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Item 1.	Financial Statements

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•	Xyrem® (sodium oxybate) oral solution, the only product approved by the U.S. Food and Drug Administration, or FDA, and marketed in the U.S. for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in adult and pediatric 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 who have developed hypersensitivity to E. coli-derived asparaginase;

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Defitelio® (defibrotide sodium), a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio® (defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy; and

•	Vyxeos® (daunorubicin and cytarabine) liposome for injection, a product approved in the U.S. and in Europe (where it is marketed as Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes.

•	Strong financial execution through growth in sales of our current lead marketed products;

•	Building a diversified product portfolio and development pipeline through a combination of our internal research and development efforts and obtaining rights to clinically meaningful and differentiated on- or near-market products and early- to late-stage product candidates through acquisitions, collaborations, licensing arrangements, partnerships and venture investments; and

•	Maximizing the value of our products and product candidates by continuing to implement our comprehensive global development plans, including through generating additional clinical data and seeking regulatory approval for new indications.

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(1)	Includes the balances recognized on January 1, 2019 on adoption of ASU No. 2016-02.

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•	Xyrem® (sodium oxybate) oral solution, the only product approved by the U.S. Food and Drug Administration, or FDA, and marketed in the U.S. for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in adult and pediatric 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;

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Defitelio® (defibrotide sodium), a product approved in the U.S. for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem cell transplantation, or HSCT, and in Europe (where it is marketed as Defitelio® (defibrotide)) for the treatment of severe VOD in adults and children undergoing HSCT therapy; and

•	Vyxeos® (daunorubicin and cytarabine) liposome for injection, a product approved in the U.S. and in Europe (where it is marketed as Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia, or t-AML, or acute myeloid leukemia, or AML, with myelodysplasia-related changes, or AML-MRC.

•	Strong financial execution through growth in sales of our current lead marketed products;

•	Building a diversified product portfolio and development pipeline through a combination of our internal research and development efforts and obtaining rights to clinically meaningful and differentiated on- or near-market products and early- to late-stage product candidates through acquisitions, collaborations, licensing arrangements, partnerships and venture investments; and

•	Maximizing the value of our products and product candidates by continuing to implement our comprehensive global development plans, including through generating additional clinical data and seeking regulatory approval for new indications.

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(1)	Comparison to prior period not meaningful.

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Item 3.	Quantitative and Qualitative Disclosures About Market Risk

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Item 4.	Controls and Procedures

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Item 1.	Legal Proceedings

Item 1A.	Risk Factors

•	the introduction of new products in the U.S. market that compete with, or otherwise disrupt the market for, Xyrem in the treatment of cataplexy and/or EDS in narcolepsy, including our recently-approved product, Sunosi™ (solriamfetol);

•	the introduction of a generic version of Xyrem in the U.S. market before the entry dates specified in our settlements with the abbreviated new drug application, or ANDA, filers or on terms that are different from those contemplated by the settlement agreements;

•	increased pricing pressure from, changes in policies by, or restrictions on reimbursement imposed by, third party payors, including pressure to agree to discounts, rebates or other restrictive pricing terms for Xyrem;

•	changes in healthcare laws and policy, including changes in requirements for patient assistance programs, rebates, reimbursement and coverage by federal healthcare programs, and changes resulting from increased scrutiny on pharmaceutical pricing and risk evaluation and mitigation strategy, or REMS, programs by government entities;

•	changes to or uncertainties around our Xyrem REMS, or any failure to comply with our REMS obligations to the satisfaction of the FDA;

•	challenges to our intellectual property around Xyrem, including the possibility of new ANDA or new drug application, or NDA, filers or new post-grant patent review proceedings;

•	operational disruptions at the Xyrem central pharmacy;

•	any supply or manufacturing problems, including any problems with our sole source Xyrem active pharmaceutical ingredient, or API, provider;

•	continued acceptance of Xyrem by physicians and patients, including as a result of negative publicity that surfaces from time to time; and

•	changes to our label, including new safety warnings or changes to our boxed warning, that further restrict how we market and sell Xyrem.

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•	the limited population of patients with ALL, and the incidence of hypersensitivity reactions to E. coli-derived asparaginase within that population;

•	the development and/or approval of new asparaginase treatments or treatment protocols for ALL that may not include asparaginase-containing regimens and prescribers’ use of alternate methods to address hypersensitivity reactions;

•	the failure to obtain regulatory approval from the FDA or UK Medicines and Healthcare Products Regulatory Agency, or MHRA, to release batches of Erwinaze requiring batch-specific approval due to quality and manufacturing issues;

•	difficulties with obtaining and maintaining favorable pricing and reimbursement arrangements;

•	potential competition from future biosimilar products;

•	PBL’s ability to meet the manufacturing post-marketing commitments imposed by the FDA in connection with its approval of our biologics license application, or BLA;

•	our failure to comply with obligations under our agreement with PBL resulting in PBL claiming an uncured material breach; and

•	our need to apply for and receive marketing authorizations, through the European Union’s, or EU’s, mutual recognition procedure or otherwise, in certain additional countries if we decide to launch promotional efforts in those countries.

