Receiving Party has the meaning set forth in Section 12.1.
Regulatory Approval means, with respect to a Product in a country or other jurisdiction in the Territory, the approval, license or authorization of the applicable Regulatory Authority necessary to Commercialize such Product in such country or other jurisdiction, including, where applicable, pricing or reimbursement approval in such country or other jurisdiction.
Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA, and PMDA) regulating or otherwise exercising authority with respect to Regulatory Approval.
Regulatory Materials means any (a) materials that are/were developed or compiled in for meetings with any Regulatory Authority or for or in support of any applications for Regulatory Approval (at any stage and for any pathway), including all INDs and related submissions, dossiers, and notifications, but excluding the internal notes and memoranda of a Party, and (b) Regulatory Approvals or other registrations or approvals granted or issued by a Regulatory Authority.
Relevant Authority means any court or government body, whether national, supra-national, federal, state, local, foreign or provincial, including any political subdivision thereof, including any department, commission, board, bureau, agency, or other regulatory or administrative governmental authority or instrumentality, and further including any quasi-governmental Person or entity exercising the functions of any of these.
Replaced Target has the meaning set forth in Section 2.2.4.
Replacement Notice has the meaning set forth in Section 2.2.4.
Replacing Target has the meaning set forth in Section 2.2.4.
Research means conducting research activities with compounds, including pre-clinical research and lead optimization, but specifically excluding Development and Commercialization. When used as a verb, Researching means to engage in Research.
Restricted Target means [***].
Right of Reference means the right to allow a Regulatory Authority or a Party to rely upon the Data and other information from Clinical Studies or other Development activities that are in the possession of a Regulatory Authority for the purpose of seeking, obtaining or maintaining Regulatory Approval, including the ability to allow such Regulatory Authority to review the underlying raw data as part of an investigation by such Regulatory Authority, if necessary.
ROFN Election Period has the meaning set forth in Section 6.8.1.
ROFN Expiration has the meaning set forth in Section 6.8.3.
ROFN Negotiation Period has the meaning set forth in Section 6.8.2.
ROFN Notice has the meaning set forth in Section 6.8
ROFN Transaction has the meaning set forth in Section 6.8.
SAD/MAD Studies means all single ascending dose (SAD) Phase 1 Studies and multiple ascending dose (MAD) Phase 1 Studies and, if applicable, associated expansions, where the principal purpose is a further determination of safety and pharmacokinetics of the compound after the initial dose escalation studies. SAD/MAD Studies may include studies aimed at exploring trends of biomarker or clinical endpoint-based dose-efficacy relationship, which are prior to commencement of Phase 2 Studies.
SHE has the meaning set forth in Section 6.5.3.