Verification of Data. At least 21 days 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.
Appears in 4 contracts
Sources: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Orexigen Therapeutics, Inc.), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Verification of Data. At least 21 days prior 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
Sources: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Manufacturing Services Agreement (Nabriva Therapeutics PLC), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Verification of Data. At least 21 days prior 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
Sources: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Verification of Data. At least 21 7 days prior to filing any documents with any Regulatory Authority the FDA that incorporate data generated by Patheon, the Client will give shall provide Patheon with a copy of the documents incorporating this such data so as to give Patheon the opportunity to verify the accuracy and regulatory validity of those such documents as they relate to the Patheon generated data.
Appears in 3 contracts
Sources: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Verification of Data. At least 21 days prior 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 generally requires 21 days to perform this review but the parties may agree to a shorter time for the review as needed.
Appears in 3 contracts
Sources: Master Manufacturing Services Agreement (Baudax Bio, Inc.), Master Manufacturing Services Agreement (Recro Pharma, Inc.), Master Manufacturing Services Agreement (TESARO, Inc.)
Verification of Data. At least 21 [***] days 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. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Sources: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)
Verification of Data. At least 21 *** days 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.
Appears in 1 contract