Right of Reference or Use means a “Right of Reference or Use” as that term is defined in 21 C.F.R. §314.3(b), and any non-United States equivalents.
Right of Reference or Use means the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining approval of an Application, including the ability to make available the underlying raw data from the investigation for FDA audit.
Right of Reference or Use means the authority to rely upon, and otherwise use, (i) an investigation of the quality, safety or efficacy of a Product (including any or all such investigations conducted in vitro, in vivo, or in silico and any and all Clinical Trials), (ii) Product Development Reports, or (iii) Product Scientific and Regulatory Material for the purpose of obtaining approval of an Application or to defend an Application, including the ability to make available the underlying raw data from the investigation, Product Development Reports, or Product Scientific and Regulatory Material for FDA audit, if necessary.
Examples of Right of Reference or Use in a sentence
Summit shall and hereby grants Akeso a Right of Reference or Use for all Clinical Studies undertaken by or on behalf of Summit, its Affiliates or Sublicensees for use in the Non-License Territory as further described herein.
Akeso shall and hereby grants Summit a Right of Reference or Use for all Clinical Studies undertaken by or on behalf of Akeso or its Affiliates for use in the License Territory as further described herein.
More Definitions of Right of Reference or Use
Right of Reference or Use means the right to cross reference, incorporate by reference or rely upon any Regulatory Documentation solely for the purpose of obtaining or maintaining Regulatory Approval, Pricing Approval or an IND for a Licensed Product, including a “Right of Reference or Use” as that term is defined in 21 C.F.R. §314.3(b) in the United States, and any equivalents thereof outside the United States.
Right of Reference or Use means a “right of reference or use” as that term is defined in 21 C.F.R. §314.3(b), or an equivalent in a country in the Territory other than the United States.
Right of Reference or Use means a “Right of Reference or Use” as that term is defined in 21 C.F.R. §3143(b), and any non-United States equivalents.
Right of Reference or Use means the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining approval of an Application, including the ability to make available the underlying raw data from the investigation for FDA (or the European Agency for the Evaluation of Medicinal Products or other comparable Agency) audit.
Right of Reference or Use means the authority to rely upon, and otherwise use all of the following:
Right of Reference or Use as that term is defined in 21 C.F.R. §314.3(b), and any non-United States equivalents.
Right of Reference or Use as such term is defined in Section 1.102 of the Agreement. 3.