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•	the continued acceptance of Defitelio in the U.S., the EU and other countries by hospital pharmacy and therapeutics committees and the continued availability of favorable pricing and adequate coverage and reimbursement by government programs and third party payors;

•	the limited experience of, and need to educate, physicians in recognizing, diagnosing and treating VOD, particularly in adults;

•	the possibility that physicians recognizing VOD symptoms may not initiate or may delay initiation of treatment while waiting for those symptoms to improve, or may terminate treatment before the end of the recommended dosing schedule;

•	our ability to successfully maintain or grow sales of Defitelio in Europe and other non-U.S. countries, including our ability to obtain marketing approval in new countries;

•	delays or problems in the supply or manufacture of the product;

•	the limited size of the population of VOD patients who are indicated for treatment with Defitelio (particularly if changes in HSCT treatment protocols reduce the incidence of VOD diagnosis);

•	our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA and by the European Commission, or EC, in connection with its marketing authorization granted “under exceptional circumstances”; and

•	our ability to maintain favorable pricing and reimbursement approvals across Europe, particularly in countries that represent significant markets.

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•	our ability to differentiate Vyxeos from other liposomal chemotherapies and generically available chemotherapy combinations with which physicians and treatment centers are more familiar;

•	the acceptance of Vyxeos in the U.S., the EU and other countries by hospital pharmacy and therapeutics committees and the availability of favorable pricing and adequate coverage and reimbursement by government programs and third party payors;

•	delays or problems in the supply or manufacture of the product, including the ability of the third parties upon which we rely to manufacture Vyxeos and its APIs to manufacture sufficient quantities in accordance with applicable specifications;

•	the increasing complexity of the AML landscape requiring changes in patient identification and treatment selection, including diagnostic tests and monitoring that clinicians may find challenging to incorporate;

•	the use of new and novel compounds in AML that are either used off-label or are only approved for use in combination with other agents and that have not been tested in combination with Vyxeos;

•	the limited size of the population of high-risk AML patients who may potentially be indicated for treatment with Vyxeos, particularly given the ongoing clinical trials by other companies with the same patient population; and

•	our ability to meet the post-marketing commitments and requirements imposed by the FDA in connection with its approval of our NDA and by the EC in connection with its marketing authorization.

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•	the clinical indications for which a product is approved and any restrictions placed upon the product in connection with its approval, such as a REMS, patient registry requirements or labeling restrictions;

•	the prevalence of the disease or condition for which the product is approved and its diagnosis;

•	the severity of side effects;

•	acceptance by physicians and patients of each product as a safe and effective treatment;

•	availability of sufficient product inventory to meet demand, particularly with respect to Erwinaze;

•	physicians’ decisions relating to treatment practices based on availability of product, particularly with respect to Erwinaze;

•	perceived advantages over alternative treatments;

•	relative convenience and ease of administration;

•	with respect to Xyrem, physician and patient assessment of the burdens associated with obtaining or maintaining the certifications required under the Xyrem REMS;

•	the cost of treatment in relation to alternative treatments, including generic products; and

•	the availability of financial or other assistance for patients who are uninsured or underinsured.

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•	our ability to successfully launch and grow sales of Sunosi in the U.S. and, if approved, in the EU;

•	any delay in U.S. launch timing due to longer than expected DEA scheduling review, which needs to be completed before commercial launch in the U.S.;

•	the availability of adequate formulary positions and pricing and adequate coverage and reimbursement by third party payors, including government programs, including the impact of any delays in coverage decisions by payors;

•	restrictions on permitted promotional activities based on limitations on the approved labeling for the product required by the FDA or the EC;

•	market acceptance of Sunosi;

•	delays or problems in the supply or manufacture of Sunosi; and

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•	our ability to satisfy the FDA’s post-marketing requirements and other post-marketing requirements or commitments, if any, imposed by the EC in connection with its potential marketing authorization.

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•	we are unable to obtain and maintain adequate funding to complete the development of, obtain regulatory approval for and commercialize an acquired product candidate;

•	a product candidate proves not to be safe or effective in later clinical trials;

•	a product fails to reach its forecasted commercial potential as a result of pricing pressures or for any other reason;

•	we experience negative publicity regarding actual or potential future price increases for that product or otherwise; or

•	the integration of a product or product candidate gives rise to unforeseen difficulties and expenditures.

•	high acquisition costs;

•	the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;

•	the potential disruption of our historical core business;

•	the strain on, and need to continue to expand, our existing operational, technical, financial and administrative infrastructure;

•	the difficulties in assimilating employees and corporate cultures;

•	the failure to retain key managers and other personnel;

•	the challenges in controlling additional costs and expenses in connection with and as a result of any acquisition;

•	the need to write down assets or recognize impairment charges;

•	the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and

•	any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.

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•	difficulty identifying or enrolling eligible patients, often based on the number of clinical trials, particularly in hematology and oncology, with enrollment criteria targeting the same patient population;

•	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;

•	delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in trials;

•	delays or failures in reaching agreement on acceptable terms with prospective study sites;

•	delays or failures in obtaining approval of our clinical trial protocol from an institutional review board, known as an ethics committee in Europe, to conduct a clinical trial at a prospective study site;

•	delays or failures in recruiting patients to participate in a clinical trial;

•	failure of our clinical trials and clinical investigators to be in compliance with the FDA and other regulatory agencies’ requirements, commonly referred to as good clinical practices;

•	unforeseen safety issues;

•	inability to monitor patients adequately during or after treatment;

•	difficulty monitoring multiple study sites;

•	failure of our third party clinical trial managers to satisfactorily perform their contractual duties, comply with regulations or meet expected deadlines; or

•	insufficient funds to complete the trials.

