Common use of Government Approvals and Clinical Trials Clause in Contracts

Government Approvals and Clinical Trials. 6.2.1. GRELAN agrees to (a) conduct or cause to be conducted all clinical trials and other studies of any nature of the Venture Products necessary or desirable for efficiently obtaining Government Regulatory Approvals in the Territory and (b) prepare and submit all documents necessary or desirable for obtaining Government Regulatory Approvals in the Territory. GRELAN shall be solely responsible for paying the costs of such clinical development and regulatory approvals described in the previous sentence and GRELAN shall reimburse KI PHARMA for all costs of any such clinical development and regulatory approvals paid by KI PHARMA. If permitted by laws in the Territory, the Government Regulatory Approvals for Venture Products shall be obtained in the name of KI PHARMA, and GRELAN shall provide such additional assistance as may be necessary to assure that such Approvals are obtained in the name of KI PHARMA. Such assistance shall include, without limitation, acting as an agent of KI PHARMA where necessary to facilitate the regulatory process. If the Government Regulatory Approvals are not permitted to be obtained by KI PHARMA in the name of KI PHARMA, then, with the consent of GRELAN and BIONUMERIK (which consent will not be unreasonably withheld) such approvals will be obtained in the name of GRELAN. To the extent permitted by laws in the Territory,