Preparation of Regulatory Filings. Each Party, at such Party’s sole cost and expense unless otherwise provided for herein, shall be responsible for preparing, filing, and maintaining, and shall own, the regulatory filings relating to the Product as set forth below:
Preparation of Regulatory Filings. Aspreva has the right to receive copies of the [ * ], which Roche shall provide upon request by Aspreva. Aspreva shall prepare all Regulatory Filings for the Product in the Field in the Territory in a form that is consistent with, and in accordance with, the [ * ], and the Development Plan. The Parties anticipate that as they work together under this Agreement, the [ * ] may be revised by the JC to facilitate the timely preparation of Regulatory Filings.
Preparation of Regulatory Filings. (a) Licensed Products in the Sanofi Field.
Preparation of Regulatory Filings. BMS shall prepare and draft all filings (including any supplements or modifications thereto and including the preparation of any electronic submission of a Drug Approval Application) to Regulatory Authorities in each such country for such Royalty-Bearing Product. Each Party shall keep the other Party informed with respect to, and shall promptly provide to the other Party copies of, all material written or electronic communications received by it from, or sent by it to: (i) a Regulatory Authority in the U.S., Japan, a Major European Country or for the EU; and (ii) a Regulatory Authority in a country or jurisdiction other than U.S., Japan, a Major European Country or for the EU to the extent that the substance of such communications: (A) vary materially from what such Party has already disclosed to the other Party with respect to the U.S., Japan, a Major European Country or for the EU under this Section 4.5(a); and (B) [ * ].
Preparation of Regulatory Filings. BMS shall prepare and draft all filings (including any supplements or modifications thereto and including the preparation of any electronic submission of a Drug Approval Application) to Regulatory Authorities in each such country for such Royalty-Bearing Product. Each of BMS and EXEL shall keep the other Party informed with [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. respect to, and shall promptly provide to the other Party copies of, all material written or electronic communications received by it from, or sent by it to: (i) a Regulatory Authority in the U.S., Japan, a Major European Country or for the EU; and (ii) a Regulatory Authority in a country or jurisdiction other than U.S., Japan, a Major European Country or for the EU to the extent that the substance of such communications: (A) vary materially from what such Party has already disclosed to the other Party with respect to the U.S., Japan, a Major European Country or for the EU under this Section 4.5(a); and (B) [*].
Preparation of Regulatory Filings. MAP is solely responsible for preparing, filing, and maintaining, and shall own, the regulatory filings relating to the Product as set forth in this Section 4.1. MAP shall, at its election, prepare and maintain Drug or Device Master Files (as the case may be) covering the Formulation, including the Particulate Formation of Compound, and a Device. MAP (or its sublicensee) shall be responsible for preparing the regulatory submissions for, and obtaining and maintaining, all Regulatory Approvals in the Territory. MAP, as the owner of such Regulatory Approvals is responsible for all interactions with Regulatory Authorities relating thereto. NEKTAR UK shall cooperate with MAP in the preparation and maintenance of such regulatory submissions and Regulatory Approvals pursuant to Section 3.4(a) and if and to the extent agreed pursuant to Section 3.3(a)(iii).
Preparation of Regulatory Filings. MRVT shall be responsible for preparing and filing in its own name any regulatory filings necessary for conducting Clinical Tests.
Preparation of Regulatory Filings. AMBION shall consult with ROSETTA in good faith in connection with the preparation of all Regulatory Filings for Collaboration Products and Collaboration Services. AMBION shall consider all comments of ROSETTA in good faith, taking into account the best interests of the Collaboration and of the Development and Commercialization of the applicable Collaboration Product and/or Collaboration Service on a global basis. In addition, subject to any Third Party confidentiality obligations, AMBION shall promptly provide ROSETTA with copies of any document or other correspondence received from the FDA pertaining to any Collaboration product and/or Collaboration Service.
Preparation of Regulatory Filings. 20 5.3 Notice of Communication with Regulatory Authorities. ..................................21 5.4
Preparation of Regulatory Filings. (a) The Parties will develop and agree to a detailed regulatory plan for the Product in or for the Territory (the “Regulatory Plan”), which Regulatory Plan, once mutually agreed by the Parties, will be deemed to form part of the Development Plan. Unless otherwise provided in the Development Plan, each Party, unless otherwise provided for in this Agreement, will be responsible for preparing, filing, and maintaining, and will own, the regulatory filings relating to the Product as set forth in Section 5.2(b). (b) Until the date of Initial BLA Approval, Fibrocell or its designee will be responsible for all interactions with Regulatory Authorities and will submit regulatory filings to the respective Regulatory Authority with regard to the Product for the purpose of filing, obtaining and maintaining Regulatory Approval thereof, and to prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals covering the Product in the Territory. CCP or its designee will be responsible for such interactions and filings thereafter. Fibrocell will provide CCP with a copy of all regulatory filings, correspondence with and minutes of meetings with Regulatory Authorities, documents included in such regulatory dossiers and Regulatory Approvals. At all times during the term of this Agreement, (i) Fibrocell will keep CCP informed of all regulatory filings for the Product and will provide CCP a meaningful opportunity to review and comment on those filings prior to submission thereof, and Fibrocell will in good faith consider incorporating such comments into, any such regulatory filings in the Territory; and (ii) CCP will have the opportunity, unless such Regulatory Authorities object, to participate in all meetings with Regulatory Authorities relating to the Product. 20 US-DOCS\106669270.9
