Technical Failure

Technical Failure. Means the inability to achieve a pharmacokinetic profile for Product (assessing Cmax (maximum concentration) and AUC (area under the curve) criteria within 80-125% of mean data) consistent with that of BiDil administered three times daily (at 6 hour intervals).

Technical Failure. Shall mean the failure of the Research Program despite the exercise of CRE to meet the respective Milestones as determined by the PAG because of: (a) material technology or product development challenges, regulatory hindrances or partnership or supplier delays that are unlikely to be resolved in a reasonable timeframe; (b) material unforeseen intellectual property issues that will adversely affect SAVARA's ability to commercialize a Product. If the PAG determines that CRE, including reasonable... expenditures, are likely to resolve any of the foregoing issues and SAVARA does not undertake such CRE, then such failure shall not constitute a Technical Failure; if the PAG determines that CRE, including reasonable expenditures, are unlikely to resolve any of the foregoing issues, then such failure shall constitute a Technical Failure. If the PAG fails to agree on whether a Technical Failure has occurred, the PAG shall attempt to resolve such deadlock expeditiously for a period of thirty (30) days by engaging in good faith discussions. If such deadlock is not resolved after such thirty (30) day period, then, such deadlock shall be resolved in accordance with the dispute resolution process set forth in subparagraph 11(b) above. View More