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•	our patent applications, or those of our licensors or partners, may not result in issued patents;

•	others may independently develop similar or therapeutically equivalent products without infringing our patents, or those of our licensors, such as products that are not covered by the claims of our patents, or for which we do not have adequate exclusive rights under our license agreements;

•	our issued patents, or those of our licensors or partners, may be held invalid or unenforceable as a result of legal challenges by third parties or may be vulnerable to legal challenges as a result of changes in applicable law;

•	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 those of our licensors or partners;

•	competitors may manufacture products in countries where we have not applied for patent protection or that have a different scope of patent protection or that do not respect our patents; or

•	others may be issued patents that prevent the sale of our products or require licensing and the payment of significant fees or royalties.

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•	the diverse regulatory, financial and legal requirements in the countries where we are located or do business, including those related to data security and the use of, or access to, commercial and personal information, taxation, trade laws, including tariffs, export quotas, custom duties or other trade restrictions, and any changes to those requirements;

•	challenges inherent in efficiently managing employees in diverse geographies, including the need to adapt systems, policies, benefits and compliance programs to differing labor and employment law and other regulations, as well as maintaining positive interactions with our unionized employees;

•	costs of, and liabilities for, our international operations, products or product candidates; and

•	fluctuations in currency rates.

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•	limit our ability to borrow additional funds for working capital, capital expenditures, acquisitions or other general business purposes;

•	limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;

•	require us to use a substantial portion of our cash flow from operations to make debt service payments;

•	limit our flexibility to plan for, or react to, changes in our business and industry;

•	result in dilution to our existing shareholders in the event exchanges of the Exchangeable Senior Notes are settled in our ordinary shares;

•	place us at a competitive disadvantage compared to our less leveraged competitors; and

•	increase our vulnerability to the impact of adverse economic and industry conditions.

•	incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;

•	issue redeemable preferred stock;

•	pay dividends or distributions or redeem or repurchase capital stock;

•	prepay, redeem or repurchase certain debt;

•	make loans, investments, acquisitions (including acquisitions of exclusive licenses) and capital expenditures;

•	enter into agreements that restrict distributions from our subsidiaries;

•	sell assets and capital stock of our subsidiaries;

•	enter into certain transactions with affiliates; and

•	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 competition for Xyrem or our other products;

•	the cost of acquiring and/or in-licensing any new products and product candidates;

•	the costs of our commercial operations;

•	the scope, rate of progress, results and costs of our development and clinical activities;

•	the cost and timing of obtaining regulatory approvals and of compliance with laws and regulations;

•	the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;

•	the cost of investigations, litigation and/or settlements related to regulatory oversight and third party claims;

•	the costs of integration activities related to any future strategic transactions we may engage in; and

•	the costs arising from 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;

•	stagger the terms of our board of directors into three classes;

•	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 our articles of association; and

•	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.	Unregistered Sales of Equity Securities and Use of Proceeds

(1)	This column includes ordinary shares that we reacquired in satisfaction of the exercise price of employee stock options upon exercise, but 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.

(2)	Average price paid per ordinary share includes brokerage commissions.

(3)

The ordinary shares reported in this column above were purchased pursuant to our publicly announced share repurchase program. In November 2016, we announced that our board of directors authorized the use of up to $300 million to repurchase our ordinary shares. In November and December 2018, our board of directors increased the existing share repurchase program authorization by $320.0 million and $400.0 million, respectively, thereby increasing the total amount authorized for repurchase to $1.02 billion. This authorization has no expiration date.

(4)

The dollar amount shown represents, as of the end of each fiscal month, 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 5.	Other Information

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Item 6.	Exhibits

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+	Indicates management contract or compensatory plan.

†	Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the SEC.

*	The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q 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.

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ATTACHMENTS:	Non-U.S. Option Agreement and Amended and Restated 2007 Non-Employee Directors Stock Award Plan

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ATTACHMENTS:	Non-U.S. Restricted Stock Unit Award Agreement, Amended and Restated 2007 Non-Employee Directors Stock Award Plan

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A.	The individual who has received this Election (the “Employee”), who is employed by one of the employing companies listed in the attached schedule (the “Employer”) and who is eligible to receive stock options and/or restricted stock units (together, the “Awards”) pursuant to the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (the “Plan”), and

B.	Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “Company”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.

1.	Introduction

1.1	This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.

1.2	In this Election the following words and phrases have the following meanings:

(a)	“Chargeable Event” means, in relation to the Awards:

(i)	the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);

(ii)	the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);

(iii)	the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);

(iv)	post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or

(v)	post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).

(b)	“ITEPA” means the Income Tax (Earnings and Pensions) Act 2003.

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(c)	“SSCBA” means the Social Security Contributions and Benefits Act 1992.

1.3	This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “Employer’s Liability”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.

1.4	This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.

1.5	This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).

2.	The Election

3.	Payment of the Employer’s Liability

3.1	The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:

(i)	by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or

(ii)	directly from the Employee by payment in cash or cleared funds; and/or

(iii)	by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“HMRC”) by the due date; and/or

(iv)	where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or

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(v)	by any other means specified in the applicable Award agreement entered into between the Employee and the Company.

3.2	The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.

3.3	The Company agrees to procure the remittance by the Employer of the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days after the end of the UK tax month during which the Chargeable Event occurs if payments are made electronically).

