Pharmacy Master Services Agreement, dated as of July 1, 2020, by and between Jazz Pharmaceuticals, Inc. and Express Scripts Specialty Distribution Services, Inc

This Pharmacy Services Agreement (the “Agreement”) is made effective as of 1 July 2020 (the “Effective Date”) by and between Jazz Pharmaceuticals, Inc. with a principal place of business at 3170 Porter Drive, Palo Alto, CA 94304 (“Jazz Pharmaceuticals”) and Express Scripts Specialty Distribution Services, Inc. with a principal place of business at One Express Way, St. Louis, MO 63121 (“ESSDS”). Jazz Pharmaceuticals and ESSDS may be referred to herein individually as a “Party” and collectively as the “Parties.”

2.7    Personnel. ESSDS shall provide the REMS Pharmacy Services through personnel who are qualified and appropriately trained to provide the REMS Pharmacy Services (the “Personnel”). ESSDS shall have sole discretion over the management and oversight of its Personnel working on the REMS Pharmacy Services, but will reasonably consult with Jazz Pharmaceuticals with respect to Jazz Pharmaceuticals’ personnel recommendations to help to ensure Jazz Pharmaceuticals’ satisfaction with the REMS Pharmacy Services. ESSDS shall provide opportunities to review and make recommendation on job descriptions prior to such job descriptions being used in the Personnel recruitment process for open positions. Prior to assigning any individual to work on the REMS Pharmacy Services on a full-time basis, Jazz Pharmaceuticals shall be given an opportunity to confirm that it is satisfied with such person’s training and qualifications. ESSDS shall ensure that all employees assigned to support the REMS Pharmacy Services are qualified and competent in their respective roles and responsibilities and have reasonable experience performing the tasks they will perform in connection with the REMS Pharmacy Services, consistent with industry standards. In addition, ESSDS will ensure that its Personnel participate in any instruction and training as required by Jazz Pharmaceuticals, including training directly from Jazz Pharmaceuticals.

Specific roles are or will be described in more detail in the applicable Work Order(s). In the event that Jazz Pharmaceuticals is dissatisfied with any individual performing REMS Pharmacy Services, it may notify ESSDS of its concerns and ESSDS will take such concerns under advisement and take corrective action as appropriate.

It is understood that ESSDS and its employees will be serving under this Agreement as an independent contractor, and will not be eligible to participate in any benefits extended by Jazz Pharmaceuticals to its employees.

ESSDS will maintain in full force and effect throughout the performance of this Agreement insurance related to Worker’s Compensation for its employees who perform REMS Pharmacy Services under this Agreement and will provide Jazz Pharmaceuticals a certificate of insurance evidencing such coverage if requested in writing by Jazz Pharmaceuticals.

2.9     Subcontracting. ESSDS may not subcontract or otherwise delegate any of its obligations with respect to the Services, except to an Affiliate, without Jazz Pharmaceuticals’ prior written consent, which will not be unreasonably withheld, including by agreeing to a Work Order specifying the subcontractor. Upon receipt of such consent, before allowing any subcontractor to being performing services, ESSDS shall enter into a binding written agreement with such subcontractor that protects Jazz Pharmaceuticals’ rights and interests to at least the same degree as this Agreement. ESSDS shall be responsible for any permitted subcontractors’ compliance with the terms hereof. Jazz Pharmaceuticals shall have no obligation to pay any such subcontractors for any Services.

2.10    Privacy.

(a)    Notwithstanding anything to the contrary herein (including the Exhibits hereto), ESSDS shall only provide information to Jazz Pharmaceuticals in a manner consistent with HIPAA. Accordingly, the Parties agree that ESSDS shall only provide Jazz Pharmaceuticals information that is de-identified in accordance with HIPAA’s de-identification provision, 45 C.F.R. § 164.514(b), unless ESSDS: (i) has on file a valid, unrevoked, HIPAA-compliant authorization for each patient whose protected health information (“PHI”) is sought to be disclosed; or (ii) authorization is not required under Applicable Law in order to disclose the PHI. Jazz Pharmaceuticals represents and warrants that it cannot and will not attempt to identify the individual who is the subject of any de-identified information. To the extent that Jazz Pharmaceuticals, or a contractor of Jazz Pharmaceuticals (e.g., a Hub), maintains the relevant HIPAA authorization, Jazz Pharmaceuticals agrees to, or to require its contractor to, appropriately communicate to ESSDS any expiration, revocation, or restriction requested by a patient related to the HIPAA authorization or the patient’s PHI.

