Review of Correspondence. The Lead Regulatory Party shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.
Review of Correspondence. To the extent practicable, the Developing Party shall provide the Non-Developing Party with drafts of any documents or other correspondence to be submitted to the applicable Regulatory Authorities with respect to a Licensed Compound or Licensed Product or in connection with any Development activity of the Non-Developing Party, sufficiently in advance of submission for the Non-Developing Party to review any such submission, and the Non-Developing Party may comment on such documents, in which case the Developing Party shall consider in good faith all such comments. The Developing Party shall provide to the Non-Developing Party as soon as reasonably practicable, copies of any documents or other correspondence received from Regulatory Authorities with respect to a Licensed Compound or Licensed Product or in connection with any Development activity of the Non-Developing Party (including any meeting minutes).
Review of Correspondence. To the extent practicable, Celgene shall provide Acceleron with drafts of any documents or other correspondence to be submitted (i) to the applicable Regulatory Authorities in North America, (ii) to Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in each case, pertaining to each Licensed Compound or Licensed Product, sufficiently in advance of submission for Acceleron to review any such submission, and Acceleron may comment on such documents to the extent that they are intended to be submitted (i) to the applicable Regulatory Authorities in North America, (ii) to Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in which case Celgene shall consider in good faith all such comments. Celgene shall provide to Acceleron, as soon as reasonably practicable, copies of any documents or other correspondence received (i) from Regulatory Authorities in North America, (ii) from Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in each case, pertaining to each Licensed Compound or Licensed Product (including any meeting minutes).
Review of Correspondence. The Lead Regulatory Party shall promptly provide to the other Party copies of any documents or other correspondence received from the applicable Regulatory Authorities pertaining to each Product (including, without limitation, any meeting minutes). To the extent practicable, the Lead Regulatory Party shall, subject to applicable Law, provide the other Party with drafts of any documents or other correspondence to be submitted to Regulatory Authorities pertaining to each Product, sufficiently in advance of submission so that such other Party may review and comment on such documents and other correspondence and have a reasonable opportunity to influence the substance of such submissions, as it may affect the Development or Commercialization of such Product. The Lead Regulatory Party agrees to consider all such comments in good faith, taking into account the best interest of such Product on a global basis. If, after considering in good faith the other Party's comments regarding the content of a proposed submission to a Regulatory Authority, the Lead Regulatory Party disagrees with such other Party's view, the Lead Regulatory Party shall notify such other Party in writing (a "Notice of Disagreement"). If such other Party believes that the Lead Regulatory Party's proposed submission is likely to have a material adverse effect on the Development or Commercialization of such Product on a global basis, it shall so notify the Lead Regulatory Party, and, provided that such notification is delivered to the Lead Regulatory Party within three (3) Business Days following receipt of the Notice of Disagreement, such other Party shall have the right to request that the Joint Operations Committee immediately convene, either in person or by telephone, in order to discuss the matter, in which case such meeting shall occur within three (3) Business Days following such other Party's request. If, after the discussions of the Joint Operations Committee, the Parties remain in disagreement regarding the proposed submission, the Lead Regulatory Party may file such submission as it reasonably deems appropriate; provided, however, that any such submission shall not be inconsistent with the best interest of such Product on a global basis, and shall not be inconsistent with the relevant approved Development Plan. Notwithstanding anything to the contrary contained herein, Idenix shall not file any submissions with respect to any Early Selection Compound or Selected Drug Candidate (includi...
Review of Correspondence. IMPH shall use reasonable efforts to provide with at least ten (10) Business Days advance notice of any material meeting with Competent Authorities which is for the purpose of obtaining Regulatory Approval for any Licensed Product. To the extent reasonably practicable and subject to any Third Party confidentiality obligations, IMPH shall provide drafts of any material documents or correspondence pertaining to any Licensed Product prepared for submission to the Competent Authority sufficiently in advance of submission so that iCo may review and comment on the substance of such material documents or correspondence. IMPH shall promptly provide copies of any material documents or other correspondence received from the Competent Authority pertaining to Licensed Product.
Review of Correspondence. The Lead Regulatory Party shall regularly inform the other Party of its current and planned regulatory activities and shall provide the other Party with drafts of any material documents and other material correspondence to be submitted to a Regulatory Authority pertaining to an LCA Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any material documents or other material correspondence received from or submitted to a Regulatory Authority pertaining to an LCA Product.
Review of Correspondence. 57 5.5 Assistance....................................................................................58 ARTICLE 6
Review of Correspondence. To the extent practicable, the Lead Regulatory Party shall provide the other Party with drafts of any documents or other correspondence to be submitted to the FDA or HPB pertaining to the relevant Joint Development Compound or Joint Development Product, sufficiently in advance of submission so that the other Party may review and comment on such documents and other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide to the other Party copies of any documents or other correspondence received from the FDA and HPB pertaining to the relevant Joint Development Compound or Joint Development Product (including without limitation any meeting minutes). To the extent relevant to the Development of a Joint Development Compound for North America, Aventis shall, subject to applicable Laws, provide Millennium with drafts of any documents or other correspondence to be submitted to regulatory authorities outside of North America pertaining to the relevant Joint Development Compound or Joint
Review of Correspondence. Subject to the terms of this Agreement (including Sections 2.3.2 and 2.3.3), to the extent practicable and to the extent a Party has the right under this Agreement to submit such documents or other correspondence, the submitting Party shall provide the other Party with drafts of any documents or other correspondence to be submitted to the applicable Regulatory Authorities pertaining to a Licensed Compound or Licensed Product in the Field in the Territory, sufficiently in advance of submission for the other Party to review any such submission, and such other Party may comment on such documents, in which case the submitting Party shall consider in good faith all such comments. The submitting Party shall provide to the other Party, as soon as reasonably practicable, copies of any documents or other correspondence received from Regulatory Authorities pertaining to each Licensed Compound or Licensed Product (including any meeting minutes).
Review of Correspondence. The Lead Regulatory Party shall provide the other Party with drafts of any material documents or other material correspondence (as generally determined by the Joint Development Committee pursuant to Section 4.2.3(h)) to be submitted to Regulatory Authorities pertaining to the relevant Joint DDC or Joint Product, including without limitation all proposed labeling, sufficiently in advance of submission so that the other Party may review and approve such documents and other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide to the other Party copies of any material documents or other material correspondence (in local language), including without limitation all proposed labeling, received from Regulatory Authorities pertaining to the relevant Joint DDC or Joint Product. The Lead Regulatory Party shall promptly provide the other Party with copies of all other documents and correspondence (in local language) after they have been submitted to, or received from, Regulatory Authorities. Both Parties shall agree on the final labeling for any Joint Product.
