definiens: ) .5.2 Lead Regulatory Parties . means the Party so assigned pursuant to this Section 5.2, with therights and responsibilities set forth under Section 5.4 . The Party that is not the Lead Regulatory Party shall be the . [COMPANY] shall be the Lead Regulatory Party with respect to all Collaboration Products for all Indications, other than with respect to(a ) the Ongoing Clinical Studies, any Melanoma Follow - Up Study permitted pursuant to Section 4.3.2(a ), and ( b ) any [COMPANY] StudyConducted under [ * * * ] 5.3 [COMPANY] Study under [ * * * ] 5.3.1 If the JDC declines to include a Proposed Study from [COMPANY] in the GDP after [ * * * ] ( or at such earlier timepermitted pursuant to Section 4.5.2 ), and [COMPANY] has right to Conduct such Proposed Study pursuant to Section 4.5.2, then BioNTechmay Conduct such Proposed Study as a [COMPANY] Study under [ * * * ]