Regulatory Interactions. In accordance with the Strategic Plan, after Option Exercise, Novartis will (i) determine the regulatory plans and strategies for the Products, (ii) (either itself or through its Affiliates or sublicensees) make all Regulatory Filings with respect to the Products, and (iii) will be responsible for obtaining and maintaining Regulatory Approvals in the name of Novartis or its Affiliates or Sublicensees. Until Regulatory Approval of a Product, Novartis will provide Akcea with material correspondence with and material submissions (NDA, MAA, briefing documents, priority review or breakthrough request) to any Regulatory Authority in each Major Market for such Product, sufficiently in advance of providing such correspondence or submission to the applicable Regulatory Authority to enable Akcea to provide comments on the contents thereof. In the event Akcea does not provide comments within [***] calendar days from receipt (or shorter notice as reasonably indicated by Novartis), it is agreed that Novartis shall be entitled to submit such submission or correspondence as the case may be. In addition, until Regulatory Approval of a Product, Novartis will notify, at JDCC meeting, Akcea of any planned significant meetings with a Regulatory Authority for a Product in a Major Market, and will, at Akcea’s request, consider in good faith inviting Akcea (or its Affiliate) to participate with one representative [***] under the direction of Novartis in any such meeting. For the avoidance of doubt, Akcea’s performance under this Section 6.6.1 shall be at no cost to Novartis.
Regulatory Interactions. In relation to the Product, UCB shall, at its sole cost and expense, have overall responsibility for the strategy, and communication and interactions with Regulatory Authorities and shall prepare and submit all Regulatory Documentation relating to the Development of the Product in the Development Indication throughout the Development Territory, except that Dermira shall carry out such specific activities delegated to Dermira under the Regulatory Responsibility Matrix, and the Parties’ respective roles and responsibilities shall be further set forth in the Regulatory Responsibility Matrix. During the Development Term, UCB shall communicate and interact with Regulatory Authorities in a manner that is consistent with such overall strategy, and shall consult with Dermira prior to any such communications and shall keep Dermira informed, through the JDT, of the progress, strategy and updates with respect to the regulatory activities for the Product in the Development Indication in the Development Territory. UCB shall provide Dermira with drafts of material Regulatory Documentation and material correspondence with the Regulatory Authorities with respect to the Development Indication and/or the Promotion Indication for Dermira’s review and comment. In addition, UCB shall, to the extent practicable, provide Dermira with advance notification of any and all meetings with the FDA, EMA and Health Canada with respect to the Development Indication and/or the Promotion Indication, and allow Dermira to participate in such meetings as agreed by the JDC prior to such meetings.
Regulatory Interactions. Following Sobi’s Opt-In for a Product, the Parties shall share information about material communications with Regulatory Authorities in their respective Territories and reasonably consider the other Party’s comments on such communications. With respect to the preceding sentence and for purposes of clause (i) below, the “materiality” threshold shall be determined by the Joint Regulatory Team. Without limiting the foregoing and in accordance with protocols and procedures established by the Joint Regulatory Team, the Parties shall:
Regulatory Interactions. Without limitation to Section 3.3.3 or Section 3.4.1(a), Licensee shall, except to the extent a need for exigent action prevents it from doing so, provide MedImmune with copies of Licensee’s initial Drug Approval Application relating to each Licensed Compound or Licensed Product to the FDA or EMA, as applicable, and to such other Regulatory Authorities as MedImmune may reasonably request, a reasonable amount of time (but no less than [***]) prior to the anticipated date for the applicable submission to allow MedImmune to review and comment on such Drug Approval Application, and Licensee shall consider all comments and proposed revisions from MedImmune in good faith in connection with effecting such submission. Licensee shall consult with MedImmune regarding, and keep MedImmune informed of, the status of the preparation of the dossier rationale and proposed labeling with respect to each Licensed Product. Upon MedImmune’s request, Licensee shall promptly (and in any event, within [***]) provide to MedImmune access to and copies of any Regulatory Documentation necessary or reasonably useful for MedImmune to Exploit the AstraZeneca Product or update the label with respect thereto. *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], 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.