(b)    If Jazz Pharmaceuticals seeks PHI from ESSDS for Jazz Pharmaceuticals’ public health activities purposes (e.g., REMS, adverse event reporting), Jazz Pharmaceuticals represents and warrants that the disclosure of such PHI by ESSDS to Jazz Pharmaceuticals, either directly to Jazz Pharmaceuticals or to Jazz Pharmaceuticals’ data collection agent, satisfies the conditions of 45 C.F.R. § 164.512(b) in that: (i) if Jazz Pharmaceuticals uses a third party to collect data for Jazz Pharmaceuticals, such third party is serving in the capacity as Jazz Pharmaceuticals’ agent for the purpose of, among other things, collecting data on behalf of Jazz Pharmaceuticals; (ii) the data to be collected is to be used and/or disclosed by Jazz Pharmaceuticals, or its data collection agent, solely for public health activities purposes and for no other purpose; (iii) de-identified data (as described in 45 C.F.R. § 164.514(b)) is not sufficient under the circumstances to enable Jazz Pharmaceuticals to satisfy its public health activities purposes; and (iv) the data to be collected includes the minimal amount of PHI required in order for Jazz Pharmaceuticals to conduct its public health activities purposes.

2.11     REMS Program Items

(a)    REMS Program Items. From the Effective Date of this Agreement, Jazz Pharmaceuticals shall provide REMS Program Items to ESSDS of the type and quantities to be reasonably determined by Jazz Pharmaceuticals for performance of REMS Pharmacy Services. ESSDS shall not utilize or distribute REMS Program Items for any purpose other than as set forth in this Agreement and the Work Orders hereunder. ESSDS is strictly prohibited from selling, utilizing, or transferring REMS Program Items to any third-party under any circumstances not contemplated by this Agreement.

(b)    Title; Storage. REMS Program Items shall be marked as property of Jazz

Pharmaceuticals. ESSDS shall furnish and maintain a suitable place for storage of REMS Program Items. Legal title to all REMS Program Items shall remain with Jazz Pharmaceuticals.

8.1    Confidentiality of Agreement. The Parties agree that the terms and conditions of

the Agreement are Confidential Information (as defined in Section 8.2 below) and shall not be disclosed to anyone for any purpose without the prior written consent of the other Party, except as expressly permitted by this Agreement.

8.2    Confidential Information. Each Party acknowledges that in connection with this Agreement, it may receive information, including and without limitation, trade secrets and innovations, information regarding the Product and planned products, the Program and the Services and planned services, contractors, customers, prospective customers, financial data, computer software processes, ideas, marketing information, strategies, forecasts, development programs, data, know-how, improvements and other valuable business information from or on behalf of the other Party (the “Disclosing Party”) which the Disclosing Party considers to be proprietary and confidential and the value of which might be lost if the confidentiality of such information is not maintained (collectively, the “Confidential Information”). The Party receiving such Confidential Information (the “Receiving Party”) agrees, at all times during the term of this Agreement, and subject to the limitations set forth herein, (i) to treat as confidential all Confidential Information received from the Disclosing Party with at least the same degree of care with which the Receiving Party treats its own confidential information, (ii) to disclose Confidential Information to only those of its employees, agents, consultants and permitted subcontractors who have a need to know such Confidential Information in order to accomplish the purposes of this Agreement and who are subject to obligations of confidentiality at least as restrictive as those obligations of confidentiality in this

Section, and (iii) to not use the Disclosing Party’s Confidential Information for any purpose except those purposes permitted by this Agreement. Unless otherwise expressly set forth herein to the contrary, each Party hereby acknowledges and agrees that, as between the Parties, the Disclosing Party owns all right, title, and interest in and to the Confidential Information disclosed to the Receiving Party.

8.3.     Exceptions. The obligations of confidentiality and nonuse set forth herein shall

not apply to information that the Receiving Party can demonstrate by competent written evidence: (i)    is or becomes generally available to the public other than as a result of a disclosure by the Receiving Party in breach this Agreement, (ii) was within the Receiving Party’s possession prior to the date of the Prior Agreement and had become known to the Receiving Party from the Receiving Party’s own sources without restriction, (iii) becomes available to the Receiving Party on a non-confidential basis from a third Party not acting on behalf of the Disclosing Party and not under any obligation to keep such information confidential, and (iv)was or is independently developed by the Receiving Party without the use of or access to any Confidential Information. Any combination of features or disclosures will not be deemed to fall within the foregoing exclusions merely because certain individual features fall within such foregoing exclusions unless the combination as a whole falls within any of the above exclusions.

