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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Ireland
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98-1032470
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of each class
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Name of each exchange on which registered
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Ordinary shares, nominal value $0.0001 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
x
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Accelerated filer
¨
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Non-accelerated filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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Page
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PART I
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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PART II
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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PART III
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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PART IV
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Item 15.
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Item 1.
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Business
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•
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Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
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•
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Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
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•
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Defitelio
®
(defibrotide)
, a product approved in Europe for the treatment of severe hepatic veno-occlusive disease, or VOD, in adults and children undergoing hematopoietic stem cell transplantation, or HSCT, therapy.
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•
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Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications;
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Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
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Pursuing targeted development of post-discovery differentiated product candidates.
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JZP-110.
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•
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Xyrem
.
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•
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Defibrotide.
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•
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Erwinaze.
We are pursuing activities related to the potential development of an effective and well-tolerated long-acting recombinant crisantaspase that would offer benefits compared to Erwinaze. We are also assessing the potential to pursue regulatory approval of Erwinaze in additional countries.
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•
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Xyrem
. Xyrem is the only product approved by the FDA for the treatment of both cataplexy and EDS in patients with narcolepsy. No product other than Xyrem is approved by the FDA for the treatment of cataplexy. The only other products approved by the FDA for the treatment of EDS in patients with narcolepsy are Provigil
®
(modafinil) and Nuvigil
®
(armodafinil), which are marketed by Teva Pharmaceutical Industries Limited, or Teva, and generic versions of Provigil. Provigil, its generic equivalents and Nuvigil are also approved for improving wakefulness in patients with EDS associated with treated OSA or shift work disorder. Xyrem is often used in conjunction with stimulants and wake-promoting drugs, which are administered during the day.
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•
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Erwinaze
. Erwinaze is a biologic product used in conjunction with chemotherapy and is indicated for patients with ALL who have developed hypersensitivity to
E. coli
-derived asparaginase. While there is currently no direct competition to Erwinaze to treat ALL patients with hypersensitivity to
E. coli
-derived asparaginase, other companies have developed or are developing new treatments for ALL, including new asparaginase treatments that could reduce the rate of hypersensitivity in patients with ALL, and new treatment protocols are being developed for ALL that may not include asparaginase-containing regimens. For example, a number of companies are developing new immunotherapy treatments for relapsed or refractory ALL patients, including one treatment that was recently approved, and a company recently announced positive efficacy and safety results from its completed Phase 2/3 pivotal trial in Europe for an alternative asparaginase treatment consisting of L-asparaginase encapsulated inside donor-derived red blood cells. Any potential new treatment could reduce the market for Erwinaze. As a biologic product, Erwinaze also faces potential competition from biosimilar products.
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Defitelio/defibrotide
.
Defitelio is the first approved treatment in the EU for the treatment of severe VOD in adults and children undergoing HSCT, and in September 2015, the FDA accepted for filing with priority review our NDA for defibrotide for the treatment of VOD with evidence of multi-organ dysfunction following HSCT. Various anti-clotting strategies have been tried by researchers in patients with VOD with mixed results, including Activase (alteplase), a recombinant tissue plasminogen activator marketed by Genentech, Inc., generic heparin sodium
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the existence of competing or alternative products in the marketplace, including generic competition, and the relative price of those products;
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the efficacy, safety and reliability of our products and product candidates compared to competing or alternative products;
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product acceptance by physicians, other health care providers and patients;
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our ability to comply with applicable laws, regulations and regulatory requirements with respect to the commercialization of our products, including any changes or increases to regulatory restrictions;
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protection of our proprietary rights;
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obtaining reimbursement for our products in approved indications;
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our ability to complete clinical development and obtain regulatory approvals for our product candidates, and the timing and scope of regulatory approvals;
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our ability to provide a reliable supply of commercial quantities of a product to the market; and
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our ability to recruit, retain and develop skilled employees, including sales and marketing and clinical development employees.
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Xyrem.
Xyrem is covered by 20 U.S. patents that expire at various times from December 2019 to March 2033, of which 16 are listed in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” or Orange Book. These patents relate to Xyrem’s stable and microbially resistant formulation, its manufacturing process, its method of use, including its restricted distribution system, and its method of administration. Of the patents listed in the Orange Book, four are formulation patents expiring between December 2019 and July 2020; seven are method of use patents covering the distribution of Xyrem expiring between December 2022 and June 2024; three are method of use patents covering Xyrem’s use in narcolepsy, which expire in December 2019; and two are method of administration patents expiring in March 2033. Four patents are not listed in the Orange Book but also relate to Xyrem: two for methods for making the formulation expiring December 2019, one for a distribution system expiring June 2024 and one for method of administration expiring March 2033. A Xyrem formulation patent has issued in multiple non-U.S. countries and will expire in December 2019. In addition to our issued patents, we have patent applications relating to Xyrem pending in the U.S. and other countries.
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Defitelio
. The unique process of deriving defibrotide from porcine DNA is extensive and uses both chemical and biological processes that rely on complex characterization methods. We have a portfolio of U.S. and non-U.S. patents and patent applications relating to various compositions, methods of use and methods of characterization, which will expire at various times between April 2017 and June 2035.
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JZP-110
. JZP-110 and its associated uses are claimed in multiple U.S. and non-U.S. patents and patent applications. We acquired rights to JZP-110 from Aerial in January 2014, including Aerial’s patent rights relating to JZP-110, other than in certain jurisdictions in Asia where SK retains rights. One of the U.S. composition of matter patents expired on September 2015. Two U.S. method of use patents covering treatment of sleep-related conditions will expire in June 2026 and August 2027, respectively, subject to any patent term extension.
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JZP-386.
Two U.S. patents cover the composition of deuterated analogs of sodium oxybate, including JZP-386, and their methods for treating certain diseases and disorders, including narcolepsy. The first patent expires in August 2030, and the second patent expires in February 2032. A European patent that corresponds to the first U.S. patent expires in April 2030. Further, patent applications corresponding to the second U.S. patent were filed in the U.S., Europe and Japan, and, if issued, would expire in February 2032. We were granted exclusive licenses to these patent rights by Concert.
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Item 1A.
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Risk Factors
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•
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the potential introduction of a generic version of Xyrem or an alternative sodium oxybate product for treating cataplexy and/or EDS in narcolepsy;
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•
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changed or increased regulatory restrictions, including changes to our Xyrem REMS, the development of a single shared REMS for sodium oxybate with potential generic competitors or other regulatory actions by the FDA;
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our suppliers’ ability to obtain sufficient quotas from the DEA to satisfy our needs for Xyrem;
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any supply, manufacturing or distribution problems arising with any of our suppliers or distributors, all of whom are sole source providers for us;
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any increase in pricing pressure from or restrictive conditions for reimbursement required by, and the availability of reimbursement from, third party payors;
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changes in healthcare laws and policy, including changes in requirements for rebates, reimbursement and coverage by federal healthcare programs;
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continued acceptance of Xyrem by physicians and patients, even in the face of negative publicity that surfaces from time to time;
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changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem; and
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operational disruptions at the central pharmacy or any failure to comply with our REMS obligations to the satisfaction of the FDA.
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the increased complexity and costs inherent in managing international operations;
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diverse regulatory, financial and legal requirements, and any future changes to such requirements, in one or more countries where we are located or do business;
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country-specific tax, labor and employment laws and regulations;
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applicable trade laws, tariffs, export quotas, custom duties or other trade restrictions and any changes to them;
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challenges inherent in efficiently managing employees in diverse geographies, including the need to adapt systems, policies, benefits and compliance programs to differing labor and other regulations, as well as maintaining positive interactions with unionized employees in one of our international locations;
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liabilities for activities of, or related to, our international operations, products or product candidates;
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changes in currency rates; and
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regulations relating to data security and the unauthorized use of, or access to, commercial and personal information.
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the clinical indications for which a product is approved, including any restrictions placed upon the product in connection with its approval, such as a REMS, patient registry or labeling restrictions;
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the prevalence of the disease or condition for which the product is approved and the severity of side effects;
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acceptance by physicians and patients of each product as a safe and effective treatment;
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perceived advantages over alternative treatments;
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relative convenience and ease of administration;
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physician and patient assessment of the burdens associated with obtaining or maintaining the certifications required under the Xyrem REMS;
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the cost of treatment in relation to alternative treatments, including generic products;
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the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations; and
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the conditions for reimbursement required by, and appropriate pricing and availability of reimbursement from, third party payors.
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high acquisition costs;
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the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;
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the potential disruption of our historical core business;
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the strain on, and need to continue to expand, our existing operational, technical, financial and administrative infrastructure;
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the difficulties in assimilating employees and corporate cultures;
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the failure to retain key managers and other personnel;
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the challenges in controlling additional costs and expenses in connection with and as a result of any acquisition;
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the need to write down assets or recognize impairment charges;
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the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and
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any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.
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delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;
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delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;
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delays or failures in reaching agreement on acceptable terms with prospective study sites;
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delays or failures in obtaining approval of our clinical trial protocol from an institutional review board, also known as Ethics Committees in Europe, to conduct a clinical trial at a prospective study site;
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delays or failures in recruiting patients to participate in a clinical trial;
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failure of our clinical trials and clinical investigators to be in compliance with the FDA and other regulatory agencies’ good clinical practice guidelines;
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unforeseen safety issues, including negative results from ongoing preclinical studies and clinical trials and adverse events associated with product candidates;
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inability to monitor patients adequately during or after treatment;
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difficulty monitoring multiple study sites;
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failure of our third party clinical trial managers to satisfactorily perform their contractual duties, comply with regulations or meet expected deadlines; or
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insufficient funds to complete the trials.
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others may be able to make products that are similar to our product candidates but that are not covered by the claims of our patents, or for which we are not licensed under our license agreements;
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we or our licensors or partners might not have been the first to invent or file, as appropriate, subject matters covered by our issued patents or pending patent applications or the pending patent applications or issued patents of our licensors or partners;
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others may independently develop similar or alternative products without infringing our intellectual property rights;
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our pending patent applications may not result in issued patents;
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our issued patents and the issued patents of our licensors or partners may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
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our issued patents may not cover our competitors’ products;
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our issued patents and the issued patents of our licensors or partners may be vulnerable to legal challenges as a result of changes in applicable law;
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we may not develop additional proprietary products that are patentable; or
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the patents of others may have an adverse effect on our business.
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limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;
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limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;
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require us to use a substantial portion of our cash flow from operations to make debt service payments;
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limit our flexibility to plan for, or react to, changes in our business and industry;
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result in dilution to our existing shareholders in the event exchanges of our 2021 Notes are settled in our ordinary shares;
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place us at a competitive disadvantage compared to our less leveraged competitors; and
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increase our vulnerability to the impact of adverse economic and industry conditions.
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incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;
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issue redeemable preferred stock;
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pay dividends or distributions or redeem or repurchase capital stock;
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prepay, redeem or repurchase certain debt;
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make loans, investments, acquisitions (including acquisitions of exclusive licenses) and capital expenditures;
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enter into agreements that restrict distributions from our subsidiaries;
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sell assets and capital stock of our subsidiaries;
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enter into certain transactions with affiliates; and
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consolidate or merge with or into, or sell substantially all of our assets to, another person.
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the revenues from our commercial products, which may be affected by many factors, including the extent of generic competition for our products;
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the costs of our commercial operations;
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the costs of integration activities related to any future strategic transactions we may engage in;
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the cost of acquiring and/or in-licensing any new products and product candidates;
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the scope, rate of progress, results and costs of our development and clinical activities;
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the cost and timing of obtaining regulatory approvals and of compliance with laws and regulations;
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the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
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the cost of investigations, litigation and/or settlements related to regulatory oversight and third party claims; and
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changes in laws and regulations, including, for example, healthcare reform legislation.
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impose advance notice requirements for shareholder proposals and nominations of directors to be considered at shareholder meetings;
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stagger the terms of our board of directors into three classes;
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require the approval of a supermajority of the voting power of the shares of our share capital entitled to vote generally at a meeting of shareholders to amend or repeal our articles of association; and
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permit our board of directors to issue one or more series of preferred shares with rights and preferences, as our shareholders may determine by ordinary resolution.
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Item 2.
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Properties
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Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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High
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Low
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Calendar Quarter—2014
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First Quarter
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$
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176.60
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$
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123.55
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Second Quarter
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$
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156.34
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$
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120.38
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Third Quarter
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$
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176.36
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$
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131.69
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Fourth Quarter
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$
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183.84
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$
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137.34
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Calendar Quarter—2015
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First Quarter
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$
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190.17
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$
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155.06
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Second Quarter
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$
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191.01
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$
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165.00
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Third Quarter
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$
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194.73
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$
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121.12
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Fourth Quarter
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$
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151.28
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$
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117.26
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(1)
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This section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, or Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
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(2)
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Information used in the graph was obtained from Research Data Group, Inc.
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Total Number of Shares Purchased (1)
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Average Price Paid per Share (2)
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Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (3)
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Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs (4)
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||||||
October 1 - October 31, 2015
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—
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$
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—
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—
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$
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—
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November 1 - November 30, 2015
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96,833
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$
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139.73
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96,833
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$
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286,472,388
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December 1 - December 31, 2015
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189,317
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$
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141.15
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189,317
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$
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259,756,866
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Total
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286,150
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$
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140.67
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286,150
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(1)
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This table does not include ordinary shares that we withheld in order to satisfy minimum tax withholding requirements in connection with the vesting of restricted stock units.
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(2)
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Average price paid per share includes brokerage commissions.
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(3)
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The ordinary shares reported in the table above were purchased pursuant to our publicly announced share repurchase program. In November 2015, we announced that our board of directors authorized the use of up to $300 million to repurchase our ordinary shares. This authorization has no expiration date.
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(4)
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The dollar amount shown represents, as of the end of each period, the approximate dollar value of ordinary shares that may yet be purchased under our publicly announced share repurchase program, exclusive of any brokerage commissions. The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under our credit agreement, corporate and regulatory requirements and market conditions, and may be modified, suspended or otherwise discontinued at any time without prior notice.
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Item 6.
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Selected Financial Data
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As of December 31,
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2015
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2014(1)
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2013
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2012(2)
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2011
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(In thousands)
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Consolidated Balance Sheet Data:
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||||||||||
Cash, cash equivalents and marketable securities
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$
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988,785
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$
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684,042
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$
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636,504
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$
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387,196
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$
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157,898
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Working capital
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1,031,025
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799,044
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660,589
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360,034
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146,261
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|||||
Total assets
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3,359,663
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3,338,955
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2,238,221
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1,966,493
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253,573
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|||||
Long-term debt, current and non-current
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1,204,503
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1,342,428
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549,976
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456,761
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|
|
—
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|||||
Retained earnings (accumulated deficit)
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302,686
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34,704
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18,532
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(61,296
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)
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(349,882
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)
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|||||
Total Jazz Pharmaceuticals plc shareholders’ equity
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1,598,646
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|
|
1,371,144
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|
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1,295,534
|
|
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1,121,292
|
|
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192,788
|
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(1)
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On January 23, 2014, pursuant to a tender offer, we became the indirect majority shareholder of Gentium S.r.l., or Gentium, acquiring control of Gentium on that date. In February 2014, we completed a subsequent offering period of the tender offer, resulting in total purchases pursuant to the tender offer of approximately
98%
of the fully diluted voting securities of Gentium. As of December 31, 2015, we had acquired the remaining
2%
interest in Gentium for cash consideration of
$17.9 million
, resulting in an aggregate acquisition cost to us of
$994.1 million
, comprising cash payments of
$1,011.2 million
offset by proceeds from the exercise of Gentium share options of
$17.1 million
. The results of operations of the acquired Gentium business, along with the estimated fair values of the assets acquired and liabilities assumed in the transaction, have been included in our consolidated financial statements since the completion of the acquisition of Gentium on January 23, 2014, which is referred to as the Gentium Acquisition in this Annual Report on Form 10-K. We recorded noncontrolling interests in our consolidated financial statements that represent the ownership interest of minority shareholders in the equity of Gentium. In future periods, we will no longer record noncontrolling Gentium interests since we had acquired all such remaining noncontrolling interests as of December 31, 2015. In connection with the Gentium Acquisition, on January 23, 2014, we entered into a second amendment to the credit agreement we entered into in June 2012, or the previous credit agreement. We used the proceeds from incremental term loans of $350.0 million and $300.0 million of loans under the revolving credit facility provided for under the previous credit agreement, together with cash on hand, to finance the Gentium Acquisition. In August 2014, we completed a private placement of $575.0 million aggregate principal amount of 1.875% exchangeable senior notes due 2021, or the 2021 Notes, resulting in net proceeds to us, after debt issuance costs, of $558.9 million. We used a portion of the net proceeds from the issuance of the 2021 Notes to repay all then outstanding borrowings under the revolving credit facility provided for under the previous credit agreement.
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(2)
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On January 18, 2012, the businesses of Jazz Pharmaceuticals, Inc. and Azur Pharma were combined in the Azur Merger pursuant to which all outstanding shares of Jazz Pharmaceuticals, Inc.’s common stock were canceled and converted into the right to receive, on a one-for-one basis, our ordinary shares. Jazz Pharmaceuticals, Inc. was treated as the acquiring company in the Azur Merger for accounting purposes, and as a result, the historical consolidated financial statements of Jazz Pharmaceuticals, Inc. became our consolidated financial statements. On June 12, 2012, we completed our acquisition of EUSA Pharma Inc., or EUSA Pharma, which we refer to as the EUSA Acquisition. At the closing of the EUSA Acquisition, we paid
$678.4 million
in cash, and agreed to make an additional contingent payment of
$50.0 million
in cash if Erwinaze achieved net sales in the U.S. of
$124.5 million
or more in 2013. In 2013, net sales of Erwinaze in the U.S. exceeded
$124.5 million
and as a result, we made this payment in 2014. The results of operations of the acquired Azur Pharma and EUSA Pharma businesses, along with the estimated fair values of the assets acquired and liabilities assumed in each transaction, are included in our consolidated financial statements since the effective dates of the Azur Merger and the EUSA Acquisition, respectively. We financed the EUSA Acquisition, in part, by entering into a credit agreement in June 2012, which at the time provided for $475.0 million principal amount of term loans and a $100.0 million revolving credit facility. We used all of the proceeds of those term loans, together with cash on hand, to finance the EUSA Acquisition.
