Regulatory Approvals and Applications. Par shall author and assemble all aspects of the Product ANDA(s). IntelGenx shall fully support Par's efforts to assemble the Product ANDA(s) by providing such assistance as Par requests, including providing any necessary documents to Par in common technical document (CTD) format, as recognized by the FDA.
Appears in 2 contracts
Samples: Development Services and Commercialization Agreement (IntelGenx Technologies Corp.), Development Services and Commercialization Agreement (IntelGenx Technologies Corp.)
Regulatory Approvals and Applications. Par shall author and assemble all aspects of the Product ANDA(s)ANDA. IntelGenx shall fully support Par's ’s efforts to assemble the Product ANDA(s) ANDA by providing such assistance as Par requests, including providing any necessary documents to Par in common technical document (CTD) format, as recognized by the FDA.
Appears in 2 contracts
Samples: Development Services and Commercialization Agreement (IntelGenx Technologies Corp.), Development Services and Commercialization Agreement (IntelGenx Technologies Corp.)