INDs and Related Communications Sample Clauses

INDs and Related Communications. (a) Prior to the License Option Effective Date (or after the License Option Effective Date, to the extent the Voyager Development Period is in effect, unless and until AbbVie agrees to assume, or otherwise relieves Voyager of, the regulatory obligations set forth in this Section 9.2.1 in writing or Voyager completes such regulatory obligations), Voyager shall have the sole right and responsibility to prepare, obtain and maintain all INDs necessary to perform its obligations under the Development Plan, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that the form and content of all such INDs (including any material amendments and supplements thereto) and communications shall be subject to the review and approval of AbbVie prior to their submission to the applicable Regulatory Authorities, such approval not to be unreasonably withheld, conditioned or delayed.
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INDs and Related Communications. (a) Subject to the terms of any applicable Co-Co Agreement, from and after the applicable Transition Date, Neurocrine shall, as between the Parties, have the sole right to prepare, obtain and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, pricing and reimbursement approvals and other submissions and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for the applicable Collaboration Products. Neurocrine will be the regulatory sponsor for all Clinical Trials commenced on Collaboration Products from and after the Effective Date. Upon Neurocrine’s request, Voyager shall provide reasonable assistance to Neurocrine in connection with the regulatory activities for Collaboration Products, including the preparation of the IND for the FA Program and other relevant Regulatory Filings.
INDs and Related Communications. (a) Subject to the terms of any applicable Co-Co Agreement, from and after the end of the Discovery Period, Neurocrine shall, as between the Parties, have the sole right to prepare, obtain and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, pricing and reimbursement approvals and other submissions and to conduct communications with the Regulatory Authorities and Governmental Authorities in the Territory for the applicable Products. Neurocrine will be the regulatory sponsor for all Clinical Trials commenced on Products from and after the Effective Date. Voyager’s rights with respect to regulatory interactions for the Co-Co Product shall be as set forth in the Co-Co Agreement. (b) Prior to [**] following the Co-Co Trigger Date (and if Voyager exercises the Co-Co Option, thereafter until entry into the Co-Co Agreement and thereafter in accordance with such Co-Co Agreement), or if earlier, Voyager’s notification to Neurocrine that it will not exercise the Co-Co Option, Neurocrine shall provide Voyager with drafts of each Regulatory Approval Application or other material submission or communication described in Section 7.2.1(a) with respect to any Product in the GBA1 Program for Voyager’s review and comment a reasonable period of time prior to submission thereof. At Neurocrine’s discretion (with EXECUTION COPY CONFIDENTIAL 42 Neurocrine having final decision-making authority), Neurocrine shall, and shall cause its Affiliates to, reasonably incorporate any comments of Voyager into such Regulatory Approval Applications and other material submissions and communications if received by Neurocrine within a reasonable period of time after Neurocrine has provided access to Voyager. (c) Prior to [**] following the Co-Co Trigger Date (and if Voyager exercises the Co-Co Option, thereafter until entry into the Co-Co Agreement and thereafter in accordance with such Co-Co Agreement), or if earlier, Voyager’s notification to Neurocrine that it will not exercise the Co-Co Option, Neurocrine shall provide Voyager with prior written notice, to the extent Neurocrine has advance knowledge, of any scheduled meeting, conference, or discussion (including any advisory committee meeting) with a Regulatory Authority in the Territory relating to any substantive matter with respect to any Product in the GBA1 Program, within [**] after Neurocrine or its Affiliate first receives notice of th...

Related to INDs and Related Communications

  • Fund Communications The Service Provider shall, upon request by the Fund, on each business day, report the number of shares on which the transfer agency fee is to be paid pursuant to this Agreement. The Service Provider shall also provide the Fund with a monthly invoice.

  • Offering Communications Other than the Preliminary Prospectus and the Prospectus, each Underwriter severally represents, warrants and agrees with VW Credit and the Seller that it has not made, used, prepared, authorized, approved or referred to and will not prepare, make, use, authorize, approve or refer to any “written communication” (as defined in Rule 405 under the Securities Act) that constitutes an offer to sell or solicitation of an offer to buy the Notes, including, but not limited to any “ABS informational and computational materials” as defined in Item 1101(a) of Regulation AB under the Securities Act unless such Underwriter has obtained the prior written approval of VW Credit and the Seller; provided, however, each Underwriter may prepare and convey to one or more of its potential investors without the consent of VW Credit, the Seller or any of their respective affiliates one or more “written communications” (as defined in Rule 405 under the Securities Act) in the form of (i) an Intex CDI file that does not contain any Issuer Information (as defined below) other than Issuer Information included in the Preliminary Prospectus previously filed with the Commission or (ii) other written communication containing no more than the following: (a) information contemplated by Rule 134 under the Securities Act, (b) information included or to be included in the Preliminary Prospectus or the Prospectus, and (c) a column or other entry showing the status of the subscriptions for the Notes and/or expected pricing parameters of the Notes (each such written communication, an “Underwriter Free Writing Prospectus”). VW Credit and the Seller each authorize each Underwriter to disseminate any “road show” (as defined under Rule 433(h) under the Securities Act) in which representatives of VW Credit or the Seller participate. As used herein, the term “Issuer Information” means any information of the type specified in clauses (1) – (5) of footnote 271 of Commission Release No. 33-8591 (Securities Offering Reform), other than Underwriter Derived Information. As used herein, the term “Underwriter Derived Information” shall refer to information of the type described in clause (5) of footnote 271 of Commission Release No. 33-8591 (Securities Offering Reform) when prepared by any Underwriter, including traditional computational and analytical materials prepared by the Underwriter.

