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. 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. (1) The Grantee shall file with the County a copy of certain communications with regulatory agencies, as follows:
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. 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, 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.
Communication with Regulatory Agencies. Upon being contacted by the FDA in the Co-Promotion Country prior to or during the Term of Co-Promotion for any regulatory purpose pertaining to this Agreement or to a Collaboration Product which the parties are co-promoting pursuant to Section 7, CoCensys and Warner shall promptly, but always within 2 business days, notify and consult with one another and the party which has filed the Drug Approval Application in the Co-Promotion Country or, if no Drug Approval Application has been filed, the party which has filed the IND shall provide an appropriate response. Upon being contacted by any drug regulatory agency in any non-Co-Promotion Country prior to or during the Term of Co-Promotion for any regulatory purpose which is relevant to the development or commercialization of such Collaboration Product, Warner shall promptly, but always within 2 business days, notify CoCensys of the content of such contact. In non-Co-Promotion Countries, Warner shall have the sole right and responsibility to respond to any regulatory agency with respect to any Collaboration Product.
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. Within fifteen (15) days, the Franchisee shall file with the County a copy of any document filed by the Franchisee with a regulatory agency (other than publicly available information) that materially and expressly pertains to the County with respect to the provision of Cable Service. In addition, the Franchisee must provide the County (upon request) any document the Franchisee files or receives from any regulatory agencies.
