Common use of FDA Clearance Clause in Contracts

FDA Clearance. 4.1 BioStar shall use commercially reasonable efforts to obtain FDA Clearance of a Diagnostic. BioStar must prepare an application for FDA Clearance of a Diagnostic in accordance with the Development Work Plan and shall provide Biota with a draft application and all relevant materials for submission as part of the application to the FDA in relation to the Diagnostic as soon as possible. BioStar must obtain Biota's prior written consent before lodging any original application for FDA Clearance such consent not to be unreasonably withheld. 4.2 Biota undertakes to review promptly any application for FDA Clearance submitted to it by BioStar, whether provided in whole or in part. In the event Biota fails to respond to BioStar within 30 days' after receiving any such materials Biota shall be deemed to have approved those materials. 4.3 Following submission of an application for FDA Clearance of the Diagnostic, BioStar must make all reasonable efforts to discuss the provision of any additional information to the FDA and must promptly make available to Biota copies and details of all information used or provided to FDA for the purposes of obtaining FDA Clearance of the Diagnostic, including records of conversations with the FDA and correspondence from or other information provided by or to the FDA, and must keep Biota fully informed of progress of the application for FDA Clearance of the Diagnostic. BioStar must use all reasonable efforts to maintain the confidentiality of any information containing or relating to Foreground IP or Biota IP and must request confidential treatment of the same by the FDA. 4.4 Biota agrees to pay BioStar the sum of [ * ] within 30 days after the grant of FDA Clearance of the Diagnostic. 4.5 BioStar shall provide Biota with such assistance (including executing documentation and assignments) as may be reasonably required by Biota to obtain regulatory approval to the use of the Diagnostic in the diagnosis of influenza in countries other than the US. 4.6 If FDA Clearance of a Diagnostic is obtained, BioStar shall immediately notify Biota and provide Biota with copies of the FDA Clearance of the relevant Diagnostic and any associated materials. 4.7 In addition to any other specific obligations under this Agreement, each party agrees with the other that it will comply with all applicable legislation, regulations and governmental requirements insofar as the same apply to it in the manufacture, use or sale of the Diagnostic.