) the exercise or disposition of the Award or (ii) the time the Shares acquired pursuant to the exercise of the Award first becomes substantially vested.

(b) Any Restricted Share Unit Award, Performance Award, Cash-Based Award or Other Share-Based Award that either (i) provides by its terms for settlement of all or any portion of the Award at a time or upon an event that will or may occur later than the end of the Short-Term Deferral Period (as defined below) or (ii) permits the Participant granted the Award to elect one or more dates or events upon which the Award will be settled after the end of the Short-Term Deferral Period.

Subject to the provisions of Section 409A, the term “Short-Term Deferral Period means the 2 12 month period ending on the later of (i) the 15th day of the third month following the end of the Participant’s taxable year in which the right to payment under the applicable portion of the Award is no longer subject to a substantial risk of forfeiture or (ii) the 15th day of the third month following the end of the Company’s taxable year in which the right to payment under the applicable portion of the Award is no longer subject to a substantial risk of forfeiture. For this purpose, the term “substantial risk of forfeiture” shall have the meaning provided by Section 409A.

13.2 Deferral and/or Distribution Elections. Except as otherwise permitted or required by Section 409A, the following rules shall apply to any compensation deferral and/or payment elections (each, an “Election”) that may be permitted or required by the Committee pursuant to an Award providing Section 409A Deferred Compensation:

(a) Elections must be in writing and specify the amount of the payment in settlement of an Award being deferred, as well as the time and form of payment as permitted by this Plan.

(b) Elections shall be made by the end of the Participant’s taxable year prior to the year in which services commence for which an Award may be granted to the Participant.

(c) Elections shall continue in effect until a written revocation or change in Election is received by the Company, except that a written revocation or change in Election must be received by the Company prior to the last day for making the Election determined in accordance with paragraph (b) above or as permitted by Section 13.3.

13.3 Subsequent Elections. Except as otherwise permitted or required by Section 409A, any Award providing Section 409A Deferred Compensation which permits a subsequent Election to delay the payment or change the form of payment in settlement of such Award shall comply with the following requirements:

(a) No subsequent Election may take effect until at least twelve (12) months after the date on which the subsequent Election is made.

 

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(b) Each subsequent Election related to a payment in settlement of an Award not described in Section 13.4(a)(ii), 13.4(a)(iii) or 13.4(a)(vi) must result in a delay of the payment for a period of not less than five (5) years from the date on which such payment would otherwise have been made.

(c) No subsequent Election related to a payment pursuant to Section 13.4(a)(iv) shall be made less than twelve (12) months before the date on which such payment would otherwise have been made.

(d) Subsequent Elections shall continue in effect until a written revocation or change in the subsequent Election is received by the Company, except that a written revocation or change in a subsequent Election must be received by the Company prior to the last day for making the subsequent Election determined in accordance the preceding paragraphs of this Section 13.3.

13.4 Payment of Section 409A Deferred Compensation.

(a) Permissible Payments. Except as otherwise permitted or required by Section 409A, an Award providing Section 409A Deferred Compensation must provide for payment in settlement of the Award only upon one or more of the following:

(i) The Participant’s “separation from service” (as defined by Section 409A);

(ii) The Participant’s becoming “disabled” (as defined by Section 409A);

(iii) The Participant’s death;

(iv) A time or fixed schedule that is either (i) specified by the Committee upon the grant of an Award and set forth in the Award Agreement evidencing such Award or (ii) specified by the Participant in an Election complying with the requirements of Section 13.2 or 13.3, as applicable;

(v) A change in the ownership or effective control or the Company or in the ownership of a substantial portion of the assets of the Company determined in accordance with Section 409A; or

(vi) The occurrence of an “unforeseeable emergency” (as defined by Section 409A).

(b) Installment Payments. It is the intent of this Plan that any right of a Participant to receive installment payments (within the meaning of Section 409A) shall, for all purposes of Section 409A, be treated as a right to a series of separate payments.

(c) Required Delay in Payment to Specified Employee Pursuant to Separation from Service. Notwithstanding any provision of the Plan or an Award Agreement to the contrary, except as otherwise permitted by Section 409A, no payment pursuant to

 

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Section 13.4(a)(i) in settlement of an Award providing for Section 409A Deferred Compensation may be made to a Participant who is a “specified employee” (as defined by Section 409A) as of the date of the Participant’s separation from service before the date (the Delayed Payment Date) that is six (6) months after the date of such Participant’s separation from service, or, if earlier, the date of the Participant’s death. All such amounts that would, but for this paragraph, become payable prior to the Delayed Payment Date shall be accumulated and paid on the Delayed Payment Date.

(d) Payment Upon Disability. All distributions of Section 409A Deferred Compensation payable pursuant to Section 13.4(a)(ii) by reason of a Participant becoming disabled shall be paid in a lump sum or in periodic installments as established by the Participant’s Election. If the Participant has made no Election with respect to distributions of Section 409A Deferred Compensation upon becoming disabled, all such distributions shall be paid in a lump sum upon the determination that the Participant has become disabled.

(e) Payment Upon Death. If a Participant dies before complete distribution of amounts payable upon settlement of an Award subject to Section 409A, such undistributed amounts shall be distributed to his or her beneficiary under the distribution method for death established by the Participant’s Election upon receipt by the Committee of satisfactory notice and confirmation of the Participant’s death. If the Participant has made no Election with respect to distributions of Section 409A Deferred Compensation upon death, all such distributions shall be paid in a lump sum upon receipt by the Committee of satisfactory notice and confirmation of the Participant’s death.

(f) Payment Upon Change in Control. Notwithstanding any provision of the Plan or an Award Agreement to the contrary, to the extent that any amount constituting Section 409A Deferred Compensation would become payable under this Plan by reason of a Change in Control, such amount shall become payable only if the event constituting a Change in Control would also constitute a change in ownership or effective control of the Company or a change in the ownership of a substantial portion of the assets of the Company within the meaning of Section 409A. Any Award which constitutes Section 409A Deferred Compensation and which would vest and otherwise become payable upon a Change in Control as a result of the failure of the Acquiror to assume, continue or substitute for such Award in accordance with Section 11.1(b) shall vest to the extent provided by such Award but shall be converted automatically at the effective time of such Change in Control into a right to receive, in cash on the date or dates such award would have been settled in accordance with its then existing settlement schedule (or as required by Section 13.4(c)), an amount or amounts equal in the aggregate to the intrinsic value of the Award at the time of the Change in Control.

