Transfer of Documentation. Within 5 days following written notice by the Secured Parties, the Grantor shall provide the Secured Parties with a copy of all documentation necessary for the Grantor and/or the Secured Parties to be in and remain in full compliance with the NDA, pursuant to section 314.72 of Title 21 of the Code of Federal Regulations, including, but not limited to: the NDA and any amendments and supplements thereto; all correspondence concerning the NDA between the FDA and Grantor whether written before or after the NDA was approved; all contracts with suppliers of ingredients and raw materials for the Product; all batch records regarding the Product; all validation studies; all stability reports; all standard operating procedures; all postmarket surveillance files, including adverse event reports; and postmarket studies. At that same time, Grantor shall also provide the Secured Parties with a copy of the following additional documentation:
Appears in 3 contracts
Samples: Security Agreement (Alliance Pharmaceutical Corp), Security Agreement (Photogen Technologies Inc), Security Agreement (Photogen Technologies Inc)
Transfer of Documentation. Within 5 days following written notice by the Secured Parties, the Grantor shall provide the Secured Parties with a copy of all documentation necessary for the Grantor and/or the Secured Parties to be in and remain in full compliance with the NDA, pursuant to section Section 314.72 of Title 21 of the Code of Federal Regulations, including, but not limited to: the NDA and any amendments and supplements thereto; all correspondence concerning the NDA between the FDA and Grantor whether written before or after the NDA was approved; all contracts with suppliers of ingredients and raw materials for the Product; all batch records regarding the Product; all validation studies; all stability reports; all standard operating procedures; all postmarket surveillance files, including adverse event reports; and postmarket studies. At that same time, Grantor shall also provide the Secured Parties with a copy of the following additional documentation:
Appears in 1 contract
Samples: Debenture Imagent Security Agreement (Alliance Pharmaceutical Corp)
Transfer of Documentation. Within 5 days following written notice by the Secured PartiesCollateral Agent, the Grantor shall provide the Secured Parties Collateral Agent with a copy of all documentation necessary for the Grantor and/or the Secured Parties Collateral Agent to be in and remain in full compliance with the NDA, pursuant to section Section 314.72 of Title 21 of the Code of Federal Regulations, including, but not limited to: the NDA and any amendments and supplements thereto; all correspondence concerning the NDA between the FDA and Grantor whether written before or after the NDA was approved; all contracts with suppliers of ingredients and raw materials for the Product; all batch records regarding the Product; all validation studies; all stability reports; all standard operating procedures; all postmarket surveillance files, including adverse event reports; and postmarket studies. At that same time, Grantor shall also provide the Secured Parties Collateral Agent with a copy of the following additional documentation:
Appears in 1 contract
Samples: Imagent Security Agreement (Alliance Pharmaceutical Corp)