definiens: has the meaning specified in Secti on 3.1 ; means the annual report to the FDA prepared by KindredBio regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2 ) ; means the applicable provisions o f any and all national, supranational, regional, state, provincial, county and local laws, statutes, treaties, ordinances, regulations, rules, administ rative codes, guidance, ordinances, by - laws, judgments, decrees, directives, injunctions, permits ( including marketi ng approvals ) or orders of or from any Authority havin g jurisdiction over or related to the subject item ; means any governmental or regulatory au thority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether national, supranational, regional, state, provincial, county or local ; means a specific quantity of the Product th at is intended to have uniform character and qualit y, within specified limits, and is produced from a sin gle run of the Manufacturing Process ; will have the meaning specified in Section 8.2(a ) ; means a day other than a Saturday, S unday or a day that is a statutory holiday in the jurisdiction where the Manufacturing Site is locate d or in the State of California ; 1 -