4.	Duration of Election

4.1	The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.

4.2	Any reference to the Company and/or the Employer shall include that entity’s successors in title and assigns as permitted in accordance with the terms of the Plan and relevant award agreement. This Election will continue in effect in respect of any awards which replace the Awards in circumstances where section 483 of ITEPA applies.

4.3	This Election will continue in effect until the earliest of the following:

(i)	the date on which the Employee and the Company agree in writing that it should cease to have effect;

(ii)	the date on which the Company serves written notice on the Employee terminating its effect;

(iii)	the date on which HMRC withdraws approval of this Election; or

(iv)	the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.

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A.	The individual who has received this Election (the “Employee”), who is employed by one of the employing companies listed in the attached schedule (the “Employer”) and who is eligible to receive stock options and/or restricted stock units (together, the “Awards”) pursuant to the Jazz Pharmaceuticals plc 2011 Equity Incentive Plan (the “Plan”), and

B.	Jazz Pharmaceuticals plc, Fourth Floor, Connaught House, 1 Burlington Road, Dublin 4, Ireland (the “Company”), which may grant Awards under the Plan and is entering into this Election on behalf of the Employer.

1.	Introduction

1.1	This Election relates to all Awards granted to the Employee under the Plan on or after January 18, 2012 up to the termination date of the Plan.

1.2	In this Election the following words and phrases have the following meanings:

(a)	“Chargeable Event” means, in relation to the Awards:

(i)	the acquisition of securities pursuant to the Awards (within section 477(3)(a) of ITEPA);

(ii)	the assignment (if applicable) or release of the Awards in return for consideration (within section 477(3)(b) of ITEPA);

(iii)	the receipt of a benefit in connection with the Awards, other than a benefit within (i) or (ii) above (within section 477(3)(c) of ITEPA);

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(iv)	post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 427 of ITEPA); and/or

(v)	post-acquisition charges relating to the Awards and/or ordinary shares of the Company acquired pursuant to the Awards (within section 439 of ITEPA).

(b)	“ITEPA” means the Income Tax (Earnings and Pensions) Act 2003.

(c)	“SSCBA” means the Social Security Contributions and Benefits Act 1992.

1.3	This Election relates to the Employer’s secondary Class 1 National Insurance Contributions (the “Employer’s Liability”) which may arise on the occurrence of a Chargeable Event in respect of the Awards pursuant to section 4(4)(a) and/or paragraph 3B(1A) of Schedule 1 of the SSCBA.

1.4	This Election does not apply in relation to any liability, or any part of any liability, arising as a result of regulations being given retrospective effect by virtue of section 4B(2) of either the SSCBA, or the Social Security Contributions and Benefits (Northern Ireland) Act 1992.

1.5	This Election does not apply to the extent that it relates to relevant employment income which is employment income of the earner by virtue of Chapter 3A of Part VII of ITEPA (employment income: securities with artificially depressed market value).

2.	The Election

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3.	Payment of the Employer’s Liability

3.1	The Employee hereby authorises the Company and/or the Employer to collect the Employer’s Liability from the Employee at any time after the Chargeable Event:

(i)	by deduction from salary or any other payment payable to the Employee at any time on or after the date of the Chargeable Event; and/or

(ii)	directly from the Employee by payment in cash or cleared funds; and/or

(iii)	by arranging, on behalf of the Employee, for the sale of some of the securities which the Employee is entitled to receive in respect of the Awards, the proceeds from which must be delivered to the Employer in sufficient time for payment to be made to Her Majesty’s Revenue & Customs (“HMRC”) by the due date; and/or

(iv)	where the proceeds of the gain are to be made through a third party, the Employee will authorize that party to withhold an amount from the payment or to sell some of the securities which the Employee is entitled to receive in respect of the Award, such amount to be paid in sufficient time to enable the Company and/or the Employer to make payment to HMRC by the due date; and/or

(v)	by any other means specified in the applicable Award agreement entered into between the Employee and the Company.

3.2	The Company hereby reserves for itself and the Employer the right to withhold the transfer of any securities to the Employee in respect of the Awards until full payment of the Employer’s Liability is received.

3.3	The Company agrees to procure the remittance by the Employer of the Employer’s Liability to HMRC on behalf of the Employee within 14 days after the end of the UK tax month during which the Chargeable Event occurs (or within 17 days after the end of the UK tax month during which the Chargeable Event occurs if payments are made electronically).

4.	Duration of Election

4.1	The Employee and the Company agree to be bound by the terms of this Election regardless of whether the Employee is transferred abroad or is not employed by the Employer on the date on which the Employer’s Liability becomes due.

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4.2	Any reference to the Company and/or the Employer shall include that entity’s successors in title and assigns as permitted in accordance with the terms of the Plan and relevant award agreement. This Election will continue in effect in respect of any awards which replace the Awards in circumstances where section 483 of ITEPA applies.

4.3	This Election will continue in effect until the earliest of the following:

(i)	the date on which the Employee and the Company agree in writing that it should cease to have effect;

(ii)	the date on which the Company serves written notice on the Employee terminating its effect;

(iii)	the date on which HMRC withdraws approval of this Election; or

(iv)	the date on which, after due payment of the Employer’s Liability in respect of the entirety of the Awards to which this Election relates or could relate, the Election ceases to have effect in accordance with its own terms.