(g) Payment Upon Unforeseeable Emergency. The Committee shall have the authority to provide in the Award Agreement evidencing any Award providing for Section 409A Deferred Compensation for payment pursuant to Section 13.4(a)(vi) in settlement of all or a portion of such Award in the event that a Participant establishes, to the satisfaction of the Committee, the occurrence of an unforeseeable emergency. In such event, the amount(s) distributed with respect to such unforeseeable emergency cannot exceed the amounts reasonably necessary to satisfy the emergency need plus amounts necessary to pay taxes reasonably anticipated as a result of such distribution(s), after taking into account the extent to which such

 

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emergency need is or may be relieved through reimbursement or compensation by insurance or otherwise, by liquidation of the Participant’s assets (to the extent the liquidation of such assets would not itself cause severe financial hardship) or by cessation of deferrals under the Award. All distributions with respect to an unforeseeable emergency shall be made in a lump sum upon the Committee’s determination that an unforeseeable emergency has occurred. The Committee’s decision with respect to whether an unforeseeable emergency has occurred and the manner in which, if at all, the payment in settlement of an Award shall be altered or modified, shall be final, conclusive, and not subject to approval or appeal.

(h) Prohibition of Acceleration of Payments. Notwithstanding any provision of the Plan or an Award Agreement to the contrary, this Plan does not permit the acceleration of the time or schedule of any payment under an Award providing Section 409A Deferred Compensation, except as permitted by Section 409A.

(i) No Representation Regarding Section 409A Compliance. Notwithstanding any other provision of the Plan, the Company makes no representation that Awards shall be exempt from or comply with Section 409A. No Participating Company shall be liable for any tax, penalty or interest imposed on a Participant by Section 409A.

 

  14. TAX WITHHOLDING.

14.1 Tax Withholding in General. The Company shall have the right to deduct from any and all payments made under the Plan, or to require the Participant, through payroll withholding, cash payment or otherwise, to make adequate provision for, the federal, state, local and foreign taxes (including social insurance), if any, required by law to be withheld by any Participating Company with respect to an Award or the shares acquired pursuant thereto. The Company shall have no obligation to deliver Shares, to release Shares from an escrow established pursuant to an Award Agreement, or to make any payment in cash under the Plan until the Participating Company Group’s tax withholding obligations have been satisfied by the Participant.

14.2 Withholding in or Directed Sale of Shares. The Company shall have the right, but not the obligation, to deduct from the Shares issuable to a Participant upon the exercise or settlement of an Award, or to accept from the Participant the tender of, a number of whole Shares having a Fair Market Value, as determined by the Company, equal to all or any part of the tax withholding obligations of any Participating Company. The Fair Market Value of any Shares withheld or tendered to satisfy any such tax withholding obligations shall not exceed the amount determined by the applicable minimum statutory withholding rates. The Company may require a Participant to direct a broker, upon the vesting, exercise or settlement of an Award, to sell a portion of the shares subject to the Award determined by the Company in its discretion to be sufficient to cover the tax withholding obligations of any Participating Company and to remit an amount equal to such tax withholding obligations to such Participating Company in cash.

 

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  15. AMENDMENT, SUSPENSION OR TERMINATION OF PLAN.

The Committee may amend, suspend or terminate the Plan at any time. However, without the approval of the Company’s shareholders, there shall be (a) no increase in the maximum aggregate number of Shares that may be issued under the Plan (except by operation of the provisions of Sections 4.2, 4.3, and 4.4), (b) no change in the class of persons eligible to receive Incentive Stock Options, and (c) no other amendment of the Plan that would require approval of the Company’s shareholders under any applicable law, regulation or rule, including the rules of any stock exchange or quotation system upon which the Shares may then be listed or quoted. No amendment, suspension or termination of the Plan shall affect any then outstanding Award unless expressly provided by the Committee. Except as provided by the next sentence, no amendment, suspension or termination of the Plan may have a materially adverse effect on any then outstanding Award without the consent of the Participant. Notwithstanding any other provision of the Plan or any Award Agreement to the contrary, the Committee may, in its sole and absolute discretion and without the consent of any Participant, amend the Plan or any Award Agreement, to take effect retroactively or otherwise, as it deems necessary or advisable for the purpose of conforming the Plan or such Award Agreement to any present or future law, regulation or rule applicable to the Plan, including, but not limited to, Section 409A.

 

  16. MISCELLANEOUS PROVISIONS.

16.1 Repurchase Rights. Shares issued under the Plan may be subject to one or more repurchase options, or other conditions and restrictions as determined by the Committee in its discretion at the time the Award is granted. The Company shall have the right to assign at any time any repurchase right it may have, whether or not such right is then exercisable, to one or more persons as may be selected by the Company. Upon request by the Company, each Participant shall execute any agreement evidencing such transfer restrictions prior to the receipt of Shares hereunder and shall promptly present to the Company any and all certificates representing Shares acquired hereunder for the placement on such certificates of appropriate legends evidencing any such transfer restrictions.

16.2 Forfeiture Events.

(a) The Committee may specify in an Award Agreement that the Participant’s rights, payments, and benefits with respect to an Award shall be subject to reduction, cancellation, forfeiture, or recoupment upon the occurrence of specified events, in addition to any otherwise applicable vesting or performance conditions of an Award. Such events may include, but shall not be limited to, termination of Service for Cause or any act by a Participant, whether before or after termination of Service, that would constitute Cause for termination of Service, or any accounting restatement due to material noncompliance of the Company with any financial reporting requirements of securities laws as a result of which, and to the extent that, such reduction, cancellation, forfeiture, or recoupment is required by applicable securities laws.

