definiens: shall mean, with respect to the Product and as to each nation in the Territory for the Certification Period : 1.9.1 1.9.2 1.9.3 1.9.4 Confidential those tasks or milestones as shall be designated from time to time by Committee Action as being, within industry norms and standards, sufficient ( together with the tasks undertaken to date for the Product ) to support the filing of an NDA with the FDA for the Product, or, as to nations other than the U.S., to support the filing of an analogous PLA in the applicable Regulatory Authority ; the filing of one or more NDAs and other PLAs with respect to the Product with the FDA and/or the other Regulatory Authorities designated by Committee Action ; obtaining Approval of such NDAs and PLAs ( on a nation - by - nation basis, as to the approval by the Regulatory Authority having jurisdiction in that nation ) ; and the preparation by [COMPANY], or if and to the extent that Sections 4.2 or 4.3 hereof, or a license to [COMPANY] under Section 6.8 hereof, are applicable, the preparation by [COMPANY], and the approval in any event 42 by Committee Action, of an initial Manufacturing and Marketing Plan for the Product . In most cases, the Certification Tasks will include all testing and studies including as to efficacy, bioequivalence, and safety and toxicology, in connection with the development, licensing, manufacture and marketing of the Product, and for compliance with all requirements imposed by the government of the United States ( inclusive without limitation of the FDA and the DEA ) and by any other government(s ) in the Territory as may be designated by Committee Action, including without limitation large - scale trials of safety and efficacy of the sort called in the FDA context, post - marketing surveillance and other studies of the sort called studies in the FDA context . However, the applicable Certification Tasks may be defined and altered in specific cases by Committee Action, whether or not in conformity with the above­described usual case as now anticipated