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TABLE OF CONTENTS

Table of Contents

As filed with the Securities and Exchange Commission on January 12, 2017.

Registration No. 333-                  


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM F-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

Strongbridge Biopharma plc
(Exact Name of Registrant as Specified in Its Charter)

Not Applicable
(Translation of Registrant's name into English)

Ireland
(State or Other Jurisdiction of
Incorporation or Organization)
  2834
(Primary Standard Industrial
Classification Code Number)
  Not Applicable
(I.R.S. Employer
Identification Number)

900 Northbrook Drive
Suite 200
Trevose, PA 19053
+1 610-254-9200

(Address, Including Zip Code, and Telephone Number, Including
Area Code, of Registrant's Principal Executive Offices)

Stephen Long, Chief Legal Officer
Strongbridge Biopharma plc
900 Northbrook Drive
Suite 200
Trevose, PA 19053
+1 610-254-9200

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)

Copies to:

Aron Izower
Reed Smith LLP
599 Lexington Avenue, 22nd Floor
New York, NY 10022

Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this registration statement.

          If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.     o

          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.     ý

          If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) 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.     o

          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.     o

          If this Form is a registration statement pursuant to General Instruction I.C. or a post-effective amendment thereto that shall become effective on filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.     o

          If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.C. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.     o

CALCULATION OF REGISTRATION FEE

               
 
Title of Securities
To Be Registered

  Amount To Be
Registered(1)

  Proposed Maximum
Offering Price Per
Share

  Proposed Maximum
Aggregate Offering
Price(2)

  Amount of
Registration Fee

 

Ordinary shares, par value $0.01 per share

  28,265,833   $2.28   $64,446,099.20   $7,469.30

 

(1)
Pursuant to Rule 416(a) of the Securities Act of 1933, as amended, this registration statement also covers such additional ordinary shares of the Registrant as may hereafter be offered or issued by reason of any share dividend, share split, bonus issue, recapitalization or similar transaction effected without the Registrant's receipt of consideration which would increase the number of outstanding ordinary shares.

(2)
Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(c) under the Securities Act of 1933, as amended. The price per share and aggregate offering price are based on the average of the high and low prices per share on January 9, 2016, as reported on The NASDAQ Global Select Market.

           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 Securities and Exchange 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 is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

Subject to Completion, dated January 12, 2017

P R O S P E C T U S



28,265,833 Ordinary Shares

LOGO

Strongbridge Biopharma plc

Ordinary Shares



        This prospectus relates to the proposed resale or other disposition of up to 28,265,833 ordinary shares of Strongbridge Biopharma plc by the selling shareholders identified in this prospectus, including 7,428,571 ordinary shares issuable upon the exercise of warrants and 74,918 ordinary shares issuable upon the exercise of options held by one of the selling shareholders. We are not selling any ordinary shares under this prospectus and will not receive any of the proceeds from the sale or other disposition of ordinary shares by the selling shareholders, other than any proceeds from the cash exercise of the warrants and/or options to purchase ordinary shares.

        This offering is not being underwritten. The selling shareholders or their pledgees, assignees or successors-in-interest may offer and sell or otherwise dispose of the ordinary shares described in this prospectus from time to time through public or private transactions at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. The selling shareholders will bear all commissions and discounts, if any, attributable to the sales of ordinary shares. We will bear all other costs, expenses and fees in connection with the registration of the shares. See "Plan of Distribution" beginning on page 27 for more information about how the selling shareholders may sell or dispose of their ordinary shares.

        The ordinary shares are traded on The NASDAQ Global Select Market under the symbol "SBBP". On January 11, 2017, the last reported sale price for the ordinary shares on The NASDAQ Global Select Market was $2.675 per share.

         Investing in our ordinary shares involves a high degree of risk. Before making an investment decision, please read the information under the heading "Risk Factors" beginning on page 7 of this prospectus and in the documents incorporated by reference into this prospectus.

         Neither the Securities and Exchange Commission, any U.S. state securities commission, the Central Bank of Ireland nor any other foreign 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 date of this prospectus is                  , 2017.


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TABLE OF CONTENTS

 
  Page  

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

    1  

ABOUT THE COMPANY

   
3
 

RISK FACTORS

   
7
 

USE OF PROCEEDS

   
18
 

CAPITALIZATION AND INDEBTEDNESS

   
19
 

PRICE RANGE OF OUR ORDINARY SHARES

   
20
 

SELLING SHAREHOLDERS

   
21
 

PLAN OF DISTRIBUTION

   
27
 

DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

   
30
 

TAXATION

   
72
 

LEGAL MATTERS

   
83
 

EXPERTS

   
83
 

ENFORCEMENT OF CIVIL LIABILITIES

   
83
 

WHERE YOU CAN FIND MORE INFORMATION

   
84
 

INCORPORATION BY REFERENCE

   
84
 

EXPENSES

   
86
 


ABOUT THIS PROSPECTUS

        This prospectus is a part of a registration statement that we filed with the Securities and Exchange Commission, or the SEC. The selling shareholders referred to in this prospectus may, from time to time, offer and sell up to 28,265,833 ordinary shares, as described in this prospectus in one or more offerings.

        We have not authorized anyone to give any information or to make any representation other than those contained or incorporated by reference in this prospectus. You must not rely upon any information or representation not contained or incorporated by reference in this prospectus. The selling shareholders are offering to sell, and seeking offers to buy, ordinary shares only in jurisdictions where it is lawful to do so. This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any ordinary shares other than the registered shares to which they relate, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy shares in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or shares are sold on a later date.

        References in this prospectus to "Strongbridge Biopharma," "Strongbridge," "the company," "we," "us," "our," or similar terms refer to Strongbridge Biopharma plc, except as otherwise indicated.


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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

        This prospectus and the documents incorporated by reference herein contain forward-looking statements that involve substantial risks and uncertainties. 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. These forward-looking statements include statements regarding:

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        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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ABOUT THE COMPANY

Overview

        We are a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Our first commercial product is KEVEYIS® (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration ("FDA") for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis. KEVEYIS has orphan drug exclusivity status in the United States through August 7, 2022. In addition to holding this neuromuscular disease franchise, we have a clinical-stage pipeline of therapies for rare endocrine diseases. Our lead compounds include COR-003 (levoketoconazole), a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome, and COR-005, a next-generation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional applications in Cushing's syndrome and neuroendocrine tumors. Both COR-003 and COR-005 have received orphan designation from the FDA and the European Medicines Agency ("EMA"). Given the well identified and concentrated prescriber base addressing our target markets, we believe we can use a small, focused sales force to effectively market our products, if approved, in the United States, the European Union and other key global markets. We believe that our ability to execute on this strategy is enhanced by the significant commercial and clinical development experience of key members of our management team. We will continue to identify and evaluate the acquisition of products and product candidates that would be complementary to our existing rare neuromuscular and endocrine franchises or that would form the basis for new rare disease franchises. We believe this approach will enable us to maximize our commercial potential by further leveraging our existing resources and expertise.

Recent Developments

Acquisition of U.S. Marketing Rights to Keveyis®

        In December 2016, we acquired the U.S. marketing rights to Keveyis® (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. ("Taro"). Keveyis is approved in the United States to treat hyperkalemic, hypokalemic and related variants of primary periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis has received orphan drug exclusivity status in the U.S through August 7, 2022. Under the terms of the Asset Purchase Agreement, dated December 12, 2016, we paid Taro an upfront payment of $1 million and will pay an additional $7.5 million to Taro by March 22, 2017, as well as an aggregate of $7.5 million in potential milestones upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase certain annual minimum amounts of product totaling approximately $29 million over a six-year period from Taro. The supply agreement may extend beyond the orphan exclusivity period unless terminated by either party pursuant to the terms of the agreement. If terminated by Taro at the conclusion of the orphan exclusivity period, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf.

Private Placement

        On December 28, 2016, we raised $35 million in aggregate proceeds in a private placement (the "2016 Private Placement"). According to the terms of the Securities Purchase Agreement, dated December 22, 2016, we issued and sold 14,000,000 ordinary shares at a purchase price of $2.50 per ordinary share, as well as warrants to purchase 7,000,000 ordinary shares (the "Investor Warrants"), to the investors (the "2016 Investors"). The Investor Warrants are exercisable at a price of $2.50 per share beginning on June 28, 2017 and expire in five years from June 28, 2017. In connection with the 2016 Private Placement, we entered into a registration rights agreement with the 2016 Investors, pursuant to

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which we agreed to file the registration statement of which this prospectus is a part, for the purpose of registering for resale (i) the ordinary shares purchased by the 2016 Investors in the 2016 Private Placement, (ii) the ordinary shares exercisable upon exercise of the Investor Warrants acquired by the 2016 Investors in the 2016 Private Placement, and (iii) any other ordinary shares held by a 2016 Investor that beneficially owned at least 1,000,000 ordinary shares following the closing of the 2016 Private Placement that qualified as "Registrable Securities" as defined therein (the "Existing Shares").

Loan Agreement with Oxford Finance LLC and Horizon Technology Finance Corporation

        On December 28, 2016, we entered into a loan and security agreement (the "Loan Agreement") with Oxford Finance LLC ("Oxford") and Horizon Technology Finance Corporation ("Horizon"). The Loan Agreement provided for a $40 million credit facility, of which $20 million was borrowed initially. Under the Loan Agreement, we have access to two additional tranches of $10 million each, which would be available to us subject to the achievement of certain specified milestones. The borrowings pursuant to the Loan Agreement mature after 48 months. The Loan Agreement provides for interest-only payments initially for the first 18 months of the loan followed by an amortization period of 30 months, provides for a final payment fee equal to 8% of the amount borrowed, and bears interest at a rate equal to the sum of 8.22% plus the greater of 0.53% or the 30-day US LIBOR rate. The credit facility provides that if we satisfy certain milestones and borrow the final $10 million tranche, the interest-only period would be extended by an additional six months and the amortization period would be 24 months. We have granted a security interest in substantially all of our existing assets and assets acquired by us in the future, including intellectual property. The Loan Agreement contains facility and prepayment fees, and customary affirmative and negative covenants, and events of default.

        Upon the execution of the Loan Agreement, we issued warrants to each of Oxford and Horizon (the "Lenders") to purchase an aggregate of 428,571 ordinary shares at an exercise price equal to $2.45 per share (the "Lender Warrants"). The Lender Warrants are immediately exercisable and expire after ten years. The Lender Warrants issued to the Lenders include a provision requiring us to file the registration statement of which this prospectus forms a part to provide for the public resale of the ordinary shares to be issued upon exercise of the Lender Warrants.

Termination of Development Program for BP-2002

        In October 2016, our wholly-owned subsidiary, BioPancreate Inc., provided a notice to Cornell University, through its Cornell Center for Technology Enterprise and Commercialization ("CCTEC"), in accordance with the terms of its agreement with CCTEC entered into in March 2011, of the termination of the agreement. The notice was provided in accordance with our decision to terminate our development program for BP-2002, a gene-modified probiotic in pre-clinical development for the potential treatment of type 1 and 2 diabetes that was the subject of the agreement. Because we had not yet reported its financial results for the three and six months ended June 30, 2016, we recorded an impairment charge of $5.2 million in June 2016 since the conditions that caused the impairment existed at that time, which represented the value of the intangible asset it had previously capitalized related to the license agreement. The agreement provides for a 90-day notice period, during which we remain responsible for certain patent costs that we do not expect to be material.

Settlement Agreement with Antisense Therapeutics

        In April 2016, we executed an agreement (the "Settlement Agreement") with Antisense Therapeutics ("Antisense") to terminate the exclusive license agreement (the "Antisense License Agreement") that we and Antisense entered into in May 2015. The Antisense License Agreement provided us with development and commercialization rights to Antisense's product candidate, ATL1103, for endocrinology applications (specifically excluding the treatment of any form of cancer and the treatment of any complications of diabetes). Pursuant to the terms of the Settlement Agreement, we

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have made a one-time payment of approximately $770,000 to Antisense and returned to Antisense, for no consideration, the shares of Antisense owned by us. We also agreed to transfer to Antisense all data, reports, records and materials resulting from our development activities and all ATL1103 drug compound in our possession. The settlement agreement provides for the release by each party of all obligations and liabilities under the Antisense License Agreement.

Corporate Information

        Strongbridge Biopharma plc, an Irish public limited company, was established on May 26, 2015 under the name Cortendo plc. On September 4, 2015, Cortendo plc changed its name to Strongbridge Biopharma plc. We also have a wholly-owned subsidiary, Cortendo AB, organized under the laws of Sweden.

        Cortendo AB was established in October 1996 under the name Stefan Kronvall Medical AB and registered in Sweden in December 1996 for the purpose of developing medically innovative products for pharmaceutical diagnostics and other health care products. Stefan Kronvall Medical AB changed its name to Cortendo AB in 1997, to Cortendo Invest AB in 2003 and then to Cortendo AB (publ) in 2011. Cortendo AB has three wholly owned subsidiaries, Strongbridge U.S. Inc., a Delaware corporation, BioPancreate Inc., a Delaware corporation, and Cortendo Cayman Ltd., an exempted company incorporated in the Cayman Islands.

        In order to effect a corporate reorganization, on September 8, 2015 we settled an exchange offer, which we refer to as the Exchange Offer, pursuant to which holders of 99.449% of the outstanding shares of Cortendo AB exchanged their shares for beneficial interests in our ordinary shares in the form of depositary receipts on a 1-for-1 basis and non-accredited holders of Cortendo AB shares located within the United States, representing 0.133% of the outstanding shares of Cortendo AB, agreed to exchange their shares for cash, which cash settlement occurred on September 14, 2015. Non-accredited U.S. holders of ordinary shares of Cortendo AB received cash in an amount equivalent to the value of one of our ordinary shares for each share of Cortendo AB validly exchanged. Pursuant to individual agreements with the holders of options to purchase shares of Cortendo AB, the outstanding options of Cortendo AB were converted to options to purchase an equivalent number of our ordinary shares.

        On September 8, 2015, we also effected a 1-for-11 reverse stock split of our ordinary shares. Accordingly, our consolidated financial statements and notes reflect our capital structure after giving effect to the exchange offer and the reverse stock split for all periods presented. With effect from September 8, 2015, the 0.418% interest in Cortendo AB not owned by us, is accounted for as a non-controlling interest.

        In September 2016, we acquired the non-controlling interest in Cortendo AB, after which Cortendo AB became a wholly-owned subsidiary of ours. Total consideration paid per share was $13.66 resulting in a payment of $1.4 million.

        Following the settlement of the Exchange Offer, we became the parent of Cortendo AB and its subsidiaries. As a result of the settlement of the Exchange Offer, the historical financial statements of Cortendo AB became, for financial reporting purposes, the historical consolidated financial statements of Strongbridge Biopharma plc and our subsidiaries as a continuation of the predecessor.

        Our principal executive offices are located at 900 Northbrook Drive, Suite 200, Trevose, Pennsylvania, 19053 and our telephone number is +1 610-254-9200. For the purposes of Irish law, our registered office is Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland.

        Our website is www.strongbridgebio.com . We do not incorporate the information on, or accessible through, our website into this prospectus, and you should not consider it a part of this prospectus.

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        Solely for convenience, the trademarks and trade names in this prospectus are referred to without the ® and ™ symbols, but such the absence of references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. The trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners.

Implications of Being an "Emerging Growth Company"

        We qualify as an "emerging growth company," as defined in the Jumpstart our Business Startups Act of 2012 or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and regulatory requirements in contrast to those otherwise applicable generally to public companies. These provisions include:

        We may take advantage of these reduced reporting and other regulatory requirements for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our ordinary shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period. In addition, the JOBS Act provides that an emerging growth company may 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. If we choose to take advantage of any of these reduced reporting burdens, the information that we provide shareholders may be different than you might get from other public companies.

Implications of Being a Foreign Private Issuer

        As a foreign private issuer under the Exchange Act, we are exempted from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

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RISK FACTORS

        Investing in our ordinary shares involves a high degree of risk. Before investing in our ordinary shares, you should carefully consider the risk factors below together with all other information included in this prospectus, including the risks discussed under the caption "Risk Factors" in our latest Annual Report on Form 20-F filed with the SEC on March 24, 2016 ("2016 Annual Report"), to the extent not otherwise updated by the risk factors below, and the risk factors discussed under the caption "Update to Risk Factors" in our Form 6-K filed on May 17, 2016 and the Forms 6-K filed on December 30, 2016, all of which are incorporated by reference into this prospectus, and information included or incorporated by reference in any applicable prospectus supplement. Those risk factors below denoted with a "*" have been updated from our 2016 Annual Report.

        Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occurs and, as a result, the market price of our ordinary shares could decline and you could 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.

The terms of our credit facility place restrictions on our operating and financial flexibility.

        The Loan Agreement with Oxford and Horizon includes affirmative and negative covenants applicable to us and any subsidiaries we create in the future. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and good standing and governmental approvals necessary for us and our subsidiaries to perform our respective businesses and obligations under the Loan Agreement, deliver certain financial reports to the Lenders, maintain insurance coverage, comply with certain financial covenants, dissolve our subsidiary, BioPancreate Inc., within six months of the effective date of the Loan Agreement, and enter into an intercompany license or other agreement with our subsidiary, Strongbridge U.S. Inc., pursuant to which Strongbridge U.S. Inc. will have the exclusive right to market and sell Keveyis products in the United States. The negative covenants include, among others, restrictions on our transferring collateral, changing our business, management, ownership or business location, engaging in mergers or acquisitions, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, or entering into transactions with affiliates, in each case subject to certain exceptions.

        The Loan Agreement also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide Oxford, as collateral agent, with the right to exercise remedies against us and the collateral securing the credit facility, including foreclosure against our properties securing the credit facilities, including our cash. These events of default include, among other things, our failure to pay any amounts due under the Loan Agreement, a breach of covenants under the Loan Agreement, a material adverse change, our insolvency, the occurrence of a default under any agreement with a third party that would result in a payment by us or our subsidiaries of greater than $100,000, and/or one or more judgments against us or our subsidiaries in an amount greater than $100,000 individually or in the aggregate.

        Our ability to make scheduled payments on or to refinance our indebtedness depends on our future performance and ability to raise additional sources of cash, which is subject to economic, financial, competitive and other factors beyond our control. If we are unable to generate sufficient cash to service our debt, we may be required to adopt one or more alternatives, such as selling assets, restructuring our debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. If we desire to refinance our indebtedness, our ability to do so will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.

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Certain provisions of the warrants issued in the 2016 Private Placement could impede a sale of the Company.

        In the event of a sale of the Company, the terms of the warrants issued to the 2016 Investors in the 2016 Private Placement require us to use our best efforts to ensure the holders of such warrants will have a continuing right to purchase shares of the acquirer and, if our efforts are unsuccessful, to make a payment to such warrant holders based on a Black-Scholes valuation (using variables as specified in the warrant agreements). Such payment must be made in cash in the event that the acquisition results in our shareholders receiving cash from the acquirer at the closing of the transaction, and must be made in shares of the Company (with the value of each ordinary share determined according to the calculation specified in the warrant agreements) in the event that the acquisition results in our shareholders receiving shares in the acquirer or other entity at the closing of the transaction. In the event that our shareholders receive both cash and shares at the closing of the transaction, such payment to the warrant holders shall also be made in both cash and shares in the same proportion as the consideration received by the shareholders.

        Notwithstanding the foregoing, in the event that as a result of an acquisition the warrants will be exercisable for anything other than shares or securities that are listed on a regulated market (within the meaning of the Markets in Financial Instruments Directive (2004/39(EC))) or a United States national securities exchange, the warrant holders will be entitled to demand to receive a cash payment in an amount equal to the Black-Scholes Value per warrant (calculated in accordance with the warrants) contemporaneously with or promptly after the consummation of such acquisition.

Risks Related to Our Being a Development-Stage Company

* We have a limited operating history on which to assess our business, have incurred significant losses over the last several years, and anticipate that we will continue to incur losses for the foreseeable future.

        Until December 2016, when we acquired the U.S. marketing rights to Keveyis, we were a development-stage biopharmaceutical company with a limited operating history. We have not yet demonstrated an ability to successfully complete a large-scale, pivotal clinical trial, obtain regulatory approval or manufacture and commercialize a product candidate. Consequently, we have no meaningful commercial operations upon which to evaluate our business and predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.

        Since inception, we have incurred significant operating losses. Our net loss was $43.6 million and $9.7 million for the years ended December 31, 2015 and 2014, respectively. For the nine months ended September 30, 2016, our net loss was $32.6 million, and as of September 30, 2016, we had an accumulated deficit of $113.4 million. We have devoted substantially all of our financial resources to identifying, in-licensing, acquiring and developing our product candidates, including conducting clinical trials and providing general and administrative support for these operations to build our business infrastructure.

        To date, we have financed our operations primarily through private placements of equity securities and the proceeds from our initial public offering of ordinary shares in the United States in October 2015. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations or grants. To become and remain profitable, we must successfully commercialize Keveyis and develop and eventually commercialize one or more of our product candidates with significant market potential.

        Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. It may be several years, if ever, before we receive regulatory approval and have a product candidate other than Keveyis approved for commercialization. Our future revenue from Keveyis sales and sales from any other product candidates approved for commercialization will depend

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upon the size of the markets in which our product candidates are marketed, or in which they may receive approval, and our ability to achieve market acceptance and adequate market share for our product candidates in those markets.

        We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:

        Further, the net losses we incur may fluctuate significantly from quarter-to-quarter and year-to-year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Moreover, if we incur substantial losses, we could be liquidated, and the value of our shares might be significantly reduced or the shares might be of no value.

*We have never generated any revenue from product sales and may never be profitable.

        We have only one product approved for commercialization, and two product candidates in development, and have never generated any revenue from product sales. We will not generate revenue from product sales unless and until we launch Keveyis or successfully complete the development of, obtain regulatory approval for and commercialize one or more of our product candidates. Our ability to generate future revenue from product sales depends heavily on our success in many areas, including, but not limited to:

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        Given the numerous risks and uncertainties associated with pharmaceutical product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Our expenses could increase beyond expectations if we are required by the FDA or the EMA, or any comparable foreign regulatory agency, to perform nonclinical and preclinical studies or clinical trials in addition to those that we currently anticipate.

        We anticipate incurring significant costs associated with commercializing Keveyis and any other product candidates that are approved. Further, our revenue will be dependent, in part, upon the size of the markets in the territories for which we have received regulatory approval, the accepted price for the product, the ability to obtain coverage and adequate reimbursement, and whether we own the commercial rights for that territory. If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of our product candidates. If we are not able to generate sufficient revenue from the sale of any approved products, we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to successfully execute any of the foregoing would decrease the value of our company and could impair our ability to raise capital, expand our business or continue our operations. A decline in the value of our company could cause you to lose all or part of your investment.

* We expect that we will need substantial additional funding before we can expect to complete the development of our two product candidates.

        We are currently advancing two product candidates through clinical development, COR-003 and COR-005. Development of product candidates is expensive, and we expect our research and development expenses to increase in connection with our ongoing activities, particularly as we continue

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our ongoing trials and initiate new trials of COR-003, COR-005 and any other product candidates we may seek to develop. We expect that we will require additional capital to obtain regulatory approval for, and to commercialize, our product candidates.

        As of September 30, 2016, we had cash and cash equivalents of $25.5 million and no outstanding debt. In December 2016, we raised $35 million in aggregate proceeds in a private placement of ordinary shares and warrants, and borrowed $20 million pursuant to a $40 million credit facility that was established in December 2016. We currently believe that our existing cash and cash equivalents, excluding any additional borrowings under the credit facility, is sufficient to fund planned operations at least through 2018. However, this estimate is based on assumptions that may prove to be incorrect, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned. Our future funding requirements will depend on many factors, including, but not limited to:

        Any additional fundraising efforts may divert our management from their day-to-day activities, which may compromise our ability to develop and commercialize our product candidates, if approved. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our shareholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our ordinary shares to decline.

        If we are unable to obtain funding on a timely basis or realize sufficient revenues from Keveyis and any other approved products, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidates, if approved, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired.

* We may not be successful in executing our growth strategy or our growth strategy may not deliver the anticipated results.

        We plan to source new product candidates that may or may not be complementary to our existing product candidates by in-licensing or acquiring them from other companies or academic institutions. If we are unable to identify, in-license or acquire and integrate product candidates in accordance with this strategy, our ability to pursue our growth strategy would be compromised.

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        Research programs and business development efforts to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful. Our research programs, business development efforts or licensing attempts may fail to yield additional complementary or successful product candidates for clinical development and commercialization for a number of reasons, including, but not limited to, the following:

        If any of these events occurs, we may not be successful in executing our growth strategy or our growth strategy may not deliver the anticipated results.

* If we acquire other businesses or in-license or acquire other product candidates and are unable to integrate them successfully, our financial performance could suffer.

        If we are presented with appropriate opportunities, we may acquire other businesses or product candidates. We have had limited experience integrating other businesses or product candidates, or in-licensing or acquiring other product candidates. Since our formation in 1996, we have in-licensed or acquired three product candidates: COR-004, COR-005 and BP-2002. The acquisition of the U.S. marketing rights of Keveyis and our acquisition of COR-005 occurred recently, and we are still in the early stages of integrating them into our business. The integration process following these or any future transactions may produce unforeseen operating difficulties and expenditures, and may absorb significant management attention that would otherwise be directed to the ongoing development of our business. Also, in any future in-licensing or acquisition transactions, we may issue shares of stock that would

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result in dilution to existing shareholders, incur debt, assume contingent liabilities or create additional expenses related to amortizing intangible assets, any of which might harm our financial results and cause our stock price to decline. Any financing we might need for future transactions may be available to us only on terms that restrict our business or impose costs that reduce our net income.

Risks Related to the Development and Clinical Testing of Our Product Candidates

* We depend entirely on the success of Keveyis and a limited number of product candidates which are still in clinical development. If we do not successfully commercialize Keveyis or obtain regulatory approval for and successfully commercialize one or more of our product candidates, or we experience significant delays in doing so, we may never become profitable.

        We currently have one product approved for sale and two product candidates in development. We have invested, and continue to expect to invest, a significant portion of our efforts and financial resources in the development of a limited number of product candidates, which are still in clinical development. Our ability to generate product revenues will depend heavily on our successful commercialization of Keveyis and our eventual commercialization, if approved, of one or more of our product candidates currently in development. We are not permitted to market or promote any product candidate before we receive regulatory approval from the FDA, EMA or any comparable foreign regulatory agency, and we may never receive such regulatory approval for our product candidates currently in development. The success of COR-003 and COR-005 will depend on several additional factors, including, but not limited to, the following:

        Many of these factors are beyond our control, including clinical development, the regulatory submission process, potential threats to our intellectual property rights and changes in the competitive landscape. If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials or eventually commercialize these product candidates, if approved.

* Clinical trials are very expensive, time consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials.

        To obtain the requisite regulatory approvals to market and sell our product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our products are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and earlier clinical trials may not be predictive of the results of later-stage clinical trials. For example, the results generated to date in preclinical studies or clinical trials for our product candidates do not ensure that later preclinical studies or clinical trials will demonstrate similar results. Further, we have limited clinical data for our product candidates and have not completed Phase 3 clinical trials for either of our product candidates. Product candidates in later stages of clinical trials

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may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Companies in the biopharmaceutical industry may suffer setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier clinical trials. For example, COR-003 was previously studied for the treatment of type 2 diabetes. In December 2005, prior to the initiation of the first clinical trial by DiObex, our licensee, the FDA placed a clinical hold relating to a safety concern for use of a dosage above 600 mg/day. DiObex modified the clinical trial protocol to limit the highest dose to 600 mg/day, and the clinical hold was lifted by the FDA in February 2006. Furthermore, COR-003 did not demonstrate a reduction in blood glucose levels in a small Phase 2 clinical trial in patients with type 2 diabetes mellitus, the original indication for which it was being developed. We may experience delays in our ongoing or future preclinical studies or clinical trials, and we do not know whether future preclinical studies or clinical trials will begin on time, need to be redesigned, enroll an adequate number of subjects or patients on time or be completed on schedule, if at all. Clinical trials may be delayed, suspended or terminated for a variety of reasons, including delay or failure to:

        Positive or timely results from preclinical or early stage clinical trials do not ensure positive or timely results in late stage clinical trials or regulatory approval by the FDA, EMA or any comparable foreign regulatory agency. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. Preclinical and clinical data are often susceptible to varying interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval for the product candidates. The FDA, EMA and any comparable foreign regulatory agency have substantial discretion in the approval process and in determining when or whether regulatory approval will be obtained for any of our product candidates. Even if we believe the data collected from clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA, EMA or any comparable foreign regulatory agency.

        In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in clinical trial procedures set forth in protocols, differences in the size and type of the patient populations, adherence to the administration regimen and other clinical trial protocols, and the rate of dropout among clinical trial participants. In the case of our late stage clinical product candidates, results may differ in general

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on the basis of the larger number of clinical trial sites and additional countries involved in Phase 3 clinical trials. Different countries have different standards of care and different levels of access to care for patients, which in part drives the heterogeneity of the patient populations that enroll in our studies.

        In June 2015, we acquired COR-005 and were not involved in and had no control over the preclinical and clinical development of this product candidate prior to such acquisition. As a result, we are dependent on the prior research and development of COR-005 having been conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, the accuracy of reported results of all clinical trials conducted prior to our acquisition and the correct interpretation of collected data from these clinical trials. These factors could result in increased costs and delays in the development of COR-005, which could hurt our ability to generate future revenues from this product candidate.

Risks Related to Commercialization of Our Product Candidates

* We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize any of our products that have received or may receive regulatory approval on our own or together with suitable partners.

        We have never commercialized a product candidate. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, in-licensing or acquiring our product candidates, identifying potential product candidates and undertaking preclinical studies and clinical trials of our product candidates. We currently have a very limited sales force or marketing or distribution capabilities. To achieve commercial success of Keveyis and any product candidates that are approved, we will have to develop our own sales, marketing and supply capabilities or outsource these activities to a third party.

        Factors that may affect our ability to commercialize our product candidates on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our product candidates and other unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing organization requires significant investment, is time consuming and could delay the launch of our product candidates. We may not be able to build an effective sales and marketing organization in the United States, the European Union or other key global markets. If we are unable to build our own distribution and marketing capabilities or to find suitable partners for the commercialization of our product candidates, we may not generate revenues from them.

Risks Related to Our Reliance on Third Parties

* The failure of our suppliers to supply us with the agreed upon drug substance or drug product could hurt our business.

        We do not currently, and do not expect to in the future, independently conduct manufacturing activities for Keveyis or our product candidates. We expect to rely on third-party suppliers for the drug substance and drug product for Keveyis, which we expect to launch in April 2017, and our product candidates. The failure of these suppliers to perform as contracted, or the need to identify new suppliers, could result in a delay in the launch of Keveyis or the development of our product candidates. A delay in the launch of Keveyis or the development of our product candidates, or having to enter into a new agreement with a different third party on less favorable terms than we have with our current suppliers, could hurt our business.

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Risks Related to Government and Regulation

* We will be subject to ongoing obligations and continued regulatory requirements which may result in significant additional expense.

        Keveyis and any of our product candidates that obtain regulatory approval will remain subject to continual regulatory review. Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA, the EMA or any comparable foreign regulatory authority approves any of our product candidates, we will be subject to ongoing regulatory obligations and oversight by regulatory authorities, including with respect to the manufacturing processes, labeling, packing, distribution, adverse event reporting, storage, advertising and marketing restrictions, and recordkeeping and, potentially, other post-marketing obligations, all of which may result in significant expense and limit our ability to commercialize such products. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and cGCPs for any clinical trials that we conduct post-regulatory approval. Because our two Phase 3 clinical trials of COR-003 will collect safety data for approximately 125 patients, we currently expect that we would be required by the FDA and the EMA to collect additional safety data post-approval.

        In addition, approved products, manufacturers and manufacturers' facilities are subject to continual review and periodic inspections. 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, or failure to comply with regulatory requirements, may result in, among other things:

        If any of these events occurs, our ability to sell such product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements. The policies of the FDA, the EMA or any comparable foreign regulatory agency may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. 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, which would compromise our ability to achieve or sustain profitability.

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* Although we have obtained orphan drug designation for our key product candidates from the FDA and EMA, orphan drug designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug exclusivity for our product candidates, we may be subject to earlier competition and our potential revenue will be reduced.

        Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if it is intended to treat an orphan disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the European Union, the EMA's Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the European Union. Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug or biological product or where there is no satisfactory method of diagnosis, prevention or treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

        In the United States, orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product receives the first FDA approval for the indication for which it has orphan drug designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity. In the European Union, orphan drug designation entitles a party to financial incentives such as a reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

        Keveyis has been granted orphan drug designation for the treatment of hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis in the United States. COR-003 has been granted orphan drug designation for the treatment of endogenous Cushing's syndrome in the United States and Europe. COR-005 has been granted orphan drug designation for the treatment of acromegaly in the United States and in Europe. Even though we have obtained orphan drug designation for our key product candidates, we may not be the first to obtain regulatory approval for any particular orphan indication due to the uncertainties associated with developing biopharmaceutical products. For example, ketoconazole was granted orphan drug exclusivity in Europe and is now being marketed for the treatment of endogenous Cushing's syndrome. Therefore, COR-003 will need to show significant benefit compared to ketoconazole in order to be marketed in Europe prior to the expiration of the ketoconazole orphan drug exclusivity. Further, even though we have obtained orphan drug designation for our key product candidates, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

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USE OF PROCEEDS

        The proceeds from the sale of the ordinary shares offered pursuant to this prospectus are solely for the account of the selling shareholders. Accordingly, we will receive no proceeds from the sale of the ordinary shares. We will receive up to an aggregate of approximately $18,549,999 from the exercise of the Investor Warrants and Lender Warrants, assuming the exercise in full of all of such warrants for cash, and approximately $832,811 upon the exercise of the options to purchase 74,918 ordinary shares held by one of the selling shareholders (although because these options are currently "underwater" it is unclear whether or when these options may be exercised). We expect to use the net proceeds from the exercise of the Investor Warrants and Lender Warrants for general corporate purposes.

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CAPITALIZATION AND INDEBTEDNESS

        The following table sets forth our capitalization and indebtedness as of September 30, 2016. The table does not take into effect the sale of the Warrants, nor does it take into effect the sale of the ordinary shares by the selling shareholders since the Company will not receive the proceeds from the sale of the ordinary shares by the selling shareholders.

 
  As of
September 30, 2016
Actual
 
 
  (in thousands except for share data)
 

Cash and cash equivalents

  $ 25,469  

Liabilities and Shareholders' Equity

   
 
 

Current liabilities:

       

Accounts payable

  $ 1,012  

Accrued liabilities

    3,228  

Total current liabilities

    4,240  

Total liabilities

    4,240  

Shareholders' equity:

       

Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at September 30, 2016

    44  

Ordinary shares, $0.01 par value, 600,000,000 shares authorized at September 30, 2016 and 21,205,382 shares issued and outstanding at September 30, 2016

    212  

Additional paid-in capital

    173,459  

Accumulated deficit

    (113,400 )

Total shareholders' equity

    60,315  

Total liabilities and shareholders' equity

  $ 64,555  

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PRICE RANGE OF OUR ORDINARY SHARES

        Our ordinary shares have traded on the Nasdaq Global Select Market under the symbol "SBBP" since October 16, 2015. The table below sets forth the high and low prices for each of the periods indicated for our ordinary shares as reported by the NASDAQ Global Select Market.

        On January 11, 2017, the last reported sale price for the ordinary shares on The NASDAQ Global Select Market was $2.675 per share.

 
  High   Low  

Years Ended

             

December 31, 2016

  $ 7.99   $ 2.05  

December 31, 2015

  $ 14.30   $ 5.00  

Quarters Ended

             

December 31, 2016

  $ 5.4235   $ 2.05  

September 30, 2016

  $ 6.239   $ 3.73  

June 30, 2016

  $ 6.3899   $ 3.30  

March 30, 2016

  $ 7.99   $ 3.51  

December 31, 2015

  $ 14.3   $ 5.00  

Months Ended

             

December 31, 2016

  $ 3.85   $ 2.05  

November 30, 2016

  $ 4.70   $ 3.70  

October 31, 2016

  $ 5.4235   $ 4.40  

September 30, 2016

  $ 6.239   $ 4.45  

August 31, 2016

  $ 5.05   $ 4.1501  

July 31, 2016

  $ 4.52   $ 3.73  

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SELLING SHAREHOLDERS

        This prospectus covers the offering for resale from time to time of up to 28,265,833 ordinary shares by the selling shareholders identified in this prospectus, consisting of (i) 21,000,000 ordinary shares sold to the 2016 Investors in the 2016 Private Placement (which includes 7,000,000 ordinary shares issuable upon the exercise of the Investor Warrants), (ii) an additional 6,837,262 Existing Shares held by the 2016 Investors (including 74,918 ordinary shares issuable upon exercise of stock options held by one of the selling shareholders), and (iii) 428,571 ordinary shares issuable upon the exercise of the Lender Warrants issued to the Lenders.

        The selling shareholders, including their transferees, pledges, donees or other successors, may from time to time offer and sell pursuant to this prospectus any or all of the ordinary shares covered by this prospectus. Any selling shareholders may also elect not to sell any of the ordinary shares covered by this prospectus held by such selling shareholders. Only those ordinary shares listed below or in any prospectus supplement hereto may be offered for resale by the selling shareholders pursuant to this prospectus. None of the selling shareholders has, or had, any position, office or other material relationship with us or any of our affiliates beyond their investment in or receipt of our securities.

        We have agreed with the 2016 Investors to use our reasonable best efforts to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (1) such time as all of the registrable securities (as such term is defined in the registration rights agreement) have been disposed of pursuant to and in accordance with the registration statement of which this prospectus forms a part or Rule 144 under the Securities Act, or (2) December 28, 2018, but only if all registrable securities are eligible for sale without restriction under Rule 144; provided, that the ordinary shares issuable upon exercise of the Warrants will be deemed registrable securities for at least six months from the date of exercise of such Warrant whether or not such ordinary shares could be freely tradable without restriction under Rule 144.

        We have agreed with the Lenders to keep this registration statement effective until the expiration of the Lender Warrants.

        The table below lists the selling shareholders. The second column lists the number of ordinary shares beneficially owned by each selling shareholder, as of January 12, 2017, which for the 2016 Investors is limited to the ordinary shares sold to the 2016 Investors in the 2016 Private Placement and any Existing Shares, and does not include any ordinary shares issuable upon exercise of the Investor Warrants, which are not exercisable until June 28, 2017, and for the Lenders consists of the ordinary shares issuable upon exercise of the Lender Warrants, which are exercisable immediately. The third column lists the ordinary shares being offered by this prospectus by each of the selling shareholders, including any Existing Shares, and assuming exercise of the warrants held by the selling shareholders, without regard to any limitations on exercise (as described below).

        Under the terms of the Investor Warrants, a holder may not exercise the Investor Warrants to the extent such exercise would cause such selling holder, together with its affiliates and attribution parties, to beneficially own a number of ordinary shares which would exceed 4.99% of our then outstanding ordinary shares following such exercise (the "Beneficial Ownership Limitation"), excluding for purposes of such determination ordinary shares issuable upon exercise of the Investor Warrants that have not been exercised; provided, however, that the holder may, upon notice to us, increase or decrease the Beneficial Ownership Limitation provided that the Beneficial Ownership Limitation in no event exceeds 9.99% (the "Maximum Percentage") of the number of ordinary shares outstanding following such exercise, excluding for purposes of such determination ordinary shares issuable upon exercise of the Investor Warrants that have not been exercised. Notwithstanding the foregoing, a 2016 Investor who opted out of the exercise limitation at the time the Securities Purchase Agreement was entered into will be permitted to increase its Beneficial Ownership Limitation above the Maximum Percentage,

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provided that the Beneficial Ownership Limitation will in no event exceed 29.999% of the number of ordinary shares outstanding following such exercise.

        The following table is prepared based on information supplied to us by the selling shareholders. Although we have assumed for purposes of the table below that the selling shareholders will sell all of the ordinary shares offered by this prospectus, because the selling shareholders may offer from time to time all or some of the ordinary shares covered by this prospectus, or in another permitted manner, no assurances can be given as to the actual number of ordinary shares that will be resold by the selling shareholders or that will be held by the selling shareholders after completion of the resales. In addition, the selling shareholders may have sold, transferred or otherwise disposed of the ordinary shares in transactions exempt from the registration requirements of the Securities Act after providing the information regarding their securities holdings. Information concerning the selling shareholders may change from time to time and changed information will be presented in a supplement to this prospectus if and when necessary and required. Except as described above, we are party to no agreements, arrangements or understandings with respect to the resale of any of the ordinary shares covered by this prospectus. Pursuant to the purchase agreements pursuant to which the ordinary shares were sold, each of the selling shareholders warranted and covenanted to us that the selling shareholder was an "accredited investor", as that term is defined under the Securities Act, and experienced in making investments of the kind represented by the ordinary shares and that the selling shareholders purchased the ordinary shares in the ordinary course of its business for its own account for investment only and not with a view towards the public sale or distribution thereof and not with a view to or for sale in connection with any distribution thereof.

        The ordinary shares offered by this prospectus may be offered from time to time by the persons or entities named below:

 
   
   
   
  Ordinary Shares
Beneficially Owned
After The
Offering(2)
 
 
  Ordinary Shares Beneficially
Owned Prior To The
Offering(1)
  Maximum
Number of
Ordinary
Shares
Being Offered
 
Name of Selling Stockholder
  Number   Percentage   Number   Percent  

CDK Associates, LLC

    5,102,433     14.4 %   6,300,000 (3)   902,433     2.1 %

731 Alexander Road, Bldg. 2

                               

Princeton, NJ 08540

                               

Karen Cross

   
20,000
   
*
   
30,000

(4)
 
0
   
*
 

731 Alexander Road, Bldg. 2

                               

Princeton, NJ 08540

                               

Kenneth Glennon

   
10,800
   
*
   
12,000

(5)
 
2,800
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

Scott D. Morenstein

   
38,640
   
*
   
45,000

(6)
 
8,640
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

Yuriy Shteinbuk

   
27,000
   
*
   
30,000

(7)
 
7,000
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

Eugene Christopher Burger

   
12,500
   
*
   
15,000

(8)
 
2,500
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

Heath N. Weisberg

   
42,021
   
*
   
48,000

(9)
 
10,021
   
*
 

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  Ordinary Shares
Beneficially Owned
After The
Offering(2)
 
 
  Ordinary Shares Beneficially
Owned Prior To The
Offering(1)
  Maximum
Number of
Ordinary
Shares
Being Offered
 
Name of Selling Stockholder
  Number   Percentage   Number   Percent  

731 Alexander Road, Bldg. 2

                               

Princeton, NJ 08540

                               

Daniel P. Klein

   
119,645
   
*
   
150,000

(10)
 
19,645
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

David Ben-Ur

   
21,955
   
*
   
30,000

(11)
 
1,955
   
*
 

1330 Sixth Ave., 20 th  Fl.

                               

New York, NY 10019

                               

Vivo Capital Fund VIII, L.P. 

   
2,636,000
   
7.5

%
 
3,954,000

(12)
 
0
   
*
 

505 Hamiltone Ave., Suite 200

                               

Palo Alto, CA 94301

                               

Vivo Capital Surplus Fund VIII, L.P. 

   
364,000
   
1.0

%
 
546,000

(13)
 
0
   
*
 

505 Hamiltone Ave., Suite 200

                               

Palo Alto, CA 94301

                               

Growth Equity Opportunities Fund III, LLC

   
4,141,308
   
11.7

%
 
5,141,308

(14)
 
0
   
*
 

1954 Greenspring Dr.

                               

Trimonium, MD 21093

                               

Opaleye L.P. 

   
1,140,000
   
3.2

%
 
1,710,000

(15)
 
0
   
*
 

36R Carver Street

                               

Cambridge, MA 02138

                               

Broadfin Healthcare Master Fund, LTD

   
2,856,706
   
8.1

%
 
2,905,056

(16)
 
0
   
*
 

300 Park Avenue, 25 th  Fl.

                               

New York, NY 10022

                               

Boxer Capital, LLC

   
940,000
   
2.7

%
 
1,410,000

(17)
 
0
   
*
 

11682 El Camino Real, Suite 320

                               

San Diego, CA 92130

                               

Healthcap VI, L.P. 

   
3,301,008

(18)
 
9.3

%
 
3,701,008

(19)
 
0
   
*
 

18, Avenue d'Ouchy

                               

1006 Lausanne, Switzerland

                               

Eigil Stray Spetalen

   
1,254,790
   
3.7

%
 
1,337,240

(20)
 
0
   
*
 

CHR. BENNECHES V. 9

                               

0286 Oslo, Norway

                               

Fougner Invest

   
82,300
   
*
   
123,450

(21)
 
0
   
*
 

NILS COLLETT VOGTSU.65

                               

0766 Oslo, Norway

                               

Zinober invest AS

   
61,700
   
*
   
92,550

(22)
 
0
   
*
 

DYNA DBYGGE 7

                               

0256 Oslo, Norway

                               

H5 Vekst AS

   
57,600
   
*
   
86,400

(23)
 
0
   
*
 

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  Ordinary Shares
Beneficially Owned
After The
Offering(2)
 
 
  Ordinary Shares Beneficially
Owned Prior To The
Offering(1)
  Maximum
Number of
Ordinary
Shares
Being Offered
 
Name of Selling Stockholder
  Number   Percentage   Number   Percent  

GALEASEN 7, 1394 NESBRU

                               

Norway

                               

Abraxas AS

   
41,100
   
*
   
61,650

(24)
 
0
   
*
 

GALEASEN 7, 1394 NESBRU

                               

Norway

                               

Pima A/S

   
39,500
   
*
   
59,250

(25)
 
0
   
*
 

LOVENSKIOLDSVEI 23

                               

1358 JAR, Norway

                               

AS Mascot Holding

   
32,900
   
*
   
49,350

(26)
 
0
   
*
 

BYGDOYNESVEIEN 116

                               

0286 Oslo, Norway

                               

Oxford Finance LLC

   
267,857

(26)
 
*
   
267,857

(27)
 
0
   
*
 

133 N. Fairfax Street

                               

Alexandria, VA 22314

                               

Horizon Technology Finance Corporation

   
160,714

(27)
 
*
   
160,714

(28)
 
0
   
*
 

312 Farmington Avenue

                               

Farmington, CT 06032

                               

*
Less than 1%.

(1)
Beneficial ownership is determined in accordance with Rule 13d-3 under the U.S. Securities Exchange Act of 1934, as amended, and includes voting or investment power with respect to the securities. The percentage of beneficial ownership of each selling shareholder is based on (i) 35,335,026 ordinary shares issued and outstanding as of January 12, 2017 and (ii) the ordinary shares underlying share options and warrants exercisable by such person or group within 60 days of January 12, 2017, not including the warrants sold to the selling shareholders in the private placement, which are not exercisable until June 28, 2017.

(2)
Assumes the sale of all securities offered in this prospectus.

(3)
This number includes 4,200,000 ordinary shares sold to CDK Associates, LLC ("CDK") in the 2016 Private Placement and 2,100,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by CDK in the 2016 Private Placement.

(4)
This number includes 20,000 ordinary shares sold to Karen Cross in the 2016 Private Placement and 10,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Ms. Cross in the 2016 Private Placement.

(5)
This number includes 8,000 ordinary shares sold to Kenneth Glennon in the 2016 Private Placement and 4,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Glennon in the 2016 Private Placement.

(6)
This number includes 30,000 ordinary shares sold to Scott D. Morenstein in the 2016 Private Placement and 15,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Morenstein in the 2016 Private Placement.

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(7)
This number includes 20,000 ordinary shares sold to Yuriy Shteinbuk in the 2016 Private Placement and 10,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Shteinbuk in the 2016 Private Placement.

(8)
This number includes 10,000 ordinary shares sold to Eugene Christopher Burger in the 2016 Private Placement and 5,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Burger in the 2016 Private Placement.

(9)
This number includes 32,000 ordinary shares sold to Heath N. Weisberg in the 2016 Private Placement and 16,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Weisberg in the 2016 Private Placement.

(10)
This number includes 100,000 ordinary shares sold to Daniel P. Klein in the 2016 Private Placement and 50,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Klein in the 2016 Private Placement.

(11)
This number includes 20,000 ordinary shares sold to David Ben-Ur in the 2016 Private Placement and 10,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Ben-Ur in the 2016 Private Placement.

(12)
This number includes 2,636,000 ordinary shares sold to Vivo Capital Fund VIII, L.P. ("Vivo") in the 2016 Private Placement and 1,318,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Vivo in the 2016 Private Placement.

(13)
This number includes 364,000 ordinary shares sold to Vivo Capital Surplus Fund VIII, L.P. ("Vivo Surplus") in the 2016 Private Placement and 182,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Vivo Surplus in the 2016 Private Placement.

(14)
This number includes 2,141,308 Existing Shares, 2,000,000 ordinary shares sold to Growth Equity Opportunities Fund III, LLC ("GEO") in the 2016 Private Placement and 1,000,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by GEO in the 2016 Private Placement. The ordinary shares and Investor Warrants directly held by GEO are indirectly held by New Enterprise Associates 15, L.P. ("NEA 15"), which is the sole member of GEO; NEA Partners 15, L.P. ("NEA Partners 15"), which is the sole general partner of NEA 15; NEA 15 GP, LLC ("NEA 15 LLC"), which is the sole general partner of NEA Partners 15; and each of the individual managers of NEA 15 LLC. The individual Managers of NEA 15 LLC (the "NEA 15 Managers") are Peter J. Barris, Forest Baskett, Anthony A. Florence, Jr., Joshua Makower, David M. Mott, Scott D. Sandell, Ravi Viswanathan, Jon Sakoda and Peter W. Sonsini. NEA 15, NEA Partners 15, NEA 15 LLC, and the NEA 15 Managers share voting and dispositive power over the ordinary shares directly owned by GEO. All indirect holders of the above referenced ordinary shares and Investor Warrants disclaim beneficial ownership of the applicable ordinary shares directly owned by GEO, except to the extent of their actual pecuniary interest therein.

(15)
This number includes 1,140,000 ordinary shares sold to Opaleye L.P. ("Opaleye") in the 2016 Private Placement and 570,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Opayleye in the 2016 Private Placement.

(16)
This number includes 1,105,056 Existing Shares, 1,200,000 ordinary shares sold to Broadfin Healthcare Master Fund, LTD ("Broadfin") in the private placement and 600,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Broadfin in the 2016 Private Placement.

(17)
This number includes 940,000 ordinary shares sold to Boxer Capital, LLC ("Boxer") in the 2016 Private Placement and 470,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Boxer in the 2016 Private Placement.

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(18)
This number includes 74,918 ordinary shares that are currently issuable upon exercise of share options held by HealthCap VI, L.P. ("HealthCap").

(19)
This number includes 2,501,008 Existing Shares (including 74,918 ordinary shares issuable upon exercise of share options), 800,000 ordinary shares sold to HealthCap in the private placement and 400,000 ordinary shares issuable upon the exercise of the Investor Warrants acquired by HealthCap in the 2016 Private Placement.

(20)
This number includes 1,089,890 Existing Shares (including 665,262 ordinary shares held by Kristianro A/S, for which Mr. Spetalen serves as Chief Executive Officer, and may be deemed to be the beneficial owner), 164,900 ordinary shares sold to Mr. Spetalen in the private placement and 82,450 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Mr. Spetalen in the 2016 Private Placement.

(21)
This number includes 82,300 ordinary shares sold to Fougner invest in the 2016 Private Placement and 41,150 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Fougner invest in the 2016 Private Placement.

(22)
This number includes 61,700 ordinary shares sold to Zinober invest AS ("Zinober") in the 2016 Private Placement and 30,850 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Zinober in the 2016 Private Placement.

(23)
This number includes 57,600 ordinary shares sold to H5 Vekst AS ("H5") in the 2016 Private Placement and 28,800 ordinary shares issuable upon the exercise of the Investor Warrants acquired by H5 in the 2016 Private Placement.

(24)
This number includes 41,100 ordinary shares sold to Abraxas AS ("Abraxas") in the 2016 Private Placement and 20,550 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Abraxas in the 2016 Private Placement.

(25)
This number includes 39,500 ordinary shares sold to Pima A/S in the 2016 Private Placement and 19,750 ordinary shares issuable upon the exercise of the Investor Warrants acquired by Pima A/S in the 2016 Private Placement.

(26)
This number includes 32,900 ordinary shares sold to AS Mascot Holding ("AS Mascot") in the 2016 Private Placement and 16,450 ordinary shares issuable upon the exercise of the Investor Warrants acquired by AS Mascot in the 2016 Private Placement.