(b) If the Company is required to prepare an accounting restatement due to the material noncompliance of the Company, as a result of misconduct, with any financial reporting requirement under the securities laws, any Participant who knowingly or through gross

 

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negligence engaged in the misconduct, or who knowingly or through gross negligence failed to prevent the misconduct, and any Participant who is one of the individuals subject to automatic forfeiture under Section 304 of the Sarbanes-Oxley Act of 2002, shall reimburse the Company for (i) the amount of any payment in settlement of an Award received by such Participant during the twelve- (12-) month period following the first public issuance or filing with the United States Securities and Exchange Commission (whichever first occurred) of the financial document embodying such financial reporting requirement, and (ii) any profits realized by such Participant from the sale of securities of the Company during such twelve- (12-) month period.

16.3 Provision of Information. Each Participant shall be given access to information concerning the Company equivalent to that information generally made available to the Company’s ordinary shareholders.

16.4 Rights as Employee, Consultant or Director. No person, even though eligible pursuant to Section 5, shall have a right to be selected as a Participant, or, having been so selected, to be selected again as a Participant. Nothing in the Plan or any Award granted under the Plan shall confer on any Participant a right to remain an Employee, Consultant or Director or interfere with or limit in any way any right of a Participating Company to terminate the Participant’s Service at any time. To the extent that an Employee of a Participating Company other than the Company receives an Award under the Plan, that Award shall in no event be understood or interpreted to mean that the Company is the Employee’s employer or that the Employee has an employment relationship with the Company.

16.5 Rights as a Shareholder. A Participant shall have no rights as a shareholder with respect to any Shares covered by an Award until the date of the issuance of such shares (as evidenced by the appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company). No adjustment shall be made for dividends, distributions or other rights for which the record date is prior to the date such shares are issued, except as provided in Section 4.4 or another provision of the Plan.

16.6 Delivery of Title to Shares. Subject to any governing rules or regulations, the Company shall issue or cause to be issued the Shares acquired pursuant to an Award and shall deliver such shares to or for the benefit of the Participant by means of one or more of the following: (a) by delivering to the Participant evidence of book entry Shares credited to the account of the Participant, (b) by depositing such Shares for the benefit of the Participant with any broker with which the Participant has an account relationship, or (c) by delivering such Shares to the Participant in certificate form.

16.7 Fractional Shares. The Company shall not be required to issue fractional shares upon the exercise or settlement of any Award.

16.8 Retirement and Welfare Plans. Neither Awards made under this Plan nor Shares or cash paid pursuant to such Awards may be included as “compensation” for purposes of computing the benefits payable to any Participant under any Participating Company’s retirement plans (both qualified and non-qualified) or welfare benefit plans unless such other plan expressly provides that such compensation shall be taken into account in computing a Participant’s benefit.

 

33


16.9 Beneficiary Designation. Subject to local laws and procedures, each Participant may file with the Company a written designation of a beneficiary who is to receive any benefit under the Plan to which the Participant is entitled in the event of such Participant’s death before he or she receives any or all of such benefit. Each designation will revoke all prior designations by the same Participant, shall be in a form prescribed by the Company, and will be effective only when filed by the Participant in writing with the Company during the Participant’s lifetime. If a married Participant designates a beneficiary other than the Participant’s spouse, the effectiveness of such designation may be subject to the consent of the Participant’s spouse. If a Participant dies without an effective designation of a beneficiary who is living at the time of the Participant’s death, the Company will pay any remaining unpaid benefits to the Participant’s legal representative.

16.10 Severability. If any one or more of the provisions (or any part thereof) of this Plan shall be held invalid, illegal or unenforceable in any respect, such provision shall be modified so as to make it valid, legal and enforceable, and the validity, legality and enforceability of the remaining provisions (or any part thereof) of the Plan shall not in any way be affected or impaired thereby.

16.11 No Constraint on Corporate Action. Nothing in this Plan shall be construed to: (a) limit, impair, or otherwise affect the Company’s or another Participating Company’s right or power to make adjustments, reclassifications, reorganizations, or changes of its capital or business structure, or to merge or consolidate, or dissolve, liquidate, sell, or transfer all or any part of its business or assets; or (b) limit the right or power of the Company or another Participating Company to take any action which such entity deems to be necessary or appropriate.

16.12 Unfunded Obligation. Participants shall have the status of general unsecured creditors of the Company. Any amounts payable to Participants pursuant to the Plan shall be considered unfunded and unsecured obligations for all purposes, including, without limitation, Title I of the Employee Retirement Income Security Act of 1974. No Participating Company shall be required to segregate any monies from its general funds, or to create any trusts, or establish any special accounts with respect to such obligations. The Company shall retain at all times beneficial ownership of any investments, including trust investments, which the Company may make to fulfill its payment obligations hereunder. Any investments or the creation or maintenance of any trust or any Participant account shall not create or constitute a trust or fiduciary relationship between the Committee or any Participating Company and a Participant, or otherwise create any vested or beneficial interest in any Participant or the Participant’s creditors in any assets of any Participating Company. The Participants shall have no claim against any Participating Company for any changes in the value of any assets which may be invested or reinvested by the Company with respect to the Plan.

16.13 No Representations or Covenants with respect to Tax Qualification. Although the Company may endeavor to (a) qualify an Award for favorable tax treatment under the laws of the United States or jurisdictions outside of the United States (e.g., incentive stock options under Section 422 of the Code) or (b) avoid adverse tax treatment (e.g., under Section 409A), the Company makes no representation to that effect and expressly disavows any covenant to maintain favorable or avoid unfavorable tax treatment, anything to the contrary in this Plan,

 

34


including Section 13 hereof, notwithstanding. The Company shall be unconstrained in its corporate activities without regard to the potential negative tax impact on holders of Awards under the Plan.

16.14 Choice of Law. Except to the extent governed by applicable federal law, the validity, interpretation, construction and performance of the Plan and each Award Agreement shall be governed by the laws of Ireland, without regard to its conflict of law rules.

IN WITNESS WHEREOF, the undersigned Secretary of the Company certifies that the foregoing sets forth the Nexvet Biopharma Public Limited Company 2014 Equity Incentive Plan as duly adopted by the Board on October 14, 2014.

 

/s/ Geraldine Farrell

Geraldine Farrell, Secretary

 

35

EX-10.19 24 d775834dex1019.htm EX-10.19 EX-10.19

Exhibit 10.19

 

LOGO

Deed of Indemnity, Insurance and Access

 

(1) Nexvet Biopharma public limited company

 

(2) [Director or Officer name]


THIS DEED is made on [Date]

BETWEEN:

 

1. Nexvet Biopharma public limited company, a company incorporated in Ireland (registered no. 547923), whose registered office is at 88 Harcourt Street, Dublin 2, Ireland (the “Company”); and

 

2. [Director or Officer name] of [Address] (the “Officer”).

