Novel Drug Product Formulations Sample Clauses

Novel Drug Product Formulations. The Parties acknowledge that SPA may from time to time elect to register Unoprotone for additional indications in the SPA Territory that may require development of a novel formulation as a new form of Drug Product form pursuant to pre-clinical testing, novel CMC manufacturing and formulation process development, new product specifications, IND enabled clinical testing and NDA approval and labeling. In the course of the selection, research and development of new Drug Product formulations, the parties will collaborate on the development of costs, processes, specifications and facilities that will optimize the safety, efficacy, cost and utility of any anticipated novel formulation. The parties shall also agree upon a process and cost improvements to that process consistent with compliance obligations with Applicable Laws that enable the most inexpensive, flexible, simplest, shortest and most reliable production process practicable. In the course of such efforts, the Parties shall reasonably agree upon the cost estimates for the production of such novel Drug Product dosage forms. Such novel Drug Product formulation shall become a new supply obligation between the Parties with such costs, timing and compliance obligations as will fairly compensate both of the Parties for their respective rights, contributions and efforts and optimize the launch and promotion of the novel Drug Product.