(27)
This number represents 267,857.14 ordinary shares that are issuable upon exercise of the Lender Warrants issued to Oxford Finance LLC, which shares are currently exercisable.

(28)
This number represents 160,714.29 ordinary shares that are issuable upon exercise of the Lender Warrants issued to Horizon Technology Finance Corporation, which shares are currently exercisable.

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PLAN OF DISTRIBUTION

        We are registering the ordinary shares issued to the selling shareholders and issuable upon the exercise of the warrants issued to the selling shareholders to permit the resale of these ordinary shares by the holders of the ordinary shares and warrants from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the selling shareholders of the ordinary shares. We will bear all fees and expenses incident to our obligation to register the ordinary shares.

        The selling shareholders may sell all or a portion of the ordinary shares beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the ordinary shares are sold through underwriters or broker-dealers, the selling stockholders will be responsible for underwriting discounts or commissions or agent's commissions. The ordinary shares may be sold on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale, in the over-the-counter market or in transactions otherwise than on these exchanges or systems or in the over-the-counter market and in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions. The selling shareholders may use any one or more of the following methods when selling shares:

        The selling shareholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(1) under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conform to the requirements of those provisions.

        Broker-dealers engaged by the selling shareholders may arrange for other broker-dealers to participate in sales. If the selling shareholders effect such transactions by selling ordinary shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling stockholders or commissions from purchasers of the ordinary shares for whom they may act as agent or to whom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

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        In connection with sales of the ordinary shares or otherwise, the selling shareholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the ordinary shares in the course of hedging in positions they assume. The selling shareholders may also sell ordinary shares short and if such short sale shall take place after the date that the registration statement of which this prospectus forms a part is declared effective by the SEC, the selling shareholders may deliver ordinary shares covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling shareholders may also loan or pledge ordinary shares to broker-dealers that in turn may sell such shares, to the extent permitted by applicable law. The selling shareholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the selling shareholders have been advised that they may not use shares registered on this registration statement to cover short sales of our ordinary shares made prior to the date the registration statement, of which this prospectus forms a part, has been declared effective by the SEC.

        The selling shareholders may, from time to time, pledge or grant a security interest in some or all of the ordinary shares owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the ordinary shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending, if necessary, the list of selling shareholders to include the pledgee, transferee or other successors in interest as selling shareholders under this prospectus. The selling shareholders also may transfer and donate the ordinary shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

        The selling shareholders and any broker-dealer or agents participating in the distribution of the ordinary shares may be deemed to be "underwriters" within the meaning of Section 2(11) of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agent and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Selling shareholders who are "underwriters" within the meaning of Section 2(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

        Each selling shareholder has informed the Company that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the ordinary shares.

        Under the securities laws of some states, the ordinary shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the ordinary shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

        There can be no assurance that any selling stockholder will sell any or all of the ordinary shares registered pursuant to the shelf registration statement, of which this prospectus forms a part.

        Each selling shareholder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the ordinary shares by the selling shareholder and any other participating

28


Table of Contents

person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the ordinary shares to engage in market-making activities with respect to the ordinary shares. All of the foregoing may affect the marketability of the ordinary shares and the ability of any person or entity to engage in market-making activities with respect to the ordinary shares.

        We will pay all expenses of the registration of the ordinary shares pursuant to the registration rights agreement, including, without limitation, SEC filing fees and expenses of compliance with state securities or "blue sky" laws; provided , however , that each selling shareholder will pay all underwriting discounts and selling commissions, if any and any related legal expenses incurred by it. We will indemnify the selling shareholders against certain liabilities, including some liabilities under the Securities Act, in accordance with the registration rights agreement, or the selling shareholders will be entitled to contribution. We may be indemnified by the selling shareholders against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by the selling shareholders specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled to contribution.

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DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

Corporate Profile

        The Company is a public limited company for the purposes of Part 17 of the Irish Companies Act 2014 (the "Irish Companies Act"). For the purposes of Irish law, our registered office is Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland.

Corporate Purpose

        According to our Memorandum of Association, the objects for which the Company was established are:

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Authorized Share Capital

        Our authorized share capital is €40,000, divided into 40,000 deferred ordinary shares with a nominal value of €1.00 per share, and $7,000,000, divided into 600,000,000 ordinary shares with a nominal value of $0.01 per share and 100,000,000 preferred shares with a nominal value of $0.01 per share.

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        The authorized and issued share capital includes 40,000 deferred ordinary shares, which are required in order to satisfy statutory minimum capital requirements of an Irish public limited company. The holders of the deferred ordinary 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 preferred shares without shareholder approval once authorized to do so by the memorandum and articles of association or by an ordinary resolution adopted by our 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 shareholders by an ordinary resolution. Accordingly, our Articles authorize our board of directors to issue new ordinary or preferred shares without shareholder approval for a period of five years from the date of the adoption of our Articles on September 9, 2015. The authority to issue preferred shares provides us with the flexibility to consider and respond to future business needs and opportunities as they arise from time to time, including in connection with capital raising, financing and acquisition transactions or opportunities.

        Under our Articles, our board of directors is authorized to issue preferred shares on a non-pre-emptive basis, with discretion as to the terms attaching to the preferred shares, including as to voting, dividend and conversion rights and priority relative to other classes of shares with respect to dividends and upon a liquidation. As described in the preceding paragraph, this authority extends until five years from the date of the adoption of our Articles on September 9, 2015, at which time it will expire unless renewed by our shareholders.

        Notwithstanding this authority, under the Irish Takeover Rules our board of directors would not be permitted to issue any of our shares, including preferred shares, during a period when an offer has been made for us or is believed to be imminent unless the issue is (i) approved by our shareholders at a general meeting; (ii) consented to by the Irish Takeover Panel on the basis it would not constitute action frustrating the offer; (iii) consented to by the Irish Takeover Panel and approved by the holders of more than 50% of our shares carrying voting rights; (iv) consented to by the Irish Takeover Panel in circumstances where a contract for the issue of the shares had been entered into prior to that period; or (v) consented to by the Irish Takeover Panel in circumstances where the issue of the shares was decided by our directors prior to that period and either action has been taken to implement the issuance (whether in part or in full) prior to such period or the issuance was otherwise in the ordinary course of business.

        While we do not have any current specific plans, arrangements or understandings, written or oral, to issue any preferred shares for any purpose, we are continually evaluating our financial position and analyzing the possible benefits of issuing additional debt securities, equity securities, convertible securities or a combination thereof in connection with, among other things: (i) repaying indebtedness; (ii) financing acquisitions; or (iii) strengthening our balance sheet. The availability of preferred shares gives us flexibility to respond to future capital raising, financing and acquisition needs and opportunities without the delay and expense associated with holding an extraordinary general meeting of our shareholders to obtain further shareholder approval.

        The rights and restrictions to which the ordinary shares will be subject are prescribed in our memorandum of association and Articles. Our Articles permit our board of directors, without shareholder approval, to determine the terms of any preferred 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

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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.

        Irish law does not recognize fractional shares held of record. Accordingly, our Articles do not provide for the issuance of fractional ordinary shares, and our official Irish share register will not reflect any fractional shares.

Development of Share Capital

        As of September 30, 2016, our fully paid, issued and outstanding share capital was 21,205,382 ordinary shares and 40,000 deferred shares. As of January 12, 2017, our fully paid, issued and outstanding share capital was 35,335,026 ordinary shares and 40,000 deferred shares. The development of our share capital since January 1, 2016 is set forth in the table below. As of January 1, 2016 our fully paid, issued and outstanding share capital was 35,335,026 ordinary shares and 40,000 deferred shares.

Date
  Share Capital Before the
Transaction
  Transaction   Share Capital After the
Transaction
  Price per
Ordinary Share
 

December 28, 2016

  21,205,382 ordinary shares and 40,000 deferred shares   Private Placement with 2016 Investors   35,205,382 ordinary shares and 40,000 deferred shares   $ 2.50  

December 28, 2016

  35,205,382 ordinary shares and 40,000 deferred shares   Option Exercise   35,335,026 ordinary shares and 40,000 deferred shares   $ 1.32  

Preemption Rights, Share Warrants and Share Options

        Under Irish law, unless otherwise authorized, when an Irish public limited company issues shares for cash to new shareholders, it is required first to offer those shares on the same or more favorable terms to existing shareholders of the company on a pro rata basis, commonly referred to as the statutory preemption right. 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 every five years by a special resolution of the shareholders, our Articles provide that this opt-out will lapse five years after the adoption of Strongbridge Biopharma plc's current Articles on September 9, 2015. A special resolution requires not less than 75% of the votes of our shareholders cast at a general meeting. If the opt-out is not renewed, shares issued for cash must be offered to pre-existing shareholders of Strongbridge pro rata to their existing shareholding before the shares can be issued to any new shareholders. The statutory preemption rights do not apply where shares are issued for non-cash consideration and do not apply 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).

Issuance of Warrants and Options

        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 Act provides that directors may issue share warrants or options without shareholder approval once authorized to do so by

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the articles of association or an ordinary resolution of shareholders. We are subject to the rules of NASDAQ and the Irish Companies Act, 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.

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 undenominated capital 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.

        The determination as to whether or not we have sufficient distributable reserves to fund a dividend must be made by reference to our "relevant financial statements." The "relevant financial statements" will be either the last set of unconsolidated annual audited financial statements or other financial statements properly prepared in accordance with the Irish Companies Act, which give a "true and fair view" of our unconsolidated financial position and accord with accepted accounting practice.

        The mechanism as to who declares a dividend and when a dividend shall become payable is governed by our Articles. 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 preferred rights to participate in dividends we declare. The holders of preferred 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, our board of directors may resolve to capitalize any amount credited to any reserve, including our undenominated capital, or credited to the profit and loss account, and use such amount for the issuance to shareholders of shares as fully paid bonus shares on the same basis of entitlement as would apply in respect of a dividend distribution.

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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 Act, includes NASDAQ.

        Except where otherwise noted, when we refer elsewhere in this prospectus to repurchasing or buying back our ordinary shares, we are referring to the redemption of our ordinary shares or the purchase of our ordinary shares by a subsidiary of us, 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 "Dividend Policy," we do not expect to have any distributable reserves for the foreseeable 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 preferred shares, which may be redeemed at the option of either us or the shareholder, depending on the terms of such preferred shares. Please see "—Authorized Share Capital" above for additional information on preferred 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 the purchase contract must be on display or must be available for inspection by our shareholders at our registered office from the date of the notice of the meeting at which the resolution approving the contract is to be proposed.

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        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 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 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. 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.

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 in any way. 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 Act.

General Meetings of Shareholders

        We are required to hold an annual general meeting within eighteen months of incorporation (our first annual general meeting was held in Dublin, Ireland on May 12, 2016) and at intervals of no more than fifteen months thereafter, provided that an annual general meeting is held in each calendar year following our first annual general meeting, no more than nine months after our fiscal year-end.

        Our extraordinary general meetings may be convened by (i) our board of directors, (ii) on requisition of shareholders holding not less than 10% of our paid up share capital carrying voting rights or (iii) on requisition of our auditors. Extraordinary general meetings are generally held for the purposes of approving shareholder resolutions as may be required from time to time.

        Notice of a general meeting must be given to all our shareholders and to our auditors. Our Articles provide that the maximum notice period is 60 days. The minimum notice periods are 21 days' notice in writing for an annual general meeting or an extraordinary general meeting to approve a special resolution and 14 days' notice in writing for any other extraordinary general meeting. General meetings may be called by shorter notice, but only with the consent of our auditors and all of our shareholders entitled to attend and vote thereat. Because of the 21-day and 14-day requirements described in this paragraph, our Articles include provisions reflecting these requirements of Irish law.

        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 this 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 the receipt of the requisition notice.

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        The only matters which must, as a matter of Irish company law, be transacted at an annual general meeting are the consideration of the Irish statutory financial statements, the report of the directors, the report of the auditors on those statements and that report and a review by the members of our affairs. If no resolution is made in respect of the reappointment of an auditor at an annual general meeting, the previous auditor will be deemed to have continued in office. Our Articles divide our board of directors into three classes, with members of each class being elected to staggered three-year terms. At each annual general meeting, directors will be elected for a full term of three years to succeed those directors of the relevant class whose terms are expiring. A nominee is elected to the board of directors by a plurality of the votes cast by the shareholders.

        Holders of our ordinary shares are entitled to one vote for each share at all meetings at which directors are elected.

        Our Articles provide for a minimum number of directors of two. In the event that an election results in only one director being elected, that director shall be elected and shall serve for a three-year term, and the nominee receiving the next greatest number of votes in favour of their election shall hold office until his or her successor shall be elected.

        If our directors become aware that our net assets are half or less of the amount of our called-up share capital, our directors must convene an extraordinary general meeting of our shareholders not later than 28 days from the date that they learn of this fact. This meeting must be convened for the purposes of considering whether any, and if so what, measures should be taken to address the situation.

Quorum for General Meetings

        The presence, in person or by proxy, of the holders of our ordinary shares outstanding which entitle the holders to a majority of our voting power constitutes a quorum for the conduct of business. No business may take place at a general meeting if a quorum is not present in person or by proxy. Our board of directors has no authority to waive quorum requirements stipulated in our Articles. Abstentions and broker non-votes will be counted as present for purposes of determining whether there is a quorum in respect of the proposals.

Adjournment of Shareholder Meetings

        Our Articles provide that if a quorum is not present, the meeting shall be adjourned and we shall notify shareholders in accordance with the usual notice requirements (as set out in "—Differences in Corporate Law Between Ireland and the State of Delaware—Record Date; Notice Provisions for Meetings of Shareholders") in the event that such meeting is to be reconvened.

Voting

        Under our Articles, each holder of our ordinary shares is entitled to one vote for each ordinary share that he or she holds as of the record date for the meeting. The holders of our deferred ordinary shares are not entitled to a vote. We may not exercise any voting rights in respect of any shares held as treasury shares. Any shares held by our subsidiaries will count as treasury shares for this purpose, and such subsidiaries cannot therefore exercise any voting rights in respect of those shares.

        Irish law distinguishes between "ordinary business" and "special business." Most business that is transacted at a general meeting is deemed "special" with the exception of declaring a dividend, the consideration of the statutory financial statements and the reports of the directors and auditors thereon, the review by the shareholders of the company's affairs, the fixing of the remuneration of auditors and the election of directors, all of which are deemed to be "ordinary business."

        Our Articles provide that, except for the election of directors and where a greater majority is required by the Irish Companies Act (such as any matters that require special resolutions of the

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shareholders) as described below, any question, business or resolution proposed at any general meeting shall be decided by a simple majority of the votes cast.

        All resolutions proposed at our general meetings will be decided on a poll. Every shareholder entitled to vote has one vote for each share held unless otherwise provided in our Articles. Voting rights may be exercised by shareholders registered in the share register as of the record date for the meeting or by a duly appointed proxy of such a registered shareholder, which proxy need not be a shareholder. Where interests in shares are held by a nominee trust company, this company may exercise the rights of the beneficial holders on their behalf as their proxy. All proxies must be appointed in accordance with our Articles. Our Articles permit the appointment of proxies by our shareholders to be notified to us electronically, when permitted by our directors.

        In accordance with our Articles, our board of directors may from time to time authorize us to issue preference shares. These preferred shares may have such voting rights as may be specified in the terms of such preferred share. For example, 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 preferred 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:

Action by Written Consent

        Our Articles provide that shareholder resolutions are to be adopted by way of poll at meetings and shareholders are not permitted to pass resolutions by unanimous written consent.

Variation of Rights Attaching to a Class or Series of Shares

        Under our Articles and the Irish Companies Act, 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.

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Inspection of Books and Records

        Under Irish law, shareholders have the right to (1) receive a copy of our Articles, (2) inspect and obtain copies of the minutes of general meetings and resolutions, (3) 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, (4) receive copies of statutory financial statements (or summary financial statements, where applicable) and directors' and auditors' reports that have previously been sent to shareholders prior to an annual general meeting and (5) receive financial statements of any our subsidiaries that have previously been sent to shareholders prior to an annual general meeting for the preceding ten years. 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:

        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. However, our Articles provide that an affirmative vote of the holders of a majority of the outstanding voting shares on the relevant record date is required to approve a sale, lease or exchange of all or substantially all of our property or 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, as amended, governing the merger of an Irish company limited by shares such as our company and a company incorporated in the European Economic Area, a shareholder (1) who voted against the special resolution approving the merger or (2) of a company in which 90% of the shares are held by the other party to the merger has the right to request in certain circumstances that the successor company acquire its shares for cash at a price determined in accordance with the share exchange ratio set out in the merger agreement.

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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 to our 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 nomination and governance committee. We have also adopted corporate governance policies, including a code of conduct and an insider trading policy.

        Our corporate governance guidelines and general approach to corporate governance as reflected in our memorandum and articles of associations and our internal policies and procedures comply with applicable federal securities laws and regulations and NASDAQ requirements, though the standards applicable to us as a foreign private issuer are generally less restrictive than those applicable to U.S. companies. Although we are an Irish public limited company, we are not be subject to the listing rules of the Irish Stock Exchange or the listing rules of the U.K. Listing Authority and we are therefore not subject to, nor will we adopt, the U.K. Corporate Governance Code or any other non-statutory Irish or U.K. governance standards or guidelines. While there are many similarities and overlaps between the U.S. corporate governance standards applied by us and the U.K. Corporate Governance Code and other Irish/U.K. governance standards or guidelines, there are differences, in particular relating to the extent of the authorization to issue share capital and effect share repurchases that may be granted to our board and the criteria for determining the independence of our directors.

Directors

Number of Directors

        The Irish Companies Act provides for a minimum of two directors for public limited companies. Our Articles provide for a minimum of two directors and a maximum of 13. Our shareholders may from time to time increase or reduce the maximum number, or increase the minimum number, of directors by ordinary resolution. Our board of directors determines the number of directors within the range of two to 13.

Election and Term of Office of Directors

        Our Articles divide our board of directors into three classes, with members of each class being elected to staggered three-year terms. At each annual general meeting, directors will be elected for a full term of three years to succeed those directors of the relevant class whose terms are expiring. A nominee is elected to the board of directors by a plurality of the votes cast by shareholders.

        Holders of our ordinary shares are entitled to one vote for each share at all meetings at which directors are elected.

        Our Articles provide for a minimum number of directors of two. In the event that an election results in only one director being elected, that director shall be elected and shall serve for a three-year term, and the nominee receiving the next greatest number of votes in favour of their election shall hold office until his or her successor shall be elected.

Board Vacancies

        Any vacancy on our board of directors, including a vacancy resulting from an increase in the number of directors or from the death, resignation, retirement, disqualification or removal of a

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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 the decision of a majority of our board of directors then in office, provided that a quorum is present and provided that the appointment does not cause the number of directors to exceed any number fixed by or in accordance with our Articles as the maximum number of directors.

        Any director of a class of directors elected to fill a vacancy resulting from an increase in the number of directors of such class shall hold office for 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.

Resignation, Removal and Disqualification of Directors

        The Irish Companies Act provide that, notwithstanding anything contained in the articles of association of a company or in any agreement between that company and a director, the shareholders may by an ordinary resolution remove a director from office before the expiration of his or her term. The power of removal is without prejudice to any claim for damages for breach of contract (e.g., employment contract) which the director may have against us in respect of his or her removal.

        Our Articles also provide that the office of a director will also be vacated if the director is restricted or disqualified to act as a director under the Irish Companies Act; resigns his or her office by notice in writing to us or in writing offers to resign and the directors resolve to accept such offer; or is requested to resign in writing by not less than 75% of the other directors.

Indemnification Agreements

        To the fullest extent permitted by Irish law, our Articles contain indemnification for the benefit of our directors, company secretary and executive officers. However, as to our directors and company secretary, this indemnity is limited by the Irish Companies Act, 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 Act 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, our company secretary or other persons who would be considered "officers" within the meaning of the Irish Companies Act.

        We are permitted under our Articles and the Irish Companies Act 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 Act indemnify and provide expense advancement for our directors and executive officers for certain 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

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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.

Legal Name; Formation; Fiscal Year; Registered Office

        Our fiscal year ends on December 31 and our registered address is Arthur Cox Building, Earlsfort Terrace, 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 if we have failed to file certain returns. We may also be dissolved by the Director of Corporate Enforcement in Ireland where our affairs have been investigated by an inspector and it appears from the report or any information obtained by the Director of Corporate Enforcement that we should be wound up.

        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 preferred shares.

Uncertificated Shares

        Holders of our ordinary shares will not have the right to require us to issue certificates for their 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 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

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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 (1) from a person who holds such shares directly to any other person, (2) from a person who holds such shares beneficially but not directly to a person who holds such shares directly, or (3) 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 (a) there is no change in beneficial ownership of the shares and (b) 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, the stamp duty thereon is paid by one of the parties and the instrument is provided to the transfer agent. We, in our absolute discretion and insofar as the Irish Companies Act or any other applicable law permits, may, or may procure that we or 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 intend to, on our behalf or on behalf of our subsidiary, take one or a combination of the following actions: (1) require the transferee to pay to us or a subsidiary of our company the amount of such stamp duty and refuse to register such transfer until that amount is paid, (2) seek reimbursement of the stamp duty from the transferee, (3) set-off the stamp duty against any dividends payable to the transferee of those ordinary shares and (4) 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 authority to our company secretary (or his or her nominee) to execute an instrument of transfer on behalf of a transferring party.

        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 have general discretion to decline to register an instrument of transfer unless the transfer is in respect of one class of shares only. Our directors may suspend registration of transfers from time to time, not exceeding 30 days in aggregate each year.

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Differences in Corporate Law Between Ireland and the State of Delaware

        As a public limited company incorporated under the laws of Ireland, the rights of our shareholders are governed by applicable Irish law, including the Irish Companies Act, and not by the 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 summary of the differences between the provisions of the Irish Companies Act 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, Delaware law and our Articles. Before investing, you should consult your legal advisor regarding the impact of Irish corporate law on your specific circumstances and reasons for investing. The summary below does not include a description of rights or obligations under the U.S. federal securities laws or NASDAQ listing requirements. You are also urged to carefully read the relevant provisions of the Delaware General Corporation Law and the Irish Companies Act for a more complete understanding of the differences between Delaware and Irish law.

 
  Delaware   Ireland

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.   Our authorised share capital may be increased or reduced, but not below the number of issued ordinary shares or preferred shares, as applicable, by a simple majority of the votes cast at a general meeting, referred to under Irish law as an "ordinary resolution."

     

Under Irish law, the directors of a company may issue new ordinary or preferred 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. Accordingly, our Articles authorize our board of directors to issue new preferred shares without shareholder approval for a period of five years from the date of the adoption of our Articles.

     

The rights and restrictions to which our ordinary shares are subject is prescribed in our Articles. Our Articles entitle our board of directors, without shareholder approval, to determine the terms of any preferred shares issued. Preferred shares may be preferred as to dividends, rights on a winding up or voting in such manner as our directors may resolve. The preferred shares may also be redeemable at the option of the holder of the preferred shares or at our option, and may be convertible into or exchangeable for shares of any other class or classes, depending on the terms of such preferred shares.

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  Delaware   Ireland

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 Act.

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, unless otherwise authorized, when an Irish public limited company issues shares for cash to new shareholders, it is required first to offer those shares on the same or more favorable terms to existing shareholders of the company on a pro rata basis, commonly referred to as the statutory preemption right. 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 every five years by a special resolution of the shareholders, our Articles provide that this opt-out will lapse five years after the adoption of our current Articles on September 9, 2015. A special resolution requires not less than 75% of the votes of our shareholders cast at a general meeting. If this opt-out is not renewed, shares issued for cash must be offered to our pre-existing shareholders pro rata to their existing shareholding before the shares can be issued to any new shareholders. Statutory preemption rights do not apply (1) where shares are issued for non-cash consideration, such as in a share-for-share acquisition, (2) 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 (3) where shares are issued pursuant to an employee share option or similar equity plan.

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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 Act.

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 (1) out of its surplus or (2) if the corporation does 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.

 

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 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 undenominated capital 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 financial statements" of that company. The "relevant financial statements" will be either the last set of unconsolidated annual audited financial statements or other financial statements properly prepared in accordance with the Irish Companies Act, which give a "true and fair view" of a company's unconsolidated financial position and accord with accepted accounting practice. The relevant financial statements must be filed in the Companies Registration Office (the official public registry for companies in Ireland).

     

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.

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Share Repurchases and Redemptions

 

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 a specified event; provided however, that immediately following any such 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: (1) 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; (2) 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 (3) redeem any of its shares, unless their redemption is authorized by Delaware law and then only in accordance with its certificate of incorporation.

 

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 by us may technically be effected as a redemption.

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 a recognized stock exchange such as the NASDAQ or off market purchases with such authority to be given 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 preferred shares, which may be redeemed at the option of either us or the shareholder, depending on the terms of such preferred 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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Purchases by Subsidiaries

 

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.

 

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 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 the purchase contract must be on display or must be available for inspection by our shareholders at our registered office from the date of the notice of the meeting at which the resolution approving the contract is to be proposed.

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.

 

Our Articles divide our board of directors into three classes, with members of each class being elected to staggered three-year terms. At each annual general meeting, directors will be elected for a full term of three years to succeed those directors of the relevant class whose terms are expiring. A nominee is elected to the board of directors by a plurality of the votes cast by shareholders.

Holders of our ordinary shares are entitled to one vote for each share at all meetings at which directors are elected.

Our Articles provide for a minimum number of directors of two. In the event that an election results in only one director being elected, that director shall be elected and shall serve for a three-year term, and the nominee receiving the next greatest number of votes in favour of their election shall hold office until his or her successor shall be elected.

Registration, Removal and Disqualification 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: (1) in the case of a corporation whose board of directors is classified, stockholders may effect such removal only for cause; and (2) 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 Act 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. Because of this provision of the Irish Companies Act, our Articles provide that we may, by ordinary resolution, remove any director before the expiration of his period of office notwithstanding anything in any agreement between us and the removed director. 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. Our Articles also provide that the office of a director will also be vacated if the director is restricted or disqualified to act as a director under the Acts; resigns his or her office by notice in writing to us or in writing offers to resign and the directors resolve to accept such offer; or is requested to resign in writing by not less than 75% of the other directors.

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 a majority of the directors in office at the time when the meeting is convened.

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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 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.

 

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 agreements and it is likely that more will be expected of them in compliance with their duties than non-executive directors. The principal fiduciary duties of directors are stated in section 228 of the Irish Companies Act and include the duties of good faith and exercising due care and skill. Directors' statutory duties also 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.

Under Irish law, a director is entitled to rely on information, opinions, reports or statements, including financial statements and other financial data, prepared or presented by (1) other directors, officers or employees of the company whom the director reasonably believes to be reliable and competent in the matters prepared or presented, (2) legal counsel, public accountants or other persons as to matters the director reasonably believes are within their professional or expert competence, or (3) a committee of the board of which the director does not serve as to matters within its designated authority, which committee the director reasonably believes to merit confidence.

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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 (1) 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, (2) 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 (3) the contract or transaction is fair to the corporation as of the time it is authorized, approved or ratified. The mere fact that an 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.

 

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 in accordance with the Irish Companies Act.

Our Articles provide that a director may vote in respect of any contract, appointment or arrangement in which he is interested, and he shall be counted in the quorum present at the meeting. Under our Articles, a director 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 (1) no director will be prevented from contracting with us because of his or her position as a director, (2) any contract entered into between a director and us will not be subject to avoidance, and (3) 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.

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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 Act, which prescribes 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 Act 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 Act.

     

Our Articles also contain indemnification and expense advancement provisions for current or former executives who are not directors or our company secretary.

     

Our directors may, on a case-by-case basis, decide at their discretion that it is in our best interests to indemnify an individual director from any liability arising from his or her position as a director of us. However, this discretion must be exercised bona fide in our best interests as a whole. Any such indemnity will be limited in the manner described in the foregoing paragraphs.

     

We are permitted under our Articles and the Irish Companies Act 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.

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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 Act indemnify and provide expense advancement for our directors and executive officers for certain 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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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: (1) any breach of the director's duty of loyalty to the corporation or its stockholders; (2) acts or omissions in bad faith or which involve intentional misconduct or a knowing violation of law; (3) intentional or negligent payments of unlawful dividends or unlawful share purchases or redemptions; or (4) 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.

General Meetings of Shareholders

 

Under Delaware law, an annual meeting of stockholders is required. Any stockholder or director may 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 are required to hold an annual general meeting within eighteen months of incorporation and at intervals of no more than fifteen months thereafter, provided that an annual general meeting is held in each calendar year following our first annual general meeting, no more than nine months after our fiscal year-end.

     

Our extraordinary general meetings may be convened by (1) our board of directors, (2) on requisition of shareholders holding not less than 10% of our paid up share capital carrying voting rights or (3) on requisition of our auditors. Extraordinary general meetings are generally held for the purposes of approving shareholder resolutions as may be required from time to time.

     

Notice of a general meeting must be given to all our shareholders and to our auditors. Our Articles provide that the maximum notice period is 60 days. The minimum notice periods are 21 days' notice in writing for an annual general meeting or an extraordinary general meeting to approve a special resolution and 14 days' notice in writing for any other extraordinary general meeting. General meetings may be called by shorter notice, but only with the consent of our auditors and all of our shareholders entitled to attend and vote thereat. Because of the 21-day and 14-day requirements described in this paragraph, our Articles include provisions reflecting these requirements of Irish law.

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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. The requisition notice can contain any resolution. Upon receipt of this 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 the receipt of the requisition notice.

     

The only matters which must, as a matter of Irish company law, be transacted at an annual general meeting are the consideration of the Irish statutory financial statements, the report of the directors, the report of the auditors on these statements and that report and a review by the members of our affairs. If no resolution is made in respect of the reappointment of an auditor at an annual general meeting, the previous auditor will be deemed to have continued in office. Our Articles divide our board of directors into three classes, with members of each class being elected to staggered three-year terms. At each annual general meeting, directors will be elected for a full term of three years to succeed those directors of the relevant class whose terms are expiring. A nominee is elected to the board of directors by a plurality of the votes cast by shareholders.

     

Holders of our ordinary shares are entitled to one vote for each share at all meetings at which directors are elected.

     

Our Articles provide for a minimum number of directors of two. In the event that an election results in only one director being elected, that director shall be elected and shall serve for a three-year term, and the nominee receiving the next greatest number of votes in favour of their election shall hold office until his or her successor shall be elected.

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If our directors become aware that our net assets are half or less of the amount of our called-up share capital, our directors must convene an extraordinary general meeting of our shareholders not later than 28 days from the date that they learn of this fact. This meeting must be convened for the purposes of considering whether any, and if so what, measures should be taken to address the situation.

Advance Notice Provisions

 

As may be set by the corporation's bylaws.

 

Our Articles provide that (a) with respect to an annual general meeting of shareholders, nominations of persons for election to the board of directors and the proposal of business to be considered by shareholders may be made only pursuant to our notice of meeting; by our board of directors; or by a shareholder who is entitled to vote at the meeting and who has complied with the advance notice procedures provided for our Articles, and (b) with respect to an extraordinary general meeting of shareholders, nominations of persons for election to our board of directors and the proposal of business to be considered by shareholders may be made only pursuant to our notice of meeting; by our board of directors; by any shareholders pursuant to the valid exercise of the power granted under the Irish Companies Act; or by a shareholder who is entitled to vote at the meeting and who has complied with the advance notice procedures provided for in our Articles.

     

In order to comply with the advance notice procedures of our Articles, a shareholder must give written notice to our Secretary on a timely basis. To be timely for an annual general meeting, notice must be delivered, or mailed and received, at least 120 days in advance of the first anniversary of the date that we released the proxy statement for the preceding year's annual general meeting, subject to certain exceptions. To be timely for an extraordinary general meeting, notice must be delivered, or mailed and received, by the later of (1) 120 days in advance of the meeting or (2) the date that is 10 days after the date of the first public announcement of the date of the meeting. For nominations to our board of directors, the notice must include all information about the director nominee that is required to be disclosed by SEC rules regarding the solicitation of proxies for the election of directors and such other information as we may reasonably require to determine the eligibility of the proposed nominee.

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For other business that a shareholder proposes to bring before the meeting, the notice must include a brief description of the business, the reasons for proposing the business at the meeting and a discussion of any material interest of the shareholder in the business. Whether the notice relates to a nomination to the board of directors or to other business to be proposed at the meeting, the notice also must include information about the shareholder and the shareholder's holdings of our shares.

     

In addition, the Irish Companies Act provides that shareholders holding not less than 10% of the total voting rights may call an extraordinary general meeting for the purpose of considering director nominations or other proposals, as described below under "—Special/Extraordinary Shareholder Meetings." The chairman of the meeting may refuse to transact any business or may disregard nomination of any person if a shareholder fails to comply with the foregoing procedures.

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 Act, 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 (1) by our board of directors, (2) on requisition of our shareholders holding not less than 10% of the paid up share capital of our carrying voting rights, (3) on requisition of our auditors, or (4) 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 the receipt of the requisition notice.

     

Under Irish law, 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 our directors learn of this fact to consider how to address the situation.

Record Date; Notice Provisions for Meetings of Shareholders

 

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 10 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 directors may, from time to time, fix a record date for the purposes of determining the rights of members to notice of and/or to vote at any general meeting, but that such record date shall be not more than 80 nor less than 10 days before the date of such meeting. Our Articles provide that if no record date is fixed by our directors, the record date for determining members entitled to notice of or to vote at a meeting of the members shall be the close of business on the day next preceding the day on which notice is given.

Notice of an annual general meeting must be given to all of our shareholders and to our auditors. Our Articles provide that the maximum notice period is 60 days. The minimum notice period is 21 days' notice in writing for an annual general meeting.

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Shareholder Quorum 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.

 

Under our Articles, each holder of our ordinary shares is entitled to one vote for each of ordinary share that he or she holds as of the record date for the meeting. The holders of our deferred ordinary shares are not entitled to a vote. We may not exercise any voting rights in respect of any shares held as treasury shares. Any shares held by our subsidiaries will count as treasury shares for this purpose, and such subsidiaries cannot therefore exercise any voting rights in respect of those shares. Irish law distinguishes between "ordinary business" and "special business." Most business that is transacted at a general meeting is deemed "special" with the exception of declaring a dividend, the consideration of the statutory financial statements and the reports of the directors and auditors thereon, the review by the shareholders of the company's affairs, the fixing of the remuneration of auditors and the election of directors, all of which are deemed to be "ordinary business."

     

Our Articles provide that, except where a greater majority is required by the Irish Companies Act (such as any matters that require special resolutions of the shareholders) as described below, any question, business or resolution proposed at any general meeting shall be decided by a simple majority of the votes cast. All resolutions proposed at our general meetings will be decided on a poll. Every shareholder entitled to vote has one vote for each share held unless otherwise provided in our Articles. Voting rights may be exercised by shareholders registered in the share register as of the record date for the meeting or by a duly appointed proxy of such a registered shareholder, which proxy need not be a shareholder. Where interests in shares are held by a nominee trust company, this company may exercise the rights of the beneficial holders on their behalf as their proxy. All proxies must be appointed in accordance with our Articles. Our Articles permit the appointment of proxies by our shareholders to be notified to us electronically, when permitted by our directors. Abstentions, including persons indicating a vote to be withheld, blank votes and broker non-votes will not be counted for the purposes of establishing the number of votes cast for the purposes of determining whether an ordinary resolution (requiring a simple majority of votes cast) or a special resolution (requiring the support of 75%) has been approved.

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  Delaware   Ireland

     

Treasury shares will not be entitled to vote at general meetings of shareholders.

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.

 

Our Articles provide that shareholder resolutions are to be adopted by way of poll at meetings and shareholders are not permitted to pass resolutions by unanimous written consent.

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 (1) that a company is entitled to the relief claimed and (2) 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 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.

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  Delaware   Ireland

Business Combinations with Interested Shareholders

 

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.

 

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, however, our Articles provide that the affirmative vote of the holders of a majority of our outstanding voting shares on the relevant record date is required to approve a sale, lease or exchange of all or substantially all of our property or assets.

Our Articles also include a provision similar to Section 203 of the DGCL, which generally prohibits us from engaging in a business combination with an interested shareholder for a period of three years following the date the person became an interested shareholder, unless, in general:

     

our board of directors approved the transaction which resulted in the shareholder becoming an interested shareholder;

     

upon consummation of the transaction which resulted in the shareholder becoming an interested shareholder, the shareholder owned at least 85% of the voting shares outstanding at the time of commencement of such transaction, excluding for purposes of determining the number of voting shares outstanding (but not the outstanding voting shares owned by the interested shareholder), voting shares owned by persons who are directors and also officers and by certain employee share plans; or

     

the business combination is approved by our board of directors and authorized at an annual or extraordinary general meeting of shareholders by the affirmative vote of the holders of at least 75% of the outstanding voting shares that are not owned by the interested shareholder.

     

A "business combination" is generally defined as a merger, asset or stock sale or other transaction resulting in a financial benefit to the interested shareholder. An "interested shareholder" is generally defined as a person who, together with affiliates and associates, owns or, within three years prior to the date in question, owned 15% or more of our outstanding voting shares.

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  Delaware   Ireland

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 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.

 

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, as amended, governing the merger of an Irish company limited by shares such as the company and a company incorporated in the EEA, a shareholder (1) who voted against the special resolution approving the merger or (2) of a company in which 90% of the shares are held by the other party to the merger, has the right in certain circumstances to request that the successor 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.

 

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.

   

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, such provisions as may be necessary to effect such change, exchange, reclassification, subdivision, combination or cancellation.

 

Irish companies may only alter their memorandum and articles of association by a resolution of shareholders approved by 75% of the votes cast at a general meeting. An Irish company is not permitted to opt out of this requirement.

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  Delaware   Ireland

 

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 preferred shares we issue from time to time. The holders of our preferred 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 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 preferred shareholders to participate under the terms of any series or class of preferred shares.

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  Delaware   Ireland

     

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. We may also be dissolved by the Director of Corporate Enforcement in Ireland where our affairs have been investigated by an inspector and it appears from the report or any information obtained by the Director of Corporate Enforcement that we should be wound up.

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;

     

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.

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Anti-Takeover Provisions

Business Combinations with Interested Shareholders

        Our Articles include a provision similar to Section 203 of the Delaware General Corporation Law, which generally prohibits us from engaging in a business combination with an interested shareholder for a period of three years following the date the person became an interested shareholder, unless, in general:

        A "business combination" is generally defined as a merger, asset or stock sale or other transaction resulting in a financial benefit to the interested shareholder. An "interested shareholder" is generally defined as a person who, together with affiliates and associates, owns or, within three years prior to the date in question, owned 15% or more of our outstanding voting shares.

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:

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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 (1) during the 12-month period prior to the commencement of the offer period that represent more than 10% of our total ordinary shares or (2) 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 clause (1), the 12-month period prior to the commencement of the offer period or, in the case of (2), 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

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and rights over shares to an aggregate of between 15% and 30% of the voting rights of the company. Except in certain 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 1) the issue of shares, options, restricted share units or convertible securities, (2) material acquisitions or disposals, (3) entering into contracts other than in the ordinary course of business or (4) 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:

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 Act, our shareholders must notify us if, as a result of a transaction, the shareholder will become interested in three percent or more of our voting shares, or if as a result of a

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transaction a shareholder who was interested in three percent or more of our voting shares ceases to be so interested. Where a shareholder is interested in three 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 Act, 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 Act, as follows:

        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—Business Combinations with Interested Shareholders," "—Differences in Corporate Law Between Ireland and The State Of Delaware—Amendments of Constituent Documents," "—Differences in Corporate Law Between Ireland and The State Of Delaware—Advance Notice Provisions," and "—Differences in Corporate Law Between Ireland and The State Of Delaware—Special/Extraordinary General Meetings."

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Limitations on the Right to Own Securities

        Neither Irish law nor our Articles impose any general limitation on the right of non-residents or foreign persons to hold our securities or exercise voting rights on our securities other than those limitations that would generally apply to all shareholders.

Listing

        Our ordinary shares are listed on The NASDAQ Global Select Market under the symbol "SBBP."

Transfer Agent and Registrar

        The transfer agent and registrar for our ordinary shares is Computershare, Inc. The transfer agent and registrar's address is 250 Royall Street, Canton, MA 02021.

Material Contracts

        For a description of our material contracts, see our 2016 Annual Report on Form 20-F filed with the SEC on March 24, 2016, the Form 6-K filed on May 17, 2016 and the Forms 6-K filed on December 30, 2016, all of which are incorporated by reference into this prospectus.

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TAXATION

         The following summary contains a description of the material Irish and U.S. federal income tax consequences of the acquisition, ownership and disposition of ordinary shares, but it does not purport to be a comprehensive description of all the tax considerations that may be relevant to a decision to purchase ordinary shares. The summary is based upon the tax laws of Ireland and regulations thereunder and on the tax laws of the United States and regulations thereunder as of the date hereof, which are subject to change.

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. 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 advisers 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 beneficially as capital assets and does not apply to all 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

Non-Resident Shareholders

        Shareholders who 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 a 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 withholding DWT at source in respect of the distributions made and remitting the tax withheld to the Irish Revenue Commissioners.

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        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:

and provided, in all cases noted above (but subject to "Shares Held by U.S. Resident Shareholders" below), Strongbridge Biopharma plc or, in respect of Strongbridge Biopharma plc shares held through DTC, any qualifying intermediary appointed by Strongbridge Biopharma plc, has received from the shareholder, where required, the relevant DWT Forms prior to the payment of the dividend. In practice, in order to ensure sufficient time to process the receipt of relevant DWT Forms, the Strongbridge Biopharma plc shareholder where required should furnish the relevant DWT Form to:

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        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

 

Ethiopia

 

Latvia

 

Panama

 

Switzerland

Belarus

 

Finland

 

Lithuania

 

Poland

 

Thailand

Belgium

 

France

 

Luxembourg

 

Portugal

 

Turkey

Bosnia and Herzegovina

 

Georgia

 

Macedonia

 

Qatar

 

Ukraine

Botswana

 

Germany

 

Malaysia

 

Romania

 

United Arab Emirates

Bulgaria

 

Greece

 

Malta

 

Russia

 

United Kingdom

Canada

 

Hong Kong

 

Mexico

 

Saudi Arabia

 

United States of America

Chile

 

Hungary

 

Moldova

 

Serbia

 

Uzbekistan

China

 

Iceland

 

Montenegro

 

Singapore

 

Vietnam

Croatia

 

India

 

Morocco

 

Slovak Republic

 

Zambia

Cyprus

 

Israel

           

        It is the responsibility of each individual shareholder to determine whether or not they are a "resident" for tax purposes in a "relevant territory." 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 cause 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 their 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.

        Dividends paid on our ordinary shares that are owned by residents of the United States should not be subject to DWT, subject to the completion and delivery of the relevant forms to us.

        Residents of the United States 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. 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 United States 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

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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.

        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 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, the General Exemptions from DWT referred to above do 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.

        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

        Irish income tax may arise for certain shareholders in respect of any dividends received from us.

Non-Irish 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 with respect to 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.

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        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 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.

Capital Acquisitions Tax

        Capital acquisitions tax, or 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 purposes 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 (1) the relationship between the donor and the donee and (2) 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 advisers 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.

        On the basis that most of our shares are 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 received written confirmation from the Irish Revenue Commissioners on June 22, 2015 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.

        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.

        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 (1) there is no change in beneficial ownership of the shares and (2) 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.

        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 entered into a composition agreement with the Irish Revenue Commissioners under which we agreed 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 (1) transfers to which any of the DTC Parties is a party or (2) 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 entered 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 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, (1) 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 (2) otherwise as DTC's rules or NSCC's rules provide.

        Notwithstanding our entry into a composition agreement with the Irish Revenue Commissioners and the indemnities given pursuant to the DTC Eligibility Agreement, any stamp duty liability resulting from a transfer of our shares will be for the "accountable person" under Irish law (generally the transferee) and, to the extent we or a subsidiary of our company discharges such liability, on behalf of any transferee, we will seek payment or reimbursement of such liability. For further details on this point, shareholders should read the discussion under "Transfer and Registration of Shares" above.

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 U.S. Federal Income Tax Considerations for U.S. Holders

        The following is a description of the material U.S. federal income tax consequences to the U.S. Holders (as defined below) of owning and disposing of our ordinary shares acquired in this offering, but it does not purport to be a comprehensive description of all tax considerations that may be relevant to a particular person's decision to acquire the ordinary shares. This discussion applies only to a U.S.

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Holder that holds ordinary shares as capital assets for U.S. federal income tax purposes. In addition, it does not describe all of the U.S. tax consequences that may be relevant in light of the U.S. Holder's particular circumstances, including alternative minimum tax consequences, any state or local tax considerations, any U.S. federal gift, estate or generation-skipping transfer tax consequences and tax consequences applicable to U.S. Holders subject to special rules, such as:

        If an entity that is classified as a partnership for U.S. federal income tax purposes holds ordinary shares, the U.S. federal income tax treatment of a partner will generally depend on the status of the partner and the activities of the partnership. Partnerships holding ordinary shares and partners in such partnerships should consult their tax advisers as to their particular U.S. federal income tax consequences of holding and disposing of the ordinary shares.

        This discussion is based on the U.S. Internal Revenue Code of 1986, as amended, or the Code, administrative pronouncements, judicial decisions, and final, temporary and proposed Treasury regulations, all as of the date hereof, any of which is subject to change, possibly with retroactive effect.

        A "U.S. Holder" is a holder who, for U.S. federal income tax purposes, is a beneficial owner of ordinary shares who is:

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        U.S. Holders should consult their tax advisers concerning the U.S. federal, state, local and foreign tax consequences of owning and disposing of ordinary shares in their particular circumstances.

Passive Foreign Investment Company Rules

        We expect to be a passive foreign investment company, or PFIC, for our current taxable year and for the foreseeable future. In addition, we may, directly or indirectly, hold equity interests in other PFICs, or Lower-tier PFICs. In general, a non-U.S. corporation will be considered a PFIC for any taxable year in which (1) 75% or more of its gross income consists of passive income or (2) 50% or more of the average quarterly value of its assets consists of assets that produce, or are held for the production of, passive income. For purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation. Passive income generally includes dividends, interest, rents, royalties and capital gains.

        We must determine our PFIC status annually based on tests which are factual in nature, and our status will depend on our income, assets and activities each year.

        Under attribution rules, if we are a PFIC, U.S. Holders will be deemed to own their proportionate shares of Lower-tier PFICs and will be subject to U.S. federal income tax according to the rules described in the following paragraphs on (1) certain distributions by a Lower-tier PFIC and (2) a disposition of shares of a Lower-tier PFIC, in each case as if the U.S. Holder held such shares directly, even though holders have not received the proceeds of those distributions or dispositions directly.

        If we are a PFIC for any taxable year during which a U.S. Holder holds our shares, the U.S. Holder may be subject to certain adverse tax consequences. Unless a holder makes a timely "mark-to-market" election or "qualified electing fund" election each as discussed below, gain recognized on a disposition (including, under certain circumstances, a pledge) of ordinary shares by the U.S. Holder, or on an indirect disposition of shares of a Lower-tier PFIC, will be allocated ratably over the U.S. Holder's holding period for the shares. The amounts allocated to the taxable year of disposition and to years before we became a PFIC will be taxed as ordinary income. The amounts allocated to each other taxable year will be subject to tax at the highest rate in effect for that taxable year for individuals or corporations, as appropriate, and an interest charge will be imposed on the tax attributable to the allocated amounts. Further, to the extent that any distribution received by a U.S. Holder on our ordinary shares (or a distribution by a Lower-tier PFIC to its shareholder that is deemed to be received by a U.S. Holder) exceeds 125% of the average of the annual distributions on the shares received during the preceding three years or the U.S. Holder's holding period, whichever is shorter, the distribution will be subject to taxation in the same manner as gain, described immediately above and lower rates of taxation applicable to long-term capital gains with respect to dividends paid to certain non-corporate U.S. Holders would not apply.

        If we are a PFIC for any year during which a U.S. Holder holds ordinary shares, we generally will continue to be treated as a PFIC with respect to the holder for all succeeding years during which the U.S. Holder holds ordinary shares, even if we cease to meet the threshold requirements for PFIC status. U.S. Holders should consult their tax advisers regarding the potential availability of a "deemed sale" election that would allow them to eliminate this continuing PFIC status under certain circumstances.

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        If the ordinary shares are "regularly traded" on a "qualified exchange," a U.S. Holder may make a mark-to-market election that would result in tax treatment different from the general tax treatment for PFICs described above. The ordinary shares will be treated as "regularly traded" in any calendar year in which more than a de minimis quantity of the ordinary shares is traded on a qualified exchange on at least 15 days during each calendar quarter. The NASDAQ Global Select Market, where our ordinary shares are listed, is a qualified exchange for this purpose. U.S. Holders should consult their tax advisers regarding the availability and advisability of making a mark-to-market election in their particular circumstances. In particular, U.S. Holders should consider carefully the impact of a mark-to-market election with respect to their ordinary shares given that we may have Lower-tier PFICs for which a mark-to-market election may not be available.

        If a U.S. Holder makes the mark-to-market election, the holder generally will recognize as ordinary income any excess of the fair market value of the ordinary shares at the end of each taxable year over their adjusted tax basis, and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of the ordinary shares over their fair market value at the end of the taxable year (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. Holder makes the election, the holder's tax basis in the ordinary shares will be adjusted to reflect the income or loss amounts recognized. Any gain recognized on the sale or other disposition of ordinary shares in a year when we are a PFIC will be treated as ordinary income and any loss will be treated as an ordinary loss (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). Distributions paid on ordinary shares will be treated as discussed below under "—Taxation of Distributions."

        Alternatively, a U.S. Holder can make an election, if we provide the necessary information, to treat us and each Lower-tier PFIC as a qualified electing fund, or a QEF Election, in the first taxable year that we are treated as a PFIC with respect to the holder. A U.S. Holder must make the QEF Election for each PFIC by attaching a separate properly completed IRS Form 8621 for each PFIC to the holder's timely filed U.S. federal income tax return. U.S. Holders should be aware that there can be no assurances that we will satisfy the record keeping requirements that apply to a QEF, or that we will supply U.S. Holders with information that such U.S. Holders are required to report under the QEF rules, in the event that we are a PFIC. Thus, U.S. Holders may not be able to make a QEF Election with respect to their ordinary shares. Further, no assurance can be given that such QEF information will be available for any Lower-tier PFIC. Each U.S. Holder should consult its own tax advisers regarding the availability of, and procedure for making, a QEF Election.

        If a U.S. Holder makes a QEF Election with respect to a PFIC, the holder will be taxed on a current basis on its pro rata share of the PFIC's ordinary earnings and net capital gain (at ordinary income and capital gain rates, respectively) for each taxable year that the entity is classified as a PFIC and for which the QEF election is in place and properly maintained. If a U.S. Holder makes a QEF Election with respect to us, any distributions paid by us out of our earnings and profits that were previously included in the holder's income under the QEF Election would not be taxable to the holder. A U.S. Holder will increase its tax basis in its ordinary shares by an amount equal to any income included under the QEF Election and will decrease its tax basis by any amount distributed on the ordinary shares that is not included in the holder's income. In addition, a U.S. Holder will recognize capital gain or loss on the disposition of ordinary shares in an amount equal to the difference between the amount realized and the holder's adjusted tax basis in the ordinary shares. U.S. Holders should note that if they make QEF Elections with respect to us and Lower-tier PFICs, they may be required to pay U.S. federal income tax with respect to their ordinary shares for any taxable year significantly in excess of any cash distributions received on the shares for such taxable year. U.S. Holders should consult their tax advisers regarding making QEF Elections in their particular circumstances.

        Furthermore, as discussed below, if we were a PFIC or, with respect to a particular U.S. Holder, were treated as a PFIC for the taxable year in which we paid a dividend or the prior taxable year, the

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20% preferential tax rate with respect to dividends paid to certain non-corporate U.S. Holders would not apply.

        If we were a PFIC for any taxable year during which a U.S. Holder held ordinary shares, such U.S. Holder would be required to file an annual information report with such U.S. Holder's U.S. Federal income tax return on IRS Form 8621.

        U.S. Holders should consult their tax advisers concerning our PFIC status and the tax considerations relevant to an investment in a PFIC.

Taxation of Distributions

        Subject to the passive foreign investment company rules described above, distributions paid on ordinary shares, other than certain pro rata distributions of ordinary shares, will be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we do not maintain calculations of our earnings and profits under U.S. federal income tax principles, it is expected that distributions generally will be reported to U.S. Holders as dividends. The amount of a dividend will include any amounts withheld by us in respect of Irish taxes. The amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will be included in a U.S. Holder's income on the date of the U.S. Holder's receipt of the dividend. The amount of any dividend income paid in Euros will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt, which will be "U.S. source" ordinary income or loss.