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(3)
|
All references to “ordinary shares” refer to Jazz Pharmaceuticals, Inc.’s common stock with respect to periods prior to the year ended December 31, 2012 and to our ordinary shares with respect to periods after and including the year ended December 31, 2012. Our earnings per share in the periods prior to the year ended December 31, 2012 were not impacted by the Azur Merger because each share of Jazz Pharmaceuticals, Inc. common stock issued and outstanding immediately prior to the effective time of the Azur Merger was canceled and converted into the right to receive one ordinary share upon the consummation of the Azur Merger.
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide)
, a product approved in Europe for the treatment of severe hepatic veno-occlusive disease, or VOD, in adults and children undergoing hematopoietic stem cell transplantation, or HSCT, therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications;
|
•
|
Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
•
|
JZP-110.
|
•
|
Xyrem
.
|
•
|
Defibrotide.
|
•
|
Erwinaze.
We are pursuing activities related to the potential development of an effective and well-tolerated long-acting recombinant crisantaspase that would offer benefits compared to Erwinaze. We are also assessing the potential to pursue regulatory approval of Erwinaze in additional countries.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products, particularly with respect to certain products as to which we maintain limited inventories, and our dependence on single source suppliers to continue to meet our ongoing commercial demand or our requirements for clinical trial supplies;
|
•
|
the need to obtain and maintain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the U.S. and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the U.S. in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by third party payors;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of the FDA, the U.S. Drug Enforcement Administration, or DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals;
|
•
|
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
|
•
|
the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses with our historic business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations.
|
|
2015
|
|
Change
|
|
2014 (1)
|
|
Change
|
|
2013
|
||||||||
Product sales, net
|
$
|
1,316,819
|
|
|
13
|
%
|
|
$
|
1,162,716
|
|
|
34
|
%
|
|
$
|
865,398
|
|
Royalties and contract revenues
|
7,984
|
|
|
(21
|
)%
|
|
10,159
|
|
|
45
|
%
|
|
7,025
|
|
|||
Cost of product sales (excluding amortization and impairment of intangible assets)
|
102,526
|
|
|
(13
|
)%
|
|
117,418
|
|
|
15
|
%
|
|
102,146
|
|
|||
Selling, general and administrative
|
449,119
|
|
|
11
|
%
|
|
406,114
|
|
|
33
|
%
|
|
304,303
|
|
|||
Research and development
|
135,253
|
|
|
59
|
%
|
|
85,181
|
|
|
105
|
%
|
|
41,632
|
|
|||
Acquired in-process research and development
|
—
|
|
|
N/A(2)
|
|
|
202,626
|
|
|
N/A(2)
|
|
|
4,988
|
|
|||
Intangible asset amortization
|
98,162
|
|
|
(22
|
)%
|
|
126,584
|
|
|
60
|
%
|
|
79,042
|
|
|||
Impairment charges
|
31,523
|
|
|
(20
|
)%
|
|
39,365
|
|
|
N/A(2)
|
|
|
—
|
|
|||
Interest expense, net
|
56,917
|
|
|
8
|
%
|
|
52,713
|
|
|
96
|
%
|
|
26,916
|
|
|||
Foreign currency (gain) loss
|
(1,445
|
)
|
|
(83
|
)%
|
|
(8,683
|
)
|
|
N/A(2)
|
|
|
1,697
|
|
|||
Loss on extinguishment and modification of debt
|
16,815
|
|
|
N/A(2)
|
|
|
—
|
|
|
N/A(2)
|
|
|
3,749
|
|
|||
Income tax provision
|
106,399
|
|
|
13
|
%
|
|
94,231
|
|
|
3
|
%
|
|
91,638
|
|
|||
Net loss attributable to noncontrolling interests, net of tax
|
(1
|
)
|
|
N/A(2)
|
|
|
(1,061
|
)
|
|
N/A(2)
|
|
|
—
|
|
(1)
|
Our financial results include the financial results of the historic Gentium business since the closing of the Gentium Acquisition on January 23, 2014.
|
(2)
|
Comparison to prior period is not meaningful.
|
|
2015
|
|
Change
|
|
2014
|
|
Change
|
|
2013
|
||||||||
Xyrem
|
$
|
955,187
|
|
|
23
|
%
|
|
$
|
778,584
|
|
|
37
|
%
|
|
$
|
569,113
|
|
Erwinaze/Erwinase
|
203,261
|
|
|
2
|
%
|
|
199,665
|
|
|
15
|
%
|
|
174,251
|
|
|||
Defitelio/defibrotide
|
70,731
|
|
|
—
|
%
|
|
70,537
|
|
|
N/A(1)
|
|
|
—
|
|
|||
Prialt
®
(ziconotide) intrathecal infusion
|
26,440
|
|
|
—
|
%
|
|
26,421
|
|
|
(3
|
%)
|
|
27,103
|
|
|||
Psychiatry
|
37,135
|
|
|
(9
|
%)
|
|
40,879
|
|
|
(17
|
%)
|
|
49,226
|
|
|||
Other
|
24,065
|
|
|
(48
|
%)
|
|
46,630
|
|
|
2
|
%
|
|
45,705
|
|
|||
Product sales, net
|
1,316,819
|
|
|
13
|
%
|
|
1,162,716
|
|
|
34
|
%
|
|
865,398
|
|
|||
Royalties and contract revenues
|
7,984
|
|
|
(21
|
%)
|
|
10,159
|
|
|
45
|
%
|
|
7,025
|
|
|||
Total revenues
|
$
|
1,324,803
|
|
|
13
|
%
|
|
$
|
1,172,875
|
|
|
34
|
%
|
|
$
|
872,423
|
|
(1)
|
Comparison to prior period is not meaningful.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Clinical studies and outside services
|
$
|
63,079
|
|
|
$
|
41,769
|
|
|
16,385
|
|
|
Personnel expenses
|
39,515
|
|
|
38,228
|
|
|
22,019
|
|
|||
Milestone
|
25,000
|
|
|
—
|
|
|
—
|
|
|||
Other
|
7,659
|
|
|
5,184
|
|
|
3,228
|
|
|||
Total
|
$
|
135,253
|
|
|
$
|
85,181
|
|
|
$
|
41,632
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014 (1)
|
|
2013 (1)
|
||||||
GAAP reported net income attributable to Jazz Pharmaceuticals plc
|
$
|
329,535
|
|
|
$
|
58,387
|
|
|
$
|
216,312
|
|
Intangible asset amortization
|
98,162
|
|
|
126,584
|
|
|
79,042
|
|
|||
Share-based compensation expense
|
91,550
|
|
|
69,638
|
|
|
44,551
|
|
|||
Impairment charges
|
31,523
|
|
|
39,365
|
|
|
—
|
|
|||
Upfront and milestone payments
|
25,000
|
|
|
202,626
|
|
|
4,988
|
|
|||
Transaction and integration related costs (2)
|
18,155
|
|
|
28,840
|
|
|
6,240
|
|
|||
Restructuring charges
|
1,641
|
|
|
1,941
|
|
|
1,457
|
|
|||
Acquisition accounting inventory fair value step-up adjustments
|
—
|
|
|
10,477
|
|
|
3,826
|
|
|||
Change in fair value of contingent consideration
|
—
|
|
|
—
|
|
|
15,200
|
|
|||
Non-cash interest expense
|
22,738
|
|
|
13,725
|
|
|
4,591
|
|
|||
Loss on extinguishment and modification of debt
|
16,815
|
|
|
—
|
|
|
3,749
|
|
|||
Income tax adjustments (3)
|
(35,009
|
)
|
|
(29,620
|
)
|
|
5,253
|
|
|||
Adjustments for amount attributable to noncontrolling interests (4)
|
(2
|
)
|
|
(1,506
|
)
|
|
—
|
|
|||
Non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc
|
$
|
600,108
|
|
|
$
|
520,457
|
|
|
$
|
385,209
|
|
|
|
|
|
|
|
||||||
GAAP reported net income attributable to Jazz Pharmaceuticals plc per diluted share
|
$
|
5.23
|
|
|
$
|
0.93
|
|
|
$
|
3.51
|
|
Non-GAAP adjusted net income attributable to Jazz Pharmaceuticals plc per diluted share
|
$
|
9.52
|
|
|
$
|
8.31
|
|
|
$
|
6.26
|
|
Weighted-average ordinary shares used in diluted per share calculation
|
63,036
|
|
|
62,614
|
|
|
61,569
|
|
(1)
|
For purposes of comparability with our 2015 presentation, non-GAAP adjusted financial measures for 2014 and 2013 do not include an adjustment for depreciation expense.
|
(2)
|
In 2014, the adjustment was primarily related to the Gentium Acquisition. In 2015, the adjustment was primarily related to a one-time charge of $18.0 million for settlement of a contract claim that was originally asserted against Azur Pharma prior to the Azur Merger.
|
(3)
|
Tax adjustments to convert the income tax provision to the estimated amount of taxes payable in cash.
|
(4)
|
The noncontrolling interests’ share of the above adjustments, as applicable.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net cash provided by operating activities
|
$
|
531,943
|
|
|
$
|
405,765
|
|
|
$
|
288,431
|
|
Net cash used in investing activities
|
(2,255
|
)
|
|
(1,067,649
|
)
|
|
(16,264
|
)
|
|||
Net cash provided by (used in) financing activities
|
(214,323
|
)
|
|
712,875
|
|
|
(23,856
|
)
|
|||
Effect of exchange rates on cash and cash equivalents
|
(10,622
|
)
|
|
(3,453
|
)
|
|
997
|
|
|||
Net increase in cash and cash equivalents
|
$
|
304,743
|
|
|
$
|
47,538
|
|
|
$
|
249,308
|
|
|
Payments due by period
|
||||||||||||||||||
Contractual Obligations (1)
|
Total
|
|
Less than
1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than
5 years
|
||||||||||
Term and other loans - principal
|
$
|
741,138
|
|
|
$
|
37,587
|
|
|
$
|
103,314
|
|
|
$
|
600,209
|
|
|
$
|
28
|
|
Term and other loans - interest (2)
|
68,562
|
|
|
17,433
|
|
|
31,784
|
|
|
19,345
|
|
|
—
|
|
|||||
2021 Notes - principal
|
575,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
575,000
|
|
|||||
2021 Notes - interest (3)
|
64,688
|
|
|
10,781
|
|
|
21,563
|
|
|
21,563
|
|
|
10,781
|
|
|||||
Revolving credit facility - commitment fee (4)
|
10,179
|
|
|
2,284
|
|
|
4,556
|
|
|
3,339
|
|
|
—
|
|
|||||
Purchase obligations (5)
|
99,022
|
|
|
97,461
|
|
|
400
|
|
|
431
|
|
|
730
|
|
|||||
Operating and facility lease obligations (6)
|
113,238
|
|
|
11,757
|
|
|
21,019
|
|
|
13,900
|
|
|
66,562
|
|
|||||
Total
|
$
|
1,671,827
|
|
|
$
|
177,303
|
|
|
$
|
182,636
|
|
|
$
|
658,787
|
|
|
$
|
653,101
|
|
(1)
|
This table does not include potential future milestone payment or royalty obligations to third parties under asset purchase, product development, license and other agreements as the timing and likelihood of such milestone payments are not known, and, in the case of royalty obligations, as the amount of such obligations are not estimable. In 2014, we signed a definitive agreement with Aerial under which we acquired worldwide development, manufacturing and commercial rights to JZP-110 (other than in certain jurisdictions in Asia where SK retains rights). Aerial and SK are currently eligible to receive milestone payments up to an aggregate of $270.0 million based on development, regulatory and sales milestones and tiered royalties from high single digits to mid-teens based on potential future sales of JZP-110. In 2014, we entered into a definitive agreement to acquire rights to defibrotide in the U.S. and all other countries in the Americas from Sigma-Tau. In 2015, the FDA accepted for filing with priority review our NDA for defibrotide and, as a result, a milestone payment of $25.0 million was made to Sigma-Tau. Sigma-Tau is eligible to receive up to an additional $150.0 million based on the timing of potential FDA approval of defibrotide for VOD.
Potential future milestone payments to other third parties under other agreements could be up to an aggregate of $250.0 million, of which up to $120.0 million will become due and payable to Perrigo Company plc (formerly Elan Pharmaceuticals, Inc.) in tiered contingent payments, with the first such payment becoming due if net sales of Prialt of at least $75.0 million are achieved in a calendar year. The remainder would become due and payable to other third parties upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones, the timing and likelihood of which are not known. We are also obligated under these agreements to pay royalties on net sales of certain products at specified rates, which royalties are dependent on future product sales and are not provided for in the table above as they are not estimable.
|
(2)
|
Estimated interest was calculated based on the interest rates in effect as of
December 31, 2015
. The interest rate for our term loan was
2.36%
at
December 31, 2015
.
|
(4)
|
Our revolving credit facility has a commitment fee payable on the undrawn amount ranging from 0.25% to 0.35% per annum based upon our secured leverage ratio. In the table above, we used a rate of 0.30% and assumed undrawn amounts of $748.9 million as of December 31, 2015 to estimate commitment fees owed. Undrawn borrowing capacity does not include an amount of $1.1 million committed under an outstanding letter of credit.
|
(5)
|
Consists primarily of non-cancelable commitments to third party manufacturers.
|
(6)
|
Includes automobile lease payments for our sales force and the minimum lease payments for our office buildings, including a lease agreement we entered into in January 2015 to lease office space located in Palo Alto, California. We expect to occupy this office space by the end of 2017. We are obligated to make lease payments totaling approximately
$88 million
over the initial term of the lease. Not included in the table above are our estimated costs of approximately $20 million associated with the design, development and construction of tenant improvements under this lease agreement, which estimate does not include a tenant improvement allowance to be provided by the landlord. Operating expenses associated with our leased office buildings are also not included in table above.
|
|
Rebates Payable
|
|
Sales Returns Reserve
|
|
Chargebacks
|
|
Discounts and Distributor Fees
|
|
Total
|
||||||||||
Balance at December 31, 2012 (1)
|
$
|
25,247
|
|
|
$
|
26,385
|
|
|
$
|
2,536
|
|
|
$
|
3,646
|
|
|
$
|
57,814
|
|
Provision, net
|
66,895
|
|
|
2,836
|
|
|
21,777
|
|
|
51,432
|
|
|
142,940
|
|
|||||
Payments/credits
|
(60,584
|
)
|
|
(8,111
|
)
|
|
(19,903
|
)
|
|
(49,188
|
)
|
|
(137,786
|
)
|
|||||
Balance at December 31, 2013 (1)
|
31,558
|
|
|
21,110
|
|
|
4,410
|
|
|
5,890
|
|
|
62,968
|
|
|||||
Provision, net
|
88,729
|
|
|
3,148
|
|
|
28,722
|
|
|
71,864
|
|
|
192,463
|
|
|||||
Payments/credits
|
(75,854
|
)
|
|
(10,219
|
)
|
|
(28,588
|
)
|
|
(71,879
|
)
|
|
(186,540
|
)
|
|||||
Balance at December 31, 2014 (1)
|
44,433
|
|
|
14,039
|
|
|
4,544
|
|
|
5,875
|
|
|
68,891
|
|
|||||
Provision, net
|
124,618
|
|
|
(4,444
|
)
|
|
39,124
|
|
|
46,533
|
|
|
205,831
|
|
|||||
Payments/credits
|
(107,013
|
)
|
|
(3,485
|
)
|
|
(38,772
|
)
|
|
(48,684
|
)
|
|
(197,954
|
)
|
|||||
Balance at December 31, 2015
|
$
|
62,038
|
|
|
$
|
6,110
|
|
|
$
|
4,896
|
|
|
$
|
3,724
|
|
|
$
|
76,768
|
|
•
|
estimating the timing of and expected costs to complete the in-process projects;
|
•
|
projecting regulatory approvals;
|
•
|
estimating future cash flows from product sales resulting from completed products and in-process projects; and
|
•
|
developing appropriate discount rates and probability rates by project.
