Communication with Regulatory Agencies. The Concessioner must provide timely written advance notice to the Director of communications, including without limitation, meetings, audits, inspections, hearings and other proceedings, between regulatory agencies and the Concessioner related to compliance with Applicable Laws concerning operations under this Contract. The Concessioner must also provide to the Director any written materials prepared or received by the Concessioner in advance of or subsequent to any such communications. The Concessioner must allow the Director to participate in any such communications. The Concessioner must also provide timely notice to the Director following any unplanned communications between regulatory agencies and the Concessioner.
Communication with Regulatory Agencies. If a Party is contacted by the FDA or any equivalent regulatory agency in any country in the Territory during the Term pertaining to this Agreement or to a Product, Tularik and JT shall promptly, but always within [ * ] days, notify and consult with one another. The Party that has filed the Drug Approval Application in such country within the Territory or, if no Drug Approval Application has been filed, the Party which has filed the IND (or foreign equivalent) in such country within the Territory shall provide an appropriate response to such contact after such consultation with the other Party.
Communication with Regulatory Agencies. A list and copies of all material written petitions, applications, communications, and reports submitted by the Grantee, and also by any Affiliate, to the Federal Communications Commission, Securities and Exchange Commission, or any other federal or state regulatory commission or agency having jurisdiction in respect to any matters affecting Cable Services or the Cable System in the Franchise Area pursuant to this Franchise, will be submitted to the Grantor upon request. In addition, copies of any communications to and from any regulatory agency pertaining to any alleged, apparent or acknowledged violation of an applicable rule or law of the agency related to or affecting Cable Services or the Cable System within the Franchise Area, will be immediately submitted to the Grantor, if the communications are to or from the Grantee, or upon written request from the Grantor if the communications are to or from an Affiliate.
Communication with Regulatory Agencies. If a party is contacted by the FDA or any equivalent regulatory agency in any country in the Territory during the term of this Agreement pertaining to a Shared Product, Immusol and NeoGenesis shall promptly, but always within two (2) business days, notify and consult with one another. The party that has responsibility for regulatory filings for a Shared Product shall provide an appropriate response to such contact after such consultation with the other party, except where an earlier response may be required by law or to assure patient safety.
Communication with Regulatory Agencies. The Concession Contractor shall provide to the Contracting Officer timely written advance notice of communications, meetings, audits, inspections, hearings, and other proceedings, between regulatory agencies and the Concession Contractor related to compliance with Applicable Laws concerning operations under this Concession Contract. The Concession Contractor shall also provide to the Contracting Officer any written materials prepared or received by the Concession Contractor in advance of or subsequent to any such communications. The Concession Contractor shall allow the Contracting Officer to participate in any such communications. The Concession Contractor shall notify the Contracting Officer immediately following any unplanned communications between regulatory agencies and the Concession Contractor.
Communication with Regulatory Agencies. (1) The Grantee shall file with the County a copy of certain communications with regulatory agencies, as follows:
(A) Any document (other than routine, publicly available agency mailings or publications) the Grantee files with or receives from the FCC, the Securities and Exchange Commission, or the Virginia State Corporation Commission, or any successor agency of any of these agencies, that relates to its Cable System and/or the provision of Cable Services under Chapter 9.1 or this Agreement, within five working days of such filing or receipt;
(B) Any document the Grantee files with or receives from other agencies, upon the County’s request;
(C) Any document that any parent of the Grantee files with or receives from any agency that directly and materially relates to the Grantee’s Cable System and/or the provision of Cable Services under this Agreement, within five working days of such filing or receipt.
(2) For purposes of this subsection 9(b), documents filed by the Grantee or a parent shall include all documents filed by or on behalf of the Grantee or its parent, but shall not include documents filed by trade associations to which the Grantee or its parent may belong unless the Grantee or a parent has authorized the use of its name by such trade association among the filing parties and its name is used.
(3) To the extent that such documents contain, to the satisfaction of the Communications Administrator, the information required by other reports hereunder, the Communications Administrator may suspend the requirement to file such other reports with the County so as to avoid duplication and the administrative costs attendant thereto.
Communication with Regulatory Agencies. (1) The Grantee shall file with the County a copy of certain communications with regulatory agencies, as follows:
(A) any document (other than routine, publicly available agency mailings or publications) the Grantee files with or receives from the FCC, the Securities and Exchange Commission, or the Virginia State Corporation Commission, or any successor agency of any of these agencies, within five (5) working days of such filing or receipt;
(B) any document the Grantee files with or receives from other agencies, upon the County's request;
(C) any document that any parent of the Grantee files with or receives from any agency that directly and materially relates to the Grantee's Cable System and/or the provision of Cable Services under this Agreement, within five (5) working days of such filing or receipt.
(2) For purposes of this subsection 9(b), documents filed by the Grantee or a parent shall include all documents filed by or on behalf of the Grantee or its parent, but shall not include documents filed by trade associations to which the Grantee or its parent may belong unless the Grantee or a parent has authorized the use of its name by such trade association among the filing parties and its name is used.
(3) To the extent that such documents contain, to the satisfaction of the Communications Administrator, the information required by other reports hereunder, the Communications Administrator may suspend the requirement to file such other reports with the County so as to avoid duplication and the administrative costs attendant thereto.
Communication with Regulatory Agencies. 9.8.1. If and to the extent requested by the City, Franchisee shall file with the City, in form acceptable to the City, all reports and materials submitted to the FCC, the Security and Exchange Commission, or any other federal or state regulatory commission or agency, including, but not limited to, any proof of performance tests and results, Equal Employment Opportunity reports, and all petitions, applications, and communications of all types regarding the Cable System, or a group of cable systems of which the Cable System is a part, submitted by Franchisee, an Affiliate of Franchisee, or any other person on behalf of Franchisee.
9.8.2. Materials filed with the City pursuant to Subsection 9.8.1. shall be submitted by Franchisee, an Affiliate, or any other person on behalf of Franchisee at the time they are submitted to the receiving agency.
Communication with Regulatory Agencies. If a Party is contacted by the FDA or any equivalent regulatory agency in any country in the Territory during the Term pertaining to this Agreement or to a Product, Tularik and JT shall promptly, but always within [*] notify and consult with one another. The Party that has responsibility for regulatory filings for a Product shall provide an appropriate response to such contact after such consultation with the other Party, except where an earlier response may be required by law or to assure patient safety.
Communication with Regulatory Agencies. If a party is contacted by the FDA or any equivalent regulatory agency in any country in the Territory during the term of this Agreement pertaining to a Shared Product, Tularik and NeoGenesis shall promptly, but always within [*], notify and consult with one another. The party that has responsibility for regulatory filings for a Shared Product shall provide an appropriate response to such contact after such consultation with the other party, except where an earlier response may be required by law or to assure patient safety. * = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
