definiens: means, withrespect to regulatory filings and Regulatory Approvals, the Party preparing, making and maintaining such filings pursuant toArticles 4.6 and 5.1 . Upon the Responsible Party ’s request, the other Party shall provide reasonable assistance with respect toregulatory filings and each Party shall have full rights of reference with respect to the other Party ’s regulatory filings andRegulatory Approvals for Licensed Products for purposes of making its own regulatory filings with respect to LicensedProducts pursuant to and in accordance with this Agreement . The Responsible Party shall be responsible for and act as the solepoint of contact with the Regulatory Authorities in connection with its regulatory filings . The Responsible Party shall invite aqualified representative from the other Party to participate in and contribute to all meetings with the Regulatory Authoritiesrelating to the Licensed Products . The Responsible Party shall provide the other Party with copies of its regulatory filings andapplications [ * * * ] prior to their submission to the Regulatory Authorities and shall consider to include in such filings andapplications any reasonable comments made and provided by the 27other Party . Notwithstanding the foregoing, material issues, such as but not limited to label scope, in communications withRegulatory Authorities shall be discussed by the Parties and approved at JSC prior to actual implementation, except that finaldetermination with respect to the Sarcoma Program shall be made by Threshold acting reasonably and in good faith and infurtherance of the Parties ’ joint interest to successfully Develop and Commercialize the Licensed Product in the Field in theTerritory . The Responsible Party shall promptly provide the other Party with all copies of any written communication betweenthe Responsible Party and the Regulatory Authorities relating to the Licensed Products . Upon Regulatory Approval of theLicensed Product for the STS Indication in the US, Licensor shall assign the related regulatory filings and RegulatoryApprovals to [COMPANY]