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a.	all owners of Jazz who are natural persons (other than shareholders who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading) and all officers and directors of Jazz;

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b.	all U.S. employees of Jazz who engage in or supervise personnel who are engaged in Covered Functions (as defined below in Section II.C.5); and

c.

all U.S. contractors, subcontractors, agents, and other persons who perform any of the Covered Functions on behalf of Jazz and in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), consumers or independent third-party patient assistance programs; or (ii) perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by a Jazz employee who is a Covered Person prior to execution or dissemination.

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a.	developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health care program requirements;

b.	making periodic (at least quarterly) reports regarding compliance matters directly to the Nominating and Governance Committee of the Board of Directors and shall be authorized to report on such matters to the Nominating and Governance Committee at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request; and

c.	monitoring the day-to-day compliance activities engaged in by Jazz and any reporting obligations created under this CIA.

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a.	meeting at least quarterly to review and oversee Jazz’s Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee;

b.	submitting to OIG a description of the documents and other materials it reviewed, as well as any additional steps taken, such as the engagement of an independent advisor or other third party resources, in its oversight of the compliance program and in support of making the resolution below during each Reporting Period; and

c.	for each Reporting Period of the CIA, adopting a resolution, signed by each member of the NGC, summarizing its review and oversight of Jazz’s compliance with Federal health care program requirements and the obligations of this CIA.

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a.	appropriate ways to conduct Contribution and Assistance Related Functions in compliance with all applicable Federal health care program requirements, including but not limited to, the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C. §§ 3729-3733);

b.

arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. These Policies and Procedures shall be designed to ensure that Jazz’s arrangements and interactions comply with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Jazz’s arrangements and interactions (including donations and sponsorship) comply with all guidance issued by OIG relating to the support and funding of patient assistance programs, including but not limited to, the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70623 (Nov. 22, 2005) and OIG’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs, 79 Fed. Reg. 31120 (May 30, 2014);

c.

the operation of, or participation in, any patient assistance program by Jazz or any entity acting on behalf of Jazz. These Policies and Procedures shall be designed to ensure that Jazz’s operation of or in participation in such programs complies with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Jazz’s operation of or participation in any such patient assistance program complies with all guidance issued by OIG relating to assistance provided to patients by pharmaceutical manufacturers to reduce or eliminate the cost of copayments for drugs, including but not limited to, the OIG’s Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons (Sept. 2014);

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d.	the materials and information that may be distributed by appropriate Jazz personnel about Independent Charity PAPs or Contribution and Assistance Related Functions and the manner in, and circumstances under, which appropriate Jazz personnel may respond to requests for information about Independent Charity PAPs or Contribution and Assistance Related Functions; and

e.	appropriate ways to conduct Promotional Functions in compliance with all: (i) applicable Federal healthcare program requirements, including but not limited to, the Federal Anti-Kickback Statute and the False Claims Act, and (ii) applicable Federal Food and Drug Administration (FDA) requirements.

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a.

Engagement of Independent Review Organization. Within 90 days after the Effective Date, Jazz shall engage an entity (or entities), such as an accounting, auditing, or consulting firm (hereinafter “Independent Review Organization” or “IRO”), to perform the reviews listed in this Section III.E. The applicable requirements relating to the IRO are outlined in Appendix A to this CIA, which is incorporated by reference.

b.	Retention of Records. The IRO and Jazz shall retain and make available to OIG, upon request, all work papers, supporting documentation, correspondence, and draft reports (those exchanged between the IRO and Jazz) related to the reviews.

c.	Access to Records and Personnel. Jazz shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in this Section III.E and that all records furnished to the IRO are accurate and complete.

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i.	is currently excluded from participation in any Federal health care program; or

ii.	has been convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded.

b.	“Exclusion List” means the HHS/OIG List of Excluded Individuals/Entities (LEIE) (available through the Internet at http://www.oig.hhs.gov).

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a.	Jazz shall screen all prospective Covered Persons against the Exclusion List prior to engaging their services and, as part of the hiring or contracting process, shall require such Covered Persons to disclose whether they are Ineligible Persons.

b.	Jazz shall screen all current Covered Persons against the Exclusion List within 90 days after the Effective Date and on an annual basis thereafter.

c.	Jazz shall implement a policy requiring all Covered Persons to disclose immediately if they become an Ineligible Person.

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a.	a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized;

b.	the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or

c.	the filing of a bankruptcy petition by Jazz.

a.	a complete description of all details relevant to the Reportable Event, including, at a minimum, the types of claims, transactions or other conduct giving rise to the Reportable Event, the period during which the conduct occurred, and the names of individuals and entities believed to be implicated, including an explanation of their roles in the Reportable Event;

b.	a statement of the Federal criminal, civil or administrative laws that are probably violated by the Reportable Event, if any;

c.	the Federal health care programs affected by the Reportable Event; and

d.	a description of Jazz’s actions taken to correct the Reportable Event and prevent it from recurring.

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a.	the identity of the Ineligible Person and the job duties performed by that individual;

b.	the dates of the Ineligible Person’s employment or contractual relationship;

c.	a description of the Exclusion List screening that Jazz completed before and/or during the Ineligible Person’s employment or contract and any flaw or breakdown in the Ineligible Persons screening process that led to the hiring or contracting with the Ineligible Person;

d.	a description of how the Ineligible Person was identified; and

e.	a description of any corrective action implemented to prevent future employment or contracting with an Ineligible Person.

a.	The Independent Charity Group shall be separate and independent from Jazz’s commercial organization.

b.	The Independent Charity Group shall operate independently from Jazz’s commercial organization and Jazz’s commercial organization shall have no involvement in, or influence over, the review, approval, or implementation of any budget or other decisions or activities relating to Independent Charity PAPs.