8.4.     Authorized Disclosure. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent such disclosure is required by Applicable Law, a valid order of a court or other governmental body having jurisdiction, or rules of a securities exchange; provided, however, that the Receiving Party both: (a) gives prompt notice to the Disclosing Party of the disclosure requirement in order to allow the Disclosing Party to obtain any available limitation on or exemptions from such disclosure requirement, where reasonably practicable, and (b) reasonably cooperates in such efforts by the Disclosing Party, where not prohibited by Applicable Law, court order, or securities exchange rules.

8.5.     Permitted Uses and Disclosures. The Receiving Party may use Confidential Information in the performance of its obligations or exercise of its rights under this Agreement or any Work Order.

8.6.     Data.     ESSDS agrees to maintain the security and confidentiality of all Data, including any Personal Data, in accordance with all Applicable Laws, applicable agreements, patient release forms, consents, and the provisions of this Agreement, the SOPs and all Work Orders. For the purposes of this Section, “Personal Data” shall mean computerized or electronic records as well as paper-based files in any medium or format collected by ESSDS in connection with the performance of Services, including by not limited to information received from any patient, health care professional, and other business-to-business customers or vendors that specifically identifies, or when used together with other available information identifies, a particular individual. Personal Data includes name, address, telephone number, fax number, Social Security number, DEA number, other government issued identifier, credit card information, insurance identification number, IP addresses, email address and information relating to the past, present or future health or condition (physical or mental) of an individual, but does not include information that is deidentified, encoded or made anonymous. The parties agree that Jazz Pharmaceuticals will not have any ownership in Personal Data created, collected or recorded by ESSDS in connection with the Services. ESSDS agreed that it will not utilize Personal Data outside the scope of this Agreement, provided however, that ESSDS

and/or its affiliates may use Personal Data in the aggregate or on a deidentified basis with other drug-use data, to the extent permitted by law, without charge, for research, cost analysis and other internal business purposes of ESSDS, provided that said use does not in any way compete with the business of Jazz Pharmaceuticals. ESSDS will establish commercially reasonable controls to ensure the confidentiality of Confidential Information and Data and to ensure that Data is not disclosed contrary to the provisions of this Agreement; provided, further, without limiting the foregoing, that ESSDS shall implement and/or maintain a comprehensive written information privacy and security program that includes appropriate administrative, technical and physical safeguards and other security measures appropriate to the size and complexity of ESSDS’ operations and the nature and scope its activities that are designed to (a) ensure the security and confidentiality of Data; (b) protect against any anticipated threats or hazards to the security, confidentiality and integrity of Data; and (c) protect against unauthorized access to or use of Data that could result in the destruction, use, modification or unauthorized disclosure of Data.

8.7     Return of Confidential Information. Upon expiration or earlier termination of this Agreement, or upon the Disclosing Party’s earlier request, the Receiving Party (a) shall return to the Disclosing Party all documents, papers, and other materials in the Receiving Party’s possession or under the Receiving Party’s control containing the Disclosing Party’s Confidential Information, or (b) shall destroy any or all such documents, papers and other materials items, thereafter sending the Disclosing Party a signed certification of destruction covering the applicable items. Notwithstanding the foregoing, each Party may retain a single archival copy of the other Party’s Confidential Information for the sole purpose of facilitating compliance with the surviving provisions of this Agreement.

(a)    Jazz Pharmaceuticals may provide ESSDS with access to the Jazz Pharmaceuticals network, system, and/or a specific application, as Jazz Pharmaceuticals may decide in its sole discretion (the “Information Technology”) for use under this Agreement.  This Information Technology will be used solely for purposes of, and in connection with, the Services provided under this Agreement and for no other purpose whatsoever.  Access to such Information Technology will be strictly limited to those ESSDS agents, employees and consultants (the “IT Access Recipients”) who are required to use such Information Technology for the performance of the Services. The Information Technology may not be copied, modified or distributed, or provided to or used by any third party.  ESSDS will be liable for any unauthorized use of Jazz Pharmaceuticals’ Information Technology by any IT Access Recipients.

8.9     Injunctive Relief. Each Party acknowledges that the disclosure or use of the other

Party’s Confidential Information, other than as expressly permitted herein, without such Party’s prior written permission may cause the Disclosing Party irreparable harm and that any material breach or threatened material breach of the obligations of confidentiality and non-use by the

Receiving Party will entitle the Disclosing Party to seek injunctive relief, in addition to any other legal remedies available to it, in any court of competent jurisdiction.

9.1    General. Each Party hereby represents, warrants, and covenants to the other that: (i) it has all requisite corporate power and authority to enter into this Agreement and perform and observe all obligations and conditions required to be performed or observed by that Party under this Agreement, (ii) neither the execution and delivery of this Agreement nor the performance by that Party of its respective obligations under this Agreement will conflict with or result in a breach of any covenant or agreement between that Party and any third party, (iii) this Agreement represents the legal, valid, and binding obligation of that Party, and (iv) as of the Effective Date, such Party has (or will have at such time as performance of its obligations under this Agreement may require) obtained all of the local, state, and federal permits, licenses, or other regulatory registrations or approvals necessary, if any, for the performance of its obligations under this Agreement.

9.2    ESSDS Representations and Warranties.

9.2.1    ESSDS represents and warrants that, to the best of its knowledge, it owns and possesses all right, title and interest in and to, or has valid licenses to use all the proprietary rights necessary to perform its obligations under this Agreement.

9.2.2    ESSDS warrants that any computer systems used in connection with the Services shall operate substantially in accordance with any descriptions or the specifications set forth in this Agreement or any applicable Work Orders. A business continuity plan, as set forth in the applicable SOP, will be implemented by ESSDS to assure that this warranty will be met.

9.2.3    ESSDS represents, warrants, and covenants that ESSDS’s contracted work with pharmaceutical/medical device manufacturers is independent from its parent company’s clinical and formulary decisions. There is a firewall between ESSDS’s pharmaceutical/medical device services business and the pharmacy benefit management (“PBM”) business. ESSDS will not be influenced by any PBM rebate or other related agreements with pharmaceutical/medical device manufacturers. Similarly, transactions between pharmaceutical/medical device manufacturers and ESSDS will not affect PBM clinical and formulary decisions.

9.2.4    ESSDS shall:

(a) provide all Services and Deliverables to Jazz Pharmaceuticals pursuant to this Agreement in compliance with Applicable Laws and in a good, workmanlike, and timely manner, consistent with standards for the industry;

(b) comply with the descriptions, specifications and representations as to the Services and Deliverables (including performance, capabilities, accuracy, completeness, characteristics, specifications, configurations, standards, functions, and requirements) as set forth in this Agreement or in a Work Order, including, without limitation, the Performance Standards and Measures included in the applicable Work Order and the specifications contained within the REMS Documents.

(c) maintain all licenses, certifications, permits and authorizations pertinent to the practice of pharmacy and required by all Applicable Laws, the REMS Documents, rules and regulations and this Agreement.

(d) make no representation, guarantee, or warranty about the Product, whether orally or in writing, except as contained in written materials delivered to ESSDS by Jazz Pharmaceuticals for use in connection with the Services; and (i) avoid deceptive, misleading or unethical practices that are or might be detrimental to Jazz Pharmaceuticals, the Product, or the public; and (ii) make no false or misleading representations with regard to Jazz Pharmaceuticals or the Product.

(e) use commercially reasonable technical measures to (i) detect and eliminate computer viruses and other destructive code introduced to any computer systems used in connection with the Services, (ii) correct any error reproducible by ESSDS in any computer systems used in connection with the Services, and (iii) ensure that any computer systems used in connection with the Services are available without interruption, except as contemplated by the business continuity plan, included as an Appendix to JPP-0002 – Inventory Control SOP.

9.3.1    Jazz Pharmaceuticals represents and warrants that, to the best of its knowledge, it owns and possesses all right, title and interest in and to, or has valid licenses to use all of the proprietary rights necessary to perform its obligations under this Agreement.

