definiens: means ( a ) all regulatory files relating to the Development o r Commercialization of Products, including any licens es ( to the extent transferable ), and minutes of meetings and telephone conferences with any Regulat ory Authorities, validation data, preclinical and clinical studies and tests related to Products incl uding original data, case report forms, study files relating to the aforementioned studies and tests, a nd all audit reports of clinical studies, plus all applications ( and amendments thereto ) for Regulator y Approvals, annual reports and safety reports associated therewith, drug master files, which are in Miragen ’s or its Affiliates ’ possession or Contr ol, and all correspondence with Regulatory Authorities regarding the marketing status of Products ; and ( b ) all records maintained under cGMPs or other record keeping or reporting requirements of Regulatory Authorities, including all correspondenc e and communications with Regulatory Authorities in connection with Products ( including any advertis ing and promotion documents ), adverse event files, complaint files and manufacturing records