definiens: as that term is defined in 21 C.F.R. § 314.3(b ), to any and all Regulatory Filings and Product Data relating d irectly to Licensed Products, which includes that related to p harmacology, toxicology, preclinical testing, clini cal testing, chemistry, manufacturing and controls data, batch r ecords, trials and studies, safety and efficacy, ma nufacturing information, analytical and quality control, and ag rees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Shore in order to effect an y such grant, solely for the purposes of Developing and seeking Regulatory Approval outside the Territory o f the Licensed Products . Upon Shore ’s reasonable re quest made from time to time, [COMPANY] shall, or shall ca use its Affiliates or sublicensees to, transfer to Shore or LifeCycle a copy of all such Regulatory Filings wit h respect to the Licensed Products