Notification of Regulatory Correspondence Sample Clauses

Notification of Regulatory Correspondence. Toyama shall promptly (and in any event, within three (3) Business Days of the date of receipt of notice) notify Cempra in writing of, and shall provide Cempra with copies of, any correspondence and other documentation received or prepared by Toyama in connection with any of the following events: (i) receipt of a material regulatory letter, warning letter, or similar item, from any Governmental Authority directed to the Development, manufacture, packaging, storage, or Commercialization of Licensed Product in the Territory or use or manufacture of Compound or Permitted Derivative pursuant to the exercise of Back-Up Supply Rights in the Manufacturing Territory, or any facility associated with manufacture of Licensed Product for use, distribution, or sale in the Territory; (ii) any recall, field correction, or market withdrawal (any of the foregoing, a “Recall”) of any Licensed Product in the Territory; and (iii) any comments from any Governmental Authority (or foreign equivalent thereof) relating to Licensed Product requiring a response or action by Toyama or any Sublicensee under Applicable Law. Toyama shall provide Cempra with reports at regularly scheduled meetings in respect to any correspondence and other documentation Toyama or any Sublicensee receives of the kind referred to in this paragraph. Toyama shall promptly notify Cempra in writing of any Regulatory Approvals Toyama (or any Sublicensees) receives. Notwithstanding foregoing, if Toyama receives a large document in Japanese with aforementioned purpose whose length exceeds the equivalent of twenty (20) standard letter-sized pages, Toyama will provide Cempra with English translated summary or abstracts for Cempra’s initial review within three (3) Business Days of receiving such document, and Toyama shall provide the complete English translated copy to Cempra within reasonable timeframe not to exceed thirty (30) Calendar Days or such shorter period that may be required to enable Cempra, any Affiliate thereof, or any licensee or sublicensee of any of the foregoing to comply with Applicable Law.
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Notification of Regulatory Correspondence. BDSI shall promptly (and in any event, within *** of the date of receipt of notice) notify Endo in writing of, and shall provide Endo with copies of, any correspondence and other documentation received or prepared by BDSI in connection with any of the following events: (i) receipt of a material regulatory letter, warning letter, Form 483, or similar item, from any Regulatory Authority (or foreign equivalent) directed to the development, Manufacture, packaging, and/or storage of Product, or any facility associated with Manufacture of Product; (ii) any recall, field correction, or market withdrawal (any of the foregoing, a “Recall”) of any Product; and (iii) any comments from any Regulatory Authority (or foreign equivalent thereof) relating to Product requiring a response or action by a Party under applicable law or regulation. Endo shall provide the JDC with reports at regularly scheduled meetings in respect to any correspondence and other documentation it receives of the kind referred to in this Section. Endo shall promptly notify BDSI in writing of any Regulatory Approvals it (or Endo’s Affiliates or sublicensees) receives.
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Notification of Regulatory Correspondence. Toyama shall use Commercially Reasonable Efforts to notify Cempra of any material correspondence and other documents from any Governmental Authority in the Territory directed to the Development and Commercialization of Licensed Product in the Territory on a reasonably regular basis. For the avoidance of doubt, Toyama shall have the right to make any decisions with respect to such regulatory correspondence in the Territory in its sole discretion and to file or respond to such regulatory correspondence without any pre-approval by Cempra. Toyama shall promptly notify Cempra in writing of any Regulatory Approvals that Toyama or any Sublicensees obtains for the Territory. 17. Section 5.4(c) of the Agreement is hereby deleted in its entirety and replaced with the following:
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Notification of Regulatory Correspondence. Each Party shall promptly (and in any event, within two (2) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by the first Party or its Affiliates in connection with any of the following events: (i) receipt of a material regulatory letter, warning letter, Form 483, or similar item, from any Regulatory Authority (or foreign equivalent) directed to the development, manufacture, packaging, and/or storage of Licensed Product, or any facility associated with conduct of Clinical Trials, pharmaceutical development activities, manufacture of Licensed Product, in the Field in the Territory; (ii) any Recall of any Licensed Product in the Field in the Territory; and (iii) any comments from any Regulatory Authority (or foreign equivalent thereof) relating to Licensed Product in the Field in the Territory requiring a response or action by a Party under applicable Law. Without prejudice to the foregoing and except if facing the notifying situation reasonably requires additional interactions between the Parties, each Party shall provide the Joint Steering Committee with reports at regularly scheduled meetings in respect to any correspondence and other documentation it receives of the kind referred to in this Section 3.5(e). Each Party shall promptly notify the other Party in writing of any Regulatory Approvals it (or Almirall’s Affiliates or its or their Sublicensees) receives with respect to Licensed Products in the Field in the Territory.
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Related to Notification of Regulatory Correspondence

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this IA shall be submitted to the following entities: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services ▇▇▇▇▇ Building, Room 5527 ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Telephone: (▇▇▇) ▇▇▇-▇▇▇▇ Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇ LFAC: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇, DPM ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇. ▇-▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Telephone: (▇▇▇) ▇▇▇-▇▇▇▇ Email: ▇▇.▇▇▇▇▇@▇▇▇▇▇.▇▇▇ Unless otherwise specified, all notifications and reports required by this IA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, LFAC may be required to provide OIG with an additional copy of each notification or report required by this IA in OIG’s requested format (electronic or paper).

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust’s CCO promptly upon detection of: (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of each Fund’s or the Adviser’s policies, guidelines or procedures with respect to the Fund. In addition, the Adviser shall respond to quarterly requests for information concerning the Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the S▇▇▇▇▇▇▇-▇▇▇▇▇ Act. The Adviser will promptly notify the Trust in the event: (x) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws; or (y) of an actual change in control of the Adviser resulting in an “assignment” (as defined in Section 15) that has occurred or is otherwise proposed to occur.

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.