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) supply Company with a copy of any correspondence from the FDA regarding the Study, including any IND, approval letter, and any other IND-related correspondence; and (d) allow Company a reasonable opportunity to comment on any correspondence being sent to the FDA by MSK or Investigator-Sponsor regarding the Study, including any submitted IND and IND annual reports.
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. Upon Grantor’s written request, copies of all non-routine and material communications between the Grantee and the Federal Communications Commission, or any other agency having jurisdiction in respect to any matters affecting the cable communications operations authorized by this Agreement, must be submitted to the Grantor within 10 days after their receipt or submittal by Grantee.
Communications with Regulatory Agencies. 5.1 The parties shall mutually agree upon a strategy for all communications by Baxter with applicable regulatory authorities in connection with the Products.
5.2 Baxter 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. Baxa shall promptly communicate to CDEX all material matters communicxxxx between Baxa and any applicable Regulatory Agency that relate to the Products. Xxxa shall endeavor to limit such communications to matters that it ix xxquired by law to discuss with such an agency.
Communications with Regulatory Agencies. Subject to the respective obligations of the parties set forth in the Transition Services Agreement, from and after the Closing Date, JDS shall have responsibility for all communication with the FDA with respect to the matters relating to the Product in or with respect to the Territory. From and after the Closing Date, Synthon shall make available to JDS, copies of all correspondence to or from the FDA or other applicable Regulatory Authority relating to the manufacturing and testing of the Product. From and after the Closing Date, Synthon shall make available to JDS copies of all regulatory correspondence regarding regulatory warning letters, withdrawal of any Product, and correspondence bearing on the safety and efficacy of the Product.
Communications with Regulatory Agencies. (a) Upon written request, Grantee shall submit to Grantor copies of any pleading, applications, notifications, communications and documents of any kind, submitted by Grantee or its Affiliates to any federal, State or local courts, regulatory agencies and other government bodies if such documents directly relate to the operations of Grantee 's Cable System within the Franchise Area. Grantee shall submit such documents to Grantor no later than thirty (30) Days after receipt of Xxxxxxx's request. Grantee shall not claim confidential, privileged or proprietary rights to such documents unless under federal, State, or local law such documents have been determined to be confidential by a court of competent jurisdiction, or a federal or State agency. With respect to all other reports, documents and notifications provided to any federal, State or local regulatory agency as a routine matter in the due course of operating Grantee 's Cable System within the Franchise Area, Grantee shall make such documents available to Grantor upon Grantor's written request.
(b) In addition, Grantee and its Affiliates shall within ten (10) Days of any communication to or from any judicial or regulatory agency regarding any alleged or actual violation of this Franchise, Grantor regulation or other requirement relating to the System, use its best efforts to provide the Grantor a copy of the communication, whether specifically requested by the Grantor to do so or not.
Communications with Regulatory Agencies. 12.4.1 If either Party (a) has the responsibility or right to make a submission to or filing with, or to communicate with, a Regulatory Agency pursuant to this Agreement or (b) is required pursuant to Legal Requirements to make a given submission or filing, or to communicate with, a Regulatory Agency, such Party shall, if not legally prohibited and if reasonably practicable, notify the other Party in advance and consult with such Party with respect to such submission, filing and communication to the extent that it is material to the development, commercialization or regulatory status of the applicable Product. In any event, each Party shall promptly notify the other Party of all material filings and submissions with any Regulatory Agency such Party has made with respect to the applicable Product, and shall include a summary of the contents of any such Regulatory Filing or submission. Each Party shall reasonably cooperate with the other Party regarding submissions to and Regulatory Filings with Regulatory Authorities with respect to Products 12.4.2 Neither Party shall make any material or substantive submissions, filings or communications with any Regulatory Agency, with respect to any Product without first providing the other Party written notice of the content and purpose of such submission, filings or communication, unless the timing imposed by Legal Requirements for making a given submission, filing or communication makes it not reasonably practicable to provide the other Party such advance notice. Notwithstanding the foregoing, the Party then responsible for clinical development of the applicable Initial Indication shall after consultation with the other Party be entitled to make all submissions and filings to the applicable Regulatory Agencies it deems appropriate, and have communications with applicable Regulatory Agencies as required by any legal requirement.
