Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions (including supplements and amendments thereto) to each applicable Regulatory Authority with respect to the VEGF Product in the jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article 7. The Lead Regulatory Party shall perform all such activities in accordance with the Co-Development Plans, Global Co-Commercialization Plans, applicable Country Co-Commercialization Plans, and all applicable Laws.
Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate applicable regulatory actions, communications and filings with and submissions (including supplements and amendments thereto) to each applicable Regulatory Authority with respect to each Licensed Product in the Field in each jurisdiction as to which it is the Lead Regulatory Party; provided that it shall adhere to the obligations in this Article VII. Without limiting the foregoing, the Lead Regulatory Party will be responsible for, and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining the applicable Approval or other Registration Filing for each Licensed Product in the Field for which it has responsibility as the Lead Regulatory Party. To the extent applicable, the Lead Regulatory Party shall perform all such activities in accordance with the Plans and all applicable Laws.
Regulatory Coordination. The Parties shall cooperate in (i) analyzing and reacting to pending material Applicable Law changes and discussing regulatory developments affecting the Program, including any of the Financial Products or Accounts established thereunder, and (ii) subject to Applicable Law regarding the confidentiality of Bank supervisory matters, responding to Regulatory Authorities regarding regulatory-related requests to the Parties.
Regulatory Coordination. (a) The Parties acknowledge and agree that beginning with the First Amendment Effective Date, neither Sanofi nor its Affiliates shall have any interest or rights whatsoever in or to any (i) biologics license application (as described in FDA regulations, including all amendments and supplements to the application and any equivalent filing with a Regulatory Authority (“BLA(s)”), (ii) investigational new drug applications (as described in FDA regulations, including all amendments and supplements to the application and any equivalent filing with any Regulatory Authority outside of the United States (“IND(s)”), (iii) registration filings to the relevant Regulatory Authority of an appropriate application seeking any Approval (“Registration Filings”), and (iv) any Approvals, in each of (i) through (iv) for any Excluded Ocular ANG2 Products, except as set forth in Section 10(c) of this First Amendment. There is no Lead Regulatory Party or non-Lead Regulatory Party for the Excluded Ocular ANG2 Products. For the purposes of this Section 10, “Approvals” shall mean, with respect to the applicable ANG2 Licensed Product or Excluded Ocular ANG2 Product, as the case may be, any marketing approvals, pricing approvals, registration, license or authorization from any Regulatory Authority required for the development, manufacture or commercialization of such product in the Field or Excluded Field, as the case may be, in a regulatory jurisdiction anywhere in the world, and shall include, without limitation, any approval, registration, license or authorization granted in connection with any Registration Filing.
Regulatory Coordination. IMPH will have exclusive control over, and authority and responsibility for, the regulatory strategies relating to the development and commercialization of all Licensed Products for use in the Licensed Field, including, without limitation (i) the preparation of all documents submitted to Competent Authorities and the filing of all INDs, Drug Approval Applications and other submissions relating to Licensed Products and (ii) all regulatory actions, communications and meetings with any Regulatory Authority with respect to any Licensed Products in the Licensed Field. IMPH shall use Reasonable Endeavors to prepare, file and prosecute all regulatory filings as needed to obtain Marketing Approvals of Licensed Product as soon as practicable in each country in the Territory where it is commercially reasonable to market Licensed Product. Subject to any confidentiality obligations to Third Parties, each Party shall provide to the other Party on a timely basis all information controlled by such Party or otherwise in such Party’s possession as a result of its activities under this Agreement that is necessary for the other Party to comply with all regulatory obligations on a global basis applicable to Licensed Products (in the case of IMPH) or Ocular Products (in the case of iCo), including filing updates, information amendments, annual reports, pharmacovigilance filings, preclinical research data, preclinical study reports, investigator notifications and chemistry, manufacturing and controls information in relation to iCo-008, the Licensed Product or Ocular Product, each of the foregoing to the extent necessary for the other Party. For clarity, IMPH is responsible for all adverse event and other safety reporting worldwide with respect to Licensed Products. All updates and reports provided hereunder shall be provided in a form as reasonably required by each Party for inclusion in any regulatory submission. IMPH shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities with respect to any Licensed Product. The Parties shall cooperate with each other to provide all reasonable assistance and take all actions reasonably requested by the other Party that are necessary to comply with any law applicable to any Licensed Product and Ocular Product, as the case may be, including, but not limited to, providing the other Party with reasonable access during ordinary business hours and upon reasonable written notice to its personnel, as reasonabl...
Regulatory Coordination. (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including supplements and amendments thereto, to, each applicable Regulatory Authority with respect to the IL-1 Product in the jurisdiction as to which it is the Lead Regulatory Party. The Lead Regulatory Party shall perform all such activities in accordance with the Joint Steering Committee-approved Consolidated Co-Development Plans and Consolidated Co-Commercialization Plans. (b) The Parties shall establish procedures to ensure that the Parties exchange on a timely basis all necessary information to enable the Lead Regulatory Party to comply with all regulatory obligations on a global basis, including, without limitation, filing -51- <PAGE> updates or supplements with Regulatory Authorities, pharmacovigilance filings, manufacturing supplements, and investigator notifications to Regulatory Authorities. The Parties shall provide to each other prompt notice of any Approval of an IL-1
Regulatory Coordination. A. These services include regulatory coordination with USACE and USFWS in support of a Section 10/404 permit. It is assumed that the following basic permit steps and processes will be conducted as part of this task:
Regulatory Coordination. The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to Regulatory Authorities with respect to the relevant Joint DDC or Joint Product.
Regulatory Coordination. Regeneron and its Affiliates and licensees shall have, and Aventis and its Affiliates hereby grant to Regeneron and its Affiliates and licensees, the right to reference the BLA(s), IND(s), and any Registration Filings and/or Approvals requested by Regeneron to support Regeneron’s (and its Affiliates’ and licensees’, as applicable) IND, BLA, Registration Filings and/or Approvals for Excluded Ocular VEGF Products anywhere in the world. Promptly upon the request of Regeneron, Aventis or its Affiliate shall submit a letter of authorization to FDA or the applicable Regulatory Authority (and take such actions or make such other filings) in order to permit any VEGF Product IND, BLA, Registration Filing and/or Approval to be incorporated by reference in such Excluded Ocular VEGF Product regulatory filings. Both Parties will cooperate with each other to develop and follow specific procedures to be agreed upon to coordinate the exchange of necessary safety/pharmacovigilance information from VEGF Products Developed and Commercialized as part of the Collaboration and Excluded Ocular VEGF Products developed and commercialized by Regeneron and its licensees to ensure prompt communication of such notifications and compliance with reporting obligations to Regulatory Authorities.
Regulatory Coordination. (a) Lung Rx shall be responsible for preparing, filing and managing all regulatory filings and efforts seeking all Regulatory Approvals in the Territory. All regulatory filings for the Product in the Territory shall be filed in the name of Lung Rx, and Lung Rx alone shall be responsible for all communications and other dealings with Regulatory Authorities relating to the Product in the Territory. As between the Parties, Lung Rx shall be the sole and exclusive legal and beneficial owner of all regulatory applications, clinical data, Regulatory Dossiers and Regulatory Approvals in the Territory. Lung Rx shall have the final authority to make all clinical and regulatory decisions with respect to the registration of Products within the Territory in its sole discretion. Lung Rx shall have the right to reference any of Aradigm’s regulatory files Controlled by Aradigm relating to the AERx pulmonary drug delivery system, in connection with regulatory filings made by or on behalf of Lung Rx and Aradigm shall reasonably cooperate with Regulatory Authorities in connection therewith.