Regulatory Interactions. Only in the case where Vanda does not enter into any Development and Commercialization Agreements and BMS does not exercise the BMS Option, Vanda shall have sole responsibility for, and shall bear the cost of preparing, all regulatory filings and related submissions with respect to Compounds or Products. Vanda shall be the primary interface with and otherwise handle all interactions with Regulatory Authorities concerning Compounds or Products. To the extent not prohibited by law or regulation, BMS shall have the right to have one representative participate in all material meetings pertaining to Development of a Product between representatives of Vanda and Regulatory Authorities of the Major Market Countries and the FDA. Vanda will provide BMS, at least five (5) business days before any such meeting, with copies of all documents, correspondence and other materials in its possession which are relevant to the matters to be addressed at any such meeting. Vanda will provide BMS with draft and final copies (which may be wholly or partly in electronic form) of all material correspondence with Regulatory Authorities relating to the Product, including any draft Marketing Authorizations, for BMS' review and comment within a reasonable time prior to filing with the Regulatory Authorities. Vanda will be responsible for meeting the requirements of all pre-approval inspections required by any Regulatory Authorities.
Regulatory Interactions. Spruce, its Affiliates or Sublicensees, or its or their designees, will have the right to conduct, and, to the extent consistent with Article 2.4, will be responsible for, all regulatory activities and interactions, at their cost, for the Licensed Products, and will own the IND(s) and any future Regulatory Application(s) and Regulatory Approval(s) for the Licensed Products globally. Spruce, its Affiliates or Sublicensees, or its or their designees, will have the right to, and, to the extent consistent with Article 2.4, shall be responsible to, oversee, monitor and manage all regulatory interactions, communications and filings with, and submissions to Regulatory Authorities with respect to the Licensed Product(s). Spruce, its Affiliates or Sublicensees, or its or their designees, have final decision making authority regarding all regulatory activities with respect to the Licensed Product(s), including the regulatory and labeling strategy and the content of submissions.
Regulatory Interactions. Unless required by Applicable Law or a Regulatory Authority, Supplier shall have no contacts or communication with any Regulatory Authority regarding the API without the consent of Purchaser, which consent shall not be unreasonably withheld or delayed. Supplier shall comply with all reasonable requests and comments by Purchaser with respect to all contacts and communications with a Regulatory Authority relating to the API as stated in the QA. Supplier must make available to Purchaser any data and/or information, including samples, required to ensure Purchaser’s compliance with its regulatory filings (such determinations to be made by Purchaser) at Purchaser’s cost. Purchaser reserves the right to submit such data to Regulatory Authorities as required to maintain compliance with its regulatory filings. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Interactions. 8.1. GUILFORD shall be responsible for maintaining the NDAs and all regulatory filings and submissions associated with the Supplied Products in the Territory. MSD IRELAND shall provide any Manufacturing-related information to GUILFORD as may be reasonably necessary for GUILFORD to meet its regulatory obligations to maintain the NDAs and file the required reports thereunder in the Territory, including, providing such information relating to any changes contemplated in Section 7.8 in accordance with the terms set forth therein. Each party shall cooperate with the other in making and maintaining all regulatory filings that may be necessary in connection with the performance of this Supply Agreement until the first annual anniversary date to occur after MSD IRELAND (or its Affiliate or third party manufacturer) ceases to supply a given Supplied Product to GUILFORD hereunder.
Regulatory Interactions. As of and after the date upon which the transfer described in Section 5.4(a) is effected, Astria shall have sole responsibility in the Territory for all Regulatory Interactions with respect to each Licensed Product.
Regulatory Interactions. Pfizer will bear all responsibility and expense for (i) determining the regulatory plans and strategies for the Product, (ii) either itself or through its Affiliates or Sublicensees, making all Regulatory Filings with respect to the Product, and (iii) being responsible for obtaining and maintaining Regulatory Approvals in the name of Pfizer or its Affiliates or Sublicensees, in each case consistent with the Development Plan and the draft Commercial plan. Pfizer will provide Akcea with material Regulatory Filings for the Product (i.e., briefing documents, priority review, breakthrough designation, end-of-Phase 2, NDA/MAA safety/efficacy summaries, original label and subsequent major updates and material responses from Regulatory Authorities) prior to submission to any Major Market Regulatory Authority, sufficiently in advance of providing such Regulatory Filing to the applicable Regulatory Authority to enable Akcea to provide comments on the contents thereof. If Akcea does not provide comments within [***] days from receipt (or shorter notice as reasonably indicated by Pfizer due to an applicable impending submission or communication deadline required by a Regulatory Authority), Pfizer will be entitled to submit such Regulatory Filing to the concerned Regulatory Authority. In addition, Pfizer will notify Akcea of any planned significant meetings with any Regulatory Authority in a Major Market Country for the Product and Akcea (or its Affiliate) will have the right, to the extent permitted by the applicable Regulatory Authority, at its cost, but not the obligation, to participate with one representative, acceptable to Pfizer, as an observer in any such meeting. 165301880