        Dividends paid by us may be taxable to a non-corporate U.S. Holder at the special reduced rate normally applicable to long-term capital gains, provided we are not a PFIC in the taxable year in which the dividends are received or in the preceding taxable year, so long as certain holding period requirements are met. As discussed above under "Passive Foreign Investment Company Rules," we expect to be a PFIC and, as a result, the special reduced rate is unlikely to be available with respect to dividends paid by us.

        Subject to applicable limitations, some of which vary depending upon the U.S. Holder's circumstances, Irish income taxes withheld from dividends on ordinary shares may be creditable against the U.S. Holder's U.S. federal income tax liability. The rules governing foreign tax credits are complex, and U.S. Holders should consult their tax advisers regarding the creditability of foreign taxes in their particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including the Irish tax, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year.

Sale or Other Disposition of Ordinary Shares

        Subject to the passive foreign investment company rules described above, for U.S. federal income tax purposes, gain or loss realized on the sale or other disposition of ordinary shares will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder held the ordinary shares for more than one year The amount of the gain or loss will equal the difference between the U.S. Holder's tax basis in the ordinary shares disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes.

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Net Investment Income Tax

        U.S. Holders that are individuals or estates or trusts that do not fall into a special class of trusts that is exempt from such tax, will be required to pay an additional 3.8% tax on the lesser of (1) the U.S. Holder's "net investment income" for the relevant taxable year and (2) the excess of the U.S. Holder's modified adjusted gross income for the taxable year over a certain threshold (which in the case of individuals will be between US $125,000 and US $250,000, depending on the individual's circumstances). A U.S. Holder's "net investment income" will generally include, among other things, dividends and capital gains. Such tax will apply to dividends and to capital gains from the sale or other disposition of the ordinary shares, unless derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). 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 advisers regarding the application of the net investment income tax to them as a result of their investment in our ordinary shares.

Information Reporting and Backup Withholding

        Payments of dividends and sales proceeds that are made within the United States or through certain U.S.-related financial intermediaries generally are subject to information reporting, and may be subject to backup withholding, unless (1) the U.S. Holder is a corporation or other exempt recipient or (2) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and certifies that it is not subject to 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 advisers regarding the application of the U.S. information reporting and backup withholding rules.

Information With Respect to Foreign Financial Assets

        Certain U.S. Holders who are individuals (and, under proposed regulations, certain entities) may be required to report information relating to an interest in our ordinary shares, subject to certain exceptions (including an exception for ordinary shares held in accounts maintained by certain U.S. financial institutions). U.S. Holders should consult their tax advisers regarding the effect, if any, of this requirement on their ownership and disposition of the ordinary shares.

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LEGAL MATTERS

        The validity of the securities being offered hereby and certain other matters of Irish law will be passed upon for us by Arthur Cox, Dublin, Ireland. Certain matters of U.S. federal and New York State law will be passed upon for us by Reed Smith LLP, New York, New York.


EXPERTS

        The consolidated financial statements of Strongbridge Biopharma plc at December 31, 2015, and for the year then ended, incorporated by reference in this Prospectus and Registration Statement have been audited by Ernst & Young LLP, independent registered public accounting firm, and at December 31, 2014, and for each of the two years in the period ended December 31, 2014, by Ernst & Young AB, independent registered public accounting firm, as set forth in their respective reports thereon incorporated elsewhere herein by reference and are incorporated herein in reliance upon such reports given on the authority of such firms as experts in accounting and auditing.


ENFORCEMENT OF CIVIL LIABILITIES

        Certain of our directors and executive officers may be nonresidents of the United States. All or a substantial portion of the assets of such nonresident persons and of our company are located outside the United States. As a result, it may not be possible to effect service of process within the United States upon such persons or our company, or to enforce against such persons or Strongbridge in U.S. Courts judgments obtained in such courts predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our Irish counsel that there is doubt as to the enforceability in Ireland against our company and our executive officers and directors who are non-residents of the United States, in original actions or in actions for enforcement of judgments of U.S. Courts, of liabilities predicated solely upon the securities laws of the United States.

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WHERE YOU CAN FIND MORE INFORMATION

        As required by the Securities Act, we have filed with the SEC a registration statement on Form F-3, of which this prospectus is a part, with respect to the ordinary shares offered hereby. This prospectus does not contain all of the information included in the registration statement. Statements in this prospectus concerning the provisions of any document are not necessarily complete. You should refer to the copies of the documents filed as exhibits to the registration statement or otherwise filed by us with the SEC for a more complete understanding of the matter involved. Each statement concerning these documents is qualified in its entirety by such reference.

        We are subject to the information reporting requirements of the Securities and Exchange Act of 1934, as amended, applicable to foreign private issuers and we comply with those requirements by submitting reports to the SEC. Those reports or other information may be inspected without charge at the SEC's Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Information on the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330. Our SEC filings and submissions also are available to the public on the SEC's website at www.sec.gov. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file quarterly and current reports with the SEC, unlike United States companies whose securities are registered under the Exchange Act. However, we are required to file with the SEC, within 180 days after the end of each fiscal year, an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm.


INCORPORATION BY REFERENCE

        The SEC allows us to "incorporate by reference" in this prospectus the information that we file with them. This means that we can disclose important information to you in this document by referring you to other filings we have made with the SEC. The information incorporated by reference is considered to be part of this prospectus, and later information we file with the SEC will update and supersede this information. We incorporate by reference the documents listed below:

        In addition, all subsequent annual reports filed on Form 20-F prior to the termination of this offering are incorporated by reference into this prospectus. Also, we may incorporate by reference our future reports on Form 6-K by stating in those Forms that they are being incorporated by reference into this prospectus.

        This prospectus may contain information that updates, modifies or is contrary to information in one or more of the documents incorporated by reference in this prospectus. Reports we file with the SEC after the date of this prospectus may also contain information that updates, modifies or is contrary to information in this prospectus or in documents incorporated by reference in this prospectus.

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Investors should review these reports as they may disclose a change in our business, prospects, financial condition or other affairs after the date of this prospectus.

        Upon your written or oral request, we will provide at no cost to you a copy of any and all of the information that is incorporated by reference in this prospectus. Requests for such documents should be directed to:

Stephen Long, Esq.
Chief Legal Officer
Strongbridge Biopharma plc
900 Northbrook Drive, Suite 200
Trevose, PA 19053

        You may also access the documents incorporated by reference in this prospectus through our website www.strongbridgebio.com. Except for the specific incorporated documents listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus or the registration statement of which it forms a part.

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EXPENSES

        The following is an estimate of the expenses (all of which are to be paid by the registrant) that we may incur in connection with the securities being registered hereby, other than the SEC registration fee.

SEC registration fee

  $ 7,480.32  

Legal fees and expenses

    29,000  

Accounting fees and expenses

    30,000  

Printing expenses

    5,000  

Total

  $ 71,480.32  

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PART II

INFORMATION NOT REQUIRED IN THE PROSPECTUS

Item 8.    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 Act, 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 Act 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 Act.

        The Registrant is permitted under its articles of association and the Irish Companies Act 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 Act 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.

Item 9.    Exhibits

Exhibit No.   Exhibit Title
  5.1   Legal Opinion of Arthur Cox
        
  10.1   Securities Purchase Agreement, dated December 22, 2016, by and among Strongbridge Biopharma plc and the several purchasers signatory thereto (incorporated by reference to Exhibit 10.1 of the Form 6-K (File No. 001-37569) filed with the Securities and Exchange Commission on December 23, 2016).
        
  10.2   Registration Rights Agreement, dated December 22, 2016, by and among Strongbridge Biopharma plc and the several purchasers signatory thereto (incorporated by reference to Exhibit 10.2 to the Form 6-K (File No. 001-37569) filed with the Securities and Exchange Commission on December 23, 2016).
        
  10.3 Asset Purchase Agreement, dated December 12, 2016, between Taro Pharmaceuticals North America, Inc. and Strongbridge Biopharma plc
        
  10.4 Supply Agreement, dated December 12, 2016, between Taro Pharmaceuticals North America, Inc. and Strongbridge Biopharma plc
        
  10.5 Loan and Security Agreement, dated December 28, 2016, among Oxford Finance LLC, Horizon Technology Finance Corporation, the other Lenders listed therein, and Strongbridge Biopharma plc, Cortendo Cayman Ltd., Cortendo AB (publ) and Strongbridge U.S. Inc.

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Exhibit No.   Exhibit Title
  23.1   Consent of Ernst & Young LLP
        
  23.2   Consent of Ernst & Young AB
        
  23.3   Consent of Arthur Cox (included in the opinion filed as Exhibit 5.1)
        
  24.1   Power of Attorney (included on the signature page hereto).

Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.

Item 10.    Undertakings

        (a)   The undersigned registrant hereby undertakes:

            (1)   To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

                (i)  To include any prospectus required in Section 10(a)(3) of the Securities Act of 1933;

               (ii)  To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table in the effective registration statement; and

              (iii)  To include any material information with respect to the "Plan of Distribution" not previously disclosed in the registration statement or any material change to such information in the registration statement;

             Provided , however , that paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424 (b) that is part of the registration statement.

            (2)   That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment 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;

            (3)   To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering;

            (4)   To file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A of Form 20-F at the start of any delayed offering or throughout a continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Securities Act of 1933 need not be furnished, provided, that the registrant includes in the prospectus, by means of a post-effective amendment, financial statements required pursuant to this paragraph (4) and other information necessary to ensure that all other information in the

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    prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Securities Act or Rule 3-19 if such financial statements and information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in Form F-3;

            (5)   That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

                (i)  Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

               (ii)  Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

        (b)   The undersigned registrant hereby undertakes, that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement 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.

        (h)   Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described under Item 8 above, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim 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 certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Trevose, Pennsylvania on January 12, 2017.

    STRONGBRIDGE BIOPHARMA PLC

 

 

By:

 

/s/ MATTHEW PAULS

        Name:   Matthew Pauls
        Title:   President and Chief Executive Officer (principal executive officer) and Director


POWER OF ATTORNEY

        KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Matthew Pauls and A. Brian Davis and each of them, individually, as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and stead in any and all capacities, in connection with this registration statement, including to sign in the name and on behalf of the undersigned, this registration statement and any and all amendments thereto, including post-effective amendments and registrations filed pursuant to Rule 462 under the U.S. Securities Act of 1933, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the U.S. Securities and Exchange Commission, granting unto such attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary 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 said attorneys-in-fact and agents, or his substitute, may lawfully do or cause to be done by virtue hereof.

        Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons on the dates and in the capacities indicated below:

NAME
 
TITLE
 
DATE

 

 

 

 

 
/s/ MATTHEW PAULS

Matthew Pauls
  President and Chief Executive Officer (principal executive officer) and Director   January 12, 2017

/s/ A. BRIAN DAVIS

A. Brian Davis

 

Chief Financial Officer (principal financial officer and principal accounting officer) and authorized representative in the United States

 

January 12, 2017

/s/ JOHN H. JOHNSON

John H. Johnson

 

Chairman, Director

 

January 12, 2017

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NAME
 
TITLE
 
DATE

 

 

 

 

 
/s/ RICHARD S. KOLLENDER

Richard S. Kollender
  Director   January 12, 2017

/s/ GARHENG KONG

Garheng Kong

 

Director

 

January 12, 2017

/s/ JEFFREY SHERMAN

Jeffrey Sherman

 

Director

 

January 12, 2017

/s/ MARTEN STEEN

Marten Steen

 

Director

 

January 12, 2017

/s/ HILDE STEINEGER

Hilde Steineger

 

Director

 

January 12, 2017

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EXHIBIT INDEX

Exhibit No.   Exhibit Title
  5.1   Legal Opinion of Arthur Cox
        
  10.1   Securities Purchase Agreement, dated December 22, 2016, by and among Strongbridge Biopharma plc and the several purchasers signatory thereto (incorporated by reference to Exhibit 10.1 of the Form 6-K (File No. 001-37569) filed with the Securities and Exchange Commission on December 23, 2016).
        
  10.2   Registration Rights Agreement, dated December 22, 2016, by and among Strongbridge Biopharma plc and the several purchasers signatory thereto (incorporated by reference to Exhibit 10.2 to the Form 6-K (File No. 001-37569) filed with the Securities and Exchange Commission on December 23, 2016).
        
  10.3 Asset Purchase Agreement, dated December 12, 2016, between Taro Pharmaceuticals North America, Inc. and Strongbridge Biopharma plc
        
  10.4 Supply Agreement, dated December 12, 2016, between Taro Pharmaceuticals North America, Inc. and Strongbridge Biopharma plc
        
  10.5 Loan and Security Agreement, dated December 28, 2016, among Oxford Finance LLC, Horizon Technology Finance Corporation, the other Lenders listed therein, and Strongbridge Biopharma plc, Cortendo Cayman Ltd., Cortendo AB (publ) and Strongbridge U.S. Inc.
        
  23.1   Consent of Ernst & Young LLP
        
  23.2   Consent of Ernst & Young AB
        
  23.3   Consent of Arthur Cox (included in the opinion filed as Exhibit 5.1)
        
  24.1   Power of Attorney (included on the signature page hereto).

Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.

II-6




Exhibit 5.1

 

 

Our Reference:          MAMcL/LMC/ST326/006

 

12 January 2017

 

Board of Directors

Strongbridge Biopharma plc

Arthur Cox Building

Earlsfort Terrace

Dublin 2

Ireland

 

Re:                              Strongbridge Biopharma plc (the “Company”)

 

Dear Sirs,

 

1.                                       BASIS OF OPINION

 

1.1                                We are acting as Irish counsel to the Company, registered number 562659, a public company limited by shares, incorporated under the laws of Ireland, with its registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland in connection with the registration statement on Form F-3 (the “ Registration Statement ”) to be filed with the United States Securities and Exchange Commission (the “ SEC ”) on 12 January 2017 under the Securities Act of 1933, as amended, with respect to the proposed resale or other disposition of up to 28,265,833 ordinary shares of US$0.01 par value per share of the Company (the “ Shares ”) by the selling shareholders identified in the prospectus forming part of the Registration Statement (the “ Selling Shareholders ”), including 7,428,571 ordinary shares issuable upon the exercise of warrants held by the Selling Shareholders (the “ Warrants ”) and 74,918 ordinary shares issuable upon the exercise of options held by one of the Selling Shareholders (the “ Options ”).

 

1.2                                This Opinion is confined to and given in all respects on the basis of the laws of Ireland (meaning Ireland exclusive of Northern Ireland) in force as at the date hereof as currently applied by the courts of Ireland. We have made no investigation of and we express no opinion as to the laws of any other jurisdiction or the effect thereof.

 

1.3                                This Opinion is also strictly confined to the matters expressly stated herein at paragraph 2 below and is not to be read as extending by implication or otherwise to any other matter.

 

 



 

 

1.4                                As Irish counsel to the Company in connection with the registration of the Shares, we have examined:

 

(a)                                  the documents listed in the schedule (the “ Schedule ”) to this opinion (the “ Documents ”);

 

(b)                                  the searches listed at paragraph 1.6 below; and

 

(c)                                   such other documents and records as we have deemed necessary to enable us to render the opinions set forth below.

 

1.5                                In giving this Opinion, we have examined and relied on copies of the Documents sent to us by e-mail in pdf or other electronic format.

 

1.6                                For the purpose of giving this Opinion, we have caused to be made the following legal searches against the Company on 12 January 2017:

 

(a)                                  on the file of the Company maintained by the Registrar of Companies in Dublin for mortgages, debentures or similar charges or notices thereof and for the appointment of any receiver, examiner or liquidator;

 

(b)                                  in the Judgments Office of the High Court for unsatisfied judgments, orders, decrees and the like for the five years immediately preceding the date of the search; and

 

(c)                                   in the Central Office of the High Court in Dublin for any proceedings and petitions filed in the last two years.

 

2.                                       OPINION

 

Subject to the assumptions set out in this Opinion and to any matters not disclosed to us, we are of the opinion that:

 

2.1                                The Company is a public company limited by shares and is duly incorporated and validly existing under the laws of Ireland.

 

2.2                                The Shares have been duly authorised pursuant to resolutions of the board of directors of the Company and, when issued upon the exercise by the Selling Shareholders of the Warrants and/or the Options, will be validly issued, fully paid up and non-assessable (which term means when used herein that no further sums are required to be paid by the holders thereof in connection with the issue of such Shares).

 

3.                                       ASSUMPTIONS

 

For the purpose of giving this Opinion, we assume the following without any responsibility on our part if any assumption proves to have been untrue as we have not verified independently any assumption:

 

3.1                                Registration Statement

 

(a)                                  that the Shares will be allotted and issued in the manner stated in the Registration Statement;

 

(b)                                  that any Shares allotted and issued upon the exercise by the Selling Shareholders of the Warrants and/or the Options will be paid up in consideration of the receipt by the Company prior to, or simultaneously with, the issue of the Shares pursuant thereto of cash at least equal to the nominal

 

2



 

 

value of such Shares and that where Shares are issued without the requirement for the payment of cash consideration by or on behalf of the relevant beneficiary, then such Shares shall either be fully paid up by the Company or one of its subsidiaries within the time permitted by section 1027 of the Companies Act 2014 (and, in the case of the Company or a subsidiary incorporated in Ireland, in a manner permitted by section 82(6) of the Companies Act 2014) or issued for consideration as set out in section 1028(2) of the Companies Act 2014;

 

(c)                                   that the exercise by the Selling Shareholders of any Options and/or Warrants and the issue of the Shares upon the exercise of such Options and/or Warrants will be conducted in accordance with the terms and the procedures described in the (i) ordinary share purchase warrant and (ii) the warrant to subscribe for shares issued in connection with the loan and security agreement entered into by the Company on 28 December 2016;

 

(d)                                  that the Company has sufficient share capital to issue the required number of Shares to be issued upon the exercise by the Selling Shareholders of the Warrants and the Options;

 

3.2                                Authenticity and bona fides

 

(a)                                  the completeness and authenticity of all Documents submitted to us as originals or copies of originals (and in the case of copies, conformity to the originals of such copies), the genuineness of all signatories, stamps and seals thereon and where incomplete Documents have been submitted to us that the originals of such Documents are identical to the last draft of the complete Documents submitted to us;

 

(b)                                  that the copies produced to us of minutes of meetings and/or of resolutions correctly record the proceedings at such meetings and/or the subject matter which they purport to record and that any meetings referred to in such copies were duly convened, duly quorate and held, that those present at any such meetings were entitled to attend and vote at the meeting and acted bona fide throughout and that no further resolutions have been passed or other action taken which would or might alter the effectiveness thereof;

 

(c)                                   that there is, at the relevant time of the allotment and issue of the Shares, no matter affecting the authority of the directors to issue and allot the Shares, not disclosed by the constitution of the Company (the “ Constitution ”) or the resolutions produced to us, which would have any adverse implications in relation to the opinions expressed in this Opinion;

 

(d)                                  that the Constitution effective as of 9 September 2015 is the current constitution of the Company, is up to date and has not been amended or superseded and that there are no other terms governing the Shares other than those set out in the Constitution;

 

3.3                                Accuracy of searches and warranties

 

(a)                                  the accuracy and completeness of the information disclosed in the searches referred to in paragraph 1.6 above and that such information has not since the time of such search or enquiry been altered (it should be noted that searches at the Companies Registration Office, Dublin, do not necessarily reveal whether or not a prior charge has been created or a resolution has been passed

 

3



 

 

or a petition presented or any other action taken for the winding-up of or the appointment of a receiver or an examiner to the Company); and

 

(b)                                  the truth, completeness and accuracy of all representations and statements as to factual matters contained in the Documents.

 

4.                                       DISCLOSURE

 

This Opinion is addressed to you in connection with the registration of the Shares with the SEC. We hereby consent to the inclusion of this Opinion as an exhibit to the Registration Statement to be filed with the SEC and any amendments thereto.

 

5.                                       NO REFRESHER

 

This opinion speaks only as of its date. We are not under any obligation to update this opinion from time to time or to notify you of any change of law, fact or circumstances referred to or relied upon in the giving of this opinion.

 

The opinion is governed by and is to be construed in accordance with the laws of Ireland as interpreted by the courts of Ireland at the date hereof.

 

Yours faithfully

 

/s/ Arthur Cox

ARTHUR COX

 

4



 

 

SCHEDULE

 

The Documents

 

1.                                       A copy of the Registration Statement.

 

2.                                       A copy of the resolutions of the board of directors of the Company dated 8 December 2016 and 13 December 2016.

 

3.                                       A copy of the corporate certificate of the secretary of the Company dated 12 January 2017.

 

4.                                       A copy of the Constitution adopted by resolution of the shareholders of the Company on 3 September 2015, effective 9 September 2015.

 

5.                                       A copy of the certificate of incorporation of the Company dated 26 May 2015.

 

6.                                       A copy of the certificate of a public company entitled to do business of the Company dated 28 May 2015.

 

7.                                       A copy of the certificate of incorporation on change of name of the Company dated 4 September 2015.

 

8.                                       A copy of the letter of status from the Irish Companies Registration Office dated 12 January 2017.

 

5




Exhibit 10.3

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

EXECUTION COPY

 

ASSET PURCHASE AGREEMENT

 

between

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

and

 

STRONGBRIDGE BIOPHARMACEUTICALS PLC

 

Dated

 

December 12, 2016

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

TABLE OF CONTENTS

 

 

 

Page

Page

 

i

 

 

 

ARTICLE I — DEFINITIONS

1

1.1

Definition

1

1.2

Interpretation

7

 

 

 

ARTICLE II — PURCHASE AND SALE

7

2.1

Purchase and Sale

7

2.2

Liabilities

8

2.3

Trademark License

8

2.4

License

9

2.5

Regulatory Approval Transfer; Retained Rights

10

2.6

Non-Compete

10

 

 

 

ARTICLE III — PAYMENTS/REPORTS/AUDITS

11

3.1

Purchase Price

11

3.2

Sales Reports

12

3.3

Audits

12

3.4

Taxes

12

3.5

Interest

13

3.6

Indemnity

13

 

 

 

ARTICLE IV — COVENANTS AND AGREEMENTS

13

4.1

Supply of Inventory Units

13

4.2

Transition for Existing Patients

14

4.3

Marketing Commitment

15

4.4

Non-Assignability

15

4.5

Minimum Purchase Quantities

15

4.6

Reversion Conditions

15

4.7

Use of Names

16

4.8

Removal of Taro Name from Tablet

16

4.9

Patient Data

16

4.10

Development by Taro

16

4.11

Provision of Information

17

 

i



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.12

Government Reporting and Payment

17

 

 

 

ARTICLE V — EXECUTION, CLOSING AND EFFECTIVENESS

17

5.1

Execution; Closing

17

5.2

Further Assurances

18

5.3

Broker Fees

18

 

 

 

ARTICLE VI — REPRESENTATIONS AND WARRANTIES

18

6.1

Taro’s Representations and Warranties

18

6.2

Strongbridge’s Representations and Warranties

19

6.3

Disclaimer of Other Warranties

20

 

 

 

ARTICLE VII — INDEMNIFICATION

20

7.1

Indemnification by Taro

20

7.2

Indemnification by Strongbridge

20

7.3

Indemnification; Notice and Settlements

21

 

 

 

ARTICLE VIII — MISCELLANEOUS

21

8.1

Notices

21

8.2

Expenses

22

8.3

Termination; Survival

22

8.4

Section 365(n) of the Bankruptcy Code

23

8.5

Bulk Sales Statutes

23

8.6

Successors and Assigns

23

8.7

Entire Agreement; Amendment

23

8.8

Public Announcement

23

8.9

Filing Requirements

23

8.10

Compliance with Applicable Law

24

8.11

Governing Law; Jurisdiction

24

8.12

Dispute Resolution

24

8.13

Language

25

8.14

Article Headings

25

8.15

Further Assurances

25

8.16

Waiver

25

8.17

Modification

25

8.18

Severability

25

8.19

Counterparts

26

8.20

No Third Party Beneficiaries

26

 

ii



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

TABLE OF SCHEDULES AND EXHIBITS

 

Schedule 1(a) Marketing Materials

Schedule 1(b) Product Trademark

Schedule 2.1(a)(ii) Domain Names

Schedule 4.3 Marketing Commitment

Schedule 5.1(b) FDA NDA Letter

Schedule 5.1(b) FDA NDA Letter

Schedule 5.1(b) Orphan Designation Acceptance Letter

Schedule 5.1(b) FDA IND Letter

 

iii



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ASSET PURCHASE AGREEMENT

 

This Asset Purchase Agreement dated December 12 2016, is by and between Taro Pharmaceuticals North America, Inc. , a Cayman Islands limited company, with a place of business at Harbour Place, 103 South Church Street, Grand Cayman KY1-1202, Cayman Islands (“ Taro ”) and Strongbridge Biopharmaceuticals plc, a company organized under the laws of Ireland, having its Company’s registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland and having its principal U.S. place of business at 900 Northbrook Drive, Suite 200, Trevose, PA 19053 (“ Strongbridge ”).

 

WHEREAS , Taro’s Affiliate acquired the rights, title and interest to the Regulatory Approval pursuant to the Merck Agreements (defined below) which Regulatory Approval was subsequently transferred to Taro;

 

WHEREAS , Strongbridge desires to purchase and Taro desires to sell to Strongbridge, the Regulatory Approval, subject to a reversionary right to Taro of the Regulatory Approval upon the occurrence of the Reversion Conditions (defined below);

 

WHEREAS , Strongbridge desires to Commercialize (defined below) the Product (defined below) and Lifecycle Product (defined below) under the Product Trademark which is registered to Taro;

 

WHEREAS , Strongbridge desires to obtain an exclusive license to the Product Trademark for Commercialization of the Product and Lifecycle Product  in the Territory, and Taro is willing to grant such exclusive license for such purpose, pursuant to the terms and conditions set forth herein; and

 

WHEREAS , Taro and Strongbridge have entered into a Supply Agreement, dated as of the Effective Date, pursuant to which Taro shall supply, and Strongbridge shall purchase, Strongbridge’s, and its Affiliates’ requirements of Product (the “ Supply Agreement ”), pursuant to the terms and conditions set forth therein.

 

THEREFORE , in consideration of the mutual covenants and agreements provided herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:

 

ARTICLE I — DEFINITIONS

 

1.1          Definition .  As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

AAA ” has the meaning set forth in Section 8.12(b).

 

Affiliate ” means any Person that controls, is controlled by, or is under common control with a Party.  For purposes of this definition, “control” means: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a

 

1



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Party; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities.  With respect to Taro, Affiliate means the following entities:  Taro Pharmaceutical Industries Ltd., Taro International Ltd., Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Laboratories, Inc., Taro Pharmaceuticals Inc., Taro Pharmaceuticals Canada, Ltd., Taro Pharmaceuticals North America, Inc., Taro Pharmaceuticals Europe B.V., Taro Pharmaceuticals (UK) Limited, Taro Pharmaceuticals Ireland Limited, and Taro Hungary KFT, provided that any entity that, after the Effective Date is newly under the control of Taro Pharmaceutical Industries Ltd. or any of the foregoing entities shall be an Affiliate of Taro for purposes of this definition.

 

Agreement ” means this Asset Purchase Agreement including all exhibits, schedules and appendices attached hereto.

 

Agreement Payments ” has the meaning set forth in Section 3.4(a).

 

API ” means the active pharmaceutical ingredient dichlorphenamide, USP.

 

Applicable Law ” means all applicable local, state, national, regional or international statute, law, ordinance, rule, treaty, regulation, common law or other legal requirement, including provisions of all statutes (including the Federal Food, Drug and Cosmetic Act), laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents (including FDA guidance documents), injunctions, awards, judgments, and permits and licenses of or from governmental authorities, and the rules of any applicable securities exchange.

 

Arbitrators ” has the meaning set forth in Section 8.12(b).

 

Assumed Liabilities ” means all claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) relating to the Product (regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number), made or brought on or after the Closing Date, including, without limitation, all liabilities arising out of: (i) the research, development, sale or use of the Product and Lifecycle Product by Strongbridge on or after the Closing; (ii) the purchase, consumption or use of the Product and Lifecycle Product by Third Parties which Product and Lifecycle Product was provided by Strongbridge to such Third Parties on or after the Closing Date; (iii) the Regulatory Approval; (iv) any payment required to be made to any Third Party on net sales of the Product and Lifecycle Product, including any payment required to be made under the Merck Agreements.

 

Back License ” has the meaning set forth in Section 2.4(b).

 

Calendar Year ” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

 

CDA ” has the meaning set forth in Section 8.7.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Commercial Launch ” means the date that Product, other than the Taro Product supplied at or about Closing as set forth in Section 4.1(a), is first dispensed by or on behalf of Strongbridge to a Third Party, which date shall not be earlier than April 1, 2017.

 

Commercialization ” or “ Commercialize ” means the ongoing process and activities generally engaged in by a pharmaceutical company marketing human pharmaceutical therapeutic products to establish and maintain a presence for such product in a given country within the Territory, including offering for sale, selling, marketing, promoting, distributing, having distributed, importing or having imported into and within the Territory, exporting and having exported within the Territory, such product.  For clarity, any activities relating to manufacturing of the human pharmaceutical therapeutic products is specifically excluded.

 

Commercially Reasonable Efforts ” with respect to any activity means the efforts and resources that would be used in the performance of the relevant activity in compliance with applicable Law by a Person (engaged in the manufacture and supply or commercialization of pharmaceutical products, as applicable) of comparable size and resources as the applicable Party with regard to a product at a similar stage in its product life taking into account the following factors to the extent reasonable and relevant: issues of safety and efficacy, product profile, market potential, competitive market conditions, duration of exclusivity or other proprietary position of the product and the potential profitability and economic return of the product, all as measured by the facts and circumstances at the time such efforts are due.  Where this Agreement requires a Party to use Commercially Reasonable Efforts, such efforts and resources that are used by such Party’s Affiliates, agents, sublicensees and licensees, as relevant, shall also be attributed to such Party.

 

Closing ” has the meaning set forth in Section 5.1(a).

 

Closing Date ” means the date on which the “Closing” occurs as defined in Section 5.1(a).

 

Competitive Product means (i) any pharmaceutical product Labelled and indicated for the Indication, or (ii) any pharmaceutical product containing the API.

 

Diplomat/Envoy ” means the distributor used to distribute the Product in the Territory by Taro prior to the Closing Date and by Strongbridge on or after the Closing Date.

 

Dispute ” has the meaning set forth in Section 8.12(b).

 

DMF ” means Taro’s Drug Master File number 26664.

 

Domain Names ” has the meaning set forth in Section 2.1(a).

 

Excluded Assets ” has the meaning set forth in Section 2.1(b).  “ Excluded Liabilities ” means all liabilities claims and complaints (including, without limitation, all damages, losses, expenses and liabilities) arising out of: (i) the research, development, manufacture, sale or use of the Product by Taro prior to the Closing Date; (ii) the purchase, consumption or use of the

 

3



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Product by Third Parties which Product was provided by Taro to such Third Parties before the Closing Date; and (iii) any Excluded Assets.

 

Existing Patients ” has the meaning set forth in Section 4.1(a).

 

FDA ” means the United States Food and Drug Administration, or any successor agency thereto.

 

First Tranche Upfront Payment ” has the meaning set forth in Section 3.1(a).

 

Generic Product ” means a pharmaceutical product that is therapeutically equivalent to the Product where “therapeutically equivalent” means, with respect to a Product, a drug product that (a) is approved under 21 U.S.C. 355(j) or 21 U.S.C. 355(b)(2) (or any respective successor law),  (b) is rated by the FDA to be therapeutically equivalent to such Product, and (c) is legally substitutable for such Product at the pharmacy under Applicable Law.

 

IND ” means the United States Investigational New Drug Application #127873.

 

Indemnified Party ” has the meaning set forth in Section 7.3.

 

Indemnifying Party ” has the meaning set forth in Section 7.3.

 

Indication ” means the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

 

Intellectual Property Rights ” means Patents, copyrights, trade secrets, database rights, proprietary Know-How and similar rights of any type (excluding trademarks) under any common law or statute, including all applications, registrations, extensions and renewals relating to any of the foregoing.

 

“Inventory Units” has the meaning set forth in Section 4.1(a).

 

Know-How ” means all technical information and other technical subject matter, proprietary methods, ideas, concepts, formulations, discoveries, inventions, devices, prototypes, technology, trade secrets, compositions, designs, formulae, data (including clinical, non-clinical and preclinical data), know-how, show-how, specifications, drawings, techniques, results, processes, methods, procedures and/or designs, whether or not patentable, and in all cases, including any of the foregoing that are included in the DMF.

 

Labeled ” means, with respect to finished goods Product, means all labels and other written, printed, or graphic matter (i) on the Product containers or wrappers, or (ii) accompanying the Product, provided, however, Label shall not include any embossing or other markings directly on the Product tablet.

 

Liens and Encumbrances ” means, with respect to the Regulatory Approval, any mortgage, lien, pledge, charge, security interest or encumbrance of any kind.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Lifecycle Product ” means a pharmaceutical product containing the API that is a natural evolution or line extension of the Product and is developed by or on behalf of Strongbridge for Commercialization in the Territory.

 

Marketing Materials ” means the documents, graphics and other materials used by Taro prior to the Closing to advertise, market and promote the Product in the Territory and identified on Schedule 1(a) .

 

Merck Agreements ” means (i) the Asset Purchase and Sale Agreement effective May 12, 2008 between Taro Pharmaceuticals USA Inc. and Merck & Co, Inc., and (ii) any ancillary agreement that was a part of the transaction contemplated by the Asset Purchase and Sale Agreement.

 

Milestone Payments ” has the meaning set forth in Section 3.1(c).

 

New York Court ” has the meaning set forth in Section 8.11.

 

NDA ” means collectively: (i) that certain United States New Drug Application #01-1366, including all amendments and supplements thereto, and (ii) the Orphan Designation Request #10-3142.

 

New Product Embossing ” has the meaning set forth in Section 4.8(a).

 

Non-Blocking License ” has the meaning set forth in Section 2.4(a).

 

Party ” means Taro or Strongbridge, individually, and “ Parties ” mean Taro and Strongbridge, collectively.

 

Patent ” and “ Patents ” mean all U.S. patents and patent applications, including any and all provisionals, continuations, divisionals, continuation-in-part applications, substitutions, reissues, renewals, re-examinations, supplementary protection certificates, patent term extensions, adjustments or restoration rights, registrations, confirmations, successor protective rights or subsequently issued protective rights of similar nature of any of the above.

 

Permitted Assignee ” has the meaning set forth in Section 4.4(a).

 

Product ” means the pharmaceutical product approved for Commercialization in the U.S. under the NDA and marketed under the Product Trademark in the Territory.

 

Product Trademark ” means the trademark registration specified in Schedule 1(b) , and the corresponding goodwill associated with such trademark.

 

Purchased Assets ” has the meaning set forth in Section 2.1(a).

 

Purchase Price ” means, collectively, the Upfront Payment and the Milestone Payments.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Regulatory Approval ” means, collectively, the NDA and the IND, along with other correspondence, documentation and files directly and solely related thereto that are maintained by or on behalf, and reasonably within the control of, Taro.

 

Reversion Conditions ” has the meaning set forth in Section 4.6

 

Reversion Rights ” has the meaning set forth in Section 4.6.

 

Second Tranche Upfront Payment ” has the meaning set forth in Section 3.1(a).

 

Sales Report ” has the meaning set forth in Section 3.2.

 

Strongbridge ” has the meaning set forth in the Preamble.

 

Strongbridge Inventory ” has the meaning set forth in Section 4.1(a).

 

“Strongbridge Product” has the meaning set forth in Section 4.1(c).

 

Supply Agreement ” has the meaning set forth in the Recitals.

 

Tablet Change ” has the meaning set forth in Section 4.8.

 

Taro ” has the meaning set forth in the Preamble.

 

Taro Inventory ” has the meaning set forth in Section 4.1(a).

 

Taro Product ” means the Product that is Labeled with Taro information and NDC number, other than Taro Inventory.

 

Taxes ” means all taxes of any kind, and all charges, fees, customs, levies, duties, imposts, required deposits or other assessments, including all federal, state, local or foreign net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, workers’ compensation, unemployment, occupation, capital stock, ad valorem, value added, transfer, gains, windfall profits, net worth, asset, transaction, and other taxes, and any interest, penalties or additions to tax with respect thereto, imposed upon any individual or entity by any taxing authority or other governmental authority under the laws of the applicable country in the Territory.

 

Territory ” means the United States of America, its possession and territories, including the Commonwealth of Puerto Rico.

 

Third Party ” means an entity other than Taro or Strongbridge or an Affiliate of either Party.

 

Trademark License ” has the meaning set forth in Section 2.3(a).

 

Units of Product ” means a bottle of Product or Lifecycle Product containing 100 tablets.

 

6


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

1.2                                Interpretation .

 

(a)           Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitation” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”);

 

(b)           All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

 

(c)           Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

 

(d)           The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recital, Exhibits and Schedules shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided , that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

 

(e)           The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

 

(f)            Unless otherwise provided, all references to Sections and Schedules in this Agreement are to Sections and Schedules of and to this Agreement;

 

(g)           Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 8.1; and

 

(h)           Wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another.

 

ARTICLE II — PURCHASE AND SALE

 

2.1          Purchase and Sale .

 

(a)           On and subject to the terms and conditions set out in this Agreement, Taro hereby sells, conveys, and transfers to Strongbridge, and Strongbridge hereby purchases and accepts the sale, conveyance and transfer of all of Taro’s right, title and interest in and to (i) the Regulatory Approval, (ii) the domain names set forth on Schedule 2.1(a)(ii)  (the “ Domain Names ”) and (iii) the Marketing Materials ((i), (ii) and (iii) collectively referred to as “ Purchased Assets ”), in each case on the Closing Date, subject to Taro’s reversionary right to the Regulatory Approval upon the occurrence of the Reversion Conditions.

 

(b)           Except for the Purchased Assets and the license rights set forth below, no other assets, property, rights and interests of Taro and its Affiliates are being sold, conveyed or

 

7



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

transferred to Strongbridge under this Agreement, including all patents, information and know how, trademarks, trade names, good will, intellectual property and proprietary rights, new drug applications and their equivalents (collectively, “ Excluded Assets ”).  For clarity, the DMF is not included as part of the Regulatory Approval.  Taro hereby grants to Strongbridge a right of reference to the DMF for the purpose of maintaining the Regulatory Approval in accordance with Applicable Law and research and development, seeking regulatory approval for and Commercialization in the Territory of Lifecycle Products.

 

(c)           The Marketing Materials shall be conveyed, transferred, assigned and provided by Taro to Strongbridge “AS IS, WHERE IS, WITH ALL FAULTS” and with no express or implied representations or warranties of any kind whatsoever, including without limitation, whether such Marketing Materials comply with Applicable Law.  If Strongbridge choose to use the Marketing Materials to Commercialize Product or Lifecycle Product in the Territory on and after the Closing Date, Strongbridge shall have sole responsibility for determining whether the Marketing Materials comply with Applicable Law or whether use of the Marketing Materials infringes upon any rights of a Third Party.

 

2.2          Liabilities .  As of the Closing Date:

 

(a)           Strongbridge shall assume and pay, perform or otherwise be responsible for the Assumed Liabilities.

 

(b)           Taro shall retain and continue to be responsible for the Excluded Liabilities.

 

2.3                                Trademark License .

 

(a)           Subject to the terms and conditions contained herein, Taro, on behalf of its Affiliate, hereby grants to Strongbridge, and Strongbridge hereby accepts, a nontransferable (except as permitted pursuant to Section 4.4(a)), non-sublicensable (except as permitted below), sole and exclusive, royalty-free license to use the Product Trademark in connection with the Product and Lifecycle Product solely in the Territory (“ Trademark License ”).  For the avoidance of doubt, without such consent from Taro, Strongbridge may nonetheless sublicense its Trademark License to its Affiliates and distributors, but only as reasonably necessary to Commercialize the Product and Lifecycle Product on behalf of Strongbridge in the Territory.  Any attempted assignment or sublicense by Strongbridge not permitted under this Section 2.3(a) shall be void and of no force or effect and shall constitute a material breach of this Agreement.

 

(b)           Strongbridge shall use and shall cause its permitted sublicensees and Permitted Assignee to use the Product Trademark only in connection with the Product and Lifecycle Product for Commercialization by or on behalf of Strongbridge in the Territory.  Taro shall not itself use, or license or otherwise permit any Third Party to use the Product Trademark in the Territory unless the Trademark License had been terminated.

 

(c)           Strongbridge agrees to use the Product Trademark only in relation to the Product and Lifecycle Product in the Territory, consistent with Taro’s standard reasonably set by Taro, as communicated from time to time to Strongbridge with sufficient prior notice.  Strongbridge agrees not to intentionally use the Product Trademark in any way that would diminish, tarnish,

 

8



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

disparage, or damage the goodwill in and to the Product Trademark.  Strongbridge agrees to use the same level of due care to avoid diminishing, tarnishing, disparaging, or damaging the goodwill of the Product Trademark as Strongbridge would use in connection with trademark owned by Strongbridge.

 

(d)           Strongbridge shall ensure that Product Trademark (i) is used in a manner sufficient to constitute trademark usage under applicable law, (ii) is clearly identified as a trademark under applicable law ( e.g. , through the use of a “®”, “™” or other appropriate identifier) and that such “Product Trademark is exclusively licensed to Strongbridge”, and (iii) are not used as combination marks with other marks or trademarks without the prior written consent of Taro.  Any and all use by Strongbridge, permitted sublicensees and Permitted Assignee of the Product Trademark and any goodwill arising therefrom shall inure to the sole benefit of Taro and its Affiliates.

 

(e)           Strongbridge may not and agrees that neither it nor any of its permitted sublicensees and Permitted Assignee will use the Product Trademark outside the Territory.

 

(f)            Strongbridge hereby expressly acknowledges Taro’s ownership of, and rights in, the Product Trademark.   Strongbridge agrees that it will not (and will not assist or authorize any Third Party to) attack, dispute or contest the validity of Taro’s ownership of the Product Trademark.

 

(g)           Taro shall prepare, file, prosecute and maintain trademark applications and registrations at the United States Patent and Trademark Office for the Product Trademark.  All costs and expenses (including but not limited to attorneys’ fees and expenses and official fees) of preparing, filing, prosecuting and maintaining the Product Trademark shall be borne by Taro.

 

2.4          License .

 

(a)           Taro hereby grants to Strongbridge an exclusive, fully paid-up, royalty-free, nontransferable (except as permitted pursuant to Section 4.4(a)), non-sublicenseable (except as permitted below) right to Commercialize the Product and to research, develop, seek regulatory approval for and Commercialize Lifecycle Products in the Territory, in each case under any Intellectual Property Rights owned or acquired by Taro or its Affiliates on or after the Closing Date, that would otherwise be violated by the Commercialization of the Product under the NDA as provided by Taro on the Closing Date by Strongbridge, its permitted sublicensee and Permitted Assignee (“ Non-Blocking License ”).  For the avoidance of doubt, without consent from Taro, Strongbridge may only sublicense the Non-Blocking License (i) to its Affiliates and distributors, but only as reasonably necessary to Commercialize the Product or Lifecycle Products in the Territory, and (ii) to Persons assisting in the research and development of Lifecycle Products solely by or on behalf of Strongbridge.  Any attempted assignment or sublicense by Strongbridge not expressly permitted under this Section 2.4(a) shall be void and of no force or effect and shall constitute a material breach of this Agreement.

 

(b)           Strongbridge hereby grants to Taro a non-exclusive, fully paid-up, royalty-free, transferable, sublicenseable (for multiple tiers) right to Commercialize the Product and to research, develop, seek regulatory approval for and Commercialize lifecycle Products in each

 

9



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

case outside the Territory, in each case under any Intellectual Property Rights created by or on behalf of Strongbridge or its Affiliates on or after the Closing Date that relies on the Intellectual Property Rights licensed by Taro to Strongbridge under Section 2.4(a), (“ Back License ”).

 

(c)           Taro hereby grants to Strongbridge an exclusive license under all copyrights in the Marketing Materials to reproduce, display, perform and create derivative works of the Marketing Materials for the sole purpose of marketing, advertising and promoting the Product and Lifecycle Products in the Territory, provided that all such use shall be subject to Section 4.7.

 

2.5          Regulatory Approval Transfer; Retained Rights .

 

(a)           On or promptly after the Closing Date, Taro shall deliver a complete copy of the Regulatory Approval to Strongbridge by shipping such items, at Strongbridge’s expense, to a destination in the United States specified by Strongbridge.

 

(b)           Taro retains the right for itself and its Affiliates to reference the clinical information and data contained in the Regulatory Approval.

 

(c)           Strongbridge acknowledges that Merck has retained certain rights under the Merck Agreements and hereby consents to the rights retained by Merck.

 

2.6          Non-Compete .

 

(a)           For so long as the Orphan Designation applies to the NDA, Taro and its Affiliates shall not, directly or indirectly (other than through Strongbridge), (i) Commercialize a Competitive Product in the Territory, (ii) promote any product in the Indication in the Territory, or (iii) undertake or have undertaken any clinical activities in the Territory with respect to a Competitive Product in the Territory for the Indication.

 

(b)           Following expiration of the Orphan Designation for the NDA until the sale of the first Generic Product, Taro and its Affiliates shall not, directly or indirectly (other than through Strongbridge), itself or by assisting any Third Party (including by sharing any Confidential Information related to the Product therewith), Commercialize a product in the Territory for the Indication or promote any product in the Indication in the Territory, provided that:

 

(i)            Taro may only Commercialize a product containing the API if such product would not reasonably be expected to have a material impact on the market for the Product (including by taking into account potential off-label prescribing of such product);

 

(ii)           In the event that the Parties disagree regarding a potential material impact on the market for the Product, the provisions of Section 8.12(a) other than the last sentence thereof shall apply to resolution of such disagreement, and if it remains unresolved thereafter, the Parties shall submit such disagreement for resolution by an independent third-party expert having at least fifteen (15) years of experience as a senior executive in the pharmaceutical industry with responsibility for marketing strategies for pharmaceutical products and reasonably acceptable to both Parties.  The Parties shall simultaneously submit their arguments in written form along with any supporting written evidence to the expert within ten (10) Business Days after the end of the

 

10



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

process set forth in Section 8.12(a) other than the last sentence thereof, for decision on such written arguments and evidence.  The expert shall render its decision within thirty (30) days of receipt of the written arguments and evidence.  The decision of the expert shall be final and binding on the Parties and the costs and expenses of such expert shall be borne by the Party against whom the expert’s decision is rendered.

 

(c)           Notwithstanding the foregoing, Strongbridge acknowledges in the event that Taro or any of its Affiliates acquires any business (or assets) which is Commercializing a Competitive Product at the time of such acquisition, Taro shall not be in violation of its obligations under this Section 2.6 if Taro or its applicable Affiliate ceases Commercializing such Competitive Product within twelve (12) months from the effective date of the closing of the acquisition.

 

(d)           In addition, if Taro or any of its Affiliates are acquired by or merged with a Third Party that is Commercializing a Competitive Product at the time of such acquisition or merger, such Third Party and its other Affiliates will not have any obligations under this Section 2.6; provided that the division, subsidiary or business group of the surviving party in such change of control that Commercializes such Competitive Product shall not have access to, and shall not refer to, rely upon or use in any manner, the Intellectual Property Rights owned by Taro or its Affiliates that are necessary for the Commercialization of the Product under the NDA provided to Strongbridge on the Closing Date with respect to such Competitive Product.

 

(e)           Following the first sale of a Generic Product in the Territory, the provisions of this Section 2.6 shall cease to apply.

 

ARTICLE III — PAYMENTS/REPORTS/AUDITS

 

3.1          Purchase Price .  In consideration of the sale, assignment, conveyance, and delivery of the Regulatory Approval and Domain Names and the grant of the Trademark License and Non-Blocking License, Strongbridge shall assume the Assumed Liabilities and make payment to Taro as follows:

 

(a)           On the Closing Date, Strongbridge shall pay to Taro a non-refundable, non-creditable payment in the amount of One Million Dollars ($1,000,000) (the “ First Tranche Upfront Payment ”), by wire transfer of immediately available funds to an account specified in writing by Taro prior to the Closing Date; and

 

(b)           One hundred (100) days after the Closing Date, Strongbridge shall pay to Taro a non-refundable, non-creditable payment in the amount of Seven Million Five Hundred Thousand Dollars ($7,500,000) (the “ Second Tranche Upfront Payment ”), by wire transfer of immediately available funds to an account specified in writing by Taro prior to the Closing Date; and

 

(c)           Strongbridge shall make milestone payments to Taro if the sales milestone event set forth below is achieved in any twelve month period with respect to the Product and Lifecycle Product in the Territory (“ Milestone Payments ”).  Strongbridge shall promptly notify Taro in writing of the achievement of such milestone event but in no event later than seven (7) days after Strongbridge’s determination that the Units of Product sold during such twelve month period have reached the threshold amount set for the applicable Milestone Payment.  Strongbridge shall

 

11



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

pay Taro within fifteen (15) days from the date of Strongbridge’s notification the applicable Milestone Payment.

 

Milestone
Event
Number

 

Milestone Event

 

Milestone
Payment

 

1.

 

Aggregate Units of Product dispensed by or on behalf of Strongbridge in any 12-month period in the Territory equal or exceed [****] Units of Product. Excludes the Inventory Units provided by Taro free of charge.

 

$

[****]

 

 

 

 

 

 

 

2.

 

Aggregate Units dispensed by or on behalf of Strongbridge in any 12-month period in the Territory equal or exceed [****] Units of Product. Excludes the Inventory Units provided by Taro free of charge.

 

$

[****]

 

 

Each of the milestone payments set forth above shall be due one time only.  For clarity, the Milestone Payments are cumulative, such that if Milestone Event #2 is reached before Strongbridge has made any milestone payments for the achievement of Milestone Event #1, then both milestone payments (i.e., Seven Million Five Hundred Thousand Dollars ($7,500,000) will be payable to Taro upon the achievement of Milestone #2.

 

3.2          Sales Reports .  For so long as Milestone Payments are still outstanding to Taro, Strongbridge shall furnish to Taro a written report on a monthly basis showing the Units of Product dispensed by or on behalf of Strongbridge, its Affiliates in the Territory (“ Sales Report ”).  Each Sales Report shall be due within ten (10) days of the end of each calendar month.

 

3.3          Audits .  Taro may request not later than two (2) years following receipt thereof, and Strongbridge shall provide to Taro, written documentation supporting the invoicing data in any Sales Report.

 

3.4                                Taxes .

 

(a)           Except as provided in Section 3.4(a), Taro shall be liable for all income and other Taxes (including interest) imposed upon any payments made by Strongbridge to Taro under this Agreement (“ Agreement Payments ”).  If applicable laws, rules or regulations require the withholding of Taxes, Strongbridge shall make such withholding payments and shall subtract the amount thereof from the Agreement Payments.  Strongbridge shall submit to Taro appropriate proof of payment of the withheld Taxes as well as the official receipts within a reasonable period of time.  Strongbridge shall provide Taro reasonable assistance in order to allow Taro to obtain the benefit of any present or future treaty against double taxation which may apply to the Agreement Payments.

 

12



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(b)           Strongbridge shall bear and be responsible for and pay all applicable Taxes related to (i) the transfer to Strongbridge of the Regulatory Approval and the license rights granted under this Agreement and (ii) the promotion, marketing, sale and distribution by Strongbridge of the Product and Lifecycle Product in the Territory, and shall indemnify and hold Taro harmless from any liability relating to such Taxes other than any taxes based on net income and imposed on Taro resulting from such transfer.

 

(c)           Taro shall indemnify and hold Strongbridge fully harmless from any amounts owed to any taxing authority in respect of any payments made under this Agreement.  If Strongbridge is assessed tax in respect of the foregoing, Taro shall have the right (but not the obligation to assume the defense of Strongbridge and represent Strongbridge, at Taro’s cost, before the taxing authority.  Failure by Strongbridge to provide notice to Taro with fifteen (15) days of such tax assessment shall relieve Taro of any responsibility to indemnify Strongbridge under this Section 3.4(c) but solely to the extent of any prejudice to Taro arising from such failure.

 

3.5          Interest .  If any payment by Strongbridge under this Agreement is not made within thirty (30) days of when due, Strongbridge shall thereafter pay interest to Taro, on all such payments in an amount equal to the lesser of the prime rate reported in the Wall Street Journal (Eastern Edition) on the payment date plus one percentage point, or the maximum rate permitted by law, such interest to be accrued and payable daily without the necessity for any notice, demand or other action by Taro until the overdue amount has been paid in full.