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 8.
|
Financial Statements and Supplementary Data
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
Item 9A.
|
Controls and Procedures
|
1.
|
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
|
2.
|
Our management used the Committee of Sponsoring Organizations of the Treadway Commission Internal Control - Integrated Framework (2013), or the COSO framework, to evaluate the effectiveness of internal control over financial reporting. Management believes that the COSO framework is a suitable framework for its evaluation of financial reporting because it is free from bias, permits reasonably consistent qualitative and quantitative measurements of our internal control over financial reporting, is sufficiently complete so that those relevant factors that would alter a conclusion about the effectiveness of our internal control over financial reporting are not omitted and is relevant to an evaluation of internal control over financial reporting.
|
3.
|
Management has assessed the effectiveness of our internal control over financial reporting as of
December 31, 2015
and has concluded that such internal control over financial reporting was effective. There were no material weaknesses in internal control over financial reporting identified by management.
|
4.
|
KPMG, our independent registered public accounting firm, has audited the consolidated financial statements of Jazz Pharmaceuticals plc as of and for the year ended
December 31, 2015
, included herein, and has issued an audit report on our internal control over financial reporting, which is included below.
|
Item 9B.
|
Other Information
|
Item 10.
|
Directors, Executive Officers and Corporate Governance
|
•
|
The information relating to our directors and nominees for director is to be included in the section entitled “Proposal 1—Election of Directors;”
|
•
|
The information relating to our executive officers is to be included in the section entitled “Executive Officers;”
|
•
|
The information relating to our audit committee, audit committee financial expert and procedures by which shareholders may recommend nominees to our board of directors is to be included in the section entitled “Corporate Governance and Board Matters;” and
|
•
|
The information regarding compliance with Section 16(a) of the Exchange Act is to be included in the section entitled “Section 16(a) Beneficial Ownership Reporting Compliance.”
|
Item 11.
|
Executive Compensation
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence
|
Item 14.
|
Principal Accountant Fees and Services
|
Item 15.
|
Exhibits and Financial Statement Schedules
|
1.
|
Index to Financial Statements:
|
2.
|
Financial Statement Schedules:
|
Exhibit
Number
|
|
Description of Document
|
|
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500) filed with the SEC on September 19, 2011).
|
|
2.2
|
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc. Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
2.3
|
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
|
2.4
|
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
|
2.5
|
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
|
2.6†
|
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
|
2.7†
|
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
|
2.8
|
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on March 23, 2015).
|
|
3.1
|
|
Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
4.1
|
|
Reference is made to Exhibit 3.1.
|
|
4.2A
|
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
|
4.2B
|
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
4.2C
|
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
4.2D
|
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
10.1†
|
|
Supply Agreement, dated as of April 1, 2010, by and between Jazz Pharmaceuticals, Inc. and Siegfried (USA) Inc. (incorporated herein by reference to Exhibit 10.54 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2010, as filed with the SEC on May 6, 2010).
|
|
10.2†
|
|
Master Services Agreement, dated April 15, 2011, by and between Jazz Pharmaceuticals, Inc., CuraScript, Inc. and Express Scripts Specialty Distribution Services, Inc. (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2011, as filed with the SEC on May 9, 2011).
|
|
10.3†
|
|
Royalty Bearing License Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between Public Health England (formerly Health Protection Agency) and EUSA Pharma SAS (formerly OPi, S.A.), as amended on each of December 22, 2009, March 23, 2012 and August 8, 2012 (incorporated herein by reference to Exhibit 10.11 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q/A (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 9, 2012).
|
|
10.4
|
|
Novation Agreement relating to Royalty Bearing Licence Agreement and Supply Agreement re Erwinia-Derived Asparaginase, dated as of May 13, 2015, by and among EUSA Pharma SAS, the Secretary of State for Health acting through Public Health England and Porton Biopharma Limited (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.5*
|
|
Master Manufacturing Services Agreement, dated as of October 1, 2015, by and between Jazz Pharmaceuticals Ireland Limited and Patheon Pharmaceuticals Inc.
|
|
10.6
|
|
Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc's Current Report on Form 8-K (File No. 0001-33500), as filed with the SEC on June 18, 2015).
|
|
10.7A
|
|
Commercial Lease, dated as of June 2, 2004, by and between Jazz Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.52 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on March 27, 2007).
|
|
10.7B
|
|
First Amendment of Lease, dated June 1, 2009, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.86 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 4, 2009).
|
|
10.7C
|
|
Second Amendment of Lease, dated February 28, 2012, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.31 in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
10.8
|
|
Lease, dated May 8, 2012, by and between John Ronan and Castle Cove Property Developments Limited and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.9
|
|
Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.10+
|
|
Form of Indemnification Agreement between Jazz Pharmaceuticals plc and its officers and directors (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
10.11+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Suzanne Sawochka Hooper (incorporated herein by reference to Exhibit 10.19 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012).
|
|
10.12+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Matthew Young (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.13A+
|
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.13B+
|
|
Amendment to Employment Agreement by and between Iain McGill and EUSA Pharma (Europe) Limited (incorporated herein by reference to Exhibit 10.15B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.14+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15A+
|
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15B+
|
|
Amendment to Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.15A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.16+
|
|
Amended and Restated Offer Letter, dated as of July 29, 2015, from Jazz Pharmaceuticals, Inc. to Karen Smith, M.D., Ph.D. ((incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2015, as filed with the SEC on November 9, 2015).
|
|
10.17A+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.17B+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.3B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.17C+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27C in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17D+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17E+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500), as filed with the SEC on February 26, 2013).
|
|
10.17F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27F in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17G+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.17H+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18A+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.18B+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.39B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.18C+
|
|
Form of Option Grant Notice and Form of Stock Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18D+
|
|
Form of Stock Option Grant Notice and Form of Option Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18E+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18G+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18H+
|
|
Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28H in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18I+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Option Grant Notice and Form of U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18J+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18K+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18L+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.19+
|
|
Jazz Pharmaceuticals plc Amended and Restated Directors Deferred Compensation Plan (incorporated herein by reference to Exhibit 99.6 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20A+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 99.4 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20B+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 10.30B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.20C+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved August 1, 2013) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.21A+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated (incorporated herein by reference to Exhibit 10.31A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.21B+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan Sub-Plan Governing Purchase Rights to Participants in the Republic of Ireland (incorporated by reference herein to Exhibit 10.14C in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012 ).
|
|
10.22A+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (incorporated herein by reference to Exhibit 10.32B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.22B+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 4, 2015).
|
|
10.22C+
|
|
Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2014) (incorporated herein by reference to Exhibit 10.24D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2013, as filed with the SEC on February 25, 2014).
|
|
10.22D+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2016).
|
|
10.23+
|
|
Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (approved February 10, 2016).
|
|
10.24+
|
|
Jazz Pharmaceuticals plc 2015 Executive Officer Compensation Arrangements (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2015, as filed with the SEC on May 7, 2015).
|
|
10.25A+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved May 1, 2014) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.25B+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved April 30, 2015) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.26+
|
|
Named Officer 2015 Target Bonus Opportunity (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on February 18, 2015).
|
|
21.1
|
|
Subsidiaries of Jazz Pharmaceuticals plc.
|
|
23.1
|
|
Consent of KPMG, Independent Registered Public Accounting Firm.
|
|
24.1
|
|
Power of Attorney (included on the signature page hereto).
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
32.1**
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
Confidential treatment has been requested with respect to certain portions of this exhibit.
|
**
|
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
Date: February 23, 2016
|
Jazz Pharmaceuticals public limited company
|
|
(Registrant)
|
|
/s/ B
RUCE
C. C
OZADD
|
|
Bruce C. Cozadd
Chairman and Chief Executive Officer and Director
(Principal Executive Officer)
|
|
|
|
/s/ M
ATTHEW
P. Y
OUNG
|
|
Matthew P. Young
Executive Vice President and Chief Financial Officer (Principal Financial Officer)
|
|
|
|
/s/ K
AREN
J. W
ILSON
|
|
Karen J. Wilson
Senior Vice President, Finance
(Principal Accounting Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ B
RUCE
C. C
OZADD
|
|
Chairman, Chief Executive Officer and Director
(Principal Executive Officer)
|
|
February 23, 2016
|
Bruce C. Cozadd
|
|
|
||
/s/ M
ATTHEW
P. Y
OUNG
|
|
Executive Vice President and Chief Financial Officer
(Principal Financial Officer)
|
|
February 23, 2016
|
Matthew P. Young
|
|
|
||
/s/ K
AREN
J. W
ILSON
|
|
Senior Vice President, Finance
(Principal Accounting Officer)
|
|
February 23, 2016
|
Karen J. Wilson
|
|
|
||
/s/ P
AUL
L. B
ERNS
|
|
Director
|
|
February 23, 2016
|
Paul L. Berns
|
|
|
||
/s/ P
ATRICK
G. E
NRIGHT
|
|
Director
|
|
February 23, 2016
|
Patrick G. Enright
|
|
|
||
/s/ P
ETER
G
RAY
|
|
Director
|
|
February 23, 2016
|
Peter Gray
|
|
|
||
/s/ H
EATHER
A
NN
M
CSHARRY
|
|
Director
|
|
February 23, 2016
|
Heather Ann McSharry
|
|
|
||
/s/ S
EAMUS
C. M
ULLIGAN
|
|
Director
|
|
February 23, 2016
|
Seamus C. Mulligan
|
|
|
||
/s/ K
ENNETH
W. O’
KEEFE
|
|
Director
|
|
February 23, 2016
|
Kenneth W. O’Keefe
|
|
|
||
/s/
N
ORBERT
G
.
R
IEDEL,
P
H.
D
.
|
|
Director
|
|
February 23, 2016
|
Norbert G. Riedel, Ph.D.
|
|
|
||
/s/ E
LMAR
S
CHNEE
|
|
Director
|
|
February 23, 2016
|
Elmar Schnee
|
|
|
||
/s/ C
ATHERINE
A. S
OHN,
P
HARM
.D.
|
|
Director
|
|
February 23, 2016
|
Catherine A. Sohn, Pharm.D.
|
|
|
||
/s/ R
ICK
E W
INNINGHAM
|
|
Director
|
|
February 23, 2016
|
Rick E Winningham
|
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
988,785
|
|
|
$
|
684,042
|
|
Accounts receivable, net of allowances of $3,693 and $3,483 at December 31, 2015 and 2014, respectively
|
209,685
|
|
|
186,371
|
|
||
Inventories
|
19,451
|
|
|
30,037
|
|
||
Prepaid expenses
|
20,699
|
|
|
12,800
|
|
||
Deferred tax assets, net
|
—
|
|
|
48,440
|
|
||
Other current assets
|
19,047
|
|
|
21,322
|
|
||
Assets held for sale
|
—
|
|
|
32,833
|
|
||
Total current assets
|
1,257,667
|
|
|
1,015,845
|
|
||
Property and equipment, net
|
85,572
|
|
|
58,363
|
|
||
Intangible assets, net
|
1,185,606
|
|
|
1,437,435
|
|
||
Goodwill
|
657,139
|
|
|
702,713
|
|
||
Deferred tax assets, net, non-current
|
122,863
|
|
|
75,494
|
|
||
Deferred financing costs
|
23,268
|
|
|
33,174
|
|
||
Other non-current assets
|
27,548
|
|
|
15,931
|
|
||
Total assets
|
$
|
3,359,663
|
|
|
$
|
3,338,955
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
21,807
|
|
|
$
|
25,126
|
|
Accrued liabilities
|
164,070
|
|
|
164,091
|
|
||
Current portion of long-term debt
|
37,587
|
|
|
9,428
|
|
||
Income taxes payable
|
1,808
|
|
|
7,588
|
|
||
Deferred tax liability, net
|
—
|
|
|
9,430
|
|
||
Deferred revenue
|
1,370
|
|
|
1,138
|
|
||
Total current liabilities
|
226,642
|
|
|
216,801
|
|
||
Deferred revenue, non-current
|
3,721
|
|
|
4,499
|
|
||
Long-term debt, less current portion
|
1,166,916
|
|
|
1,333,000
|
|
||
Deferred tax liability, net, non-current
|
294,485
|
|
|
375,054
|
|
||
Other non-current liabilities
|
69,253
|
|
|
38,393
|
|
||
Commitments and contingencies (Note 11)
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Ordinary shares, nominal value $0.0001 per share; 300,000 shares authorized; 61,305 and 60,643 shares issued and outstanding at December 31, 2015 and 2014, respectively
|
6
|
|
|
6
|
|
||
Non-voting euro deferred shares, €0.01 par value per share; 4,000 shares authorized, issued and outstanding at both December 31, 2015 and 2014
|
55
|
|
|
55
|
|
||
Capital redemption reserve
|
471
|
|
|
471
|
|
||
Additional paid-in capital
|
1,562,900
|
|
|
1,458,005
|
|
||
Accumulated other comprehensive loss
|
(267,472
|
)
|
|
(122,097
|
)
|
||
Retained earnings
|
302,686
|
|
|
34,704
|
|
||
Total Jazz Pharmaceuticals plc shareholders’ equity
|
1,598,646
|
|
|
1,371,144
|
|
||
Noncontrolling interests
|
—
|
|
|
64
|
|
||
Total shareholders’ equity
|
1,598,646
|
|
|
1,371,208
|
|
||
Total liabilities and shareholders’ equity
|
$
|
3,359,663
|
|
|
$
|
3,338,955
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
1,316,819
|
|
|
$
|
1,162,716
|
|
|
$
|
865,398
|
|
Royalties and contract revenues
|
7,984
|
|
|
10,159
|
|
|
7,025
|
|
|||
Total revenues
|
1,324,803
|
|
|
1,172,875
|
|
|
872,423
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of product sales (excluding amortization and impairment of intangible assets)
|
102,526
|
|
|
117,418
|
|
|
102,146
|
|
|||
Selling, general and administrative
|
449,119
|
|
|
406,114
|
|
|
304,303
|
|
|||
Research and development
|
135,253
|
|
|
85,181
|
|
|
41,632
|
|
|||
Acquired in-process research and development
|
—
|
|
|
202,626
|
|
|
4,988
|
|
|||
Intangible asset amortization
|
98,162
|
|
|
126,584
|
|
|
79,042
|
|
|||
Impairment charges
|
31,523
|
|
|
39,365
|
|
|
—
|
|
|||
Total operating expenses
|
816,583
|
|
|
977,288
|
|
|
532,111
|
|
|||
Income from operations
|
508,220
|
|
|
195,587
|
|
|
340,312
|
|
|||
Interest expense, net
|
(56,917
|
)
|
|
(52,713
|
)
|
|
(26,916
|
)
|
|||
Foreign currency gain (loss)
|
1,445
|
|
|
8,683
|
|
|
(1,697
|
)
|
|||
Loss on extinguishment and modification of debt
|
(16,815
|
)
|
|
—
|
|
|
(3,749
|
)
|
|||
Income before income tax provision
|
435,933
|
|
|
151,557
|
|
|
307,950
|
|
|||
Income tax provision
|
106,399
|
|
|
94,231
|
|
|
91,638
|
|
|||
Net income
|
329,534
|
|
|
57,326
|
|
|
216,312
|
|
|||
Net loss attributable to noncontrolling interests, net of tax
|
(1
|
)
|
|
(1,061
|
)
|
|
—
|
|
|||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
329,535
|
|
|
$
|
58,387
|
|
|
$
|
216,312
|
|
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share:
|
|
|
|
|
|
||||||
Basic
|
$
|
5.38
|
|
|
$
|
0.98
|
|
|
$
|
3.71
|
|
Diluted
|
$
|
5.23
|
|
|
$
|
0.93
|
|
|
$
|
3.51
|
|
Weighted-average ordinary shares used in per share calculation - basic
|
61,232
|
|
|
59,746
|
|
|
58,298
|
|
|||
Weighted-average ordinary shares used in per share calculation - diluted
|
63,036
|
|
|
62,614
|
|
|
61,569
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net income
|
$
|
329,534
|
|
|
$
|
57,326
|
|
|
$
|
216,312
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
(145,375
|
)
|
|
(178,264
|
)
|
|
25,107
|
|
|||
Other comprehensive income (loss)
|
(145,375
|
)
|
|
(178,264
|
)
|
|
25,107
|
|
|||
Total comprehensive income (loss)
|
184,159
|
|
|
(120,938
|
)
|
|
241,419
|
|
|||
Comprehensive loss attributable to noncontrolling interests, net of tax
|
(1
|
)
|
|
(1,075
|
)
|
|
—
|
|
|||
Comprehensive income (loss) attributable to Jazz Pharmaceuticals plc
|
$
|
184,160
|
|
|
$
|
(119,863
|
)
|
|
$
|
241,419
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings (Accumu-lated
Deficit)
|
|
Total Jazz Pharma-ceuticals plc
Share-holders’
Equity
|
|
Non-control-ling interest
|
|
Total
Equity
|
||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||||||||||
Balance at December 31, 2012
|
58,014
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,151,010
|
|
|
$
|
31,046
|
|
|
$
|
(61,296
|
)
|
|
$
|
1,121,292
|
|
|
$
|
—
|
|
|
$
|
1,121,292
|
|
Issuance of ordinary shares in conjunction with exercise of share options
|
904
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
20,895
|
|
|
—
|
|
|
—
|
|
|
20,895
|
|
|
—
|
|
|
20,895
|
|
|||||||||
Issuance of ordinary shares under employee stock purchase plan
|
147
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,410
|
|
|
—
|
|
|
—
|
|
|
5,410
|
|
|
—
|
|
|
5,410
|
|
|||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
146
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,590
|
)
|
|
—
|
|
|
—
|
|
|
(5,590
|
)
|
|
—
|
|
|
(5,590
|
)
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of warrants
|
471
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,398
|
|
|
—
|
|
|
—
|
|
|
4,398
|
|
|
—
|
|
|
4,398
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
44,367
|
|
|
—
|
|
|
—
|
|
|
44,367
|
|
|
—
|
|
|
44,367
|
|
|||||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(173
|
)
|
|
—
|
|
|
—
|
|
|
(173
|
)
|
|
—
|
|
|
(173
|
)
|
|||||||||
Shares repurchased
|
(1,828
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(136,484
|
)
|
|
(136,484
|
)
|
|
—
|
|
|
(136,484
|
)
|
|||||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
