definiens: means IND and MAA filings, [ * ] or materialsthat : ( i ) are [ * ] a Regulatory Authority ; ( ii ) contain [ * ] such Regulatory Authority ; ( iii ) contain [ * ] tosuch Regulatory Authority ; or ( iv ) [ * ] the relevant Tirasemtiv or Product or its Development orCommercialization ; 23 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of1934, as amended.(b ) shall provide the other Party with drafts of any [ * ] Regulatory Materials forTirasemtiv and Product to be submitted by such Party to the Regulatory Authority in [ * ] prior tosubmission for review and comment ( or if [ * ] such as in the event of [ * ] by Regulatory Authoritythat [ * ] but in no event in a manner that would [ * ] such reporting or response ), and shall considerin good faith any comments received from the other Party;(c ) shall provide the other Party with copies of [ * ] Regulatory Materials ( [ * ] foreach calendar month as well as copies of [ * ] correspondence ( [ * ] ) received from the RegulatoryAuthority [ * ] pertaining to Tirasemtiv and Product for [ * ] Business Days [ * ] to a RegulatoryAuthority that : ( i ) is [ * ] from a Regulatory Authority or is in response to an administrative request orinquiry from a Regulatory Authority ; ( ii ) contains [ * ] provided to such Regulatory Authority ; ( iii)contains [ * ] to such Regulatory Authority ; ( iv ) [ * ] the receiving Regulatory Authority [ * ] to therelevant Tirasemtiv or Product or its Development or Commercialization ; and ( v ) is required bylaw or regulation to be periodically filed to an existing IND or MAA . [ * ] includes correspondencesuch as [ * ], notifications and non - substantive amendments, but excludes all [ * ] ; and(d ) shall provide the other Party written minutes or other records of any oral keydiscussions ( such as Type A, Type B and Type C meetings in the U.S. and foreign similar orequivalent meetings ) with the Regulatory Authority [ * ] pertaining to Tirasemtiv and Productpromptly after any such discussion