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
Concurrent with the effectiveness of any such license, upon written request of Calithera, Incyte hereby grants to Calithera, solely for the purpose of developing and commercializing Retained Compounds, a Right of Reference or Use to any and all Regulatory [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sometimes all a specific API requires from “a file-like object” is that it has a .read() method that returns bytes.
More Definitions of Right of Reference or Use
Right of Reference or Use means the right to cross reference, copy, incorporate by reference or rely upon any Regulatory Documentation solely for the purposes of obtaining or maintaining Regulatory Approval or Marketing Authorization for a Collaboration Product, including (1) a “Right of Reference or Use” as that term is defined in 21 C.F.R. §314.3(b) in the United States, (2) any analogous procedures with respect to biologics or BLAs in the United States and (3) 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 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 Clincial Trials), (ii) Product Development Reports, or (iii) Product Scientific and Regulatory Material for the