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c.	Jazz shall vest in the Independent Charity Group sole responsibility and authority for communicating with Independent Charity PAPs regarding Jazz’s donations to such PAPs and Jazz’s commercial organization shall not communicate with, influence, or be involved in any communications with, or receive information from the Independent Charity PAPs.

d.	Jazz’s Independent Charity Group shall gather information about Independent Charity PAPs and their disease funds in a manner that does not exert or attempt to exert any direct or indirect control over the entity operating the PAP or over its assistance program.

e.	For purposes of this CIA, the “commercial organization” shall be defined to include the sales, marketing, and similar commercial business units of Jazz.

a.	The Independent Charity Group shall develop an annual budget for donations to Independent Charity PAPs based on objective criteria in accordance with general guidelines approved by the legal department with input from the compliance department.

b.	Jazz shall approve the annual budget for donations to Independent Charity PAPs at a level within the organization above the commercial organization (e.g., at the executive level).

c.	The Independent Charity Group shall have sole responsibility for allocating the approved budget across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.

e.

The Independent Charity Group shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardized, objective criteria established by the Independent Charity Group. Any such requests also shall be subject to legal and compliance personnel review and approval, to ensure that any supplemental funding to the Independent Charity PAP is provided in accordance with applicable Federal health care program requirements, OIG guidance, and Jazz Policies and Procedures.

f.	The commercial organization shall have no involvement in the budget process, and the budget to be used for donations to Independent Charity PAPs shall not be based on monies allocated to the Independent Charity Group from the commercial organization.

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a.

Jazz does not and shall not exert (directly or through any affiliate) any influence or control over the identification, delineation, establishment, or modification of any specific disease funds operated by the Independent Charity PAP. Among other things, Jazz has not made and shall not make (directly or through any affiliate) suggestions or requests to the Independent Charity PAP about the identification, delineation, establishment, or modification of disease state funds.

b.	Jazz does not and shall not exert (directly or through any affiliate) any direct or indirect influence or control over the Independent Charity PAP’s process or criteria for determining eligibility of patients who qualify for its assistance program.

c.	Jazz does not and shall not solicit or receive (directly or indirectly through third parties) any data or information from the Independent Charity PAP that would enable it to correlate the amount or frequency of its donations with support for Jazz’s products or services.

d.	Jazz does not and shall not provide donations for a disease state fund that covers only a single product or that covers only Jazz’s products.

e.	Personnel from Jazz’s legal and/or compliance departments shall review all proposed donations and arrangements between Jazz and any Independent Charity PAP prior to such donations being made or arrangements being entered into by Jazz.

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a.	to the best of his or her knowledge, except as otherwise described in the report, Jazz is in compliance with all of the requirements of this CIA; and

b.	he or she has reviewed the report and has made reasonable inquiry regarding its content and believes that the information in the report is accurate and truthful.

a.	to the best of his or her knowledge, except as otherwise described in the report, Jazz is in compliance with all of the requirements of this CIA;

b.	he or she has reviewed the report and has made reasonable inquiry regarding its content and believes that the information in the report is accurate and truthful;

c.	he or she understands that the certification is being provided to and relied upon by the United States;

d.	for each disease fund of an Independent Charity PAP to which Jazz made a donation during the Reporting Period, the facts and circumstances relating to the donation were reviewed by competent legal counsel and were found to be in compliance with all applicable Federal health care program requirements, OIG guidance, and Jazz policies and procedures (including those outlined in Section III.J); and

e.	for each patient assistance program that Jazz or any entity acting on behalf of Jazz operates or participates in (e.g., through cash or in-kind donations), the facts and circumstances relating to the program were reviewed by competent legal counsel and were found to be in compliance with all applicable Federal health care program requirements, OIG guidance, and Jazz policies and procedures.

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a.	a Compliance Officer;

b.	a Compliance Committee;

c.	the NGC compliance obligations;

d.	the management certification obligations;

e.	written Policies and Procedures;

f.	the development of a written training plan and the training and education of Covered Persons and Board Members;

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g.	a risk assessment and internal review process;

h.	a Disclosure Program;

i.	Ineligible Persons screening and removal requirements;

j.	notification of Government investigations or legal proceedings;

k.	reporting of Reportable Events; and

1.	the Independent Charity PAP policies, procedures, and practices required by Section III.J.

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a.	repeated violations or a flagrant violation of any of the obligations under this CIA, including, but not limited to, the obligations addressed in Section X.A;

b.	a failure by Jazz to report a Reportable Event and take corrective action as required in Section III.I;

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c.	a failure to engage and use an IRO in accordance with Section III.E, Appendix A, or Appendix B; or

d.	a failure to respond to a Demand Letter concerning the payment of Stipulated Penalties in accordance with Section X.C.

a.	the alleged material breach has been cured; or

b.	the alleged material breach cannot be cured within the 30 day period, but that: (i) Jazz has begun to take action to cure the material breach; (ii) Jazz is pursuing such action with due diligence; and (iii) Jazz has provided to OIG a reasonable timetable for curing the material breach.

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a.	Jazz cured such breach within 30 days of its receipt of the Notice of Material Breach; or

b.

the alleged material breach could not have been cured within the 30 day period, but that, during the 30 day period following Jazz’s receipt of the Notice of Material Breach: (i) Jazz had begun to take action to cure the material breach within that period; (ii) Jazz pursued such action with due diligence; and (iii) Jazz provided to OIG within that period a reasonable timetable for curing the material breach.

