definiens: or means all development activities, other than Rese arch, for a Collaboration Construct or the associated Collaboration Product t hat are directed to obtaining Marketing Appr oval(s ) of such Collaboration Product, including all non- clinical, preclinical and clinical activities, test ing and studies of such Collaboration Product performed after the date of t he [ * * * ] Decision ; manufacturing development, process and formulation development ; toxicology, pharmacokineti c, pharmacodynamic, drug- drug interaction, safety, tolerability and pharmacological studies ; distribut ion of such Collaboration Product for use in Clinic al Studies ( including placebos and comparators ) ; statistical a nalys es ; and the preparation, filing and prosecution of any MAA or IND for such Collaboration Product ; development activities directed to label expansion ( including p rescribing information ) or obtaining Marketing Approval for on e or more additional Indications following initial Marketing Approval ; development activities conducted after receipt of M arketing Approval which were a condition for the receipt of such Marketing Approval ; and pharmacoeco nomic studies relating to the Indication for which such Collaboration Product is being developed ; in each c ase above, including investigator- or institution- sponsored studies for which a Party is providing material or assistance or otherwise has written obligations to such investigator or institution ; and all regulatory a ctivities related to any of the foregoing