1.51“Registrational Trial” means the earlier to occur of: (a) a Phase III Clinical Trial or (b) any other Clinical Trial of a Licensed Product for which the applicable Regulatory Authority has agreed in writing, whether before Initiation of such Clinical Trial (e.g., pursuant to a written agreement with or written statement from the FDA or the EMA on a ‘Special Protocol Assessment’ or equivalent or other written minutes issued by the FDA or EMA) or after Initiation of such Clinical Trial (e.g., based on an interim data analysis), is sufficient to form the primary basis for Regulatory Approval. If a Clinical Trial is determined in writing by the applicable Regulatory Authority, after review of the efficacy and safety data from a Phase II Clinical Trial for the Licensed Product, to be sufficient to form the primary basis for Regulatory Approval (i.e. Clinical Trial constitutes a Registrational Trial) without the need for a Phase III Clinical Trial(s) prior to submission, then, for purposes of the Development and Regulatory Milestone Payment, the Initiation of such Registrational Trial will be deemed to occur on the date of such written determination by the applicable Regulatory Authority.
1.52“Regulatory Approval” means, with respect to a product in a country or jurisdiction, all approvals from the relevant Regulatory Authority necessary to initiate marketing and selling of such product (including a Licensed Product) in such country or jurisdiction.
1.53“Regulatory Authority” means the FDA or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of a pharmaceutical product (including a Licensed Product), which may include the authority to grant the required reimbursement and pricing approvals for such sale.
1.54“Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product in a country or jurisdiction in the Territory, other than a Patent Right, including exclusivity for an approved BLA, new clinical data exclusivity, orphan drug exclusivity, pediatric exclusivity, or rights similar thereto in other countries or jurisdictions.
1.55“Regulatory Filing” means all applications, filings, submissions, approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations, permits, notifications, and authorizations (including marketing and labeling authorizations) or waivers with respect to the testing, research, development, registration, manufacture (including formulation), use, storage, import, export, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a product made to or received from any Regulatory Authority in a given country or jurisdiction, including INDs.
1.56“Related Party” means each Party, its Affiliates, and their respective Sublicensees (which term excludes any Third Parties to the extent functioning as distributors), as applicable. In no event shall Zymeworks be a Related Party with respect to Atreca or Atreca be a Related Party with respect to Zymeworks.
1.57“Research Product” means any pharmaceutical product that comprises a Conjugate discovered, identified or made in the performance of the Research Program or [***].