 

3.6          Indemnity .  Each Party shall indemnify the other Party for all costs and expenses (including but not limited to attorneys’ fees) incurred in attempts) to collect any payments due or to enforce any remedy provided under this Agreement, provided that no such indemnification shall be required for any matter that was subject to a bona fide dispute by either Party.

 

ARTICLE IV — COVENANTS AND AGREEMENTS

 

4.1          Supply of Inventory Units .

 

(a)           Promptly following Closing, Taro shall deliver such quantities of Units of Product to Diplomat/Envoy such that Diplomat/Envoy shall have Four Hundred (400) Units of inventory of Taro Product free of charge to Strongbridge (“ Taro Inventory ”) and/or inventory of Product that is Labeled with Strongbridge information and NDC number free of charge to Strongbridge, to the extent available (“ Strongbridge Inventory ” and collectively with the Taro Inventory, the “Inventory Units”) on a consignment basis.  The Inventory Units shall be supplied to patients receiving the Product from Taro free of charge prior to the Closing Date (“ Existing Patients ”).  After the Closing, the Parties shall agree on the quantity of Taro Inventory and Strongbridge Inventory that will comprise the Inventory Units to be delivered and the delivery date.  The Parties agree that Strongbridge shall cause Diplomat/Envoy to exhaust all Taro Inventory to Existing Patients, prior to distributing any Strongbridge Inventory.  Strongbridge shall be responsible for all fees charged by Diplomat/Envoy for distribution of the Inventory Units, the cost of insurance and shipping associated with delivery of such Inventory Units to Diplomat/Envoy.  Risk of loss for the Inventory Units shall transfer to Strongbridge after the Inventory Units have been loaded onto the carrier at Seller’s facility in Cranbury Twp., NJ.  Taro

 

13



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

agrees to hold title to the Inventory Units until distributed to the Existing Patients by Diplomat/Envoy.  If there remains any Strongbridge Inventory at Diplomat/Envoy on March 31, 2017, title for the Strongbridge Inventory shall be transferred to Strongbridge at 11:59PM on March 31, 2017 and Strongbridge shall be permitted to dispense such Strongbridge Inventory for a charge on April 1, 2017.  If there remains any inventory of Taro Inventory at Diplomat/Envoy on March 31, 2017 and such Taro Inventory is not needed for meeting Strongbridge market demand pursuant to Section  Section 4.1(c)(B), Strongbridge shall have such Taro Inventory destroyed at its cost and expense. For clarity, Strongbridge shall supply Inventory Units free of charge to Existing Patients through March 31, 2017.

 

(b)           Taro shall maintain and store the Inventory Units supplied to Diplomat/Envoy under Section 4.1(a) in accordance with the specification for the Product.

 

(c)           All Inventory Units must be provided to patients free of charge prior to April 1, 2017.  Strongbridge may not dispense any Product, including Inventory Units, for a charge unless and until: (i) April 1, 2017, (ii) the Products are Labeled with Strongbridge’s information, Strongbridge’s NDC number and contains the Tablet Change (defined below) (“ Strongbridge Product ”), provided that if Taro is unable to manufacture and ship Product that is not Taro Product in sufficient time prior to April 1, 2017 to enable the uninterrupted supply of Product to patients, then until such time as Product that is not Taro Product can be so supplied by Taro, and only to the extent of such inability to supply, (A) Strongbridge may supply, for a charge to patients, any Strongbridge Inventory remaining at Diplomat, (B) if available from Taro, Taro shall supply under the Supply Agreement and Strongbridge shall be permitted to transfer to patients for a charge Product that bears the Taro name on the tablet but is otherwise Labeled with Strongbridge’s information and NDC number, or (C) if the Product packaged as described  in the foregoing (B) is not available, then Taro shall supply sufficient quantities of Taro Product to Strongbridge under the Supply Agreement to enable Strongbridge to meet market demand until Strongbridge Product can be supplied by Taro.  The Taro Product supplied pursuant to this Section 4.1(c)(B) may be transferred to patients for a charge by Strongbridge.

 

4.2          Transition for Existing Patients .

 

(a)           Promptly following the Closing Date, Strongbridge agrees to establish a patient assistance program for the Product.  Strongbridge shall be responsible for all costs associated with such program, and for ensuring that such program complies with applicable law.

 

(b)           Between the Closing Date and Commercial Launch of the Product, Strongbridge shall ensure that all Existing Patients with insurance to cover the Product are transitioned for coverage of the Product to Existing Patients’ insurance and Existing Patients without insurance coverage are transitioned for coverage of the Product to the Patient Assistance Program established by Strongbridge.

 

(c)           For a period of two (2) years following Commercial Launch, to the extent that there are any Existing Patients that do not have insurance to cover the Product and do not qualify for any Patient Assistance Programs, Strongbridge agrees that will continue to provide such Existing Patients with Products free of charge which Product shall be under the Strongbridge Label and NDC number.

 

14


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.3          Marketing Commitment .

 

(a)           After the Closing, Strongbridge shall use Commercially Reasonable Efforts to Commercialize the Product in the Territory.  Notwithstanding the immediately preceding sentence, Strongbridge agrees to the marketing commitment set forth on Schedule 4.3 .  Commencing on January 15, 2018 and on each anniversary thereafter through January 15, 2023, Strongbridge will provide reasonable documentation demonstrating its compliance under Schedule 4.3 .

 

(b)           Strongbridge shall provide Taro, no later than thirty (30) days prior to April 1 of each calendar year during the Term, a marketing and sales plan, including forecasts and sales for the Product in the Territory.

 

4.4                                Non-Assignability .

 

(a)           For a period of two years after the Commercial Launch, Strongbridge may not transfer or assign its rights to the Regulatory Approval without the prior written consent of Taro, provided that Strongbridge may assign its right to the Regulatory Approval to an Affiliate or an acquirer of or all or substantially all of its assets or business (whether by merger, consolidation, stock purchase or otherwise), without the prior written consent of Taro (a “ Permitted Assignee ”) but with prior notice to Taro.  Permitted Assignee shall agree in writing that it agrees to assume all of Strongbridge’s obligations under this Agreement.

 

(b)           For a period of two years after the Commercial Launch, Strongbridge may not transfer or assign its rights to the Trademark License and the Non-Blocking License without the prior written consent of Taro, provided that Strongbridge may assign its rights to the Trademark License and the Non-Blocking License to an Affiliate or an acquirer of or all or substantially all of its assets or business (whether by merger, consolidation, stock purchase or otherwise), without the prior written consent of Taro.

 

(c)           Following expiration of the two-year period in the foregoing (a) and (b), Strongbridge may transfer or assign its rights to the Regulatory Approval together with the Trademark License and Non-Blocking license without the prior written consent of Taro to an acquirer of all of Strongbridge’s right title and interest hereunder, provided that such acquirer agrees in writing to assume all of Strongbridge’s obligations hereunder.

 

4.5          Minimum Purchase Quantities .  Strongbridge shall purchase the minimum Units of Products as agreed between the Parties under the Supply Agreement.

 

4.6          Reversion Conditions .  Strongbridge’s obligations under Sections 4.1, 4.2, 4.3, 4.4 and 4.5 are collectively referred to as the “ Reversion Conditions ”.  Any material non-compliance with any Reversion Condition shall be deemed a material breach of Strongbridge’s obligation under this Agreement.  In the event that Taro notifies Strongbridge in writing that Strongbridge is in material breach of a Reversion Condition and Strongbridge does not cure such breach within ninety (90) days following such notice or such breach cannot be cured, then, after such ninety-day period, Taro may elect to have the Purchased Assets returned to Taro and to terminate the Trademark License and the Non-Blocking License (“ Reversion Right ”).  In such event,

 

15



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Strongbridge shall cooperate with Taro and take, or cause to be taken, all actions, or to do, or cause to be done, all reasonable things necessary to return the Purchased Assets to Taro and termination of the license rights granted hereunder.

 

4.7          Use of Names .  Subject to Section 4.1(c) and except as Required by Applicable Law:, (a) Taro will mark clearly all Product and Lifecycle Product manufactured or distributed following Commercial Launch to indicate Strongbridge’s ownership of the Product and Lifecycle Product and (b) Strongbridge, except for the Taro Product, will not use the trade name  Taro in connection with the Product or Lifecycle Product and shall not otherwise  use the tradename of Taro, including as part of the name of Strongbridge or any Affiliate of the Strongbridge.  Subject to the immediately preceding sentence, after the Closing Date, Strongbridge shall not give the impression to the public, to physicians or the pharmaceutical marketplace that the Product or Lifecycle Product is a product of Taro or in any way connected to Taro except as specifically agreed to by Taro under this Agreement with respect to the Product Trademark.

 

4.8          Removal of Taro Name from Tablet .  Promptly following the Closing,

 

(a)           The Parties shall confer and decide on a new embossing design for the Product tablets that is reasonably acceptable to both Parties and does not include the Taro name (the “ New Product Embossing ”);

 

(b)           Taro shall provide to Strongbridge a plan for the changeover in the manufacturing of the Product to produce Product having the New Product Embossing;

 

(c)           Promptly thereafter Strongbridge shall file changes to the NDA with the FDA for notification of the New Product embossing as required by the FDA to enable dispensing of the Product therewith; and

 

(d)           The Parties shall reasonably cooperate to implement Taro’s changeover plan.

 

(the foregoing process in this Section 4.8, the “ Tablet Change ”).

 

4.9          Patient Data .  Strongbridge shall comply with all applicable laws, rules and regulations, as amended from time to time, with respect to the use and disclosure of individually identifiable health information contained in the Regulatory Approval, and ensure that: (a) such information is used and/or disclosed only in accordance with applicable law or regulation; and (b) all appropriate technical and organizational measures are taken to protect such information against accidental, unauthorized or unlawful destruction, loss, alteration, access or disclosure.

 

4.10        Development by Taro .  To the extent that Taro undertakes any clinical trials for the further development of the Product outside the Territory, Taro shall keep Strongbridge reasonably informed with respect to such activities by providing to Strongbridge a draft copy of any such clinical trial protocol at least sixty (60) days prior to the date anticipated for its submission to a regulatory authority to permit Strongbridge to provide comments which comments Taro shall consider in good faith.

 

16



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.11        Provision of Information .  In the event that Strongbridge receives any inquiries or requests from any regulatory authority outside the Territory to provide Product for compassionate use or otherwise, Strongbridge shall promptly provide such information to Taro at:  Taro customer service 1-888-827-6872 (TAR-OUSA).  .  Strongbridge hereby authorizes Taro to ship Product to such regulatory authority directly from the facility where the Product is manufactured, at Taro’s costs and expense.

 

4.12        Government Reporting and Payment .

 

(a)           Strongbridge shall be responsible for payment of all rebates, chargebacks and any other similar payments for all Product dispensed after the Closing Date, regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number.

 

(b)           Taro shall be responsible for all governmental reporting and processing of all rebates, chargebacks and the processing of any other similar payments for all Product dispensed in the Territory Labeled with Taro information and Taro NDC number.  Strongbridge shall provide all necessary information to Taro with respect to Product dispensed in the Territory with Taro information and Taro NDC number after the Closing Date so that Taro may comply with such reporting obligation.  Strongbridge shall reimburse Taro for any payment made by Taro for rebates, chargebacks and any other similar payments with respect to such Product.

 

(c)           Strongbridge shall be responsible for all governmental reporting and processing of all rebates, chargebacks and any processing of other similar payments for all Product dispensed in the Territory Labeled with Strongbridge information and Strongbridge NDC number.

 

(d)           Strongbridge shall be responsible for responding to all complaints (in accordance with the Quality Agreement and/or Pharmacovigiliance Agreement) and processing and payment of returns for Product dispensed after the Closing Date, regardless of whether the Product is Labelled with Taro information and NDC number or Strongbridge information and NDC number.

 

ARTICLE V — EXECUTION, CLOSING AND EFFECTIVENESS

 

5.1                                Execution; Closing .

 

(a)           The transactions contemplated by this Agreement shall be consummated at a closing (the “ Closing ”) to occur by electronic transmission of signature pages on such date as may be mutually agreed by Strongbridge and Taro (the “ Closing Date ”).  The Closing shall be deemed to occur at 12:01 a.m. ET on the Closing Date.

 

(b)           Taro and Strongbridge will file or cause to be filed with the FDA, as soon as practicable after the Closing Date, the notices (substantially in the form of Schedule 5.1(b)  attached hereto), required to be filed by it in connection with its transfer of the NDA and acceptance of the NDA, IND and Orphan Designation.

 

17



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

5.2          Further Assurances .  Taro and Strongbridge agree that at any time or from time to time after the Closing, each Party, at the request and expense of the other, shall execute and deliver to the other all such instruments and documents or further assurances as the other Party may reasonably request in order to transfer to Strongbridge all of Taro’s right, title and interest in and to the Regulatory Approval and the grant of the Trademark License and Non-Blocking License, as contemplated hereby; provided, however, that after the Closing, apart from such customary further assurances, the Taro and Strongbridge shall have no other obligations except as specifically set forth and described herein.

 

5.3          Broker Fees .  Each Party agrees that should any claim be made against the other Party for any broker’s commission or finder’s fee by reason of the acts of such Party, the Party upon whose acts such claim is adjudicated shall hold the other Party harmless from and against all liability and expense in connection therewith.

 

ARTICLE VI — REPRESENTATIONS AND WARRANTIES

 

6.1          Taro’s Representations and Warranties .  Taro represents and warrants to Strongbridge as of the Closing Date that:

 

(a)           Corporate Existence; Authorization; Non-contravention .

 

(i)            Taro is a corporation duly organized, validly existing and in good standing under the laws of the Cayman Islands.

 

(ii)           The execution, delivery and performance by Taro of this Agreement and each of the documents contemplated hereby to which the Taro is a party are within Taro’s corporate power, have been duly authorized by all necessary corporate action and do not contravene or constitute a default under any of the constitutive documents of Taro or of applicable law or regulation or of any agreement, judgment, injunction, order, decree or other instrument binding upon Taro or to which the Regulatory Approval or Product Trademark is subject.  This Agreement and each of the documents contemplated hereby to which the Taro is a party is a legal, valid and binding agreement of Taro enforceable against Taro in accordance with its terms.

 

(iii)          Except for the requirement that both Strongbridge and Taro provide written notice to the FDA, in the forms attached hereto as Schedule 5.1(b)  of the transfer of the NDA from Taro to Strongbridge, the execution, delivery and performance by Taro of this Agreement, and the consummation by Taro of the transactions contemplated hereby, require no action by or in respect of, or filing with, any governmental body, agency or official or any other consent of any person, firm or other entity.

 

(b)           Product Rights, the NDA and License Grants .

 

(i)            The NDA has been approved by the FDA with respect to the marketing of the Product in the United States, and as of the Closing Date, remains in full force and effect.  Taro is the applicant of the NDA.  Taro owns all right, title and interest in and to the NDA and

 

18



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

the NDA is free and clear of all Liens and Encumbrances.  Taro has the right to transfer the NDA to Strongbridge in accordance with the terms of this Agreement.

 

(ii)           Taro has provided Strongbridge with a complete copy of the Regulatory Approval or will do so promptly after Closing.

 

(iii)          Taro has the right to grant to Strongbridge the rights granted under the Trademark License, and Taro has not granted prior to the Closing Date any options or licenses with respect to the Product Trademark that are inconsistent with the grants Taro has made to Strongbridge in this Agreement.

 

(iv)          To Taro’s knowledge, Taro and its Affiliates and licensees have maintained, and retained the NDA and related documentation that is required to be maintained or retained pursuant to and in accordance with Applicable Law in the Territory.

 

(c)           Litigation .  There are no pending, and to Taro’s knowledge upon reasonable investigation, threatened, private or governmental proceedings, claims, or actions in the Territory against the Taro involving the NDA, the Product or the Product Trademark.

 

(d)           Merck Agreements .  To Taro’s knowledge, Taro has not committed any breach of, and no counterparty has committed any breach of, any Merck Agreement.

 

(e)           No Consents .  Neither the execution, delivery nor performance by Taro of this Agreement and the Supply Agreement, nor the consummation by Taro of the transactions contemplated hereby or thereby, will require Taro to (i) obtain any consent or authorization of, or (ii) give any notice to, or make any filing or registration with, any Person.

 

(f)            Disclosure .  No representation or warranty by Taro in this Agreement contains any untrue statement of material fact.

 

6.2          Strongbridge’s Representations and Warranties .  Strongbridge represents and warrants as of the Execution Date and the Closing Date that:

 

(a)           Corporate Existence; Authorization; Non-contravention .

 

(i)            Strongbridge is a corporation duly organized and validly existing under the laws of Ireland.

 

(ii)           The execution, delivery and performance by Strongbridge of this Agreement and each of the documents contemplated hereby to which the Strongbridge is a party are within Strongbridge’s corporate power, have been duly approved and authorized by all necessary corporate action and do not contravene or constitute a default under the constitutive documents of Strongbridge or of applicable law or regulation or of any agreement, judgment, injunction, order, decree or other instrument binding upon Strongbridge.  This Agreement is a legal, valid and binding agreement of Strongbridge enforceable against Strongbridge in accordance with its terms.

 

19


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(iii)          Except for the requirement that both Strongbridge and Taro provide written notice to the FDA, in the forms attached hereto as Schedule 5.1(b)  of the transfer of the NDA from Taro to Strongbridge, the execution, delivery and performance by Strongbridge of this Agreement, and the consummation by Strongbridge of the transactions contemplated hereby, require no action by or in respect of, or filing with, any governmental body, agency or official or any other consent of any person, firm or other entity.

 

(b)           Disclosure .  No representation or warranty by Strongbridge in this Agreement contains any untrue statement of material fact.

 

6.3          Disclaimer of Other Warranties .  EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS AND COVENANTS CONTAINED IN THIS AGREEMENT, OR THE EXHIBITS AND SCHEDULES ATTACHED HERETO OR THERETO, NEITHER TARO NOR STRONGBRIDGE MAKES, AND EACH HEREBY EXPRESSLY DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

ARTICLE VII — INDEMNIFICATION

 

7.1          Indemnification by Taro .  Taro shall indemnify and defend Strongbridge, its Affiliates, and their respective officers, directors and employees, against any and all damage, loss, liability and expense (including, without limitation, reasonable attorneys’ fees in connection with any action, claim, suit or proceeding brought by third parties) and the cost of remedial action under applicable laws and regulations (collectively “ Claims ”) arising out of: (a) any Excluded Liabilities, (b) any misrepresentation or breach of covenant, agreement, representation or warranty of Taro contained in this Agreement (collectively, the “ Taro Rep Claim ”), and (c) any and all acts and omissions of Taro and its Affiliates, sublicensees or assignees, and their respective officers, directors, employees and agents after the Closing Date, whether or not such acts are negligent, unlawful or otherwise wrongful in any manner, in connection with Taro’s or its assignees’ or sublicensees’ Commercialization of the Product outside the Territory, provided, however, that Strongbridge shall not be entitled to any indemnification for any Taro Rep Claim unless and until the amount of claims for which Strongbridge is entitled to be indemnified exceeds in the aggregate $75,000.  Except with respect to the representations and warranties set forth in Sections 6.1(b)(i) and 6.1(b)(iii) (for which Taro’s indemnification obligations shall extend indefinitely), the indemnification obligation for any Taro Rep Claim shall expire on the first anniversary of the Closing Date.

 

7.2          Indemnification by Strongbridge .  Strongbridge shall indemnify and defend Taro and its Affiliates, and their respective officers, directors and employees, against any Claims arising out of: (a) any and all acts and omissions of Strongbridge and its Affiliates and their respective officers, directors, employees and agents after the Closing Date, whether or not such acts are negligent, unlawful or otherwise wrongful in any manner, in connection with Strongbridge’s or its Permitted Assignee’s and permitted sublicensees’ Commercialization of the Product or a Lifecycle Product, (b) use of the Marketing Materials by Strongbridge, its Permitted Assignee and permitted sublicensees, (c) Assumed Liabilities, and (d) any misrepresentation or breach of

 

20



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

covenant, agreement, representation or warranty of Strongbridge contained in this Agreement (collectively, the “ Strongbridge Rep Claim ”), provided, however, that Taro shall not be entitled to any indemnification for any Strongbridge Rep Claim unless and until the amount of claims for which Taro is entitled to be indemnified exceeds in the aggregate $75,000.  The indemnification obligation for any Strongbridge Rep Claim shall expire on the first anniversary of the Closing Date.

 

7.3          Indemnification; Notice and Settlements .  A Party seeking indemnification pursuant to Section 7.1 or 7.2 (an “ Indemnified Party ”) shall give prompt notice to the Party from whom such indemnification is sought (the “ Indemnifying Party ”) of the assertion of any claim, or the commencement of any action or proceeding, in respect of which indemnity may be sought hereunder.  The Indemnifying Party shall have the right to, and shall at the request of the Indemnified Party, assume the defense, with counsel reasonably satisfactory to the Indemnified Party, of any such suit, action or proceeding at its own expense; provided that the Indemnifying Party shall not have the right to assume control of such defense and shall pay the fees and expenses of counsel retained by the Indemnified Party, if the claim which the Indemnifying Party seeks to assume control (i) seeks non-monetary relief (except where non-monetary relief is merely incidental to a primary claim or claims for monetary damages), (ii) constitutes criminal allegations against the Indemnified Party, (iii) is one in which the Indemnifying Party is also a party and joint representation would be inappropriate or there may be legal defenses available to the Indemnified Party which are different from or additional to those available to the Indemnifying Party, or (iv) involves a claim which, upon petition by the Indemnified Party, the appropriate court rules that the Indemnifying Party failed or is failing to vigorously prosecute or defend.  If the Indemnifying Party assumes the defense of such Third Party Claim, the Indemnified Party shall have the right to employ separate counsel and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of the Indemnified Party unless the employment thereof has been specifically authorized by the Indemnifying Party in writing.  If the Indemnifying Party shall control the defense of any claim, the Indemnifying Party shall obtain the prior written consent of the Indemnified Party (which shall not be unreasonably withheld) before entering into any settlement of a claim or ceasing to defend such claim, if pursuant to or as a result of such settlement or cessation, injunction, or other equitable relief will be imposed against the Indemnified Party, if such settlement or cessation does not expressly unconditionally release the Indemnified Party from all liabilities and obligations with respect to such claim, or if such settlement or cessation requires a payment by the Indemnified Party.  In addition, an Indemnifying Party shall not be liable under Section 7.1 or 7.2 for any settlement effected without its consent of any claim, litigation or proceeding in respect of which indemnity may be sought hereunder, which consent shall not be unreasonably withheld.]

 

ARTICLE VIII — MISCELLANEOUS

 

8.1          Notices .  Notices required or permitted under this Agreement shall be in writing and sent by prepaid registered or certified air mail or by overnight express mail (e.g., FedEx), or by electronic mail confirmed by electronic mail (including an electronic “read receipt” notice), or by tele-facsimile confirmed by a written act of the receiving Party (e.g., a telefacsimile from the receiving Party submitting its receipt of such notice) and shall be deemed to have been properly

 

21



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

served to the addressee (A) upon delivery in the case of prepaid registered or certified air mail or by overnight express mail, or (B) upon receipt of written confirmation in the case of electronic mail or telefacsimile, to the following addresses of the Parties or such other address(es) as such Party may hereafter specify by written notice to the other Party in accordance herewith:

 

If to Strongbridge:

 

Strongbridge Biopharma plc (registered office)

Arthur Cox Building

Earlsfort Terrace

Dublin 2, Ireland

 

With a copy to:

 

Strongbridge Biopharma plc (registered office)

900 Northbrook Drive

Suite 200

Trevose, Pennsylvania 19053

 

If to Taro:

 

Taro Pharmaceuticals North America, Inc.

Harbour Place

103 South Church Street

Grand Cayman KY1-1202

Cayman Islands

Attention:  General Manager

 

With a copy to:

 

Taro Pharmaceuticals USA, Inc.

3 Skyline Drive

Hawthorne, NY 10532

Attention:  General Counsel

 

8.2          Expenses .  All legal and other costs and expenses incurred in connection herewith and the transactions contemplated hereby, whether or not the transactions contemplated are consummated, shall (except as otherwise provided herein) be paid by the Party incurring such expenses; provided that all transfer taxes in connection with the purchase of the Regulatory Approval and the grant of the Trademark License and Non-Blocking License shall be borne by Strongbridge.

 

8.3          Termination; Survival .

 

(a)           This Agreement shall terminate upon: (i) the termination of the Supply Agreement or (ii) Taro’s exercise of its Reversion Right in accordance with Section 4.6.  In either case, if Strongbridge is not continuing to Commercialize the Product or Lifecycle Product

 

22



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

after the termination date, Strongbridge shall promptly assign and transfer the Purchased Assets back to Taro; the Trademark License and Product Trademark shall terminate; and Strongbridge, its Permitted Assignee and permitted sublicensees shall immediately cease all Commercialization of the Product and Lifecycle Product in the Territory.  If Strongbridge is continuing to Commercialize the Product after termination, Sections 2.3, 2.4, 3.1(c), 4.7 shall survive.

 

(b)           Sections 3.4, 7.1, 7.2, and 7.3 shall survive termination of this Agreement.

 

8.4          Section 365(n) of the Bankruptcy Code .  All rights and licenses granted under or pursuant to this Agreement by Taro to Strongbridge are, for all purposes of 11 U.S.C. Section 365(n), licenses of rights to intellectual property as defined in Title 11.  Strongbridge may elect to retain and may fully exercise all of its rights and elections under 11 U.S.C. Section 365(n).

 

8.5          Bulk Sales Statutes .  Strongbridge hereby waives compliance by Taro with any applicable bulk sales statutes in any jurisdiction in connection with the transactions under this Agreement.

 

8.6          Successors and Assigns .  Except as provided in Section 4.4, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party; provided, however, that (a) Taro may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the subject matter of this Agreement, or in the event of its merger or consolidation or change in control or similar transaction.  Any attempted assignment not in accordance with this Sections 4.4 and 8.6 shall be void.  Any Permitted Assignee shall assume all assigned obligations of its assignor under this Agreement.

 

8.7          Entire Agreement; Amendment .

 

(a)           Taro and Strongbridge are parties to that certain Confidentiality Agreement (“ CDA ”) dated July 13, 2016, the terms of which are hereby incorporated into this Agreement and made an integral part hereof.  This Agreement, including, without limitation, the CDA and the Schedules hereto, embodies the entire agreement of the Parties with respect to the sale of Regulatory Approval and Domain Names and the grant of rights of the Trademark License and the Non-Blocking License and supersedes any and all prior agreements with respect thereto.

 

(b)           No waiver, amendment or modification of any provision hereof or of any right or remedy hereunder shall be effective unless in writing and signed by an authorized representative of the Party against whom such waiver, amendment or modification is sought to be enforced.

 

8.8          Public Announcement .  Subject to Section 8.9, the Seller and Buyer shall agree on the content of any press release(s), public announcement(s) or other information publicly released by the Parties relating to this Agreement and the Supply Agreement.

 

8.9          Filing Requirements .  If the execution of or the activities or obligations under this Agreement were to trigger or otherwise instigate a reporting, filing or other disclosure obligation on a Party (or any of its Affiliates) pursuant to Applicable Law, such Party shall notify the other

 

23



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Party as promptly as practicable of such obligation, and provide whatever reasonable opportunity may be available for the other Party to comment on a draft version of any such disclosure. Subject to the foregoing sentence, such Party shall have the right to make any such filing or obligated disclosure.

 

8.10        Compliance with Applicable Law .  Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Regulatory Authorities confidential or other information received from the other Party, subject to limitations on disclosures required by Applicable Law under the terms of the CDA.

 

8.11        Governing Law; Jurisdiction .  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, United States without regard to its conflicts of laws principles.  The Parties consent to the exclusive jurisdiction of the Federal courts and the State courts of the State of New York, in each case, located in the borough of Manhattan, City of New York (the “ New York Courts ) for any action in aid of arbitration, for provisional relief of the status quo or to prevent irreparable harm prior to the appointment of the Arbitrators in Section 8.12(b) , and to the non-exclusive jurisdiction of the New York Courts for any action to enter or enforce any arbitral award entered in connection with this Agreement.  THE PARTIES HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN SUCH ACTIONS.

 

8.12        Dispute Resolution .  In the event the Parties have a dispute under the terms of this Agreement or any agreement ancillary to this Agreement, the Parties will follow the following procedure, subject to the rights of either Party to pursue equitable remedies:

 

(a)           The Parties will attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between a representative appointed by Taro, and for Strongbridge, the President and CEO of Strongbridge Biopharmaceuticals plc or his/her designee.  Any person may give the other Party written notice of any dispute not resolved in the normal course of business.  Within fifteen (15) days after delivery of the notice, the receiving Party will submit to the other a written response.  The notice and response will include (i) a statement of that Party’s position and summary of arguments supporting that position, and (ii) the name and title of the executive who will represent that Party and of any other person who will accompany the executive.  After delivery of the initial notice, the executives of both Parties will meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute.  All reasonable requests for information made by one Party to the other will be honored.  All negotiations pursuant to this clause are confidential and will be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.  In the event the negotiation between the executives is not successful in resolving the dispute within thirty (30) days after the delivery of the initial notice, the dispute will be referred to arbitration as described below.

 

(b)           Except as expressly otherwise provided in this Agreement, in the event of any dispute arising out of or relating to the interpretation of any provisions of this Agreement or the failure of either Party to perform or comply with any obligation of such Party pursuant to this

 

24



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Agreement or the breach, termination or validity hereof (a “ Dispute ”), such Dispute shall be finally settled by arbitration in accordance with the commercial arbitration rules of the American Arbitration Association (“ AAA ”), then in force and the Federal Arbitration Act, 9 U.S.C. § 1 et seq., by three (3) arbitrators (the “ Arbitrators ”) appointed in accordance with said rules, provided that the appointed arbitrators shall have appropriate experience in the pharmaceutical industry.  The place of arbitration shall be New York, New York, and the Arbitrators shall decide the dispute in accordance with the substantive law of the State of New York.  The Arbitrators, by accepting their appointment, undertake to conduct the process such that the award shall be rendered within six (6) months of their appointment and shall be final and binding upon all parties participating in such arbitration.  The judgment rendered by the Arbitrators may, at the arbitrator’s discretion, include costs of arbitration, reasonable attorneys’ fees and reasonable costs for any expert and other witnesses.  Judgment upon the award may be entered in any court having jurisdiction, or application may be made to such court for judicial acceptance of the award and/or an order of enforcement as the case may be.  Notwithstanding the foregoing, any Disputes regarding the scope, validity, enforceability or inventorship of any patents or patent applications shall be submitted for final resolution by a court of competent jurisdiction.  Any period of limitations or Survival Period that would otherwise expire between the initiation of the procedures described in this Section 8.12(b)  and the conclusion of such procedures shall be extended until twenty (20) days following the conclusion of such procedures.  This Section 8.12(b)  shall not prohibit a Party from seeking preliminary injunctive relief in aid of arbitration from a court of competent jurisdiction.

 

8.13        Language .  This Agreement, and any amendments or modifications thereto, shall be executed in the English language.  No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto.

 

8.14        Article Headings .  The Article headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement.

 

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

 

8.16        Waiver .  The waiver by either Party of a breach or a default of any provision of this Agreement by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision, nor shall any delay or omission on the part of either Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such Party.

 

8.17        Modification .  No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties by their respective officers thereunto duly authorized.

 

8.18        Severability .  If any part of this Agreement is declared invalid by any legally governing authority having jurisdiction over either Party, then such declaration shall not affect the

 

25



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

remainder of the Agreement and the Parties shall revise the invalidated part in a manner that will render such provision valid without impairing the Parties’ original intent.

 

8.19        Counterparts .  This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute but one and the same instrument.

 

8.20        No Third Party Beneficiaries .  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party.

 

26



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Asset Purchase Agreement to be executed as of the Closing Date by their duly authorized representatives.

 

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

 

 

 

 

By:

/s/ Paul Woodhouse

 

 

 

 

Name:

Paul Woodhouse

 

 

 

 

Title:

Vice President, General Manager

 

 

 

 

 

STRONGBRIDGE BIOPHARMA PLC

 

 

 

 

 

By:

/s/ Matthew Pauls

 

 

 

 

Name:

Matthew Pauls

 

 

 

 

Title:

President and CEO

 

27


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 1(a)

 

MARKETING MATERIALS

 

Taro Project List

 

Job #

 

Name

2015

 

 

TRO-N15-002

 

Clinical Digital Landscape

TRO-N15-004

 

Keveyis Positioning

TRO-N15-005

 

Keveyis Logo & Branding

TRO-N15-006

 

Keveyis Support Services Logo & Branding

TRO-N15-008

 

Keveyis Day 1 Messages

TRO-N15-009

 

Support Services Messages

TRO-N15-010

 

Disease Branding

TRO-N15-013

 

Disease Messaging

TRO-N15-014

 

Day 1 Website

TRO-N15-015

 

Day 1 Support Services Brochure

TRO-N15-016

 

Day 1 HCP Product Sell Sheet

TRO-N15-017

 

Now Available HCP Email

TRO-N15-018

 

Now Available Patient Email

TRO-N15-024

 

Day 1 Support Services Enrollment Form

TRO-N15-026

 

Keveyis PPT Template

TRO-N15-028

 

Keveyis Now Available Site

TRO-N15-029

 

AANEM Conference

TRO-N15-030

 

PP Infographic

TRO-N15-032

 

HCP Swipey iPad Sell Sheet

TRO-N15-033

 

Patient Letters

TRO-N15-034

 

Keveyis Patient Stories

TRO-N15-035

 

AANEM Conference Email

TRO-N15-036

 

Tawil Reprint

 

28



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Job #

 

Name

TRO-N15-038

 

Keveyis PAP Application Form

TRO-N15-039

 

Patient K2C Communications

TRO-N15-040

 

Disease Positioning

TRO-N15-041

 

Taro SEM

TRO-N15-042

 

AANEM Infographic

TRO-N15-043

 

PPA Conference Tabletop Display

TRO-N15-044

 

PPA Conference Keveyis FAQ Sheet

TRO-N15-045

 

Keveyis Creative Concept

TRO-N15-046

 

Brand Planning

TRO-N15-047

 

Taro Disease Website

TRO-N15-048

 

Keveyis Patient Email #3

TRO-N15-049

 

Keveyis HCP Email #3

TRO-N15-051

 

Keveyis Quick Hit Sales Aid

TRO-N15-053

 

Taro Rep Buisness Card Holder Leave Behind

TRO-N15-054

 

Digital Detail Aid

2016

 

 

TRO-N16-003

 

AAN Conference Booth

TRO-N16-005

 

Taro RM Campaign

TRO-N16-006

 

Periodic Paralysis Patient Disease Concept

TRO-N16-007

 

Periodic Paralysis Champions Campaign

TRO-N16-008

 

Doctor Discussion Guide

TRO-N16-010

 

Disease Booth Handout

TRO-N16-012

 

Driver Strategy

TRO-N16-013

 

AAN Pre & Post Show Emails

TRO-N16-014

 

Keveyis.com 1.5 Planning

TRO-N16-015

 

Keveyis RX PAF Insert

TRO-N16-016

 

Unbranded Patient Emails

TRO-N16-017

 

Patient Product Brochure

TRO-N16-018

 

PP Disease UX Expansion

 

29



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 1(b)

 

PRODUCT TRADEMARK

 

Country

 

Name

 

Status

 

Application
Number

 

Filing Date

 

Registration
Number

 

Registration
Date

 

Expiration
Date

 

US

 

KEVEYIS

 

Active

 

86/724,075

 

Aug 13, 2015

 

5,034,655

 

Sept 6, 2016

 

Sept 6, 2026

 

 

Owner: Taro Pharmaceuticals U.S.A., Inc.

 

30



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 2.1(a)(ii)

 

Domain Names

 

 

keveyis.com

 

keveyis.net

 

keveyis.us

 

keveyiskeys2care.com

 

31



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 4.3

 

MARKETING COMMITMENT

 

 

 

2017

 

2018

 

2019

 

2020

 

2021

 

2022

 

Strongbridge SG&A Target *

 

$

[****]

 

$

[****]

 

$

[****]

 

$

[****]

 

$

[****]

 

$

[****]

 

 


* in millions of US dollars and as measured by GAAP accounting on Strongbridge’s Financial statements

 

32


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA NDA LETTER

 

December   , 2016

 

Attention: Cathleen Michaloski, BSN, MPH, RAC

Sr. Regulatory Project Manager

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

Re:

NDA #011366 Keveyis ®  (dichlorphenamide tablets USP) 50 mg

 

GENERAL CORRESPONDENCE-Transfer of NDA Ownership

 

Dear Sir/Madam

 

Reference is made to the NDA 011366 Keveyis ® (dichlorphenamide tablets USP) 50 mg.  Taro Pharmaceuticals North America (“Taro”) hereby submits a General Correspondence-Transfer of NDA ownership to notify that we have transferred ownership of this application from Taro to a new sponsor:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200, Trevose, PA 19053

Attn: Susan Thornton

e-mail: s.thornton@strongbridgebio.com

Phone: 484-589-0395

 

Effective December XX, 2016, all rights and responsibilities regarding NDA 011366 are transferred to Strongbridge US Inc. (“ Strongbridge ”). Strongbridge will concurrently notify the Agency of its acceptance of ownership of the designation under separate cover. A complete copy of the NDA 011366, including IND (#127873), has been provided to Strongbridge for their files.

 

If there are any questions, or if additional information is required, please contact me at XXX-XXX-XXXX.

 

Sincerely,

 

33



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA NDA LETTER

 

December   , 2016

 

Billy Dunn, M.D.

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

Re:

NDA #011366 Keveyis ®  (dichlorphenamide tablets USP) 50 mg

 

Transfer of NDA Ownership

 

Dear Dr. Dunn,

 

Pursuant to 21 CFR §314.72 Strongbridge US Inc., hereby notifies the FDA of a change in ownership of NDA 011366 Keveyis ® .  As indicated in correspondence dated XXXX, from Taro Pharmaceuticals North America (“Taro”) (copy enclosed), all rights to NDA 011366 Keveyis ®  (dichlorphenamide tablets USP) 50 mg have been transferred from Taro to Strongbridge, effective December   , 2016 with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the NDA 011366, including supplements, and records that are required to be kept under 21 CFR 314.81. In addition, Strongbridge reserves the right to request a copy of the application from FDA’s files under the fee schedule in 20.45 of FDA’s public information regulations.Strongbridge hereby commits to the agreements, promises, and conditions made by the former owner and contained in the application.

 

Provided herein is a new form FDA 356h signed by the Strongbridge agent of record .

 

With the next NDA annual report, Strongbridge will provide any changes in the drug product’s label or labeling and file the appropriate drug listing for any change in the product NDC.

 

34



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

If there are any questions, or if additional information is required, please contact me at 484-589-0395.

 

Sincerely,

 

Susan Thornton

Vice President, Regulatory Affairs and Acting Head of Quality

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395/Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

CC: Cathleen Michaloski, BSN, MPH, RAC, Sr. Regulatory Project Manager

 

35



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

ORPHAN DESIGNATION ACCEPTANCE LETTER

 

December    , 2016

 

Gayatri R. Rao, MD., JD.

Director, Office of Orphan Products Development

Food and Drug Administration

WO32-5271

10903 New Hampshire Avenue

Silver Spring, MD 200993-002

 

RE:

Designation #10-3142

 

Acceptance of Ownership

 

Dear Dr. Rao,

 

Reference is made to Orphan Designation #10-3142 for the treatment of Treatment of primary hyperkalemic periodic paralysis, primary hypokalemic period paralysis, and related variants  granted by the Office of Orphan Products Development on September 2, 2010 and the supplemental New Drug Application (sNDA) approved by the Division of Neurology Products of  on August 7, 2015. Further reference is made to the subsequent transfer of ownership from Taro Pharmaceuticals, see attached letter dated, to Strongbridge US Inc.

 

Effective today, December   , 2016, Strongbridge US Inc. is hereby officially accepting ownership of Orphan Designation #10-3142. All rights to develop and commercialize Orphan Designation #10-3142 are now the responsibility of, Strongbridge US Inc. with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the Orphan Designation #10-3142.

 

If you have any questions or comments, please feel free to contact me by e-mail at s.thornton@strongbridgebio.com or by phone at (484) 589-0395 [office] or (215)518-2620 [mobile].

 

Sincerely,

 

36



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Susan Thornton

Vice President, Regulatory Affairs

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395/Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

37



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Schedule 5.1(b)

 

FDA IND LETTER

 

December   , 2016

 

Billy Dunn, M.D.

Division of Neurology Products,

ODE I/ OND/CDER

Central Document Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

Re:

IND #127,873 Keveyis ®  (dichlorphenamide tablets USP) 50 mg

 

Transfer of IND Ownership

 

Dear Dr. Dunn,

 

Reference is made to Administrative IND #127,873 originally submitted on September 29, 2015 for Keveyis ®  (dichlorphenamide tablets USP) 50 mg, for the purposes of submitting the  Required Postmarketing Protocol Under 505(o).

 

Pursuant to 21 CFR §312 Strongbridge US Inc., hereby notifies the FDA of a change in ownership of IND #127,873 Keveyis ® .  As indicated in correspondence dated XXXX, from Taro Pharmaceuticals North America (“Taro”) (copy enclosed), all rights to IND127,873 Keveyis ®  (dichlorphenamide tablets USP) 50 mg have been transferred from Taro to Strongbridge, effective December   , 2016 with the following associated address:

 

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 610-254-9200

Fax: 215-355-7389

 

Provided herein is a new form FDA 1571 signed by the Strongbridge agent of record.

 

Strongbridge has made arrangements with Taro to obtain a complete copy of the IND #127,873, including amendments, and records. Strongbridge hereby commits to the agreements, promises, and conditions made by the former owner and contained in the application.

 

If there are any questions, or if additional information is required, please contact me at 484-589-0395

 

Sincerely,

 

38



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Susan Thornton

Vice President, Regulatory Affairs and Acting Head of Quality

Strongbridge US Inc.

900 Northbrook Drive, Suite 200

Trevose, PA 19053 USA

Office: 484-589-0395

Mobile: 215-518-2620

s.thornton@strongbridgebio.com

 

CC: Cathleen Michaloski, BSN, MPH, RAC, Sr. Regulatory Project Manager

 

39




Exhibit 10.4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

EXECUTION COPY

 

SUPPLY AGREEMENT

 

between

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

and

 

STRONGBRIDGE BIOPHARMACEUTICALS PLC

 

Effective as of

 

December 12, 2016

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

SUPPLY AGREEMENT

1

 

 

 

ARTICLE I. DEFINITIONS

1

1.1

Definition

1

1.2

Interpretation

6

 

 

 

ARTICLE II. PAYMENTS & REPORTING

7

2.1

Payments

7

 

 

 

ARTICLE III. MANUFACTURE AND SUPPLY

8

3.1

Manufacture and Supply

8

3.2

Ordering/Forecasting/Inventory

9

3.3

Minimum Ordering; Economic Non-Viability

10

3.4

Materials and Components

10

3.5

Use of Forms

10

3.6

Labeling

10

3.7

Delivery

11

3.8

Rejection and No Returns to Seller

11

3.9

Buyer Inspection

12

3.10

Inability to Supply

13

 

 

 

ARTICLE IV. REGULATORY AND QUALITY RESPONSIBILITIES

14

4.1

Regulatory Matters

14

4.2

Quality Agreement

14

4.3

Changes in Specifications and Process

15

4.4

Product Complaints

15

4.5

Pharmacovigilance Agreement

16

4.6

Recalls, Withdrawals, Field Alerts and Other Field Corrections

16

4.7

Regulatory Inspections

17

4.8

PDUFA

17

4.9

Stability

17

 

 

 

ARTICLE V. REPRESENTATIONS, WARRANTIES AND COVENANTS

17

5.1

Mutual Representations and Warranties

17

5.2

Product Warranty

18

5.3

No Other Representations and Warranties

18

5.4

No Reliance by Third Parties

18

 

 

 

ARTICLE VI. INTELLECTUAL PROPERTY AND CONFIDENTIAL INFORMATION

18

6.1

Ownership of Pre-Existing Intellectual Property Rights

18

 

i



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

6.2

Confidential Information, Publicity and Publication

19

6.3

Publicity

20

6.4

Filing Requirements

20

6.5

Compliance with Applicable Law

21

 

 

 

ARTICLE VII. TERM AND TERMINATION

21

7.1

Term

21

7.2

Termination

21

7.3

Effect of Termination

22

 

 

 

ARTICLE VIII. INDEMNIFICATION, INSURANCE AND DISPUTE RESOLUTION

23

8.1

Indemnification

23

8.2

Dispute Resolution

26

8.3

Limitation of Liability

27

8.4

Insurance

27

 

 

 

ARTICLE IX. MISCELLANEOUS

28

9.1

Assignment

28

9.2

Counterparts

28

9.3

Force Majeure

28

9.4

Further Assurances

28

9.5

Modification

28

9.6

Independent Contractors

28

9.7

Governing Law; Jurisdiction

28

9.8

Language

29

9.9

Article Headings

29

9.10

Notices

29

9.11

Third Parties

30

9.12

Waiver

30

9.13

Severability

30

9.14

Entire Agreement

30

9.15

Conflict

30

9.16

Drafting Ambiguities

30

9.17

International Sale of Goods Act

31

 

ii



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

TABLE OF SCHEDULES AND EXHIBITS

 

SCHEDULE 2.1(a)

 

TRANSFER PRICE

 

 

 

SCHEDULE 3.1

 

PRODUCT SUPPLY DETAILS

 

 

 

SCHEDULE 3.3

 

DELIVERY SCHEDULE FOR MINIMUM ORDER QUANTITIES

 

 

 

SCHEDULE 3.6

 

PROCEDURE FOR LABELING CHANGE

 

 

 

EXHIBIT A

 

QUALITY AGREEMENT

 

 

 

EXHIBIT B

 

PHARMACOVIGILANCE AGREEMENT

 

iii



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

SUPPLY AGREEMENT

 

This Supply Agreement dated as of December 12, 2016 (the “ Effective Date ”), is by and between Taro Pharmaceuticals North America, Inc. a company organized under the laws of the country of Cayman Islands with a place of business at Harbour Place, 103 South Church Street, Grand Cayman KY1-1202, Cayman Islands (“ Seller ”) and Strongbridge Biopharmaceuticals plc , a company organized under the laws of Ireland, having its Company’s registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland and having its principal U.S. place of business at 900 Northbrook Drive, Suite 200, Trevose, PA 19053 (“ Buyer ”).  Buyer and Seller are sometimes collectively referred to herein as the “ Parties ” and separately as a “ Party .”

 

WHEREAS , Seller has developed the Product (defined below);

 

WHEREAS , Seller has secured the Regulatory Approval required in order to promote, market and sell the Product in the United States as a treatment for patients suffering from periodic paralysis;

 

WHEREAS , Seller and Buyer are parties to that certain Asset Purchase Agreement, dated December 12, 2016 (the “ APA ”) pursuant to which Buyer acquired the Product NDA and obtained the exclusive right to market, distribute and sell the Product in the Territory (defined below) under the Trademark (as defined in the APA);  and

 

WHEREAS , the Parties agree to enter into this Supply Agreement to govern the purchase and sale of the Product from Seller (or its Affiliate) to Buyer (or its Affiliate) for marketing, distribution and sale in the Territory.

 

NOW, THEREFORE , in consideration of the mutual covenants, agreements and stipulations set forth herein, the receipt and legal sufficiency of which are hereby mutually acknowledged, the Parties hereby agree as follows.

 

ARTICLE I.
 DEFINITIONS

 

1.1          Definition .  As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

AAA ” has the meaning set forth in Section 8.2(b).

 

Adverse Finding ” has the meaning set forth in Section 4.1(c).

 

Affiliate ” means any Person that controls, is controlled by, or is under common control with a Party.  For purposes of this definition, “control” means: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) entitled to vote for the election of directors or otherwise having the power to vote on or direct the affairs of such Party; and (b) in the case of non-corporate entities,

 

1



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities.  With respect to Taro, Affiliate means the following entities:  Taro Pharmaceutical Industries Ltd., Taro International Ltd., Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Laboratories, Inc., Taro Pharmaceuticals Inc., Taro Pharmaceuticals Canada, Ltd., Taro Pharmaceuticals North America, Inc., Taro Pharmaceuticals Europe B.V., Taro Pharmaceuticals (UK) Limited, Taro Pharmaceuticals Ireland Limited, and Taro Hungary KFT, provided that any entity that, after the Effective Date is newly under the control of Taro Pharmaceutical Industries Ltd. or any of the foregoing entities shall be an Affiliate of Taro for purposes of this definition.

 

Agreement ” means this Supply Agreement including all exhibits, schedules and appendices attached hereto.

 

APA ” has the meaning set forth in the Preamble.

 

API ” means the active pharmaceutical ingredient dichlorphenamide, USP.

 

Applicable Law ” means all applicable local, state, national, regional or international statute, law, ordinance, rule, treaty, regulation, common law or other legal requirement, including provisions of all statutes (including the Federal Food, Drug and Cosmetic Act), laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, guidance documents (including FDA guidance documents), injunctions, awards, judgments, and permits and licenses of or from governmental authorities, and the rules of any applicable securities exchange.

 

Arbitrators ” has the meaning set forth in Section 8.2(b).

 

Business Day ” means any day other than a day which is a Saturday, a Sunday or federal bank or federal government holiday in the United States.

 

Buyer ” has the meaning set forth in the Preamble.

 

Buyer Claim ” has the meaning set forth in Section 8.1(a).

 

Buyer Losses ” has the meaning set forth in Section 8.1(a).

 

Buyer Party ” has the meaning set forth in Section 8.1(a).

 

Buyer Specification Change ” has the meaning set forth in Section 4.3(a)(i).

 

cGMP ” means the then-current good manufacturing practices of the FDA, as set forth in 21 C.F.R. Parts 210 and 211 and all applicable rules, regulations, guides and guidances.

 

Claim ” has the meaning set forth in Section 8.1(d)(i).

 

Commercially Reasonable Efforts ” with respect to any activity means the efforts and resources that would be used in the performance of the relevant activity in compliance with applicable Law by a Person (engaged in the manufacture and supply or commercialization of

 

2



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

pharmaceutical products, as applicable) of comparable size and resources as the applicable Party with regard to a product at a similar stage in its product life taking into account the following factors to the extent reasonable and relevant: issues of safety and efficacy, product profile, market potential, competitive market conditions, duration of exclusivity or other proprietary position of the product and the potential profitability and economic return of the product, all as measured by the facts and circumstances at the time such efforts are due.  Where this Agreement requires a Party to use Commercially Reasonable Efforts, such efforts and resources that are used by such Party’s Affiliates, agents, sublicensees and licensees, as relevant, shall also be attributed to such Party.

 

Confidential Information ” means (a) any and all information or material that, at any time before or after the date hereof, has been or is provided or communicated to the Recipient by or on behalf of the Disclosing Party pursuant to this Agreement or in connection with the transactions contemplated hereby or any discussions or negotiations with respect to this Agreement; (b) any and all confidential information regarding, related to, or associated with the Product that is disclosed by the Disclosing Party to the Recipient.  Provided, however, that Confidential Information shall not include information which: (i) at the time of disclosure is in the public domain, (ii) after disclosure becomes part of the public domain, except through breach of this Agreement by the Receiving Party, (iii) the Recipient can demonstrate by reasonable proof was in its possession prior to the time of disclosure by the Disclosing Party hereunder, and was not acquired directly or indirectly from the Disclosing Party, (iv) becomes available to Recipient on a non-confidential basis from a Third Party who did not acquire such information directly or indirectly from the Disclosing Party and who is not otherwise prohibited from disclosing such information, or (v) is independently developed by the Recipient without reference to Confidential Information disclosed by the Disclosing Party.

 

Contract Year ” means each successive period of twelve (12) months commencing on April 1 and ending on March 31, provided that the portion of the Term that is prior to April 1, 2017 shall be included in Contract Year 2017 for purposes of Minimum Order Quantities.

 

Disclosing Party ” has the meaning set forth in Section 6.2(b).

 

Dispute ” has the meaning set forth in Section 8.2(b).

 

DMF ” means Taro’s Drug Master File number 26664.

 

Effective Date ” has the meaning set forth in the Preamble.

 

Extension Term ” has the meaning set forth in Section 7.1

 

Facility ” means Seller’s Affiliate’s manufacturing facility located at 14 Hakitor Street, Haifa Bay 2624761, Israel.

 

FDA ” means the United States Food and Drug Administration, or any successor agency thereto.

