definiens: means any data or market exclusivity granted to the Product in the Field in the Territory by anyRegulatory Authority as of the Effective Date or at any time during the Term . * or means, with respect to the Product in the Field in the Territory, all research, all pre - clinicaland clinical activities conducted relating to the Product for the CIC Indication, including without limitation, test methoddevelopment and stability testing, toxicology, animal studies, formulation, process development, manufacturing scale - up, quality assurance / quality control development for Clinical Studies, statistical analysis and report writing, and ClinicalStudies, including clinical trial design, operations, data collection and analysis and report writing, publication planning andsupport, risk assessment mitigation strategies, health economics outcomes research planning and support, clinical laboratorywork, disposal of drugs and regulatory activities in connection therewith, the transfer of information, materials, Productregulatory documentation and other technology with respect to the foregoing, the preparation of Regulatory Filings, andobtaining and/ or maintaining Regulatory Approvals for the Product in the Field in the Territory ( including regulatory affairsactivities and preparation of meetings with Regulatory Authorities in the Territory ) . When used as a verb,5 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIESAND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED