Common use of Regulatory and Compliance Audits and Information Requests Clause in Contracts

Regulatory and Compliance Audits and Information Requests. (a) SDS shall provide to Orphan and/or the FDA, DEA or any other governmental body all documents and information requested by the FDA, DEA or any other governmental body in support of Orphan’s regulatory filings or any governmental investigations or inquires. Copies of all documents to be provided to the FDA or DEA shall be provided to Orphan in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA. SDS shall notify Orphan immediately upon receipt of notice of any inspection by the FDA or DEA directed specifically toward Product, and Orphan shall have the right to have an employee present at any such inspection, if allowed by law. In addition, SDS shall notify Orphan of any FDA or DEA correspondence or inspections that concern SDS generally and which are related to any SDS compliance issues that may adversely impact SDS’s ability to perform the services contemplated by this Agreement. SDS shall notify Orphan immediately of any notices, requests for information or other communications related to Product from the U.S. Department of Health and Human Services or any other government agency or any state healthcare program or other state agency and, to the extent permitted under applicable law, shall give Orphan copies of such communications. (b) SDS shall from time to time submit to audits and inspections by Orphan during normal business hours or at any other time during which the services being audited are ongoing, including but not limited to, audits of regulatory and quality assurance SOPs and of records of contacts with regulatory agencies, provided the scope of any such audit or inspection shall be limited to information and facilities pertaining to Orphan’s program. Orphan shall give SDS at least two (2) business days prior notice of any such inspection and at least thirty (30) days prior notice for any such audit, and Orphan shall bear the out of pocket costs of such audit or inspection.

Regulatory and Compliance Audits and Information Requests. (a) SDS CuraScript shall provide to Orphan Jazz Pharmaceuticals and/or the FDA, DEA DEA, or any other governmental body all reasonable documents and information reasonably necessary and requested by the FDA, DEA DEA, or any other governmental body in support of Orphan’s Jazz Pharmaceuticals’ regulatory filings or any governmental investigations or inquiresinquiries. Copies of all documents to be provided to the FDA or DEA shall be provided to Orphan Jazz Pharmaceuticals in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA, unless prohibited by law. SDS CuraScript shall notify Orphan Jazz Pharmaceuticals immediately upon receipt of notice of any inspection inspection, notice or request by the FDA or DEA directed specifically toward ProductProduct or the Central Pharmacy, and Orphan Jazz Pharmaceuticals shall have the right to have an employee present at any such inspection, if allowed by law. In addition, SDS shall notify Orphan of any FDA or DEA correspondence or inspections that concern SDS generally and which are related subject to any SDS compliance issues that may adversely impact SDS’s ability to perform the services contemplated by this Agreement. SDS shall notify Orphan immediately of any notices, requests for information or other communications related to Product from the U.S. Department of Health and Human Services or any other government agency or any state healthcare program or other state agency and, to the extent permitted under applicable law, shall give Orphan copies of such communicationslegal confidentiality constraints imposed upon ESSDS. (b) SDS CuraScript and ESSDS shall from time to time (except in the months of December and January) submit to reasonable audits and reasonable inspections, including inspections of the Central Pharmacy, by Orphan Jazz Pharmaceuticals during normal business hours or at any other time during which the services being audited are ongoinghours, including including, but not limited to, audits of regulatory and quality assurance SOPs and of records of contacts with regulatory agenciesassurance, Business Rules, SOPs, provided the scope of any such audit or inspection is reasonable and shall be limited to information for a period not to exceed the most recent prior twenty-four (24) month period from the date of the audit and information and facilities pertaining to Orphan’s programJazz Pharmaceuticals and subject to the restrictions contained in Section 5.1. Orphan Jazz Pharmaceuticals shall give SDS CuraScript or ESSDS, as applicable, at least two three (23) business days days’ prior notice of the date of any such inspection and at least thirty (30) days days’ prior notice for of the initial date of any such audit, and Orphan Jazz Pharmaceuticals shall bear the out of pocket costs of such audit or inspection. Jazz Pharmaceuticals will provide a reasonably detailed audit scope of work and an agenda document with its notice prior to any such audit. If Jazz Pharmaceuticals uses a third party to conduct the inspection or audit, such third party: (i) shall not have a conflict of interest with CuraScript (or any CuraScript affiliate) as reasonably determined by CuraScript, and (ii) will be required to sign a confidentiality agreement in a form reasonably acceptable to CuraScript prior to commencing such inspection or audit. (c) No employee of CuraScript or ESSDS who has been the subject of any disciplinary action by any State Board of Pharmacy or has been “debarred” or had debarment proceedings commenced against them by the FDA shall be entitled to perform Covered Services. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (d) CuraScript and ESSDS represent and warrant to Jazz Pharmaceuticals that they (i) are not currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs or is proposed for exclusion under such programs, and (ii) have not been convicted of a criminal offense that falls within the ambits of 42 U.S.C. §1320a-(7)a or §1320a-7(b)(1)-(3) but have not yet been excluded, debarred, suspended, or otherwise declared ineligible to participate in the Federal health care programs or in federal procurement or non-procurement programs. CuraScript and ESSDS agree that they will promptly notify Jazz Pharmaceuticals in writing if any of the representations and warranties made by CuraScript or ESSDS in this subsection (d) ceases to be true at any time during the term of this 2011 Master Services Agreement.

