Common use of Impax Regulatory Responsibilities Clause in Contracts

Impax Regulatory Responsibilities. (i) Subject to Section 5.1.1, except as otherwise agreed by the Parties, Impax shall have the sole right and responsibility [***] for (a) preparing, submitting and maintaining all Regulatory Documentation and Regulatory Approvals in accordance with Applicable Law and (b) and conducting all written and oral communication and discussions with, and preparing and responding to all correspondence with, Regulatory Authorities in the Field in the Territory in accordance with Applicable Law, in each case ((a) and (b)) with respect to (1) any Additional Products, (2) any Impax Studies (including the INDs filed by Impax or its Affiliates therefor), and (3) the Manufacture of Licensed Products other than Supplied Products (collectively, the “Impax Primary Regulatory Responsibilities”). (ii) Except as otherwise agreed by the Parties, Impax shall have primary operational responsibility for preparing (a) all Regulatory Documentation and Regulatory Approvals and (b) all correspondence with, Regulatory Authorities in the Field in the Territory, in each case ((a) and (b)) with respect to (1) the Existing Products in any dosage strength other than (A) the dosage strengths approved by the FDA in the Territory as of the Effective Date and (B) [***], (2) the Existing Products in any New Indication, and (3) any changes to the Product Labels and Inserts proposed by Impax for Existing Products in the Approved Indications (collectively, the “Impax Supporting Regulatory Responsibilities”). All Regulatory Documentation and correspondence prepared by Impax pursuant to this Section 5.2.2(ii) shall be submitted to the FDA by and in the name of, and [***]. Any such [***], and AstraZeneca shall [***] such Regulatory Documentation within [***]. (iii) Impax shall perform the Impax Primary Regulatory Responsibilities and the Impax Supporting Regulatory Responsibilities at its sole cost; provided, however, that Impax shall not be obligated to reimburse AstraZeneca for any costs AstraZeneca incurs in providing materials for, attending, and assisting with any Impax Primary Regulatory Responsibilities or Impax Supporting Regulatory Responsibilities. (iv) Prior to submission to any Regulatory Authority, Impax shall submit to AstraZeneca [***] the form and content of, and strategy for, each item of Material Impax Regulatory Documentation proposed by Impax. AstraZeneca’s [***] pursuant to this Section 5.2.2(iv) shall [***]. AstraZeneca shall use Commercially Reasonable Efforts to [***] within (i) [***] of receipt by AstraZeneca of such proposed Material Impax Regulatory Documentation that relates to the Additional Products and (ii) [***] of receipt by AstraZeneca of such proposed Material Impax Regulatory Documentation that relates to the Existing Products, in each case, except as otherwise set forth in Section 4.1.3 (i) with respect to proposed protocols and amendments thereto for Impax Studies. (v) Except as provided in Section 5.2.2(i), 3.14.4 or 3.15.5, or as required by Applicable Law, Impax shall not communicate directly with any Regulatory Authorities regarding the Licensed Compound or the Licensed Products or otherwise take any action concerning any Regulatory Approval, and in no event shall Impax communicate with any Regulatory Authority, regarding the AstraZeneca Regulatory Documentation or any Existing Product without [***]. (vi) From time to time Impax may propose changes to the Product Labels and Inserts for Existing Products in the Approved Indications; provided that [***].