10.1    Intellectual Property of Jazz Pharmaceuticals. All Intellectual Property (including patents, copyrights, trademarks, trade secrets, ideas, improvements, discoveries, enhancements,

modifications, know-how, data, and information of every kind and description) either (a) conceived, generated, made, fixed in a tangible medium of expression or reduced to practice, as the case may be, by ESSDS within the scope and course of providing the Services to Jazz Pharmaceuticals under this Agreement, either alone or jointly with others or (b) owned or controlled by Jazz Pharmaceuticals on the Effective Date and/or otherwise independently of ESSDS and this Agreement which arise out of or relate to this Agreement, the Services, or the Jazz Pharmaceuticals Confidential Information (the “Jazz Intellectual Property”) will be the sole and exclusive property of Jazz Pharmaceuticals. ESSDS will disclose Jazz Intellectual Property under subpart (a) of this paragraph promptly to Jazz Pharmaceuticals, and hereby assigns all of ESSDS’s right, title and interest in and to any such Jazz Intellectual Property to Jazz Pharmaceuticals without royalty or any other consideration (other than compensation for the Services as provided by this Agreement or an applicable Work Order). For the avoidance of doubt, this includes, but may not be limited to, all Records, Deliverables, Program Items, and Data. Jazz Pharmaceuticals shall also own all right, title, and interest in any telephone numbers, fax numbers, web, and email domains established by ESSDS solely in connection with the Services hereunder and all such Intellectual Property rights therein, and the Parties will take all actions necessary so that any such numbers and domains will be registered with Jazz Pharmaceuticals following the expiration or termination of this Agreement for any reason, at Jazz Pharmaceuticals’ sole cost and expense. ESSDS will cooperate fully with Jazz Pharmaceuticals in the process of securing and enforcing Jazz Pharmaceuticals’ rights to such Jazz Intellectual Property, which may include executing applications, assignments or other instruments, and Jazz Pharmaceuticals will compensate ESSDS for ESSDS’s reasonable time devoted to such activities at Jazz Pharmaceuticals’ request and reimburse ESSDS for reasonable expenses incurred in connection therewith. If any part of the Jazz Intellectual Property under subpart (a) of this paragraph is based on, incorporates or is an improvement or derivative of, or cannot be reasonably and fully made, used, reproduced, modified, distributed or otherwise exploited without using, any technology or intellectual property rights owned or licensed by ESSDS and not assigned hereunder, then ESSDS hereby grants to Jazz Pharmaceuticals and its Affiliates a nonexclusive, either (i) perpetual and irrevocable (with respect to Records, Deliverables, Program Items, and Data supplied by ESSDS that incorporate such technology or intellectual property) or (ii) term-based (with respect to Jazz Pharmaceuticals’ receipt of Services, as provided in Section 10.3), worldwide, royalty-free, sublicensable (other than for receipt of Services) right and license to exploit and exercise all such technology and intellectual property rights in support of Jazz Pharmaceuticals’ receipt of the Services (as provided in Section 10.3) and exercise or exploitation of the Jazz Intellectual Property or any rights to the foregoing assigned to Jazz Pharmaceuticals (including, without limitation, any modifications, improvements and derivatives of any of them). Any copyrightable work, whether published or unpublished, created by ESSDS in connection with or during the performance of any Services will be considered a work made for hire to the fullest extent permitted by law. If any such copyrightable work is not classified as a work made for hire, then ESSDS assigns all worldwide rights in the work to Jazz Pharmaceuticals without royalty or any other consideration. No third party has or will have any claim of ownership for Intellectual Property assigned by ESSDS to Jazz Pharmaceuticals under this Agreement.

10.2    Intellectual Property of ESSDS. Notwithstanding anything to the contrary in Section 10.1 or otherwise, the Jazz Intellectual Property does not include, and ESSDS shall retain all right, title and interest in and to, the ESSDS IP. “ESSDS IP” shall mean (a) all Intellectual Property (including trade secrets, trademarks, patents, copyrights and other non-registered intellectual property) owned or control by ESSDS on the Effective Date and/or otherwise independently of Jazz Pharmaceuticals and this Agreement, including but not limited to, all Intellectual Property embodied in the ESSDS

Software and all ESSDS Prior Works that ESSDS shall use in connection with performing the Services under this Agreement. The term “ESSDS Prior Works” shall mean any and all Intellectual Property or other products developed, owned, controlled or acquired by ESSDS prior to the Effective Date of this Agreement and/or otherwise independently of Jazz Pharmaceuticals and this Agreement, including, but not limited to (i) computer software, technology, patient-centric services and analytics for pharmaceutical, biotechnology, medical device, vaccine and diagnostic manufacturers (“ESSDS Software”), (ii) specialty pharmacy industry knowledge, (iii) specialty pharmacy distribution and services software, and (iv) specialty pharmacy data reporting to payers and manufacturers, subject to any data reporting restrictions set forth elsewhere in this Agreement.