Regulatory and Compliance Audits and Information Requests. (a) SDS CuraScript shall provide to Orphan Jazz Pharmaceuticals and/or the FDA, DEA DEA, or any other governmental body all reasonable documents and information reasonably necessary and requested by the FDA, DEA DEA, or any other governmental body in support of Orphan’s Jazz Pharmaceuticals’ regulatory filings or any governmental investigations or inquiresinquiries. Copies of all documents to be provided to the FDA or DEA shall be provided to Orphan Jazz Pharmaceuticals in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA, unless prohibited by law. SDS CuraScript shall notify Orphan Jazz Pharmaceuticals immediately upon receipt of notice of any inspection inspection, notice or request by the FDA or DEA directed specifically toward ProductProduct or Facility, and Orphan Jazz Pharmaceuticals shall have the right to have an employee present at any such inspection, if allowed by law. In addition, SDS shall notify Orphan of any FDA or DEA correspondence or inspections that concern SDS generally and which are related subject to any SDS compliance issues that may adversely impact SDS’s ability to perform the services contemplated by this Agreement. SDS shall notify Orphan immediately of any notices, requests for information or other communications related to Product from the U.S. Department of Health and Human Services or any other government agency or any state healthcare program or other state agency and, to the extent permitted under applicable law, shall give Orphan copies of such communicationslegal confidentiality constraints imposed upon ESSDS. (b) SDS CuraScript and ESSDS shall from time to time (except in the months of December and January) submit to reasonable audits and reasonable inspections, including inspections of the Facility, by Orphan Jazz Pharmaceuticals during normal business hours or at any other time during which the services being audited are ongoinghours, including including, but not limited to, audits of regulatory and quality assurance SOPs and of records of contacts with regulatory agenciesassurance, Business Rules, SOPs, provided the [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as amended. scope of any such audit or inspection is reasonable and shall be limited to information and facilities pertaining to Orphan’s programJazz Pharmaceuticals and subject to the restrictions contained in Section 5.1. Orphan Jazz Pharmaceuticals shall give SDS CuraScript or ESSDS, as applicable, at least two three (23) business days days’ prior notice of any such inspection and at least thirty (30) days days’ prior notice for any such audit, and Orphan Jazz Pharmaceuticals shall bear the out of pocket costs of such audit or inspection. Jazz Pharmaceuticals will provide an audit scope of work and an agenda document prior to any such audit. If Jazz Pharmaceuticals uses a third party to conduct the inspection or audit, such third party: (i) shall not have a conflict of interest with CuraScript (or any CuraScript affiliate) as reasonably determined by CuraScript, and (ii) will be required to sign a confidentiality agreement in a form reasonably acceptable to CuraScript prior to commencing such inspection or audit. (c) No employee of CuraScript or ESSDS who has been the subject of any disciplinary action by any State Board of Pharmacy or has been “debarred” or had debarment proceedings commenced against them by the FDA shall be entitled to perform Covered Services. (d) CuraScript and ESSDS represent and warrant to Jazz Pharmaceuticals that they (i) are not currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs or is proposed for exclusion under such programs, and (ii) have not been convicted of a criminal offense that falls within the ambits of 42 U.S.C. §1320a-(7)a or §1320a-7(b)(1)-(3) but have not yet been excluded, debarred, suspended, or otherwise declared ineligible to participate in the Federal health care programs or in federal procurement or nonprocurement programs. CuraScript and ESSDS agree that they will promptly notify Jazz Pharmaceuticals in writing if any of the representations and warranties made by CuraScript or ESSDS in this subsection (d) cease to be true at any time during the term of this Agreement.

Regulatory and Compliance Audits and Information Requests. (a) SDS shall provide to Orphan and/or the FDA, DEA or any other governmental body all documents and information requested by the FDA, DEA or any other governmental body in support of Orphan’s 's regulatory filings or any governmental investigations or inquires. Copies of all documents to be provided to the FDA or DEA shall be provided to Orphan in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA. SDS shall notify Orphan immediately upon receipt of notice of any inspection by the FDA or DEA directed specifically toward Product, and Orphan shall have the right to have an employee present at any such inspection, if allowed by law. In addition, SDS shall notify Orphan of any FDA or DEA correspondence or inspections that concern SDS generally and which are related to any SDS compliance issues that may adversely impact SDS’s 's ability to perform the services contemplated by this Agreement. SDS shall notify Orphan immediately of any notices, requests for information or other communications related to Product from the U.S. Department of Health and Human Services or any other government agency or any state healthcare program or other state agency and, to the extent permitted under applicable law, shall give Orphan copies of such communications. (b) SDS shall from time to time submit to audits and inspections by Orphan during normal business hours or at any other time during which the services being audited are ongoing, including but not limited to, audits of regulatory and quality assurance SOPs and of records of contacts with regulatory agencies, provided the scope of any such audit or inspection shall be limited to information and facilities pertaining to Orphan’s 's program. Orphan shall give SDS at least two (2) business days prior notice of any such inspection and at least thirty (30) days prior notice for any such audit, and Orphan shall bear the out of pocket costs of such audit or inspection.