Preparation of Regulatory Materials Clause Samples

The "Preparation of Regulatory Materials" clause defines the responsibilities and procedures for creating, compiling, and submitting documents required by regulatory authorities. Typically, this clause specifies which party is responsible for preparing applications, reports, or filings, and may outline timelines, required formats, and cooperation obligations between parties. Its core function is to ensure that all necessary regulatory submissions are handled efficiently and in compliance with applicable laws, thereby facilitating timely approvals and reducing the risk of regulatory delays.
Preparation of Regulatory Materials. (a) After the Effective Date (or, as applicable, the IND Date), the Lead Regulatory Party shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials, including the Product INDs, the Product Regulatory Approvals, and other submissions, and to conduct communications with the FDA, for the relevant Products in the applicable indication in the Territory or applicable portion thereof, except in the case of Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, during which time Takeda shall hold the IND and Ultragenyx (i.e., the Lead Regulatory Party) shall receive a right of reference from Takeda. Except with respect to Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, all Product INDs and Product Regulatory Approvals generated after the Effective Date, including any supplements or amendments to those Product INDs and Product Regulatory Approvals in existence as of the Effective Date, with respect to such Products in the
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Preparation of Regulatory Materials. (a) Licensee shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials in the Territory, including the Product INDs and other submissions, and to conduct communications with the relevant Regulatory Authorities, related to or needed for the Commercialization of Product in the Field in the Territory. Notwithstanding the foregoing, Takeda or its applicable Affiliate, or sublicensees, any of their Third Party contractors, will be solely responsible for all Regulatory Materials related to (i) the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, (ii) Takeda’s, or any of its Affiliates or sublicensees’ or any of their Third Party contractors’ Development or Manufacture activities in the Territory. Except with respect to the Designated Clinical Trial, and any other Clinical Trials in the Territory consented to by Licensee pursuant to the last sentence of Section 4.1, all Product INDs generated after the Effective Date with respect to the Product in the Field in the Territory under this Agreement shall be owned by, and shall be the sole property and held in the name of, Licensee or its designee. (b) Licensee shall provide Takeda with an opportunity to review and comment on [***] in each case reasonably in advance of when Licensee or any of its Affiliates or sublicensees intends to submit such Regulatory Materials to the applicable Regulatory Authority. Takeda shall provide its comments within [***], or such other period of time mutually agreed to by the Parties. Licensee shall consider in good faith any such comments of Takeda. Licensee shall provide Takeda with a copy in electronic form of all material Regulatory Materials filed related to the use of the Products in the Field. Licensee shall be the MAH with respect to Regulatory Approvals in the Territory. Takeda, its Affiliates, and/or their sublicensees or designees shall be the MAH for any and all Regulatory Approvals outside of the Territory. (c) Notwithstanding the above, Takeda shall file an application for United States Adopted Name (USAN) at its own expense.
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Preparation of Regulatory Materials. (a) Subject to Section 2.1(h), Takeda shall have the responsibility to Take the Lead, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials, including the Product INDs, the Product NDAs, and other submissions, and to conduct communications with the Regulatory Authority, for the Products in the Field in the Territory (other than Israel); provided that within [*] following each Regulatory Approval in the Core Orphan Territory (other than Israel), Takeda shall timely transfer to Ovid copies of all Regulatory Materials (in electronic or other format) in its possession related to the use of the Products in the Field in such Core Orphan Territory and which support the Product INDs and the Product NDAs. Promptly after such transfer, Takeda shall take all steps necessary to transfer ownership of all such Product INDs and Product NDAs in such in such jurisdiction of the Core Orphan Territory to Ovid, including submitting to the Regulatory Authorities a letter or other necessary documentation (with a copy to Ovid) notifying the Regulatory Authorities of the transfer of such ownership. The date of such transfer shall be the “Transfer Date” with respect to such Product in the applicable jurisdiction. (b) Subject to Section 2.1(h), Ovid shall Take the Lead, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials, including the Product INDs, the Product NDAs, and other submissions, and to conduct communications with the Regulatory Authority, for the Products in the Field in: (i) Israel; (ii) each Core Orphan Territory (other than Israel), following the applicable Transfer Date; and (iii) any other jurisdiction in the ROW Territory mutually agreed by the Parties. (c) Notwithstanding anything contained in the foregoing to the contrary, the Party responsible for the Manufacture of the Product shall be responsible for preparing the CMC Module 3 (or its non-U.S. equivalent) for the Product in a manner suitable for filing with the FDA and EMA.
