Correspondence with Authorities. Unless prohibited by Applicable Law in a particular country in the Territory, the Responsible Party will have the right to conduct all communications with Regulatory Authorities in the Territory related to the Products, including all written or electronic correspondence and meetings, conferences, and discussions (including advisory committee meetings). Without limiting Section 5.2.2 (Regulatory Filings), no later than five Business Days following receipt thereof each Responsible Party will provide the PCC with (a) access to or copies of all substantive written or electronic correspondence and communications received by that Responsible Party (or its Affiliates, Sublicensees, or Subcontractors) from, or forwarded by that Responsible Party (or its Affiliates, Sublicensees, or Subcontractors) to, the Regulatory Authorities in the Territory, and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by that Responsible Party (or its Affiliates, Sublicensees, or Subcontractors) with the Regulatory Authorities in the Territory, including copies of all contact reports produced by that Responsible Party (or its Affiliates, Sublicensees, or Subcontractors), in each case (subsections (a) and (b)), relating to the Products 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 Product, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning the safety of a Product, then the Responsible Party will notify the other Party and provide the other Party with copies of such written or electronic correspondence as soon as practicable and, in any event, within two Business Days after receipt of such correspondence. Without limiting the foregoing, the Responsible Party for each country in the Territory will provide the other Party with a reasonable opportunity to review and comment on all substantive written or electronic correspondence and communications to be submitted to any Regulatory Authority in the Territory by or on behalf of the Responsible Party with respect to each Product in the applicable country reasonably in advance of the date such correspondence is to be finalized to allow for the other Party’s review and comment. The Responsible Party for each country in the Territory will, and will cause its Affiliates (and, in the case of ALJ as the Responsible Party, Sublicensee...
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. Without limiting the generality of clauses 2.2 and 2.3, the parties must:
(a) use all reasonable endeavours in good faith to diligently pursue the applications to the extent required to satisfy each Condition Precedent;
(b) in the case of D&J, AMS and DMS, provide to EFR drafts of all material applications, agreements, consents and releases to be entered into between D&J, AMS, DMS, the JV Company and/or any Affiliate of D&J and Third Parties, and not to execute the same until EFR has agreed to their terms and conditions (acting reasonably);
(c) before any submission or correspondence is sent to any Authority, consult with the other party in relation to, and provide the other party with a draft copy of, and the opportunity to comment on, such submission or correspondence as soon as practical;
(d) provide reasonable notice to the other party of all material communications between it and any Authority, for the purposes of satisfying the Conditions Precedent (including any letters, meetings and written submissions);
(e) respond to reasonable requests for information that are made by any Authority at the earliest practicable time;
(f) in the case of D&J, AMS and DMS, provide to EFR such reasonably necessary information and assistance as EFR may reasonably request in connection with its preparation and filing of the FIRB Submission; and
(g) in the case of clauses 2.4(b) and 2.4(c), EFR approval will be deemed to be given if no opposition or comments have been provided by EFR within 5 Business Days after the relevant document has been provided to EFR (or such alternative period as agreed by the parties (acting reasonably)).
Correspondence with Authorities. Copies of all correspondence with authorities shall be sent at the same time to the Department’s Representative.