25,107
|
|
|
—
|
|
|
25,107
|
|
|
—
|
|
|
25,107
|
|
|||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
216,312
|
|
|
216,312
|
|
|
—
|
|
|
216,312
|
|
|||||||||
Balance at December 31, 2013
|
57,854
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,220,317
|
|
|
$
|
56,153
|
|
|
$
|
18,532
|
|
|
$
|
1,295,534
|
|
|
$
|
—
|
|
|
$
|
1,295,534
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings
|
|
Total Jazz Pharma-ceuticals plc
Share-holders’
Equity
|
|
Non-control-ling interest
|
|
Total
Equity
|
||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||||||||||
Balance at December 31, 2013
|
57,854
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,220,317
|
|
|
$
|
56,153
|
|
|
$
|
18,532
|
|
|
$
|
1,295,534
|
|
|
$
|
—
|
|
|
$
|
1,295,534
|
|
Noncontrolling interest on Gentium Acquisition
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
136,578
|
|
|
136,578
|
|
|||||||||
Acquisition of noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,530
|
)
|
|
—
|
|
|
—
|
|
|
(1,530
|
)
|
|
(135,439
|
)
|
|
(136,969
|
)
|
|||||||||
Issuance of exchangeable senior notes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
126,863
|
|
|
—
|
|
|
—
|
|
|
126,863
|
|
|
—
|
|
|
126,863
|
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
1,185
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
43,043
|
|
|
—
|
|
|
—
|
|
|
43,043
|
|
|
—
|
|
|
43,043
|
|
|||||||||
Issuance of ordinary shares under employee stock purchase plan
|
117
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,197
|
|
|
—
|
|
|
—
|
|
|
7,197
|
|
|
—
|
|
|
7,197
|
|
|||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
222
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,030
|
)
|
|
—
|
|
|
—
|
|
|
(18,030
|
)
|
|
—
|
|
|
(18,030
|
)
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of warrants
|
1,552
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,247
|
|
|
—
|
|
|
—
|
|
|
8,247
|
|
|
—
|
|
|
8,247
|
|
|||||||||
Shares issued under directors deferred compensation plan
|
17
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
70,057
|
|
|
—
|
|
|
—
|
|
|
70,057
|
|
|
—
|
|
|
70,057
|
|
|||||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,841
|
|
|
—
|
|
|
—
|
|
|
1,841
|
|
|
—
|
|
|
1,841
|
|
|||||||||
Shares repurchased
|
(304
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(42,215
|
)
|
|
(42,215
|
)
|
|
—
|
|
|
(42,215
|
)
|
|||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(178,250
|
)
|
|
—
|
|
|
(178,250
|
)
|
|
(14
|
)
|
|
(178,264
|
)
|
|||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
58,387
|
|
|
58,387
|
|
|
(1,061
|
)
|
|
57,326
|
|
|||||||||
Balance at December 31, 2014
|
60,643
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,458,005
|
|
|
$
|
(122,097
|
)
|
|
$
|
34,704
|
|
|
$
|
1,371,144
|
|
|
$
|
64
|
|
|
$
|
1,371,208
|
|
|
Ordinary Shares
|
|
Non-voting Euro Deferred
|
|
Capital Redemp-tion Reserve
|
|
Additional
Paid-in
Capital
|
|
Accumu-lated
Other
Compre-hensive
Income (Loss)
|
|
Retained Earnings
|
|
Total Jazz Pharma-ceuticals plc
Share-holders’
Equity
|
|
Non-control-ling interest
|
|
Total
Equity
|
||||||||||||||||||||||||
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|||||||||||||||||||||||||||||||||
Balance at December 31, 2014
|
60,643
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,458,005
|
|
|
$
|
(122,097
|
)
|
|
$
|
34,704
|
|
|
$
|
1,371,144
|
|
|
$
|
64
|
|
|
$
|
1,371,208
|
|
Acquisition of noncontrolling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
(63
|
)
|
|
(73
|
)
|
|||||||||
Issuance of ordinary shares in conjunction with exercise of share options
|
732
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32,982
|
|
|
—
|
|
|
—
|
|
|
32,982
|
|
|
—
|
|
|
32,982
|
|
|||||||||
Issuance of ordinary shares under employee stock purchase plan
|
75
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,541
|
|
|
—
|
|
|
—
|
|
|
7,541
|
|
|
—
|
|
|
7,541
|
|
|||||||||
Issuance of ordinary shares in conjunction with vesting of restricted stock units
|
265
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(26,102
|
)
|
|
—
|
|
|
—
|
|
|
(26,102
|
)
|
|
—
|
|
|
(26,102
|
)
|
|||||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
91,795
|
|
|
—
|
|
|
—
|
|
|
91,795
|
|
|
—
|
|
|
91,795
|
|
|||||||||
Excess tax benefits from employee share options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,311
|
)
|
|
—
|
|
|
—
|
|
|
(1,311
|
)
|
|
—
|
|
|
(1,311
|
)
|
|||||||||
Shares repurchased
|
(410
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(61,553
|
)
|
|
(61,553
|
)
|
|
—
|
|
|
(61,553
|
)
|
|||||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(145,375
|
)
|
|
—
|
|
|
(145,375
|
)
|
|
—
|
|
|
(145,375
|
)
|
|||||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
329,535
|
|
|
329,535
|
|
|
(1
|
)
|
|
329,534
|
|
|||||||||
Balance at December 31, 2015
|
61,305
|
|
|
$
|
6
|
|
|
4,000
|
|
|
$
|
55
|
|
|
$
|
471
|
|
|
$
|
1,562,900
|
|
|
$
|
(267,472
|
)
|
|
$
|
302,686
|
|
|
$
|
1,598,646
|
|
|
$
|
—
|
|
|
$
|
1,598,646
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net income
|
$
|
329,534
|
|
|
$
|
57,326
|
|
|
$
|
216,312
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Intangible asset amortization
|
98,162
|
|
|
126,584
|
|
|
79,042
|
|
|||
Share-based compensation
|
91,550
|
|
|
69,638
|
|
|
44,551
|
|
|||
Impairment charges
|
31,523
|
|
|
39,365
|
|
|
—
|
|
|||
Depreciation
|
9,894
|
|
|
7,097
|
|
|
3,048
|
|
|||
Acquired in-process research and development
|
—
|
|
|
202,626
|
|
|
4,988
|
|
|||
Loss on disposal of property and equipment
|
172
|
|
|
24
|
|
|
46
|
|
|||
Excess tax benefit from share-based compensation
|
—
|
|
|
(1,841
|
)
|
|
—
|
|
|||
Acquisition accounting inventory fair value step-up adjustments
|
—
|
|
|
10,477
|
|
|
3,826
|
|
|||
Change in fair value of contingent consideration
|
—
|
|
|
—
|
|
|
15,200
|
|
|||
Deferred income taxes
|
(61,209
|
)
|
|
(43,423
|
)
|
|
(10,097
|
)
|
|||
Provision for losses on accounts receivable and inventory
|
4,062
|
|
|
2,493
|
|
|
2,446
|
|
|||
Loss on extinguishment and modification of debt
|
16,815
|
|
|
—
|
|
|
3,749
|
|
|||
Amortization of debt discount and deferred financing costs
|
22,738
|
|
|
13,725
|
|
|
4,591
|
|
|||
Other non-cash transactions
|
(5,187
|
)
|
|
(11,986
|
)
|
|
1,687
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(24,841
|
)
|
|
(55,041
|
)
|
|
(48,846
|
)
|
|||
Inventories
|
6,271
|
|
|
(7,630
|
)
|
|
(8,516
|
)
|
|||
Prepaid expenses and other current assets
|
3,720
|
|
|
11,936
|
|
|
(13,871
|
)
|
|||
Other long-term assets
|
(11,722
|
)
|
|
(8,891
|
)
|
|
(4,306
|
)
|
|||
Accounts payable
|
(2,280
|
)
|
|
(37,966
|
)
|
|
5,089
|
|
|||
Accrued liabilities
|
2,986
|
|
|
20,997
|
|
|
14,717
|
|
|||
Income taxes payable
|
(6,271
|
)
|
|
8,634
|
|
|
(38,984
|
)
|
|||
Deferred revenue
|
(536
|
)
|
|
(1,203
|
)
|
|
(1,061
|
)
|
|||
Contingent consideration
|
—
|
|
|
(14,900
|
)
|
|
—
|
|
|||
Other non-current liabilities
|
26,562
|
|
|
17,724
|
|
|
14,820
|
|
|||
Net cash provided by operating activities
|
531,943
|
|
|
405,765
|
|
|
288,431
|
|
|||
Investing activities
|
|
|
|
|
|
||||||
Acquisitions, net of cash acquired
|
—
|
|
|
(828,676
|
)
|
|
—
|
|
|||
Acquisition of in-process research and development
|
—
|
|
|
(202,626
|
)
|
|
(4,988
|
)
|
|||
Purchases of property and equipment
|
(35,958
|
)
|
|
(36,347
|
)
|
|
(9,976
|
)
|
|||
Net proceeds from sale of business
|
33,703
|
|
|
—
|
|
|
—
|
|
|||
Acquisition of intangible assets
|
—
|
|
|
—
|
|
|
(1,300
|
)
|
|||
Net cash used in investing activities
|
(2,255
|
)
|
|
(1,067,649
|
)
|
|
(16,264
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Net proceeds from issuance of debt
|
898,642
|
|
|
1,194,385
|
|
|
553,425
|
|
|||
Proceeds from employee equity incentive and purchase plans and exercise of warrants
|
40,523
|
|
|
58,487
|
|
|
30,703
|
|
|||
Share repurchases
|
(61,553
|
)
|
|
(42,215
|
)
|
|
(136,484
|
)
|
|||
Acquisition of noncontrolling interests
|
(73
|
)
|
|
(136,969
|
)
|
|
—
|
|
|||
Payment of contingent consideration
|
—
|
|
|
(35,100
|
)
|
|
—
|
|
|||
Payment of employee withholding taxes related to share-based awards
|
(26,102
|
)
|
|
(18,030
|
)
|
|
(5,590
|
)
|
|||
Excess tax benefit from share-based compensation
|
—
|
|
|
1,841
|
|
|
—
|
|
|||
Repayments of long-term debt
|
(905,760
|
)
|
|
(9,524
|
)
|
|
(465,910
|
)
|
|||
Repayments under revolving credit facility
|
(160,000
|
)
|
|
(300,000
|
)
|
|
—
|
|
|||
Net cash provided by (used in) financing activities
|
(214,323
|
)
|
|
712,875
|
|
|
(23,856
|
)
|
|||
Effect of exchange rates on cash and cash equivalents
|
(10,622
|
)
|
|
(3,453
|
)
|
|
997
|
|
|||
Net increase in cash and cash equivalents
|
304,743
|
|
|
47,538
|
|
|
249,308
|
|
|||
Cash and cash equivalents, at beginning of period
|
684,042
|
|
|
636,504
|
|
|
387,196
|
|
|||
Cash and cash equivalents, at end of period
|
$
|
988,785
|
|
|
$
|
684,042
|
|
|
$
|
636,504
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
40,099
|
|
|
$
|
31,978
|
|
|
$
|
18,278
|
|
Cash paid for income taxes
|
145,597
|
|
|
108,189
|
|
|
137,616
|
|
|||
Non-cash investing activities:
|
|
|
|
|
|
||||||
Construction-in-progress related to facility lease obligation
|
4,351
|
|
|
—
|
|
|
—
|
|
•
|
Xyrem
®
(sodium oxybate) oral solution
, the only product approved by the U.S. Food and Drug Administration, or FDA, for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy;
|
•
|
Erwinaze
®
(asparaginase
Erwinia chrysanthemi
)
, a treatment approved in the U.S. and in certain markets in Europe (where it is marketed as Erwinase
®
) for patients with acute lymphoblastic leukemia, or ALL, who have developed hypersensitivity to
E. coli
-derived asparaginase; and
|
•
|
Defitelio
®
(defibrotide)
, a product approved in Europe for the treatment of severe hepatic veno-occlusive disease, or VOD, in adults and children undergoing hematopoietic stem cell transplantation, or HSCT, therapy.
|
•
|
Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications;
|
•
|
Acquiring clinically meaningful and differentiated products that are on the market or product candidates that are in late-stage development; and
|
•
|
Pursuing targeted development of post-discovery differentiated product candidates.
|
•
|
the challenges of protecting and enhancing our intellectual property rights;
|
•
|
the challenges of achieving and maintaining commercial success of our products;
|
•
|
delays or problems in the supply or manufacture of our products, particularly with respect to certain products as to which we maintain limited inventories, and our dependence on single source suppliers to continue to meet our ongoing commercial demand or our requirements for clinical trial supplies;
|
•
|
the need to obtain and maintain appropriate pricing and reimbursement for our products in an increasingly challenging environment due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the United States and worldwide, including the need to obtain and maintain reimbursement for Xyrem in the United States in an environment in which we are subject to increasingly restrictive conditions for reimbursement required by third party payors;
|
•
|
our ability to identify and acquire, in-license or develop additional products or product candidates to grow our business;
|
•
|
the challenges of compliance with the requirements of the FDA, the DEA, and non-U.S. regulatory agencies, including with respect to product labeling, requirements for distribution, obtaining sufficient DEA quotas where needed, marketing and promotional activities, adverse event reporting and product recalls or withdrawals;
|
•
|
the difficulty and uncertainty of pharmaceutical product development, including the timing thereof, and the uncertainty of clinical success, such as the risk that results from preclinical studies and/or early clinical trials may not be predictive of results obtained in later and larger clinical trials planned or anticipated to be conducted for our product candidates;
|
•
|
the inherent uncertainty associated with the regulatory approval process, especially as we continue to undertake increased activities and make growing investment in our product pipeline development projects;
|
•
|
the risks associated with business combination or product or product candidate acquisition transactions, such as the challenges inherent in the integration of acquired businesses with our historic business, the increase in geographic dispersion among our centers of operation and the risks that we may acquire unanticipated liabilities along with acquired businesses or otherwise fail to realize the anticipated benefits (commercial or otherwise) from such transactions; and
|
•
|
possible restrictions on our ability and flexibility to pursue certain future opportunities as a result of our substantial outstanding debt obligations.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc
|
$
|
329,535
|
|
|
$
|
58,387
|
|
|
$
|
216,312
|
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average ordinary shares used in per share calculation - basic
|
61,232
|
|
|
59,746
|
|
|
58,298
|
|
|||
Dilutive effect of employee equity incentive and purchase plans
|
1,804
|
|
|
2,402
|
|
|
1,772
|
|
|||
Dilutive effect of warrants
|
—
|
|
|
466
|
|
|
1,499
|
|
|||
Weighted-average ordinary shares used in per share calculation - diluted
|
63,036
|
|
|
62,614
|
|
|
61,569
|
|
|||
|
|
|
|
|
|
||||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share :
|
|
|
|
|
|
||||||
Basic
|
$
|
5.38
|
|
|
$
|
0.98
|
|
|
$
|
3.71
|
|
Diluted
|
$
|
5.23
|
|
|
$
|
0.93
|
|
|
$
|
3.51
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Options to purchase ordinary shares and RSUs
|
1,609
|
|
|
819
|
|
|
1,584
|
|
1.875% exchangeable senior notes due 2021
|
2,878
|
|
|
1,112
|
|
|
—
|
|
|
December 31, 2015
|
||||||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Cash and Cash Equivalents
|
||||||||||
Cash
|
$
|
274,945
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
274,945
|
|
|
$
|
274,945
|
|
Time deposits
|
713,840
|
|
|
—
|
|
|
—
|
|
|
713,840
|
|
|
713,840
|
|
|||||
Totals
|
$
|
988,785
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
988,785
|
|
|
$
|
988,785
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||||
|
December 31, 2014
|
||||||||||||||||||
|
Amortized
Cost |
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Estimated
Fair Value |
|
Cash and
Cash Equivalents |
||||||||||
Cash
|
$
|
338,262
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
338,262
|
|
|
$
|
338,262
|
|
Time deposits
|
345,780
|
|
|
—
|
|
|
—
|
|
|
345,780
|
|
|
345,780
|
|
|||||
Totals
|
$
|
684,042
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
684,042
|
|
|
$
|
684,042
|
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
|
Significant
Other Observable Inputs (Level 2) |
|
Total
Estimated Fair Value |
||||||||
Time deposits
|
$
|
713,840
|
|
|
$
|
713,840
|
|
|
$
|
345,780
|
|
|
$
|
345,780
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Construction-in-progress
|
$
|
63,008
|
|
|
$
|
37,145
|
|
Computer software
|
15,797
|
|
|
10,634
|
|
||
Leasehold improvements
|
9,301
|
|
|
7,931
|
|
||
Computer equipment
|
10,963
|
|
|
7,670
|
|
||
Machinery and equipment
|
5,828
|
|
|
6,408
|
|
||
Furniture and fixtures
|
2,580
|
|
|
2,220
|
|
||
Land and buildings
|
1,775
|
|
|
1,547
|
|
||
Subtotal
|
109,252
|
|
|
73,555
|
|
||
Less accumulated depreciation and amortization
|
(23,680
|
)
|
|
(15,192
|
)
|
||
Property and equipment, net
|
$
|
85,572
|
|
|
$
|
58,363
|
|
Balance at December 31, 2014
|
$
|
702,713
|
|
Foreign exchange
|
(45,574
|
)
|
|
Balance at December 31, 2015
|
$
|
657,139
|
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||||||||||||
|
Remaining
Weighted- Average Useful Life (In years) |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
|
Gross
Carrying Amount |
|
Accumulated
Amortization |
|
Net Book
Value |
||||||||||||
Acquired developed technologies
|
12.0
|
|
$
|
1,321,324
|
|
|
$
|
(324,044
|
)
|
|
$
|
997,280
|
|
|
$
|
1,450,606
|
|
|
$
|
(259,889
|
)
|
|
$
|
1,190,717
|
|
Manufacturing contracts
|
2.1
|
|
11,697
|
|
|
(5,676
|
)
|
|
6,021
|
|
|
13,012
|
|
|
(3,060
|
)
|
|
9,952
|
|
||||||
Trademarks
|
—
|
|
2,882
|
|
|
(2,882
|
)
|
|
—
|
|
|
2,914
|
|
|
(2,896
|
)
|
|
18
|
|
||||||
Total finite-lived intangible assets
|
|
|
1,335,903
|
|
|
(332,602
|
)
|
|
1,003,301
|
|
|
1,466,532
|
|
|
(265,845
|
)
|
|
1,200,687
|
|
||||||
Acquired IPR&D assets
|
|
|
182,305
|
|
|
—
|
|
|
182,305
|
|
|
236,748
|
|
|
—
|
|
|
236,748
|
|
||||||
Total intangible assets
|
|
|
$
|
1,518,208
|
|
|
$
|
(332,602
|
)
|
|
$
|
1,185,606
|
|
|
$
|
1,703,280
|
|
|
$
|
(265,845
|
)
|
|
$
|
1,437,435
|
|
Year Ending December 31,
|
Estimated Amortization Expense
|
||
2016
|
$
|
90,442
|
|
2017
|
90,442
|
|
|
2018
|
87,636
|
|
|
2019
|
87,419
|
|
|
2020
|
86,249
|
|
|
Thereafter
|
561,113
|
|
|
Total
|
$
|
1,003,301
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Rebates and other sales deductions
|
$
|
67,454
|
|
|
$
|
51,899
|
|
Employee compensation and benefits
|
35,595
|
|
|
46,143
|
|
||
Contract claim settlement
|
18,000
|
|
|
—
|
|
||
Sales returns reserve
|
6,110
|
|
|
14,039
|
|
||
Royalties
|
4,211
|
|
|
7,964
|
|
||
Accrued interest
|
4,043
|
|
|
10,327
|
|
||
Professional fees
|
3,038
|
|
|
3,295
|
|
||
Accrued construction-in-progress
|
1,637
|
|
|
4,931
|
|
||
Other
|
23,982
|
|
|
25,493
|
|
||
Total accrued liabilities
|
$
|
164,070
|
|
|
$
|
164,091
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
1.875% exchangeable senior notes due 2021
|
$
|
575,000
|
|
|
$
|
575,000
|
|
Unamortized discount on 1.875% exchangeable senior notes due 2021
|
(109,048
|
)
|
|
(124,735
|
)
|
||
1.875% exchangeable senior notes due 2021, net
|
465,952
|
|
|
450,265
|
|
||
Term loans
|
738,038
|
|
|
890,479
|
|
||
Other borrowings
|
513
|
|
|
1,684
|
|
||
Total debt
|
1,204,503
|
|
|
1,342,428
|
|
||
Less current portion
|
37,587
|
|
|
9,428
|
|
||
Total long-term debt
|
$
|
1,166,916
|
|
|
$
|
1,333,000
|
|
Year Ending December 31,
|
Scheduled Long-Term Debt Maturities
|
||
2016
|
$
|
37,587
|
|
2017
|
42,280
|
|
|
2018
|
61,034
|
|
|
2019
|
79,789
|
|
|
2020
|
520,420
|
|
|
Thereafter
|
575,028
|
|
|
Total
|
$
|
1,316,138
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Lease expense
|
$
|
10,479
|
|
|
$
|
10,678
|
|
|
$
|
9,114
|
|
Year ending December 31,
|
Lease
Payments
|
||
2016
|
$
|
11,757
|
|
2017
|
12,709
|
|
|
2018
|
8,310
|
|
|
2019
|
7,165
|
|
|
2020
|
6,735
|
|
|
Thereafter
|
66,562
|
|
|
Total
|
$
|
113,238
|
|
|
December 31, 2015
|
|
2011 Equity Incentive Plan
|
11,900
|
|
2007 Equity Incentive Plan
|
937
|
|
2007 Employee Stock Purchase Plan
|
512
|
|
Amended and Restated 2007 Non-Employee Directors Stock Option Plan
|
451
|
|
Amended and Restated Directors Deferred Compensation Plan
|
178
|
|
Total
|
13,978
|
|
|
Foreign
Currency Translation Adjustments |
|
Total
Accumulated Other Comprehensive Loss |
||||
Balance at December 31, 2014
|
$
|
(122,097
|
)
|
|
$
|
(122,097
|
)
|
Other comprehensive loss
|
(145,375
|
)
|
|
(145,375
|
)
|
||
Balance at December 31, 2015
|
$
|
(267,472
|
)
|
|
$
|
(267,472
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Xyrem
|
$
|
955,187
|
|
|
$
|
778,584
|
|
|
$
|
569,113
|
|
Erwinaze/Erwinase
|
203,261
|
|
|
199,665
|
|
|
174,251
|
|
|||
Defitelio/defibrotide
|
70,731
|
|
|
70,537
|
|
|
—
|
|
|||
Prialt
®
(ziconotide) intrathecal infusion
|
26,440
|
|
|
26,421
|
|
|
27,103
|
|
|||
Psychiatry
|
37,135
|
|
|
40,879
|
|
|
49,226
|
|
|||
Other
|
24,065
|
|
|
46,630
|
|
|
45,705
|
|
|||
Product sales, net
|
1,316,819
|
|
|
1,162,716
|
|
|
865,398
|
|
|||
Royalties and contract revenues
|
7,984
|
|
|
10,159
|
|
|
7,025
|
|
|||
Total revenues
|
$
|
1,324,803
|
|
|
$
|
1,172,875
|
|
|
$
|
872,423
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
United States
|
$
|
1,192,879
|
|
|
$
|
1,007,396
|
|
|
$
|
792,518
|
|
Europe
|
103,614
|
|
|
126,715
|
|
|
61,843
|
|
|||
All other
|
28,310
|
|
|
38,764
|
|
|
18,062
|
|
|||
Total revenues
|
$
|
1,324,803
|
|
|
$
|
1,172,875
|
|
|
$
|
872,423
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Express Scripts
|
72
|
%
|
|
66
|
%
|
|
65
|
%
|
Accredo Health Group, Inc.
