Right of Reference means a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any comparable right existing under the laws or regulations of any foreign country.
Right of Reference means the “right of reference” defined in 21 CFR 314.3(b), including with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Party’s Compound, only to the extent necessary for the conduct of the Study in such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder.
Right of Reference means the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining a regulatory approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority, if necessary.
Examples of Right of Reference in a sentence
Collaborator shall act as the sponsor of the Collaborator Clinical Trial under its own IND for the Collaborator Compound with a Right of Reference to the IND of the MSD Xxxxxxxx as described in Section 3.5 (Regulatory Matters); provided, however, that in no event shall Collaborator file an additional IND for the MSD Compound Study unless required by Regulatory Authorities to do so.
More Definitions of Right of Reference
Right of Reference means the “right of reference” defined in 21 CFR 314.3(ii) including, with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information and data (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation filed with such Regulatory Authority with respect to a Party’s Compound.
Right of Reference means the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any equivalent regulation outside the U.S., as each may be amended.
Right of Reference is defined in Section 2.4.
Right of Reference means: (a) in the United States, a “right of reference or use,” as such term is defined in 21 C.F.R. 314.3(b); or (b) in any other country or jurisdiction, the equivalent authority to rely upon, and otherwise use, an investigation for the purpose of filing, and conducting a clinical trial under, an IND, or obtaining approval of an NDA, MAA or other Regulatory Approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority in such country or other jurisdiction, if necessary.
Right of Reference has the meaning set forth in Section 2.7.
Right of Reference means the “right of reference or use” defined in 21 CFR 314.3(b), or its equivalents outside the United States, and shall in any event include the right to allow the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Filings (and any data contained or referenced therein) filed with such Regulatory Authority.
Right of Reference shall have the meaning set forth in 21 C.F.R. §314.3(b) or equivalents thereto under Applicable Law in countries or jurisdictions outside the U.S.