10.3    Licenses to Jazz Pharmaceuticals. ESSDS hereby grants to Jazz Pharmaceuticals a limited, non-transferable, non-exclusive, royalty-free right and license to the ESSDS IP, including the ESSDS Software, ESSDS Portal, and ESSDS Prior Works, solely as reasonably necessary in Jazz Pharmaceuticals’ normal course of receiving and using the Services during the term of this Agreement.

11.1    Term; Renewal. Unless otherwise terminated in accordance with the terms hereof, this Agreement will remain in effect for a period of two (2) years from the Effective Date. If no such notice of termination is given, this Agreement can be renewed for one (1) additional one (1) year term at the discretion of Jazz Pharmaceuticals by a written amendment hereto, subject to the right of termination as otherwise provided herein.

11.2    Termination Without Cause. Either Party may terminate this Agreement or any Work Order at any time without cause on one hundred eighty (180) days’ prior written notice to the other Party.

11.3    Termination for Cause. Either Party may terminate this Agreement immediately upon written notice to the other Party if such other Party materially breaches this Agreement and, after receiving written notice identifying such breach, fails to cure such material breach within thirty (30) days after receipt of such notice. Such notice will include the effective date of termination.

11.4    Termination for Legal Necessity. Either Party may terminate this Agreement immediately upon written notice to the other Party in the event that (1) any Applicable Law, court decision, or the like is enacted, promulgated, published, or otherwise made effective, which would make ESSDS’ performance of the Pharmacy Services illegal or otherwise commercially impracticable or Jazz Pharmaceuticals’ development or commercialization of the Product commercially, medically, or technically impracticable or (2) Jazz Pharmaceuticals receives notice of regulatory action by the FDA that results in the termination or suspension of its rights to manufacture or distribute the Product in the United States.

11.5    Bankruptcy or Insolvency. Either Party may terminate this Agreement immediately upon written notice to the other Party, if such other Party makes an assignment for the benefit of creditors, files a petition in bankruptcy, is adjudicated insolvent or bankrupt, a receiver or trustee is appointed with respect to a substantial part of such other Party’s property, or a proceeding is commenced against it which will substantially impair its ability to perform hereunder.

11.6    Partial Termination. A Party shall have the option and right to terminate (i) all of the Services or (ii) one or more specific services that may be part of the Services (collectively or individually referred to as “Specified Service”) as provided for in this Article X with one hundred eighty (180) days’ prior written notice to the other Party.

11.7    Effect of Termination. Upon expiration or earlier termination of this Agreement:

11.7.1 ESSDS shall deliver to Jazz Pharmaceutical, at Jazz Pharmaceuticals’ expense, all tangible materials in ESSDS’ possession or control belonging to Jazz Pharmaceuticals.

11.7.2 ESSDS shall notify any person or entity who contacts ESSDS in connection with any matter related to the Services that ESSDS is no longer providing those Services and direct them as requested by Jazz Pharmaceuticals.

11.7.3 ESSDS shall invoice Jazz Pharmaceuticals for any payments due for the applicable Services through the date of termination, pursuant to Section 2.8 and Jazz Pharmaceuticals shall pay such invoice(s) in accordance with Section 2.7.

11.7.4 ESSDS shall otherwise provide all other cooperation reasonably requested by Jazz Pharmaceuticals to ensure a smooth transition and the uninterrupted operation of the Specified Service.

11.8    Transition of Services. Upon termination or expiration of this Agreement or any Specified Service, the Parties shall mutually agree on an expeditious schedule of transition of the applicable Services.

11.9    Transition of Patient Information. In connection with any of the Services, Jazz Pharmaceuticals may request that ESSDS transfer all prescriptions, all patient and prescriber data required to administer and maintain compliance with the REMS Program, SOPs and Business Rules at Jazz Pharmaceutical’s request to a pharmacy assuming responsibility for such services for the purpose of continuing “treatment” (as that term is defined by HIPAA) of affected Patients, and ESSDS shall expeditiously honor that request to the extent disclosure of such Patient Data by ESSDS is permitted under Applicable Law, including, but not limited to, HIPAA. All such Patient Data shall be transferred in standard NCPDP format. The purpose of any transfer of Patient Data is to assure, to the extent possible, as smooth transition for Patients.

11.10    Survival. Termination or expiration of the Agreement for any reason shall not affect the continuing rights and obligations of the Parties under Articles III; VII; VIII; X; XII; and XIV; and Sections 2.3; 2.4.1; 5.1; 5.2; 9.1; 11.7; 11.8; 11.9; 11.10; and 13.4 of this Agreement.

