Common use of Clinical Development Product Approval and Launch Clause in Contracts

Clinical Development Product Approval and Launch. 3.1 CLINICAL DEVELOPMENT (a) SuperGen shall exercise its reasonable efforts to pursue, and shall bear the full cost and expense of, the Clinical Development of the Product to support Regulatory Approval for the treatment of pancreatic cancer for the U.S. Territory, Canada, and those countries in the International Territory which are, as of the Effective Date, member states of the European Union ("EU"). For purposes of this Agreement, "Clinical Development" includes but is not limited to all clinical studies and trials, and all safety, toxicology, efficacy, and other data required to pursue, obtain and maintain Regulatory Approval in the U.S. Territory, in Canada, and in the EU, as well as the clinical studies set forth in Exhibit 3.1 attached to this Agreement. In performing its obligations under this Article 3.1(a), SuperGen shall act in accordance with Article 4.4 below, and in so doing SuperGen shall keep Xxxxxx fully apprised with respect to its clinical development activities and shall provide Xxxxxx with reasonable advance opportunity for input regarding these activities, including the right to review and approve the protocols and SuperGen's audit reports relating to all clinical studies. (b) Xxxxxx shall exercise its reasonable efforts to pursue, and shall bear the full cost and expense of the clinical development of the Product for the countries of the International Territory other than Canada and the EU. Xxxxxx shall keep SuperGen fully apprised with respect to its clinical development activities and shall provide SuperGen with reasonable advance opportunity for input regarding these activities, including the right to review the protocols and Xxxxxx audit reports relating to all clinical studies.

Clinical Development Product Approval and Launch. 3.1 CLINICAL DEVELOPMENT (a) SuperGen shall exercise its reasonable efforts to pursue, and shall bear the full cost and expense of, the Clinical Development of the Product to support Regulatory Approval for the treatment of pancreatic cancer for the U.S. Territory, Canada, and those countries in the International Territory which are, as of the Effective Date, member states of the European Union ("EU"). For purposes of this Agreement, "Clinical Development" includes but is not limited to all clinical studies and trials, and all safety, toxicology, efficacy, and other data required to pursue, obtain and maintain Regulatory Approval in the U.S. Territory, in Canada, and in the EU, as well as the clinical studies set forth in Exhibit 3.1 attached to this Agreement. In performing its obligations under this Article 3.1(a), SuperGen shall act in accordance with Article 4.4 below, and in so doing SuperGen shall keep Xxxxxx Abbott fully apprised with respect to its clinical development activities and shall provide Xxxxxx Abbott with reasonable advance opportunity for input regarding these activities, including the right to review and approve the protocols and SuperGen's audit reports relating to all clinical studies. (b) Xxxxxx Abbott shall exercise its reasonable efforts to pursue, and shall bear the full cost and expense of the clinical development of the Product for the countries of the International Territory other than Canada and the EU. Xxxxxx Abbott shall keep SuperGen fully apprised with respect to its clinical development activities and shall provide SuperGen with reasonable advance opportunity for input regarding these activities, including the right to review the protocols and Xxxxxx Abbott audit reports relating to all clinical studies.