WHEREAS:

 

(A) The Officer is a director of the Company.

 

(B) The Company has agreed, subject always to the prohibitions and limitations imposed by law, to indemnify the Officer in respect of certain liabilities as set out in this Deed and the Officer has agreed to comply with certain related obligations also as set out in this Deed.

IT IS AGREED as follows:

 

1. DEFINITIONS AND INTERPRETATION

IN THIS DEED, UNLESS THE CONTEXT OTHERWISE REQUIRES:

 

1.1 Definitions

The following words bear the meanings assigned to them below:

Act” means the Companies Act 1963.

Associated Company” means:

 

  (a) a subsidiary undertaking of the Company from time to time, or

 

  (b) any undertaking (a) in which the Company or any of its subsidiary undertakings holds any share capital and (b) of which the Officer is a director and in such capacity is a nominee of the Company or any of its subsidiary undertakings; or

 

  (c) any undertaking in which the Officer is acting as officer, employee, trustee or agent at the Company’s request.

Board Documents” includes all:

 

  (a) written communications circulated or made available to the Officer by the Company;

 

  (b) minutes of meetings of the Company and the Board; and

 

  (c) Documents circulated to the directors of the Company in connection with any meetings or deliberations of the Board.

Books” means all the financial, technical and commercial information belonging to the Company from time to time and includes the Board Documents.

Business Day” means a day other than a Saturday or Sunday on which banks are generally open for business in Dublin.

 

1


Claim” means any claim, action, proceeding, investigation, demand or judgment made by a person other than the Officer.

Commencement Date” means [Date].

Connected Person” means in relation to a person, any other person:

 

  (a) who is a connected person for the purposes of section 10 of the Taxes Consolidation Act 1997 to the first mentioned person; and/or

 

  (b) with whom the first mentioned person is acting in concert (as defined in section 1(13) of the Irish Takeover Panel Act 1997).

Information” means all or any part of information contained in or related to the business or a transaction of the Company, a Book or a discussion at a meeting of the Company.

Permitted Purpose” means

 

  (a) to discharge the Officer’s duty as a director of the Company;

 

  (b) in connection with a claim commenced or arising during the Term in which the Officer:

 

  (i) is subject or is a party (except where claiming against or being claimed against by the Company);

 

  (ii) is directly involved in (including as a witness);

 

  (iii) proposes in good faith to bring (except against the Company); or

 

  (iv) believes on reasonable grounds will be brought against the Company (except by the Company); or

 

  (c) any other purpose in respect of which the Company gives its written consent.

Term” means the period set out in Clause 5.

 

1.2 Interpretation

 

  1.2.1 References to a statute or statutory provision include:

 

  (a) that statute or provision as from time to time modified, re-enacted or consolidated whether before, on or after the date of this Deed; and

 

  (b) any subordinate legislation made from time to time under that statute or statutory provision.

 

  1.2.2 References to one gender include all genders and references to the singular include the plural and vice versa.

 

  1.2.3 References to a company shall include any company, corporation or any body corporate, wherever incorporated.

 

  1.2.4 The words “holding company”, “undertaking” and “subsidiary undertaking” shall have the same meaning in this Deed as their respective definitions in the Act.

 

  1.2.5 Reference to Clauses are to Clauses of this Deed;

 

2


  1.2.6 A conviction, judgment or refusal of relief becomes final:

 

  (a) if not appealed against, at the end of the period for bringing an appeal; or

 

  (b) if appealed against, at the time when the appeal (or any further appeal) is determined and the period for bringing any further appeal has ended or if the appeal is abandoned or otherwise ceases to have effect.

 

  1.2.7 Headings shall be ignored in interpreting this Deed.

 

2. INDEMNITY

 

2.1 Subject to the provisions of this Deed, the Company agrees to indemnify the Officer out of its own funds against any liability incurred by, or attaching to, the Officer on or after the Commencement Date:

 

  2.1.1 in connection with any negligence, default, breach of duty or breach of trust by the Officer in relation to the Company or any Associated Company; or
 
  2.1.2 in the actual or purported execution and/or discharge of the Officer’s duties and/or the actual or purported exercise of the Officer’s powers and/or otherwise in relation to, or in connection with, the Officer’s duties, powers or office as an employee, officer, trustee or agent of the Company and/or any Associated Company.

 

2.2 This indemnity shall extend to such costs and expenses incurred by the Officer in relation to the matters in respect of which he is indemnified in this Clause 2 in respect of:

 

  2.2.1 Claims based on acts or failures to act in the exercise of the Officer’s duties or any other duties currently or previously performed by the Officer at the Company’s or any Associate Company’s request, in the actual or purported execution and/or discharge of the Officer’s duties and/or the actual or purported exercise of the Officer’s powers and/or otherwise in relation to, or in connection with, the Officer’s duties, powers or office as an employee, officer, advisor or agent of the Company and/or any Associated Company;
 
  2.2.2 the reasonable costs and expenses of conducting a defence, using counsel of the Officer’s choosing, against any such Claim (including for the avoidance of doubt reasonable fees and expenses of the Officer’s legal advisers);
 
  2.2.3 any damage, fines or other costs payable by the Officer as a result of an act or failure to act as referred to above; and
 
  2.2.4 the reasonable costs of appearing in other legal, judicial, administrative or regulatory proceedings in which the Officer is involved as current or former Officer of the Company, with the exception of proceedings primarily aimed at pursuing such a claim by or on the Officer’s own behalf.

 

2.3 The Officer shall take all reasonable steps to mitigate any loss which, in the absence of mitigation, might give rise to a claim or demand under this Deed against the Company.

 

2.4 Notwithstanding anything to the contrary herein, the rights of the Officer under this Deed shall only have effect insofar as they are not contrary to or in violation of the laws of Ireland, including section 200 of the Companies Act 1963.

