Common use of Government Approvals and Clinical Trials Clause in Contracts

Government Approvals and Clinical Trials. 4.2.1. ASTA Medica agrees at its sole expense to (a) conduct or cause to be conducted all clinical trials and other studies of any nature of the Product(s) necessary or desirable for obtaining Government Regulatory Approvals and (b) prepare and submit all documents necessary or desirable for obtaining Government Regulatory Approvals. The Alliance Steering Committee will mutually determine the priority of each country in the Territory for development, registration and marketing of the Product(s) within a reasonable period of time following the date of this Agreement. The Alliance Steering Committee will update the priority list on a semi-annual basis. In connection therewith, ASTA Medica shall, at its own expense and in accordance with the priorities determined by the Alliance Steering Committee, apply for all health registrations and Government Regulatory Approvals required to execute and to perform this Agreement. To the extent permitted by laws in the Territory and if requested by ASTA Medica, BioNumerik agrees to assist and support the process of obtaining the Government Regulatory Approvals by providing input and assistance from Xx. Xxxxxxxxx

Government Approvals and Clinical Trials. 4.2.1. ASTA Medica agrees at its sole expense to (a) conduct or cause to be conducted all clinical trials and other studies of any nature of the Product(s) necessary or desirable for obtaining Government Regulatory Approvals and (b) prepare and submit all documents necessary or desirable for obtaining Government Regulatory Approvals. The Alliance Steering Committee will mutually determine the priority of each country in the Territory for development, registration and marketing of the Product(s) within a reasonable period of time following the date of this Agreement. The Alliance Steering Committee will update the priority list on a semi-annual basis. In connection therewith, ASTA Medica shall, at its own expense and in accordance with the priorities determined by the Alliance Steering Committee, apply for all health registrations and Government Regulatory Approvals required to execute and to perform this Agreement. To the extent permitted by laws in the Territory and if requested by ASTA Medica, BioNumerik agrees to assist and support the process of obtaining the Government Regulatory Approvals by providing input and assistance from Xx. Dr. Xxxxxxxxx