Common use of GOVERNMENTAL CONTACT REPORTING Clause in Contracts

GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party upon being contacted by the FDA or any other competent governmental authority or agency in the Territories for any material regulatory purpose pertaining to this Agreement or to the Product. Neither Party shall respond to the FDA or such other authority or agency before consulting with the other Party, unless under the circumstances pursuant to which FDA or such other authority or agency contacts such Party, it is not practical or lawful for the contacted Party to give the other Party advance notice, in which event the contacted Party shall inform the other Party of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any other authority or agency.

GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party upon being contacted by the FDA or any other competent federal, state or local governmental authority or agency in the Territories for any material regulatory purpose pertaining to this Agreement or to the ProductProducts. Neither Party shall respond to the FDA or such other authority or governmental agency before consulting with the other Party, unless under the circumstances pursuant to which FDA or such other authority federal, state, local, national or supranational governmental agency contacts such Party, it is not practical or lawful for the contacted Party to give the other Party advance notice, in which event the contacted Party shall inform the other Party of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Products. On the other Party's written request with respect to any Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all each Party shall supply detailed information regarding such safety, efficacy and medical information issues and issues, including, if requested, copies of safety reports filed with the FDA or any other authority or governmental agency.

GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party upon being contacted by the FDA or any other competent governmental authority or agency in the Territories Territory for any material regulatory purpose pertaining to this Agreement or to the Product. Neither Party shall respond to the FDA or such other authority or agency before consulting with the other Party, unless under the circumstances pursuant to which FDA or such other authority or agency contacts such Party, it is not practical or lawful for the contacted Party to give the other Party advance notice, in which event the contacted Party shall inform the other Party of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any other authority or agency.

GOVERNMENTAL CONTACT REPORTING. Each Party shall promptly notify the other Party upon being contacted by the FDA or any other competent governmental authority or agency in the Territories for any material regulatory purpose pertaining to this Agreement or to the Product. Neither Party shall respond to the FDA or such other authority or agency before consulting with the other Party, unless under the circumstances pursuant to which FDA or such other authority or agency contacts such Party, it is not practical or lawful for the contacted Party to give the other Party advance notice, in which event the contacted Party shall inform the other Party of such contact as soon as practical and lawful. In addition, each Party shall keep the other Party advised with respect to information concerning the safety or efficacy of the Product, including but not limited to providing, within three (3) business days of the creation or receipt thereof, all information regarding such safety, efficacy and medical information issues and copies of safety reports filed with the FDA or any other authority or agency.. ARTICLE 11: