Inspection and Auditing Rights. Paratek and its representatives shall have the right, at Paratek’s expense, to audit, inspect and observe the Facility, the performance by CIPAN of its obligations under this Agreement and the Quality Agreement, CIPAN’s compliance with applicable laws and regulations in the performance of its obligations under this Agreement and the Quality Agreement, and the handling, Manufacture, testing, inspection, storage, disposal and transportation of the Product by CIPAN and its permitted subcontractors, during normal business hours and upon at least [* * *] prior notice, provided that, [* * *] CIPAN shall make available to Paratek all relevant records and reports and Paratek shall have the right to copy all such records and reports. CIPAN agrees to respond to Paratek’s audit findings within [* * *] of receipt of Paratek’s audit report, to take prompt corrective action to remedy any observed violations of the terms of this Agreement, the Quality Agreement or of applicable law or regulations and to be responsive to the recommendations contained therein. Such audits may be conducted no more than [* * *] at [* * *] expense, provided that Paratek may also conduct follow-up audits or inspections at [* * *] expense at any time or times during a Calendar Year that are directed at [* * *].
Appears in 1 contract
Samples: Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)
Inspection and Auditing Rights. Paratek and its representatives shall have the right, at Paratek’s expense, to audit, inspect and observe the Facility, the performance by CIPAN Almac of its obligations under this Agreement and the Quality Agreement, CIPANAlmac’s compliance with applicable laws and regulations Applicable Laws in the performance of its obligations under this Agreement and the Quality Agreement, and the handling, Manufacture, testing, inspection, storage, disposal and transportation of the Product by CIPAN Almac THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. and its permitted subcontractors, during normal business hours and upon at least [* * *] prior notice, provided that, [* * *] CIPAN notice unless otherwise set forth in the Quality Agreement. Almac shall make available to Paratek all relevant records and reports and Paratek shall have the right to copy all during such records and reportsaudit or inspection. CIPAN Almac agrees to respond to Paratek’s audit findings within [* * *] of receipt of Paratek’s audit reportreport (such response may not be final but shall be responsive to the findings), to take prompt corrective action to remedy any observed violations of the terms of this Agreement, the Quality Agreement or of applicable law or regulations Applicable Laws and to be responsive to the recommendations contained therein. Such audits may be conducted no more than [* * *] at [* * *] Paratek’s expense, provided that Paratek may also conduct follow-up audits or inspections at [* * *] expense at any time or times during a Calendar Year that are directed at [* * *]. The costs associated with any follow-up audit by Paratek shall be discussed in good faith and agreed between the Parties in advance.
Appears in 1 contract
Samples: Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)
Inspection and Auditing Rights. Paratek and its representatives shall have the right, at Paratek’s expense, to audit, inspect and observe the Facility, the performance by CIPAN of its obligations under this Agreement and the Quality Agreement, CIPAN’s compliance with applicable laws and regulations in the performance of its obligations under this Agreement and the Quality Agreement, and the handling, Manufacture, testing, inspection, storage, disposal and transportation of the Product by CIPAN and its permitted subcontractors, during normal business hours and upon at least [* * *] prior notice, provided that, [* * *] CIPAN shall make available to Paratek all relevant records and reports and Paratek shall have the right to copy all such records and reports. CIPAN agrees to respond to Paratek’s audit findings within [* * *] of receipt of Paratek’s audit report, to take prompt corrective action to remedy any observed violations of the terms of this Agreement, the Quality Agreement or of applicable law or regulations and to be responsive to the recommendations contained therein. Such audits may be conducted no more than [* * *] at [* * *] expense, provided that Paratek may also conduct follow-up audits or inspections at [* * *] expense at any time or times during a Calendar Year that are directed at [* * *]. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Appears in 1 contract
Samples: Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)
Inspection and Auditing Rights. Paratek and its representatives shall have the right, at Paratek’s expense, to audit, inspect and observe the Facility, the performance by CIPAN Almac of its obligations under this Agreement and the Quality Agreement, CIPANAlmac’s compliance with applicable laws and regulations Applicable Laws in the performance of its obligations under this Agreement and the Quality Agreement, and the handling, Manufacture, testing, inspection, storage, disposal and transportation of the Product by CIPAN Almac and its permitted subcontractors, during normal business hours and upon at least [* * *] prior notice, provided that, [* * *] CIPAN notice unless otherwise set forth in the Quality Agreement. Almac shall make available to Paratek all relevant records and reports and Paratek shall have the right to copy all during such records and reportsaudit or inspection. CIPAN Almac agrees to respond to Paratek’s audit findings within [* * *] of receipt of Paratek’s audit reportreport (such response may not be final but shall be responsive to the findings), to take prompt corrective action to remedy any observed violations of the terms of this Agreement, the Quality Agreement or of applicable law or regulations Applicable Laws and to be responsive to the recommendations contained therein. Such audits may be conducted no more than [* * *] at [* * *] Paratek’s expense, provided that Paratek may also conduct follow-up audits or inspections at [* * *] expense at any time or times during a Calendar Year that are directed at [* * *]. The costs associated with any follow-up audit by Paratek shall be discussed in good faith and agreed between the Parties in advance.
Appears in 1 contract
Samples: Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)