|
6
|
%
|
|
14
|
%
|
|
16
|
%
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Ireland
|
$
|
62,795
|
|
|
$
|
37,775
|
|
United States
|
12,794
|
|
|
9,795
|
|
||
Italy
|
7,928
|
|
|
8,462
|
|
||
Other
|
2,055
|
|
|
2,331
|
|
||
Total long-lived assets (1)
|
$
|
85,572
|
|
|
$
|
58,363
|
|
(1)
|
Long-lived assets consist of property and equipment.
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Grant date fair value
|
$
|
57.19
|
|
|
$
|
60.29
|
|
|
$
|
29.09
|
|
Volatility
|
39
|
%
|
|
45
|
%
|
|
58
|
%
|
|||
Expected term (years)
|
4.2
|
|
|
4.3
|
|
|
4.4
|
|
|||
Range of risk-free rates
|
1.1-1.5%
|
|
|
1.1-1.4%
|
|
|
0.5-1.4%
|
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Selling, general and administrative
|
$
|
74,653
|
|
|
$
|
55,083
|
|
|
$
|
35,674
|
|
Research and development
|
13,356
|
|
|
12,179
|
|
|
6,673
|
|
|||
Cost of product sales
|
3,541
|
|
|
2,376
|
|
|
2,204
|
|
|||
Total share-based compensation expense, pre-tax
|
91,550
|
|
|
69,638
|
|
|
44,551
|
|
|||
Tax benefit from share-based compensation expense
|
(26,608
|
)
|
|
(20,795
|
)
|
|
(13,822
|
)
|
|||
Total share-based compensation expense, net of tax
|
$
|
64,942
|
|
|
$
|
48,843
|
|
|
$
|
30,729
|
|
|
Shares
Subject to
Outstanding
Options
(In thousands)
|
|
Weighted-
Average
Exercise
Price
|
|
Weighted-
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
(In thousands)
|
|||||
Outstanding at January 1, 2015
|
3,870
|
|
|
$
|
72.77
|
|
|
|
|
|
||
Options granted
|
1,118
|
|
|
173.30
|
|
|
|
|
|
|||
Options exercised
|
(732
|
)
|
|
45.04
|
|
|
|
|
|
|||
Options forfeited
|
(319
|
)
|
|
118.05
|
|
|
|
|
|
|||
Options expired
|
—
|
|
|
—
|
|
|
|
|
|
|||
Outstanding at December 31, 2015
|
3,937
|
|
|
102.81
|
|
|
7.4
|
|
$
|
198,666
|
|
|
Vested and expected to vest at December 31, 2015
|
3,731
|
|
|
99.87
|
|
|
7.3
|
|
196,654
|
|
||
Exercisable at December 31, 2015
|
1,992
|
|
|
64.48
|
|
|
6.3
|
|
159,156
|
|
|
Number of RSUs (in thousands)
|
|
Weighted-
Average Grant-Date Fair Value |
|
Weighted-
Average Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value (In thousands) |
|||||
Outstanding at January 1, 2015
|
1,188
|
|
|
$
|
96.41
|
|
|
|
|
|
||
RSUs granted
|
430
|
|
|
173.25
|
|
|
|
|
|
|||
RSUs released
|
(414
|
)
|
|
86.03
|
|
|
|
|
|
|||
RSUs forfeited
|
(150
|
)
|
|
113.44
|
|
|
|
|
|
|||
RSUs expired
|
—
|
|
|
—
|
|
|
|
|
|
|||
Outstanding at December 31, 2015
|
1,054
|
|
|
129.40
|
|
|
1.2
|
|
$
|
148,172
|
|
|
Termination Benefits
|
|
Facility Closure Costs
|
|
Total
|
||||||
Balance at December 31, 2012
|
$
|
1,227
|
|
|
$
|
—
|
|
|
$
|
1,227
|
|
Expense
|
1,045
|
|
|
412
|
|
|
1,457
|
|
|||
Payments
|
(2,272
|
)
|
|
(160
|
)
|
|
(2,432
|
)
|
|||
Balance at December 31, 2013
|
—
|
|
|
252
|
|
|
252
|
|
|||
Expense
|
1,823
|
|
|
118
|
|
|
1,941
|
|
|||
Payments
|
—
|
|
|
(252
|
)
|
|
(252
|
)
|
|||
Balance at December 31, 2014
|
1,823
|
|
|
118
|
|
|
1,941
|
|
|||
Expense
|
1,469
|
|
|
172
|
|
|
1,641
|
|
|||
Payments
|
(2,187
|
)
|
|
(290
|
)
|
|
(2,477
|
)
|
|||
Balance at December 31, 2015
|
$
|
1,105
|
|
|
$
|
—
|
|
|
$
|
1,105
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Ireland
|
$
|
233,785
|
|
|
$
|
238,351
|
|
|
$
|
186,903
|
|
United States
|
285,420
|
|
|
222,328
|
|
|
132,855
|
|
|||
Other
|
(83,272
|
)
|
|
(309,122
|
)
|
|
(11,808
|
)
|
|||
Total
|
$
|
435,933
|
|
|
$
|
151,557
|
|
|
$
|
307,950
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Current
|
|
|
|
|
|
||||||
Ireland
|
$
|
22,599
|
|
|
$
|
23,506
|
|
|
$
|
17,089
|
|
United States
|
116,301
|
|
|
97,679
|
|
|
71,964
|
|
|||
Other
|
28,708
|
|
|
16,469
|
|
|
12,682
|
|
|||
Total current income tax
|
167,608
|
|
|
137,654
|
|
|
101,735
|
|
|||
Deferred, exclusive of other components below
|
|
|
|
|
|
||||||
Ireland
|
494
|
|
|
2,323
|
|
|
8,353
|
|
|||
United States
|
332
|
|
|
(15,003
|
)
|
|
(3,513
|
)
|
|||
Other
|
(40,532
|
)
|
|
(30,743
|
)
|
|
(14,937
|
)
|
|||
Total deferred, exclusive of other components
|
(39,706
|
)
|
|
(43,423
|
)
|
|
(10,097
|
)
|
|||
Deferred, change in tax rates
|
|
|
|
|
|
||||||
United States
|
294
|
|
|
—
|
|
|
—
|
|
|||
Other
|
(21,797
|
)
|
|
—
|
|
|
—
|
|
|||
Total deferred, change in tax rates
|
(21,503
|
)
|
|
—
|
|
|
—
|
|
|||
Total deferred income tax benefit
|
(61,209
|
)
|
|
(43,423
|
)
|
|
(10,097
|
)
|
|||
Total income tax provision
|
$
|
106,399
|
|
|
$
|
94,231
|
|
|
$
|
91,638
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Statutory income tax rate
|
12.5
|
%
|
|
12.5
|
%
|
|
12.5
|
%
|
Foreign income tax rate differential
|
19.1
|
%
|
|
50.0
|
%
|
|
10.3
|
%
|
Change in tax rate
|
(4.5
|
)%
|
|
—
|
%
|
|
—
|
%
|
Research and other tax credits
|
(3.8
|
)%
|
|
(9.4
|
)%
|
|
(1.9
|
)%
|
Change in unrecognized tax benefits
|
3.6
|
%
|
|
6.2
|
%
|
|
2.8
|
%
|
Deduction on subsidiary equity
|
(2.7
|
)%
|
|
(7.5
|
)%
|
|
—
|
%
|
Change in estimates
|
(1.0
|
)%
|
|
(3.0
|
)%
|
|
1.1
|
%
|
Non-deductible compensation
|
1.9
|
%
|
|
4.6
|
%
|
|
1.3
|
%
|
Change in valuation allowance
|
(0.6
|
)%
|
|
5.7
|
%
|
|
1.1
|
%
|
Financing costs
|
(0.4
|
)%
|
|
0.7
|
%
|
|
—
|
%
|
Acquisition-related costs
|
—
|
%
|
|
3.1
|
%
|
|
1.7
|
%
|
Other
|
0.3
|
%
|
|
(0.7
|
)%
|
|
0.9
|
%
|
Effective income tax rate
|
24.4
|
%
|
|
62.2
|
%
|
|
29.8
|
%
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
57,091
|
|
|
$
|
74,057
|
|
Tax credit carryforwards
|
36,797
|
|
|
23,946
|
|
||
Intangible assets
|
25,384
|
|
|
19,507
|
|
||
Share-based compensation
|
20,050
|
|
|
14,033
|
|
||
Accruals
|
32,355
|
|
|
36,157
|
|
||
Other
|
31,144
|
|
|
36,222
|
|
||
Total deferred tax assets
|
202,821
|
|
|
203,922
|
|
||
Valuation allowance
|
(33,949
|
)
|
|
(29,697
|
)
|
||
Net deferred tax assets
|
168,872
|
|
|
174,225
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Acquired intangible assets
|
(307,356
|
)
|
|
(395,651
|
)
|
||
Other
|
(33,138
|
)
|
|
(39,124
|
)
|
||
Total deferred tax liabilities
|
(340,494
|
)
|
|
(434,775
|
)
|
||
Net deferred tax liabilities
|
$
|
(171,622
|
)
|
|
$
|
(260,550
|
)
|
|
Year Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Current deferred tax assets
|
$
|
—
|
|
|
$
|
48,440
|
|
Current deferred tax liabilities
|
—
|
|
|
(9,430
|
)
|
||
Non-current deferred tax assets
|
122,863
|
|
|
75,494
|
|
||
Non-current deferred tax liabilities
|
(294,485
|
)
|
|
(375,054
|
)
|
||
Net deferred tax liabilities
|
$
|
(171,622
|
)
|
|
$
|
(260,550
|
)
|
|
December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Balance at the beginning of the year
|
$
|
40,802
|
|
|
$
|
21,637
|
|
|
$
|
7,288
|
|
Increases related to current year tax positions
|
23,664
|
|
|
19,837
|
|
|
14,308
|
|
|||
Increases related to prior year tax positions
|
2,833
|
|
|
—
|
|
|
183
|
|
|||
Decreases related to prior year tax positions
|
(646
|
)
|
|
(672
|
)
|
|
(142
|
)
|
|||
Lapse of the applicable statute of limitations
|
(268
|
)
|
|
—
|
|
|
—
|
|
|||
Balance at the end of the year
|
$
|
66,385
|
|
|
$
|
40,802
|
|
|
$
|
21,637
|
|
|
2015
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues
|
$
|
309,303
|
|
|
$
|
333,747
|
|
|
$
|
340,872
|
|
|
$
|
340,881
|
|
Gross margin (1)
|
278,737
|
|
|
310,293
|
|
|
310,369
|
|
|
314,894
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc
|
70,700
|
|
|
88,114
|
|
|
87,960
|
|
|
82,761
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, basic
|
1.16
|
|
|
1.44
|
|
|
1.43
|
|
|
1.35
|
|
||||
Net income attributable to Jazz Pharmaceuticals plc per ordinary share, diluted
|
1.12
|
|
|
1.40
|
|
|
1.39
|
|
|
1.32
|
|
|
2014
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
Revenues
|
$
|
246,919
|
|
|
$
|
291,230
|
|
|
$
|
306,584
|
|
|
$
|
328,142
|
|
Gross margin (1)
|
214,062
|
|
|
258,408
|
|
|
277,413
|
|
|
295,415
|
|
||||
Net income (loss) attributable to Jazz Pharmaceuticals plc
|
(92,650
|
)
|
|
43,659
|
|
|
25,766
|
|
|
81,612
|
|
||||
Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, basic
|
(1.58
|
)
|
|
0.73
|
|
|
0.43
|
|
|
1.35
|
|
||||
Net income (loss) attributable to Jazz Pharmaceuticals plc per ordinary share, diluted
|
(1.58
|
)
|
|
0.70
|
|
|
0.41
|
|
|
1.30
|
|
(1)
|
Gross margin is computed by subtracting cost of product sales (excluding amortization and impairment of intangible assets) from product sales, net.
|
•
|
Impairment charges of
$31.5 million
in the fourth quarter of 2015 and
$32.8 million
and
$6.6 million
in the second and fourth quarters of 2014, respectively. The 2015 charge resulted from our decision to terminate a pivotal Phase 2 clinical trial of JZP-416. The 2014 charges related to certain products acquired as part of the EUSA Acquisition that we sold in March 2015;
|
•
|
Upfront and milestone payments of
$25.0 million
in the third quarter of 2015 and
$127.0 million
,
$75.0 million
and
$0.6 million
in the first, third and fourth quarters of 2014, respectively;
|
•
|
A one-time charge of
$18.0 million
in the fourth quarter of 2015 for settlement of a contract claim that was originally asserted against Azur Pharma prior to the Azur Merger;
|
•
|
A loss on extinguishment and modification of debt of
$16.8 million
in the second quarter of 2015;
|
•
|
Acquisition accounting inventory value step-up adjustments
$8.0 million
and
$2.5 million
in the first and second quarters of 2014, respectively; and
|
•
|
Transaction costs of
$17.1 million
,
$4.4 million
,
$0.7 million
and
$5.2 million
in the first, second, third and fourth quarters of 2014, respectively.
