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.

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Right of Reference means a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) or any analogous Applicable Law recognized outside of the United States.

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 Party terminates this Agreement prior to a License Trigger Event, the licenses and sublicenses and rights granted to the Funding Parties under this Agreement pursuant to Section 5.1(a) (Non-Exclusive License) and Section 3.9(a) (Right of Reference) will terminate.

• For clarity, upon expiration of this Agreement, the licenses, sublicenses and rights granted by Opus to the Funding Parties under Section 3.9(a) (Right of Reference) and Section 5.1(a) (Non-Exclusive License) shall automatically terminate and be of no further force and effect.

• The Funding Parties will not practice, and shall not permit or cause any of their Affiliates or any Third Party to practice, any of the rights granted under Section 3.9(a) (Right of Reference) or Section 5.1(a) (Non-Exclusive License) unless and until a License Trigger Event occurs.

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 has the meaning set forth in Section 3.2.2.

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 is defined in Section 2.4.

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.

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.