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

Regulatory and Compliance Audits and Information Requests. (a) CuraScript shall provide to Jazz Pharmaceuticals and/or the FDA, DEA, or any other governmental body all reasonable documents and information reasonably necessary and requested by the FDA, DEA, or any other governmental body in support of Jazz Pharmaceuticals’ regulatory filings or any governmental investigations or inquiries. Copies of all documents to be provided to the FDA or DEA shall be provided to Jazz Pharmaceuticals in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA, unless prohibited by law. CuraScript shall notify Jazz Pharmaceuticals immediately upon receipt of notice of any inspection, notice or request by the FDA or DEA directed specifically toward Product or Facility, and Jazz Pharmaceuticals shall have the right to have an employee present at any such inspection, subject to legal confidentiality constraints imposed upon ESSDS. (b) 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 Jazz Pharmaceuticals during normal business hours, including, but not limited to, audits of regulatory and quality assurance, 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 Jazz Pharmaceuticals and subject to the restrictions contained in Section 5.1. Jazz Pharmaceuticals shall give CuraScript or ESSDS, as applicable, at least three (3) business days’ prior notice of any such inspection and at least thirty (30) days’ prior notice for any such audit, and 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) CuraScript shall provide to Jazz Pharmaceuticals and/or the FDA, DEA, or any other governmental body all reasonable documents and information reasonably necessary and requested by the FDA, DEA, or any other governmental body in support of Jazz Pharmaceuticals’ regulatory filings or any governmental investigations or inquiries. Copies of all documents to be provided to the FDA or DEA shall be provided to Jazz Pharmaceuticals in advance, if practicable, or otherwise within two (2) business days of delivery to the FDA or DEA, unless prohibited by law. CuraScript shall notify Jazz Pharmaceuticals immediately upon receipt of notice of any inspection, notice or request by the FDA or DEA directed specifically toward Product or Facilitythe Central Pharmacy, and Jazz Pharmaceuticals shall have the right to have an employee present at any such inspection, subject to legal confidentiality constraints imposed upon ESSDS. (b) 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 FacilityCentral Pharmacy, by Jazz Pharmaceuticals during normal business hours, including, but not limited to, audits of regulatory and quality assurance, 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 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 Jazz Pharmaceuticals and subject to the restrictions contained in Section 5.1. Jazz Pharmaceuticals shall give CuraScript or ESSDS, as applicable, at least three (3) business days’ prior notice of the date of any such inspection and at least thirty (30) days’ prior notice for of the initial date of any such audit, and Jazz Pharmaceuticals shall bear the out of pocket costs of such audit or inspection. Jazz Pharmaceuticals will provide an 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 nonprocurement 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 nonprocurement 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) cease ceases to be true at any time during the term of this 2011 Master Services Agreement.