Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [**] days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Manufacturing Services Agreement (Nabriva Therapeutics PLC), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Verification of Data. Prior At least [***] prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [**] days to perform this review but ; provided, however, that the parties may agree to a shorter time for the review as needed.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires […***…] days to perform this review but the parties Parties may agree to a shorter time for the review as needed, including as mandated by a Regulatory Authority. These documents will be Confidential Information of Client.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [**] 21 days to perform this review but the parties may agree to a shorter time for the review as needed. In any event. Patheon’s review of this data will not prohibit Client from filing the documents with a Regulatory Authority.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires […***…] days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Verification of Data. Prior At least […***…] prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [**] days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Horizon Pharma PLC)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. The Parties agree that Patheon requires shall have [* * **] days ]. Any review by Patheon under this Section 7.8(b) shall be at no cost to perform this review but the parties may agree to a shorter time for the review as neededClient.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.), Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [***] days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Verification of Data. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires [**] days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)