definiens: means all confidential know - how and information to the extent relating to andnecessary for the development, manufacture or Commercialization of the Licensed Product, including clinical, technical, scientific, and medical information, know - how, methods, inventions, practices, and trade secrets, qualitycontrol information and procedures, pharmacological, toxicological and clinical test data and results and regulatoryinformation, in each case, which Council Controls as of the Effective Date or at any time thereafter . Notwithstandingthe foregoing, Council Know - How will not include ( a ) information which is or becomes part of the public domain throughno breach of this Agreement by LICENSEE ; ( b ) information which LICENSEE can demonstrate by its written recordswas known by LICENSEE or its Affiliates prior to the disclosure thereof by Council ; ( c ) information which isindependently developed by LICENSEE or its Affiliates outside of the Program, so long as such development doesnot result from use of Council Know - How, and such independent development can be demonstrated by writtenrecords ; and ( d ) information that becomes available to LICENSEE or its Affiliates on a non - confidential basis, whetherdirectly or indirectly, from a Third Party who is not bound by a confidentiality obligation to Council . For the avoidanceof doubt, the Drug Master File jointly owned by the Council with [ * * * ] shall not be considered Council Know - How orCouncil Technology Controlled by Council for purposes of this Agreement until such time as Council may seek andthereafter obtains consent of [ * * * ] to the licensing thereof hereunder