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Preparation of Regulatory Materials. The Parties shall use Commercially Reasonable Efforts, in compliance with applicable Laws and other regulatory obligations related to Development and Regulatory Approval in the Licensed Territory, to prepare and file the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. appropriate Regulatory Materials for those countries for which Regulatory Approval is sought under this Agreement.
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Preparation of Regulatory Materials. (1) The regulatory strategy for the Territory shall be consistent with the overall objective of facilitating Regulatory Approval in the Territory in connection with the Global Development Plan. After the License Option Exercise, Takeda shall, with respect to the Products in the Field in the Territory, have the sole right, at its own expense, to: (i) develop and implement the overall regulatory strategy; (ii) prepare, obtain, and maintain all Regulatory Documentation, including all INDs, Drug Approval Applications and Regulatory Approvals; and (iii) conduct communications with the relevant Regulatory Authorities. Notwithstanding any term or condition of this Agreement to the contrary, all Regulatory Materials (including all Regulatory Approvals) generated with respect to the Products under this Agreement shall be owned by, and shall be the sole property and held in the name of, Takeda or its designee. Notwithstanding the foregoing, in the event that any Regulatory Documentation is required to be submitted to a Regulatory Authority during the transition of regulatory responsibilities as provided in Section 6.5(a), the Parties shall mutually agree as to whether such Regulatory Documentation will be prepared and submitted by Takeda or MacroGenics; provided that if the Parties shall not agree, Takeda shall have the right to submit such Regulatory Documentation.
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Preparation of Regulatory Materials 
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Related to Preparation of Regulatory Materials

  • Regulatory Filings From the date of this Agreement until the Closing, each of the Buyer and the Seller shall, and shall cause their respective Affiliates to: (a) make or cause to be made such other filings required of such Party or any of its Affiliates under any Laws with respect to this Agreement and the other Transaction Documents and to pay any fees due of it in connection with such filings, in each case as promptly as is reasonably practicable; (b) cooperate with the other Party and furnish all information in such Party’s possession that is necessary in connection with such other Party’s filings; (c) use commercially reasonable efforts to cause the expiration or termination of the notice or waiting periods under any applicable Laws with respect to this Agreement and the other Transaction Documents as promptly as is reasonably practicable; (d) promptly inform the other Party of (and, at the other Party’s reasonable request, supply to such other Party) any communication (or other correspondence or memoranda) from or to, and any proposed understanding or agreement with, any Governmental Body in respect of such filings; (e) consult and cooperate with the other Party in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, and opinions made or submitted by or on behalf of any Party in connection with all meetings, actions, discussions, and proceedings with Governmental Bodies relating to such filings, including, subject to applicable Law; permitting the other Party to review in advance any proposed written communication between it and any Governmental Body; (f) comply, as promptly as is reasonably practicable and with due regard to maintaining the confidentiality of information the Parties have agreed would be commercially harmful if publicly disclosed, with any requests received by such Party or any of its Affiliates under the HSR Act and any other Laws for additional information, documents, or other materials; (g) use commercially reasonable efforts to resolve any objections as may be asserted by any Governmental Body with respect to this Agreement and the other Transaction Documents; and (h) use commercially reasonable efforts to contest and resist any action or proceeding instituted (or threatened in writing to be instituted) by any Governmental Body challenging this Agreement and the other Transaction Documents as violative of any Law; provided, that, notwithstanding anything to the contrary in this Agreement or the other Transaction Documents, in no event shall Buyer, Seller or any of their respective Affiliates or any member of the Company Group (including direct and indirect equity owners) be required to agree to, enter into or offer to enter into any agreement or consent order requiring divestiture, hold-separate, business limitation, limitation on conduct or governance of the Buyer, Seller, or any of UNIT PURCHASE AGREEMENT 40 their respective Affiliates or any member of the Company Group (including direct and indirect equity owners), or similar arrangement or undertaking in connection with this Agreement, the Transaction Documents or any of the transactions contemplated hereby or thereby. If a Party or any of its Affiliates intends to participate in any meeting or discussion with any Governmental Body with respect to such filings, it shall give the other Party reasonable prior notice of, and an opportunity to participate in, such meeting or discussion.