Preparation of Regulatory Filings Clause Samples
The "Preparation of Regulatory Filings" clause defines the responsibility for creating, compiling, and submitting documents required by governmental or regulatory authorities in connection with the agreement. Typically, this clause specifies which party is responsible for preparing the necessary filings, outlines the process for review and approval, and may address the sharing of information or cooperation between parties. Its core function is to ensure that all regulatory requirements are met in a timely and organized manner, thereby reducing the risk of non-compliance and associated penalties.
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:
(a) At its expense, Nektar shall use Commercially Reasonable Efforts to prepare and maintain DMFs covering the Device, and Nektar shall own any such DMFs. Nektar shall also use Commercially Reasonable Efforts to prepare and maintain DMFs covering Formulated Amikacin and the Product; provided, however, that the Party conducting Manufacturing for Commercialization of the Formulated Amikacin and Product shall own and maintain any such DMFs, it being understood and agreed that during the term hereof, such Manufacture of Formulated Amikacin and Product may be conducted by Bayer. During the term of this Agreement, Nektar grants to Bayer and its Sublicensees a right of reference to the DMFs for the Device owned by Nektar to the extent necessary for, and for the purposes of, preparing, filing or maintaining INDs, NDAs, ▇▇▇▇ and other regulatory filings relating to the Product in the Shared Territory or the Royalty Territory, including without limitation CMC Data. Nektar shall share with Bayer relevant CMC Data (redacted, if deemed necessary in Nektar’s reasonable opinion) portions of such DMFs, with the right to inspect, upon Bayer’s request. The Party that owns a DMF shall be responsible for all interactions with Regulatory Authorities relating to such DMF. The foregoing notwithstanding, all Information required by Bayer for regulatory filings will be provided to Bayer by Nektar for all countries where such filings are required.
(b) At its expense, Bayer, its Affiliates and its Sublicensees shall use Commercially Reasonable Efforts to prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals covering the Product in the Territory, and shall provide Nektar, [***], with a copy of all documents included in such regulatory dossiers and Regulatory Approvals. Except as provided in Section 5.2(a), Bayer or its designee shall be the owner of all such filings and shall be responsible for all interactions with Regulatory Authorities relating thereto; provided, however, that at all times during the term hereof, Nektar shall have the opportunity to participate in all meetings and other communications with Regulatory Authorities relating to the Product, [***]. In addition to Bayer’s other obligations under this Section 5.2(b), Bay...
Preparation of Regulatory Filings. (a) Licensed Products in the Sanofi Field.
(i) Sanofi shall be the responsible party, at its cost and expense, for filing, in its name, any and all Regulatory Filings for Licensed Products in the Sanofi Field in the Territory, and will hold any such Regulatory Filings in its name. Such Regulatory Filings and related Regulatory Approvals shall be owned solely by Sanofi and Sanofi shall be solely responsible for preparing any and all Regulatory Filings for the Licensed Products in the Sanofi Field in the Territory, subject to the terms of this Article 5. KaloBios shall assist Sanofi as it may reasonably request in connection with the preparation and filing of such Regulatory Filings, at Sanofi’s expense.
(ii) Sanofi shall keep KaloBios regularly informed, through the JSC, of material regulatory developments specific to Licensed Products in the Sanofi Field throughout the Territory. Sanofi shall provide to KaloBios all information as reasonably necessary in order for KaloBios to carry out its rights and obligations hereunder.
(iii) To the extent permitted by FDA and/or EMEA and reasonably requested by KaloBios, Sanofi shall allow a designated representative of KaloBios reasonably acceptable to Sanofi to participate, as a silent observer, in any significant meeting between Sanofi and the FDA and/or EMEA primarily related to any Licensed Product.
(b) Licensed Products in the KaloBios Field.
(i) KaloBios shall be the responsible party, at its cost and expense, for filing, in its name, any and all Regulatory Filings for Licensed Products in the KaloBios Field in the Territory, and will hold any such Regulatory Filings in its name. Such Regulatory Filings and related Regulatory Approvals shall be owned solely by KaloBios and KaloBios shall be solely responsible for preparing any and all Regulatory Filings for the Licensed Product in the KaloBios Field in the Territory, subject to the terms of this Article 5. Sanofi shall assist KaloBios as it may reasonably request in connection with the preparation and filing of such Regulatory Filings, at KaloBios’ expense.
(ii) KaloBios shall keep Sanofi regularly informed, through the JSC, of material regulatory developments specific to Licensed Products in the KaloBios Field throughout the Territory. KaloBios shall provide to Sanofi all information as reasonably necessary in order for Sanofi to carry out its rights and obligations hereunder. [***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND SEPARATELY FILED WITH THE C...
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. 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. 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. 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. 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. 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. 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) [*].
Preparation of Regulatory Filings. MRVT shall be responsible for preparing and filing in its own name any regulatory filings necessary for conducting Clinical Tests.