 

FDC Act ” means the United States Federal Food, Drug, and Cosmetic Act, enacted in 1938 as Public Law 75-717, as such may have been amended, and which is contained in Title

 

3



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

21 of the U.S. Code, Section 301 et seq., as amended, and the regulations promulgated thereunder from time to time.

 

Firm Zone ” has the meaning set forth in Section 3.2(b).

 

Force Majeure ” has the meaning set forth in Section 9.3.

 

Forecast ” has the meaning set forth in Section 3.2(a)

 

Generic Product ” means a pharmaceutical product that is therapeutically equivalent to the Product where “therapeutically equivalent” means, with respect to a Product, a drug product that (a) is approved under 21 U.S.C. 355(j) or 21 U.S.C. 355(b)(2) (or any respective successor law),  (b) is rated by the FDA to be therapeutically equivalent to such Product, and (c) is legally substitutable for such Product at the pharmacy under Applicable Law.

 

Initial Term ” has the meaning set forth in Section 7.1.

 

Label or Labeling ” means, with respect to finished goods Product, means all labels and other written, printed, or graphic matter (i) on the Product containers or wrappers, or (ii) accompanying the Product, provided, however, Label shall not include any embossing or other markings directly on the Product tablet.

 

Latent Defect ” means any failure of a Product to meet Specifications or otherwise comply with cGMP that either (i) existed at the time of acceptance but was not discovered at such time or (ii) arose as a result of any condition existing before the expiration of the shelf life of the Product, by no fault of Buyer or its Affiliates, sublicensees, distributors, wholesalers or its or their customers.

 

Lifecycle Product ” means a pharmaceutical product containing the API that is a natural evolution or line extension of the Product and is developed by or on behalf of Strongbridge for commercialization in the Territory.

 

Losses ” means any costs, losses, liabilities, damages, lawsuits, deficiencies, claims, fines, penalties, interest and expenses (including reasonable fees and disbursements of attorneys), in all cases subject to any applicable exclusions of damages and limitations on liability hereunder.

 

Manufacture ” or “ Manufacturing ” means the activities ordinarily undertaken by a manufacturer of an active pharmaceutical ingredient or finished good pharmaceutical product to manufacture such active pharmaceutical ingredient or finished good product, including the planning, purchasing, manufacture, processing, compounding, storage, filling, testing, sample retention, stability testing, labelling, packaging and release of the Products .

 

Minimum Order Quantities ” has the meaning set forth in Section 3.3.

 

NDA ” means a New Drug Application as defined in the U.S. Federal Food, Drug, and Cosmetic Act and all applicable regulations promulgated thereunder.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

NDC ” means the National Drug Code, which is the ten digit code, including the labeler code, product code and package code, with respect to a pharmaceutical product registered by a company with the FDA in accordance with Applicable Law.

 

New York Courts ” has the meaning set forth in Section 9.7.

 

Orange Book ” means the then-current edition of FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any then current supplement to such publication, as referred to in 21 C.F.R. §314.3.

 

Party ” or “ Parties ” has the meaning set forth in the Preamble.

 

Person ” means any natural person, corporation, unincorporated organization, partnership, association, joint stock company, joint venture, limited liability company, trust or government, or any agency or political subdivision of any government, or any other entity.

 

Pharmacovigilance Agreement ” has the meaning set forth in Section 4.5.

 

Prime Rate ” means the rate of interest that Citibank N.A. lists as its prime lending rate in effect on the due date of the applicable payment, or if such rate is not available, the prime lending rate listed in the New York City, United States version of The Wall Street Journal in effect on the due date of the applicable payment.

 

Product ” means the following finished products Manufactured for sale in the Territory: KEVEYIS® (dichlorophenamide) 50 mg tablets in labeled final packaging in accordance with the Specifications.

 

Product Action ” has the meaning set forth in Section 4.6.

 

Product Claims ” means Third Parties’ actual or threatened demands or causes of action related to Product that seek monetary or equitable relief for injuries or deaths to the extent caused by the failure of Seller to deliver Products under this Agreement that meet Specifications.

 

Product NDA ” means New Drug Application No. 011366, including all amendments and supplements thereto for Keveyis® (dichlorphenamide) 50 mg tablets.

 

Purchase Order ” has the meaning set forth in Section 3.2(c).

 

Quality Agreement ” has the meaning set forth in Section 4.2.

 

Recipient ” has the meaning set forth in Section 6.2(b).

 

Regulatory Approval ” means, with respect to the Product, all approvals, product and/or establishment licenses, registrations or authorizations of any Regulatory Authority including, without limitation, approval of any NDA, necessary for the manufacturing, use, storage, import, transport and sale of the Product.

 

5


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Regulatory Audit Materials ” has the meaning set forth in Section 4.7.

 

Regulatory Authority ” means any federal, national, state or local regulatory agency, department, bureau or other governmental entity, including the FDA, with authority over the Manufacture or commercialization (including approval of Regulatory Approvals) of the Product in the Territory.

 

Remediation Plan ” ha the meaning set forth in Section 3.10(b).

 

Seller ” has the meaning set forth in the Preamble.

 

Seller Claim ” has the meaning set forth in Section 8.1(b).

 

Seller Losses ” has the meaning set forth in Section 8.1(b).

 

Seller Party ” has the meaning set forth in Section 8.1(b).

 

SKU ” means particular form and package size of Product unless the Parties agree otherwise in writing.

 

Specifications ” means the specifications with respect to the Product as set forth in the NDA.

 

Supply Price ” has the meaning set forth in Section 2.1(a).

 

Term ” means collectively, the Initial Term and the Extension Term(s) (if any).

 

Territory ” means the United States of America and its territories and possessions.

 

Third Party ” means any Person other than Buyer or Seller, or an Affiliate of either of them.

 

Third Party Complaints ” has the meaning set forth in Section 4.4.

 

Units of Product ” means a bottle of Product containing one hundred (100) tablets.

 

1.2          Interpretation .

 

(a)           Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitation” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”);

 

(b)           Capitalized terms used but not otherwise defined in this Agreement shall be governed by the meaning set forth in the APA;

 

(c)           All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

 

6



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(d)           Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

 

(e)           The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recital, Exhibits and Schedules shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided , that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

 

(f)            The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

 

(g)           Unless otherwise provided, all references to Sections and Schedules in this Agreement are to Sections and Schedules of and to this Agreement;

 

(h)           Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 9.10; and

 

(i)            Wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another.

 

ARTICLE II.
 PAYMENTS & REPORTING

 

2.1          Payments .

 

(a)           Supply Price .  The per unit supply price for the Product to be purchased by Buyer from Seller pursuant to the terms of this Agreement is set forth on Schedule 2.1(a)  (as such price may be adjusted in accordance with Schedule 2.1(a) .  Upon the first sale in the Territory of a Generic Product, the supply price as set forth on Schedule 2.1(a)  shall be reduced to fifty percent (50%) of the amount set forth on such Schedule.

 

(b)           Late Payments .  Any payment due Seller from Buyer that is past due under this Agreement shall bear interest at a rate equal to the lesser of (i) Prime Rate plus two percent (2%) per year, or (ii) the maximum rate permitted by Applicable Law, calculated based on the number of days that the payment is delinquent.

 

(c)           Method of Payment .  Buyer shall make payments to Seller of all undisputed amounts owed to Buyer not later than forty-five (45) days after Seller’s receipt of an invoice therefor, in lawful money of the United States by electronic transfer to an account designated by Seller, or by such other means as may be agreed in advance by both Parties.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(d)           Taxes .

 

(i)            Seller shall be responsible for and shall pay all taxes payable on any Seller income or any payments by Buyer to Seller.  Buyer shall be responsible for and shall pay all taxes payable on any Buyer income.  Buyer and Seller shall bear sole responsibility for payment of compensation to their respective personnel, employees or subcontractors and for all employment taxes and withholding with respect to such compensation pursuant to Applicable Law.

 

(ii)           Buyer shall have the right to withhold taxes in the event that the income tax law in any country requires the withholding of taxes on amounts paid hereunder to Seller.  Any tax, duty or other levy paid or required to be withheld by Buyer on account of Supply Price or other payments payable to Seller under this Agreement shall be deducted from the amount of Supply Price or other payments due Seller.  Buyer shall secure and promptly send to Seller proof of such taxes, duties or other levies withheld and paid by Buyer or its Affiliates for the benefit of Seller.  Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

 

(iii)          Seller shall indemnify and hold Buyer fully harmless from any amounts conclusively determined to be owed to any taxing or other governmental authority as a result of any finding that the payments under this Agreement are not properly treated as a supply or transfer price for the Product sold hereunder.  If Buyer is assessed tax in respect of the foregoing, Seller shall have the right (but not the obligation to assume the defense of Buyer and represent Buyer, at Seller’s cost, before the taxing authority.  Failure by Buyer to provide notice to Seller with fifteen (15) days of such tax assessment shall relieve Seller of any responsibility to indemnify Buyer under this Section 2.1(d)(iii) but solely to the extent of any prejudice to Taro arising from such failure.

 

ARTICLE III.
 MANUFACTURE AND SUPPLY

 

3.1          Manufacture and Supply .

 

(a)           During the Term and subject to the terms and conditions of this Agreement, Seller agrees to manufacture and supply (or have manufactured and supplied) to Buyer the Minimum Order Quantities (defined below) and the quantities ordered by Buyer pursuant to Purchase Orders accepted by Seller in accordance with Section 3.2.  Buyer agrees to exclusively purchase from Seller, the Product for sale in the Territory.  Seller shall not move the Manufacturing operations of the API or Product finished goods from the Facility without twelve (12) months’ prior written notice to Buyer.

 

(b)           The Product shall be manufactured and supplied in accordance with the terms of this Agreement, the Quality Agreement and Applicable Law.

 

(c)           In the event that Buyer obtains Regulatory Approval for any Lifecycle Product, Buyer agrees to offer Seller the first right to negotiate the terms for the manufacture and supply of such Lifecycle Product.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

3.2          Ordering/Forecasting/Inventory .

 

(a)           During the Term, Buyer shall provide to Seller a rolling good faith projection for the next succeeding twenty-four (24) month (or such shorter period remaining under the term of this Agreement) (the “ Forecast ”) of the monthly quantities of the Product that Buyer intends to purchase during such 24-month period.  Buyer shall provide such projections to Seller on or before the first day of each month during the Term.  Such projections shall be consistent with the Minimum Order Quantities set forth in Section 3.3(a).

 

(b)           The volume requirements for the Product for each of the first six (6) months of each Forecast will be a binding commitment to purchase the specified quantities of Products (such six-month period shall be referred to herein as the “ Firm Zone ”).  In the event Buyer does not provide an updated monthly Forecast by the first day of each month, Seller may at its discretion include the first month of the previous non-binding Forecast as part of next Firm Zone.  The Product quantities specified for months seven (7) through twenty-four (24) of each Forecast shall be non-binding estimates of Product requirements.

 

(c)           Buyer shall deliver to Seller a purchase order not less than one hundred twenty (120) days prior to the requested delivery date for the Product (“ Purchase Order ”).  Each Purchase Order shall specify the quantities of Product requested, the delivery date and the destination for delivery of the Product.  The Purchase Order may be delivered electronically or by other means to such Person or location as Seller shall designate.  Seller shall accept all Purchase Orders that comply with the provisions of this Agreement and shall confirm each Purchase Order in writing within ten (10) Business Days of receipt and after such confirmation. Seller shall meet Buyer’s requirements and deliver the Product according to such Purchase Order, provided that it shall not be considered a breach of this Agreement if Seller delivers the Product up to fifteen (15) days following the delivery date specified on the relevant Purchase Order so long as Seller uses Commercially Reasonable Efforts to deliver the Product by the relevant delivery date specified in the Purchase Order.  Seller may at its discretion accept changes to any Purchase Order submitted by Buyer.  Purchase Order quantities delivered by Seller may vary by plus or minus (±) ten percent (10%) from the quantities ordered.  Such variances shall not constitute a breach of contract by Seller, provided that Buyer shall only be obligated to pay for the amount of invoiced Product actually received.  The last Purchase Order issued must be received no later than one hundred twenty (120) days prior to the expiration or termination of the Term.

 

(d)           Should a Purchase Order call for quantities of Product in excess of one hundred and twenty percent (120%) of the immediately preceding estimated requirements previously provided to Seller in the Forecast, Seller will use its Commercially Reasonable Efforts, but shall not be obligated, to supply any portion of the excess quantities requested by Buyer.

 

(e)           Buyer shall promptly reimburse Seller for its direct costs and associated expenses, which costs and expenses shall be evidenced by written documentation, that arise from any cancelled or materially modified Purchase Order that has been consented to by Seller.  Seller shall use Commercially Reasonable Efforts to mitigate such costs and expenses upon learning of a cancelled or modified Purchase Order.

 

9



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

3.3          Minimum Ordering; Economic Non-Viability .

 

(a)           Buyer agrees to purchase the minimum Units of Product per Contract Year, according to the following schedule (the “ Minimum Order Quantities ”):

 

(i)            Contract Year 2017:  [****] Units of Product

 

(ii)           Contract Year 2018:  [****] Units of Product

 

(iii)          Contract Year 2019:  [****] Units of Product

 

(iv)          Contract Year 2020:  [****] Units of Product

 

(v)           Contract Year 2021:  [****] Units of Product

 

(vi)          Contract Year 2022:  [****] Units of Product

 

(b)           Upon the first sale in the Territory of a Generic Product, the Minimum Order Quantities set forth above shall be reduced to fifty percent (50%) of the amounts set forth above.

 

(c)           If, in accordance with the time periods set forth in Section 7.2(b), the gross profit less the cost of goods for the Units of Product that is difference between the Minimum Order Quantities and the actual quantities of Units of Product dispensed by Buyer is less than [****] Dollars ($[****]), Buyer shall promptly notify Seller.  The Parties shall promptly meet and discuss in good faith the projection made by Buyer; provided however, that Seller shall not be obligated to modify the Minimum Order Quantities.  In the event that the Parties are unable to reach a decision within twenty (20) Business Days of its meeting to discuss the projection made by Buyer, either Party may terminate this Agreement pursuant to Section 7.2(b).

 

3.4          Materials and Components .  Buyer shall reimburse Seller for its reasonable out of pocket costs for materials or components if Seller is unable to use the materials or components ordered to meet Buyer’s Firm Zone requirements due to Buyer’s (i) cancelled Purchase Orders; or (ii) failure to meet Firm Zone purchase requirements or (iii) changes in packaging or Labeling requested by Buyer, in each case where Seller is unable to use such materials and components in supplying a future Purchase Order.

 

3.5          Use of Forms .  In ordering and delivering Product, as the case may be, Seller and Buyer may use their respective standard forms and documents in ordering and delivering the Product, provided that nothing in those forms or documents shall be construed to modify or amend the terms and conditions of this Agreement, and, in the case of any conflict herewith, the terms and conditions of this Agreement shall control.

 

3.6          Labeling .  The process for determining the initial Product labelling and the process for changing Product labelling (including any artwork changes) is set forth on Schedule 3.6.

 

10



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

3.7          Delivery.

 

(a)           Subject to Section 3.2(c), Seller shall deliver to Buyer the Product ordered under a Purchase Order by the delivery date specified in the Purchase Order.  The Minimum Order Quantities shall be delivered in accordance to the schedule set forth on Schedule 3.3 .  Nothing herein shall be construed as limiting the Parties’ ability to mutually agree in writing to any adjustment to a delivery date without any modification to a then outstanding Purchase Order or Forecast.  Seller (or its Affiliate) shall provide an invoice, batch record, certificate of analysis and certificate of conformance to Buyer for each lot of Product shipped in accordance with the Quality Agreement to Buyer.

 

(b)           Delivery of Product ordered hereunder from Seller (or its Affiliate) to Buyer shall be FCA Seller’s facility in Cranbury Twp., NJ (Incoterms 2010), whereby Seller will load Product onto the transport vehicle of Buyer’s designated carrier and Buyer shall bear all risk of loss or damage, and costs of insurance and shipping associated with the Product once such Product is loaded and tendered to Buyer’s designated carrier (or its agents or representatives) at such Seller facility.

 

(c)           Title to and risk of loss of Product shall automatically transfer to Buyer when Seller loads the shipment onto Buyer’s designated carrier’s transport vehicle and Buyer shall bear all risk of loss associated with the Product thereafter.  Seller will store Product in accordance with the Quality Agreement in one of its facilities.  Seller will send Buyer electronic copies of the batch records, certificates of analysis and certificate of conformance relating to the Product on or before the date of delivery.

 

3.8          Rejection and No Returns to Seller .

 

(a)           Within thirty (30) days of receipt of any Product supplied under this Agreement, Buyer may perform a visual inspection with reasonable care to determine whether the Product meets the Specifications and in accordance with the Quality Agreement and the requirements of this Agreement or is otherwise obviously damaged.  Buyer shall either refuse acceptance of any portion of the Product that fails to meet Specifications or is otherwise obviously damaged within thirty (30) days of receipt or, with respect to a Latent Defect that is not discoverable upon a reasonable visual inspection, revoke acceptance within thirty (30) days of discovery of the Latent Defect using Commercially Reasonable Efforts or otherwise.  Otherwise, the shipment will be deemed accepted by Buyer.

 

(b)           If Buyer wishes to refuse or revoke acceptance, Buyer shall within such applicable thirty (30) day time period, inform Seller in writing of its refusal to accept or revocation of acceptance of the shipment, and the reasons therefore.  Such report shall be provided as a noncompliance report (NCR) to the Seller that includes the quality inspection report upon receipt and reasons for refusal based upon scientific evidence.  In the event that Buyer refuses or revokes acceptance, Seller, upon confirmation of the reasons for refusal or revocation of the Product shall replace the defective Product.  Provided that Seller is able to do so, Seller’s replacement of the defective Product shall be Buyer’s sole and exclusive remedy against Seller for delivery of non-conforming Product, except that Buyer shall also retain its rights of reimbursement for recall expenses as provided for under and subject to the terms of

 

11



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Section 4.6(c).  In the event that four consecutive batches of Product manufactured hereunder fail to meet Specifications, Seller shall promptly notify Buyer of such failure, and either Party shall have a right to notify the other Party so as to require the Parties to engage in the process set forth in Section 3.10, and such notice shall constitute the notice required under Section 3.10(a).  Following completion of the process set forth in Section 3.10, provided that Seller is able to replace the defective Product in compliance with a Remediation Plan as may be agreed between the Parties in accordance therewith, Seller shall not be deemed to be in material breach of this Agreement.

 

(c)           If the Parties do not agree on the refusal or rejection of Product, then either Party may refer the matter for final review to an independent Third Party of national reputation, reasonably acceptable to both Parties, for the sole purpose of determining whether or not the Product conforms to Specifications and was properly rejected or refused.  Any determination by such Third Party shall be binding upon both Parties.  The cost of any such review and evaluation by an independent Third Party shall be borne by Buyer if it is determined that the Product conforms to the requirements of this Agreement, and by Seller if it is determined that it does not.  Seller shall, as promptly as is reasonably possible, either make replacement delivery of conforming Product, with the Party responsible for the defect bearing the reasonable expenses associated therewith.  Buyer shall return to Seller any non-conforming Product and reasonable destruction costs shall be borne by the Party responsible for the defect.  The procedure set forth in this subsection (c) shall be the sole and exclusive procedure by which replacement shall be made of non-conforming Product.

 

(d)           Except as set forth in this Section 3.8 with respect to initial inspection of Product and with respect to latent defects, all sales of Products from Seller to Buyer shall be deemed final and non-returnable to Seller, and Buyer shall be responsible for and shall process any and all aspects of its customer returns of Product to Buyer.  For the avoidance of doubt, if Buyer elects to have Seller replace any revoked or rejected Product, then the Parties acknowledge and agree that Seller shall have a commercially reasonable period of time in which to cure the defect resulting in the revocation or rejection; provided, however, that such cure period shall not exceed one hundred and twenty (120) days unless otherwise agreed by the Parties prior to the expiration of such 120-day cure period.

 

3.9          Buyer Inspection .  Buyer shall have the right, not more than once biennially (or more than once biennially if Buyer has a commercially reasonable basis to believe there is cause, which cause shall be specifically related to, or would reasonably be expected to have a material adverse impact on, the Product delivered pursuant to this Agreement), and upon providing Seller with thirty (30) days advance written notice, to inspect Seller’s Facility (provided that Seller shall permit such inspection as promptly as practicable, and in no event later than five (5) days following written notice from Buyer, in the event that such inspection is for cause), on a confidential basis and during normal business hours, for the sole purposes of ensuring such Facility is in compliance with applicable cGMP and Applicable Law, solely relating to the manufacture and storage of the Product.  Buyer’s inspection rights under this Section shall not extend to any portions of the Facility, documents, records or other information which do not directly relate to the manufacture and supply of the Product under this Agreement.  Further, Buyer’s inspection rights under this Section shall be limited in duration to no more than one (1) Business Days for API-related inspections and independently two (2) Business Days for

 

12



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

finished-goods-related inspections, and shall be limited to no more than two (2) Buyer inspectors at any one time.  Inspection by Buyer or documentation provided to Buyer related to any of Seller’s suppliers or subcontractors related to the manufacturing and storage of Product is subject to consent of such Seller supplier or subcontractor.  Seller will use Commercially Reasonable Efforts to obtain such consent.

 

3.10        Inability to Supply .

 

(a)           Seller shall notify Buyer promptly upon becoming aware of an event of Force Majeure or any other event that would render Seller unable to supply the quantity of conforming Product to Buyer that Seller is required to supply pursuant to a confirmed Purchase Order or the Minimum Order Quantities.  Promptly following such notice, Seller shall prepare a plan to address any deficiencies or cause(s) of such inability to supply (including timelines therefor) and provide a draft of the plan to Buyer.

 

(b)           Promptly following receipt thereof, Buyer shall review such plan and provide comments thereto, or shall notify Seller that it has no such comments (in which case the plan shall be deemed to have been agreed between the Parties for purposes of the immediately following sentence).  The Parties promptly thereafter shall discuss Buyer’s comments, if any, and negotiate, acting reasonably, to attempt to agree on a remediation plan (any such plan agreed between the Parties, a “ Remediation Plan ”).

 

(c)           If the Parties are unable to agree on a Remediation Plan, either Party may, upon twenty (20) days’ written notice to the other Party, submit the disagreement to a Third Party expert mutually agreeable to the Parties and having at least fifteen (15) years’ experience as a senior executive in the pharmaceutical industry with oversight responsibility for manufacturing operations for oral dosage pharmaceutical products.  On the last day of the foregoing twenty (20) day notice period, each Party shall submit a version of a plan (or if such Party believes no plan would reasonably solve the inability to supply, a detailed explanation of the reasons for such belief) to such expert along with explanation as a to why it rejects the other Party’s proposal.  Not later than thirty (30) days following submission of proposals by the Parties, the expert shall adopt one of the two proposals submitted by the Parties or determine that neither proposal is reasonably likely to resolve the inability to supply issue, and shall have no ability to alter either proposal.  If one Party’s proposal prevails (either as a plan chosen by the expert or if such proposal is that no plan would reasonably resolve the inability to supply and the expert does not adopt the other Party’s plan), then the non-prevailing Party shall pay the fees and expenses of the expert (and otherwise such fees shall be shared equally by the Parties).  If the expert adopts a remediation plan submitted by a Party, such plan shall become the Remediation Plan and be deemed agreed by the Parties.  The expert’s determination shall be final and binding on the Parties.

 

(d)           Provided that a Remediation Plan is agreed by the Parties, the Seller is able to remedy a supply failure materially in compliance such Remediation Plan (including the timelines therein), Seller shall not be deemed to be in material breach of this Agreement.  If despite Seller’s effort, Seller determines that it is unable to remedy the supply failure, Seller shall notify Buyer and either Party may terminate this Agreement pursuant to Section 7.2(f).

 

13


 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

ARTICLE IV.
 REGULATORY AND QUALITY RESPONSIBILITIES

 

4.1          Regulatory Matters.

 

(a)           Seller shall obtain and maintain all Regulatory Approvals and other permits and licenses that are necessary for Seller to Manufacture the Product for sale to Buyer in accordance with the terms of this Agreement and Applicable Law.

 

(b)           Buyer shall be responsible during the Term to obtain and maintain all Regulatory Approval necessary to market, distribute and sell the Product in the Territory in accordance with Applicable Law.  Buyer agrees to distribute and sell any Product Manufactured and supplied pursuant to a Purchase Order under this Agreement using only a Buyer (or its Affiliate’s) NDC number.  As appropriate, Seller or Seller’s designated supplier shall be listed as the manufacturer on the Label for the Product.  Buyer shall be solely responsible for communications and filings with and submissions to any regulatory agency concerning sales of Product, prices, discounts, rebates, fees, charge-backs, and other payments associated with Buyer’s distribution and sale of the Product.

 

(c)           During the Term, Seller shall within five (5) Business Days after Seller’s receipt thereof (or within two (2) Business Days in the case of a notice that would reasonably result in an obligation of Buyer to report a significant safety issue to the FDA), inform Buyer of any adverse manufacturing notice to Seller that has a negative impact on the manufacture of the Product, including any FDA Form 483 Warning Letter, consent decree, or other regulatory action that directly impacts the Product (each, an “ Adverse Finding” ).  So long as Seller is taking all reasonable measures to correct and address an Adverse Finding, it shall not be deemed to be in material breach of this Agreement.  Buyer shall be responsible for any required reporting of matters regarding the manufacture, integrity, and conformance to specifications of Product to the FDA in accordance with Applicable Law.

 

(d)           Seller shall be responsible for handling and responding to any FDA or other governmental agency inspections relating to the Facility and Buyer shall be responsible for handling and responding to any FDA or other governmental agency inspection with respect to the Product supplied to Buyer pursuant to this Agreement.  Seller shall, within two (2) Business Days, provide to Buyer any information reasonably requested by Buyer and all information requested by any governmental agency in connection with any governmental inspection, redacted as needed, related to the Product supplied to Buyer hereunder (subject to any confidentiality or privilege restrictions or obligations to which Seller is subject).

 

4.2          Quality Agreement .  The Parties agree to enter into a quality agreement within ninety (90) days of the Effective Date (but in any event, prior to delivery of the Product to Buyer under Buyer’s NDC number) which sets forth (a) the roles and responsibilities of Buyer and Seller with respect to quality system regulations for the Product as required under Applicable Laws, and (b) how the Parties shall interact with each other in connection with same (the “Quality Agreement”), a copy of which shall be attached hereto as Exhibit A when executed by the Parties.

 

14



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

4.3          Changes in Specifications and Process.

 

(a)           A change in the Specifications shall only be made in accordance with this Section 4.3 and the Quality Agreement unless otherwise required by Applicable Law.

 

(i)            In the event Buyer desires any change to the Specification, Buyer shall deliver a written request (a “ Buyer Specification Change ”) to Seller specifying such requested change.  Seller shall evaluate such Buyer Specification Change promptly after Seller’s receipt thereof.  Seller shall have the obligation to accept and implement any Buyer Specification Change unless in its reasonable judgment, after reasonable consultation with Buyer, Seller determines that such Buyer Specification Change is not technically feasible.  If any such proposed change to the Specification requires additional capital expenditure or other expenditures by Seller, Seller shall notify Buyer in writing of the applicable additional capital expenditures, and the Buyer Specification Change shall not be deemed accepted until Buyer has consented in writing to reimburse Seller for the same.  Prior to shipment of any Product Manufactured under the new Specifications, Buyer shall be obligated to purchase any inventory of in-process and Product Manufactured under the unmodified Specifications held by Seller on behalf of Buyer as a result of the binding portions of any Forecast which in-process inventory and Product have been rendered obsolete by such new Specifications.

 

(ii)           In the event that Seller desires any change to the Specification that is not required by Applicable Law or Regulatory Authority, Seller shall deliver a written request (a “ Seller Specification Change ”) to Buyer specifying such requested change.  Buyer shall evaluate such Seller Specification Change promptly after Buyer’s receipt thereof.  Buyer may accept or deny any Seller Specification Change in its reasonable discretion, including with respect to any allocation of costs therefor, which shall be agreed between the Parties prior to any such acceptance.  If Buyer agrees to the Seller Specification Change and the Specifications are changed based on it, Buyer shall, in reasonable consultation with Seller, determine the date upon which to Manufacture the Product under the new Specifications, taking into account technical and other applicable factors.

 

(b)           Notwithstanding Section 4.3(a), if either Party becomes aware of any Applicable Law or Regulatory Authority that requires a change in the Specifications, that Party shall promptly notify the other Party, and the Parties shall cooperate in a timely manner in connection with any modifications of the Specifications required to meet those requirements.  Any costs associated with a change in Specifications required by Applicable Law or any Regulatory Authority or due to a Third Party supplier’s inability to provide a given material shall be borne by Buyer pro-rata to the unit proportion of Products or components thereof Manufactured for Buyer during the prior twelve (12) month period relative to the units of any other components or products manufactured for Seller or any other licensee or customer of Seller during such period and to which such modifications apply.

 

4.4          Product Complaints .  Each Party shall, within two (2) Business Days after receipt, or in the case of a complaint that would not reasonably result in an obligation of a Party to report a significant safety issue to the FDA, not longer than five (5) Business Days after receipt, provide the other Party with written notice via facsimile or email of all Third Party complaints it receives that relate to, or arise from, the Product (“Third Party Complaints”).

 

15



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Notwithstanding the foregoing, each Party shall use its Commercially Reasonable Efforts to within one (1) Business Day after receipt of notice of a Third Party Complaint provide the other Party with written notice via facsimile or email of all reports of complaints of tampering or contamination that relate to, or arise from, Product.  Seller will investigate all Third Party Complaints associated with the Manufacture of the Product and provide a written summary to Buyer.  Buyer will investigate all other Third Party Complaints associated with the transportation, storage, distribution, sale and use of Product and provide a written summary to Seller.  The Parties will reasonably cooperate with each other concerning the investigation of the Third Party Complaints, including testing of Product and review of documents, and will provide such information as reasonably requested by the other Party in connection with such investigations; provided however, that neither Party shall have any obligation to provide its Confidential Information to the other Party unless required by Applicable Law.  The Parties shall collaborate in developing procedures for providing information on the Third Party Complaints and inquiries and such procedures will be outlined in the Quality Agreement and/or Pharmacoviligance Agreement.  Nothing in this Section 4.4 shall affect the Parties’ obligations with respect to pharmacovigilance reporting, as detailed in the Pharmacoviligance Agreement.

 

4.5          Pharmacovigilance Agreement .  The Parties agree to enter into a pharmacovigilance agreement within forty-five (45) days of the Effective Date which sets forth the pharmacovigilance responsibilities of each Party (the “Pharmacovigilance Agreement”) a copy of which shall be attached hereto as Exhibit B when executed by the Parties.  These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange of adverse experience reports, pregnancy reports, and any other information concerning the safety of the Product.  Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill their obligations under, Applicable Law and reporting obligations to the Regulatory Authorities.

 

4.6          Recalls, Withdrawals, Field Alerts and Other Field Corrections.

 

(a)           Each Party shall promptly, within two (2) Business Days, provide to the other Party any information obtained by it suggesting that a recall, field alert, product withdrawal, or other field action relating to the Product in the Territory (“ Product Action ”) is or may be necessary.  Further, the Parties shall cooperate with each other in obtaining any additional information that may bear upon whether to initiate a Product Action.  The final decision regarding whether to initiate a Product Action shall rest with Buyer.

 

(b)           Buyer shall provide Seller with prompt notice of any determination by Buyer to initiate a Product Action (provided, Buyer will use its Commercially Reasonable Efforts to provide Seller with such determination within twenty-four (24) hours after such determination is made).  Seller shall provide reasonable cooperation to Buyer in implementing such Product Action.

 

(c)           The reasonable costs of any Product Action (including the reasonable costs of notifying customers, the reasonable costs associated with shipment of the Product from Buyer’s customers, reasonable credits extended to Buyer’s (and its Affiliates) customers as a result of the Product Action, and other reasonable costs incurred) shall be borne by Buyer;

 

16



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

provided, however, Seller shall be responsible for all such reasonable costs associated with a Product Action to the extent resulting from any Seller’s failure to deliver Product that meets the Specifications.

 

4.7          Regulatory Inspections .  Seller shall inform Buyer of any FDA or other Regulatory Authority inspection of the Facility within the same Business Day that an authorized agent of any Regulatory Authority notifies Seller that it intends to or does visit the Facility.  Seller shall, within twenty-four (24) hours after receipt by Seller, provide copies to Buyer of all inspection observation reports and other regulatory communications directly related to, or that would have a material adverse effect on the Product, including any Adverse Findings.  Seller shall also provide copies of Seller’s proposed responses to such inspection observation reports and other regulatory communications within three (3) Business Days of their completion (the inspection observation reports, other regulatory communications and Seller’s response are referred to collectively as “Regulatory Audit Materials”).  Buyer will be allowed to review and comment on the Regulatory Audit Materials which directly relate to Product or its manufacture.  For clarity, Seller reserves the right to redact information in such Regulatory Audit Materials that are not directly related to the Manufacture of the Product supplied hereunder.

 

4.8          PDUFA .  Buyer shall be responsible for the Facility fees associated with the Manufacture of the Product supplied hereunder on a pro rata basis, taking into account other products to which such fees are attributed and any part of a year that is not part of the Term.  Such fees for FDA fiscal year 2017 are as follows:  (a) four hundred twenty six thousand eight hundred thirty three dollars and thirty three cents ($426,833.33) for 2017 Establishment Fee; and (b) eighty-one thousand four hundred fifty eight dollars and thirty three cents ($81,458.33) for 2017 Product Fee.

 

4.9          Stability . Seller agrees to continue stability testing for the Product in accordance with the protocol in place as of the Effective Date and shall provide to Strongbridge the data and reports from this stability testing necessary to support filing of extensions for the retest period for API and shelf life for drug product as promptly as practicable following finalization thereof.

 

ARTICLE V.
 REPRESENTATIONS, WARRANTIES AND COVENANTS

 

5.1          Mutual Representations and Warranties .  Each of the Parties hereby represents, warrants and covenants to the other Party as of the Effective Date as follows:

 

(a)           It is an entity duly organized, validly existing and is in good standing under the laws of its jurisdictions of formation, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.

 

(b)           The execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action and do not and will not (i) require any consent or approval of its stockholders, (ii) violate any provision of any Applicable Law or any provision of its certificate of incorporation, by-laws or other founding document, or (iii) result in a breach of or constitute a default under any material agreement, mortgage, lease, license,

 

17



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

permit or other instrument or obligation to which it is a party or by which it or its properties may be bound or affected.

 

(c)           It (and its Affiliates) are not currently debarred, suspended or otherwise excluded by any government agency from receiving government contracts in the Territory, nor is it, or its Affiliates or any of its employees debarred under the applicable provisions of the Food, Drug, and Cosmetic Act.

 

(d)           It is not under any obligation to any Third Party, or entity, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.

 

(e)           This Agreement is a legal, valid and binding obligation of such Party, enforceable against it in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar laws, from time to time in effect, affecting creditor’s rights generally.

 

5.2          Product Warranty .  Seller represents, warrants and covenants to Buyer the Product supplied pursuant to this Agreement at the time of delivery shall: (a) not be misbranded, mislabeled or adulterated within the meaning of the FDC Act, (b) meet the Specifications, (c) has the minimum product dating set forth on Schedule 3.1; and (d) be free from any lawful security, interest, lien or encumbrances.

 

5.3          No Other Representations and Warranties .  EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS AND COVENANTS CONTAINED IN THIS AGREEMENT OR THE EXHIBITS AND SCHEDULES ATTACHED THERETO, NEITHER BUYER NOR SELLER MAKES, AND EACH HEREBY EXPRESSLY DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED, WHETHER IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

5.4          No Reliance by Third Parties .  The representations and warranties of a Party set forth in this Agreement are intended for the sole and exclusive benefit of the other Parties hereto, and may not be relied upon by any Third Party.

 

ARTICLE VI.
 INTELLECTUAL PROPERTY AND CONFIDENTIAL INFORMATION

 

6.1          Ownership of Pre-Existing Intellectual Property Rights .  Except as expressly provided in this Agreement or the APA:

 

(a)           As between the Parties, any intellectual property rights (including patents, patent applications, know-how, trade secrets, copyrights, trade dress, housemarks and trademarks) owned by either Party and their respective Affiliates on the Effective Date shall remain solely owned by such Party (or their respective Affiliates, as applicable); and

 

18



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

(b)           neither Party shall represent or assert that it is the owner of any such intellectual property rights of the other Party (or their respective Affiliates), whether or not such rights are registered.

 

For the avoidance of doubt, the Parties agree that each of the Parties shall have no rights to use any trademark, housemark, copyright, or trade dress, of the other, except expressly provided for under this Agreement or the APA.

 

6.2          Confidential Information, Publicity and Publication .  Buyer and Seller each hereby recognize and acknowledge that the other Party’s Confidential Information constitutes valuable and confidential information.  Subject to other express provisions of this Agreement, the Parties each agree that during the Term, and for a period of five (5) years after the Term:

 

(a)           Any information owned by Buyer as a result of the operation of the APA that remains in the possession or control of Seller on or after the Effective Date shall be deemed to be Confidential Information of Buyer and to have been disclosed by Buyer as Disclosing Party to Seller as Receiving Party for purposes of this ARTICLE VI.

 

(b)           The Parties shall not disclose, directly or indirectly, in any manner whatsoever to any Third Parties any Confidential Information received from the other Party (or its Affiliates, as applicable) (the “ Disclosing Party ”) without first obtaining the written consent of the Disclosing Party, and the other Party (“ Recipient ”) shall keep confidential, all of the Disclosing Party’s Confidential Information that is disclosed to Recipient.  Recipient agrees to use the same level of care in safeguarding the Disclosing Party’s Confidential Information that Recipient uses with its own confidential information of a similar nature, but in no event less than reasonable care.  Recipient shall restrict disclosure of the Disclosing Party’s Confidential Information solely to those of its (or its Affiliate’s) employees or representatives having a need to know such Confidential Information in order to accomplish the purposes of this Agreement.  Each Party represents that its respective employees and representatives who receive the Confidential Information of the Disclosing Party are advised by such Party of the confidentiality obligations of this Agreement and shall maintain such Confidential Information in accordance with the confidentiality obligations set forth in this ARTICLE VI.

 

(c)           Recipient shall not use the Disclosing Party’s Confidential Information in any manner whatsoever other than solely in connection with the exercise of its rights and the performance of its obligations under this Agreement or the APA.

 

(d)           In the event Recipient is requested pursuant to, or required by, Applicable Law to disclose any of the Disclosing Party’s Confidential Information, it will, to the extent reasonably practicable and permitted by Applicable Law, notify the Disclosing Party promptly so that the Disclosing Party may seek a protective order or other appropriate remedy or, in the Disclosing Party’s sole discretion, waive compliance with the confidentiality provisions of this Agreement.  At the Disclosing Party’s expense, Recipient will co-operate in all reasonable respects, in connection with any reasonable actions to be taken for the foregoing purpose.  In any event, Recipient may furnish such Confidential Information as requested or required pursuant to Applicable Law (subject to any such protective order or other appropriate remedy) without liability hereunder, provided that the Recipient furnishes only that portion of the

 

19



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

Confidential Information which Recipient is advised by its counsel is legally required, and Recipient exercises reasonable efforts to obtain reliable assurances that confidential treatment will be accorded the Disclosing Party’s Confidential Information.

 

(e)           Upon the date of the expiration or termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either: (i) promptly destroy all copies of the requesting Party’s Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (ii) promptly deliver to the requesting Party, at the other Party’s expense, all copies of such Confidential Information in the possession of the other Party, provided, however, the other Party shall be permitted to retain one (1) copy of the requesting Party’s Confidential Information for the sole purpose of determining any continuing obligations hereunder.  Additionally, both Parties shall immediately cease all use of the other Party’s Confidential Information including, without limitation, removing all references to such Confidential Information from its analyses, compilations, studies or other documents unless maintenance of such documentation is required by Applicable Law.  All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in this Section 6.2.

 

(f)            Each Party represents and warrants to the other Party that it (or its respective Affiliates, as applicable) has, and shall have, all right, title, and ownership interest in and to its Confidential Information or it has, and shall have, the right to disclose its Confidential Information to the other Party.  Each Party may seek to enforce all rights and legal remedies available under this ARTICLE VI or by law, including, without limitation, injunctive relief, specific performance and other equitable remedies in the event of a breach of the provisions of this ARTICLE VI by the other Party.

 

(g)           Recipient shall cause its Affiliates to observe the terms of this ARTICLE VI hereof, and shall be responsible for any breach of its provisions by any of its Affiliates.

 

(h)           Notwithstanding the provisions of this ARTICLE VI, the Parties agree that nothing contained in this ARTICLE VI shall prevent Recipient in any way whatsoever from disclosing any of the Disclosing Party’s Confidential Information, without obtaining Disclosing Party’s prior consent, to any Affiliate of Recipient or to any Third Party for the purposes of conducting their respective rights and obligations under this Agreement, provided such Third Party has undertaken an obligation of confidentiality similar to such obligations contained in ARTICLE VI herein with respect to the Disclosing Party’s Confidential Information.

 

6.3          Publicity .  Subject to Section 6.4, the Seller and Buyer shall agree on the content of any press release(s), public announcement(s) or other information publicly released by the Parties relating to this Agreement and the APA.

 

6.4          Filing Requirements .  If the execution of or the activities or obligations under this Agreement were to trigger or otherwise instigate a reporting, filing or other disclosure obligation on a Party (or any of its Affiliates) pursuant to Applicable Law, such Party shall notify the other Party as promptly as practicable of such obligation, and provide whatever reasonable opportunity may be available for the other Party to comment on a draft version of

 

20



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

any such disclosure. Subject to the foregoing sentence, such Party shall have the right to make any such filing or obligated disclosure.

 

6.5          Compliance with Applicable Law .  Nothing in this Agreement shall be construed as preventing or in any way inhibiting either Party from complying with Applicable Law governing activities and obligations undertaken pursuant to this Agreement, in any manner which it reasonably deems appropriate, including, for example, by disclosing to Regulatory Authorities confidential or other information received from the other Party, subject to Section 6.2(d).

 

ARTICLE VII.
 TERM AND TERMINATION

 

7.1          Term .  This Agreement shall become effective as of the Effective Date and, unless sooner terminated pursuant to Section 7.2 below, shall continue in full force and effect thereafter until the termination of the Orphan Exclusivity Designation granted by the FDA under the NDA (the “ Initial Term ”) and, thereafter, shall automatically renew for additional two (2) year periods (“ Extension Term ”) on the same terms unless at least four (4) months prior to the expiration of the then current Term:  (a) a Party makes a written request to the other Party to discuss in good faith new terms for the Agreement for the Extension Term; or (b) a Party notifies the other Party in writing that it desires to terminate the Agreement.  If the Parties agree on the new terms of the Agreement for the Extension Term, this Agreement shall be amended in writing to reflect the new terms.  If the Parties do not agree on the new terms of the Agreement for the Extension Term, either Party may terminate this Agreement under this Section 7.1.

 

7.2          Termination .

 

(a)           Reversion Rights .  This Agreement shall automatically terminate upon the reversion of rights under the APA.

 

(b)           Termination for Economic Non-Viability .  Either Party shall have the right to terminate this Agreement for economic non-viability pursuant to Section 3.3(c) by providing one (1) year prior written notice to the other Party, provided that (i) in no event shall notice of such termination for economic non-viability be given prior to the first (1 st ) anniversary of the Commercial Launch (as defined in the APA).

 

(c)           Termination for Breach .  Each Party shall be entitled to terminate this Agreement by written notice to the other Party in the event that the other Party shall be in material default or breach of any of its obligations hereunder in any material respect, and shall fail to remedy any such default or breach within sixty (60) days after written notice thereof by the non-defaulting/non-breaching Party.  If such default or breach is not corrected within the foregoing sixty (60) day period, the non-breaching Party shall have the right to terminate this Agreement by giving written notice to the Party in default, provided the notice of termination is given within six (6) months of the default and prior to correction of the default.

 

(d)           Termination upon Bankruptcy .  Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for

 

21



 

CONFIDENTIAL TREATMENT REQUESTED UNDER

C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

[****] INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

 

reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed with sixty (60) days after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of creditors.

 

(e)           Termination Due to Safety or Efficacy .  This Agreement will automatically terminate upon written notice by Buyer to Seller in the event that, after  consultation with Seller to the extent practicable under the circumstances, Buyer reasonably determines that there is a safety or efficacy issue with the Product that warrants cessation of sales and marketing of the Product, including in the event that the FDA withdraws its approval of the NDA for the Product for reason of safety or efficacy, and Buyer determines to permanently withdraw the Product from the market throughout the Territory.  Any dispute with respect to any such Buyer determination shall be handled pursuant to Section 8.2.

 

(f)            Termination for Failure to Supply .  Either Party may terminate this Agreement in the event that Seller advises Buyer, pursuant to Section 3.10, that it is unable to remedy the failure to supply situation.

 

7.3          Effect of Termination .

 

(a)           If Seller chooses not to extend this Agreement pursuant to Section 7.1, Seller shall provide two (2) years of Product to Buyer based in the latest Forecast.  In addition, at Buyer’s option, Buyer may acquire the DMF from Seller for five hundred thousand dollars ($500,000) and have Seller provide technology transfer assistance to Buyer or Buyer’s designee with respect to the manufacturing process for the Product at an hourly rate to be agreed between the Parties, provided that in no event shall the number of hours for such technology transfer exceed one hundred (100) hours.  If Buyer chooses to acquire the DMF and have Seller assist with the technology transfer of the manufacturing process, Seller shall transfer such DMF to Buyer as soon as reasonably practicable and provide technology transfer assistance as reasonably requested by Buyer.

 

(b)           If this Agreement is terminated pursuant to Section 7.2(a), 7.2(b), 7.2(e) or by Seller pursuant to Section 7.2(c) or 7.2(d) or if Buyer chooses not to extend this Agreement pursuant to Section 7.1:

 

(i)            the Trademark License and Non-Blocking License shall terminate immediately and Buyer shall cooperate with Seller and take, or cause to be taken, all actions, or to do, or cause to be done, all reasonable things necessary to transfer the Regulatory Approval and Domain Names back to Seller;

 

(ii)           Buyer shall take delivery of and pay for all undelivered Product that is Manufactured pursuant to a Purchase Order, at the Price in effect at the time the Purchase Order was placed provided that Buyer shall be permitted to continue to sell such Product until inventories thereof are exhausted or three months from the date of termination, whichever is earlier; and

 

22


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(iii)          Buyer shall purchase, at Seller’s book value (as reflected in Seller’s then-current books and records), the materials which were purchased, produced or maintained by Seller in contemplation of filling Purchase Orders within the binding portion of the Forecast prior to notice of termination being given to the extent the same are obsolete or cannot reasonably be used for other products being manufactured by Seller.  Seller shall deliver all such materials to Buyer promptly upon receipt or other control thereof by Seller.

 

(c)           If this Agreement is terminated by Buyer pursuant to Section 7.2(c), 7.2(d) or 7.2(f):

 

(i)            Seller shall grant Buyer a license to its manufacturing know-how for the purpose of manufacturing the Product for sale in the Territory and a right to reference the DMF for such purpose;

 

(ii)           Buyer shall take delivery of and pay for all undelivered Product that is Manufactured pursuant to a Purchase Order, at the Price in effect at the time the Purchase Order was placed provided that Buyer shall be permitted to continue to sell such Product until inventories thereof are exhausted; and

 

(iii)          Buyer shall purchase, at Seller’s book value (as reflected in Seller’s then-current books and records), the materials which were purchased, produced or maintained by Seller in contemplation of filling Purchase Orders within the binding portion of the Forecast prior to notice of termination being given to the extent the same are obsolete or cannot reasonably be used for other products being manufactured by Seller.  Seller shall deliver all such materials to Buyer promptly upon receipt or other control thereof by Seller.

 

(d)           Upon termination of this Agreement for any reason:

 

(i)            Seller will continue to fulfill its remaining obligations pursuant to Sections 4.2 and 4.5; and

 

(ii)           All relevant records and materials in a Receiving Party’s possession or control containing Disclosing Party’s Confidential Information shall be promptly returned to the Disclosing Party.

 

(iii)          The following provisions will survive termination of this Agreement:  Section 2.1(d), Section 7.3, Article VI, Article VIII and Article IX.

 

ARTICLE VIII.
 INDEMNIFICATION, INSURANCE AND DISPUTE RESOLUTION

 

8.1          Indemnification .

 

(a)           Seller Indemnification Obligations .  Seller shall indemnify, defend and hold Buyer, its Affiliates, and its and their officers, directors, agents and employees (individually and/or collectively referred to herein as a “ Buyer Party ”) harmless from and against any and all losses, liabilities, damages, fees (including reasonable attorneys’ fees), and expenses paid or payable by Buyer or a Buyer Party to a Third Party (collectively, “ Buyer

 

23



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Losses ”) to the extent that such Buyer Losses result or arise from a claim, suit or other proceeding made or brought by a Third Party against Buyer or a Buyer Party (a “ Buyer Claim ”) based on, resulting from, or arising in connection with:

 

(i)            the breach of any material obligation, covenant, agreement, representation or warranty of Seller contained in this Agreement;

 

(ii)           any act or omission by Seller that constitutes recklessness, gross negligence, or willful misconduct on the part of Seller in connection with the performance of its obligations under this Agreement;

 

(iii)          any violation of Applicable Law by Seller in connection with the performance of Seller’s obligations under this Agreement; or

 

(iv)          any infringement or alleged infringement of any Third Party intellectual property right to the extent the claim is based on or arises out of the manufacturing process used by Seller to Manufacture the Product;

 

provided, however, that Seller shall not be obligated to indemnify or hold harmless Buyer or any Buyer Party for any Buyer Claim or Buyer Losses to the extent that such Buyer Claim or Buyer Losses fall within the scope of Buyer’s indemnification obligations in Section 8.1(b), or arise out of or are attributable to any act or omission by Buyer or any Buyer Party which constitutes recklessness, gross negligence or willful misconduct on the part of Buyer or Buyer Party.

 

(b)           Buyer Indemnification Obligations .  Buyer shall indemnify, defend and hold Seller, and its Affiliates, and its and their employees, agents, officers, and directors (individually and/or collectively referred to hereinafter as a “ Seller Party ”) harmless from and against any and all losses, liabilities, damages, fees (including reasonable attorneys’ fees) and expenses paid or payable by Seller or a Seller Party to a Third Party (collectively, “ Seller Losses ”) to the extent that such Seller Losses result or arise from a claim, suit or other proceeding made or brought by a Third Party against Seller or a Seller Party (a “ Seller Claim ”) based on, resulting from, or arising in connection with:

 

(i)            marketing, distribution and sale of the Product;

 

(ii)           the breach of any material obligation, covenant, agreement, representation or warranty of Buyer, or a Buyer Party, contained in this Agreement;

 

(iii)          any act or omission by Buyer that constitutes recklessness, gross negligence, or willful misconduct on the part of Buyer or results from any Buyer’s failure to perform its obligations under this Agreement;

 

(iv)          any violation of Applicable Law by Buyer in connection with the performance of Buyer’s obligations under this Agreement;

 

provided, however, that Buyer shall not be obligated to indemnify or hold harmless Seller or any Seller Party for any Seller Claim or Seller Losses to the extent that such Seller Claim or

 

24



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Seller Losses fall within the scope of Seller’s indemnification obligations in Section 8.1(a), or arise out of or are attributable to any act or omission by Seller or any Seller Party which constitutes recklessness, gross negligence or willful misconduct on the part of Seller or Seller Party.

 

(c)           Apportionment .  For clarity, in the event that both Parties have indemnification obligations hereunder for a particular claim or loss, the liability for such claim or loss will be allocated proportionately between the Parties in accordance with such Party’s respective fault.

 

(d)           Indemnification Procedures .

 

(i)            Each indemnified Party shall notify the indemnifying Party in writing (and in reasonable detail) of the Claim within ten (10) Business Days after receipt by such indemnified Party of notice of the Seller Claim or Buyer Claim, as the case may be, or otherwise becoming aware of the existence or threatened existence thereof (such Seller Claim or Buyer Claim being referred to as a “ Claim ”).  Failure to give such notice shall not constitute a defense, in whole or in part, to any claim by an indemnified Party hereunder except to the extent the rights of the indemnifying Party are materially prejudiced by such failure to give notice.  The Indemnifying Party shall notify the indemnified Party of its intentions as to defense of the Claim or potential Claim in writing within ten (10) Business Days after receipt of notice of the Claim.  If the indemnifying Party assumes the defense of a Claim against an indemnified Party, an indemnifying Party shall have no obligation or liability under this ARTICLE VIII as to any Claim for which settlement or compromise of such Claim or an offer of settlement or compromise of such Claim is made by an indemnified Party without the prior written consent of the indemnifying Party, which consent shall not be unreasonably withheld.

