definiens: or means all development activities for any LicensedProduct that are directed to obtaining Marketing Approval(s ) of such Licensed Product, including : all non - clinical, preclinical and clinical activities, testing and studies of such Licensed Product;manufacturing development, process and formulation development ; toxicology, pharmacokinetic, pharmacodynamic, drug - drug interaction, safety, tolerability and pharmacological studies;distribution of such Licensed Product for use in clinical trials ( including placebos andcomparators ) ; statistical analyses ; and the preparation, filing and prosecution of any MAA forsuch Licensed Product ; development activities directed to label expansion ( including prescribinginformation ) and/or obtaining Marketing Approval for one or more additional Indications followinginitial Marketing Approval ; development activities conducted after receipt of Marketing Approvalwhich were a condition for the receipt of such Marketing Approval ; and pharmacoeconomicstudies relating to the Indication for which the applicable Licensed Product is being developed ; ineach case above, including investigator- and/or institution - sponsored studies for which a Party isproviding material-4- [ * ] Certain confidential information contained in this document, marked by brackets, has been omitted andfiled separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the SecuritiesExchange Act of 1934, as amended . Exhibit 10.1Confidential Execution Versionor assistance or otherwise has written obligations to such investigator and/or institution ; and allregulatory activities related to any of the foregoing