definiens: ( as defined in USFDA 21 CFR 314.3(b ) ), or similar as defined in applicable regulations in the relevant part of theTerritory ( only if possible, i.e., a CTA for the respective Compound was already submitted to the local HealthAuthorities ), with respect to Study Data and results related to Compounds, solely as necessary for the other Party toprepare, submit and maintain regulatory submissions of the Study related to the other Party ’s Compound andRegulatory Approvals . In all other cases, where a is not possible, the parties will promptly discussin good faith on how to provide the required documentation for CTA of the Study . Further, each Party shall provide tothe other a cross - reference letter or similar communication to the applicable Regulatory Authority to effectuate suchright of reference . Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right toaccess the other Party ’s CMC data with respect to its Compound