definiens: means, with respect to any product, any and all internal and external research, development or regulatory activitiesregarding such product, including ( a ) research, process development, non - clinical testing, toxicology, non - clinical activities, IND - Enabling Studies, andclinical trials [ * * * ], ( b ) test method development and stability testing, and toxicology, and ( c ) preparation, submission, review, and development of data orinformation for the purpose of submission to a Regulatory Authority to obtain authorization to conduct clinical trials and to obtain Regulatory Approval ofsuch product and interacting with Regulatory Authorities regarding any of the foregoing, but excluding any activities directed to Manufacturing, MedicalAﬀairs, or Commercialization . Development will include research, development, and regulatory activities for additional presentations or indications for aproduct after receipt of Regulatory Approval of such product, including clinical trials initiated following receipt of Regulatory Approval or to be conductedafter receipt of Regulatory Approval, in each case, that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approvalwith respect to an approved indication ( such as post - marketing approval studies and observational studies, if required by any Regulatory Authority in anycountry in the Territory to support or maintain Regulatory Approval for a product in such country ) . and will beconstrued accordingly