|
|
|
|
Balance at
beginning
of period
|
|
Additions
charged to
costs and
expenses
|
|
Other Additions
|
|
Deductions
|
|
Balance at
end of
period
|
|||||||||||
For the year ended December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
530
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(41
|
)
|
|
$
|
489
|
|
Allowance for sales discounts
|
(1
|
)
|
|
238
|
|
|
2,900
|
|
|
—
|
|
|
(2,957
|
)
|
|
181
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
2,715
|
|
|
39,079
|
|
|
—
|
|
|
(38,771
|
)
|
|
3,023
|
|
|||||
Deferred tax asset valuation allowance
|
(2)(3)(4)
|
|
|
29,697
|
|
|
5,044
|
|
|
1,888
|
|
|
(2,680
|
)
|
|
33,949
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
For the year ended December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
594
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(64
|
)
|
|
$
|
530
|
|
Allowance for sales discounts
|
(1
|
)
|
|
378
|
|
|
3,794
|
|
|
—
|
|
|
(3,934
|
)
|
|
238
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
2,708
|
|
|
28,614
|
|
|
—
|
|
|
(28,607
|
)
|
|
2,715
|
|
|||||
Deferred tax asset valuation allowance
|
(2)(3)
|
|
|
20,691
|
|
|
18,971
|
|
|
—
|
|
|
(9,965
|
)
|
|
29,697
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
For the year ended December 31, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Allowance for doubtful accounts
|
(1
|
)
|
|
$
|
715
|
|
|
$
|
(4
|
)
|
|
$
|
—
|
|
|
$
|
(117
|
)
|
|
$
|
594
|
|
Allowance for sales discounts
|
(1
|
)
|
|
528
|
|
|
5,267
|
|
|
—
|
|
|
(5,417
|
)
|
|
378
|
|
|||||
Allowance for chargebacks
|
(1
|
)
|
|
2,536
|
|
|
21,047
|
|
|
—
|
|
|
(20,875
|
)
|
|
2,708
|
|
|||||
Deferred tax asset valuation allowance
|
(2
|
)
|
|
17,471
|
|
|
3,220
|
|
|
—
|
|
|
—
|
|
|
20,691
|
|
(1)
|
Shown as a reduction of accounts receivable. Charges related to sales discounts and chargebacks are reflected as a reduction of revenue.
|
(2)
|
Additions to the deferred tax asset valuation allowance relate to movements on certain U.S. state and other foreign deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal.
|
(3)
|
Deductions to the deferred tax asset valuation allowance include movements relating to utilization of NOLs and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns.
|
(4)
|
Other additions to the deferred tax asset valuation allowance relate to currency translation adjustments recorded directly in equity.
|
Exhibit
Number
|
|
Description of Document
|
|
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated as of September 19, 2011, by and among Azur Pharma Limited (now Jazz Pharmaceuticals plc), Jaguar Merger Sub Inc., Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500) filed with the SEC on September 19, 2011).
|
|
2.2
|
|
Letter Agreement, dated as of January 17, 2012, by and among Jazz Pharmaceuticals plc, Jaguar Merger Sub Inc. Jazz Pharmaceuticals, Inc. and Seamus Mulligan, solely in his capacity as the Indemnitors’ Representative (incorporated by reference to Exhibit 2.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
2.3
|
|
Agreement and Plan of Merger, dated as of April 26, 2012, by and among Jazz Pharmaceuticals plc, Jewel Merger Sub Inc., EUSA Pharma Inc., and Essex Woodlands Health Ventures, Inc., Mayflower L.P., and Bryan Morton, in their capacity as the representatives of the equity holders of EUSA Pharma Inc. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on April 27, 2012).
|
|
2.4
|
|
Assignment, dated as of June 11, 2012, by and among Jazz Pharmaceuticals plc and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1B in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 12, 2012).
|
|
2.5
|
|
Tender Offer Agreement, dated December 19, 2013, by and among Jazz Pharmaceuticals Public Limited Company, Jazz Pharmaceuticals Italy S.r.l. and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K/A (File No. 001-33500), as filed with the SEC on December 20, 2013).
|
|
2.6†
|
|
Asset Purchase Agreement, dated January 13, 2014, by and among Jazz Pharmaceuticals International III Limited, Aerial BioPharma, LLC and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 13, 2014).
|
|
2.7†
|
|
Assignment Agreement, dated July 1, 2014, by and among Jazz Pharmaceuticals International II Limited, Sigma-Tau Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and Gentium S.p.A. (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 5, 2014).
|
|
2.8
|
|
Amended and Restated Agreement for the Acquisition of the Topaz Portfolio Business of Jazz Pharmaceuticals plc, dated March 20, 2015, between Jazz Pharmaceuticals plc and Essex Bidco Limited (incorporated herein by reference to Exhibit 2.1 in Jazz Pharmaceuticals plc’s current report on Form 8-K (File No. 001-33500), as filed with the SEC on March 23, 2015).
|
|
3.1
|
|
Memorandum and Articles of Association of Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 3.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
4.1
|
|
Reference is made to Exhibit 3.1.
|
|
4.2A
|
|
Investor Rights Agreement, dated July 7, 2009 by and between Jazz Pharmaceuticals, Inc. and the other parties named therein (incorporated herein by reference to Exhibit 10.88 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on July 7, 2009).
|
|
4.2B
|
|
Assignment, Assumption and Amendment Agreement, dated as of January 18, 2012, by and among Jazz Pharmaceuticals, Inc., Jazz Pharmaceuticals plc and the other parties named therein (incorporated herein by reference to Exhibit 4.7B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
4.2C
|
|
Indenture, dated as of August 13, 2014, by and among Jazz Pharmaceuticals plc, Jazz Investments I Limited and U.S. Bank National Association (incorporated herein by reference to Exhibit 4.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
4.2D
|
|
Form of 1.875% Exchangeable Senior Note due 2021 (incorporated herein by reference to Exhibit 4.2 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on August 13, 2014).
|
|
10.1†
|
|
Supply Agreement, dated as of April 1, 2010, by and between Jazz Pharmaceuticals, Inc. and Siegfried (USA) Inc. (incorporated herein by reference to Exhibit 10.54 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2010, as filed with the SEC on May 6, 2010).
|
|
10.2†
|
|
Master Services Agreement, dated April 15, 2011, by and between Jazz Pharmaceuticals, Inc., CuraScript, Inc. and Express Scripts Specialty Distribution Services, Inc. (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2011, as filed with the SEC on May 9, 2011).
|
|
10.3†
|
|
Royalty Bearing License Agreement and Supply Agreement Re Erwinia-Derived Asparaginase, dated July 22, 2005, between Public Health England (formerly Health Protection Agency) and EUSA Pharma SAS (formerly OPi, S.A.), as amended on each of December 22, 2009, March 23, 2012 and August 8, 2012 (incorporated herein by reference to Exhibit 10.11 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q/A (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 9, 2012).
|
|
10.4
|
|
Novation Agreement relating to Royalty Bearing Licence Agreement and Supply Agreement re Erwinia-Derived Asparaginase, dated as of May 13, 2015, by and among EUSA Pharma SAS, the Secretary of State for Health acting through Public Health England and Porton Biopharma Limited (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.5*
|
|
Master Manufacturing Services Agreement, dated as of October 1, 2015, by and between Jazz Pharmaceuticals Ireland Limited and Patheon Pharmaceuticals Inc.
|
|
10.6
|
|
Credit Agreement, dated as of June 18, 2015, among Jazz Pharmaceuticals plc, Jazz Securities Limited, Jazz Pharmaceuticals, Inc., Jazz Financing I Limited, Jazz Pharmaceuticals Ireland Limited, the lenders party thereto and Bank of America, N.A., as Collateral Agent, Administrative Agent, Swing Line Lender and L/C Issuer (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc's Current Report on Form 8-K (File No. 0001-33500), as filed with the SEC on June 18, 2015).
|
|
10.7A
|
|
Commercial Lease, dated as of June 2, 2004, by and between Jazz Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.52 in Jazz Pharmaceuticals, Inc.’s registration statement on Form S-1, as amended (File No. 333-141164), as filed with the SEC on March 27, 2007).
|
|
10.7B
|
|
First Amendment of Lease, dated June 1, 2009, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.86 in Jazz Pharmaceuticals, Inc.’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on June 4, 2009).
|
|
10.7C
|
|
Second Amendment of Lease, dated February 28, 2012, by and between Jazz Pharmaceuticals, Inc. and Wheatley-Fields, LLC, successor in interest to The Board of Trustees of the Leland Stanford Junior University (incorporated herein by reference to Exhibit 10.31 in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals, Inc. with the SEC on February 28, 2012).
|
|
10.8
|
|
Lease, dated May 8, 2012, by and between John Ronan and Castle Cove Property Developments Limited and Jazz Pharmaceuticals plc (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.9
|
|
Commercial Lease, dated as of January 7, 2015, by and between The Board of Trustees of the Leland Stanford Junior University and Jazz Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.10+
|
|
Form of Indemnification Agreement between Jazz Pharmaceuticals plc and its officers and directors (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on January 18, 2012).
|
|
10.11+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Suzanne Sawochka Hooper (incorporated herein by reference to Exhibit 10.19 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012).
|
|
10.12+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Matthew Young (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.13A+
|
|
Employment Agreement by and between EUSA Pharma Inc. and Iain McGill (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.13B+
|
|
Amendment to Employment Agreement by and between Iain McGill and EUSA Pharma (Europe) Limited (incorporated herein by reference to Exhibit 10.15B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.14+
|
|
Offer Letter from Jazz Pharmaceuticals, Inc. to Michael Miller (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15A+
|
|
Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2014, as filed with the SEC on November 4, 2014).
|
|
10.15B+
|
|
Amendment to Employment Agreement by and between Jazz Pharmaceuticals Ireland Limited and Paul Treacy (incorporated herein by reference to Exhibit 10.15A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2014, as filed with the SEC on February 24, 2015).
|
|
10.16+
|
|
Amended and Restated Offer Letter, dated as of July 29, 2015, from Jazz Pharmaceuticals, Inc. to Karen Smith, M.D., Ph.D. ((incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2015, as filed with the SEC on November 9, 2015).
|
|
10.17A+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.3 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.17B+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.3B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.17C+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27C in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17D+
|
|
Form of Notice of Grant of Stock Options and Form of Option Agreement (Irish) under Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17E+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500), as filed with the SEC on February 26, 2013).
|
|
10.17F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.27F in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.17G+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.17H+
|
|
Jazz Pharmaceuticals plc 2007 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18A+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.1 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.18B+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan Sub-Plan Governing Awards to Participants in the Republic of Ireland (incorporated herein by reference to Exhibit 10.39B in the Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2011, as filed by Jazz Pharmaceuticals plc on behalf of and as successor to Jazz Pharmaceuticals Inc. with the SEC on February 28, 2012).
|
|
10.18C+
|
|
Form of Option Grant Notice and Form of Stock Option Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18D+
|
|
Form of Stock Option Grant Notice and Form of Option Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18E+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28E in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18F+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (U.S.) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.9 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18G+
|
|
Form of Restricted Stock Unit Grant Notice and Form of Restricted Stock Unit Award Agreement (Irish) under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2012, as filed with the SEC on August 7, 2012).
|
|
10.18H+
|
|
Form of Non-U.S. Restricted Stock Unit Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement under the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.28H in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.18I+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Option Grant Notice and Form of U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18J+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of U.S. Restricted Stock Unit Award Grant Notice and Form of U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.4 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18K+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.5 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.18L+
|
|
Jazz Pharmaceuticals plc 2011 Equity Incentive Plan - Form of Non-U.S. Restricted Stock Unit Award Grant Notice and Form of Non-U.S. Restricted Stock Unit Award Agreement (approved July 31, 2013) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.19+
|
|
Jazz Pharmaceuticals plc Amended and Restated Directors Deferred Compensation Plan (incorporated herein by reference to Exhibit 99.6 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20A+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 99.4 in Jazz Pharmaceuticals plc’s registration statement on Form S-8 (File No. 333-179075), as filed with the SEC on January 18, 2012).
|
|
10.20B+
|
|
Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement under the Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan (incorporated herein by reference to Exhibit 10.30B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.20C+
|
|
Jazz Pharmaceuticals plc Amended and Restated 2007 Non-Employee Directors Stock Option Plan - Form of Non-U.S. Option Grant Notice and Form of Non-U.S. Option Agreement (approved August 1, 2013) (incorporated herein by reference to Exhibit 10.7 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended September 30, 2013, as filed with the SEC on November 5, 2013).
|
|
10.21A+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan, as amended and restated (incorporated herein by reference to Exhibit 10.31A in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.21B+
|
|
Jazz Pharmaceuticals plc 2007 Employee Stock Purchase Plan Sub-Plan Governing Purchase Rights to Participants in the Republic of Ireland (incorporated by reference herein to Exhibit 10.14C in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2012, as filed with the SEC on May 8, 2012 ).
|
|
10.22A+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (incorporated herein by reference to Exhibit 10.32B in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2012, as filed with the SEC on February 26, 2013).
|
|
10.22B+
|
|
Jazz Pharmaceuticals plc Cash Bonus Plan for U.S. Affiliates (approved November 4, 2015).
|
|
10.22C+
|
|
Jazz Pharmaceuticals Cash Bonus Plan for International Affiliates (2014) (incorporated herein by reference to Exhibit 10.24D in Jazz Pharmaceuticals plc’s Annual Report on Form 10-K (File No. 001-33500) for the period ended December 31, 2013, as filed with the SEC on February 25, 2014).
|
|
10.22D+
|
|
Jazz Pharmaceuticals Cash Bonus Plan (Ireland and Other Specified Affiliates) (Calendar Year 2016).
|
|
10.23+
|
|
Jazz Pharmaceuticals plc Amended and Restated Executive Change in Control and Severance Benefit Plan (approved February 10, 2016).
|
|
10.24+
|
|
Jazz Pharmaceuticals plc 2015 Executive Officer Compensation Arrangements (incorporated herein by reference to Exhibit 10.3 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2015, as filed with the SEC on May 7, 2015).
|
|
10.25A+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved May 1, 2014) (incorporated herein by reference to Exhibit 10.6 in Jazz Pharmaceuticals plc’s quarterly report on Form 10-Q (File No. 001-33500) for the period ended March 31, 2014, as filed with the SEC on May 8, 2014).
|
|
10.25B+
|
|
Jazz Pharmaceuticals plc Non-Employee Director Compensation Policy (approved April 30, 2015) (incorporated herein by reference to Exhibit 10.2 in Jazz Pharmaceuticals plc’s Quarterly Report on Form 10-Q (File No. 001-33500) for the period ended June 30, 2015, as filed with the SEC on August 5, 2015).
|
|
10.26+
|
|
Named Officer 2015 Target Bonus Opportunity (incorporated herein by reference to Exhibit 10.1 in Jazz Pharmaceuticals plc’s Current Report on Form 8-K (File No. 001-33500), as filed with the SEC on February 18, 2015).
|
|
21.1
|
|
Subsidiaries of Jazz Pharmaceuticals plc.
|
|
23.1
|
|
Consent of KPMG, Independent Registered Public Accounting Firm.
|
|
24.1
|
|
Power of Attorney (included on the signature page hereto).
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.
|
|
32.1**
|
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
+
|
Indicates management contract or compensatory plan.
|
†
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
*
|
Confidential treatment has been requested with respect to certain portions of this exhibit.
|
**
|
The certifications attached as Exhibit 32.1 accompany this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
ARTICLE 1
|
1
|
|
STRUCTURE OF AGREEMENT AND INTERPRETATION
|
1
|
|
1.1
|
Master Agreement.
|
1
|
1.2
|
Product Agreements.
|
1
|
1.3
|
Definitions.
|
2
|
1.4
|
Currency.
|
7
|
1.5
|
Sections and Headings.
|
7
|
1.6
|
Singular Terms.
|
8
|
1.7
|
Appendix 1, Schedules and Exhibits.
|
8
|
PATHEON'S MANUFACTURING SERVICES
|
9
|
|
2.1
|
Manufacturing Services.
|
9
|
2.2
|
Active Material Yield.
|
11
|
ARTICLE 3
|
13
|
|
CLIENT'S OBLIGATIONS
|
13
|
|
3.1
|
Payment.
|
13
|
3.2
|
Active Materials and Qualification of Additional Sources of Supply.
|
13
|
ARTICLE 4
|
14
|
|
CONVERSION FEES AND COMPONENT COSTS
|
14
|
|
4.1
|
First Year Pricing.
|
14
|
4.2
|
Price Adjustments - Subsequent Years’ Pricing.
|
14
|
4.3
|
Price Adjustments - Current Year Pricing.
|
15
|
4.4
|
Adjustments Due to Technical Changes or Regulatory Authority
|
|
Requirements.
|
16
|
|
4.5
|
Multi-Country Packaging Requirements.
|
17
|
ARTICLE 5
|
17
|
|
ORDERS, SHIPMENT, INVOICING, PAYMENT
|
17
|
|
5.1
|
Orders and Forecasts.
|
17
|
5.2
|
Reliance by Patheon.
|
18
|
5.3
|
Minimum Orders.
|
19
|
5.4
|
Delivery and Shipping.
|
19
|
5.5
|
Invoices and Payment.
|
19
|
ARTICLE 6
|
20
|
|
PRODUCT CLAIMS AND RECALLS
|
20
|
|
6.1
|
Product Claims.
|
20
|
6.2
|
Product Recalls and Returns.
|
20
|
6.3
|
Patheon’s Responsibility for Defective and Recalled Products.
|
21
|
6.4
|
Disposition of Defective or Recalled Products.
|
22
|
6.5
|
Healthcare Provider or Patient Questions and Complaints.
|
22
|
6.6
|
Sole Remedy.
|
22
|
ARTICLE 7
|
23
|
|
CO-OPERATION
|
23
|
|
7.1
|
Quarterly Review.
|
23
|
7.2
|
Governmental Agencies.
|
23
|
7.3
|
Records and Accounting by Patheon.
|
23
|
7.4
|
Inspection.
|
23
|
7.5
|
Access.
|
23
|
7.6
|
Notification of Regulatory Inspections.
|
24
|
7.7
|
Reports.
|
24
|
7.8
|
Regulatory Filings.
|
24
|
7.9
|
Inspection by Regulatory Authorities.
|
25
|
ARTICLE 8
|
25
|
|
TERM AND TERMINATION
|
25
|
|
8.1
|
Initial Term.
|
25
|
8.2
|
Termination for Cause.
|
26
|
8.3
|
Termination by Client.
|
26
|
8.4
|
Product Discontinuation.
|
27
|
8.5
|
Obligations on Termination.
|
27
|
ARTICLE 9
|
28
|
|
REPRESENTATIONS, WARRANTIES AND COVENANTS
|
28
|
|
9.1
|
Authority.
|
28
|
9.2
|
Client Warranties.
|
28
|
9.3
|
Patheon Warranties.
|
29
|
9.4
|
Debarred Persons.
|
29
|
9.5
|
Permits.
|
29
|
9.6
|
Compliance with Laws. .
|
30
|
9.7
|
No Warranty.
