Common use of Governmental Inspections and Requests Clause in Contracts

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorised agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the 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 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 costs associated with inspections by Regulatory Authorities in connection with Product.

Appears in 1 contract

Samples: Commercial Supply Agreement (Minerva Neurosciences, Inc.)

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Governmental Inspections and Requests. Catalent shall promptly advise Client in writing if an authorised authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the ProcessingProcessing or inspecting the Facility which may affect Client Product. 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. . Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities in connection with that are specifically attributable to the Client Product.

Appears in 1 contract

Samples: Supply Agreement (Acelrx Pharmaceuticals Inc)

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorised authorized agent of any Regulatory Authority notifies Catalent that it the agent intends to or does visit the Facility for the where at least one purpose of reviewing the 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 and 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.

Appears in 1 contract

Samples: Zydis® Commercial Supply Agreement (Biohaven Pharmaceutical Holding Co Ltd.)

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Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorised authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the 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 and Catalent’s ' 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.

Appears in 1 contract

Samples: Softgel Commercial Supply Agreement (Aurinia Pharmaceuticals Inc.)

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