Common use of Carrier Characterization Clause in Contracts

Carrier Characterization. As part of the Programme, and in the event of a decision by Novartis in its sole discretion not to proceed with the Development of the Lead Carrier or Back-up Carrier, Novartis shall be responsible for characterizing in its sole discretion each replacement Programme Carrier at such time as it requests including conducting polymorph identification, salt form selection and synthesis. Novartis shall be solely responsible for selecting which Programme Carrier (whether the Lead Carrier or Back-up Carrier or a replacement Programme Carrier as selected by Novartis in its sole discretion as per section 4.1a) is to be Developed for commercial use in Products after the performance by Novartis of proof of concept clinical trials in humans (the “Commercial Carrier”). Novartis shall promptly notify Emisphere of its selection of the Commercial Carrier. Novartis shall be solely responsible for the profiling of impurities and the separation, identification and characterization of impurities present in the Commercial Carrier, including stress impurity profiling of the Commercial Carrier in combination with the Compound (the “Impurity Profiling”).