Notification of Regulatory Correspondence Sample Clauses

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.
Sample 1
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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.
Sample 1
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.
Sample 1
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:
Sample 1

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 Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 LFAC: Xxxxxxx X. Xxxxx, DPM 0000 Xxxxxxxxxxx Xx. X-000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Email: xx.xxxxx@xxxxx.xxx 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.

  • Reports; Regulatory Matters (a) Each of the Companies and their Subsidiaries have timely filed or furnished, as applicable, all reports, registrations, statements and certifications, together with any amendments required to be made with respect thereto, that they were required to file or furnish, as applicable, since January 1, 2006 with (i) any state regulatory authority, (ii) the SEC, (iii) any foreign regulatory authority, and (iv) any self-regulatory authority, (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed or furnished by them since January 1, 2006, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or other Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Section 3.5 of the Company Disclosure Schedule, no Regulatory Agency or other Governmental Entity has initiated since January 1, 2006 or has pending any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. Since January 1, 2006, no Regulatory Agency or other Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. There is no unresolved, or, to Seller’s knowledge, threatened criticism, comment, exception or stop order by any Regulatory Agency or other Governmental Entity with respect to any report or statement relating to any examinations or inspections of any of the Companies or any of its Subsidiaries. Since January 1, 2006, there have been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or other Governmental Entity with respect to the business, operations, policies or procedures of any of the Companies or any of its Subsidiaries (other than normal inquiries made by a Regulatory Agency or other Governmental Entity in the Companies’ ordinary course of business). (b) No Company nor any of its Subsidiaries is subject to any cease-and-desist or other order or enforcement action issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been ordered to pay any civil money penalty by, or has been since January 1, 2006 a recipient of any supervisory letter from, or since January 1, 2006 has adopted any policies, procedures or board resolutions at the request or suggestion of, any Regulatory Agency or other Governmental Entity that currently restricts or affects in any material respect the conduct of its business (or to Seller’s knowledge that, upon consummation of the transactions contemplated hereby, would restrict in any material respect the conduct of the business of either Buyer or any of its Subsidiaries), or that in any material manner relates to its capital adequacy, its ability to pay dividends, its credit, risk management or compliance policies, its internal controls, its management or its business, other than those of general application that apply to similarly situated companies or their Subsidiaries (each item in this sentence, a “Company Regulatory Agreement”), nor has any of the Companies or any of their Subsidiaries been advised since January 1, 2006 by any Regulatory Agency or other Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Company Regulatory Agreement. (c) Seller has previously made available to Buyers an accurate and complete copy of each (i) final registration statement, prospectus, report, schedule and definitive proxy statement filed with the SEC by Seller pursuant to the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2006 (the “Seller SEC Reports”) and prior to the date of this Agreement and (ii) communication mailed by Seller to its shareholders since January 1, 2006 and prior to the date of this Agreement. No such Seller SEC Report or communication, at the time filed or communicated (or, if amended prior to the date hereof, as of the date of such amendment), with respect to the Companies and their Subsidiaries only, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances in which they were made, not misleading. To the knowledge of Seller, other than as set forth in Section 3.5 of the Company Disclosure Schedule, none of the Seller SEC Reports is the subject of any ongoing review or investigation by the SEC or any other Governmental Entity and there are no unresolved SEC comments with respect to any of such documents.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately 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 the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each 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, as applicable, 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 Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) 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 (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) 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.

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Notification of Recall Notification of recall from layoff shall be sent by certified mail, return receipt requested, deliverable to addressee only, to the employee's last known address. The notice shall give the employee a minimum of ten (10) calendar days within which to respond after the notice of recall has been mailed. Employees who decline recall or who, in the absence of extenuating circumstances, fail to respond within the time set for return to work, shall be presumed to have resigned and their name shall be removed from the seniority and preferred eligibility list.

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement.

  • SUBMISSION OF REPORTS All applicable study reports shall be submitted in preliminary form for approval by the State before a final report is issued. The State's comments on the Engineer's preliminary report must be addressed in the final report.

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