  • Employee Communications Seller and Buyer shall cooperate in communications with Business Employees with respect to employee benefit plans maintained by Seller or Buyer and with respect to other matters arising in connection with the transactions contemplated by this Agreement.

  • Documents and Communications The Collateral Trustee will permit each Secured Debt Representative and each holder of Secured Obligations upon reasonable written notice from time to time to inspect and copy, at the cost and expense of the party requesting such copies, any and all Security Documents and other documents, notices, certificates, instructions or communications received by the Collateral Trustee in its capacity as such.

  • Privileged Communications Xxxxx X. Xxxxx (the “Counsel”) has acted as counsel for the Company and Sellers in connection with this Agreement and the Related Agreements and the consummation of the Transactions (the “Transaction Engagement”). Notwithstanding the Transaction Engagement, Sellers agree that (a) all communications in any form or format whatsoever between or among Counsel, on the one hand, and the Company or any of its directors, officers, employees, agents, or advisors, on the other hand, that relate in any way to the Transaction Engagement (collectively, the “Privileged Communications”) will be deemed to be attorney-client privileged communications that belong to the Company, (b) immediately prior to the Closing, without the need for any further action on the part of any Person, all right, title, and interest of Sellers in and to any and all Privileged Communications shall transfer to and be vested solely in the Company, (c) from and after the Closing, the Privileged Communications and the expectation of client confidence relating thereto shall belong solely to the Company and may be controlled by the Company and shall not be claimed by Sellers or any of their Affiliates, and (d) Counsel shall have no duty whatsoever to reveal or disclose any such Privileged Communications, or any of its files relating to the Transaction Engagement, to Sellers, any of their Affiliates, or any of their respective Representatives by reason of any attorney-client relationship between Counsel and Sellers or otherwise. Sellers and their Affiliates will not have access to any such Privileged Communications, or to the files of Counsel relating to the Transaction Engagement. Notwithstanding anything set forth in the foregoing provisions of this Section 10.15 to the contrary, if after the Closing a dispute arises between Sellers or any of their Affiliates, on the one hand, and a third party, other than the Company or any of its Affiliates, on the other hand, Sellers may assert the attorney-client privilege to prevent disclosure of Privileged Communications to such third party; provided, however, that Sellers may not waive such privilege without the written Consent of Purchaser or the Company.

  • Voting Communications The Purchaser shall notify the Trustee and the Voting Consultant as soon as possible, and in any event, not later than five Business Days after receipt of notice that a vote of the holders of VRDP Shares has been requested or permitted on any Voting Matter and the Purchaser shall, within such same time frame, forward any information sent to the Purchaser in connection with such vote to the Trustee and the Voting Consultant by Electronic Means. The Voting Consultant shall analyze and provide a voting or consent recommendation to the Trustee with respect to each Voting Matter in respect of the Subject Shares. The Trustee is obligated to act in accordance with the voting or consent recommendation made by the Voting Consultant in its voting or consent direction to the Purchaser. In all Voting Matters, the Trustee shall use the proxies granted to it by the Purchaser to vote or consent the Subject Shares in accordance with the voting or consent recommendation made by the Voting Consultant and the Purchaser shall not exercise any voting or consent rights in such matters. If the Voting Consultant fails to provide a voting or consent recommendation to the Trustee on or prior to the deadline for submission of such vote or consent, the Trustee shall not provide a vote or consent on behalf of the Purchaser on such deadline and shall provide notice of the failure to receive a voting or consent recommendation to the Purchaser and the Voting Consultant. For the avoidance of doubt, the Purchaser shall not retain the right to vote or consent on any Voting Matters for which the Trustee does not provide a vote or consent on behalf of the Purchaser.

  • 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.

  • 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 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.

  • Investor Communications If the Administrator receives, during any Collection Period, a request from a Noteholder or Verified Note Owner to communicate with other Noteholders and Note Owners regarding the exercise of rights under the terms of the Basic Documents, the Administrator will include in the Form 10-D for the such Collection Period the following information, to the extent provided by the Noteholder or Verified Note Owner in its request: (i) the name of the Noteholder or Verified Note Owner making the request, (ii) the date the request was received; (iii) a statement that the Administrator has received the request from that Noteholder or Verified Note Owner that it is interested in communicating with other Noteholders and Note Owners with regard to the possible exercise of rights under the Basic Documents; and (iv) a description of the method other Noteholders and Note Owners may use to contact the requesting Noteholder or Verified Note Owner. The Administrator is not required to include any additional information regarding the Noteholder or Verified Note Owner and its request in the Form 10-D, and is required to disclose a Noteholder’s or a Verified Note Owner’s request only where the communication relates to the exercise by a Noteholder or Verified Note Owner of its rights under the Basic Documents. The Administrator will be responsible for the expenses of administering the investor communications provisions set forth in this Section 23(b), which will be compensated by means of the fee payable to it by the Servicer, as described in Section 3.

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