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. 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. (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 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. Tanabe and its Affiliates shall use commercially reasonable efforts in filing for and obtaining Regulatory Approval for Tanabe Products in the Territory and shall conduct such efforts in accordance with the Product Development Plan and the express terms and conditions of this Agreement. During the term of this Agreement, upon Tanabe's reasonable written request, Genelabs shall provide Tanabe with reasonable assistance in obtaining Regulatory Approval which is not otherwise expressly stated herein for Tanabe Products at Tanabe's expense. All regulatory filings by Tanabe for Tanabe Products shall constitute the sole property of Tanabe except to the extent otherwise provided in this Article 4.
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 [ * ] = 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.
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. Peninsula shall be responsible for any and all regulatory filings covering Licensed Products in the Territory. Shionogi shall, at Peninsula's reasonable request, cooperate in the preparation and maintenance of such filings, including preparing all sections of regulatory filings covering Licensed Products related to Shionogi's manufacturing activities such as drafting CMC sections of the IND and NDA for Licensed Products and the Compound. In addition, at Peninsula's request, Shionogi shall make appropriate personnel reasonably available for meetings with Regulatory Authorities related to the manufacture of the Compound and/or Licensed Products. Upon Peninsula's consent, which consent shall not be unreasonably withheld, Shionogi may have representatives attend any of Peninsula's scheduled meetings with Regulatory Authorities related to the Licensed Product at
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. BMS shall keep EXEL informed with respect to, and shall promptly provide to EXEL copies of, all material written or electronic communications received by it from, or sent by it to: (a) a Regulatory Authority in the U.S., Japan, a Major European Country or for the EU; and (b) a Regulatory Authority outside the Major European Countries to the extent that the substance of such communications: (i) vary materially from what BMS has already disclosed to EXEL with respect to the U.S., Japan, a Major European Country or for the EU under this Section 5.4(a); and (ii) [*].
