Governmental Inspections and Requests. Catalent shall promptly advise Palatin if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action with respect to the Product or the Processing. Catalent shall promptly provide to Palatin a report of the result of any such inspection by any Regulatory Authority to the extent directly related to the Processing of the Product and furnish to Palatin a copy of all written information provided by such Regulatory Authority to the extent specifically and directly related to the Processing of the Product, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action taken.
Governmental Inspections and Requests. Cardinal Health shall immediately advise Reliant if an authorized agent of any Regulatory Authority visits the Facility concerning the Manufacturing or Packaging of the Product. Cardinal Health shall furnish to Reliant a copy of the report by such Regulatory Authority, if any, within ten (10) days of Cardinal Health’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or audit Cardinal Health’s books and records with respect to Manufacturing or Packaging under this Agreement, Cardinal Health shall immediately notify Reliant, and shall provide Reliant with a copy of any written document received from such Regulatory Authority. Cardinal Health shall permit Reliant to have a representative present for any such Product-specific Facility inspection unless such presence would be unreasonable under the circumstances. To the extent specifically related to the Manufacturing or Packaging hereunder, Cardinal Health shall provide Reliant with a copy of any proposed written response prior to submission and a reasonable opportunity for Reliant to review and approve, provided such approval is not unreasonably withheld, conditioned or delayed.
Governmental Inspections and Requests. Catalent will promptly advise Client if it is aware that any Regulatory Authority intends to inspect Catalent’s Facility with respect to the Processing of the Product. Client will have the right to have its representatives present at the Facility (but not as part of the inspection unless specifically requested to answer questions) for such inspection relating to the Product. Catalent will also promptly provide a report of the result of any such inspection to Client and will promptly notify Client of any notice of any deficiencies regarding the Processing of the Product by any Regulatory Authority, including, in each case, a copy of redacted copies of any inspection reports regarding the Processing of the Product (excluding any third party confidential information or Catalent Confidential Information) issued as a result of such inspections and any follow-up written communications between Catalent and the relevant Regulatory Authority or other governmental agency regarding the Processing of the Product. Catalent will use commercially reasonable efforts to correct all deficiencies identified in such written communications in a timely manner and advise Client periodically of progress being made, as well as when all deficiencies are corrected.
Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing. In the event that any such review is directed primarily at Catalent’s Processing of Products then upon Client’s reasonable prior written notice to Catalent and during regular business hours, Client’s Representative(s) may be on site in a room specifically allocated to such Representative(s) and Catalent shall confer and consult with such Representatives with respect to any material matters that arise during such review directly related to Client’s Product; provided that Client’s Representative shall not be given access to the agents of the Regulatory Authority without Catalent’s consent; and provided further that such Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers within [**] business days of Catalent’s receipt of such report. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities in connection with Product, and pay the fees specified in Attachment D, to the extent applicable.
Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that the agent intends to or does visit the Facility where at least one purpose relates to Processing. Upon request, Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent or Catalent’s other customers. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities in connection with Product, and pay the fees specified in Attachment D, to the extent applicable.
Governmental Inspections and Requests. Catalent shall immediately advise Client if an authorized agent of any Regulatory Authority visits any of the Facilities concerning or affecting the Processing or Packaging of the Product. Catalent shall furnish to Client a copy of the report by such Regulatory Authority, if any, within […***…] days of Catalent’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or audit Catalent’s books and records with respect to Processing or Packaging under this Agreement, Catalent shall immediately notify Client, and shall provide Client with a copy of any written document received from such Regulatory Authority.
Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit a Facility or any other site for the purpose of reviewing the Processing or testing. Upon request, Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities, but such acknowledgement shall not be construed to vitiate Catalent’s obligations to Client pursuant to this Agreement. Client shall reimburse Catalent for all reasonable and documented costs, at a rate of [***] per hour, associated with inspections by Regulatory Authorities specifically concerning the Product, such as the pre-approval inspection. Client will not be required to pay costs to mitigate any deficiencies cited in a Form 483 or Catalent’s Facility deficiencies. Such documentation will include a description of the activities and time expended for such inspections.
Governmental Inspections and Requests. Catalent shall promptly advise Client of any communications from any Regulatory Authority that impacts or changes or may reasonably and negatively impact the Processing of Product under this Agreement, or if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing, Catalent shall promptly notify Client of such requests. Catalent shall within 15 business days after its receipt of any report issued by such Regulatory Authority to Catalent following such visit, provide to Client a copy of such report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Client shall reimburse Catalent for all reasonable and documented direct costs associated with inspections by Regulatory Authorities solely and directly related to the Product, such as Pre-Approval inspections. Catalent shall permit Client to review unredacted observations specific to the Product at the Facility. Client retains the right to be on the Catalent premises during Regulatory Inspections with respect to the Product.
Governmental Inspections and Requests. PROVIDER shall immediately advise CUSTOMER if an authorized agent of any Regulatory Authority requests to visit the Facility concerning the Product. PROVIDER shall permit CUSTOMER to have a representative present for any such Product-specific Facility inspection. PROVIDER shall also advise the CUSTOMER of any audits by Regulatory Authorities that may have an impact on the Product and provide audit results upon request.
Governmental Inspections and Requests. CPL and OptiNose shall as soon as reasonably practicable (on the same day as receipt of notice of same, where feasible, but in no event more than within [***] of receipt of notice) inform each other in writing of any inspection, application for inspection, and other regulatory action, by any regulatory agency substantially relating to the Product or the manufacture of Product and/or, in the case of the Facility, substantially related to CPL’s manufacturing, packaging, testing and storage of the Product, so that the other party has as much advance notice as reasonably possible to enable it to, as applicable and relevant, participate in preparation and/or strategy regarding and/or attend the inspection. Each Party will permit the other’s representatives to be present during any such inspection related directly to the Product, and in the case of OptiNose, CPL will also permit it to be present at any inspection of the Facility to the extent such inspection is directly related to CPL’s manufacturing, packaging, testing or storage of the Product, provided that in such case, it is understood and agreed by OptiNose that all communication with the Regulatory Authority shall be directly between CPL and the Regulatory Authority unless the FDA requests to communicate with OptiNose. Each Party will provide the other with the results of all regulatory inspection or audits directly related to the Product within [***] ([***]) business days after such Party’s receipt of such results.
