definiens: as that term is defined in 21 C.F.R. § 314.3(b ), and any foreign equivalents, to any and all data and information relating to the Specified Studies or Licensed Products or Products, as the case may be, and necessary for such Party to submit a complete NDA for Licensed Products in the Territory in the case of ALPHARMA or outside the Territory in the case of [COMPANY], and each Party agrees to sign, and cause its Affiliates to sign, any instruments and take any actions reasonably requested by the other Party in order to effect such grant . Alternatively, at each Party 's request, the other Party shall provide to the requesting Party complete copies of all documents, including without limitation pre - clinical and clinical databases ( raw case report files and final study reports, pharmacology and toxicology reports, regulatory information, and such other information and data as is reasonably requested ), documents related to pharmacology, toxicology, chemistry, manufacturing and controls, batch records, manufacturing information, analytical and quality control, as necessary for the requesting Party 's submission of a complete NDA or foreign equivalent for any Licensed Product in the Territory in the case of ALPHARMA or outside the Territory in the case of [COMPANY]