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A.	IRO Engagement

B.	IRO Qualifications

C.	IRO Responsibilities

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D.	Jazz Responsibilities

E.	IRO Independence and Objectivity

F.	IRO Removal/Termination

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1)	Jazz’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) independent third-party patient assistance programs (Independent Charity PAPs).

a.	Jazz’s organizational structure as it relates to arrangements and interactions with Independent Charity PAPS, including:

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i.	the identification of those individuals, departments, or groups within Jazz (e.g., the Corporate Giving Executive Review Committee, Corporate Affairs, Finance, Legal and Compliance) that have responsibility for, or involvement with, such arrangements and interactions;

ii.	the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs;

iii.	the identification of those individuals, departments, or groups within Jazz (e.g., the commercial organization) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and

iv.	the methods that Jazz uses to separate Independent Charity PAP-related responsibilities from the commercial organization.

b.	Jazz’s written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including:

i.	the criteria governing whether and under what circumstances Jazz would donate to an Independent Charity PAP or any specific disease state fund of such a PAP;

ii.	communications (including any limitations on such communications) between any representatives of Jazz and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data);

iii.	communications (including any limitations on such communications) between those individuals, departments, or groups within Jazz with responsibility for Independent Charity PAPs and the commercial organization of Jazz (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and

iv.	communications (including any limitations on such communications) between representatives of Jazz and health care providers or patients regarding assistance available through any Independent Charity PAP.

c.	Jazz’s policies and practices as they relate to the budgeting process applicable to donations to Independent Charity PAPs as outlined in Section III.J.2 of the CIA, including as it relates to initial or annual donation amounts and any supplemental amounts;

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d.	Jazz’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to donate (or continue to donate) to a particular Independent Charity PAP; and ii) the amount of the donation (including any initial or annual amount and any supplemental amount);

e.	Jazz’s criteria, policies, and practices as they relate to donations made by Jazz to any Independent Charity PAPs as referenced in Section III.J.3, including the internal review process followed in connection with any donations to Independent Charity PAPs; and

f.	Jazz’s policies and practices as they relate to information provided, directly or indirectly, to the public about the availability of patient assistance for Jazz’s products.

2)

Jazz’s systems, policies, processes, and procedures relating to any patient assistance program that was formed or is funded, controlled, or operated (directly or indirectly) by Jazz or any person or entity acting on behalf of (or affiliated with) Jazz (including, but not limited to, its employees, agents, vendors, officers, shareholders, or contractors). This shall include any programs designed to provide free product or to provide other assistance (e.g., coupons or vouchers) to patients to reduce or eliminate the cost of copayments for drugs. These programs shall be collectively referred to as “Pharmaceutical Manufacturer PAPs”.

a.

The general elements of Pharmaceutical Manufacturer PAPs, including: i) the types of assistance that are made available through the Pharmaceutical Manufacturer PAPs; ii) the types of patients to whom each type of assistance is made available; iii) the eligibility criteria for the various types of assistance provided; and iv) the controls used to implement the eligibility criteria (i.e., controls employed to ensure that appropriate patients receive the various types of assistance);

b.

Jazz’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to provide (or continue to provide) the various types of assistance through any Pharmaceutical Manufacturer PAP; and ii) the amount (or value) of the assistance to be provided through each program (including any initial or annual amount and any supplemental amount); and

c.	Jazz’s policies and practices as they relate to any contracts or agreements entered between Jazz and outside entities relating to any Pharmaceutical Manufacturers PAPs or the distribution of free product, including the individuals, groups, or departments involved in the negotiation process, the

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1)	a description of the documentation (including policies) reviewed and any personnel interviewed;

2)	a detailed description of Jazz’s systems, policies, processes, and procedures relating to the items identified in Sections II.1-2 above, including a general description of Jazz’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;

3)	a description of the manner in which the control and accountability systems and the written policies relating to the items identified in Sections II.1-2 above are made known or disseminated within Jazz;

4)	a detailed description of any system(s) used to track requests for donations or other assistance from any Independent Charity PAP;

5)	a detailed description of any system(s) used to track donations or other assistance provided in response to requests from Independent Charity PAPs;

6)	a detailed description of any system(s) used to track assistance provided through any Pharmaceutical Manufacturer PAP;

7)	findings and supporting rationale regarding any weaknesses in Jazz’s systems, processes, policies, and procedures relating to the Reviewed Policies and Procedures, if any; and

8)	recommendations to improve any of the systems, policies, processes, or procedures relating to the Reviewed Policies and Procedures, if any.

