Communications with Regulatory Agencies Clause Samples

Communications with Regulatory Agencies. MSK will, to the extent permitted by law and MSK policy, and after review by MSK’s legal counsel (a) notify Company of any communications from or to any regulatory authority having an impact on the Study; (b) include Company in any discussions or meetings with the FDA regarding the Study; (c) allow Company a reasonable opportunity to comment on any correspondence being sent to the FDA by MSK or Investigator-Sponsor regarding the Study; and (d) allow Company a reasonable opportunity to review copies of the “Safe to Proceed” letter from the FDA.”

Communications with Regulatory Agencies. Prior to the transfer of the Current NDAs to Jazz Pharmaceuticals, Solvay shall have primary responsibility for communications with the FDA; provided, however, that (a) Solvay will promptly provide Jazz Pharmaceuticals with copies of all correspondence (and summaries of all communications) from or to the FDA with respect to the API and the Products and the Current NDAs, (b) Jazz Pharmaceuticals will have the right to review and comment upon any filings and correspondence from Solvay to the FDA with respect to the API, the Products and the Current NDAs prior to filing and Solvay will include any changes reasonably requested by Jazz Pharmaceuticals; (c) Jazz Pharmaceuticals will have the right to participate in all meetings and significant telephone calls with the FDA with respect to the API, the Products and the Current NDAs and (d) Solvay will not make any agreements with, or commitments to, the FDA or otherwise in connection with the API, the Products or the Current NDAs between the Effective Date and the Closing Date, and thereafter until the effective date of the transfers of the Current NDAs, without the prior written consent of Jazz Pharmaceuticals, which consent shall not be unreasonably delayed or withheld. After the transfer of the each Current NDA (and the corresponding INDs), Jazz Pharmaceuticals shall have responsibility for all communications with the FDA with respect matters relating to the Products and the Current NDAs and corresponding INDs. To the extent reasonably requested by Jazz Pharmaceuticals, Solvay will cooperate with and assist Jazz Pharmaceuticals in its communications with the FDA relating to the Products and the Current NDAs and corresponding INDs for a reasonable transition period after the effective date of the transfers of the Current NDAs.

Communications with Regulatory Agencies. Copies of all publicly available petitions, applications, communications and reports submitted by Grantee, to any federal or state regulatory commission or agency relating to the Cable System operated pursuant to this Franchise shall also be made available to the Grantor upon request. Copies of publicly available responses from the regulatory agencies to Grantee shall likewise be made available to the Grantor upon request.

Communications 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 or any Cable Operator of the Cable System authorized by this Franchise, to the FCC, Securities and Exchange Commission, or any other federal or state regulatory commission or agency having jurisdiction in respect to any matters affecting Cable System operations authorized pursuant to this Franchise Agreement, shall 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 operations of the Cable System within the Franchise Area shall 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 of the Cable System authorized by this Franchise.

Communications with Regulatory Agencies. Licensee shall have sole responsibility for all communication with the FDA and other applicable Regulatory Authorities in the Recro Territory with respect to all matters relating to the Recro Product. From and after the Effective Date, each Party shall, or shall cause its Affiliates to, promptly make available to the other Party copies of all relevant correspondence with any Regulatory Authority regarding regulatory warning letters, withdrawal of the Recro Product, and correspondence bearing on the safety and/or efficacy of the Recro Product, as well as all minutes from meetings with Regulatory Authorities regarding Recro Product.

Communications with Regulatory Agencies. 5.1 The parties shall mutually agree upon a strategy for all communications by ▇▇▇▇▇▇ with applicable regulatory authorities in connection with the Products. 5.2 ▇▇▇▇▇▇ shall be responsible for communications with applicable regulatory authorities in the Territory if such regulatory authorities require notification in connection with their regulation of the Products.

Communications with Regulatory Agencies. Upon request, the Franchisee shall provide the City with a copy of any document (redacted and confidential information excluded) filed by the Franchisee with any regulatory agency or other legislative body (other than publicly available agency mailings or publications) that materially and expressly pertains to the provision of Cable Services within the City

Communications with Regulatory Agencies. From and after the Effective Date, Licensee shall have responsibility for all communication with the FDA and other applicable Regulatory Authorities with respect to all matters relating to the Licensed Products in the Territory, and Licensor shall not make any such communications with the FDA or other applicable Regulatory Authority without the prior written consent of Licensee. From and after the Effective Date, each Party shall, or shall cause its Affiliates or agents to, promptly make available to the other Party copies of all correspondence with any Regulatory Authority regarding regulatory warning letters, withdrawal of any Licensed Product, and correspondence bearing on the safety and efficacy of the Licensed Product.

Communications with Regulatory Agencies. Subject to the respective obligations of the Parties set forth in the Transition Plan, from and after the Transition Date (or, if earlier, the date of transfer of the NDA Approval to Orexo in accordance with Section 8.6(a) above), Orexo shall have responsibility for all communication with the FDA with respect to the matters relating to the Product in or with respect to the Orexo Territory. From and after the Signature Date, Strakan shall make available to Orexo, copies of all correspondence to or from the FDA or other applicable regulatory authority relating to the manufacturing and testing of the Product in the Orexo Territory. From and after the Signature Date, Strakan shall make available to Orexo copies of all regulatory correspondence regarding regulatory warning letters, untitled letters, and correspondence bearing on the safety and efficacy of the Product in the Orexo Territory.