12.1    Indemnification by Jazz Pharmaceuticals. Subject to the terms hereof, Jazz Pharmaceuticals shall indemnify and defend ESSDS, its Affiliates, and their respective directors, officers, employees, agents, successors and permitted assigns, from and against any liabilities, damages, loss, judgments, settlements or expense (including reasonable attorneys’ fees) (collectively, “Losses”) as a result of any third-party claim, demand, or action (collectively, “Claims”) to the extent arising from (a) the manufacture, sale or use, of the Product; (b) the negligence, recklessness, or willful misconduct of Jazz Pharmaceuticals or any of its employees, or (c) Jazz Pharmaceuticals’ failure to comply with its obligations under this Agreement. Such obligation to indemnify, defend, and hold harmless shall not apply to the extent Losses and Claims are caused by ESSDS’ breach hereof, negligence, recklessness, or willful misconduct.

12.2    Indemnification by ESSDS. Subject to the terms hereof, ESSDS shall indemnify and defend Jazz Pharmaceuticals, its Affiliates, and their respective directors, officers, employees, agents, successors and permitted assigns, from and against any Losses as a result of any third-party Claims, to the extent arising from (a) the negligence, recklessness or willful misconduct of ESSDS or any of its employees, or (b) ESSDS’ breach of any representation, warranty, or obligation under this Agreement. Such obligation to indemnify, defend, and hold harmless shall not apply to the extent Losses and Claims are caused by Jazz Pharmaceuticals’ breach hereof, negligence, recklessness or willful misconduct.

12.3    Indemnification Conditions and Procedures. The Party seeking indemnification (the “Requesting Party”) shall (a) promptly notify the other Party (the “Indemnifying Party”) in writing upon receipt of oral or written notice of any actual or alleged Claim, (b) allow the Indemnifying Party, at its discretion and cost, to undertake and control the defense of such Claim, (c) diligently assist the Indemnifying Party and cooperate in defending against such Claim; and (d) not, except at its own cost, voluntarily make or agree to make any payment or incur any expense in connection with any such Claim without the prior written consent of the Indemnifying Party.

12.4    Limitation of Liability. EXCEPT WITH RESPECT TO BREACHES OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE VIII, INTELLECTUAL PROPERTY INFRINGEMENT CLAIMS, AND THE PARTIES’ INDEMNIFICATION OBLIGATIONS UNDER SECTIONS 11.1 AND 11.2, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR LOST PROFITS OR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SIMILAR DAMAGES, HOWEVER CAUSED AND ON ANY LEGAL THEORY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

12.5    Insurance. Each Party will maintain at least [***] of commercial general liability insurance and [***] of product liability insurance. ESSDS will maintain Workers’ Compensation coverage (or its equivalent) in compliance with Applicable Law, automotive liability insurance of at least [***] and professional liability insurance of at least [***]. As evidence of the coverage required by this Agreement, either Party may, in lieu of actual policies, accept Certificates of Insurance setting forth the nature of the coverage, the limits of liability, the name of the insurance carrier, policy number and the date of expiration, which shall be furnished on demand.

13.2    Regular Meetings and Communication. Jazz Pharmaceuticals and ESSDS agree to meet (whether in-person or by teleconference) as necessary, for ESSDS to effectively perform the Services specified in each Work Order hereunder. Jazz Pharmaceuticals and ESSDS agree to meet formally on at least a quarterly basis during the Term to, among other things, discuss performance under the Agreement, strategic planning, and to evaluate the progress being made against objectives established in this Agreement or Work Orders and any enhancements that might be made to the processes set forth herein.

14.2    Waiver. A failure by either Party to insist upon strict compliance with any term of this Agreement, to exercise any option, to enforce any right, or to seek any remedy upon any default of the other Party shall not affect, or constitute a waiver of, such Party’s right to insist upon strict compliance with that term, to exercise that option, to enforce that right, or to seek that remedy with respect to that default or any prior, contemporaneous, or subsequent default. No custom or practice of the Parties at variance with any provision of this Agreement shall affect, or constitute a waiver of, a Party’s right to demand strict compliance with all provisions of this Agreement.

