Common use of Transfer of Documentation Clause in Contracts

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: (i) a list of the names, addresses, and job descriptions of all employees involved in the manufacturing, sale and distribution of the Product; (ii) a list of the names, addresses and job descriptions of all employees involved in purchasing ingredients or raw materials for the Product; (iii) a list of the names, addresses and job descriptions of all employees involved in quality control and quality assurance for the Product; (iv) all employment and consulting agreements for any person or entity involved in the manufacturing, sale and/or distribution of the Product; (v) all audit and consulting reports done by any person or entity concerning Grantor’s compliance with, or potential failure to comply with, obligations relating to the Federal Food, Drug, and Cosmetic Act and/or all other applicable federal and state regulatory requirements; and (vi) a list of the names and addresses of all customers for, and suppliers of, the Product or any of its ingredients.

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: (i) a list of the names, addresses, and job descriptions of all employees involved in the manufacturing, sale and distribution of the Product; (ii) a list of the names, addresses and job descriptions of all employees involved in purchasing ingredients or raw materials for the Product; (iii) a list of the names, addresses and job descriptions of all employees involved in quality control and quality assurance for the Product; (iv) all employment and consulting agreements for any person or entity involved in the manufacturing, sale and/or distribution of the Product; (v) all audit and consulting reports done by any person or entity concerning Grantor’s 's compliance with, or potential failure to comply with, obligations relating to the Federal Food, Drug, and Cosmetic Act and/or all other applicable federal and state regulatory requirements; and (vi) a list of the names and addresses of all customers forfor (the "Customers"), and suppliers of, the Product or any of its ingredients.

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: (i) a list of the names, addresses, and job descriptions of all employees involved in the manufacturing, sale and distribution of the Product; (ii) a list of the names, addresses and job descriptions of all employees involved in purchasing ingredients or raw materials for the Product; (iii) a list of the names, addresses and job descriptions of all employees involved in quality control and quality assurance for the Product; (iv) all employment and consulting agreements for any person or entity involved in the manufacturing, sale and/or distribution of the Product; (v) all audit and consulting reports done by any person or entity concerning Grantor’s 's compliance with, or potential failure to comply with, obligations relating to the Federal Food, Drug, and Cosmetic Act and/or all other applicable federal and state regulatory requirements; and (vi) a list of the names and addresses of all customers forfor (the "Customers"), and suppliers of, the Product or any of its ingredients.

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: (i) a list of the names, addresses, and job descriptions of all employees involved in the manufacturing, sale and distribution of the Product; (ii) a list of the names, addresses and job descriptions of all employees involved in purchasing ingredients or raw materials for the Product; (iii) a list of the names, addresses and job descriptions of all employees involved in quality control and quality assurance for the Product; (iv) all employment and consulting agreements for any person or entity involved in the manufacturing, sale and/or distribution of the Product; (v) all audit and consulting reports done by any person or entity concerning Grantor’s 's compliance with, or potential failure to comply with, obligations relating to the Federal Food, Drug, and Cosmetic Act and/or all other applicable federal and state regulatory requirements; and (vi) a list of the names and addresses of all customers for, and suppliers of, the Product or any of its ingredients.