 

(ii)           The indemnifying Party shall assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such Claim (so long as it has confirmed its indemnification obligation responsibility to such indemnified Party under this Section 8.1(d) with respect to a given Claim); provided, however, that the indemnifying Party may not settle such Claim in any manner that would require payment by the indemnified Party, or would materially adversely affect the rights granted to the indemnified Party hereunder, or would materially conflict with the terms of this Agreement, or adversely affect the Product in or outside the Territory, without first obtaining the indemnified Party’s prior written consent, which consent shall not be unreasonably withheld.

 

(iii)          The indemnified Party shall reasonably cooperate with the indemnifying Party in its defense of the Claim (including, without limitation, making documents and records available for review and copying and making persons within its control available for pertinent testimony in accordance with the confidentiality provisions of ARTICLE VI, and neither Party shall be required to divulge privileged material to the other) at the indemnifying Party’s expense.  If the indemnifying Party assumes defense of the Claim, an indemnified Party may participate in, but not control, the defense of such Claim using attorneys of its choice and at its sole cost and expense, with such cost and expense not being covered by the indemnifying Party.  If an indemnifying Party does not agree to assume the defense of the Claim asserted against the indemnified Party (or does not give notice that it is assuming such

 

25



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

defense), or if the indemnifying Party assumes the defense of the Claim in accordance with Section 8.1(d) yet fails to defend or take other reasonable, timely action, in response to such Claim asserted against the indemnified Party, or in the event that either Party determines on the advice of counsel that a conflict of interest exists between the Parties necessitating separate counsel, the indemnified Party shall have the right to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such Claim; provided, however, that no Party shall have the right to settle a Claim in a manner that would adversely affect the rights granted to the other Party hereunder, or would materially conflict with this Agreement, or would require a payment by the Party, or adversely affect the Product in or outside the Territory, without the prior written consent of the Party entitled to control the defense of such Claim.

 

8.2          Dispute Resolution .  In the event the Parties have a dispute under the terms of this Agreement or any agreement ancillary to this Agreement, the Parties shall follow the following procedure, subject to the rights of either Party to pursue pre-arbitration equitable remedies consistent with Section 9.7:

 

(a)           The Parties will attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiation between a representative appointed by Seller, and for Buyer, the President and CEO of Strongbridge Biopharmaceuticals plc or his/her designee.  Any person may give the other Party written notice of any dispute not resolved in the normal course of business.  Within fifteen (15) days after delivery of the notice, the receiving Party will submit to the other a written response.  The notice and response will include (i) a statement of that Party’s position and summary of arguments supporting that position, and (ii) the name and title of the executive who will represent that Party and of any other person who will accompany the executive.  After delivery of the initial notice, the executives of both Parties will meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute.  All reasonable requests for information made by one Party to the other will be honored.  All negotiations pursuant to this clause are confidential and will be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.  In the event the negotiation between the executives is not successful in resolving the dispute within thirty (30) days after the delivery of the initial notice, the dispute shall be referred to arbitration as described below.

 

(b)           Except as expressly otherwise provided in this Agreement, all disputes arising out of or relating to the interpretation of any provisions of this Agreement or the failure of either Party to perform or comply with any obligation of such Party pursuant to this Agreement or the breach, termination or validity hereof (a “ Dispute ”), regardless whether such Dispute is based upon a claim or action in contract, warranty, negligence, strict liability or other tort, shall be finally settled by binding arbitration in accordance with the commercial arbitration rules of the American Arbitration Association (“ AAA ”), then in force and the Federal Arbitration Act, 9 U.S.C. § 1 et seq., by three (3) arbitrators (the “ Arbitrators ”).  Each Party, within thirty (30) days after the filing of the arbitration demand with the AAA, shall nominate an independent, conflict free arbitrator who shall be appointed in accordance with said rules, provided that the party-appointed arbitrators shall also have appropriate experience in the pharmaceutical industry and may or may not be part of the AAA’s National Roster of arbitrators.  No later than thirty (30) days after the disclosure of the party-appointed arbitrators,

 

26



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

said arbitrators shall meet and select a Chair from a Party-generated list of arbitrators that shall not exceed ten (10) in number and who shall be selected from the AAA National Roster.  The place of arbitration shall be New York, New York, and the Arbitrators shall decide the dispute in accordance with the substantive law of the State of New York.  The Arbitrators, by accepting their appointment, undertake to conduct the process such that the award shall be rendered within six (6) months and in no event later than nine (9) months from the date of the Preliminary Hearing that shall be held by the full arbitral panel within thirty (30) of their final appointment.  The award shall be written and reasoned and shall be final and binding upon all parties participating in such arbitration.  The judgment rendered by the Arbitrators may, at the arbitrator’s discretion, include costs of arbitration, reasonable attorneys’ fees and reasonable costs for any expert and other witnesses.  Judgment upon the award may be entered in any court having jurisdiction, or application may be made to such court for judicial acceptance of the award and/or an order of enforcement as the case may be.  Notwithstanding the foregoing, any Disputes regarding the scope, validity, enforceability or inventorship of any patents or patent applications shall be submitted for final resolution by a court of competent jurisdiction.  Any period of limitations or Survival Period that would otherwise expire between the initiation of the procedures described in this Section 8.2(b) and the conclusion of such procedures shall be extended until twenty (20) days following the conclusion of such procedures.  This Section 8.2(b) shall not prohibit a Party from seeking preliminary injunctive relief in aid of arbitration from a court of competent jurisdiction as set forth in Section 9.7.

 

8.3          Limitation of Liability .  EXCEPT AS EXPRESSLY SET FORTH IN LIABILITY ARISING FROM ARTICLE VI, OR SUCH DAMAGES OWED TO ANY THIRD PARTY AND INDEMNIFIED HEREUNDER PURSUANT TO SECTION 8.1(a) OR SECTION 8.1(b), IN NO EVENT SHALL EITHER PARTY, ITS AFFILIATES, ITS AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS BE LIABLE TO THE OTHER PARTY FOR ANY LOST PROFITS OR LOST SALE DAMAGES, ANY SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR OTHER SIMILAR DAMAGES, OR ANY PUNITIVE DAMAGES, WHETHER ARISING DIRECTLY OR INDIRECTLY OUT OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT AND REGARDLESS WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, A PRODUCT CLAIM, OR OTHERWISE ARISING OUT OF OR RELATED TO THIS AGREEMENT.

 

8.4          Insurance .  Each Party hereby represents and warrants to the other Party that during the Term and for five (5) years thereafter, it shall maintain, at its cost, adequate insurance against liability and other risks associated with its activities contemplated by this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are customary for prudent practices in the pharmaceutical industry for the activities to be conducted by it under this Agreement.  Each Party shall furnish to the other Party evidence of such insurance, upon request.

 

27



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

ARTICLE IX.
 MISCELLANEOUS

 

9.1          Assignment .  Neither this Agreement, nor any of the rights or obligations of a Party may be directly or indirectly assigned, sold, delegated or otherwise disposed of without the prior written consent of the other Parties. Notwithstanding the foregoing, either Party may assign this Agreement to an Affiliate, including any successor in interest by way of any reincorporation or other reorganization, and any Party may assign this Agreement to a successor by merger, acquisition, or sale of all or substantially all of such Party’s business assets in the field to which this Agreement relates without the consent of the other Parties, provided that in each case such assigning Party shall provide prompt notification of such assignment the other Party.

 

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

 

9.3          Force Majeure .  No liability will result from delay in performance or non-performance under this Agreement, in whole or in part, by either of the Parties to the extent that such delay or non-performance is caused by an event of Force Majeure.  “ Force Majeure ” means an event that is beyond a non-performing Party’s reasonable control, including an act of God, act of the other Party, strike, lock-out or other industrial/labor dispute, war, acts of war (whether war to be declared or not) riot, insolvency or cessation of operations of a third party supplier, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, or natural disaster.

 

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

 

9.5          Modification .  No waiver, alteration or modification of any of the provisions hereof shall be binding unless made in writing and signed by the Parties by their respective officers thereunto duly authorized.

 

9.6          Independent Contractors .  The Parties are independent contractors and this Agreement shall not constitute or give rise to an employer-employee, agency, partnership or joint venture relationship among the Parties and each Party’s performance hereunder is that of a separate, independent entity.

 

9.7          Governing Law; Jurisdiction .  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, United States without regard to its conflicts of laws principles. The Parties consent to the exclusive jurisdiction of the Federal courts and the State courts of the State of New York, in each case, located in the borough of Manhattan, City of New York (the “ New York Courts ”) for any action in aid of arbitration, for provisional relief of the status quo or to prevent irreparable harm prior to the appointment of the Arbitrators in Section 8.2(b) above, and to the non-exclusive jurisdiction of the New York Courts for any action to enter or enforce any arbitral award entered in connection with this

 

28



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Agreement.  THE PARTIES HEREBY IRREVOCABLY WAIVE, AND AGREE TO CAUSE THEIR RESPECTIVE AFFILIATES TO WAIVE, THE RIGHT TO TRIAL BY JURY IN SUCH ACTIONS.

 

9.8          Language .  This Agreement, and any amendments or modifications thereto, shall be executed in the English language.  No translation, if any, of this Agreement into any other language shall be of any force or effect in the interpretation of this Agreement or in determination of the intent of either of the Parties hereto.

 

9.9          Article Headings .  The Article headings are placed herein merely as a matter of convenience and shall not affect the construction or interpretation of any of the provisions of this Agreement.

 

9.10        Notices .  Notices required or permitted under this Agreement shall be in writing and sent by prepaid registered or certified air mail or by overnight express mail (e.g., FedEx), or by electronic mail confirmed by electronic mail (including an electronic “read receipt” notice), or by tele-facsimile confirmed by a written act of the receiving Party (e.g., a telefacsimile from the receiving Party submitting its receipt of such notice) and shall be deemed to have been properly served to the addressee (A) upon delivery in the case of prepaid registered or certified air mail or by overnight express mail, or (B) upon receipt of written confirmation in the case of electronic mail or telefacsimile, to the following addresses of the Parties:

 

If to Buyer:

 

Strongbridge Biopharma plc (registered office)

Arthur Cox Building

Earlsfort Terrace

Dublin 2, Ireland

 

With a copy to:

 

Strongbridge Biopharma plc (registered office)

900 Northbrook Drive

Suite 200

Trevose, Pennsylvania 19053

 

If to Seller:

 

Taro Pharmaceuticals North America, Inc.

Harbour Place

103 South Church Street

Grand Cayman KY1-1202

Cayman Islands

Attention:  General Manager

 

29



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

With a copy to:

 

Taro Pharmaceuticals USA, Inc.

3 Skyline Drive

Hawthorne, NY 10532

Attention:  General Counsel

 

9.11        Third Parties .  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party.

 

9.12        Waiver .  The waiver by either Party of a breach or a default of any provision of this Agreement by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision, nor shall any delay or omission on the part of either Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such Party.

 

9.13        Severability .  If any part of this Agreement is declared invalid by any legally governing authority having jurisdiction over either Party, then such declaration shall not affect the remainder of the Agreement and the Parties shall revise the invalidated part in a manner that will render such provision valid without impairing the Parties’ original intent.

 

9.14        Entire Agreement .  This Agreement and the APA (including the ancillary agreements referenced therein) constitute the entire agreement between the Parties relating to the subject matter hereof and supersedes all previous writings and understandings, whether written or oral, with respect to the subject matter hereof.

 

9.15        Conflict .  In the event of a conflict between the APA and this Agreement, the terms of the APA shall control, except that in connection with the terms relating to the manufacture of the Product by Seller, this Agreement shall control.  In the event of a conflict between this Agreement, the Quality Agreement or the Pharmacovigilance Agreement, this Agreement shall control, unless: (i) the conflict is between the Quality Agreement and this Agreement and the term at issue pertains to the quality manufacture of the Product, in such case, the Quality Agreement shall control; or (ii) the conflict is between the Pharmacovigilance Agreement and this Agreement and the term at issue pertains the exchange of safety data information relating to the Product, in such case, the Pharmacovigilance Agreement shall control.  In the event of a conflict between the Quality Agreement and the Pharmacovigilance Agreement, the Quality Agreement shall control unless the term at issue pertains to the exchange of safety data information relating to the Product, in which case, the Pharmacovigilance Agreement shall control.

 

9.16        Drafting Ambiguities .  Each Party to this Agreement and its counsel have reviewed and revised this Agreement.  The rule of construction to the effect that any ambiguities are to be resolved against the drafting Party shall not be employed in the interpretation of this Agreement or any amendment, Exhibit or Schedule to this Agreement.

 

30



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

9.17        International Sale of Goods Act .  The Parties acknowledge and agree that the International Sale of Goods Act and the United Nations Convention on Contracts for the International Sale of Goods have no application to this Agreement.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

31



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF, the Parties hereto have caused this Supply Agreement to be executed as of the Effective Date by their duly authorized representatives.

 

 

TARO PHARMACEUTICALS NORTH AMERICA, INC.

 

 

 

By:

/s/ Paul Woodhouse

 

 

 

 

Name:

Paul Woodhouse

 

 

 

 

Title:

Vice President, General Manager

 

 

 

 

 

STRONGBRIDGE BIOPHARMA PLC

 

 

 

 

 

By:

/s/ Matthew Pauls

 

 

 

 

Name:

Matthew Pauls

 

 

 

 

Title:

President and CEO

 

Supply Agreement

Signature Page

 

32


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 2.1(A)

 

TRANSFER PRICE

 

Transfer Price:  $[****] per Unit of Product.

 

The Transfer Price shall be firm for the first year of the Term. Thereafter, on an annual basis, the Transfer Price is subject to adjustment by [****] percent ([****]%).  Any such adjustment will be effective for the entire subsequent twelve (12) month period of the applicable Term.

 

33



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.1

 

PRODUCT SUPPLY DETAILS

 

Minimum Remaining Shelf Life at the time of Delivery: not less than the current approved Product shelf life less four (4) months.

 

34



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.3

 

DELIVERY SCHEDULE FOR
MINIMUM ORDER QUANTITIES

 

35



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 3.6

 

PROCEDURE FOR LABELING CHANGE

 

If Strongbridge Changing :

 

1. Taro provides files to Strongbridge to review and make DRAFT revisions

2. Taro receives artwork and Regulatory Reviews

3. Taro Regulatory responds with any further correction or revision requests depending on Strongbridge alterations

4.  If no change request, routing within Taro internal artwork system is initiated within Production, Marketing and further Regulatory

5.  If change requested, than first step is visited above and process continues through each point until agreed and approved

6.  Artwork then FTP’d and routed to vendor for print

 

If Taro Changes :

 

1. Taro graphics team seeks graphics material from Strongbridge (text or branding requirements)

2. Taro graphics team makes proper DRAFT revisions

3. Taro Regulatory Reviews for any corrections or further revision needs

4. Taro sends artwork for Strongbridge to review for comment

5.  If no change request, routing within Taro internal artwork system is initiated within Production, Marketing and further Regulatory

6.  If change request from Strongbridge, than step 2 is visited above and process continues through each point until agreed and approved

7.  Artwork then FTP’d and routed to vendor for print

 

36



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT A

 

QUALITY AGREEMENT

 

[TO BE ATTACHED]

 

37



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT B

 

PHARMACOVIGILANCE AGREEMENT

 

[TO BE ATTACHED]

 

38




Exhibit 10.5

 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

LOAN AND SECURITY AGREEMENT

 

THIS LOAN AND SECURITY AGREEMENT (as the same may from time to time be amended, modified, supplemented or restated, this “ Agreement ”) dated as of December 28, 2016 (the “ Effective Date ”) among OXFORD FINANCE LLC, a Delaware limited liability company with an office located at 133 North Fairfax Street, Alexandria, Virginia 22314 (“ Oxford ”), as collateral agent (in such capacity, “ Collateral Agent ”), the Lenders listed on Schedule 1.1 hereof or otherwise a party hereto from time to time including Oxford in its capacity as a Lender and HORIZON TECHNOLOGY FINANCE CORPORATION, a Delaware corporation with an office located at 312 Farmington Avenue, Farmington, Connecticut 06032 (“ Horizon ”) (each a “ Lender ” and collectively, the “ Lenders ”), and STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland with company number 562659 and having its registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland (“ Irish Borrower ”), CORTENDO CAYMAN LTD., an exempted company incorporated in the Cayman Islands with its registered office located at Maples Corporate Services PO Box 309 Ugland House Grand Cayman KY1-1104 (“ Cayman Borrower ”), CORTENDO AB (PUBL), a public limited company incorporated under the laws of Sweden with corporate identity number 556537-6554 and having its registered office at Box 47 433 21 Partille Gothenburg Sweden (“ Swedish Borrower ”) and STRONGBRIDGE U.S. INC., a Delaware corporation with an office located at 900 Northbrook Drive, Suite 200, Trevose, Pennsylvania 19053 (“ US Borrower ” and together with Irish Borrower, Cayman Borrower and Swedish Borrower, individually and collectively, jointly and severally, “ Borrower ”), provides the terms on which the Lenders shall lend to Borrower and Borrower shall repay the Lenders.  The parties agree as follows:

 

1.                                       ACCOUNTING AND OTHER TERMS

 

1.1                                Accounting terms not defined in this Agreement shall be construed in accordance with GAAP.  Calculations and determinations must be made in accordance with GAAP.  Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 13.  All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.  All references to “ Dollars ” or “ $ ” are United States Dollars, unless otherwise noted.

 

1.2                                In this Agreement, where it relates to Irish Borrower, a reference to the term “examiner” shall have the meaning given to it in Section 508 of the Irish Companies Act and the term “examinership” shall be construed in accordance with the Irish Companies Act.

 

2.                                       LOANS AND TERMS OF PAYMENT

 

2.1                                Promise to Pay.   Borrower hereby unconditionally promises to pay each Lender, the outstanding principal amount of all Term Loans advanced to Borrower by such Lender and accrued and unpaid interest thereon and any other amounts due hereunder as and when due in accordance with this Agreement.

 

2.2                                Term Loans.

 

(a)                                  Availability .  (i) Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, to make term loans to Borrower on the Effective Date in an aggregate amount of Twenty Million Dollars ($20,000,000.00) according to each Lender’s Term A Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly as a “ Term A Loan ”, and collectively as the “ Term A Loans ”).  After repayment, no Term A Loan may be re-borrowed.

 

(ii)                                   Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, during the Second Draw Period, to make term loans to Borrower in an aggregate amount up to Ten Million Dollars ($10,000,000.00) according to each Lender’s Term B Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly as a “ Term B Loan ”, and collectively as the “ Term B Loans ”).  After repayment, no Term B Loan may be re-borrowed.

 

(iii)                                Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, during the Third Draw Period, to make term loans to Borrower in an aggregate amount up

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

to Ten Million Dollars ($10,000,000.00) according to each Lender’s Term C Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly as a “ Term C Loan ”, and collectively as the “ Term C Loans ”; each Term A Loan, Term B Loan or Term C Loan is hereinafter referred to singly as a “ Term Loan ” and the Term A Loans, the Term B Loans and the Term C Loans are hereinafter referred to collectively as the “ Term Loans ”).  After repayment, no Term C Loan may be re-borrowed.

 

(b)                                  Repayment .  Borrower shall make monthly payments of interest only commencing on the first (1 st ) Payment Date following the Funding Date of each Term Loan, and continuing on the Payment Date of each successive month thereafter through and including the Payment Date immediately preceding the Amortization Date.  Borrower agrees to pay, on the Funding Date of each Term Loan, any initial partial monthly interest payment otherwise due for the period between the Funding Date of such Term Loan and the first Payment Date thereof.  Commencing on the Amortization Date, and continuing on the Payment Date of each month thereafter, Borrower shall make consecutive equal monthly payments of principal, together with applicable interest, in arrears, to each Lender, as calculated by Collateral Agent (which calculations shall be deemed correct absent manifest error) based upon: (1) the amount of such Lender’s Term Loan, (2) the effective rate of interest, as determined in Section 2.3(a), and (3) a repayment schedule equal to (i) thirty (30) months if Term C Loans are not made hereunder and (ii) twenty-four (24) months if Term C Loans are made hereunder.  All unpaid principal and accrued and unpaid interest with respect to each Term Loan is due and payable in full on the Maturity Date.  Each Term Loan may only be prepaid in accordance with Sections 2.2(c) and 2.2(d).

 

(c)                                   Mandatory Prepayments .  If the Term Loans are accelerated following the occurrence of an Event of Default, Borrower shall immediately pay to Lenders, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of: (i) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (ii) the Final Payment, (iii) the Prepayment Fee, plus (iv) all other Obligations that are due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. Notwithstanding (but without duplication with) the foregoing, on the Maturity Date, if the Final Payment had not previously been paid in full in connection with the prepayment of the Term Loans in full, Borrower shall pay to Collateral Agent, for payment to each Lender in accordance with its respective Pro Rata Share, the Final Payment in respect of the Term Loan(s).

 

(d)                                  Permitted Prepayment of Term Loans .  Borrower shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under this Agreement, provided Borrower (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least thirty (30) days prior to such prepayment, and (ii) pays to the Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Payment, (C) the Prepayment Fee, plus (D) all other Obligations that are due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

 

2.3                                Payment of Interest on the Credit Extensions.

 

(a)                                  Interest Rate.   Subject to Section 2.3(b), the principal amount outstanding under the Term Loans shall accrue interest at a floating per annum rate equal to the Basic Rate, determined by Collateral Agent on the Funding Date of the applicable Term Loan and monthly thereafter, which interest shall be payable monthly in arrears in accordance with Sections 2.2(b) and 2.3(e). Interest shall accrue on each Term Loan commencing on, and including, the Funding Date of such Term Loan, and shall accrue on the principal amount outstanding under such Term Loan through and including the day on which such Term Loan is paid in full.

 

(b)                                  Default Rate . Immediately upon the occurrence and during the continuance of an Event of Default, Obligations shall accrue interest at a floating per annum rate equal to the rate that is otherwise applicable thereto plus five percentage points (5.00%) (the “ Default Rate ”).  Payment or acceptance of the increased interest rate provided in this Section 2.3(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Collateral Agent.

 

(c)                                   360-Day Year .  Interest shall be computed on the basis of a three hundred sixty (360) day year, and the actual number of days elapsed.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(d)                                  Debit of Accounts .  Collateral Agent and each Lender may debit (or ACH) any deposit accounts, maintained by Borrower or any of its Subsidiaries, including the Designated Deposit Account, for principal and interest payments or any other amounts Borrower owes the Lenders under the Loan Documents when due.  Any such debits (or ACH activity) shall not constitute a set-off.

 

(e)                                   Payments .  Except as otherwise expressly provided herein, all payments by Borrower under the Loan Documents shall be made to the respective Lender to which such payments are owed, at such Lender’s office in immediately available funds on the date specified herein. Unless otherwise provided, interest is payable monthly on the Payment Date of each month.  Payments of principal and/or interest received after 12:00 noon Eastern time are considered received at the opening of business on the next Business Day.  When a payment is due on a day that is not a Business Day, the payment is due the next Business Day and additional fees or interest, as applicable, shall continue to accrue until paid. All payments to be made by Borrower hereunder or under any other Loan Document, including payments of principal and interest, and all fees, expenses, indemnities and reimbursements, shall be made without set-off, recoupment or counterclaim, in Dollars and in immediately available funds.

 

2.4                                Secured Promissory Notes.   The Term Loans shall be evidenced by a Secured Promissory Note or Notes in the form attached as Exhibit D hereto (each a “ Secured Promissory Note ”), and shall be repayable as set forth in this Agreement.  Borrower irrevocably authorizes each Lender to make or cause to be made, on or about the Funding Date of any Term Loan or at the time of receipt of any payment of principal on such Lender’s Secured Promissory Note, an appropriate notation on such Lender’s Secured Promissory Note Record reflecting the making of such Term Loan or (as the case may be) the receipt of such payment.  The outstanding amount of each Term Loan set forth on such Lender’s Secured Promissory Note Record shall be prima facie evidence of the principal amount thereof owing and unpaid to such Lender, but the failure to record, or any error in so recording, any such amount on such Lender’s Secured Promissory Note Record shall not limit or otherwise affect the obligations of Borrower under any Secured Promissory Note or any other Loan Document to make payments of principal of or interest on any Secured Promissory Note when due.  Upon receipt of an affidavit of an officer of a Lender as to the loss, theft, destruction, or mutilation of its Secured Promissory Note , Borrower shall issue, in lieu thereof, a replacement Secured Promissory Note in the same principal amount thereof and of like tenor.

 

2.5                                Fees .   Borrower shall pay to Collateral Agent:

 

(a)                                  Good Faith Deposit .  An amount of One Hundred Thousand Dollars ($100,000.00) has been received by Collateral Agent as good faith deposit from Borrower on or about November 14, 2016 and after deduction therefrom of Lenders’ Expenses incurred through the Effective Date payable pursuant to Section 2.5(e) hereof, the remaining balance, if any, shall be applied towards the facility fee due on the Effective Date.  For the purposes of clarity, Borrower shall be responsible for all Lender’s Expenses payable pursuant to Section 2.5(e) hereof.

 

(b)                                  Facility Fee .  A fully earned, non-refundable facility fee of Two Hundred Thousand Dollars ($200,000.00) to be shared between the Lenders pursuant to their respective Commitment Percentages payable on the Effective Date;

 

(c)                                   Final Payment .  The Final Payment, when due hereunder, to be shared between the Lenders in accordance with their respective Pro Rata Shares;

 

(d)                                  Prepayment Fee .  The Prepayment Fee, if and when due hereunder, to be shared between the Lenders in accordance with their respective Pro Rata Shares; and

 

(e)                                   Lenders’ Expenses .  All Lenders’ Expenses incurred through and after the Effective Date, when due.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

2.6                                Withholding.

 

(a)                                  Payments received by the Lenders from Borrower hereunder will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any governmental authority (including any interest, additions to tax or penalties applicable thereto).  Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to the Lenders, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, each Lender receives a net sum equal to the sum which it would have received had no withholding or deduction been required and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority; provided, that a Lender that shall have become a Lender pursuant to a Lender Transfer shall be entitled to receive only such additional amounts as a Lender party hereto on the Effective Date would have been entitled to receive pursuant to this Section 2.6.  Borrower will, upon request, furnish the Lenders with proof reasonably satisfactory to the Lenders indicating that Borrower has made such withholding payment; provided, however, that Borrower need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Borrower.  The agreements and obligations of Borrower contained in this Section 2.6 shall survive the termination of this Agreement.

 

(b)                                  On or prior to the date of this Agreement, each Lender shall deliver to Borrower a complete and properly executed IRS Form W-9 certifying that it is not subject to back-up withholding.  If any assignee of a Lender’s rights under Section 12.1 of this Agreement is not a “United States Person” as defined in Section 7701(a)(30) of the IRC (“ Non-U.S. Lender ”), such Non-U.S. Lender shall, upon becoming party to this Agreement, deliver to Borrower a complete and properly executed IRS Form W-8BEN, W-8BEN-E, W-8ECI or W-8IMY, as appropriate, or any successor form prescribed by the IRS, certifying that such Non-U.S. Lender is entitled to an exemption from U.S. withholding tax on interest and other amounts payable under this Agreement.

 

3.                                       CONDITIONS OF LOANS

 

3.1                                Conditions Precedent to Initial Credit Extension .   Each Lender’s obligation to make a Term A Loan is subject to the condition precedent that Collateral Agent and each Lender shall consent to or shall have received, in form and substance satisfactory to Collateral Agent and each Lender, such documents, and completion of such other matters, as Collateral Agent and each Lender may reasonably deem necessary or appropriate, including, without limitation:

 

(a)                                  Loan Documents, each duly executed by Borrower and each Subsidiary, as applicable;

 

(b)                                  duly executed Control Agreements with respect to any Collateral Accounts maintained by Borrower or any of its Subsidiaries;

 

(c)                                   duly executed original Secured Promissory Notes in favor of each Lender according to its Term A Loan Commitment Percentage;

 

(d)                                  if applicable, the certificate(s) for the Shares, together with Assignment(s) Separate from Certificate, duly executed in blank;

 

(e)                                   share pledge agreements with respect to Shares of Swedish Borrower, US Borrower and Cayman Borrower, each in such form and substance as is acceptable to Collateral Agent in its sole discretion;

 

(f)                                    duly executed notices and acknowledgments required under the Irish Security Documents;

 

(g)                                   the Operating Documents and good standing certificates (to the extent such concept or a similar concept exists under the laws of any relevant jurisdiction) of Borrower and its Subsidiaries certified by the Secretary of State (or equivalent agency) of Borrower’s and such Subsidiaries’ jurisdiction of organization or

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

formation and each jurisdiction in which Borrower and each Subsidiary is qualified to conduct business, each as of a date no earlier than thirty (30) days prior to the Effective Date;

 

(h)                                  a completed Perfection Certificate for Borrower and each of its Subsidiaries;

 

(i)                                      duly executed officer’s certificate for Irish Borrower executed by the chief financial officer of Irish Borrower, attaching the Annual Projections, for fiscal years 2017 and 2018;

 

(j)                                     duly executed Officer’s Certificate for Borrower;

 

(k)                                  certified copies, dated as of date no earlier than thirty (30) days prior to the Effective Date, of financing statement searches, as Collateral Agent shall request, accompanied by written evidence (including any UCC termination statements) that the Liens indicated in any such financing statements either constitute Permitted Liens or have been or, in connection with the initial Credit Extension, will be terminated or released;

 

(l)                                      a landlord’s consent executed in favor of Collateral Agent in respect of all of Borrower’s and each Subsidiaries’ leased locations;

 

(m)                              a bailee waiver (if applicable) executed in favor of Collateral Agent in respect of each third party bailee where Borrower or any Subsidiary maintains Collateral having a book value in excess of One Hundred Thousand Dollars ($100,000.00);

 

(n)                                  a duly executed legal opinion of counsel to US Borrower and a duly executed legal opinion of William Fry (as Irish counsel to the Collateral Agent in respect of Irish Borrower and Irish Security Documents) dated as of the Effective Date;

 

(o)                                  evidence satisfactory to Collateral Agent and the Lenders that the insurance policies required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing loss payable and/or additional insured clauses or endorsements required under Section 6.5 in favor of Collateral Agent, for the ratable benefit of the Lenders, and the Lenders; and

 

(p)                                  evidence satisfactory to Collateral Agent and the Lenders that the Keveyis Acquisition Event has occurred;

 

(q)                                  evidence satisfactory to Collateral Agent and the Lenders that the First Equity Event has occurred; and

 

(r)                                     payment of the fees and Lenders’ Expenses then due as specified in Section 2.5 hereof.

 

3.2                                Conditions Precedent to all Credit Extensions .   The obligation of each Lender to make each Credit Extension, including the initial Credit Extension, is subject to the following conditions precedent:

 

(a)                                  receipt by the Lenders of an executed Disbursement Letter in the form of Exhibit B attached hereto;

 

(b)                                  the representations and warranties in Section 5 hereof shall be true, accurate and complete in all material respects on the date of the Disbursement Letter and on the Funding Date of each Credit Extension; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension.  Each Credit Extension is Borrower’s representation and warranty on that date that the representations and warranties in Section 5 hereof are true, accurate and complete in all material respects; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date;

 

(c)                                   in such Lender’s sole discretion, there has not been any Material Adverse Change or any material adverse deviation by Borrower from the Annual Projections of Borrower presented to and accepted by Collateral Agent and each Lender;

 

(d)                                  to the extent not delivered at the Effective Date, duly executed original Secured Promissory Notes and Warrants, in number, form and content acceptable to each Lender, and in favor of each Lender according to its Commitment Percentage, with respect to each Credit Extension made by such Lender after the Effective Date; and

 

(e)                                   payment of the fees and Lenders’ Expenses then due as specified in Section 2.5 hereof.

 

3.3                                Covenant to Deliver .   Borrower agrees to deliver to Collateral Agent and the Lenders each item required to be delivered to Collateral Agent under this Agreement as a condition precedent to any Credit Extension.  Borrower expressly agrees that a Credit Extension made prior to the receipt by Collateral Agent or any Lender of any such item shall not constitute a waiver by Collateral Agent or any Lender of Borrower’s obligation to deliver such item, and any such Credit Extension in the absence of a required item shall be made in each Lender’s sole discretion.

 

3.4                                Procedures for Borrowing.   Subject to the prior satisfaction of all other applicable conditions to the making of a Term Loan set forth in this Agreement, to obtain a Term Loan, Borrower shall notify the Lenders (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 12:00 noon Eastern time three (3) Business Days prior to the date the Term Loan is to be made.  Together with any such electronic, facsimile or telephonic notification, Borrower shall deliver to the Lenders by electronic mail or facsimile a completed Disbursement Letter executed by a Responsible Officer or his or her designee.  The Lenders may rely on any telephone notice given by a person whom a Lender reasonably believes is a Responsible Officer or designee.  On the Funding Date, each Lender shall credit and/or transfer (as applicable) to the Designated Deposit Account, an amount equal to its Term Loan Commitment.

 

4.                                       CREATION OF SECURITY INTEREST

 

4.1                                Grant of Security Interest .   Borrower hereby grants Collateral Agent, for the ratable benefit of the Lenders, and each Lender, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Collateral Agent, for the ratable benefit of the Lenders, and each Lender, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof.  Borrower represents, warrants, and covenants that the security interest granted herein is and shall at all times continue to be a first priority perfected security interest in the Collateral, subject only to Permitted Liens that are permitted by the terms of this Agreement to have priority to Collateral Agent’s Lien.  If Borrower shall acquire a commercial tort claim (as defined in the Code), Borrower, shall promptly notify Collateral Agent in a writing signed by Borrower, as the case may be, of the general details thereof (and further details as may be required by Collateral Agent) and grant to Collateral Agent, for the ratable benefit of the Lenders, and each Lender, in such writing a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Collateral Agent.

 

Notwithstanding anything to the contrary in this Agreement, the Swedish Borrower is not granting any security interests in its assets or property located in Sweden on the Effective Date (other than the pledge of its Shares in US Borrower and Cayman Borrower), provided that it is affirmatively agreed that the Swedish Borrower is granting hereby a security interest in its Intellectual Property and is granting a security interest in any cash that it holds in Collateral Accounts at institutions located in the United States .  Lenders and Borrower hereby agree that the enforcement of Lenders’ security interest under this Agreement in the assets of the Swedish Borrower shall not require any enforcement order, including without limitation through a Swedish public court judgment or by the Swedish Enforcement Authority (“Enforcement Order”) and Borrower shall not object to the enforcement of Lenders’ security interest under this Agreement in the assets of the Swedish Borrower, regardless of where such assets may be located, on the basis that an Enforcement Order was not obtained.

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Without limiting the provisions of the foregoing and in furtherance thereof, Irish Borrower has entered into the Debenture that is part of the Irish Security Documents and the Swedish Share Pledge, Swedish Borrower has entered into the Cayman Share Pledge and the Security Deed that is part of the Irish Security Documents, and the Cayman Borrower has entered into the Cayman Security Documents.

 

Borrower agrees that, within 30 days after the date hereof, it will either (i) cause Swedish Borrower to enter into the Swedish Security Document and to take all actions necessary, including, without limitation, causing proper recordation of the Swedish Security Document in Sweden and paying all stamp duties and other costs attendant thereto, or (ii) present to the Lenders a written plan acceptable to the Lenders in their sole discretion to have Swedish Borrower enter into an exclusive, perpetual, worldwide written license agreement or a sale agreement with Borrower licensing or selling to the US Borrower all Intellectual Property owned by Swedish Borrower.  Provided that such plan is acceptable to the Lenders in their sole discretion, Borrower will then have 60 days following the approval of such plan by the Lenders to enter into such license agreement or to transfer all Intellectual Property owned by the Swedish Borrower to the US Borrower in accordance with the terms of such sale agreement (the last day of such 60 day period to be not later than the 90 th  day after the date of this Agreement), the terms and conditions of which shall be satisfactory to the Lenders in their sole discretion.  If Borrower is unable or fails to enter into such license agreement or effectuate such sale and transfer within such 60 day period it shall be required to comply with the terms of subsection (i) of this paragraph within such 60 day period.  Failure to comply with the foregoing shall be deemed to be an Event of Default under this Agreement.  Until such time as Borrower has complied with either subsection (i) or entered into a license agreement or effectuated such sale and transfer complying with subsection (ii) of this paragraph, and notwithstanding anything to the contrary set forth in any of the Loan Documents, Borrower shall maintain at all times in U.S. Collateral Accounts owned by the U.S. Borrower and the Irish Borrower, in the aggregate, an amount of cash and Cash Equivalents equal to 150% of the outstanding principal balance of the Term Loans.

 

If this Agreement is terminated, Collateral Agent’s Lien and each Lender’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash.  Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as the Lenders’ obligation to make Credit Extensions has terminated, Collateral Agent shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower.

 

4.2                                Authorization to File Financing Statements .   Borrower hereby authorizes Collateral Agent to file financing statements or take any other action required to perfect Collateral Agent’s security interests in the Collateral (including, without limitation, registration of particulars of this Agreement, the Irish Security Documents, the IP Agreement and the Swedish Share Pledge entered into by Irish Borrower at the Companies Registration Office in Ireland), without notice to Borrower, with all appropriate jurisdictions to perfect or protect Collateral Agent’s interest or rights under the Loan Documents, including a notice that any disposition of the Collateral, except to the extent permitted by the terms of this Agreement, by Borrower, or any other Person, shall be deemed to violate the rights of Collateral Agent under the Code.

 

4.3                                Pledge of Collateral.   Borrower hereby pledges, assigns and grants to Collateral Agent, for the ratable benefit of the Lenders, and each Lender, a security interest in all the Shares, together with all proceeds and substitutions thereof, all cash, stock and other moneys and property paid thereon, all rights to subscribe for securities declared or granted in connection therewith, and all other cash and noncash proceeds of the foregoing, as security for the performance of the Obligations.  On the Effective Date, or, to the extent not certificated as of the Effective Date, within ten (10) days of the certification of any Shares, the certificate or certificates for the Shares will be delivered to Collateral Agent, accompanied by an instrument of assignment or transfer duly executed in blank by Borrower.  To the extent required by the terms and conditions governing the Shares, Borrower shall cause the books of each entity whose Shares are part of the Collateral and any transfer agent to reflect the pledge of the Shares.  Upon the occurrence and during the continuance of an Event of Default hereunder, Collateral Agent may effect the transfer of any securities included in the Collateral (including but not limited to the Shares) into the name of Collateral Agent and cause new (as applicable) certificates representing such securities to be issued in the name of Collateral Agent or its transferee.  Borrower will execute and deliver such documents, and take or cause to be taken such actions, as Collateral Agent may reasonably request to perfect or continue the perfection of Collateral Agent’s security interest in the Shares.  Unless an Event of Default shall have occurred and be continuing, Borrower shall be entitled to exercise any voting rights with respect to the Shares and to give consents, waivers and ratifications in

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

respect thereof, provided that no vote shall be cast or consent, waiver or ratification given or action taken which would be inconsistent with any of the terms of this Agreement or which would constitute or create any violation of any of such terms.  All such rights to vote and give consents, waivers and ratifications shall terminate upon the occurrence and continuance of an Event of Default.

 

5.                                       REPRESENTATIONS AND WARRANTIES

 

Borrower represents and warrants to Collateral Agent and the Lenders as follows:

 

5.1                                Due Organization, Authorization: Power and Authority .   Borrower and each of its Subsidiaries is duly incorporated or organized, validly existing and in good standing (where such concept exists in the any relevant jurisdiction) as a Registered Organization in its jurisdictions of organization or formation and Borrower and each of its Subsidiaries is qualified and licensed to do business and is in good standing (where such concept exists in any relevant jurisdiction) in any jurisdiction in which the conduct of its businesses or its ownership of property requires that it be qualified except where the failure to do so could not reasonably be expected to have a Material Adverse Change.  In connection with this Agreement, Borrower and each of its Subsidiaries has delivered to Collateral Agent a completed perfection certificate signed by an officer (or, if applicable in any relevant jurisdiction, an authorized signatory) of Borrower or such Subsidiary (each a “ Perfection Certificate ” and collectively, the “ Perfection Certificates ”).  Borrower represents and warrants that (a) Borrower and each of its Subsidiaries’ exact legal name is that which is indicated on its respective Perfection Certificate and on the signature page of each Loan Document to which it is a party; (b) Borrower and each of its Subsidiaries is an organization of the type and is organized in the jurisdiction set forth on its respective Perfection Certificate; (c) each Perfection Certificate accurately sets forth the applicable Borrower’s and its Subsidiaries’ organizational identification number(s) or accurately states that Borrower or such Subsidiary has none; (d) each Perfection Certificate accurately sets forth the applicable Borrower’s or its Subsidiaries’ place of business, or, if more than one, its chief executive office as well as such Borrower’s and such Subsidiaries’ mailing address (if different than its chief executive office); (e) except as disclosed to the Collateral Agent in the Perfection Certificates, Borrower and each of its Subsidiaries (and each of its respective predecessors) have not, in the past five (5) years, changed its jurisdiction of organization, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all other information set forth on the Perfection Certificates pertaining to Borrower and each of its Subsidiaries, is accurate and complete in all material respects (it being understood and agreed that Borrower and each of its Subsidiaries may from time to time update certain information in the Perfection Certificates (including the information set forth in clause (d) above) after the Effective Date to the extent permitted by one or more specific provisions in this Agreement); such updated Perfection Certificates subject to the review and approval of Collateral Agent.  If Borrower or any of its Subsidiaries is not now a Registered Organization but later becomes one, Borrower shall notify Collateral Agent of such occurrence and provide Collateral Agent with such Person’s organizational identification number within five (5) Business Days of receiving such organizational identification number.

 

The execution, delivery and performance by Borrower and each of its Subsidiaries of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s or such Subsidiaries’ organizational documents, including its respective Operating Documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law applicable thereto, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or such Subsidiary, or any of their property or assets may be bound or affected, (iv) except for filings referred to in Section 4.2 above, require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect) or are being obtained pursuant to Section 6.1(b), or (v) constitute an event of default under any material agreement by which Borrower or any of such Subsidiaries, or their respective properties, is bound.  Neither Borrower nor any of its Subsidiaries is in default under any agreement to which it is a party or by which it or any of its assets is bound in which such default could reasonably be expected to have a Material Adverse Change.

 

5.2                                Collateral .

 

(a)                                  Borrower and each of the Guarantors have good title to, have rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien under the Loan Documents, free and clear

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

of any and all Liens except Permitted Liens, and neither Borrower nor any of its Subsidiaries have any Deposit Accounts, Securities Accounts, Commodity Accounts or other investment accounts other than the Collateral Accounts or the Permitted Bank of America Account, with respect to which Borrower or such Subsidiary has given Collateral Agent notice and taken such actions as are necessary to give Collateral Agent a perfected first priority security interest therein, except for  the Permitted Bank of America Account in which Collateral Agent shall have an unperfected lien as a result of there being no Control Agreement and the Deposit Account referred to in clause (d) of Permitted Liens definition.  To Borrower’s knowledge, the Accounts are bona fide, existing obligations of the Account Debtors.

 

(b)                                  On the Effective Date, and except as disclosed on the Perfection Certificate (i) the Collateral is not in the possession of any third party bailee (such as a warehouse), and (ii)  no such third party bailee possesses components of the Collateral in excess of One Hundred Thousand Dollars ($100,000.00).  None of the components of the Collateral shall be maintained at locations other than as disclosed in the Perfection Certificates on the Effective Date or as permitted pursuant to Section 6.11.

 

(c)                                   All Inventory is in all material respects of good and marketable quality, free from material defects.

 

(d)                                  Borrower and each of its Subsidiaries is the sole owner of the Intellectual Property each respectively purports to own, free and clear of all Liens other than Permitted Liens.  (i) Each of Borrower’s and its Subsidiaries’ Patents is valid and enforceable and no part of Borrower’s or its Subsidiaries’ Intellectual Property has been judged invalid or unenforceable, in whole or in part, and (ii) to the best of Borrower’s knowledge, no claim has been made that any part of the Intellectual Property or any practice by Borrower or its Subsidiaries violates the rights of any third party except to the extent such claim could not reasonably be expected to have a Material Adverse Change.  Except as noted on the Perfection Certificates, neither Borrower nor any of its Subsidiaries is a party to, nor is bound by, any material license or other material agreement with respect to which Borrower or such Subsidiary is the licensee that (i) prohibits or otherwise restricts Borrower or its Subsidiaries from granting a security interest in Borrower’s or such Subsidiaries’ interest in such material license or material agreement or any other property, or (ii) for which a default under or termination of could interfere with Collateral Agent’s or any Lender’s right to sell any Collateral.  Borrower shall provide written notice to Collateral Agent and each Lender within ten (10) days of Borrower or any of its Subsidiaries entering into or becoming bound by any license or agreement with respect to which Borrower or any Subsidiary is the licensee (other than over-the-counter software that is commercially available to the public).

 

5.3                                Litigation .   Except as disclosed (i) on the Perfection Certificates, or (ii) in accordance with Section 6.9 hereof, there are no actions, suits, investigations, or proceedings pending or, to the knowledge of the Responsible Officers, threatened in writing by or against Borrower or any of its Subsidiaries involving more than One Hundred Thousand Dollars ($100,000.00).

 

5.4                                No Material Deterioration in Financial Condition; Financial Statements .   All consolidated financial statements for Borrower and its Subsidiaries, delivered to Collateral Agent fairly present, in conformity with GAAP, in all material respects the consolidated financial condition of Borrower and its Subsidiaries, and the consolidated results of operations of Borrower and its Subsidiaries.  There has not been any material deterioration in the consolidated financial condition of Borrower and its Subsidiaries since the date of the most recent financial statements submitted to any Lender.

 

5.5                                Solvency .   Borrower and each of its Subsidiaries is Solvent.

 

5.6                                Regulatory Compliance .   Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended.  Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors).  Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act.  Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change.  Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws.  Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.

 

None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person.  None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

 

5.7                                Investments .   Neither Borrower nor any of its Subsidiaries owns any stock, shares, partnership interests or other equity securities except for Permitted Investments.

 

5.8                                Tax Returns and Payments; Pension Contributions .   Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower and each of its Subsidiaries, has timely paid all foreign and federal taxes, assessments, deposits and contributions, and material state, and local taxes, assessments, deposits and contributions, owed by Borrower and such Subsidiaries, in all jurisdictions in which Borrower or any such Subsidiary is subject to taxes, including the United States, unless such taxes are being contested in accordance with the following sentence.  Borrower and each of its Subsidiaries, may defer payment of any contested taxes, provided that Borrower or such Subsidiary, (a) in good faith contests its obligation to pay the taxes by appropriate proceedings promptly and diligently instituted and conducted, (b) notifies Collateral Agent in writing of the commencement of, and any material development in, the proceedings, and (c)  posts bonds or takes any other steps required to prevent the Governmental Authority levying such contested taxes from obtaining a Lien upon any of the Collateral that is other than a Permitted Lien.  Neither Borrower nor any of its Subsidiaries is aware of any claims or adjustments proposed for any of Borrower’s or such Subsidiaries’, prior tax years which could result in additional taxes becoming due and payable by Borrower or its Subsidiaries.  Borrower and each of its Subsidiaries have paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and neither Borrower nor any of its Subsidiaries have, withdrawn from participation in, and have not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower or its Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.  For the purposes of this Section 5.8, “material state, and local taxes, assessments, deposits and contributions” shall mean state, and local taxes, assessments, deposits and contributions, in the aggregate amount of Twenty-Five Thousand Dollars ($25,000.00) or more.

 

5.9                                Use of Proceeds .   Borrower shall use the proceeds of the Credit Extensions solely as working capital and to fund its general business requirements in accordance with the provisions of this Agreement, and not for personal, family, household or agricultural purposes.  A portion of the proceeds of the Term A Loans may be used by Borrower for the consummation of the Keveyis Acquisition Event or for its obligations related thereto.

 

5.10                         Shares.   Borrower has full power and authority to create a first priority lien on the Shares and no disability or contractual obligation exists that would prohibit Borrower from pledging the Shares pursuant to this Agreement.  To Borrower’s knowledge, there are no subscriptions, warrants, rights of first refusal or other restrictions on transfer relative to, or options exercisable with respect to the Shares.  The Shares have been and will be duly authorized and validly issued, and are fully paid and non-assessable.  To Borrower’s knowledge, the Shares are not the subject of any present or threatened suit, action, arbitration, administrative or other proceeding, and Borrower knows of no reasonable grounds for the institution of any such proceedings.

 

5.11                         Full Disclosure .   No written representation, warranty or other statement of Borrower or any of its Subsidiaries in any certificate or written statement given to Collateral Agent or any Lender, as of the date such

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

representation, warranty, or other statement was made, taken together with all such written certificates and written statements given to Collateral Agent or any Lender, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not misleading (it being recognized that the projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

 

5.12                         Definition of Knowledge. ”  For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of the Responsible Officers.

 

6.                                       AFFIRMATIVE COVENANTS

 

Borrower shall, and shall cause each of its Subsidiaries to, do all of the following:

 

6.1                                Government Compliance.

 

(a)                                  Maintain its and all its Subsidiaries’ legal existence and good standing (where such concept exists in any relevant jurisdiction) in their respective jurisdictions of organization or incorporation and maintain qualification in each jurisdiction in which the failure to so qualify could reasonably be expected to have a Material Adverse Change.  Comply with all laws (where such concept exists in any relevant jurisdiction), ordinances and regulations to which Borrower or any of its Subsidiaries is subject, the noncompliance with which could reasonably be expected to have a Material Adverse Change.

 

(b)                                  Obtain and keep in full force and effect, all of the material Governmental Approvals necessary for the performance by Borrower and its Subsidiaries of their respective businesses and obligations under the Loan Documents and the grant of a security interest to Collateral Agent, for the ratable benefit of the Lenders, in all of the Collateral.  Borrower shall promptly provide copies to Collateral Agent of any material Governmental Approvals obtained by Borrower or any of its Subsidiaries.

 

6.2                                Financial Statements, Reports, Certificates.

 

(a)                                  Deliver to each Lender:

 

(i)                                      as soon as available, but no later than thirty (30) days after the last day of each month, a company prepared consolidated and consolidating balance sheet, income statement and cash flow statement covering the consolidated operations of Borrower and its Subsidiaries for such month certified by a Responsible Officer and in a form reasonably acceptable to Collateral Agent;

 

(ii)                                   as soon as available, but no later than one hundred twenty (120) days after the last day of Borrower’s fiscal year or within five (5) days of filing with the SEC or other applicable authority in the relevant jurisdiction, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified public accounting firm acceptable to Collateral Agent in its reasonable discretion ;

 

(iii)                                as soon as available, but no later than thirty (30) days after the last day of each of Borrower’s fiscal years, Borrower’s annual financial projections for the entire current fiscal year which shall be approved by Borrower’s Board of Directors, which annual financial projections shall be set forth in a month-by-month format with respect to the Net Product Revenues (the “ Annual Net Product Revenue Projections ”) and in a quarter-by-quarter format with respect to all other financial projections contained therein (the Annual Net Product Revenue Projections and the other annual financial projections as originally delivered to Collateral Agent and the Lenders in a certificate of the chief financial officer or controller of Irish Borrower are referred to herein, collectively, as the “ Annual Projections ”; provided that, any revisions of the Annual Projections (which shall also

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

be approved by Borrower’s Board of Directors) shall be delivered to Collateral Agent and the Lenders no later than seven (7) days after any changes thereto);

 

(iv)                               within five (5) days of delivery, copies of all statements, reports and notices made available to Borrower’s security holders or holders of Subordinated Debt;

 

(v)                                  in the event that Borrower becomes subject to the reporting requirements under the Securities Exchange Act of 1934, as amended, within five (5) days of filing, all reports on Form 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission,

 

(vi)                               prompt notice of any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries, together with any copies reflecting such amendments or changes with respect thereto;

 

(vii)                            prompt notice of (A) any material change in the composition of the Intellectual Property, (B) the registration of any copyright, including any subsequent ownership right of Borrower or any of its Subsidiaries in or to any copyright, patent or trademark, including a copy of any such registration, and (C) any event that could reasonably be expected to materially and adversely affect the value of the Intellectual Property;

 

(viii)                         as soon as available, but no later than thirty (30) days after the last day of each month, copies of the month-end account statements for each Collateral Account maintained by Borrower or its Subsidiaries, which statements may be provided to Collateral Agent and each Lender by Borrower or directly from the applicable institution(s), and

 

(ix)                               other information as reasonably requested by Collateral Agent or any Lender.

