Common use of Ownership of Regulatory Documentation Clause in Contracts

Ownership of Regulatory Documentation. 5.1.1. All Regulatory Documentation (including NDAs and Product Labeling and Inserts) relating to the Existing Products and Impax Generic Versions (whether for the Approved Indications or any New Indication) other than INDs filed by Impax or its Affiliates for Impax Studies relating to Existing Products, shall be retained and owned by, and shall be the sole property and held in the name of, AstraZeneca or its designated Affiliate (the “AstraZeneca Regulatory Documentation”). 5.1.2. All Regulatory Documentation (including NDAs and Product Labeling and Inserts) relating to Additional Products, and all INDs filed by Impax or its Affiliates for Impax Studies relating to Existing Products, shall be retained and owned by, and shall be the sole property and held in the name of, Impax or its designated Affiliate (or the applicable Third Party in the case of an ISS) (the “Impax Regulatory Documentation”). For clarity, notwithstanding the ownership thereof by Impax or its designated Affiliate (or the applicable Third Party, the case of an ISS), the content of all Material Impax Regulatory Documentation shall be subject to approval by AstraZeneca pursuant to Section 5.2.2.