Regulatory Communications and Meetings Sample Clauses

Regulatory Communications and Meetings. Notwithstanding anything in Section 5 or elsewhere in the Agreement to the contrary, the Parties agree that during the Moderna Lead Period, Moderna will have primary responsibility for conducting communications with the TGA (and any other applicable Regulatory Authorities) that pertain to the RSV IND or relate to the performance of the RSV Phase I Study or otherwise relate to the Moderna RSV Lead Activities, including [***]. The Parties (through the JSC) will discuss the strategy and shall endeavor to mutually agree upon the objectives for any such meeting or conference call. If it is not possible to provide the JSC advance notice of any such meeting or conference call, Moderna shall thereafter provide Merck with a reasonably detailed summary of such meeting or conference call. Moderna shall promptly furnish Merck with copies of all correspondence or material Moderna provides to or receives from the TGA (or any other applicable Regulatory Authority), including [***]. To the extent there is a disagreement between Merck and Moderna within the JSC regarding [***] after each Party reasonably and in good faith considers the other Party’s comments on such matter, such disagreement shall be referred to the Executive Officers (or their designees, which designee is required to have decision-making authority on behalf of such Party), who will attempt in good faith to resolve such dispute by negotiation and consultation for a [***] day period following such referral. If, despite such efforts, agreement cannot be reached by the Executive Officers within such [***] day period, [***].
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Regulatory Communications and Meetings. (i) Licensee shall keep Inventiva timely (in any case, no later than [***] following Licensee’s submission or receipt, as applicable) and fully informed of the preparation and Regulatory Authority review and approval of submissions and communications with Regulatory Authorities with respect to the Licensed Product(s) in the Field in the Territory; (ii) Licensee shall provide Inventiva with sufficient advance notice and time to review and comment on Licensee’s material communications and filings with Regulatory Authorities and shall consider Inventiva’s comments in good faith and incorporate all Inventiva’s reasonable comments; (iii) in addition, Licensee shall promptly (and in any event not later than [***] following Licensee’s submission or receipt, as applicable) provide Inventiva with copies of all material documents, submissions, filings, information and correspondence submitted to or received from a Regulatory Authority by Licensee (or its Affiliate or Sublicensee), and upon Inventiva’s request, together with copies of any other documents, reports and communications from or to any Regulatory Authority relating to the Licensed Products or activities under this Agreement; (iv) if any documents that Licensee provides to Inventiva pursuant to the foregoing are not in English, Licensee shall provide copies of such documents in their original format and language together with an English summary of such documents; (v) Licensee shall provide Inventiva with written notice within [***] after its receipt of the meeting notice from a Regulatory Authority of any meeting with such Regulatory Authority in the Territory (including advisory committee meetings and any other meeting of experts convened by a ​ Regulatory Authority) regarding a Licensed Product unless expressly prohibited by the Applicable Laws or the applicable Regulatory Authority; and (vi) Inventiva will have the right to request to participate in all such meetings with Regulatory Authorities to the extent not prohibited under the Applicable Laws and by the applicable Regulatory Authorities. [***].
Sample 1
Regulatory Communications and Meetings. (a) Licensee shall [*] keep C4T [*] informed in all material respects of the preparation and Regulatory Authority review and approval of submissions and communications with Regulatory Authorities with respect to the Products in the Field in the Licensee Territory and shall respond [*] to any request from a Regulatory Authority related to the Product in the Field in the Licensee Territory. [*].
Sample 1
Regulatory Communications and Meetings. XX will keep TSVT timely and fully informed of the preparation and Regulatory Authority review and approval of submissions and communications with Regulatory Authorities with respect to the Products in the Field in the JW Territory. JW will provide TSVT with sufficient advance notice and time (but no less than ten (10) Business Days) to review and comment on JW’s material communications and filings with Regulatory Authorities and will incorporate TSVT’s comments therein. In addition, with the exception of CMC Information (subject to Section 7.12) JW will promptly provide TSVT with copies of all material documents, submissions, filings, information and correspondence submitted to or received from a Regulatory Authority by JW (or its Affiliate or Sublicensee) and upon reasonable request, with copies of any other documents, reports and communications from or to any Regulatory Authority relating to the Products or activities under this Agreement. If any documents that JW provides to TSVT pursuant to the foregoing are not in English, JW will provide copies of such documents in their original format and language, and accurate English summaries (or, at TSVT’s expense) translations of such documents. JW will provide TSVT with written notice within three (3) Business Days after its receipt of the meeting notice from a Regulatory Authority of any meeting with such Regulatory Authority in the Territory (including advisory committee meetings and any other meeting of experts convened by a Regulatory Authority) regarding a Product unless expressly prohibited by the Applicable Laws or the applicable Regulatory Authority. TSVT will have the right to request to participate in all such meetings with Regulatory Authorities to the extent not prohibited under the Applicable Laws and by the applicable Regulatory Authorities.
Sample 1

Related to Regulatory Communications and Meetings

  • Regulatory Communications Each Party agrees to notify the other immediately by telephone (with prompt written follow-up) of any inquiry, contact or communication received from any governmental regulatory agency or other official body that materially and adversely relates to or impacts upon the Product(s) or any component or ingredient thereof, and will promptly furnish the other Party with copies of all written communications relating thereto sent to or received from said regulatory agency.

  • Communications Regulatory Matters (A) Schedule 5.13(A) sets forth a true and complete list of the following information for each License issued to each Loan Party or its Subsidiaries: the name of the licensee, the type of service, the expiration date and the geographic area covered by such License.

