Common use of Evaluation of LTI Clause in Contracts

Evaluation of LTI. During the ******* period immediately after the License Effective Date (the “Evaluation Period”) the Parties shall meet to discuss whether or not ViroPharma should be permitted to proceed with the development and commercialization of the Compound and Products in the Territory for the prevention or treatment of certain life-threatening disease or conditions caused by picornaviruses, which may include, without limitation, the ViroPharma Compassionate Use Indications (the “Life Threatening Indications” or “LTI”). Such discussions shall include, without limitation, consulting with the FDA and/or other regulatory authorities in the Territory to assess the risk that such development and/or commercialization activities would be relevant to and/or could raise issues with respect to, or otherwise adversely affect, the Compound and/or Products being developed and commercialized by Schering in the Field under the License Agreement. On or before the expiration of the Evaluation Period, Schering shall determine, based upon the discussions and risk assessment conducted by the Parties, whether or not the continued development and subsequent commercialization of the Compound and/or Products for LTI presents an unacceptable risk to the development and/or commercialization of the Compound and/or Products in the Field. Schering shall notify ViroPharma in writing of such determination on or before the expiration of the Evaluation Period.

Evaluation of LTI. During the [******* ] period immediately after the License Effective Date (the “Evaluation Period”) the Parties shall meet to discuss whether or not ViroPharma should be permitted to proceed with the development and commercialization of the Compound and Products in the Territory for the prevention or treatment of certain life-threatening disease or conditions caused by picornaviruses, which may include, without limitation, the ViroPharma Compassionate Use Indications (the “Life Threatening Indications” or “LTI”). Such discussions shall may include, without limitation, consulting with the FDA and/or other regulatory authorities in the Territory to assess the risk that such development and/or commercialization activities would be relevant to and/or could raise issues with respect to, or otherwise adversely affect, the Compound and/or Products being developed and commercialized by Schering in the Field under the License this Agreement. On or before the expiration of the Evaluation Period, Schering shall determine, based upon the discussions and risk assessment conducted by the Parties, whether or not the continued development and subsequent commercialization of the Compound and/or Products for LTI presents an unacceptable risk to the development and/or commercialization of the Compound and/or Products in the Field. Schering shall notify ViroPharma in writing of such determination on or before the expiration of the Evaluation Period.