EXECUTION VERSION
1.1.55 “Cover”, “Covered” or “Covering” shall mean, as to a product and Patent Rights, that, in the absence of a license granted under, or ownership of, such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights or, as to a pending claim included in such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights if such pending claim were to issue in an issued patent.
1.1.56 “CPI” shall mean the Consumer Price Index – Urban Wage Earners and Clerical Workers, U.S. City Average, All Items,1982-84 = 100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index) in the United States.
1.1.57 “DC Workplan” shall have the meaning set forth in Section 3.2(a).
1.1.58 “Debar”, “Debarred” or “Debarment” shall mean (a) being debarred, or being subject to a pending debarment, pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, (b) being listed by any federal and/or state agencies, excluded, debarred, suspended or otherwise made ineligible to participate in federal or state healthcare programs or federal procurement ornon-procurement programs (as that term is defined in 42 U.S.C.§ 1320a-7b(f), or being subject to any pending process by which any such listing, exclusion, debarment, suspension or other ineligibility could occur, (c) being disqualified by any government or regulatory agency from performing specific services, or being subject to a pending disqualification proceeding, or (d) being convicted of a criminal offense related to the provision of healthcare items or services or being subject to any pending criminal action related to the provision of healthcare items or services.
1.1.59 “Develop” or “Development” shall mean, with respect to a product, discovery, research, preclinical development, clinical development, and regulatory activities with respect to such product, including test method development and stability testing, design, compatibility testing, toxicology, animal efficacy studies, formulation, quality assurance/quality control development, statistical analysis, clinical studies (including Clinical Studies), regulatory affairs, product approval and registration, chemical development and Manufacturing development, packaging development and Manufacturing and development documentation efforts in support of development activities anywhere in the world, whether before or after Regulatory Approval for such product has been obtained.
1.1.60 “Development Candidate” shall have the meaning set forth in Section 3.3(a).
1.1.61 “Development Plan” shall have the meaning set forth in the Section 3.2(a).
1.1.62 “Development Supply Agreement” shall have the meaning set forth in the Section 5.2.
1.1.63 “Directed to” shall mean, with respect to an siRNA and a Target, that such siRNA [***] of the messenger RNA of such Target, and with respect to a product and a Target, that such product contains an siRNA that [***] of the messenger RNA of such Target.
1.1.64 “Disclosing Party” shall have the meaning set forth in Section 9.1(a).
1.1.65 “Divest”, “Divesting” and “Divestiture” shall have the meaning set forth in Section 10.5(a).
1.1.66 “Dollars” and “$” shall mean United States dollars.
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