  • Posting of Communications (a) The Borrower agrees that the Administrative Agent may, but shall not be obligated to, make any Communications available to the Lenders and the Issuing Banks by posting the Communications on IntraLinks™, DebtDomain, SyndTrak, ClearPar or any other electronic platform chosen by the Administrative Agent to be its electronic transmission system (the “Approved Electronic Platform”).

  • Direct Website Communications Each of Holdings and the Borrower may, at its option, provide to the Administrative Agent any information, documents and other materials that it is obligated to furnish to the Administrative Agent pursuant to the Credit Documents, including, without limitation, all notices, requests, financial statements, financial, and other reports, certificates, and other information materials, but excluding any such communication that (A) relates to a request for a new, or a conversion of an existing, borrowing or other extension of credit (including any election of an interest rate or interest period relating thereto, (B) relates to the payment of any principal or other amount due under this Agreement prior to the scheduled date therefor, (C) provides notice of any default or event of default under this Agreement or (D) is required to be delivered to satisfy any condition precedent to the effectiveness of this Agreement and/or any borrowing or other extension of credit thereunder (all such non-excluded communications being referred to herein collectively as “Communications”), by transmitting the Communications in an electronic/soft medium in a format reasonably acceptable to the Administrative Agent to the Administrative Agent at an email address provided by the Administrative Agent from time to time; provided that (i) upon written request by the Administrative Agent, Holdings or the Borrower shall deliver paper copies of such documents to the Administrative Agent for further distribution to each Lender until a written request to cease delivering paper copies is given by the Administrative Agent and (ii) Holdings or the Borrower shall notify (which may be by facsimile or electronic mail) the Administrative Agent of the posting of any such documents and provide to the Administrative Agent by electronic mail electronic versions (i.e., soft copies) of such documents. Each Lender shall be solely responsible for timely accessing posted documents or requesting delivery of paper copies of such documents from the Administrative Agent and maintaining its copies of such documents. Nothing in this Section 13.17 shall prejudice the right of Holdings, the Borrower, the Administrative Agent, any other Agent or any Lender to give any notice or other communication pursuant to any Credit Document in any other manner specified in such Credit Document. The Administrative Agent agrees that the receipt of the Communications by the Administrative Agent at its e-mail address set forth above shall constitute effective delivery of the Communications to the Administrative Agent for purposes of the Credit Documents. Each Lender agrees that notice to it (as provided in the next sentence) specifying that the Communications have been posted to the Platform shall constitute effective delivery of the Communications to such Lender for purposes of the Credit Documents. Each Lender agrees (A) to notify the Administrative Agent in writing (including by electronic communication) from time to time of such Lender’s e-mail address to which the foregoing notice may be sent by electronic transmission and (B) that the foregoing notice may be sent to such e-mail address.

  • Regulatory Notices Manager will, within 2 Business Days after its receipt, give Sprint PCS written notice of all oral and written communications it receives from regulatory authorities (including but not limited to the FCC, the FAA, state public service commissions, environmental authorities, and historic preservation authorities) and complaints respecting Manager's construction, operation, and management of the Service Area Network that could result in actions affecting the License as well as written notice of the details respecting such communications and complaints, including a copy of any written material received in connection with such communications and complaints. Manager will cooperate with Sprint PCS in responding to such communications and complaints received by Manager. Sprint PCS has the right to respond to all such communications and complaints, with counsel and consultants of its own choice. If Sprint PCS chooses to respond to such communications and complaints, Manager will not respond to them without the consent of Sprint PCS, and Manager will pay the costs of Sprint PCS' responding to such communications and complaints, including reasonable attorneys' and consultants' fees, investigation costs, and all other reasonable costs and expenses incurred by Sprint PCS.

  • Public Communications Prior to the Closing Date, the Company will not issue any press release or other communication directly or indirectly or hold any press conference with respect to the Company, its condition, financial or otherwise, or the earnings, business, operations or prospects of any of them, or the offering of the Securities, without the prior written consent of the Placement Agent, unless in the reasonable judgment of the Company and its counsel, and after notification to the Placement Agent, such press release or communication is required by law, in which case the Company shall use its reasonable best efforts to allow the Placement Agent reasonable time to comment on such release or other communication in advance of such issuance.

  • Regulatory Meetings The Regulatory Lead Party shall provide the other Party with notice of all meetings, conferences, and discussions (including FDA advisory committee meetings and any other meeting of experts convened by the FDA concerning any topic relevant to a Product, as well as Product labeling and post-Regulatory Approval Product labeling discussions with the FDA) scheduled with the FDA concerning any pending Drug Approval Application or any material regulatory matters relating to a Product within [****]* after the Regulatory Lead Party receives notice of the scheduling of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party a reasonable opportunity to participate in such meetings, conferences and discussions). The other Party shall be entitled to be present at, and to participate in, all such meetings, conferences or discussions. PDL’s and BMS’ respective members of the JDC shall use reasonable efforts to agree in advance on the scheduling of such meetings and on the objectives to be accomplished at such meetings, conferences, and discussions and the agenda for the meetings, conferences, and discussions with the FDA. The Regulatory Lead Party shall also include the other Party in any unscheduled, ad-hoc meetings, conferences and discussions with the FDA concerning any pending IND, Drug Approval Application or any material regulatory matters relating to a Product. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.

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