AstraZeneca Regulatory Responsibilities Sample Clauses

AstraZeneca Regulatory Responsibilities. (i) Except as otherwise agreed by the Parties, AstraZeneca or its designated Affiliate shall have the sole right and responsibility (subject to Impax’ rights under Section 5.2.1(iii)) for (a) preparing, submitting and maintaining all Regulatory Documentation and Regulatory Approvals in accordance with Applicable Law and (b) conducting all written and oral communication and discussions with, and preparing and responding to all correspondence with, Regulatory Authorities in the Territory in accordance with Applicable Law, in each case ((a) and (b)), with respect to (1) (A) the Existing Products in the dosage strengths approved by the FDA in the Territory as of the Effective Date and (B) [***] , in each case ((A) and (B)) in the Approved Indications (except as set forth in Section 5.2.2(ii) with respect to changes in Product Labeling and Inserts proposed by Impax), (2) the Selected Mandated Studies, (3) any AstraZeneca Studies, and (4) the Manufacture of the Supplied Products (collectively, the “AstraZeneca Regulatory Responsibilities”). (ii) AstraZeneca shall perform the AstraZeneca Regulatory Responsibilities at its sole cost; provided, however, that AstraZeneca shall not be obligated to reimburse Impax for any costs Impax incurs in providing materials for, attending, and assisting with any AstraZeneca Regulatory Responsibilities. (iii) AstraZeneca shall provide to Impax, reasonably in advance of the submission date therefor, each item of Material AstraZeneca Regulatory Documentation for the Territory proposed by AstraZeneca (other than Material AstraZeneca Regulatory Documentation prepared by Impax pursuant to Section 5.2.2(ii)), and AstraZeneca shall consider in good faith any comments thereon made by Impax in a timely manner. (iv) Impax, at its sole cost, shall provide AstraZeneca with such information as AstraZeneca reasonably requests (in writing, and no less than [***] in advance, unless a shorter time period is required to satisfy the requirements or requests of the Regulatory Authorities) to enable AstraZeneca to maintain the AstraZeneca Regulatory Documentation and related Regulatory Approvals for the Existing Products and the Impax Generic Versions in the Territory or as may be requested or required by Regulatory Authorities from time to time and which is in the possession of Impax, including details of the Existing Products and the Impax Generic Versions sold by Impax by NDC number. In addition, Impax at its sole cost shall make its employees, co...
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Related to AstraZeneca Regulatory Responsibilities

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