definiens: shall mean all information, data and trade secrets Controlled by Carbylan or its Affiliates as ofthe Effective Date or during the Term of this Agreement in the Territory relating to the Compound and / orthe Licensed Products to the extent necessary or reasonably useful to develop for the purpose ofobtaining Regulatory Approval of, to manufacture or to commercialize the Licensed Product, whetherprotected by intellectual property rights or not, including but not limited to ( A ) materials, documents, data, notes, memoranda, research briefs, articles, correspondence, processes, specifications, formulae, procedures, techniques, practices, quality control processes and procedures, designs, apparatus, manufacturing processes and data, and instructions of, and scientific, analytical and technical data andstudies for, the efficacy, pharmacology, toxicology, synthesis, 2 pharmaceutical processing and manufacture, packaging, storage and transportation of the Compoundand / or Licensed Products, ( B ) non - clinical, pre - clinical, and clinical data and studies, including clinical trialdesign and protocols, knowledge, technology, written and oral rectifications of data relating to theCompound and/or Licensed Products which are owned or Controlled by Carbylan or its Affiliates nowand / or in the future and may be necessary or reasonably useful to enable [COMPANY] to obtain theRegulatory Approval, ( C ) any and all submissions to, responses, requests and/or comments from, andcorrespondence with the U.S. Food & Drug Administration ( ) and/or any analogous regulatoryauthority outside the United States, and ( D ) other intellectual property rights with respect to any invention, discovery, use, modification or improvement arising out of or relating to the technology described in thePatents, in each case irrespective of whether such technology is ( i ) developed inside or outside theTerritory, ( ii ) performed or in existence as of the Effective Date or subsequent thereto, ( iii ) in draft or finalform, and ( iv ) the subject of a patent application, patent or other right inside or outside of the Territory, ineach case of ( A)-(D ) above, Controlled by Carbylan or its Affiliates as of the Effective Date or during theTerm of this Agreement in the Territory relating to the Compound and/or the Licensed Products to theextent necessary or reasonably useful to develop for the purpose of obtaining Regulatory Approval of, tomanufacture or to commercialize the Licensed Product . For clarity, Know - How shall exclude Patents