Right of Reference definition

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 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 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

• If a Right of Reference is necessary, each Party shall provide to the other a cross-reference letter or similar communication to the applicable Regulatory Authority if needed to effectuate the Right of Reference.

• Each Party shall provide to the other, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference.

• OXIS shall have the right to sub-license the Right of Reference to its sub-licensees and Affiliates provided said sub-licensees and Affiliates comply fully with all applicable terms herein.

• Oxis shall have the right to (sub)license the Right of Reference to its sublicensees and Affiliates.

• The Licensor shall, at Alzheon’s request, provide a signed statement in accordance with 21 C.F.R. 314.50(g)(3) (or any analogous Law outside the United States), or otherwise provide appropriate notification of such right to the applicable Regulatory Authority, to the extent necessary for Alzheon and its Affiliates and sublicensees to exercise the Right of Reference granted hereunder.

More Definitions of Right of Reference

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 is defined in Section 2.4.

Right of Reference has the meaning set forth for such term in 21 C.F.R. § 314.3(b) or an equivalent right of access or reference under any Applicable Law in any other jurisdiction outside the United States.

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.

Right of Reference means the right of a Party and its licensees or designees to reference or cross-reference Clinical IP in any regulatory applications or filings.