definiens: means IND and MAAfilings, [ * ] or materials that : ( i ) are [ * ] a Regulatory Authority ; ( ii ) contain [ * ] such Regulatory Authority ; ( iii ) contain [ * ] suchRegulatory Authority ; or ( iv ) [ * ] the relevant Compound or Collaboration Product or its Development or Commercialization;(b ) shall provide the other Party with drafts of any [ * ] Regulatory Materials for the Compounds and CollaborationProducts to be submitted by such Party to the Regulatory Authority [ * ] days prior to submission for review and comment ( or if [ * ] such as in the event of [ * ] by Regulatory Authority that [ * ] but in no event in a manner that would [ * ] such reporting orresponse ), and shall consider in good faith any comments received from the other Party;(c ) shall provide the other Party with copies of [ * ] Regulatory Materials ( [ * ] ( as defined below ) ) submitted to theRegulatory Authority [ * ] for each calendar month as well as copies of [ * ] correspondence ( [ * ] ) received from the RegulatoryAuthority [ * ] pertaining to the Compounds and Collaboration Products for [ * ] . means [ * ] a Regulatory Authority that:(i ) is [ * ] from a Regulatory Authority or is [ * ] from a Regulatory Authority ; ( ii ) contains [ * ] provided to such RegulatoryAuthority ; ( iii ) contains [ * ] to such Regulatory Authority ; ( iv ) [ * ] the receiving Regulatory Authority [ * ] the relevantCompound or Collaboration Product or its Development or Commercialization ; and ( v ) is required by law or regulation to beperiodically filed to an existing IND or MAA . [ * ] includes correspondence such as [ * ] but excludes all [ * ] ; and(d ) shall provide the other Party written minutes or other records of any oral key discussions ( such as Type A, TypeB and Type C meetings in the U.S. and foreign similar or equivalent meetings ) with the Regulatory Authority [ * ] pertaining tothe Compounds and Collaboration Products promptly after any such discussion