EXECUTION COPY
1.65 “Phase II Clinical Study” shall mean a preliminary efficacy, dose-focusing (to provide initial information on exposure-response or dose-response relationships, and help determine appropriate dose-range) or safety human clinical study of a Product in the target patient population, as described under 21 C.F.R. §312.21(b) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.
1.66 “Phase III Clinical Study” shall mean a clinical study designed as a pivotal confirmatory study to demonstrate the efficacy and safety of a Product with respect to a given indication, which study is performed for purposes of filing an NDA, BLA, MAA or similar application to obtain Regulatory Approval for such Product for such indication in any country (regardless of whether such Clinical Study is identified as a phase III clinical study on ClinicalTrials.gov), including a clinical study as described under 21 C.F.R. §312.21(c) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study. For clarity, the portion of a Phase I Clinical Study or Phase II Clinical Study that meets the foregoing criteria shall be deemed to be a Phase III Clinical Study.
1.67 “Price and Reimbursement Approval” shall mean any approvals, licences, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or Government Authority, required by Applicable Law to determine or set the pricing of a Product, or its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranational, national, regional, state or local level.
1.68 “Product” shall mean any product: (i) comprising a [***] Multispecific Antibody in which one variable domain is specific to [***]; and (ii) [***].
1.69 “Prosecution and Maintenance” or “Prosecute and Maintain” with regard to a Patent shall mean the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, requests for patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent.
1.70 “Regulatory Approval” shall mean the approval of the applicable Regulatory Authority necessary for the marketing and sale of a Product in the Field in a country. “Regulatory Approval” shall not include any government pricing or reimbursement approvals or authorisations issued by a Regulatory Authority or any other Government Authority in any country or jurisdiction.
1.71 “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other Government Authority with authority over the marketing and sale of a pharmaceutical product in a country, including the United States Food and Drug Administration and the European Medicines Agency.
1.72 “Regulatory Filing” shall mean any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to a Product, or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs, NDAs, BLAs and MAAs, and all correspondence with any Regulatory Authority with respect to any Product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).
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