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 X. Hausheer regarding the design and conduct of non-clinical studies, clinical trials, preparation of regulatory submissions and review, analysis and presentation of laboratory data. During the term of this Agreement, ASTA Medica shall be the marketing, development and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. distribution authorization holder of the Product(s) in the Territory unless otherwise agreed to by the Alliance Steering Committee. ASTA Medica shall keep BioNumerik regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BioNumerik upon BioNumerik's reasonable request with copies of all of the documents, data and other information supplied to or received from applicable government authorities in connection with the applications for the Government Regulatory Approvals. Upon receipt of the Government Regulatory Approvals, ASTA Medica shall promptly furnish BioNumerik copies or other satisfactory evidence thereof. In addition, ASTA Medica may conduct research and development (including studies and clinical trials) of the Product(s) outside the Territory for the purpose of supporting the development and commercialization of the Product(s) in the Territory. BioNumerik will have the right to review and consent to any such studies and clinical trials outside the Territory in advance of their commencement, which consent will not be unreasonably withheld.

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 X. Hausheer Xxxxxxxx regarding the design and conduct of non-clinical studies, clinical trials, preparation of regulatory submissions and review, analysis and presentation of laboratory data. During the term of this Agreement, ASTA Medica shall be the marketing, development and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONCOMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. distribution authorization holder of the Product(s) in the Territory unless otherwise agreed to by the Alliance Steering Committee. ASTA Medica shall keep BioNumerik regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BioNumerik upon BioNumerik's reasonable request with copies of all of the documents, data and other information supplied to or received from applicable government authorities in connection with the applications for the Government Regulatory Approvals. Upon receipt of the Government Regulatory Approvals, ASTA Medica shall promptly furnish BioNumerik copies or other satisfactory evidence thereof. In addition, ASTA Medica may conduct research and development (including studies and clinical trials) of the Product(s) outside the Territory for the purpose of supporting the development and commercialization of the Product(s) in the Territory. BioNumerik will have the right to review and consent to any such studies and clinical trials outside the Territory in advance of their commencement, which consent will not be unreasonably withheld.