ANDA. ▇▇▇▇▇▇ shall be the sponsor and owner of the ANDA for the Product Elite will provide copies of all correspondence with the FDA and required supporting filing (i.e. copies of annual reports etc.) to ▇▇▇▇▇▇ within ten (10) days of filing such documents with the FDA. ▇▇▇▇▇▇, Elite and Tishtec shall be responsible for prosecuting and filing the ANDA. ▇▇▇▇▇▇ shall be responsible for maintaining the ANDA after approval of the ANDA.
Appears in 2 contracts
Sources: Product Development, Manufacturing, and Distribution Agreement (Elite Pharmaceuticals Inc /De/), Product Development, Manufacturing, and Distribution Agreement (Elite Pharmaceuticals Inc /De/)
ANDA. ▇▇▇▇▇▇ [ * ] shall be the sponsor and owner of the ANDA for the Product Elite will provide copies of all correspondence with the FDA and required supporting filing (i.e. copies of annual reports etc.) to ▇▇▇▇▇▇ [ * ] within ten (10) days of filing such documents with the FDA. ▇▇▇▇▇▇[ * ], Elite and Tishtec [ * ] shall be responsible for prosecuting and filing the ANDA. ▇▇▇▇▇▇ [ * ] shall be responsible for maintaining the ANDA after approval of the ANDA.
Appears in 1 contract
Sources: Product Development, Manufacturing, and Distribution Agreement (Elite Pharmaceuticals Inc /De/)