 

3


3. LIMITATIONS ON INDEMNITY

 

3.1 Without prejudice to any other rights or remedies which may be available to the Officer, the indemnity granted by the Company to the Officer in Clause 2 shall not extend to any liability (including any costs and expenses) incurred by, or attaching to, the Officer:

 

  3.1.1 to the Company or any Associated Company;
 
  3.1.2 to pay a fine imposed in criminal proceedings;
 
  3.1.3 in defending any criminal proceedings in which he is convicted, where such conviction is final;
 
  3.1.4 in defending any civil proceedings brought by the Company or an Associated Company in which judgment is given against him, where such judgment is final; or
 
  3.1.5 in connection with any application under Section 42(3) or (4) of the Companies (Amendment) Act 1983 (acquisition of shares by innocent nominee) or Section 391 of the Act (general power to grant relief in case of honest and reasonable conduct), where the court refuses to grant the Officer relief, and such refusal is final.

 

3.2 Furthermore, this indemnity shall not apply:

 

  3.2.1 to the extent that it is not permitted by, or consistent with, law or statute from time to time in force, the memorandum and articles of association of the Company or the rules and regulations of any regulatory body;
 
  3.2.2 to the extent that the Officer is entitled to be indemnified or reimbursed by any directors’ or officers’ liability insurance or any other insurance and the insurer has paid out;
 
  3.2.3 where there has been gross negligence, fraud or wilful default by the Officer; nor
 
  3.2.4 to the extent the Officer or a Connected Person has improperly derived a personal benefit or profit, whether directly or indirectly, from the matter in respect of which a liability arises.

 

4. FUNDING OF COSTS AND FINANCIAL LOSS

 

4.1 Subject to the Officer complying with his obligations under this Deed, the Company:

 

  (a) subject to any applicable laws, will do such reasonable things as may enable the Officer to avoid incurring cost or financial loss from a liability described in Clause 2; and / or

 

  (b) shall pay directly (or if necessary reimburse) any such costs and financial loss within 10 Business Days of receipt of the invoices or any other document evidencing the costs or financial loss of the Officer from a liability described in Clause 2.

 

4.2 If the Company chooses to provide funds or do other things as set out in Clause 4.1 then such funds will become repayable by the Officer (on a pro rata basis, as the case may be, in accordance with Clause 4.3), and the liability of the Company under Clause 4.1 will be discharged (on a pro rata basis, as the case may be, in accordance with Clause 4.3), as follows:

 

4


  4.2.1 in the event of the Officer being convicted in the criminal proceedings referred to in Clause 3.1.2 or 3.1.3, the date when the conviction becomes final;
 
  4.2.2 in the event of judgment being given against the Officer in the civil proceedings referred to in Clause 3.1.4 or 3.1.5, the date when the judgment becomes final; and
 
  4.2.3 in the event of the court refusing to grant the Officer relief on the application, the date when the refusal of relief becomes final.

 

4.3 In the event that in the criminal or civil proceedings referred to in Clause 4.2 more than one criminal or civil charge is brought against the Officer and the Officer is convicted or judgment is rendered against him, as the case may be, in respect of some but not all of the relevant charges, the funds referred to in Clause 4.2 will become repayable and the Company’s liability will be discharged only on a pro rata basis, to be determined by and between the Company and the Officer in good faith and in accordance with the principles of reasonableness and fairness, on the basis of the contents of the relevant criminal or civil judgment rendered.

 

4.4 If an amount is paid under Clause 4.1 and is subsequently found to be for a liability or costs or expenses which are not covered by the indemnities set out in Clause 2 or is the subject of another payment to the Officer under directors and officers insurance policy, another insurance policy or another indemnity, then, within 28 days after receipt of a written request from the Company, the Officer must repay such monies to the Company.

 

4.5 Without prejudice to any rights of the Company, the Company may, with the prior agreement of the Officer, deduct from any money due to the Officer (including remuneration) in connection with his services to the Company or any Associated Company, any amount which he owes to the Company under this Deed.

 

5. CONTINUATION OF OBLIGATIONS

 

     The obligations of the Company contained in this Deed shall continue during the period in which the Officer is an officer of the Company or of an Associated Company and for a period of seven years thereafter.

 

6. NOTIFICATION AND CONDUCT OF CLAIMS

 

6.1 The Officer will promptly, and in any event within 10 Business Days of the date on which the Officer becomes aware of a Claim, notify the Company in writing of any Claim which may give rise to a claim or demand by the Officer against the Company under this Deed setting out as much information as is available to the Officer (including details of the person(s) making the Claim, the circumstances which gave rise to it and an estimate of the amount of the Claim).

 

6.2 The Company shall be entitled at any time by notice to the Officer to assume sole conduct of all matters relating to any Claim (including the conduct of any counterclaim or related claim against any person) provided that it shall only settle, compromise or consent to the entry of any judgment with respect to any Claim with the consent of the Officer, such consent not to be unreasonably withheld.

 

6.3 The Officer shall do all such things as the Company may reasonably request in order to permit the Company fully to exercise its rights under Clauses 6.2. and 6.3, and in particular shall:

 

5


  6.3.1 provide the Company with such information and copies of such documents relating to any Claim as the Company may reasonably request;
 
  6.3.2 not, without the prior written consent of the Company, make any admission in relation to any claim, nor settle, compromise or consent to the entry of any judgment (or offer to do so), with respect to any Claim;
 
  6.3.3 assist the Company as it may require in resisting, defending or settling such Claim; and
 
  6.3.4 allow the Company to take such actions which the Company may deem appropriate in relation to any Claim in the name and on behalf of the Officer, including (without prejudice to the Officer’s right to choose counsel referred to in Clause 2.2.2) appointing and giving instructions to Counsel and any other professional advisers, under the Company’s sole instructions and commencing and taking any step in any proceedings (including making any admission and lodging any appeal).

 

6.4 If the Officer does not comply with his obligations under Clauses 6.1 and/or 6.3 or the Officer and the Company cannot agree on a course of action in accordance with Clause 6.3, the Company may on giving notice to the Officer require the Officer to assume the sole conduct of defence of the Claim.