 

Notwithstanding the foregoing, documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the internet at Borrower’s website address.

 

(b)                                  Concurrently with the delivery of the financial statements specified in Section 6.2(a)(i) above but no later than thirty (30) days after the last day of each month, deliver to each Lender, a duly completed Compliance Certificate signed by a Responsible Officer.

 

(c)                                   Keep proper books of record and account in accordance with GAAP in all material respects, in which full, true and correct entries shall be made of all dealings and transactions in relation to its business and activities.  Borrower shall, and shall cause each of its Subsidiaries to, allow, at the sole cost of Borrower, Collateral Agent or any Lender, during regular business hours upon reasonable prior notice (provided that no notice shall be required when an Event of Default has occurred and is continuing), to visit and inspect any of its properties, to examine and make abstracts or copies from any of its books and records, and to conduct a collateral audit and analysis of its operations and the Collateral.  Such audits shall be conducted no more often than twice every year unless (and more frequently if) an Event of Default has occurred and is continuing.

 

6.3                                Inventory; Returns .   Keep all Inventory in good and marketable condition, free from material defects.  Returns and allowances between Borrower, or any of its Subsidiaries, and their respective Account Debtors shall follow Borrower’s, or such Subsidiary’s, customary practices as they exist at the Effective Date.  Borrower must promptly notify Collateral Agent and the Lenders of all returns, recoveries, disputes and claims that involve more than One Hundred Thousand Dollars ($100,000.00) individually or in the aggregate in any calendar year.

 

6.4                                Taxes; Pensions .   Timely file and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely file, all foreign and federal taxes, assessments, deposits and contributions, and material state, and local taxes, assessments, deposits and contributions,  owed by Borrower or its Subsidiaries, except for deferred payment of any taxes contested pursuant to the terms of Section 5.8 hereof, and shall deliver to Lenders, on demand, appropriate certificates attesting to such payments, and

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with the terms of such plans.  For the purposes of this Section 6.4, “material state, and local taxes, assessments, deposits and contributions” shall mean state, and local taxes, assessments, deposits and contributions, in the aggregate amount of Twenty-Five Thousand Dollars ($25,000.00) or more.

 

6.5                                Insurance .   Keep Borrower’s and its Subsidiaries’ business and the Collateral insured for risks and in amounts standard for companies in Borrower’s and its Subsidiaries’ industry and location and as Collateral Agent may reasonably request.  Insurance policies shall be in a form, with companies, and in amounts that are reasonably satisfactory to Collateral Agent and Lenders.  All property policies shall have a lender’s loss payable endorsement showing Collateral Agent and each Lender as lender loss payee and waive subrogation against Collateral Agent, and all liability policies (other than those policies issued by insurers located outside of the United States covering activities of the Borrower and its Subsidiaries taking place outside of the United States) shall show, or have endorsements showing, Collateral Agent and each Lender, as additional insured.  The Collateral Agent and each Lender shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral (other than those liability policies issued by insurers located outside of the United States covering activities of the Borrower and its Subsidiaries taking place outside of the United States), and each provider of any such insurance shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to the Collateral Agent and the Lenders, that it will give the Collateral Agent and the Lenders thirty (30) days prior written notice before any such policy or policies shall be materially altered or canceled.  At Collateral Agent’s request, Borrower shall deliver certified copies of policies and evidence of all premium payments.  Proceeds payable under any policy shall, at Collateral Agent’s option, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations.  Notwithstanding the foregoing, (a) so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy up to One Hundred Thousand Dollars ($100,000.00) with respect to any loss, but not exceeding One Hundred Thousand Dollars ($100,000.00), in the aggregate for all losses under all casualty policies in any one year, toward the replacement or repair of destroyed or damaged property; provided that any such replaced or repaired property (i) shall be of equal or like value as the replaced or repaired Collateral and (ii) shall be deemed Collateral in which Collateral Agent has been granted a first priority security interest, and (b) after the occurrence and during the continuance of an Event of Default, all proceeds payable under such casualty policy shall, at the option of Collateral Agent, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations.  If Borrower or any of its Subsidiaries fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons, Collateral Agent and/or any Lender may make, at Borrower’s expense, all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Collateral Agent or such Lender deems prudent.

 

6.6                                Operating Accounts.

 

(a)                                  Maintain all of Borrower’s and its Subsidiaries’ Collateral Accounts in accounts which are subject to a Control Agreement in favor of Collateral Agent; provided, however, the Irish Collateral Accounts shall be subject to and must comply with the provisions set forth in the Irish Security Documents, the Cayman Collateral Accounts shall be subject to and must comply with the provisions set forth in the Cayman Security Documents and the Swedish Collateral Accounts shall be subject to and must comply with the provisions set forth in the Swedish Security Document (if the Swedish Security Document is entered into in accordance with Section 4.1).

 

(b)                                  Borrower shall provide Collateral Agent five (5) days’ prior written notice before Borrower or any of its Subsidiaries establishes any new Collateral Account.  In addition, for each Collateral Account that Borrower or any of its Subsidiaries, at any time maintains, Borrower or such Subsidiary shall cause the applicable bank or financial institution at or with which such Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Collateral Agent’s Lien in such Collateral Account in accordance with the terms hereunder prior to the establishment of such Collateral Account, which Control Agreement may not be terminated without prior written consent of Collateral Agent.  The provisions of the previous sentence shall not apply to (i) deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees and identified to Collateral Agent by Borrower as such in the Perfection Certificates; provided, however, that in no event shall any of the accounts listed in this clause (i) contain funds on deposit in excess of the amount required for Borrower to fund one (1) payroll cycle, (ii) the Irish Collateral Accounts which

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

shall be subject to and must comply with the provisions set forth in the Irish Security Documents, (iii) the Cayman Collateral Accounts which shall be subject to and must comply with the provisions set forth in the Cayman Security Documents and (iv) the Swedish Collateral Account which shall be subject to and must comply with the provisions set forth in the Swedish Security Document.

 

(c)                                   Neither Borrower nor any of its Subsidiaries shall maintain any Collateral Accounts except Collateral Accounts maintained in accordance with Sections 6.6(a) and (b).

 

(d)                                  All proceeds from the sale or licensing of Keveyis™ (dichlorphenamide) product shall be deposited in Collateral Accounts maintained in the United States and subject to Collateral Agreements in favor of the Collateral Agent.

 

6.7                                Protection of Intellectual Property Rights.   Borrower and each of its Subsidiaries shall: (a) use commercially reasonable efforts to protect, defend and maintain the validity and enforceability of its Intellectual Property that is material to Borrower’s business; (b) promptly advise Collateral Agent in writing of material infringement by a third party of its Intellectual Property; and (c) not allow any Intellectual Property material to Borrower’s business to be abandoned, forfeited or dedicated to the public without Collateral Agent’s prior written consent.  If Borrower or any of its Subsidiaries (i) obtains any patent, registered trademark or servicemark, registered copyright, registered mask work, or any pending application for any of the foregoing, whether as owner, licensee or otherwise, or (ii) applies for any patent or the registration of any trademark or servicemark, in any part of the world, then Borrower or such Subsidiary shall promptly provide written notice thereof to Collateral Agent and each Lender and shall execute such intellectual property security agreements and other documents and take such other actions as Collateral Agent shall reasonably request in its good faith business judgment to perfect and maintain a first priority perfected security interest in favor of Collateral Agent, for the ratable benefit of the Lenders, and each Lender, in such property.  If Borrower or any of its Subsidiaries decides to register any copyrights or mask works in the United States Copyright Office, Borrower or such Subsidiary shall: (x) provide Collateral Agent and each Lender with at least fifteen (15) days prior written notice of Borrower’s or such Subsidiary’s intent to register such copyrights or mask works together with a copy of the application it intends to file with the United States Copyright Office (excluding exhibits thereto); (y) execute an intellectual property security agreement and such other documents and take such other actions as Collateral Agent may reasonably request in its good faith business judgment to perfect and maintain a first priority perfected security interest in favor of Collateral Agent, for the ratable benefit of the Lenders, and each Lender, in the copyrights or mask works intended to be registered with the United States Copyright Office; and (z) record such intellectual property security agreement with the United States Copyright Office contemporaneously with filing the copyright or mask work application(s) with the United States Copyright Office.  Borrower or such Subsidiary shall promptly provide to Collateral Agent and each Lender with evidence of the recording of the intellectual property security agreement necessary for Collateral Agent to perfect and maintain a first priority perfected security interest in such property.

 

6.8                                Litigation Cooperation .   Commencing on the Effective Date and continuing through the termination of this Agreement, make available to Collateral Agent and the Lenders, without expense to Collateral Agent or the Lenders, Borrower and each of Borrower’s officers, employees and agents and Borrower’s Books, to the extent that Collateral Agent or any Lender may reasonably deem them necessary to prosecute or defend any third-party suit or proceeding instituted by or against Collateral Agent or any Lender with respect to any Collateral or relating to Borrower.

 

6.9                                Notices of Litigation and Default.   Borrower will give prompt written notice to Collateral Agent and the Lenders of any litigation or governmental proceedings pending or threatened (in writing) against Borrower or any of its Subsidiaries, which could reasonably be expected to result in damages or costs to Borrower or any of its Subsidiaries of One Hundred Thousand Dollars ($100,000.00) or more or which could reasonably be expected to have a Material Adverse Change.  Without limiting or contradicting any other more specific provision of this Agreement, promptly (and in any event within three (3) Business Days) upon Borrower becoming aware of the existence of any Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default, Borrower shall give written notice to Collateral Agent and the Lenders of such occurrence, which such notice shall include a reasonably detailed description of such Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

6.10                         Financial Covenant. Irish Borrower shall achieve the following, to be tested as of the last day of the applicable month for each month ending after the Effective Date, on a consolidated basis with respect to Irish Borrower and its Subsidiaries: a minimum amount of Net Products Revenues for the twelve months ended (i) at the end of the applicable month in 2017 and 2018 shown on a schedule to the certificate of the chief financial officer of Irish Borrower delivered on the Effective Date, and (ii) thereafter at the end of each month of at least eighty percent (80%) of the Net Product Revenues projected for such twelve-month period in the Annual Net Product Revenue Projections as delivered to Collateral Agent and Lenders in a certificate of the chief financial officer or controller of Irish Borrower in accordance with Section 6.2(a)(iii), which Annual Net Product Revenue Projections must be reviewed and approved by Collateral Agent and Lenders.

 

6.11                         Landlord Waivers; Bailee Waivers.   In the event that Borrower or any of its Subsidiaries, after the Effective Date, intends to add any new offices or business locations, including warehouses, or otherwise store any portion of the Collateral with, or deliver any portion of the Collateral to, a bailee, in each case pursuant to Section 7.2, then Borrower or such Subsidiary will first receive the written consent of Collateral Agent and, in the event that the new location is the chief executive office of the Borrower or such Subsidiary or the Collateral at any such new location is valued in excess of One Hundred Thousand ($100,000.00) in the aggregate, such bailee or landlord, as applicable, must execute and deliver a bailee waiver or landlord waiver, as applicable, in form and substance reasonably satisfactory to Collateral Agent prior to the addition of any new offices or business locations, or any such storage with or delivery to any such bailee, as the case may be.

 

6.12                         Creation/Acquisition of Subsidiaries.   In the event Borrower, or any of its Subsidiaries creates or acquires any Subsidiary, Borrower shall provide prior written notice to Collateral Agent and each Lender of the creation or acquisition of such new Subsidiary and take all such action as may be reasonably required by Collateral Agent or any Lender to cause each such Subsidiary to become a co-Borrower hereunder or to guarantee the Obligations of Borrower under the Loan Documents and, in each case, grant a continuing pledge and security interest in and to the assets of such Subsidiary (substantially as described on Exhibit A hereto); and Borrower (or its Subsidiary, as applicable) shall grant and pledge to Collateral Agent, for the ratable benefit of the Lenders, a perfected security interest in the Shares of each such newly created Subsidiary.

 

6.13                         Further Assurances .

 

(a)                                  Subject to the provisions of the Loan Documents, execute any further instruments and take further action as Collateral Agent or any Lender reasonably requests to perfect or continue Collateral Agent’s Lien and each Lender’s Lien in the Collateral or to effect the purposes of this Agreement.

 

(b)                                  Deliver to Collateral Agent and Lenders, within five (5) days after the same are sent or received, copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any of the Governmental Approvals material to Borrower’s business or otherwise could reasonably be expected to have a Material Adverse Change.

 

6.14                         Dissolution of BioPancreate.  No later than the six (6) month anniversary of the Effective Date, deliver to Collateral Agent and Lenders evidence satisfactory to them of the dissolution of BioPancreate Inc., a Delaware corporation and wholly owned subsidiary of US Borrower on the Effective Date; provided, however, that during such six-month period, BioPancreate Inc. may not hold assets with an aggregate value in excess of Twenty Five Thousand Dollars ($25,000.00) or any Intellectual Property.

 

6.15                         Notifications relating to Irish Borrower.  Irish Borrower shall promptly notify the Collateral Agent in writing:

 

(a)                                  of any restrictions imposed on any shares of the Irish Borrower pursuant to the Irish Companies Act;

 

(b)                                  of any report made by inspectors appointed to the Irish Borrower pursuant to the Irish Companies Act;

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(c)                                   of any disclosure made relating to any shares or debentures of the Irish Borrower under the Irish Companies Act;

 

(d)                                  of any declaration, order or deemed order for disqualification or restriction under the Irish Companies Act including Part 14, Chapters 3 and 4 and any notice under the Irish Companies Act including Part 14, Chapter 5, regarding a disqualification or restriction undertaking in respect of any director of the Irish Borrower;

 

(e)                                   of any intention on the part of any person of which it becomes aware to hold the Irish Borrower liable for the whole, or part of any of the debts of any other Borrower or a Subsidiary of any Borrower or of any contribution order or pooling order made under Sections 599 or 600 of the Irish Companies Act;

 

(f)                                    of its intention (and shall notify Collateral Agent forthwith of any intention on the part of any person of which it becomes aware) to present a petition before any competent court or any analogous proceedings or actions for the appointment of an examiner, an administrator, a liquidator or any similar officer to, or over the whole or any part of the assets of any Borrower or any Subsidiary of any Borrower;

 

(g)                                   of any notice received by the Irish Borrower under Section 1002 of the TCA.

 

6.16                         License Agreement between Irish Borrower and U.S. Borrower .  On or before February 28, 2017, the Irish Borrower must enter into an inter-company license or other agreement with U.S. Borrower pursuant to which U.S. Borrower shall have the exclusive rights to market and sell Keveyis™ products in the United States, which license or agreement must be in such form and substance as is reasonably acceptable to Collateral Agent and Lenders.

 

7.                                       NEGATIVE COVENANTS

 

Borrower shall not, and shall not permit any of its Subsidiaries to, do any of the following without the prior written consent of the Required Lenders:

 

7.1                                Dispositions .   Convey, sell, lease, transfer, assign, or otherwise dispose of (collectively, “ Transfer ”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) of Swedish Borrower’s Intellectual Property to Borrower pursuant to Section 4.1, (b) of Inventory in the ordinary course of business; (c) of worn out or obsolete Equipment; and (d) in connection with Permitted Liens, Permitted Investments and Permitted Licenses.

 

7.2                                Changes in Business, Management, Ownership, or Business Locations .   (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses engaged in by Borrower as of the Effective Date or reasonably related thereto; (b) liquidate or dissolve; or (c) (i) any Key Person shall cease to be actively engaged in the management of Borrower unless written notice thereof is provided to Collateral Agent within five (5) days of such change, or (ii) enter into any transaction or series of related transactions in which the stockholders of Borrower who were not stockholders immediately prior to the first such transaction own more than forty nine percent (49%) of the voting stock of Borrower immediately after giving effect to such transaction or related series of such transactions (other than by the sale of Borrower’s equity securities in a public offering, a private placement of public equity or to venture capital investors so long as Borrower identifies to Collateral Agent the venture capital investors prior to the closing of the transaction).  Borrower shall not, without at least thirty (30) days’ prior written notice to Collateral Agent: (A) add any new offices or business locations, including warehouses (unless such new offices or business locations (i) contain less than One Hundred Thousand Dollars ($100,000.00) in assets or property of Borrower or any of its Subsidiaries and (ii) are not Borrower’s or its Subsidiaries’ chief executive office); (B) change its jurisdiction of organization, (C) change its organizational structure or type, (D) change its legal name, or (E) change any organizational number (if any) assigned by its jurisdiction of organization.

 

7.3                                Mergers or Acquisitions .   Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock, shares or property of another Person. A Subsidiary may merge or consolidate into another Subsidiary (provided such surviving Subsidiary is a “co-Borrower” hereunder or has provided a secured Guaranty of

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Borrower’s Obligations hereunder) or with (or into) Borrower provided Borrower is the surviving legal entity, and as long as no Event of Default is occurring prior thereto or arises as a result therefrom.  Without limiting the foregoing, Borrower shall not, without Collateral Agent’s prior written consent, enter into any binding contractual arrangement with any Person to attempt to facilitate a merger or acquisition of Borrower, unless (i) no Event of Default exists when such agreement is entered into by Borrower, (ii) (A) no Event of Default exists when such agreement is entered into by Borrower, and (B) (x) such agreement does not give such Person the right to claim any fees, payments or damages from Borrower in excess of Five Hundred Thousand Dollars ($500,000) or (y) at the time of entering into such agreement Borrower has sufficient cash reserves (net of any fees, payments or damages that Borrower may become liable to pay to such Person under such agreement) to meet its operating needs for the following twelve month period, and (iii) Borrower notifies Collateral Agent in advance of entering into such an agreement.

 

7.4                                Indebtedness .   Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.

 

7.5                                Encumbrance .   Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, or permit any Collateral not to be subject to the first priority security interest granted herein (except for Permitted Liens that are permitted by the terms of this Agreement to have priority over Collateral Agent’s Lien and each Lender’s Lien), or enter into any agreement, document, instrument or other arrangement (except with or in favor of Collateral Agent, for the ratable benefit of the Lenders) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower, or any of its Subsidiaries, from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or such Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of Permitted Liens herein.

 

7.6                                Maintenance of Collateral Accounts .   Maintain any Collateral Account except pursuant to the terms of Section 6.6 hereof.

 

7.7                                Distributions; Investments . (a) Pay any dividends (other than dividends payable solely in capital stock) or make any distribution or payment in respect of or redeem, retire or purchase any capital stock (other than repurchases pursuant to the terms of employee stock purchase plans, employee restricted stock agreements, stockholder rights plans, director or consultant stock option plans, or similar plans, provided such repurchases do not exceed One Hundred Thousand Dollars ($100,000.00) in the aggregate per fiscal year) or (b) directly or indirectly make any Investment other than Permitted Investments, or permit any of its Subsidiaries to do so.

 

7.8                                Transactions with Affiliates .   Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower or any of its Subsidiaries, except for (a) transactions that are in the ordinary course of Borrower’s or such Subsidiary’s business, upon fair and reasonable terms that are no less favorable to Borrower or such Subsidiary than would be obtained in an arm’s length transaction with a non-affiliated Person, and (b) Subordinated Debt or equity investments by Borrower’s investors in Borrower or its Subsidiaries.

 

7.9                                Subordinated Debt .   (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof or adversely affect the subordination thereof to Obligations owed to the Lenders.

 

7.10                         Compliance .   Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to meet the minimum funding requirements of ERISA, permit a Reportable Event or Prohibited Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair Labor Standards Act or violate any other law or regulation, if the violation could reasonably be expected to have a Material Adverse Change, or permit any of its Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower or any of its

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.

 

7.11                         Compliance with Anti-Terrorism Laws.   Collateral Agent hereby notifies Borrower and each of its Subsidiaries that pursuant to the requirements of Anti-Terrorism Laws, and Collateral Agent’s policies and practices, Collateral Agent is required to obtain, verify and record certain information and documentation that identifies Borrower and each of its Subsidiaries and their principals, which information includes the name and address of Borrower and each of its Subsidiaries and their principals and such other information that will allow Collateral Agent to identify such party in accordance with Anti-Terrorism Laws.  Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries permit any Affiliate to, directly or indirectly, knowingly enter into any documents, instruments, agreements or contracts with any Person listed on the OFAC Lists.  Borrower and each of its Subsidiaries shall immediately notify Collateral Agent if Borrower or such Subsidiary has knowledge that Borrower, or any Subsidiary or Affiliate of Borrower, is listed on the OFAC Lists or (a) is convicted on, (b) pleads nolo contendere to, (c) is indicted on, or (d) is arraigned and held over on charges involving money laundering or predicate crimes to money laundering.  Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries, permit any Affiliate to, directly or indirectly, (i) conduct any business or engage in any transaction or dealing with any Blocked Person, including, without limitation, the making or receiving of any contribution of funds, goods or services to or for the benefit of any Blocked Person, (ii) deal in, or otherwise engage in any transaction relating to, any property or interests in property blocked pursuant to Executive Order No. 13224 or any similar executive order or other Anti-Terrorism Law, or (iii) engage in or conspire to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in Executive Order No. 13224 or other Anti-Terrorism Law.

 

7.12                         Non-U.S. Collateral Accounts .  Have an aggregate balance of greater than Two Hundred Fifty Thousand Dollars ($250,000.00) in all Collateral Accounts that are not U.S. Collateral Accounts.

 

7.13                         Negative Pledge Regarding Intellectual Property.   Create, incur, assume or suffer to exist, or permit any Subsidiary to create, incur, assume or suffer to exist, any Lien of any kind upon any Intellectual Property or Transfer any Intellectual Property, whether now owned or hereafter acquired, other than pursuant to Permitted Licenses.

 

8.                                       EVENTS OF DEFAULT

 

Any one of the following shall constitute an event of default (an “ Event of Default ”) under this Agreement:

 

8.1                                Payment Default .   Borrower fails to (a) make any payment of principal or interest on any Credit Extension on its due date, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day grace period shall not apply to payments due on the Maturity Date or the date of acceleration pursuant to Section 9.1 (a) hereof).  During the cure period, the failure to cure the payment default is not an Event of Default (but no Credit Extension will be made during the cure period);

 

8.2                                Covenant Default.

 

(a)                                  Borrower or any of its Subsidiaries fails or neglects to perform any obligation in Sections 4.1 (Grant of Security Interest), 6.2 (Financial Statements, Reports, Certificates), 6.4 (Taxes), 6.5 (Insurance), 6.6 (Operating Accounts), 6.7 (Protection of Intellectual Property Rights), 6.9 (Notice of Litigation and Default), 6.10 (Financial Covenant), 6.12 (Creation/Acquisition of Subsidiaries) or 6.13 (Further Assurances) or Borrower violates any covenant in Section 7; or

 

(b)                                  Borrower, or any of its Subsidiaries, fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within ten (10) days after the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the ten (10) day period or cannot after

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

diligent attempts by Borrower be cured within such ten (10) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period).  Grace periods provided under this Section shall not apply, among other things, to financial covenants or any other covenants set forth in subsection (a) above;

 

8.3                                Material Adverse Change.   A Material Adverse Change occurs;

 

8.4                                Attachment; Levy; Restraint on Business.

 

(a)                                  The service of process seeking to attach, by trustee or similar process, any funds of Borrower or any of its Subsidiaries or of any entity under control of Borrower or its Subsidiaries on deposit with any Lender or any Lender’s Affiliate or any bank or other institution at which Borrower or any of its Subsidiaries maintains a Collateral Account, or (ii) a notice of lien, levy, or assessment is filed against Borrower or any of its Subsidiaries or their respective assets by any government agency, and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; and

 

(b)                                  (i) any material portion of Borrower’s or any of its Subsidiaries’ assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower or any of its Subsidiaries from conducting any part of its business;

 

8.5                                Insolvency.   (a) Borrower or any of its Subsidiaries is or becomes Insolvent; (b) Borrower or any of its Subsidiaries begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower or any of its Subsidiaries and not dismissed or stayed within forty-five (45) days (but no Credit Extensions shall be made while Borrower or any Subsidiary is Insolvent and/or until any Insolvency Proceeding is dismissed);

 

8.6                                Other Agreements .   There is a default in any agreement to which Borrower or any of its Subsidiaries is a party with a third party or parties resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of One Hundred Thousand Dollars ($100,000.00) or that could reasonably be expected to have a Material Adverse Change;

 

8.7                                Judgments .   One or more judgments, orders, or decrees for the payment of money in an amount, individually or in the aggregate, of at least One Hundred Thousand Dollars ($100,000.00) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower or any of its Subsidiaries and shall remain unsatisfied, unvacated, or unstayed for a period of ten (10) days after the entry thereof (provided that no Credit Extensions will be made prior to the satisfaction, vacation, or stay of such judgment, order or decree);

 

8.8                                Misrepresentations .   Borrower or any of its Subsidiaries or any Person acting for Borrower or any of its Subsidiaries makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Collateral Agent and/or Lenders or to induce Collateral Agent and/or the Lenders to enter this Agreement or any Loan Document, and such representation, warranty, or other statement is incorrect in any material respect when made;

 

8.9                                Subordinated Debt .   A default or breach occurs under any agreement between Borrower or any of its Subsidiaries party to a Loan Document and any creditor of Borrower or any of its Subsidiaries party to a Loan Document that signed a subordination, intercreditor, or other similar agreement with Collateral Agent or the Lenders, or any creditor that has signed such an agreement with Collateral Agent or the Lenders breaches any terms of such agreement;

 

8.10                         Guaranty.   (a) Any Guaranty terminates or ceases for any reason to be in full force and effect; (b) any Guarantor does not perform any obligation or covenant under any Guaranty; (c) any circumstance described

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

in Sections 8.3, 8.4, 8.5, 8.7, or 8.8 occurs with respect to any Guarantor, or (d) the death of a Guarantor who is a natural person or the liquidation, winding up, or termination of existence of any Guarantor that is an entity;

 

8.11                         Governmental Approvals.  Any Governmental Approval shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non-renewal has resulted in or could reasonably be expected to result in a Material Adverse Change; or

 

8.12                         Lien Priority .  Any Lien created hereunder or by any other Loan Document shall at any time fail to constitute a valid and perfected Lien on any of the Collateral purported to be secured thereby, subject to no prior or equal Lien, other than Permitted Liens which are permitted to have priority in accordance with the terms of this Agreement.

 

8.13                         Delisting . The shares of common stock of Irish Borrower are delisted from NASDAQ because of failure to comply with continued listing standards thereof or due to a voluntary delisting which results in such shares not being listed on any other nationally recognized stock exchange in the United States having listing standards at least as restrictive as the  NASDAQ.

 

9.                                       RIGHTS AND REMEDIES

 

9.1                                Rights and Remedies.

 

(a)                                  Upon the occurrence and during the continuance of an Event of Default, Collateral Agent may, and at the written direction of Required Lenders shall, without notice or demand, do any or all of the following: (i) deliver notice of the Event of Default to Borrower, (ii) by notice to Borrower declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations shall be immediately due and payable without any action by Collateral Agent or the Lenders) or (iii) by notice to Borrower suspend or terminate the obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders (but if an Event of Default described in Section 8.5 occurs all obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders shall be immediately terminated without any action by Collateral Agent or the Lenders).

 

(b)                                  Without limiting the rights of Collateral Agent and the Lenders set forth in Section 9.1(a) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right , without notice or demand, to do any or all of the following:

 

(i)                                      foreclose upon and/or sell or otherwise liquidate, the Collateral;

 

(ii)                                   apply to the Obligations any (a) balances and deposits of Borrower that Collateral Agent or any Lender holds or controls, or (b) any amount held or controlled by Collateral Agent or any Lender owing to or for the credit or the account of Borrower; and/or

 

(iii)                                commence and prosecute an Insolvency Proceeding or consent to Borrower commencing any Insolvency Proceeding.

 

(c)                                   Without limiting the rights of Collateral Agent and the Lenders set forth in Sections 9.1(a) and (b) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right, without notice or demand, to do any or all of the following:

 

(i)                                      settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Collateral Agent considers advisable, notify any Person owing Borrower money of Collateral Agent’s security interest in such funds, and verify the amount of such account;

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(ii)                                   make any payments and do any acts it considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral.  Borrower shall assemble the Collateral if Collateral Agent requests and make it available in a location as Collateral Agent reasonably designates.  Collateral Agent may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Collateral Agent a license to enter and occupy any of its premises, without charge, to exercise any of Collateral Agent’s rights or remedies;

 

(iii)                                ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, and/or advertise for sale, the Collateral.  Collateral Agent is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s and each of its Subsidiaries’ labels, patents, copyrights, mask works, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Collateral Agent’s exercise of its rights under this Section 9.1, Borrower’s and each of its Subsidiaries’ rights under all licenses and all franchise agreements inure to Collateral Agent, for the benefit of the Lenders;

 

(iv)                               place a “hold” on any account maintained with Collateral Agent or the Lenders and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;

 

(v)                                  demand and receive possession of Borrower’s Books;

 

(vi)                               appoint a receiver to seize, manage and realize any of the Collateral, and such receiver shall have any right and authority as any competent court will grant or authorize in accordance with any applicable law, including any power or authority to manage the business of Borrower or any of its Subsidiaries; and

 

(vii)                            subject to clauses 9.1(a) and (b), exercise all rights and remedies available to Collateral Agent and each Lender under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).

 

Notwithstanding any provision of this Section 9.1 to the contrary, upon the occurrence of any Event of Default, Collateral Agent shall have the right to exercise any and all remedies referenced in this Section 9.1 without the written consent of Required Lenders following the occurrence of an Exigent Circumstance.  As used in the immediately preceding sentence, “ Exigent Circumstance ” means any event or circumstance that, in the reasonable judgment of Collateral Agent, imminently threatens the ability of Collateral Agent to realize upon all or any material portion of the Collateral, such as, without limitation, fraudulent removal, concealment, or abscondment thereof, destruction or material waste thereof, or failure of Borrower or any of its Subsidiaries after reasonable demand to maintain or reinstate adequate casualty insurance coverage, or which, in the judgment of Collateral Agent, could reasonably be expected to result in a material diminution in value of the Collateral.

 

9.2                                Power of Attorney.   To the extent permitted by law, Borrower hereby irrevocably appoints Collateral Agent as its lawful attorney-in-fact, exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s or any of its Subsidiaries’ name on any checks or other forms of payment or security; (b) sign Borrower’s or any of its Subsidiaries’ name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about the Accounts directly with Account Debtors, for amounts and on terms Collateral Agent determines reasonable; (d) make, settle, and adjust all claims under Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Collateral Agent or a third party as the Code or any applicable law permits.  Borrower hereby appoints Collateral Agent as its lawful attorney in fact to sign Borrower’s or any of its Subsidiaries’ name on any documents necessary to perfect or continue the perfection of Collateral Agent’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations (other than inchoate indemnity obligations) have been satisfied in full and Collateral Agent and the Lenders are under no further obligation to make Credit Extensions hereunder.  Collateral Agent’s foregoing appointment as Borrower’s or any of its Subsidiaries’ attorney in fact, and all of Collateral Agent’s rights

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

and powers, coupled with an interest, are irrevocable until all Obligations (other than inchoate indemnity obligations) have been fully repaid and performed and Collateral Agent’s and the Lenders’ obligation to provide Credit Extensions terminates.

 

9.3                                Protective Payments.   If Borrower or any of its Subsidiaries fail to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower or any of its Subsidiaries is obligated to pay under this Agreement or any other Loan Document, Collateral Agent may obtain such insurance or make such payment, and all amounts so paid by Collateral Agent are Lenders’ Expenses and immediately due and payable, bearing interest at the Default Rate, and secured by the Collateral.  Collateral Agent will make reasonable efforts to provide Borrower with notice of Collateral Agent obtaining such insurance or making such payment at the time it is obtained or paid or within a reasonable time thereafter.  No such payments by Collateral Agent are deemed an agreement to make similar payments in the future or Collateral Agent’s waiver of any Event of Default.

 

9.4                                Application of Payments and Proceeds.   Notwithstanding anything to the contrary contained in this Agreement, upon the occurrence and during the continuance of an Event of Default, (a) Borrower irrevocably waives the right to direct the application of any and all payments at any time or times thereafter received by Collateral Agent from or on behalf of Borrower or  any of its Subsidiaries of all or any part of the Obligations, and, as between Borrower on the one hand and Collateral Agent and Lenders on the other, Collateral Agent shall have the continuing and exclusive right to apply and to reapply any and all payments received against the Obligations in such manner as Collateral Agent may deem advisable notwithstanding any previous application by Collateral Agent, and (b) the proceeds of any sale of, or other realization upon all or any part of the Collateral shall be applied: first, to the Lenders’ Expenses; second, to accrued and unpaid interest on the Obligations (including any interest which, but for the provisions of the United States Bankruptcy Code, would have accrued on such amounts); third, to the principal amount of the Obligations outstanding; and fourth, to any other indebtedness or obligations of Borrower owing to Collateral Agent or any Lender under the Loan Documents.  Any balance remaining shall be delivered to Borrower or to whoever may be lawfully entitled to receive such balance or as a court of competent jurisdiction may direct.  In carrying out the foregoing, (x) amounts received shall be applied in the numerical order provided until exhausted prior to the application to the next succeeding category, and (y) each of the Persons entitled to receive a payment in any particular category shall receive an amount equal to its pro rata share of amounts available to be applied pursuant thereto for such category.  Any reference in this Agreement to an allocation between or sharing by the Lenders of any right, interest or obligation “ratably,” “proportionally” or in similar terms shall refer to Pro Rata Share unless expressly provided otherwise.  Collateral Agent, or if applicable, each Lender, shall promptly remit to the other Lenders such sums as may be necessary to ensure the ratable repayment of each Lender’s portion of any Term Loan and the ratable distribution of interest, fees and reimbursements paid or made by Borrower.  Notwithstanding the foregoing, a Lender receiving a scheduled payment shall not be responsible for determining whether the other Lenders also received their scheduled payment on such date; provided, however, if it is later determined that a Lender received more than its ratable share of scheduled payments made on any date or dates, then such Lender shall remit to Collateral Agent or other Lenders such sums as may be necessary to ensure the ratable payment of such scheduled payments, as instructed by Collateral Agent.  If any payment or distribution of any kind or character, whether in cash, properties or securities, shall be received by a Lender in excess of its ratable share, then the portion of such payment or distribution in excess of such Lender’s ratable share shall be received by such Lender in trust for and shall be promptly paid over to the other Lender for application to the payments of amounts due on the other Lenders’ claims.  To the extent any payment for the account of Borrower is required to be returned as a voidable transfer or otherwise, the Lenders shall contribute to one another as is necessary to ensure that such return of payment is on a pro rata basis.  If any Lender shall obtain possession of any Collateral, it shall hold such Collateral for itself and as agent and bailee for Collateral Agent and other Lenders for purposes of perfecting Collateral Agent’s security interest therein.

 

9.5                                Liability for Collateral.   So long as Collateral Agent and the Lenders comply with reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Collateral Agent and the Lenders, Collateral Agent and the Lenders shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person.  Borrower bears all risk of loss, damage or destruction of the Collateral.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

9.6                                No Waiver; Remedies Cumulative.   Failure by Collateral Agent or any Lender, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Collateral Agent or any Lender thereafter to demand strict performance and compliance herewith or therewith.  No waiver hereunder shall be effective unless signed by Collateral Agent and the Required Lenders and then is only effective for the specific instance and purpose for which it is given.  The rights and remedies of Collateral Agent and the Lenders under this Agreement and the other Loan Documents are cumulative.  Collateral Agent and the Lenders have all rights and remedies provided under the Code, any applicable law, by law, or in equity.  The exercise by Collateral Agent or any Lender of one right or remedy is not an election, and Collateral Agent’s or any Lender’s waiver of any Event of Default is not a continuing waiver.  Collateral Agent’s or any Lender’s delay in exercising any remedy is not a waiver, election, or acquiescence.

 

9.7                                Demand Waiver.   Borrower waives, to the fullest extent permitted by law, demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Collateral Agent or any Lender on which Borrower or any Subsidiary is liable.

 

10.                                NOTICES

 

All notices, consents, requests, approvals, demands, or other communication by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below.  Any of Collateral Agent, Lender or Borrower may change its mailing address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section 10.

 

If to Borrower:

 

STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY
CORTENDO AB
CORTENDO CAYMAN LTD.
STRONGBRIDGE U.S. INC.
900 Northbrook Drive
Suite 200
Trevose, Pennsylvania 19053
Attn: Chief Legal Officer
Fax: 215-355-7389
Email: s.long@strongbridgebio.com

 

 

 

with a copy (which shall not constitute notice) to:

 

Reed Smith LLP
599 Lexington Avenue
New York, New York 10022
Attn: Lee Ann Dillon
Fax: 212-521-5450
Email: ldillon@reedsmith.com

 

 

 

If to Collateral Agent or Oxford:

 

OXFORD FINANCE LLC
133 North Fairfax Street
Alexandria, Virginia 22314
Attention: Legal Department
Fax: (703) 519-5225
Email: LegalDepartment@oxfordfinance.com

 

 

 

If to Horizon:

 

HORIZON TECHNOLOGY FINANCE CORPORATION

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

 

 

312 Farmington Avenue
Farmington, Connecticut 06032
Attn: Legal Department
Fax: (860) 676-8655
Email: Jay@horizontechfinance.com

 

 

 

with a copy (which shall not constitute notice) to:

 

Greenberg Traurig, LLP
One International Place
Boston, MA 02110
Attn: Jonathan Bell
Fax: (617) 310-6001
Email: bellj@gtlaw.com

 

11.                                CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER

 

New York law governs the Loan Documents without regard to principles of conflicts of law (except as to any other Loan Documents, as expressly set forth therein).  Borrower, Lenders and Collateral Agent each submit to the exclusive jurisdiction of the State and Federal courts in the City of New York, Borough of Manhattan.  NOTWITHSTANDING THE FOREGOING, COLLATERAL AGENT AND THE LENDERS SHALL HAVE THE RIGHT TO BRING ANY ACTION OR PROCEEDING AGAINST BORROWER OR ITS PROPERTY IN THE COURTS OF ANY OTHER JURISDICTION WHICH COLLATERAL AGENT AND THE LENDERS (IN ACCORDANCE WITH THE PROVISIONS OF SECTION 9.1) DEEM NECESSARY OR APPROPRIATE TO REALIZE ON THE COLLATERAL OR TO OTHERWISE ENFORCE COLLATERAL AGENT’S AND THE LENDERS’ RIGHTS AGAINST BORROWER OR ITS PROPERTY.  Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any such court, and Borrower hereby waives any objection that it may have based upon lack of personal jurisdiction, improper venue, or forum non conveniens and hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court.  Borrower hereby waives personal service of the summons, complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 10 of this Agreement and that service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or three (3) days after deposit in the U.S. mails, first class, registered or certified mail return receipt requested, proper postage prepaid.

 

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER, COLLATERAL AGENT, AND THE LENDERS EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR EACH PARTY TO ENTER INTO THIS AGREEMENT.  EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.

 

12.                                GENERAL PROVISIONS

 

12.1                         Successors and Assigns. This Agreement binds and is for the benefit of the successors and permitted assigns of each party.  Borrower may not transfer, pledge or assign this Agreement or any rights or obligations under it without Collateral Agent’s and each Lender’s prior written consent (which may be granted or withheld in Collateral Agent’s and each Lender’s discretion, subject to Section 12.6).  The Lenders have the right, without the consent of or notice to Borrower, to sell, transfer, assign, pledge, negotiate, or grant participation in (any such sale, transfer, assignment, negotiation , or grant of a participation, a “Lender Transfer”) all or any part of, or any interest in, the Lenders’ obligations, rights, and benefits under this Agreement and the other Loan Documents; provided , however , that any such Lender Transfer (other than a transfer, pledge, sale or assignment to an Eligible Assignee) of its obligations, rights, and benefits under this Agreement and the other Loan Documents shall require the prior written consent of the Required Lenders (such approved assignee, an “ Approved Lender ”) .   Borrower and Collateral Agent shall be entitled to continue to deal solely and directly with such Lender in connection with the interests so assigned until Collateral Agent shall have received and accepted an effective assignment agreement in

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

form satisfactory to Collateral Agent executed, delivered and fully completed by the applicable parties thereto, and shall have received such other information regarding such Eligible Assignee or Approved Lender as Collateral Agent reasonably shall require.  The Collateral Agent, acting solely for this purpose as an agent of Borrower, shall maintain in the United States a copy of each effective assignment and assumption agreement received and accepted by it and a register for the recordation of the names and addresses of the Lenders, and the interest and principal amount of the Term Loans owing to each Lender pursuant to the terms hereof from time to time (the “ Register ”).  The entries in the Register shall be conclusive and binding for all purposes, absent manifest error, and Borrower, the Collateral Agent and the Lenders shall treat each person whose name is recorded in the Register as a Lender hereunder for all purposes of this Agreement.  The Register shall be available for inspection by Borrower or any Lender at any reasonable time and from time to time upon reasonable prior notice.  Notwithstanding anything to the contrary contained herein, so long as no Event of Default has occurred and is continuing, no Lender Transfer (other than a Lender Transfer (i) in respect of the Warrants or (ii) in connection with (x) assignments by a Lender due to a forced divestiture at the request of any regulatory agency; or (y) upon the occurrence of a default, event of default or similar occurrence with respect to a Lender’s own financing or securitization transactions) shall be permitted, without Borrower’s consent, to any Person which is an Affiliate or Subsidiary of Borrower, a direct competitor of Borrower or a vulture hedge fund, each as determined by Collateral Agent.

 

12.2                         Indemnification.   Borrower agrees to indemnify, defend and hold Collateral Agent and the Lenders and their respective directors, officers, employees, agents, attorneys, or any other Person affiliated with or representing Collateral Agent or the Lenders (each, an “ Indemnified Person ”) harmless against:  (a) all obligations, demands, claims, and liabilities (collectively, “ Claims ”) asserted by any other party in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents; and (b) all losses or Lenders’ Expenses incurred, or paid by Indemnified Person in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents between Collateral Agent, and/or the Lenders and Borrower (including reasonable attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s  gross negligence or willful misconduct.  Borrower hereby further indemnifies, defends and holds each Indemnified Person harmless from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements of any kind or nature whatsoever (including the fees and disbursements of counsel for such Indemnified Person) in connection with any investigative, response, remedial, administrative or judicial matter or proceeding, whether or not such Indemnified Person shall be designated a party thereto and including any such proceeding initiated by or on behalf of Borrower, and the reasonable expenses of investigation by engineers, environmental consultants and similar technical personnel and any commission, fee or compensation claimed by any broker (other than any broker retained by Collateral Agent or Lenders) asserting any right to payment for the transactions contemplated hereby which may be imposed on, incurred by or asserted against such Indemnified Person as a result of or in connection with the transactions contemplated hereby and the use or intended use of the proceeds of the loan proceeds except for liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements directly caused by such Indemnified Person’s gross negligence or willful misconduct.

 

12.3                         Time of Essence .   Time is of the essence for the performance of all Obligations in this Agreement.

 

12.4                         Severability of Provisions .   Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.

 

12.5                         Correction of Loan Documents.   Collateral Agent and the Lenders may correct patent errors and fill in any blanks in this Agreement and the other Loan Documents consistent with the agreement of the parties so long as Collateral Agent provides Borrower with written notice of such correction and allows Borrower at least ten (10) days to object to such correction. In the event of such objection, such correction shall not be made except by an amendment signed by both Collateral Agent and Borrower .

 

12.6                         Amendments in Writing; Integration .   (a) No amendment, modification, termination or waiver of any provision of this Agreement or any other Loan Document, no approval or consent thereunder, or any consent to any departure by Borrower or any of its Subsidiaries therefrom, shall in any event be effective unless the same shall be in writing and signed by Borrower, Collateral Agent and the Required Lenders provided that:

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(i)                                      no such amendment, waiver or other modification that would have the effect of increasing or reducing a Lender’s Term Loan Commitment or Commitment Percentage shall be effective as to such Lender without such Lender’s written consent;

 

(ii)                                   no such amendment, waiver or modification that would affect the rights and duties of Collateral Agent shall be effective without Collateral Agent’s written consent or signature;

 

(iii)                                no such amendment, waiver or other modification shall, unless signed by all the Lenders directly affected thereby, (A) reduce the principal of, rate of interest on or any fees with respect to any Term Loan or forgive any principal, interest (other than default interest) or fees (other than late charges) with respect to any Term Loan (B) postpone the date fixed for, or waive, any payment of principal of any Term Loan or of interest on any Term Loan (other than default interest) or any fees provided for hereunder (other than late charges or for any termination of any commitment); (C) change the definition of the term “ Required Lenders ” or the percentage of Lenders which shall be required for the Lenders to take any action hereunder; (D) release all or substantially all of any material portion of the Collateral, authorize Borrower to sell or otherwise dispose of all or substantially all or any material portion of the Collateral or release any Guarantor of all or any portion of the Obligations or its guaranty obligations with respect thereto, except, in each case with respect to this clause (D), as otherwise may be expressly permitted under this Agreement or the other Loan Documents (including in connection with any disposition permitted hereunder); (E) amend, waive or otherwise modify this Section 12.6 or the definitions of the terms used in this Section 12.6 insofar as the definitions affect the substance of this Section 12.6; (F) consent to the assignment, delegation or other transfer by Borrower of any of its rights and obligations under any Loan Document or release Borrower of its payment obligations under any Loan Document, except, in each case with respect to this clause (F), pursuant to a merger or consolidation permitted pursuant to this Agreement; (G) amend any of the provisions of Section 9.4 or amend any of the definitions of Pro Rata Share, Term Loan Commitment, Commitment Percentage or that provide for the Lenders to receive their Pro Rata Shares of any fees, payments, setoffs or proceeds of Collateral hereunder; (H) subordinate the Liens granted in favor of Collateral Agent securing the Obligations; or (I) amend any of the provisions of Section 12.10.  It is hereby understood and agreed that all Lenders shall be deemed directly affected by an amendment, waiver or other modification of the type described in the preceding clauses (C), (D), (E), (F), (G) and (H) of the preceding sentence;

 

(iv)                               the provisions of the foregoing clauses (i), (ii) and (iii) are subject to the provisions of any interlender or agency agreement among the Lenders and Collateral Agent pursuant to which any Lender may agree to give its consent in connection with any amendment, waiver or modification of the Loan Documents only in the event of the unanimous agreement of all Lenders.

 

(b)                                  This Agreement and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements.  All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Agreement and the Loan Documents merge into this Agreement and the Loan Documents.

 

12.7                         Counterparts .   This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

 

12.8                         Survival .   All covenants, representations and warranties made in this Agreement continue in full force and effect until this Agreement has terminated pursuant to its terms and all Obligations (other than inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement) have been satisfied.  The obligation of Borrower in Section 12.2 to indemnify each Lender and Collateral Agent, as well as the confidentiality provisions in Section 12.9 below, shall survive until the statute of limitations with respect to such claim or cause of action shall have run.

 

12.9                         Confidentiality .   In handling any confidential information of Borrower, the Lenders and Collateral Agent shall exercise the same degree of care that it exercises for their own proprietary information, but disclosure of information may be made: (a) subject to the terms and conditions of this Agreement, to the Lenders’ and Collateral Agent’s Subsidiaries or Affiliates, or in connection with a Lender’s own financing or securitization transactions and upon the occurrence of a default, event of default or similar occurrence with respect to such

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

financing or securitization transaction; (b) to prospective transferees (other than those identified in (a) above) or purchasers of any interest in the Credit Extensions (provided, however, the Lenders and Collateral Agent shall, except upon the occurrence and during the continuation of an Event of Default, obtain such prospective transferee’s or purchaser’s agreement to the terms of this provision or to similar confidentiality terms); (c) as required by law, regulation, subpoena, or other order; (d) to Lenders’ or Collateral Agent’s regulators or as otherwise required in connection with an examination or audit; (e) as Collateral Agent reasonably considers appropriate in exercising remedies under the Loan Documents; and (f) to third party service providers of the Lenders and/or Collateral Agent so long as such service providers have executed a confidentiality agreement with the Lenders and Collateral Agent with terms no less restrictive than those contained herein. Confidential information does not include information that either: (i) is in the public domain or in the Lenders’ and/or Collateral Agent’s possession when disclosed to the Lenders and/or Collateral Agent, or becomes part of the public domain after disclosure to the Lenders and/or Collateral Agent; or (ii) is disclosed to the Lenders and/or Collateral Agent by a third party, if the Lenders and/or Collateral Agent does not know that the third party is prohibited from disclosing the information.  Collateral Agent and the Lenders may use confidential information for any purpose, including, without limitation, for the development of client databases, reporting purposes, and market analysis.  The provisions of the immediately preceding sentence shall survive the termination of this Agreement.  The agreements provided under this Section 12.9 supersede all prior agreements, understanding, representations, warranties, and negotiations between the parties about the subject matter of this Section 12.9.

 

12.10                  Right of Set Off .   Borrower hereby grants to Collateral Agent and to each Lender, a lien, security interest and right of set off as security for all Obligations to Collateral Agent and each Lender hereunder, whether now existing or hereafter arising upon and against all deposits, credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Collateral Agent or the Lenders or any entity under the control of Collateral Agent or the Lenders (including a Collateral Agent affiliate) or in transit to any of them.  At any time after the occurrence and during the continuance of an Event of Default, without demand or notice, Collateral Agent or the Lenders may set off the same or any part thereof and apply the same to any liability or obligation of Borrower even though unmatured and regardless of the adequacy of any other collateral securing the Obligations.  ANY AND ALL RIGHTS TO REQUIRE COLLATERAL AGENT TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED.

 

12.11                  Cooperation of Borrower.   If necessary, Borrower agrees to (i) execute any documents (including new Secured Promissory Notes) reasonably required to effectuate and acknowledge each assignment of a Term Loan Commitment or Loan to an assignee in accordance with Section 12.1, (ii) make Borrower’s management available to meet with Collateral Agent and prospective participants and assignees of Term Loan Commitments or Credit Extensions (which meetings shall be conducted no more often than twice every twelve months unless an Event of Default has occurred and is continuing), and (iii) assist Collateral Agent or the Lenders in the preparation of information relating to the financial affairs of Borrower as any prospective participant or assignee of a Term Loan Commitment or Term Loan reasonably may request.

 

12.12                  Borrower Liability .  Any Borrower may, acting singly, request Credit Extensions hereunder provided that no Credit Extensions may occur hereunder to the extent that a violation of Section 7.12 hereof would occur as a result thereof.  Each Borrower hereby appoints the other as agent for the other for all purposes hereunder, including with respect to requesting Credit Extensions hereunder.  Each Borrower hereunder shall be jointly and severally obligated to repay all Credit Extensions made hereunder, regardless of which Borrower actually receives said Credit Extension, as if each Borrower hereunder directly received all Credit Extensions.  Each Borrower waives (a) any suretyship defenses available to it under the Code or any other applicable law, and (b) any right to require Collateral Agent or any Lender to: (i) proceed against any Borrower or any other person; (ii) proceed against or exhaust any security; or (iii) pursue any other remedy.  Collateral Agent and or any Lender may exercise or not exercise any right or remedy it has against any Borrower or any security it holds (including the right to foreclose by judicial or non-judicial sale) without affecting any Borrower’s liability.  Notwithstanding any other provision of this Agreement or other related document, each Borrower irrevocably waives all rights that it may have at law or in equity (including, without limitation, any law subrogating Borrower to the rights of Collateral Agent and the Lenders under this Agreement) to seek contribution, indemnification or any other form of reimbursement from any other Borrower, or any other Person now or hereafter primarily or secondarily liable for any of the Obligations, for

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

any payment made by Borrower with respect to the Obligations in connection with this Agreement or otherwise and all rights that it might have to benefit from, or to participate in, any security for the Obligations as a result of any payment made by Borrower with respect to the Obligations in connection with this Agreement or otherwise.  Any agreement providing for indemnification, reimbursement or any other arrangement prohibited under this Section shall be null and void.  If any payment is made to a Borrower in contravention of this Section, (x) such Borrower (other than Swedish Borrower) shall hold such payment in trust for Collateral Agent and the Lenders and such payment shall be promptly delivered to Collateral Agent for application to the Obligations, whether matured or unmatured, and (y) Swedish Borrower shall hold such payment as agent on behalf of the Collateral Agent and the Lenders and such payment shall be treated as “escrow funds” ( redovisningsmedel ) and held on a separate account in accordance with the Swedish Act of 1944 in respect of assets held on account ( Lag (1944:181) om redovisningsmedel ) and shall promptly pay or transfer the same to the Collateral Agent or as the Collateral Agent may direct for application to the Obligations, whether matured or unmatured.

