Health Authority Communication definition

Health Authority Communication means any communication from any Competent Authority that concerns significant issues, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., serious adverse events, emerging safety signals), clinical or non-clinical findings affecting patient safety, or lack of efficacy.
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Health Authority Communication means any communication from any Competent Authority that concerns significant issues, including any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., serious adverse events, emerging safety signals), clinical or non- clinical findings affecting patient safety, or lack of efficacy.
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Examples of Health Authority Communication in a sentence

  • Within [***] after receipt of any Health Authority Communication from a Competent Authority in its Territory with respect to the Lead Product, the recipient Party will provide the other Party, through its Alliance Manager, with a brief written description of the principal issues raised in such Health Authority Communication and, upon such other Party’s request, the recipient Party will also provide complete copies of such correspondence within a reasonable period of time following such request.

  • After the termination of the Collaboration Term, such information shall be limited to any Health Authority Communication with regard to the Building Blocks used in any Product that is being Developed, Manufactured or Commercialized which could be relevant for the Development of such Product.