 

6.5 For the avoidance of doubt, after notice has been given by the Company to the Officer of its election to assume the conduct of matters relating to a Claim in accordance with the provisions of Clause 6.2, or after notice has been given by the Company to the Officer requiring the Officer to assume the sole conduct of all matters relating to a Claim pursuant to Clause 6.4, the Officer may engage separate legal or other representation and participate in the defence of a Claim but any expenses incurred by the Officer in relation to such representation or participation will only be borne by the Company

 

  6.5.1 the extent that those expenses are the subject of an Indemnity; and
 
  6.5.2 those expenses incurred in circumstances where the Company has refused to authorise representation or participation by lawyers other than lawyers acting also for the Company; and
 
  6.5.3 there is a reasonable likelihood that the interests of the Officer and of the Company would conflict if the same lawyers were to act on behalf of both the Officer and the Company.

 

7. DIRECTORS’ AND OFFICERS’ LIABILITY INSURANCE

 

     The Company undertakes that for the duration of the Officer’s appointment as a director of the Company and for a period of seven years after the termination of the Officer’s appointment as a director of the Company, the Officer shall be covered by the Company’s directors’ and officers’ liability insurance policy pursuant to and subject to the terms of such policy from time to time in force and to the Company’s policy on such insurance from time to time. The Officer understands and agrees that in the event that a liability arises (regardless of whether the liability is covered under the terms of such policy) and the insurer fails or refuses to provide him with any benefit under the directors’ and officers’ liability insurance arrangements provided by the Company, the Officer shall have no right of action against the Company specifically from the fact that the insurer fails or refuses to pay (but, for the avoidance of doubt, this does not affect the indemnity granted to the Officer under this Deed).

 

6


8. SUBROGATION

 

     If the Company makes any payment under this Deed, it shall be subrogated to the extent of such payment to any right the Officer may have for recovery of the amounts so paid from any third party. The Officer agrees to execute all documents required and do all other acts necessary to effect the foregoing provisions and permit the Company to enforce the rights so subrogated.

 

9. INDEMNITIES IN ARTICLES OF ASSOCIATION

 

     The indemnification provided by this Deed shall not be deemed exclusive of any rights to which the Officer may be entitled under the memorandum or articles of association of the Company, any agreement, any vote of shareholders or of the board of directors of the Company, or otherwise, or under any laws or regulations in effect now or in the future.

 

10. ACCESS TO COMPANY BOOKS

 

10.1 Right to access Books

 

  10.1.1 Subject to Clause 10.1.2, during the Term, the Company must, on request, allow the Officer to inspect and take copies (free of charge) of any Books during business hours.

 

  10.1.2 After the Officer ceases to be an officer of the Company, the right of access and copying is limited to:

 

  (a) Books to which the Director was entitled to have access while an officer of the Company; and

 

  (b) Information the Director reasonably believes may be relevant to a Permitted Purpose.

 

10.2 Obligations of the Company

 

     During the Term, the Company, must use its reasonable efforts to keep:

 

  (a) all Books safe and secure from damage; and

 

  (b) a complete set of all Books.

 

10.3 Return of Books

 

     After the Officer ceases to be an officer of the Company, the Officer must return any copies of any Books taken:

 

  (a) while he was an officer of the Company, promptly after ceasing to be an officer of the Company; and

 

  (b) after he ceased to be an officer of the Company, promptly after they are no longer required for a Permitted Purpose.

 

7


10.4 Statutory Rights of Access

 

     This Clause 10 does not adversely affect any statutory right of access which the Officer may have to the Books, including without limitation under Section 202(8) Companies Act, 1990.

 

10.5 Confidentiality

 

  10.5.1 Without limiting the Officer’s duties as a director of the Company and subject to Clause 10.5.2, during the Term the Officer must:

 

  (a) keep all Information contained in the Books confidential;

 

  (b) must not disclose Information to any person; and

 

  (c) must not use Information other than for a Permitted Purpose.

 

  10.5.2 The obligations in Clause 10.5.1 do not apply to Information if and to the extent that:

 

  (a) the disclosure or use is required by law, any regulatory body or any recognised stock exchange on which the shares of the Company or any Associated Company are listed;

 

  (b) the Information is or comes into the public domain (other than as a result of a contravention by the Director of this deed or any other obligation of confidence);

 

  (c) disclosure of the Information is reasonably necessary for a Permitted Purpose or to obtain legal, financial or taxation advice for the Officer and, in each case, disclosure of the Information:

 

  (i) is made on a confidential basis; and

 

  (ii) will not cause the Company’s right to claim legal privilege in regard to any other Information or documents to be waived;

 

  (d) disclosure of the Information is reasonably necessary for the purposes of the discharge of the duties of the Officer as a director of the Company; or

 

  (e) the Company has given its prior written consent to the disclosure of the Information.

 

  10.5.3 The provisions of this Clause 10.5 shall continue to apply after the termination of the Officer’s appointment as a director of the Company and/or any Associated Company without limitation in time.

 

11. NOTICES

 

11.1 Any notice or other communication in connection with this Deed (each, a “Notice”) shall be:

 

  (a) in writing;

 

  (b) delivered by hand, fax, pre-paid first class post or courier.

 

11.2 A Notice to the Company shall be sent to the following address, or such other person or address as the Company may notify to the Officer from time to time:

 

8


Address: the Company’s registered office from time to time

 

Attention:

   [Chief Executive Officer]

With copy by email to:

   [Email Address]

 

11.3 A Notice to the Officer shall be sent to the Officer at the following address, or such other person or address as the Officer may notify to the Company from time to time:

 

Address:

   [Director’s or Officer’s Address]

With copy by email to:

   [Director’s or Officer’s Email]

 

11.4 A Notice shall be effective upon receipt and shall be deemed to have been received:

 

  (a) 60 hours after posting, if delivered by pre-paid first class post;

 

  (b) at the time of delivery, if delivered by hand or courier;

 

  (c) at the time of transmission in legible form, if delivered by fax.

 

12. INVALIDITY

 

  12.1.1 If any provision in this Deed shall be held to be illegal, invalid or unenforceable, in whole or in part, the provision shall apply with whatever deletion or modification is necessary so that the provision is legal, valid and enforceable and gives effect to the intention of the parties.

 

  12.1.2 To the extent it is not possible to delete or modify the provision, in whole or in part, under Clause 12.2.1, then such provision or part of it shall, to the extent that it is illegal, invalid or unenforceable, be deemed not to form part of this Deed and the legality, validity and enforceability of the remainder of this Deed shall, subject to any deletion or modification made under Clause 12.2.1, not be affected.

 

13. VARIATION AND WAIVER

 

13.1 No variation of this Deed shall be effective unless in writing and signed by or on behalf of each of the parties.

 

13.2 No waiver of any of the provisions of this Deed shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.

 

14. COUNTERPARTS

 

     This Deed may be entered into in any number of counterparts, all of which taken together shall constitute one and the same instrument.

 

15. WHOLE AGREEMENT

 

15.1 This Deed contains the whole agreement between the parties relating to the subject matter of this Deed at the date of this Deed to the exclusion of any terms implied by law which may be excluded by contract and supersedes any previous written or oral agreement between the Company and the Officer in relation to the matters dealt with in this Deed.

 

9


15.2 The Officer acknowledges that he has not been induced to execute this Deed by any representation, warranty, assurance or undertaking not expressly incorporated into it.

 

16. ASSIGNMENT

 

16.1 The Company may at any time assign to an Associated Company the benefit of the whole or any part of its rights under this Deed provided that such assignment shall be expressed to have effect only for so long as the assignee remains an Associated Company.

 

16.2 The Officer may not assign the benefit of all or any part of his rights under this Deed.

 

17. GOVERNING LAW AND SUBMISSION TO JURISDICTION

 

17.1 This Deed shall be governed by the laws of Ireland. The parties irrevocably agree that the courts of Ireland are to have exclusive jurisdiction to settle any dispute which may arise out of or in connection with this Deed. The Company agrees to reimburse the Officer for any reasonable travelling expenses incurred by him in attending any court hearings in Ireland, upon production of adequate receipts and to the extent that the Officer may not recover such costs from any other person. The Officer will repay to the Company any money which he subsequently recovers for such costs from any other person.

 

17.2 In the event of any change in applicable law, statute or rule which restricts the right of the Company to indemnify a person serving in a capacity referred to in this Deed, such change, to the extent not otherwise required by such law, statute or rule to be applied to this Deed, shall have no effect on this Deed or the parties’ rights and obligations hereunder.

 

10


IN WITNESS WHEREOF this Deed has been delivered on the date first stated above.

Given under the Common Seal of

NEXVET BIOPHARMA LIMITED

which was affixed hereto and

this Deed was delivered:

 

 

 

 

Signature of [Director or Officer]   Signature of Director/Company Secretary

 

 

 

Name of [Director or Officer] (print)   Name of Director/Company Secretary (print)

Date:         

Signed and Delivered as a Deed by

[DIRECTOR] in the presence of:

 

 

 

 

Signature of Witness

  Signature of [Director or Officer]

 

 

Name of Witness (print)

 

 

 

Address of Witness (print)

 

 

 

Occupation of Witness (print)

 

Date:                                       

 

11

EX-16.1 25 d775834dex161.htm EX-16.1 EX-16.1

Exhibit 16.1

September 5, 2014

Securities and Exchange Commission

100 F Street, N.E.

Washington, DC 20549

Ladies and Gentlemen:

We have read the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Change in Principal Auditor” in the Registration Statement Form S-1, confidentially submitted on September 5, 2014, of Nexvet Biopharma plc and are in agreement with the statements contained in the first and second paragraphs therein. We have no basis to agree or disagree with other statements contained therein.

Regarding the statement concerning the lack of internal control to prepare financial statements included in the second paragraph under the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Change in Principal Auditor,” we had considered such matter in determining the nature, timing and extent of procedures performed in our audits of Nexvet Biopharma Pty Ltd’s 2012 and 2013 financial statements which were audited in accordance with generally accepted auditing standards in Australia and prepared in accordance with international financial reporting standards generally accepted in Australia.

Sincerely,

/s/ Ernst & Young

Melbourne, Victoria

Australia

EX-21.1 26 d775834dex211.htm EX-21.1 EX-21.1

EXHIBIT 21.1

List of Subsidiaries of Nexvet Biopharma public limited company

 

Subsidiary

  

Jurisdiction of Incorporation or Organization

Nexvet Australia Pty Ltd

   Australia

NVIP Pty Ltd

   Australia

Nexvet US, Inc.

   Delaware

Nexvet Ireland Limited

   Ireland

Tevxen Limited

   Ireland

Nexvet UK Limited

   United Kingdom
EX-23.2 27 d775834dex232.htm EX-23.2 EX-23.2

EXHIBIT 23.2

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We hereby consent to the use in this Registration Statement on Form S-1 of Nexvet Biopharma public limited company of our report dated September 4, 2014 (except for Notes 1 and 16, as to which the date is December 30, 2014) relating to the consolidated financial statements of Nexvet Biopharma public limited company, which appears in such Registration Statement. We also consent to the reference to us under the heading “Experts” in such Registration Statement.

/s/ PricewaterhouseCoopers

PricewaterhouseCoopers

Melbourne, Australia

December 30, 2014

EX-99.1 28 d775834dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

CONSENT OF RAJIV PATEL

Pursuant to Rule 438 of Regulation C promulgated under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned hereby consents to being named in the registration statement on Form S-1 and in all subsequent amendments or supplements thereto and in any registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act (collectively, the “Registration Statement”) of Nexvet Biopharma public limited company (the “Company”) as an individual to become a director of the Company and to the inclusion of his biographical and other information in the Registration Statement. The undersigned further consents to the filing of this consent as an exhibit to the Registration Statement.

The undersigned also hereby consents to being named in any registration statement on Form S-8 filed by the Company that incorporates by reference the prospectus forming part of the Registration Statement.

In witness whereof, this consent is signed and dated as of the date set forth below.