|
30
|
ARTICLE 10
|
30
|
|
REMEDIES AND INDEMNITIES
|
30
|
|
10.1
|
Consequential Damages.
|
30
|
10.2
|
Limitation of Liability.
|
30
|
10.3
|
Patheon Indemnity.
|
31
|
10.4
|
Client Indemnity.
|
31
|
10.5
|
Reasonable Allocation of Risk.
|
31
|
ARTICLE 11
|
32
|
|
CONFIDENTIALITY
|
32
|
|
11.1
|
Confidential Information.
|
32
|
11.2
|
Use Of Confidential Information.
|
32
|
11.3
|
Exclusions.
|
32
|
11.4
|
Photographs And Recordings.
|
33
|
11.5
|
Permitted Disclosure.
|
33
|
11.6
|
Return of Confidential Information.
|
33
|
11.7
|
Remedies.
|
33
|
ARTICLE 12
|
34
|
|
DISPUTE RESOLUTION
|
34
|
|
12.1
|
Commercial Disputes.
|
34
|
12.2
|
Technical Dispute Resolution.
|
34
|
ARTICLE 13
|
34
|
|
MISCELLANEOUS
|
34
|
|
13.1
|
Inventions.
|
34
|
13.2
|
Intellectual Property.
|
35
|
13.3
|
Insurance.
|
35
|
13.4
|
Independent Contractors.
|
35
|
13.5
|
No Waiver.
|
36
|
13.6
|
Assignment.
|
36
|
13.7
|
Force Majeure.
|
36
|
13.8
|
Additional Product.
|
36
|
13.9
|
Notices.
|
36
|
13.10
|
Severability.
|
37
|
13.11
|
Entire Agreement.
|
38
|
13.12
|
Other Terms.
|
38
|
13.13
|
No Third Party Benefit or Right.
|
38
|
13.14
|
Execution In Counterparts.
|
38
|
13.15
|
Use Of Client Name.
|
38
|
13.16
|
Taxes.
|
38
|
13.17
|
Governing Law.
|
39
|
1.1
|
Master Agreement
.
|
1.2
|
Product Agreements
.
|
1.3
|
Definitions
.
|
(a)
|
a business entity which owns, directly or indirectly, a controlling interest in a party to this Agreement, by stock ownership or otherwise; or
|
(b)
|
a business entity which is controlled by a party to this Agreement, either directly or indirectly, by stock ownership or otherwise; or
|
(c)
|
a business entity, the controlling interest of which is, directly or indirectly, under common control with a party to this Agreement;
|
(a)
|
Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations;
|
(b)
|
EC Directive 2003/94/EC; and
|
(c)
|
Division 2 of Part C of the
Food and Drug Regulations
(Canada);
|
(a)
|
specifications for Active Materials and Components including approved vendor;
|
(b)
|
manufacturing specifications, directions, and processes;
|
(c)
|
storage requirements;
|
(d)
|
environmental, health and safety information for each Product including material safety data sheets; and
|
(e)
|
the finished Product specifications, packaging specifications and shipping requirements for each Product;
|
1.4
|
Currency
.
|
1.5
|
Sections and Headings
.
|
1.6
|
Singular Terms
.
|
1.7
|
Appendix 1, Schedules and Exhibits
.
|
2.1
|
Manufacturing Services
.
|
(a)
|
Conversion of Active Materials and Components
. Patheon will convert each Active Material and the applicable Components into Product, as set forth in the applicable Product Agreement..
|
(b)
|
Quality Control and Quality Assurance
. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Unless otherwise set forth in the Quality Agreement, Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Unless otherwise set forth in the applicable Product Agreement or Quality Agreement, each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a certification that the Batch has been evaluated by Patheon’s Quality Control/Quality Assurance department and that the Product complies with the Specifications and was manufactured in accordance with cGMPs. Patheon will test each Batch of Product to be supplied pursuant to this Agreement in accordance with the methods for the Product set forth in the Specifications before delivery of the Batch to Client. Client reserves the right to test or have tested all Products supplied by Patheon and to reject Product that fails to comply with the applicable Specifications or Product that was not manufactured in accordance with cGMPs or Applicable Laws. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those Batch documents is Client Property.
|
(c)
|
Components
. Patheon will purchase and test all Components (with the exception of Client-Supplied Components) at Patheon's expense and as required by the Specifications. But Patheon may agree to test certain Client-Supplied Components as specified in the applicable Product Agreement. Client will have the right to specify the suppliers for the Components but if the supplier is not an approved supplier currently used by Patheon, it will be Client’s responsibility to audit and approve the supplier. At Client’s request and for an additional fee, Patheon may agree to audit and approve the supplier. Patheon will not change any Specifications or supplier of any Components without the prior written consent of Client.
|
(d)
|
Active Material
. Promptly following receipt of the Active Material to be supplied by Client, Patheon will test (pursuant to test methods and drug specifications to be provided by Client) and approve the Active Material as acceptable for performing Manufacturing Services under this Agreement and the applicable Product Agreement. Unless otherwise agreed in a Product Agreement, Patheon will notify Client in writing within [*] days of receipt of any failure of Active Material unless earlier notice is required by Applicable Law; absent this notice, the Active Material will be deemed to be accepted and approved by Patheon.
|
(e)
|
Stability Testing
. Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the fees and at the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols or Specifications without prior written consent of Client. Patheon will promptly provide any and all data and results relating to the stability testing upon request by Client. If any Batch of a Product fails or is suspected to fail stability testing, Patheon will notify Client within [*], after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications and cGMPs. Patheon will give Client all stability test data and results at Client’s request.
|
(f)
|
Packaging and Artwork
. Patheon will package the Products in accordance with the Specifications. Client will be responsible for the cost of artwork development. Patheon will determine and imprint the Batch numbers and expiration dates for each Product shipped. The Batch numbers expiration dates, and when agreed upon by the Parties, serial numbers will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Those changes will be submitted by Client to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Client will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4. Patheon's name will not appear on the label or anywhere else on the Products unless: (i) required by any Laws; or (ii) Patheon consents in writing to the use of its name. At least [*] days prior to the Delivery Date of Product for which new or modified artwork is required, Client will provide at no cost to Patheon, final camera ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. But if this new or modified artwork is required in connection with a Product launch or is due to changes in safety information or Regulatory Authority requirements, then Patheon will use commercially reasonable efforts to implement the changes to the artwork on an expedited basis. For the avoidance of doubt, the parties acknowledge and agree that Client will be responsible for complying with any and all regulatory requirements for the labeling of the Product.
|
(g)
|
Active Materials and Client-Supplied Components
. If Patheon has advised Client of the scheduled production date, then, at least [*] days before the scheduled production date, Client will deliver the Active Materials and any Client-Supplied Components to the Manufacturing Site [*] (Incoterms 2010), at no cost to Patheon, in sufficient quantity to enable Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If the Active Materials and/or Client-Supplied Components are not received [*] days before the scheduled production date, Patheon may delay the shipment
|
(h)
|
Bill Back Items
. Bill Back Items will be charged to Client at Patheon’s cost plus a [*] handling fee.
|
(i)
|
Validation Activities (if applicable)
. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement.
|
(j)
|
Additional Services
. If Client requests services other than those expressly set forth herein or in any Product Agreement (such as qualification of a new packaging configuration or shipping studies, or validation of alternative Batch sizes), Patheon will provide a good faith and reasonable written quote of the fee for the additional services and Client will advise Patheon whether it wishes to have the additional services performed by Patheon. The scope of work and fees will be set forth in a separate statement of work signed by the parties, which will subject to the terms and conditions hereof. The title of this statement of work will reference the applicable Product Agreement and will be numbered sequentially.
.
|
2.2
|
Active Material Yield
.
|
(a)
|
Reporting
. Patheon will give Client a monthly inventory report of the Active Materials held by Patheon using the inventory report form set out in Exhibit C, which will contain the following information for the month:
|
(b)
|
Shortfall Credit Calculation
. The parties will agree in each Product Agreement to a specific Loss Tolerance Percentage, which will be used to calculate whether a shortfall in Active Material yield has occurred. If the Actual Annual Yield falls more than the agreed Loss Tolerance Percentage below the respective Target Yield in a Year, then the shortfall for the Year (the "
Shortfall
") for such Product will be calculated as follows:
|
(c)
|
Credit for Shortfall
. If there is a Shortfall for a Product in a Year, then Patheon will credit Client’s account for the amount of the Shortfall not later than [*] days after the end of the Year. Each credit under this Section 2.2(c) will be summarized on the reconciliation report form set forth in Exhibit D. Upon expiration or termination of a Product Agreement, any remaining credit owing under this Section will be paid to Client. The Annual Shortfall, if any, will be disclosed by Patheon on the reconciliation report form.
|
(d)
|
Maximum Credit
. Patheon's liability for Active Materials calculated in accordance with this Section 2.2
[for any Product]
in a Year will not exceed, in the aggregate, the Maximum Credit Value set forth in Schedule D to a Product Agreement.
|
(e)
|
No Material Breach
. If Patheon has used commercially reasonable efforts to achieve the Target Yield and if the Actual Yield is not less than 80% of the Target Yield, it will not be a material breach of this Agreement by Patheon under Section 8.2(a) if the Actual Annual Yield is less than the Target Yield.
|
3.1
|
Payment
.
|
3.2
|
Active Materials and Qualification of Additional Sources of Supply
.
|
(a)
|
Client will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(g). If applicable, Patheon and Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority.
Client or Client’s designated broker will be the “
Importer of Record
” for Active Materials imported to the Manufacturing Site. [*] The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Client will be responsible for paying for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications.
|
(b)
|
If Client asks Patheon to qualify an additional source for an Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Client’s cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing specifications; (ii) manufacture of an experimental Batch of Product that will be placed on three months accelerated stability; and (iii) manufacture of a mutually agreed upon number of full-scale validation Batches that will be placed on concurrent stability (one Batch may be the registration Batch if manufactured at full scale). Section 6.1(d) will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply.
|
(c)
|
If will promptly advise Client if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from a Client designated additional source. Patheon and Client will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Client will be obligated to re-qualify all Client designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual re-qualifications. If Patheon agrees to qualify or re-qualify Client designated additional sources of supply on behalf of Client, it will do so at Client’s expense.
|
4.1
|
First Year Pricing
.
|
4.2
|
Price Adjustments – Subsequent Years’ Pricing
.
|
(a)
|
Manufacturing and Stability Testing Costs
. For Products manufactured in the United States or Puerto Rico, the conversion component of the Price and the annual stability testing costs may be adjusted to the extent of the preliminary number for any change in the Producer Price Index pcu325412325412 for Pharmaceutical Preparation Manufacturing (“
PPI
”) published by the United States Department of Labor, Bureau of Labor Statistics in August of the preceding Year compared to the final number for the same month
of the Year prior to that, unless the parties otherwise agree in writing. On or before November 30 of each Year, Patheon will give Client a statement setting forth the calculation for the adjustment to be applied in calculating the Price for the next Year. For Products manufactured outside the United States or Puerto Rico, the conversion component of the Price and the annual stability testing costs may be adjusted to the extent of the corresponding changes using an inflation index to be agreed by the parties in the applicable Product Agreement.
|
(b)
|
Component Costs
. If Patheon incurs an increase in Component costs during the Year, it may increase the Price for the next Year to pass through the additional Component costs at Patheon’s actual cost. [*] On or before November 30 of each Year, Patheon will give Client information about the increase or decrease in Component costs which will be applied to the calculation of the Price for the next Year together with reasonable documentation to demonstrate that the Price increase or decrease is justified. But Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers. Patheon will use commercially reasonable efforts to minimize Component costs.
|
(c)
|
Pricing Basis
. Client acknowledges that the Price in any Year is quoted based upon the Annual Volume specified in Schedule B to each Product Agreement. The Price is subject to change if [*].
|
(d)
|
Adjustments Due to Currency Fluctuations
. If the parties agree in a Product Agreement to invoice in a currency other than the local currency for the Manufacturing Site, Patheon will adjust the Price to reflect currency fluctuations. The adjustment will be calculated after all other annual Price adjustments under this Section 4.2 have been made. The adjustment will proportionately reflect the increase or decrease, if any, in the Set Exchange Rate compared to the Set Exchange Rate established for the prior Year or the Initial Set Exchange Rate, as the case may be. An example of the calculation of the price adjustment (for a Canadian Manufacturing Site invoiced in USD) is set forth in Exhibit E.
|
(e)
|
Tier Pricing (if specified in a Product Agreement)
. If the pricing in Schedule B of a Product Agreement is set forth in Annual Volume tiers based upon Client’s volume forecasts under Section 5.1(a), the parties will estimate the Price in any Year based on Client’s [*] forecast provided pursuant to Section 5.1(a). Within [*] days of the end of each Year, the parties will reconcile the difference which may be payable by either party based on the Actual Ordered Product for the Year. If the Actual Ordered Product for the Year is in a tier with a higher cost than that used to calculate the Price for the Year, Client will pay Patheon the difference owed in accordance with Section 5.5. If the Actual Ordered Product for the year is in a tier with a lower cost than that used by the parties to estimate the Price for the year, Patheon will credit or refund, at Client’s option, Client for the overpayment.
|
(f)
|
For all Price adjustments under this Section 4.2, Patheon will deliver to Client on or before November 30 of each Year a revised Schedule B to the Product Agreement to be effective for Product delivered on or after the first day of the next Year. If in any Year Patheon would have been entitled to increase the Price based on any of the provisions of this Section 4.2 but Patheon did not exercise its right to do so, then at the expiry of any subsequent Year, Patheon will be entitled to make cumulative adjustments only for Product sold after the expiry of such Year, as set out in Section 4.2 to the extent of any permitted changes for all of the preceding Years since Patheon last adjusted the Price.
|
4.3
|
Price Adjustments – Current Year Pricing
.
|
4.4
|
Adjustments Due to Technical Changes or Regulatory Authority Requirements
.
|
4.5
|
Multi-Country Packaging Requirements
.
|
5.1
|
Orders and Forecasts
.
|
(a)
|
Long Term Forecast
. When each Product Agreement is executed, Client will give Patheon a non-binding [*] year forecast of Client’s volume requirements for the Product for each Year during the term of the Product Agreement (the “
Long Term Forecast
”). The Long Term Forecast will thereafter be updated every six months (as of June 1 and December 1) during the Initial Product Term. If Patheon is unable to accommodate any portion of the Long Term Forecast, it will notify Client and the parties will agree on any revisions to the forecast.
|
(b)
|
Rolling [*] Month Forecast
. When each Product Agreement is executed, Client will give Patheon a non-binding [*] month forecast of the volume of Product that Client expects to order in the first [*] months of commercial manufacture of the Product. This forecast will then be updated by Client on or before the [*] day of each month on a rolling forward basis. Client will update the forecast forthwith if it determines that the volumes estimated in the most recent forecast are anticipated to change by more than [*]. The most recent [*]
month forecast will prevail over prior forecasts.
|
(c)
|
Firm Orders
. On or before the [*] day of each month Client will issue firm written orders (“
Firm Orders
”) for each Product from time to time at Client’s discretion to be produced and delivered to Client on a date not less than [*] months from the [*] date of the month immediately following the date that the Firm Order is submitted unless otherwise agreed in a Product Agreement. Firm Orders submitted to Patheon will specify Client’s purchase order number, quantities by Product, type of packaging, delivery schedule and any other elements necessary to ensure the timely production and shipment of each Product. The quantities of Product ordered in Firm Orders will be firm and binding on Client. Notwithstanding the foregoing, and subject to the availability of required Components, for each Product, Patheon will permit amendments and substitutions to Firm Orders issued by Client upon prior written notice to Patheon for Product packaging no more than [*] per Year. But Patheon will not accept these amendments or substitutions once manufacturing or packaging has commenced.
|
(d)
|
Acceptance of Firm Order
. Firm Orders placed with Patheon by Client pursuant to the provisions of Section 5.1(b) will be acknowledged by Patheon in writing within [*] days of receipt thereof. Patheon will use commercially reasonable efforts to ensure that all Product ordered by Client in accordance with this Agreement will be shipped in
|
(e)
|
Cancellation of a Firm Order
. Client may cancel a Firm Order upon written notice to Patheon within the first [*] days of the firm period if Patheon has not started the manufacturing process under the Firm Order before receipt of the cancellation notice. If Client cancels a Firm Order in any other circumstances, Client will pay Patheon [*] of the Price for the Firm Order.
|
(f)
|
Controlled Substance Quota Requirements (if applicable)
. Client will give Patheon the information set forth below for obtaining any required DEA or equivalent agency quotas needed to perform the Manufacturing Services. Patheon will be responsible for management of DEA quota information in accordance with DEA regulations. Patheon and Client will cooperate to communicate the information and to assist each other in DEA information requirements related to the Product as follows: (i) as of [*] for the applicable Product, Client will provide to Patheon the next Year’s annual quota requirements for the Product; (ii) as of [*], Client will provide to Patheon any changes to the next Year’s quota requirements; (iii) Client will pro-actively communicate any changes to the quota requirements for the then-current Year reasonably in advance of the time for Patheon to file and finalize DEA filings supporting the changes; (iv) upon Patheon receiving the necessary forecast information from Client in order to request additional quota, Patheon will submit to the DEA, on a timely basis, all filings necessary to obtain DEA or equivalent agency quotas for Active Materials and will use commercially reasonable efforts to secure sufficient quota from the DEA so as to achieve Delivery Dates for Product as set forth in applicable purchase orders and forecasts submitted to Patheon by Client or its designee; and (v) Patheon will not be responsible for DEA’s refusal or failure to grant sufficient quota for reasons beyond the reasonable control of Patheon, provided that Patheon has met its obligations above. PATHEON ACKNOWLEDGES THAT TIME IS OF THE ESSENCE IN PERFORMING ITS OBLIGATIONS UNDER THS PROVISION.
|
5.2
|
Reliance by Patheon
.
|
5.3
|
Minimum Orders
.
|
5.4
|
Delivery and Shipping
.
|
5.5
|
Invoices and Payment
.
|
6.1
|
Product Claims
.
|
6.2
|
Product Recalls and Returns
.