 

13.                                DEFINITIONS

 

13.1                         Definitions .   As used in this Agreement, the following terms have the following meanings:

 

Account ” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.

 

Account Debtor ” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made.

 

Affiliate ” of any Person is a Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person’s managers and members.

 

Agreement ” is defined in the preamble hereof.

 

Amortization Date ” is, (i) July 1, 2018, if Term C Loans are not made hereunder, and (ii) January 1, 2019, if Term C Loans are made hereunder.

 

Annual Net Product Revenue Projections ” is defined in Section 6.2(a).

 

Annual Projections ” is defined in Section 6.2(a).

 

Anti-Terrorism Laws ” are any laws relating to terrorism or money laundering, including Executive Order No. 13224 (effective September 24, 2001), the USA PATRIOT Act, the laws comprising or implementing the Bank Secrecy Act, and the laws administered by OFAC.

 

Approved Fund ” is any (i) investment company, fund, trust, securitization vehicle or conduit that is (or will be) engaged in making, purchasing, holding or otherwise investing in commercial loans and similar extensions of credit in the ordinary course of its business or (ii) any Person (other than a natural person) which temporarily warehouses loans for any Lender or any entity described in the preceding clause (i) and that, with respect to each of the preceding clauses (i) and (ii), is administered or managed by (a) a Lender, (b) an Affiliate of a Lender or (c) a Person (other than a natural person) or an Affiliate of a Person (other than a natural person) that administers or manages a Lender.

 

Approved Lender ” is defined in Section 12.1.

 

Basic Rate ” is with respect to the Term Loan, the per annum rate of interest (based on a year of three hundred sixty (360) days) equal to the sum of (a) the greater of (i) the thirty (30) day U.S. LIBOR rate reported in The Wall Street Journal on the last Business Day of the month that immediately precedes the month in which the interest will accrue and (ii) fifty three hundredths percent (0.53%), plus (b) Eight and twenty two hundredths percent

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(8.22%).  Notwithstanding the foregoing, under no circumstances shall the Basic Rate for the Term Loans be less than Eight and seventy-five hundredths percent (8.75%).

 

Blocked Person is any Person:  (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list.

 

Borrower ” is defined in the preamble hereof.

 

Borrower’s Books ” are Borrower’s or any of its Subsidiaries’ books and records including ledgers, federal, and state tax returns, records regarding Borrower’s or its Subsidiaries’ assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.

 

Business Day ” is any day that is not a Saturday, Sunday or a day on which Collateral Agent is closed.

 

Cash Equivalents are (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., and (c) certificates of deposit maturing no more than one (1) year after issue provided that the account in which any such certificate of deposit is maintained is subject to a Control Agreement in favor of Collateral Agent.  For the avoidance of doubt, the direct purchase by Borrower or any of its Subsidiaries of any Auction Rate Securities, or purchasing participations in, or entering into any type of swap or other derivative transaction, or otherwise holding or engaging in any ownership interest in any type of Auction Rate Security by Borrower or any of its Subsidiaries shall be conclusively determined by the Lenders as an ineligible Cash Equivalent, and any such transaction shall expressly violate each other provision of this Agreement governing Permitted Investments.  Notwithstanding the foregoing, Cash Equivalents does not include and Borrower, and each of its Subsidiaries, are prohibited from purchasing, purchasing participations in, entering into any type of swap or other equivalent derivative transaction, or otherwise holding or engaging in any ownership interest in any type of debt instrument, including, without limitation, any corporate or municipal bonds with a long-term nominal maturity for which the interest rate is reset through a dutch auction and more commonly referred to as an auction rate security (each, an “ Auction Rate Security ”).

 

Cayman Collateral Accounts ” means the Collateral Accounts maintained by Cayman Borrower in the Cayman Islands.

 

Cayman Security Documents ” means the debenture and related security documents entered into by the Cayman Borrower in furtherance hereof.

 

Claims ” are defined in Section 12.2.

 

Code ” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the State of New York; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Collateral Agent’s Lien and each Lender’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of New York, the term “Code” shall mean the Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Collateral ” is any and all properties, rights and assets of Borrower described on Exhibit A , provided that to the extent that any property, assets and rights of Borrower in Ireland or Sweden to which a first position lien is created in favor of the Collateral Agent pursuant to the terms of the Irish Security Documents also constitutes Collateral for the purposes of this Agreement the terms of the Irish Security Documents shall prevail in determining the rights of the Collateral Agent and the Lenders with respect thereto.

 

Collateral Account ” is any Deposit Account, Securities Account, or Commodity Account, or any other bank account maintained by Borrower or any of its Subsidiaries at any time.

 

Collateral Agent ” is defined in the preamble hereof.

 

Commitment Percentage ” is set forth in Schedule 1.1 , as amended from time to time.

 

Commodity Account ” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made.

 

Compliance Certificate ” is that certain certificate in the form attached hereto as Exhibit C .

 

Contingent Obligation ” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation directly or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn letters of credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business.  The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.

 

Control Agreement ” is any control agreement entered into among the depository institution at which Borrower or any of its Subsidiaries maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower or any of its Subsidiaries maintains a Securities Account or a Commodity Account, pursuant to which Collateral Agent obtains control (within the meaning of the Code) for the benefit of the Lenders over such Deposit Account, Securities Account, or Commodity Account.

 

Copyrights ” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work or authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.

 

Credit Extension ” is any Term Loan or any other extension of credit by Collateral Agent or Lenders for Borrower’s benefit.

 

Default Rate ” is defined in Section 2.3(b).

 

Deposit Account ” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.

 

Designated Deposit Account ” is Borrower’s deposit account, account number 3302076072 maintained with Silicon Valley Bank.

 

Disbursement Letter ” is that certain form attached hereto as Exhibit B.

 

Dollars , ” “ dollars ” and “ $ ” each mean lawful money of the United States.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Effective Date ” is defined in the preamble hereof.

 

Eligible Assignee ” is (i) a Lender, (ii) an Affiliate of a Lender, (iii) an Approved Fund and (iv) any commercial bank, savings and loan association or savings bank or any other entity which is an “accredited investor” (as defined in Regulation D under the Securities Act of 1933, as amended) and which extends credit or buys loans as one of its businesses, including insurance companies, mutual funds, lease financing companies and commercial finance companies, in each case, which either (A) has a rating of BBB or higher from Standard & Poor’s Rating Group and a rating of Baa2 or higher from Moody’s Investors Service, Inc. at the date that it becomes a Lender or (B) has total assets in excess of Five Billion Dollars ($5,000,000,000.00), and in each case of clauses (i) through (iv), which, through its applicable lending office, is capable of lending to Borrower without the imposition of any withholding or similar taxes; provided that notwithstanding the foregoing, “Eligible Assignee” shall not include, unless an Event of Default has occurred and is continuing, (i) Borrower or any of Borrower’s Affiliates or Subsidiaries or (ii) a direct competitor of Borrower or a vulture hedge fund, each as determined by Collateral Agent.  Notwithstanding the foregoing, (x) in connection with assignments by a Lender due to a forced divestiture at the request of any regulatory agency, the restrictions set forth herein shall not apply and Eligible Assignee shall mean any Person or party and (y) in connection with a Lender’s own financing or securitization transactions, the restrictions set forth herein shall not apply and Eligible Assignee shall mean any Person or party providing such financing or formed to undertake such securitization transaction and any transferee of such Person or party upon the occurrence of a default, event of default or similar occurrence with respect to such financing or securitization transaction; provided that no such sale, transfer, pledge or assignment under this clause (y) shall release such Lender from any of its obligations hereunder or substitute any such Person or party for such Lender as a party hereto until Collateral Agent shall have received and accepted an effective assignment agreement from such Person or party in form satisfactory to Collateral Agent executed, delivered and fully completed by the applicable parties thereto, and shall have received such other information regarding such Eligible Assignee as Collateral Agent reasonably shall require.

 

Enforcement Order ” shall have the meaning set forth in Section 4.1

 

Equipment ” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.

 

ERISA ” is the Employee Retirement Income Security Act of 1974, as amended, and its regulations.

 

Event of Default ” is defined in Section 8.

 

Final Payment ” is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest) due on the earliest to occur of (a) the Maturity Date, or (b) the acceleration of any Term Loan, or (c) the prepayment of a Term Loan pursuant to Section 2.2(c) or (d), equal to the original principal amount of such Term Loan multiplied by the Final Payment Percentage, payable to Lenders in accordance with their respective Pro Rata Shares.

 

Final Payment Percentage ” is Eight percent (8.00%).

 

First Equity Event ” is the receipt by Irish Borrower on or after November 14, 2016 and on or prior to the Effective Date of unrestricted gross cash proceeds of not less than Twenty Million Dollars ($20,000,000.00) from the issuance and sale by Borrower of its equity securities.

 

First Revenue Event ” is the achievement by U.S. Borrower on or after the Effective Date for each of its months and or before October 31, 2017 (with respect to the six-month period then ending), of consolidated trailing six-month Keveyis Net Product Revenues of at least [****] Dollars ($[****]), as determined by Collateral Agent based upon written evidence satisfactory to Collateral Agent.

 

Funding Date ” is any date on which a Credit Extension is made to or on account of Borrower which shall be a Business Day.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

GAAP ” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other Person as may be approved by a significant segment of the accounting profession in the United States, which are applicable to the circumstances as of the date of determination.

 

General Intangibles ” are all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work, whether published or unpublished, any patents, trademarks, service marks and, to the extent permitted under applicable law, any applications therefor, whether registered or not, any trade secret rights, including any rights to unpatented inventions, payment intangibles, royalties, contract rights, goodwill, franchise agreements, purchase orders, customer lists, route lists, telephone numbers, domain names, claims, income and other tax refunds, security and other deposits, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.

 

Governmental Approval ” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

 

Governmental Authority ” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.

 

Guarantor ” is any Person providing a Guaranty in favor of Collateral Agent.

 

Guaranty ” is any guarantee of all or any part of the Obligations, as the same may from time to time be amended, restated, modified or otherwise supplemented.

 

Indebtedness ” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.

 

Indemnified Person ” is defined in Section 12.2.

 

Insolvency Proceeding ” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other applicable bankruptcy or insolvency law relating to bankruptcy, suspension of payments, a moratorium of any indebtedness, administration, examinership, insolvency, liquidation, receivership, dissolution, winding up or relief of debtors including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization (including by way of a voluntary arrangement, scheme of arrangement or otherwise), arrangement, or other relief.

 

Insolvent ” means not Solvent.

 

Intellectual Property ” means all of Borrower’s or any Subsidiary’s right, title and interest in and to the following:

 

(a)                                  its Copyrights, Trademarks and Patents;

 

(b)                                  any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know-how, operating manuals;

 

(c)                                   any and all source code;

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(d)                                  any and all design rights which may be available to Borrower;

 

(e)                                   any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and

 

(f)                                    all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.

 

Inventory ” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of any Person’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

 

Investment ” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance, payment or capital contribution to any Person.

 

IP Agreement ” is that certain Intellectual Property Security Agreement entered into by and between Borrower and Collateral Agent dated as of the Effective Date, as such may be amended from time to time.

 

IRC ” means the U.S. Internal Revenue Code of 1986, as amended.

 

Irish Collateral Accounts ” means the Collateral Accounts maintained by Irish Borrower in Ireland.

 

Irish Companies Act ” means the Companies Act 2014 of Ireland.

 

Irish Security Documents ” means, collectively, the all-asset debenture entered into by Irish Borrower in furtherance hereof, incorporating first ranking fixed and floating charges over all of its assets and undertaking, including, but not limited to, a fixed charge over the Irish Collateral Accounts and the Security Deed entered into by the Swedish Borrower in furtherance hereof, incorporating first ranking fixed and floating charges over certain of its assets and undertaking located in Ireland.

 

Keveyis Acquisition Event ” is the acquisition by Borrower of marketing rights in the United States to Keveyis™ (dichlorphenamide), as well as an exclusive license in the United States to the trademark Keveyis™, in each case from an affiliate of Taro Pharmaceutical Industries Ltd.

 

Keveyis Net Product Revenue ” is calculated as gross product revenue of Keveyis® less (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) reserves for expected product returns, (d) estimated costs of any patient co-pay assistance program, and (e) any other revenue deductions in accordance with GAAP.

 

Key Person ” is each of Borrower’s (i) Chief Executive Officer, who is Matthew Pauls as of the Effective Date, (ii) Chief Financial Officer, who is A. Brian Davis as of the Effective Date and (iii) Senior Vice President, Global Research & Development, who is Fredric Cohen as of the Effective Date.

 

Lender ” is any one of the Lenders.

 

Lenders ” are the Persons identified on Schedule 1.1 hereto and each assignee that becomes a party to this Agreement pursuant to Section 12.1.

 

Lenders’ Expenses ” are all audit fees and expenses, costs, and expenses (including reasonable attorneys’ fees and expenses, as well as appraisal fees, fees incurred on account of lien searches, inspection fees, and filing fees) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (including,

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred by Oxford in connection with the Loan Documents.

 

Lien ” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest, or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.

 

Loan Documents ” are, collectively, this Agreement, the Officer’s Certificates, the Warrants, the Perfection Certificates, each Compliance Certificate, each Disbursement Letter, the IP Agreement, the Cayman Security Documents, the Swedish Security Document, the Irish Security Documents, any subordination agreements, any note, or notes or guaranties executed by Borrower or any other Person, and any other present or future agreement entered into by Borrower, any Guarantor or any other Person for the benefit of the Lenders and Collateral Agent in connection with this Agreement; all as amended, amended and restated, supplemented or otherwise modified.

 

Material Adverse Change ” is (a) a material impairment in the perfection or priority of Collateral Agent’s Lien or any Lender’s Lien in the Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations or condition (financial or otherwise) of Borrower or any Subsidiary; or (c) a material impairment of the prospect of repayment of any portion of the Obligations.

 

Maturity Date ” is, for each Term Loan, December 1, 2020.

 

Net Product Revenue ” is gross product revenue of the Irish Borrower less (a) trade allowances, such as discounts for prompt payment, (b) estimated government rebates and chargebacks, (c) reserves for expected product returns, (d) estimated costs of any patient co-pay assistance program, and (e) any other revenue deductions in accordance with GAAP.

 

Non-US Lender ” shall have the meaning assigned to such term in Section 2.6(b).

 

Obligations ” are all of Borrower’s obligations to pay when due any debts, principal, interest, Lenders’ Expenses, the Prepayment Fee, the Final Payment, and other amounts Borrower owes the Lenders now or later, in connection with, related to, following, or arising from, out of or under, this Agreement or, the other Loan Documents (other than the Warrants), or otherwise, and including interest accruing after Insolvency Proceedings begin (whether or not allowed) and debts, liabilities, or obligations of Borrower assigned to the Lenders and/or Collateral Agent, and the performance of Borrower’s duties under the Loan Documents (other than the Warrants).

 

OFAC ” is the U.S. Department of Treasury Office of Foreign Assets Control.

 

OFAC Lists ” are, collectively, the Specially Designated Nationals and Blocked Persons List maintained by OFAC pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001) and/or any other list of terrorists or other restricted Persons maintained pursuant to any of the rules and regulations of OFAC or pursuant to any other applicable Executive Orders.

 

Officer’s Certificates ” are the corporate borrowing certificates for Borrower (which, in the case of Irish Borrower, shall be executed by a director and, in the case of Swedish Borrower, shall be executed by an authorized signatory) to be delivered as a condition precedent under Section 3.1(i).

 

Operating Documents ” are, for any Person, such Person’s constitutional documents, formation documents and/or certificate of incorporation (or equivalent thereof), as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form, (b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto or in all such cases, the equivalent thereof in any relevant jurisdiction.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Patents ” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

 

Payment Date ” is the first (1 st ) calendar day of each calendar month, commencing on February 1, 2017.

 

Perfection Certificate ” and “ Perfection Certificates ” is defined in Section 5.1.

 

Permitted Bank of America Account ” means a Deposit Account of Borrower held at Bank of America, N.A. for not more than 30 days from the Effective Date without a Control Agreement in favor of the Collateral Agent, for the ratable benefit of the Lenders, in an amount not to exceed at any time the lesser of (i) $5,000,000.00, or (ii) an amount of Borrower’s cash and Cash Equivalents in excess of an amount equal to 1.5 times the outstanding principal balance of the Term Loans.

 

Permitted Indebtedness ” is:

 

(a)                                  Borrower’s Indebtedness to the Lenders and Collateral Agent under this Agreement and the other Loan Documents;

 

(b)                                  Indebtedness existing on the Effective Date and disclosed on the Perfection Certificate(s);

 

(c)                                   Subordinated Debt;

 

(d)                                  unsecured Indebtedness to trade creditors incurred in the ordinary course of business and aged less than one hundred eighty (180) days;

 

(e)                                   Indebtedness consisting of capitalized lease obligations and purchase money Indebtedness, in each case incurred by Borrower or any of its Subsidiaries to finance the acquisition, repair, improvement or construction of fixed or capital assets of such person, provided that (i) the aggregate outstanding principal amount of all such Indebtedness does not exceed One Hundred Thousand Dollars ($100,000.00) at any time and (ii) the principal amount of such Indebtedness does not exceed the lower of the cost or fair market value of the property so acquired or built or of such repairs or improvements financed with such Indebtedness (each measured at the time of such acquisition, repair, improvement or construction is made);

 

(f)                                    Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of Borrower’s business;

 

(g)                                   Indebtedness not to exceed $100,000.00 in the aggregate at any one time outstanding owed to Bank of America, N.A. or any of its Affiliates under a corporate credit card program between the Borrower and such lender; and

 

(h)                                  extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (e)  and (g) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose materially more burdensome terms upon Borrower, or its Subsidiary, as the case may be.

 

Permitted Investments ” are:

 

(a)                                  Investments disclosed on the Perfection Certificate(s) and existing on the Effective Date;

 

(b)                                  (i) Investments consisting of cash and Cash Equivalents, and (ii) any other Investments permitted by Borrower’s investment policy, as amended from time to time, provided that such investment policy (and any such amendment thereto) has been approved in writing by Collateral Agent;

 

(c)                                   Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of Borrower;

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(d)           Investments consisting of deposit accounts in which Collateral Agent has a perfected security interest;

 

(e)           Investments in connection with Transfers permitted by Section 7.1;

 

(f)            (i) Investments by a Borrower or a Guarantor in another Borrower or Guarantor, and (ii) other Investments by Borrower or Guarantor in Subsidiaries that are not a Borrower or a Guarantor (other than BioPancreate Inc.) not to exceed One Hundred Thousand Dollars ($100,000.00) in any given fiscal year, provided that in no event may any investment permitted hereunder result in a violation of Section 7.12 hereof;

 

(g)           Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) subject to an applicable Requirement of Law, loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by Borrower’s Board of Directors; not to exceed One Hundred Thousand Dollars ($100,000.00) in the aggregate for (i) and (ii) in any fiscal year;

 

(h)           Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business;

 

(i)            Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; provided that this paragraph (i) shall not apply to Investments of Borrower in any Subsidiary; and

 

(j)            non-cash Investments in joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of the non-exclusive licensing of technology, the development of technology or the providing of technical support.

 

Permitted Licenses ” are (A) licenses granted in accordance with Section 4.1, (B) licenses of over-the-counter software that is commercially available to the public, and (C) non-exclusive and exclusive licenses for the use of the Intellectual Property of Borrower or any of its Subsidiaries entered into in the ordinary course of business, provided , that, with respect to each such license described in clause (C), (i) no Event of Default has occurred or is continuing at the time of such license; (ii) the license constitutes an arms-length transaction, the terms of which, on their face, do not provide for a sale or assignment of any Intellectual Property and do not restrict the ability of Borrower or any of its Subsidiaries, as applicable, to pledge, grant a security interest in or lien on, or assign or otherwise Transfer any Intellectual Property; (iii) in the case of any exclusive license, (x) Borrower delivers ten (10) days’ prior written notice and a brief summary of the terms of the proposed license to Collateral Agent and the Lenders and delivers to Collateral Agent and the Lenders copies of the final executed licensing documents in connection with the exclusive license promptly upon consummation thereof, and (y) any such license could not result in a legal transfer of title of the licensed property but may be exclusive in respects other than territory and may be exclusive as to territory only as to discrete geographical areas outside of the United States; and (iv) all upfront payments, royalties, milestone payments or other proceeds arising from the licensing agreement that are payable to Borrower or any of its Subsidiaries are paid to a Deposit Account that is governed by a Control Agreement.

 

Permitted Liens ” are:

 

(a)           Liens existing on the Effective Date and disclosed on the Perfection Certificates or  arising under this Agreement and the other Loan Documents;

 

(b)           Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on its Books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

(c)           liens securing Indebtedness permitted under clause (e) of the definition of “ Permitted Indebtedness ,” provided that (i) such liens exist prior to the acquisition of, or attach substantially simultaneous with, or within twenty (20) days after the, acquisition, lease, repair, improvement or construction of, such property financed or leased by such Indebtedness and (ii) such liens do not extend to any property of Borrower other than the property (and proceeds thereof) acquired, leased or built, or the improvements or repairs, financed by such Indebtedness;

 

(d)           liens securing Indebtedness permitted under clause (g) of the definition of “ Permitted Indebtedness ” provided that such liens only attach to cash collateral located in an account of Borrower held at the lender of such Indebtedness in an amount not to exceed $100,000.00 at any one time;

 

(e)           Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed Twenty Five Thousand Dollars ($25,000.00), and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

 

(f)            Liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);

 

(g)           Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;

 

(h)           leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non-exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Collateral Agent or any Lender a security interest therein;

 

(i)            banker’s liens, rights of setoff and Liens in favor of financial institutions incurred in the ordinary course of business arising in connection with Borrower’s deposit accounts or securities accounts held at such institutions solely to secure payment of fees and similar costs and expenses and provided such accounts are maintained in compliance with Section 6.6(b) hereof;

 

(j)            Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default under Section 8.4 or 8.7; and

 

(k)           Liens consisting of Permitted Licenses.

 

Person ” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.

 

Positive Data Event means Collateral Agent’s and Lenders’ receipt, on or before March 31, 2018, of the following, in such form and substance as are acceptable to Collateral Agent and Lenders in their respective discretion: (i) evidence of meeting of primary endpoint within the overall group of SONICS (COR-2012-01) as described in Protocol Amendment #6 to SONICS dated 25 October 2016, filed with the US Food and Drug Administration to IND #115,968 on 22 November 2016 (Serial #047) along with evidence from the same study that COR-003 has an acceptable safety profile, in the opinion of the study’s Independent Data Safety Monitoring Board (as reflected in meeting minutes), which combined evidence supports continued development of the drug, (ii) a Responsible Officer’s certificate certifying that the primary endpoint within the overall group of SONICS (COR-2012-01) as described in Protocol Amendment #6 to SONICS dated 25 October 2016, filed with the US Food and

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Drug Administration to IND #115,968 on 22 November 2016 (Serial #047) has been met along with evidence from the same study that COR-003 has an acceptable safety profile, in the opinion of the study’s Independent Data Safety Monitoring Board (as reflected in meeting minutes), which combined evidence supports continued development of the drug and (iii) a copy of a press release issued by the Borrower announcing that the events described in clause (i) hereof have occurred.

 

Prepayment Fee ” is, with respect to any Term Loan subject to prepayment prior to the Maturity Date, whether by mandatory or voluntary prepayment, acceleration or otherwise, an additional fee payable to the Lenders in amount equal to:

 

(i)            for a prepayment made on or after the Funding Date of such Term Loan through and including the first anniversary of the Funding Date of such Term Loan, four percent (4.00%) of the outstanding principal amount of such Term Loan prepaid;

 

(ii)           for a prepayment made after the date which is after the first anniversary of the Funding Date of such Term Loan through and including the second anniversary of the Funding Date of such Term Loan, three percent (3.00%) of the outstanding principal amount of such Term Loan prepaid; and

 

(iii)          for a prepayment made after the date which is after the second anniversary of the Funding Date of such Term Loan and prior to the Maturity Date, two percent (2.00%) of the outstanding principal amount of such Term Loan prepaid.

 

Pro Rata Share ” is, as of any date of determination, with respect to each Lender, a percentage (expressed as a decimal, rounded to the ninth decimal place) determined by dividing the outstanding principal amount of Term Loans held by such Lender by the aggregate outstanding principal amount of all Term Loans.

 

Registered Organization ” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made.

 

Required Lenders ” means (i) for so long as all of the Persons that are Lenders on the Effective Date (each an “ Original Lender ”) have not assigned or transferred any of their interests in their Term Loan, Lenders holding one hundred percent (100%) of the aggregate outstanding principal balance of the Term Loan, or (ii) at any time from and after any Original Lender has assigned or transferred any interest in its Term Loan, Lenders holding at least sixty six percent (66%) of the aggregate outstanding principal balance of the Term Loan and, in respect of this clause (ii), (A) each Original Lender that has not assigned or transferred any portion of its Term Loan, (B) each assignee or transferee of an Original Lender’s interest in the Term Loan, but only to the extent that such assignee or transferee is an Affiliate or Approved Fund of such Original Lender, and (C) any Person providing financing to any Person described in clauses (A) and (B) above; provided, however, that this clause (C) shall only apply upon the occurrence of a default, event of default or similar occurrence with respect to such financing.

 

Requirement of Law ” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

 

Responsible Officer ” is any of the President, Chief Executive Officer, or Chief Financial Officer of Borrower acting alone (provided, in the case of Irish Borrower, such person is also a director) or in the case of Swedish Borrower, an authorized signatory.

 

Second Draw Period ” is the period commencing on the date that is the later of the (i) the date of the occurrence of the First Revenue Event, (ii) Positive Data Event and (iii) the date of the occurrence of the Second Equity Event and ending on the earliest of (i) the date that is thirty (30) days immediately following the date of on which the Second Draw Period commenced, (ii) April 30, 2018 and (iii) the occurrence of an Event of Default; provided, however, that the Second Draw Period shall not commence if on the date of the occurrence of the First Revenue Event, the date of occurrence of the Positive Data Event or the date of the occurrence of the Second Equity

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Event, an Event of Default has occurred and is continuing; provided, further, that the Second Draw Period shall not commence until all of the First Revenue Event, Positive Data Event and the Second Equity Event have occurred.

 

Second Equity Event ” is the receipt by Irish Borrower on or after November 14, 2016 and on or prior to March 31, 2018 of unrestricted gross cash proceeds of not less than Thirty Million Dollars ($30,000,000.00), which amount shall include the proceeds received as part of the equity financing transaction constituting the First Equity Event, from the issuance and sale by Borrower of its equity securities.

 

Second Revenue Event ” is the achievement by U.S. Borrower on or after the Effective Date and on or before June 30, 2018 of consolidated trailing six-month Keveyis Net Product Revenues of at least [****] Dollars ($[****]), as determined by Collateral Agent based upon written evidence satisfactory to Collateral Agent.

 

Secured Promissory Note ” is defined in Section 2.4.

 

Secured Promissory Note Record ” is a record maintained by each Lender with respect to the outstanding Obligations owed by Borrower to Lender and credits made thereto.

 

Securities Account ” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made.

 

Shares ” is one hundred percent (100%) of the issued and outstanding capital stock, membership units or other securities owned or held of record by Borrower or Borrower’s Subsidiary, in any Subsidiary.

 

Solvent ” is, with respect to any Person: the fair salable value of such Person’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of such Person’s liabilities (or, in the case of Irish Borrower, the value of its assets is not less than its liabilities (taking into account contingent and prospective liabilities)); such Person is not left with unreasonably small capital after the transactions in this Agreement; and such Person is able to pay its debts (including trade debts) as they mature and is not deemed or declared to be unable to pay its debts under applicable law.

 

Subordinated Debt ” is indebtedness incurred by Borrower or any of its Subsidiaries party to a Loan Document subordinated to all Indebtedness of Borrower and/or its Subsidiaries party to a Loan Document to the Lenders (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Collateral Agent and the Lenders entered into between Collateral Agent, Borrower, and/or any of its Subsidiaries party to a Loan Document, and the other creditor), on terms acceptable to Collateral Agent and the Lenders.

 

Subsidiary ” is, with respect to any Person, any Person of which more than fifty percent (50%) of the voting stock or other equity interests (in the case of Persons other than corporations) is owned or controlled, directly or indirectly, by such Person or through one or more intermediaries.

 

Swedish Collateral Accounts ” means the Collateral Accounts maintained by the Swedish Borrower in Sweden.

 

Swedish Security Document ” means the all-asset debenture entered into by Swedish Borrower in furtherance hereof, incorporating first ranking fixed and floating charges over all of its assets and undertaking, including, but not limited to, a fixed charge over the Swedish Collateral Accounts.

 

Swedish Share Pledge ” means the Swedish law-governed share pledge entered into by Irish Borrower with respect to Shares in the Swedish Borrower.

 

TCA ” means the Irish Taxes Consolidation Act 1997.

 

Term A Loan ” is defined in Section 2.2(a)(i) hereof.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Term B Loan ” is defined in Section 2.2(a)(ii) hereof.

 

Term C Loan ” is defined in Section 2.2(a)(iii) hereof.

 

Term Loan ” is defined in Section 2.2(a)(iii) hereof.

 

Term Loan Commitment ” is, for any Lender, the obligation of such Lender to make a Term Loan, up to the principal amount shown on Schedule 1.1 .   “ Term Loan Commitments ” means the aggregate amount of such commitments of all Lenders.

 

Third Draw Period ” is the period commencing on the date that is later of the (i) the date of the occurrence of the Second Revenue Event and (ii) the Funding Date of the Term B Loans and ending on the earliest of (i) the date that is thirty (30) days immediately following the date of on which the Third Draw Period commenced, (ii) June 30, 2018 and (iii) the occurrence of an Event of Default; provided, however, that the Third Draw Period shall not commence if on the date of the occurrence of the Second Revenue Event an Event of Default has occurred and is continuing; provided, further, that the Third Draw Period shall not commence until the Second Revenue Event and the funding of the Term B Loans have occurred.

 

Trademarks ” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.

 

Transfer ” is defined in Section 7.1.

 

U.S. Collateral Account ” means Borrower’s Collateral Account that is maintained in the United States and is subject to a Control Agreement in favor of Collateral Agent.

 

Warrants ” are those certain Warrants to Purchase Stock dated as of the Effective Date, or any date thereafter, issued by Irish Borrower in favor of each Lender or such Lender’s Affiliates.

 

[ Balance of Page Intentionally Left Blank ]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be executed (in the case of Irish Borrower, as a deed) as of the Effective Date.

 

BORROWER:

 

 

 

 

 

STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY

 

 

 

 

 

 

 

 

By

/s/ Stephen Long

 

 

Name:

Stephen Long

 

 

Title:

Chief Legal Officer

 

 

 

 

 

 

 

 

CORTENDO AB

 

 

 

 

 

 

 

 

By

/s/ Stephen Long

 

 

Name:

Stephen Long

 

 

Title:

Authorized Officer

 

 

 

 

 

STRONGBRIDGE U.S. INC.

 

 

 

 

 

By

/s/ Stephen Long

 

 

Name:

Stephen Long

 

 

Title:

Chief Legal Officer

 

 

 

 

 

 

 

 

CORTENDO CAYMAN LTD.

 

 

 

 

 

By

/s/ Stephen Long

 

 

Name:

Stephen Long

 

 

Title:

Director

 

 

 

 

 

LENDER AND COLLATERAL AGENT:

 

 

 

 

 

OXFORD FINANCE LLC

 

 

 

 

 

 

 

 

By

/s/ Mark Davis

 

 

Name:

Mark Davis

 

 

Title:

Vice President of Finance

 

 

 

 

 

 

 

 

 

 

LENDER:

 

 

 

HORIZON TECHNOLOGY FINANCE CORPORATION

 

 

 

 

 

 

 

 

 

 

By

/s/ Robert D. Pomeroy, Jr.

 

 

Name:

Robert D. Pomeroy, Jr.

 

 

Title:

Chief Executive Officer

 

[ Signature Page to Loan and Security Agreement ]

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SCHEDULE 1.1

 

Lenders and Commitments

 

Term A Loans

 

Lender

 

Term Loan Commitment

 

Commitment Percentage

 

OXFORD FINANCE LLC

 

$

12,500,000.00

 

62.5

%

HORIZON TECHNOLOGY FINANCE CORPORATION

 

$

7,500,000.00

 

37.5

%

TOTAL

 

$

20,000,000.00

 

100.00

%

 

Term B Loans

 

Lender

 

Term Loan Commitment

 

Commitment Percentage

 

OXFORD FINANCE LLC

 

$

6,250,000.00

 

62.5

%

HORIZON TECHNOLOGY FINANCE CORPORATION

 

$

3,750,000.00

 

37.5

%

TOTAL

 

$

10,000,000.00

 

100.00

%

 

Term C Loans

 

Lender

 

Term Loan Commitment

 

Commitment Percentage

 

OXFORD FINANCE LLC

 

$

6,250,000.00

 

62.5

%

HORIZON TECHNOLOGY FINANCE CORPORATION

 

$

3,750,000.00

 

37.5

%

TOTAL

 

$

10,000,000.00

 

100.00

%

 

Aggregate (all Term Loans)

 

Lender

 

Term Loan Commitment

 

Commitment Percentage

 

OXFORD FINANCE LLC

 

$

25,000,000.00

 

62.5

%

HORIZON TECHNOLOGY FINANCE CORPORATION

 

$

15,000,000.00

 

37.5

%

TOTAL

 

$

40,000,000.00

 

100.00

%

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT A

 

Description of Collateral

 

The Collateral consists of all of Borrower’s right, title and interest in and to the following personal property:

 

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (including all Intellectual Property, commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts and other Collateral Accounts, all certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other personal property, investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

 

All Borrower’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT B

 

Form of Disbursement Letter

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

DISBURSEMENT LETTER

 

[DATE]

 

The undersigned, being the duly elected and acting                                            of                              STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland with company number 562659 and having its registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2, Ireland , on behalf of itself and each other Borrower under the Loan Agreement (as defined below) (individually and collectively, jointly and severally, “ Borrower ”), does hereby certify to OXFORD FINANCE LLC (“ Oxford ” and “ Lender ”), as collateral agent (the “ Collateral Agent ”) and in connection with that certain Loan and Security Agreement dated as of December [_], 2016, by and among Borrower, Collateral Agent and the Lenders from time to time party thereto (the “ Loan Agreement ”; with other capitalized terms used below having the meanings ascribed thereto in the Loan Agreement) that:

 

1.             The representations and warranties made by Borrower in Section 5 of the Loan Agreement and in the other Loan Documents are true and correct in all material respects as of the date hereof.

 

2.             No event or condition has occurred that would constitute an Event of Default under the Loan Agreement or any other Loan Document.

 

3.             Borrower is in compliance with the covenants and requirements contained in Sections 4, 6 and 7 of the Loan Agreement.

 

4.             All conditions referred to in Section 3 of the Loan Agreement to the making of the Loan to be made on or about the date hereof have been satisfied or waived by Collateral Agent.

 

5.             No Material Adverse Change has occurred.

 

6.             The undersigned is a Responsible Officer.

 

[Balance of Page Intentionally Left Blank]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

7.             The proceeds of the Term [A][B][C] Loan shall be disbursed to US Borrower as follows:

 

 

Disbursement from Oxford:

 

 

 

 

Loan Amount

 

$                       

 

 

Plus:

 

 

 

 

—Deposit Received

 

$              

 

 

 

 

 

 

 

Less:

 

 

 

 

—Facility Fee

 

($             

)

 

[—Interim Interest

 

($               

)]

 

—Lender’s Legal Fees

 

($             

)*

 

 

 

 

 

 

Net Proceeds due from Oxford:

 

$                       

 

 

 

 

 

 

 

Disbursement from Horizon:

 

 

 

 

Loan Amount

 

$                       

 

 

Plus:

 

 

 

 

—Deposit Received

 

$               

 

 

 

 

 

 

 

Less:

 

 

 

 

—Facility Fee

 

($             

)

 

[—Interim Interest

 

($               

)]

 

 

 

 

 

 

Net Proceeds due from Horizon:

 

$                       

 

 

 

 

 

 

 

TOTAL TERM [A][B][C] LOAN NET PROCEEDS FROM LENDERS

 

$                       

 

 

8.             The [initial][Term Loan][Term A Loan] shall amortize in accordance with the Amortization Table attached hereto.

 

9.             The aggregate net proceeds of the Term Loans shall be transferred to the Designated Deposit Account as follows:

 

 

Account Name:

 

[BORROWER]

 

 

Bank Name:

 

[       ]

 

 

Bank Address:

 

[       ]

 

 

Account Number:

 

 

 

 

ABA Number:

 

[       ]

 

 

[Balance of Page Intentionally Left Blank]

 


* Legal fees and costs are through the Effective Date.  Post-closing legal fees and costs, payable after the Effective Date, to be invoiced and paid post-closing.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Dated as of the date first set forth above.

 

BORROWER:

 

 

 

 

 

STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, on behalf of itself and all other Borrowers

 

 

 

 

 

 

 

 

By

 

 

 

Name:

 

 

 

Title:

 

 

 

 

 

 

 

 

 

COLLATERAL AGENT AND LENDER:

 

 

 

 

 

OXFORD FINANCE LLC

 

 

 

 

 

 

 

 

By

 

 

 

Name:

 

 

 

Title:

 

 

 

 

 

 

LENDER:

 

 

HORIZON TECHNOLOGY FINANCE CORPORATION

 

 

 

 

 

 

 

 

By

 

 

 

Name:

 

 

 

Title:

 

 

 

 

[ Signature Page to Disbursement Letter ]

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

AMORTIZATION TABLE
(Term [A][B][C] Loan)

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT C

 

Compliance Certificate

 

TO:

 

OXFORD FINANCE LLC, as Collateral Agent and Lender
HORIZON TECHNOLOGY FINANCE CORPORATION, as Lender

 

 

 

FROM:

 

STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, on behalf of itself and all other Borrowers

 

The undersigned authorized officer (“ Officer ”) of STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, on behalf of itself and all other Borrowers under and as defined in the Loan Agreement (as defined herein below) (individually and collectively, jointly and severally, “ Borrower ”), hereby certifies that in accordance with the terms and conditions of the Loan and Security Agreement by and among Borrower, Collateral Agent, and the Lenders from time to time party thereto (the “ Loan Agreement ;” capitalized terms used but not otherwise defined herein shall have the meanings given them in the Loan Agreement),

 

(a)                                  Borrower is in complete compliance for the period ending                 with all required covenants except as noted below;

 

(b)                                  There are no Events of Default, except as noted below;

 

(c)                                   Except as noted below, all representations and warranties of Borrower stated in the Loan Documents are true and correct in all material respects on this date and for the period described in (a), above; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date.

 

(d)                                  Borrower, and each of Borrower’s Subsidiaries, has timely filed all required tax returns and reports, Borrower, and each of Borrower’s Subsidiaries, has timely paid all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower, or Subsidiary, except as otherwise permitted pursuant to the terms of Section 5.8 of the Loan Agreement;

 

(e)                                   No Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Collateral Agent and the Lenders.

 

Attached are the required documents, if any, supporting our certification(s).  The Officer, on behalf of Borrower, further certifies that the attached financial statements are prepared in accordance with Generally Accepted Accounting Principles (GAAP) and are consistently applied from one period to the next except as explained in an accompanying letter or footnotes and except, in the case of unaudited financial statements, for the absence of footnotes and subject to year-end audit adjustments as to the interim financial statements.

 

Please indicate compliance status since the last Compliance Certificate by circling Yes, No, or N/A under “Complies” column.

 

 

 

Reporting Covenant

 

Requirement

 

Actual

 

Complies

 

 

 

 

 

 

 

 

 

 

 

 

 

1)

 

Financial statements

 

Monthly within 30 days

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

2)

 

Annual (CPA Audited) statements

 

Within 120 days after FYE

 

 

 

Yes

 

No

 

N/A

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

3)

 

Annual Financial Projections/Budget (prepared on a monthly basis)

 

Annually (within 30 days of FYE), and when revised

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

4)

 

A/R & A/P agings

 

If applicable

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

5)

 

8-K, 10-K and 10-Q Filings

 

If applicable, within 5 days of filing

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

6)

 

Compliance Certificate

 

Monthly within 30 days

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

7)

 

IP Report

 

When required

 

 

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

8)

 

Total amount of Borrower’s cash and cash equivalents at the last day of the measurement period

 

 

 

$

 

Yes

 

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

9)

 

Total amount of Borrower’s Subsidiaries’ cash and cash equivalents at the last day of the measurement period

 

 

 

$

 

Yes

 

No

 

N/A

 

Deposit and Securities Accounts

(Please list all accounts; attach separate sheet if additional space needed)

 

 

 

Account
Holder

 

Institution
Name

 

Account
Number

 

New
Account?

 

Account Control Agreement in
place?

 

 

 

 

 

 

 

 

 

 

 

 

 

1)

 

 

 

 

 

 

 

Yes

 

No

 

Yes

 

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2)

 

 

 

 

 

 

 

Yes

 

No

 

Yes

 

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3)

 

 

 

 

 

 

 

Yes

 

No

 

Yes

 

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4)

 

 

 

 

 

 

 

Yes

 

No

 

Yes

 

No

 

Financial Covenants

 

 

 

Covenant

 

Requirement

 

Actual

 

Compliance

 

 

 

 

 

 

 

 

 

 

 

 

 

1)

 

Minimum Product Revenues
(trailing twelve months)]

 

As shown in the officer’s certificate referenced in Section 6.2(a)(iii) or at least 80% of Annual Net Product Revenue Projections

 

[      %]

 

Yes

 

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[$         ]

 

[$            ]

 

 

 

 

 

 

Other Matters

 

1)

 

Have there been any changes in management since the last Compliance Certificate?

 

Yes

 

No

 

 

 

 

 

 

 

 

 

2)

 

Have there been any transfers/sales/disposals/retirement of Collateral or IP prohibited by the Loan Agreement?

 

Yes

 

No

 

 

 

 

 

 

 

 

 

3)

 

Have there been any new or pending claims or causes of action against Borrower that involve more than One Hundred Thousand Dollars ($100,000.00)?

 

Yes

 

No

 

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

4)

 

Have there been any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries?  If yes, provide copies of any such amendments or changes with this Compliance Certificate.

 

Yes

 

No

 

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

Exceptions

 

Please explain any exceptions with respect to the certification above: (If no exceptions exist, state “No exceptions.”  Attach separate sheet if additional space needed.)

 

STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, on behalf of itself and all other Borrowers

 

By

 

 

 

Name:

 

 

 

Title:

 

 

 

 

 

 

 

Date:

 

 

 

 

 

 

 

LENDER USE ONLY

 

 

 

Received by:

 

Date:

 

 

 

 

 

 

 

Verified by:

 

Date:

 

 

 

 

 

Compliance Status:                 Yes                 No

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT D

 

Form of Secured Promissory Note

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

SECURED PROMISSORY NOTE
(Term [A][B][C] Loan)

 

$

Dated: [DATE]

 

FOR VALUE RECEIVED, the undersigned, and STRONGBRIDGE BIOPHARMA PUBLIC LIMITED COMPANY, a public limited company incorporated under the laws of Ireland with company number 562659 and having its registered office at Arthur Cox Building, Earlsfort Terrace, Dublin 2 (“ Irish Borrower ”), CORTENDO CAYMAN LTD., an exempted company incorporated in the Cayman Islands with its registered office located at Maples Corporate Services PO Box 309 Ugland House Grand Cayman KY1-1104 (“ Cayman Borrower ”), CORTENDO AB (PUBL), a public limited company incorporate under the laws of Sweden with corporate identity number 556537-6554 and having its registered office at Box 47 433 21 Partille Gothenburg Sweden (“ Swedish Borrower ”) and STRONGBRIDGE U.S. INC., a Delaware corporation with an office located at 900 Northbrook Drive, Suite 200, Trevose, Pennsylvania 19053 (“ US Borrower ” and together with Irish Borrower, Cayman Borrower and Swedish Borrower, individually and collectively, jointly and severally, “ Borrower ”) HEREBY PROMISES TO PAY [OXFORD FINANCE LLC][ HORIZON TECHNOLOGY FINANCE CORPORATION] (“ Lender ”) the principal amount of [           ] MILLION DOLLARS ($              ) or such lesser amount as shall equal the outstanding principal balance of the Term [A][B][C] Loan made to Borrower by Lender, plus interest on the aggregate unpaid principal amount of such Term [A][B][C] Loan, at the rates and in accordance with the terms of the Loan and Security Agreement dated [DATE] by and among Borrower, Lender, Oxford Finance LLC, as Collateral Agent, and the other Lenders from time to time party thereto (as amended, restated, supplemented or otherwise modified from time to time, the “ Loan Agreement ”).  If not sooner paid, the entire principal amount and all accrued and unpaid interest hereunder shall be due and payable on the Maturity Date as set forth in the Loan Agreement.  Any capitalized term not otherwise defined herein shall have the meaning attributed to such term in the Loan Agreement.

 

Principal, interest and all other amounts due with respect to the Term [A][B][C] Loan, are payable in lawful money of the United States of America to Lender as set forth in the Loan Agreement and this Secured Promissory Note (this “ Note ”).  The principal amount of this Note and the interest rate applicable thereto, and all payments made with respect thereto, shall be recorded by Lender and, prior to any transfer hereof, endorsed on the grid attached hereto which is part of this Note.

 

The Loan Agreement, among other things, (a) provides for the making of a secured Term [A][B][C] Loan by Lender to Borrower, and (b) contains provisions for acceleration of the maturity hereof upon the happening of certain stated events.

 

This Note may not be prepaid except as set forth in Section 2.2 (c) and Section 2.2(d) of the Loan Agreement.

 

This Note and the obligation of Borrower to repay the unpaid principal amount of the Term [A][B][C] Loan, interest on the Term [A][B][C] Loan and all other amounts due Lender under the Loan Agreement is secured under the Loan Agreement.

 

Presentment for payment, demand, notice of protest and all other demands and notices of any kind in connection with the execution, delivery, performance and enforcement of this Note are hereby waived.

 

Borrower shall pay all reasonable fees and expenses, including, without limitation, reasonable attorneys’ fees and costs, incurred by Lender in the enforcement or attempt to enforce any of Borrower’s obligations hereunder not performed when due.

 

This Note shall be governed by, and construed and interpreted in accordance with, the internal laws of the State of New York.

 

The ownership of an interest in this Note shall be registered on a record of ownership maintained by Lender or its agent.  Notwithstanding anything else in this Note to the contrary, the right to the principal of, and stated interest on, this Note may be transferred only if the transfer is registered on such record of ownership and the transferee is

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

identified as the owner of an interest in the obligation.  Borrower shall be entitled to treat the registered holder of this Note (as recorded on such record of ownership) as the owner in fact thereof for all purposes and shall not be bound to recognize any equitable or other claim to or interest in this Note on the part of any other person or entity.

 

[Balance of Page Intentionally Left Blank]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

IN WITNESS WHEREOF, Borrower has caused this Note to be duly executed by one of its officers thereunto duly authorized on the date hereof.

 

 

BORROWER:

 

 

 

STRONGBRIDGE BIOPHARMA

 

PUBLIC LIMITED COMPANY

 

 

 

 

 

By

 

 

Name:

 

 

Title:

 

 

 

 

 

 

BORROWER:

 

 

 

CORTENDO AB

 

 

 

 

 

By

 

 

Name:

 

 

Title:

 

 

 

 

 

 

BORROWER:

 

 

 

STRONGBRIDGE U.S. INC.

 

 

 

 

 

By

 

 

Name:

 

 

Title:

 

 

 

 

 

 

BORROWER:

 

 

 

CORTENDO CAYMAN LTD.

 

 

 

 

 

By

 

 

Name:

 

 

Title:

 

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

LOAN INTEREST RATE AND PAYMENTS OF PRINCIPAL

 

Name of
Borrower
Receiving Term
[A][B][C] Loan

 

Date

 

Principal
Amount

 

Interest Rate

 

Scheduled
Payment
Amount

 

Notation By

 

 

 

 

 

 

 

 

 

 

 

Strongbridge U.S. Inc.

 

 

 

 

 

 

 

 

 

 

 


 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

CORPORATE BORROWING CERTIFICATE

 

BORROWER :

[BORROWER]

DATE : [DATE]

LENDER[S]:

OXFORD FINANCE LLC, as Collateral Agent and Lender

 

 

HORIZON TECHNOLOGY FINANCE CORPORATION, as Lender

 

 

 

I hereby certify as follows, as of the date set forth above:

 

1.             I am the Secretary, Assistant Secretary or other officer of Borrower.  My title is as set forth below.

 

2.             Borrower’s exact legal name is set forth above.  Borrower is a [BORROWER ORGANIZATION] existing under the laws of the State of [BORROWER STATE].

 

3.             Attached hereto as Exhibit A and Exhibit B , respectively, are true, correct and complete copies of (i) Borrower’s Articles/Certificate of Incorporation (including amendments), as filed with the Secretary of State of the state in which Borrower is incorporated as set forth in paragraph 2 above; and (ii) Borrower’s Bylaws.  Neither such Articles/Certificate of Incorporation nor such Bylaws have been amended, annulled, rescinded, revoked or supplemented, and such Articles/Certificate of Incorporation and such Bylaws remain in full force and effect as of the date hereof.

 

4.             The resolutions attached hereto as Exhibit C were duly and validly adopted by Borrower’s Board of Directors at a duly held meeting of such directors (or pursuant to a unanimous written consent or other authorized corporate action).  Such resolutions are in full force and effect as of the date hereof and have not been in any way modified, repealed, rescinded, amended or revoked, and the Lenders may rely on them until each Lender receives written notice of revocation from Borrower.

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

[ Balance of Page Intentionally Left Blank ]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

5.             T he persons listed below are Borrower’s officers or employees with their titles and signatures shown next to their names and are authorized to act on behalf of Borrower.

 

Name

 

Title

 

Signature

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

*** If the Secretary, Assistant Secretary or other certifying officer executing above is designated by the resolutions set forth in paragraph 4 as one of the authorized signing officers, this Certificate must also be signed by a second authorized officer or director of Borrower.

 

I, the                                      of Borrower, hereby certify as to paragraphs 1 through 5 above, as of the date set forth above.

                       [print title]

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

 

[ Signature Page to Corporate Borrowing Certificate

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT A

 

Articles/Certificate of Incorporation (including amendments)

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT B

 

Bylaws

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

EXHIBIT C

 

Resolutions

 

[see attached]

 



 

CONFIDENTIAL TREATMENT REQUESTED UNDER
C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.
[****] INDICATES OMITTED MATERIAL THAT IS
THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST
FILED SEPARATELY WITH THE COMMISSION.
THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE COMMISSION.

 

DEBTOR:

[BORROWER]

SECURED PARTY:

OXFORD FINANCE LLC,

 

as Collateral Agent

 

EXHIBIT A TO UCC FINANCING STATEMENT

 

Description of Collateral

 

The Collateral consists of all of Debtor’s right, title and interest in and to the following personal property:

 

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (including all Intellectual Property, commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts and other Collateral Accounts, all certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

 

All Borrower’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

 

Capitalized terms used but not defined herein have the meanings ascribed in the Uniform Commercial Code in effect in the State of New York as in effect from time to time (the “Code”) or, if not defined in the Code, then in the Loan and Security Agreement by and between Debtor, Secured Party and the other Lenders party thereto (as modified, amended and/or restated from time to time).

 




Exhibit 23.1

 

Consent of Independent Registered Public Accounting Firm

 

We consent to the reference to our firm under the caption “Experts” in this Registration Statement (Form F-3) and related Prospectus of Strongbridge Biopharma plc for the registration of 28,265,833 of its ordinary shares and to the incorporation by reference therein of our report dated March 24, 2016, with respect to the consolidated financial statements of Strongbridge Biopharma, included in its Annual Report (Form 20-F) for the year ended December 31, 2015, filed with the Securities and Exchange Commission.

 

/s/ Ernst & Young LLP

 

Philadelphia, PA

January 12, 2017

 




Exhibit 23.2

 

Consent of Independent Registered Public Accounting Firm

 

We consent to the reference to our firm under the caption “Experts” in this Registration Statement (Form F-3) and related Prospectus of Strongbridge Biopharma plc for the registration of 28,265,833 of its ordinary shares and to the incorporation by reference therein of our report dated August 17, 2015, with respect to the consolidated financial statements of Strongbridge Biopharma, included in its Annual Report (Form 20-F) for the year ended December 31, 2014, filed with the Securities and Exchange Commission.

 

/s/ Ernst & Young AB

 

Gothenburg, Sweden

January 12, 2017