 

/s/ Rajiv Patel

Name:  

Rajiv Patel

Date:  

Dec. 30, 2014

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LOGO   

DLA Piper LLP (US)

1251 Avenue of the Americas, 27th Floor

New York, New York 10020-1104

www.dlapiper.com

 

Marjorie Sybul Adams

marjorie.adams@dlapiper.com

T    212.335.4517

F    212.884.8517

December 30, 2014    OUR FILE NO. 375565-000003
VIA EDGAR AND UNITED PARCEL SERVICE   

Jeffrey P. Riedler

Assistant Director

Division of Corporation Finance

Securities and Exchange Commission

100 F Street, N.E.

Mail Stop 4561

Washington, D.C. 20549-6010

 

Re: Nexvet Biopharma public limited company
   Draft Registration Statement on Form S-1
   Originally Confidentially Submitted September 5, 2014
   CIK No. 0001618561

Dear Mr. Riedler:

This letter is submitted on behalf of Nexvet Biopharma public limited company (together with its subsidiaries, the “Company”) in response to the comments that you provided on behalf of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “SEC”) with respect to the Company’s Draft Registration Statement No. 2 on Form S-1 confidentially submitted on November 19, 2014 (“Draft No. 2”), as set forth in your letter to Dr. Mark Heffernan dated December 4, 2014. The Company is filing under separate cover its Registration Statement on Form S-1 (the “Registration Statement”) in response to the Staff’s comments. Please note that the Registration Statement also includes other updates to the Company’s disclosure. For reference purposes, the numbered comments contained in your letter dated December 4, 2014 have been reproduced herein (in bold italics), with the Company’s response below each numbered comment.

Prospectus Summary

Product Pipeline, page 1

 

  1. We note your response to prior comment 6. As proof-of-concept studies for both NV-02 and NV-08 remain underway, please move the bars in your tables for those product candidates to the midpoint of the proof-of-concept studies column to more accurately reflect their current status.

Company Response: In response to the Staff’s comment, the Company has made various revisions to the tables on pages 2 and 80 of the Registration Statement to simplify the presentation, while retaining an approach that allows for a rapid visual understanding of which proof-of-concept studies remain pending for NV-02 and NV-08.


Mr. Jeffrey P. Riedler

December 30, 2014

Page Two

 

The Company believes that the Staff’s comment reflects a concern about whether a reader will be able to quickly and clearly see that NV-02 and NV-08 have not completed all proof-of-concept studies and have not progressed to pivotal safety and efficacy studies. To address this concern, the Company has removed the vertical text in the proof-of-concept column (which had been intended to demarcate the Company’s four proof-of-concept studies) and has instead created more conventional column subheadings for each of these proof-of-concept studies. The Company has added vertical lines before and after each of these column subheadings, which clearly demarcate where each of the four proof-of-concept studies starts and ends. In addition, in response to Comment 2 below, the Company has removed the prior column relating to clonal cell manufacturing, which causes the flow of columns in the table to proceed directly from proof-of-concept studies to pivotal safety and efficacy studies. The Company respectfully submits that this simplifies the visual presentation in a way that makes it abundantly clear to a reader that NV-02 and NV-08 have not completed the final proof-of-concept study and have not progressed to pivotal safety and efficacy studies.

The Company believes it is important for investors to be able to rapidly understand, through the visual presentation of the information in the tables on pages 2 and 80 of the Registration Statement, where the Company’s lead product candidates are in their development. The Company conducts a series of sequential, distinct proof-of-concept studies in the order presented in these tables. These proof-of-concept studies are designed to ensure that the Company understands how a companion animal’s body processes a product candidate, whether a product candidate may cause observable safety issues, whether a product candidate may elicit observable negative immune responses and whether a product candidate appears to work as intended and without any observable safety issues. These studies are important milestones for the Company internally, as they impact various Company research and development decisions and related activities, and the Company does not proceed to the next sequential proof-of-concept study until satisfactorily completing the prior proof-of-concept study. The Company does not seek regulatory concurrence with the protocols for any pivotal safety and efficacy studies until the Company has completed each of its proof-of-concept studies, each of which is important when designing pivotal safety and efficacy studies to meet applicable regulatory requirements for licensure or approval of the product candidate.

While it is true that the final proof-of-concept study for both NV-02 and NV-08 remains underway, it is also true that the Company’s first three proof-of-concept studies have been completed for both NV-02 and NV-08. The Company is well into its final proof-of-concept study for NV-02 (which is approximately 50% enrolled) and is commencing its final proof-of-concept study for NV-08. Accordingly, the Company respectfully submits that the horizontal bars in the tables accurately reflect the status of each of the Company’s lead product candidates, as these bars indicate which studies have been completed, which studies are in progress (and the approximate level of progress) and which studies have not yet been initiated.

In the Company’s experience, the status of its lead product candidates as they progress through proof-of-concept studies has been important information to its current stakeholders, and the Company believes this will also matter to public investors in making an investment decision. The Company respectfully submits that public investors and analysts will benefit from a convenient visual presentation of the status of product candidates as they progress through each of its proof-of-concept studies and into pivotal safety and efficacy studies.

 

  2. We note your response of prior comment 7. As clonal cell manufacture is only an adjunct to your product development, please remove the column relating to it from your tables. You may continue to discuss it in a footnote by moving footnote 1 to the pivotal safety and efficacy studies column.

Company Response: In response to the Staff’s comment, the Company has removed the column relating to clonal cell manufacturing from the tables on pages 2 and 80 of the Registration Statement.

*                *                 *


Mr. Jeffrey P. Riedler

December 30, 2014

Page Three

 

We and the Company very much appreciate the Staff’s attention to the review of the Registration Statement. Please do not hesitate to contact me at (212) 335-4517 or my colleague Andrew D. Ledbetter at (206) 839-4845 if you have any questions regarding this letter or the Registration Statement.

Sincerely,

DLA Piper LLP (US)

Marjorie Sybul Adams

marjorie.adams@dlapiper.com

 

cc: Via E-mail
   Dana Hartz (Staff Accountant, SEC Division of Corporation Finance)
   Mark Brunhofer (Senior Staff Accountant, SEC Division of Corporation Finance)
   Scot Foley (Staff Attorney, SEC Division of Corporation Finance)
   John Krug (Senior Counsel, SEC Division of Corporation Finance)
   Mark Heffernan (CEO, Nexvet Biopharma plc)
   Damian Lismore (CFO, Nexvet Biopharma plc)
   Geraldine Farrell (General Counsel, Nexvet Biopharma plc)
   Andrew D. Ledbetter (DLA Piper LLP (US))
   Mark B. Weeks (Cooley LLP)
   John T. McKenna (Cooley LLP)