Correspondence with Authorities. Without limiting Section 5.2.1 (Regulatory Submissions), to the extent permitted by Applicable Law, each Party shall provide the other Party with (a) access to or copies of all material written or electronic correspondence and communications received by or on behalf of such Party or any of its Affiliates, sub/licensees, or Sublicensees from, or forwarded by or on behalf of such Party or any of its Affiliates, sub/licensees, or Sublicensees, to, any Regulatory Authority in the Apellis Territory or any Major Market, and (b) copies of all material meeting minutes and summaries of all material meetings, conferences, and discussions held by such Party or any of its Affiliates, sub/licensees, or Sublicensees, with any Regulatory Authority in the Apellis Territory or any Major Market, in each case ((a) and (b)), relating to the Exploitation of any Compound or Product, but any information or data not related to any Compound or Product may be redacted. Notwithstanding the foregoing, and without limiting a Party’s obligations under Section 5.4 (Adverse Event Reporting), if (i) a Party is unable (having used Commercially Reasonable Efforts to procure the same) to include the obligation on a sub/licensee or Sublicensee to provide the access and copies referred to in the foregoing sentence in the agreement between such Party and such sub/licensees or Sublicensee, or (ii) a sub/licensee or Sublicensee fails to comply with such obligation, despite the relevant Party having used Commercially Reasonable Efforts to enforce the same, the relevant Party shall not be in breach of its obligation to provide such access and copies received, forwarded, or produced by the relevant sub/licensee or Sublicensee. If such written or electronic correspondence received from any such Regulatory Authority relates to any non-approval of an IND or CTA with respect to any Product or the prohibition or suspension of the supply of any Compound or Product, or the initiation of any investigation, review, or inquiry by any Regulatory Authority concerning the safety of any Compound or Product, then the applicable Party shall notify the other Party, and provide the other Party with copies of such written or electronic correspondence, as soon as practicable, but not later than [**] following the applicable Party’s receipt, forwarding, or production thereof. Otherwise, each Party shall provide all such correspondence, communications, minutes, summaries, contact reports, and other materials within (a) [...
Correspondence with Authorities. Without limiting the generality of clauses 2.2 and 2.3, the parties must:
Correspondence with Authorities. Except as otherwise set forth in this Agreement, and without limiting Section 3.3.1 (Regulatory Submissions), promptly following the Regulatory Responsible Party’s receipt, forwarding, or production thereof, the Regulatory Responsible Party will provide the other Party with (a) access to or copies of all material written or electronic correspondence and communications (other than Regulatory Submissions) received by the Regulatory Responsible Party or its Affiliates or Sublicensees from, or forwarded by the Regulatory Responsible Party or its Affiliates or Sublicensees to, the Regulatory Authorities in the Territory, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by the Regulatory Responsible Party or its Affiliates or Sublicensees with the Regulatory Authorities in the Field in the Territory. If such written or electronic correspondence received from any such Regulatory Authority relates to the prohibition or suspension of the supply of a Licensed Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Licensed Product, then the Regulatory Responsible Party will notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable, but not later than [***] after receipt of such correspondence.
Correspondence with Authorities. Copies of all correspondence with authorities shall be sent at the same time to the Department’s Representative.