|
6.3
|
Patheon’s Responsibility for Defective and Recalled Products
.
|
6.4
|
Disposition of Defective or Recalled Products
.
|
6.5
|
Healthcare Provider or Patient Questions and Complaints
.
|
6.6
|
Sole Remedy
.
|
7.1
|
Quarterly Review
.
|
7.2
|
Governmental Agencies
.
|
7.3
|
Records and Accounting by Patheon
.
|
7.4
|
Inspection
.
|
7.5
|
Access
.
|
7.6
|
Notification of Regulatory Inspections
.
|
7.7
|
Reports
.
|
7.8
|
Regulatory Filings
.
|
7.9
|
Inspection by Regulatory Authorities
.
|
8.1
|
Initial Term
.
|
8.2
|
Termination for Cause
.
|
8.3
|
Termination by Client
.
|
(a)
|
The Client may terminate this Agreement or any Product Agreement at any time upon 12 months’ prior written notice to Patheon.
|
(b)
|
For any Product that has not obtained Regulatory Authority approval at the time the applicable Product Agreement is executed, the Client may terminate the applicable Product Agreement at any time on 60 days prior written notice.
|
8.4
|
Product Discontinuation
.
|
8.5
|
Obligations on Termination
.
|
(a)
|
Client will take delivery of and pay for all undelivered Product that was manufactured and/or packaged in compliance with the Product Agreement and this Agreement under a Firm Order at the price in effect at the time the Firm Order was placed;
|
(b)
|
Client will purchase, at Patheon's cost (plus a [*] handling fee for Components), the Inventory applicable to the Products which was purchased, produced or maintained by Patheon in reliance on Firm Orders or in accordance with Section 5.2 prior to notice of termination being given;
|
(c)
|
Client will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;
|
(d)
|
Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by Client).
|
(e)
|
Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and
|
(f)
|
Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s), within [*] days, all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is otherwise under Patheon’s care and control (“
Client Property
”). If Client fails to remove the Client Property within [*] days following the completion, termination, or expiration of the Product Agreement, Client will pay Patheon [*] per pallet, per month, [*] minimum (except that Client will pay [*] per pallet, per month, [*] minimum, for any of the Client Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.5 of this Agreement.
|
(g)
|
In connection with the expiration or termination of this Agreement or any Product Agreement hereunder, at Client’s request, Patheon will provide assistance reasonably required to transfer the Manufacturing Services. Such assistance may include, without limitation, providing documents required for the Manufacturing Services, attending meetings (in person or via teleconference), and subject to the confidentiality provisions hereof, hosting a Manufacturing Site visit. Except in cases of termination by Client pursuant to Section 8.2, Client will reimburse Patheon for its costs incurred in providing
|
9.1
|
Authority
.
|
9.2
|
Client Warranties
.
|
(c)
|
Non-Infringement
.
|
(i)
|
Client has the right to disclose the Specifications to Patheon;
|
(ii)
|
any Client Intellectual Property, used by Patheon in performing the Manufacturing Services according to the Specifications (A) is Client’s or its Affiliate's property or is the subject of a license to Client, (B and to Client’s knowledge, does not infringe and will not infringe any Third Party Rights;
|
(iii)
|
there are no actions or other legal proceedings against Client pending or threatened in writing alleging that the any of the Specifications, any of the Active Materials or Components, or the sale, use, or other disposition of any Product made in accordance with the Specifications as contemplated by this Agreement and the applicable Product Agreement infringes the Intellectual Property rights of any Third Party;
|
(d)
|
Quality and Compliance.
|
(i)
|
the Specifications for each Product conforms to the applicable regulatory approval;
|
(ii)
|
the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws may be lawfully sold and distributed in every jurisdiction in which Client markets the Products; ;
|
(iii)
|
on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and the API will be contained, packaged, and labelled in accordance with Applicable Law and the Specifications, and will conform to the affirmations of fact on the container.
|
9.3
|
Patheon Warranties
.
|
(a)
|
it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws and that any Product supplied by it hereunder at the time of shipment, will comply with the Specifications;
|
(b)
|
Patheon is not aware of any Intellectual Property of any third party that is necessary for Patheon to manufacture any Product as contemplated hereby; and
|
(c)
|
The Active Material will not be used for any purposes beyond or different from the scope of the Manufacturing Services or otherwise in violation of the terms and conditions of this Agreement. Patheon acknowledges that certain of the Products are controlled under the Controlled Substances Act and, as such, are subject to regulations and restrictions concerning sale and distribution. Patheon agrees to comply with these regulations and restrictions, as well as any reasonable instructions from Client with respect to the use and storage of the Products. Without limiting the foregoing, (a) Patheon will obtain and/or maintain in force during the term of the Agreement all licenses and authorizations from the Drug Enforcement Administration or any other regulatory or governmental agency which are necessary for it to manufacture and possess these Products; and (b) Patheon will keep these Products in a secure location with access limited to authorized employees.
|
(d)
|
any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights.
|
9.4
|
Debarred Persons
.
|
9.5
|
Permits
.
|
9.6
|
Compliance with Laws
. Each party, in connection with its performance under this Agreement, will comply with all Applicable Laws.
|
9.7
|
No Warranty
.
|
10.1
|
Consequential Damages
.
|
10.2
|
Limitation of Liability
.
|
10.3
|
Patheon Indemnity
.
|
10.4
|
Client Indemnity
.
|
10.5
|
Reasonable Allocation of Risk
.
|
11.1
|
Confidential Information
.
|
11.2
|
Use of Confidential Information
.
|
11.3
|
Exclusions
.
|
11.4
|
Photographs and Recordings
.
|
11.5
|
Permitted Disclosure
.
|
11.6
|
Return of Confidential Information
.
|
11.7
|
Remedies
.
|
12.1
|
Commercial Disputes
.
|
12.2
|
Technical Dispute Resolution
.
|
13.1
|
Inventions
.
|
13.2
|
Intellectual Property
.
|
13.3
|
Insurance
.
|
13.4
|
Independent Contractors
.
|
13.5
|
No Waiver
.
|
13.6
|
Assignment
.
|
(a)
|
Patheon may not assign this Agreement or any Product Agreement or any of its associated rights or obligations without the written consent of Client, this consent not to be unreasonably withheld. Patheon may subcontract any part of the Manufacturing Services under a Product Agreement to any of its Affiliates but Patheon will remain fully liable to Client for the Affiliate’s performance.
|
(b)
|
Subject to Section 8.2(d), Client may assign this Agreement or any Product Agreement or any of its associated rights or obligations without approval from Patheon. But Client will give Patheon prompt written notice of any assignment, any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement or the Product Agreement.
|
(c)
|
Despite the foregoing provisions of this Section 13.6, either party may assign this Agreement or any Product Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, but the assignee must execute an agreement with the non-assigning party whereby it agrees to be bound hereunder.
|
13.7
|
Force Majeure
.
|
13.8
|
Additional Product
.
|
13.9
|
Notices
.
|
13.10
|
Severability
.
|
13.11
|
Entire Agreement
.
|
13.12
|
Other Terms
.
|
13.13
|
No Third Party Benefit or Right
.
|
13.14
|
Execution in Counterparts
.
|
13.15
|
Use of Client Name
.
|
13.16
|
Taxes.
|
(i)
|
any Tax based on net income or gross income that is imposed on Patheon by its jurisdiction of formation or incorporation ("
Resident Jurisdiction
");
|
(ii)
|
any Tax based on net income or gross income that is imposed on Patheon by jurisdictions other than its Resident Jurisdiction if this tax is based on a permanent establishment of Patheon; and
|
(iii)
|
any Tax that is recoverable by Patheon in the ordinary course of business for purchases made by Patheon in the course of providing its Services, such as Value Added Tax (as more fully defined in subparagraph (d) below), Goods & Services Tax ("
GST
") and similar taxes.
|
13.17
|
Governing Law
.
|
PATHEON PHARMACEUTICALS INC.
|
|
|
|
By:
|
/s/ Francis P. McCune
|
Name:
|
Francis P. McCune
|
Title:
|
Secretary
|
|
|
JAZZ PHARMACEUTICALS IRELAND LIMITED
|
|
|
|
By:
|
/s/ Shawn Mindus
|
Name:
|
Shawn Mindus
|
Title:
|
VP, Head of Ireland Finance
|
|
|
1.
|
Product List and Specifications
(See Schedule A attached hereto)
|
2.
|
Minimum Order Quantity, Annual Volume, and Price
(See Schedule B attached hereto)
|
3.
|
Annual Stability Testing and Validation Activities (if applicable)
(See Schedule C attached hereto)
|
4.
|
Active Materials, Active Materials Credit Value, and Maximum Credit Value
(See Schedule D attached hereto)
|
5.
|
Business Day
(if different from a Business Day at the Manufacturing Site under the definition in Section 1.3 of the Master Agreement)
|
6.
|
Manufacturing Site
: (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)
|
7.
|
Territory
: (insert the description of the Territory here)
|
8.
|
Loss Tolerance Percentage
(per Section 2.2(b) of the Master Agreement)
|
9.
|
Extraordinary Increase in Component Cost materiality percentage
(if different from the [*] that is stated in Section 4.3 of the Master Agreement)
|
10.
|
Yearly Forecasted Volume:
(insert for sterile products if applicable under Section 4.2.1)
|
11.
|
Delivery Date Under Firm Order (
if different from the three month period set forth in Section 5.1(c) of the Master Agreement)
|
12
.
|
Payment Terms
: (if different from Section 5.5 of the Master Agreement)
|
13.
|
Governing Law
: (if applicable under Section 13.17 of the Master Agreement)
|
14
.
|
Inflation Index:
(if applicable under Section
4.2(a) of the Master Agreement
for Products manufactured outside of the Unites States or Puerto Rico)
|
15
.
|
Currency
: (if applicable under Section 1.4 of the Master Agreement)
|
16
.
|
Initial Set Exchange Rate
: (if applicable under Section 4.2(d) of the Master Agreement)
|
19.
|
Other Modifications to the Master Agreement
: (if applicable under Section 1.2 of the Master Agreement)
|
PATHEON PHARMACEUTICALS INC.
[or applicable Patheon Affiliate]
|
|
|
|
By:
|
|
Name:
|
|
Title:
|
|
|
|
JAZZ PHARMACEUTICALS IRELAND LIMITED [or applicable Jazz Affiliate]
|
|
|
|
By:
|
|
Name:
|
|
Title:
|
|
|
|
Active Materials
|
Supplier
|
|
|
|
|
PRODUCT
|
ACTIVE MATERIALS
|
ACTIVE MATERIALS
CREDIT VALUE
|
|
|
[*]
|
PRODUCT
|
MAXIMUM CREDIT VALUE
|
|
|
(a)
|
Timing
. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [*] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
|
(b)
|
Disclosure of Evidence
. The parties undertake one to the other to give to any expert all the evidence and information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within [*] Business Days of a written request from the relevant expert to do so.
|
(c)
|
Advisors
. Each party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the parties will co-operate and seek to narrow and limit the issues to be determined.
|
(d)
|
Appointment of New Expert
. If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either party) be appointed and the appointment of the
|
(e)
|
Final and Binding
. The determination of the expert will, except for fraud or manifest error, be final and binding upon the parties.
|
(f)
|
Costs
. Each party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the parties.
|
TO:
|
JAZZ PHARMACEUTICALS IRELAND LIMITED
|
|||
|
|
|
|
|
FROM:
|
PATHEON PHARMACEUTICALS INC. [or applicable Patheon entity]
|
|||
|
|
|
|
|
RE:
|
Active Materials quarterly inventory report under Section 2.2(a) of the Master Manufacturing Services Agreement dated October 1, 2015 (the "
Agreement
")
|
|||
|
|
|
|
|
TO:
|
JAZZ PHARMACEUTICALS IRELAND LIMITED
|
|||
|
|
|
|
|
FROM:
|
PATHEON PHARMACEUTICALS INC. [or applicable Patheon entity]
|
|||
|
|
|
|
|
RE:
|
Active Materials annual inventory reconciliation report and calculation of Actual Annual Yield under Section 2.2(a) of the Master Manufacturing Services Agreement dated October 1, 2015 (the "Agreement")
|
|||
|
|
|
|
|
|
|
|
|
|
|
Reporting Year ending:
|
|
|
|
|
|
|
|
|
|
|
|
Active Materials on hand
at beginning of Year:
|
|
|
kg
|
(A)
|
|
|
|
|
|
|
|
Active Materials on hand
at end of Year:
|
|
|
kg
|
(B)
|
|
|
|
|
|
|
|
Quantity Received during Year:
|
|
|
kg
|
(C)
|
|
|
|
|
|
|
|
[*]
|
|
|
|
|
|
|
|
|
|
|
|
Quantity Converted during Year:
|
|
|
kg
|
(E)
|
|
(total Active Materials in Products produced and not rejected, recalled or returned)
|
|
|
|
|
|
|
|
|
|
|
|
Active Materials Credit Value:
|
|
$
|
|
/kg
|
(F)
|
|
|
|
|
|
|
Target Yield:
|
|
|
%
|
(G)
|
|
|
|
|
|
|
|
Actual Annual Yield:
|
|
|
%
|
(H)
|
|
((E ∕ D) * 100)
|
|
|
|
|
|
|
|
|
|
|
|
DATE:
|
|
|
||
|
|
|||
PATHEON PHARMACEUTICALS INC.
|
|
|
||
[or applicable Patheon Affiliate]
|
|
|
||
|
|
|
||
Per:
|
|
|
|
|
Name:
|
|
|
|
|
Title:
|
|
|
|
Position
|
Target
Bonus Range (Percent of Base Salary) |
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
55%
|
Position
|
Target
Bonus Range (Percent of Base Salary) |
Chairman of the Board, Chief Executive Officer, President
|
100%
|
Executive Vice President
|
55%
|
Senior Vice President who is an Executive Committee Member or is a Section 16 Officer
|
45%
|
Senior Vice President who is not an Executive Committee Member or a Section 16 Officer
|
40%
|
Vice President
|
25-35%
|
Senior Director/Executive Director
|
20-30%
|
Associate Director/Director
|
15-25%
|
Managers (all levels)
|
10-20%
|
Other
|
5-15%
|
SECTION 1.
|
INTRODUCTION.
|
SECTION 1.
|
DEFINITIONS.
|
SECTION 3.
|
ELIGIBILITY FOR BENEFITS.
|
SECTION 4.
|
AMOUNT OF BENEFITS.
|
If the Participant is at the time of the Covered Termination a:
|
|
Applicable Percentage:
|
|
Vice President
|
|
100
|
%
|
Senior Vice President, Executive Vice President, or above (but not Chief Executive Officer, Executive Chairman or President)
|
|
150
|
%
|
Chief Executive Officer, Executive Chairman or President
|
|
200
|
%
|
SECTION 5.
|
LIMITATIONS ON BENEFITS.
|
SECTION 6.
|
TIME OF PAYMENT AND FORM OF BENEFITS.
|
SECTION 7.
|
RIGHT TO INTERPRET PLAN; AMENDMENT AND TERMINATION.
|
SECTION 8.
|
NO IMPLIED EMPLOYMENT CONTRACT.
|
SECTION 9.
|
LEGAL CONSTRUCTION.
|
SECTION 10.
|
CLAIMS, INQUIRIES AND APPEALS.
|
SECTION 11.
|
BASIS OF PAYMENTS TO AND FROM PLAN.
|
SECTION 12.
|
OTHER PLAN INFORMATION.
|
SECTION 13.
|
STATEMENT OF ERISA RIGHTS.
|
SECTION 14.
|
GENERAL PROVISIONS.
|
SECTION 15.
|
EXECUTION.
|
|
|
|
JAZZ PHARMACEUTICALS PLC
|
||
|
|
|
By:
|
|
/s/ Suzanne Sawochka Hooper
|
Title:
|
|
Executive Vice President & General Counsel
|
|
|
|
|
EXECUTIVE
|
|||
|
|
||
Name:
|
|
|
|
|
|
||
Date:
|
|
|
|
|
|
|
EXECUTIVE
|
|||
|
|
||
Name:
|
|
|
|
|
|
||
Date:
|
|
|
|
|
|
EXECUTIVE
|
||
|
|
|
Name:
|
|
|
|
|
|
Date:
|
|
Name of Subsidiary
|
State or Jurisdiction of Incorporation or Organization
|
|
|
|
|
Jazz Pharmaceuticals Ireland Limited
|
Ireland
|
Jazz Financing I Limited
|
Ireland
|
Jazz Capital Limited
|
Ireland
|
Jazz Pharmaceuticals, Inc.
|
Delaware
|
Jazz Pharmaceuticals Holdings Inc.
|
Delaware
|
Jazz Pharmaceuticals Europe Holdings Limited
|
Gibraltar
|
EUSA Pharma SAS
|
France
|
EUSA Pharma Holdings SAS
|
France
|
Jazz Pharmaceuticals Lux S.à.r.l.
|
Luxembourg
|
Jazz Pharmaceuticals Italy S.r.l.
|
Italy
|
Gentium S.r.l.
|
Italy
|
1.
|
I have reviewed this Annual Report on Form 10-K of Jazz Pharmaceuticals public limited company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 23, 2016
|
By:
|
/s/ Bruce C. Cozadd
|
|
|
Bruce C. Cozadd
Chairman and Chief Executive Officer and Director
|
1.
|
I have reviewed this Annual Report on Form 10-K of Jazz Pharmaceuticals public limited company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: February 23, 2016
|
By:
|
/s/ Matthew P. Young
|
|
|
Matthew P. Young
Executive Vice President and Chief Financial Officer
|
1.
|
The Company’s Annual Report on Form 10-K for the year ended
December 31, 2015
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Bruce C. Cozadd
|
Bruce C. Cozadd
|
Chairman and Chief Executive Officer and Director
|
|
/s/ Matthew P. Young
|
Matthew P. Young
|
Executive Vice President and Chief Financial Officer
|
(1)
|
This certification accompanies the Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Jazz Pharmaceuticals public limited company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Jazz Pharmaceuticals public limited company and will be retained by Jazz Pharmaceuticals public limited company and furnished to the Securities and Exchange Commission or its staff upon request.
|