14.3    Assignment. Jazz Pharmaceuticals may assign this Agreement, in whole or in part, to any Affiliate or to a third-party successor to substantially all of the business to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other transaction. ESSDS may assign this Agreement, in whole or in part, upon consent of Jazz Pharmaceuticals, such consent not to be unreasonably withheld.

14.5    Entire Agreement. This Agreement (together with all Exhibits and Work Orders hereto incorporated by reference) constitutes the entire agreement between the Parties with respect to the Services and supersedes all prior negotiations, representations or agreements, written or oral, regarding the subject matter hereof, which will remain in full force and effect in accordance with its terms with respect to disclosures made prior to the date hereof. Jazz Pharmaceuticals specifically rejects and will not be bound by any other terms and conditions.

14.6    Tax Liability. ESSDS will be solely responsible for meeting its corporation tax and any applicable social security (or equivalent in any other country, e.g., national insurance obligations) and for enabling that its employees meet their respective income tax and applicable social security obligations (or equivalent in any other country) and all other applicable social insurances. ESSDS shall indemnify and hold harmless Jazz Pharmaceuticals for all taxes, social security or its equivalent and other contributions, costs, claims, penalties, interest, expenses or proceedings which Jazz Pharmaceuticals may incur arising from or in connection with the failure of ESSDS or its employees to meet their respective responsibilities under this Section.

14.7    Relationship of the Parties. ESSDS will be an independent contractor of Jazz Pharmaceuticals, and nothing in this Agreement will be construed to create any partnership, joint venture, agency, or employment relationship between the Parties or between Jazz Pharmaceuticals and the Personnel of ESSDS. ESSDS is and will remain responsible for its respective Personnel and will make no claim against Jazz Pharmaceuticals or its Affiliates for eligibility to participate in any benefits extended by Jazz Pharmaceuticals to its employees. ESSDS will have no authority to act for, bind or commit Jazz Pharmaceuticals or its Affiliates in any way.

14.8    Force Majeure. If the performance of any part of this Agreement by either party shall be affected for any length of time by fire or other casualty, government restrictions, war, riots, strikes, or labor disputes, lock outs, transportation delays, and acts of God, or any such similar causes which are beyond the reasonable control of such Party, such Party shall not be responsible for delay or failure of the performance of this Agreement for such length of time; provided, however, that the obligation of the Parties to pay amounts then due shall not be suspended or delayed; and provided, further, that if ESSDS is precluded from rendering Services for a continuous period in excess of ten (10) business days, Jazz Pharmaceuticals shall be entitled to terminate this agreement upon five (5) days’ notice.

14.9    Severability. If any of the provisions or any portion of any provision of this Agreement is held to be unenforceable or invalid by a court or arbitration panel of competent jurisdiction, the validity and enforceability of the enforceable portion of any such provision and/or the remaining provisions will not be affected.

14.10    Governing Law. This Agreement, and any dispute related hereto, will be governed and construed in accordance with the laws of the State of Delaware, excluding any choice of law rules which may direct the application of the laws of another jurisdiction. In the event of any dispute between the Parties, prior to any Party commencing an action for damages, each Party will designate a representative and the representatives will meet in person or telephonically in a good-faith attempt to resolve their differences. Prior to such meeting, the complaining Party will provide a written explanation of the dispute.

14.11 Notices. Any notice delivered to a Party pursuant to this Agreement must be in writing and may be delivered: personally (effective upon receipt); by depositing with a nationally-recognized overnight courier (effective one business day after deposit); or by depositing in the United States Mail, postage prepaid, registered or certified mail, return receipt requested (effective five days after deposit). All notices hereunder will be addressed to the Party at the address indicated below, or at such other address that may have been specified by written notice delivered in accordance with this Section:

14.12    Counterparts. This Agreement, any Work Order, and any amendments hereto or thereto, may be executed in counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Facsimile and pdf signatures will be considered original signatures.

14.13    Compliance with Laws. Each Party shall, in its respective performance of this Agreement, take all actions necessary and appropriate to assure that it complies with all applicable federal, state, and local laws and regulations, including, without limitation, the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Public Contracts Anti-Kickback Act (41 U.S.C. § 51 et seq.) and the Stark Law (42 U.S.C. § 1395nn).

14.14    Publicity. Neither Party shall cause or permit the oral or written release of any statement, advertisement, information or publicity referring to the other Party or any of its personnel without such Party’s prior written consent.

Intending to be bound by the provisions hereof, each of the parties hereto have caused this Agreement to be executed personally or by its duly authorized representative, to be effective as of the Effective Date.