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B) For a product to be considered a Product, the results of the product research and development efforts as contemplated herein must provide: 1) Ixora with documentation of the NDA approval from the FDA and an estimation of its capablity of being rendered Commercially Viable, or 2) for a product not requiring FDA approval, IXORA with an independent legal opinion from an arm's length third party satisfactory to IXORA and with statistically significant clinical evidence from an arm's length third party satisfactory to IXORA, acting reasonably, that such substance demonstrates clinically an efficacious (effective in treating the target condition in a timely manner) and efficient. (without side effects or if any exists such being safe to the user) (collectively the) quot;Performance Profilequot; (herein referred to Beneficial Therapeutic Effect) to treat the Target Application and an estimation of its capablity of being rendered Commercially Viable. c) Commercially Viable refers to a Product comparing favorably to other therapeutically effective alternatives if available for the Target Application including, without limitation, a consideration of the potential cost to manufacture such product to enable Ixora to establish a minimum price to achieve profitability and the therapeutic effects of such product when compared to actual or known foreseeable competitive alternatives.]