Development of Licensed Product. As between the Parties, Durect shall be solely responsible, at its own cost, expense and discretion, for designing, creating and finalizing a commercially reasonable plan for the development of Licensed Product sufficient to obtain Regulatory Approval of such product within the Territory, and then implementing and carrying out all activities contemplated under such development plan such as all research, development, scientific, medical, regulatory and other activities including, but limited to the design, production and/or implementation of all clinical studies, non-clinical studies, manufacturing process development, scale-up and validation, CMC activities, ICH registration batches, pre-approval inspection preparation, pharmaceutical development including quality control and stability, manufacturing, qualification and regulatory tasks. Notwithstanding the foregoing, Durect shall EpiCept License (final) use Commercially Reasonable Efforts to develop and commercialize Licensed Product throughout the Territory.
Appears in 1 contract
Sources: License Agreement (Epicept Corp)
Development of Licensed Product. As between the Parties, Durect shall be solely responsible, at its own cost, expense and discretion, for designing, creating and finalizing a commercially reasonable plan for the development of Licensed Product sufficient to obtain Regulatory Approval of such product within the Territory, and then implementing and carrying out all activities contemplated under such development plan such as all research, development, scientific, medical, regulatory and other activities including, but limited to the design, production and/or implementation of all clinical studies, non-clinical studies, manufacturing process development, scale-up and validation, CMC activities, ICH registration batches, pre-approval inspection preparation, pharmaceutical development including quality control and stability, manufacturing, qualification and regulatory tasks. Notwithstanding the foregoing, Durect shall EpiCept License (final) use Commercially Reasonable Efforts to develop and commercialize Licensed Product throughout the Territory.
Appears in 1 contract
Sources: License Agreement (Durect Corp)