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A.	IRO Review of Arrangements with Independent Charity PAPs

1)	the information on Jazz’s website regarding Corporate Giving, including the online application portal through which Independent Charity PAPs must submit written requests for contributions;

2)	donation requests from Independent Charity PAPs (which includes information on the particular disease state funds; details regarding patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs (e.g., information about administrative fees, patient grant amounts, average processing time to assist patients, etc.));

3)	the approved annual budget for charitable giving, allocating the budget for donations to Independent Charity PAPs, and to any disease state funds established by the Independent Charity PAPs;

4)	documentation that shows the objective criteria used to evaluate Independent Charity PAPs and the allocation of the approved budget across disease states and Independent Charity PAPs (e.g., Corporate Giving Executive Review Committee presentations and related documentation; documentation of due diligence performed by Jazz; and other relevant information, as applicable);

5)

documents regarding donations to Independent Charity PAPs required by Jazz policy to evidence or document the review and approval of a decision to provide a donation to a particular fund of an Independent Charity PAP (i.e., minutes from Jazz’s Corporate Giving Executive Review Committee that memorialize donation decisions, including budget allocation across disease states and Independent Charity PAPs, and final determinations (approvals or rejections) on proposed donations to Independent Charity PAPs);

6)	to the extent not covered by item 2 above, all correspondence between Jazz and an Independent Charity PAP relating to any donation arrangement with the Independent Charity PAP;

7)	any donation agreement documents entered into between Jazz and an Independent Charity PAP during the relevant Reporting Period; and

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8)	payment documentation required by Jazz policy reflecting: a) the total amount of donations Jazz agreed to make to an Independent Charity PAP broken down by disease fund, if applicable; b) the schedule of such payments, if applicable; c) the actual payments made; and d) any decisions to change the initial donation amount agreed to by Jazz.

1)	Whether activities relating to arrangements with the Independent Charity PAP were undertaken by the appropriate individuals, departments, or groups within Jazz in accordance with the company’s policies and procedures including those outlined in Section III.J;

2)	Whether Jazz’s commercial organization (as defined in Section III.J) influenced or were involved in Jazz’s decisions to enter into an arrangement with an Independent Charity PAP in violation of Jazz’s policies and procedures or OIG guidance;

3)	Whether Jazz followed the budgeting policies and practices outlined in Section III.J.2 with regard to any initial or annual donation amounts to the Independent Charity PAP and any supplemental amounts;

4)

Whether Jazz followed the decision-making and approval process outlined in Section III.J of the CIA with regard to any decisions: i) whether to donate (or continue to donate) to the Independent Charity PAP; ii) the amount of the donation (including any initial or annual amount and any supplemental amount); and iii) the criteria governing whether Jazz would donate to the Independent Charity PAP or any specific disease state fund of such a PAP;

5)	Whether Jazz followed the criteria, policies, and practices outlined in Section III.J.3 of the CIA in connection with all donations made by Jazz to any Independent Charity PAP, including as they pertain to the internal review of potential donations and the adherence to the criteria specified in Section III.J.3;

6)	Any communications that occurred between any representatives of Jazz and the Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications (including the exchange of any

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7)	Whether, for each donation from Jazz to any Independent Charity PAP, Jazz complied with the requirements outlined in Section III.J.3; and

8)	Whether, based on its review, the IRO found that Jazz exerted influence or control over the Independent Charity PAP in violation of Jazz’s policies and procedures, including those outlined in Section III.J.3.

B.	IRO Review of Additional Items

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C.	Transactions Review Report

a)	Review Objectives: A clear statement of the objectives intended to be achieved by each part of the review;

b)	Review Protocol: A detailed narrative description of the procedures performed and a description of the sampling unit and universe utilized in performing the procedures for each sample reviewed; and

c)	Sources of Data: A full description of documentation and other information, if applicable, relied upon by the IRO in performing the Transactions Review.

a)	a list of the Independent Charity PAPs to which Jazz made donations during the Reporting Period;

b)	for each Independent Charity PAP arrangement reviewed by the IRO during the Reporting Period: i) a description of the review conducted by IRO; and ii) a summary of all instances in which it appears that Jazz failed to follow its policies and procedures and/or OIG guidance regarding its arrangements or interactions with an Independent Charity PAP;

c)	for each Independent Charity PAP reviewed by the IRO, findings regarding each element specified above in Sections IV.A.1-8;

d)	the findings and supporting rationale regarding any overall weaknesses in Jazz’s systems, processes, policies, procedures,

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e)	recommendations, if any, for changes in Jazz’s systems, processes, policies, procedures, and practices that would correct or address any weaknesses or deficiencies uncovered during the Transactions Review with respect to its arrangements and interactions with Independent Charity PAPs.

a)	for each Additional Item reviewed, a description of the review conducted;

b)	for each Additional Item reviewed, the IRO’s findings based on its review;

c)	for each Additional Item reviewed, the findings and supporting rationale regarding any weaknesses in Jazz’s systems, processes, policies, procedures, and practices relating to the Additional Item; and

d)	for each Additional Item reviewed, recommendations, if any, for changes in Jazz’s systems, processes, policies, and procedures that would correct or address any weaknesses or deficiencies uncovered during the review.

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a.	Any liability arising under Title 26, U.S. Code (Internal Revenue Code);

b.	Any criminal liability;

c.	Except as explicitly stated in this Agreement, any administrative liability, including mandatory exclusion from Federal health care programs;

d.	Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;

e.	Any liability based upon obligations created by this Agreement;

f.	Any liability of individuals;

g.	Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;

h.	Any liability for failure to deliver goods or services due; and

i.	Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct.

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1.	In accordance Section 11.1 of the Pharmacy Master Services agreement, Jazz Pharmaceuticals is extending the term of the agreement. It shall be extended through June 30, 2020.

2.	Except as expressly amended herein, the Agreement shall remain unchanged and in full force and effect.

1.	I have reviewed this Quarterly Report on Form 10-Q 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.

1.	I have reviewed this Quarterly Report on Form 10-Q 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.

1.	The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2019, 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.

(1)

This certification accompanies the Quarterly Report on Form 10-Q 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-Q), 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.