Regulatory Communications definition

Regulatory Communications means, collectively, whether existing before or after the NDA Transfer Date: (a) all written or electronic filings or submissions made with Regulatory Authorities in satisfaction of applicable regulatory and notification requirements with respect to Products in the Territory (including, without limitation, Annual Periodic Reports, Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports, and filings and submissions regarding recalls); (b) all written or electronic correspondence to or from the FDA with respect to any of the foregoing; (c) minutes of any meeting between a party and the FDA regarding the Regulatory Approvals, or Manufacture or Commercialization of the Products in or for the Territory; and (d) written summaries of oral communications between a party and the FDA that would impact, or would reasonably be expected to be material to, the development, Manufacture, commercialization of the Products and/or any ROR Product.
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Regulatory Communications has the meaning set forth in Section 6.1(b) hereof.
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Regulatory Communications any meetings, submissions, filings by CASI with any Regulatory Authority in a Region and any notices, correspondences, communications, or other filings received by CASI from any Regulatory Authority in a Region relating to the Development, manufacture, packaging, obtaining marketing authorization, marketing, selling or otherwise Commercialization of the Licensed Product in such Region.
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Examples of Regulatory Communications in a sentence

  • Prior to responding to any Regulatory Communications, You will provide a copy of any such responses to Us for Our review and comment.

  • Prior to responding to any Regulatory Communications, PROVIDER will provide a copy of any such responses to MYLAN for XXXXX’s review and comment.

  • Prior to responding to any Regulatory Communications, Seller will provide a copy of any such responses to Buyer for Buyer’s review and comment.

  • Policy and Regulatory Communications InitiativesAs the primary guiding force in NASA’s communication of knowledge, the Space Act of 1958 is relatively unique in its direction and scope among Agency charters in setting the course for NASA’s communications efforts.

  • Depomed may provide all such Regulatory Communications and Regulatory Data to the applicable Third Parties under the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements as Depomed determines is reasonably necessary to comply with the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements.

  • Prior to responding to any Regulatory Communications, supplier will provide a copy of any such responses to Mylan for Xxxxx’s review and comment.

  • Except as expressly provided in Section 10.1.1 (Regulatory Communications and Filings) GSK will cooperate with Amgen, at its request, with respect to any regulatory matters related to Ivory.

  • Depomed shall have the right to request review and approve, with reasonable notice, any and all Regulatory Communications, Regulatory Approvals, and related regulatory documents that pertain to the Product NDAs before they are submitted to FDA or other Regulatory Authorities by Collegium or Newco.

  • Prior to responding to any Regulatory Communications, Seller will provide a copy of any such responses to Mylan for Mylan’s review and comment.

  • Prior to responding to any Regulatory Communications, supplier will provide a copy of any such responses to Viatris for Viatris’ review and comment.


More Definitions of Regulatory Communications

Regulatory Communications means any action, request, order, instruction, communication, complaint, notice, public announcement or inquiry by a Regulatory Authority or any submission, filing, letter or other communication by Pharmos, BLP or any manufacturer of Drug Substance to a Regulatory Authority, with respect to Drug Product, Placebo Product, Development Product or Drug Substance which is sent by or is received by either party (or, in the case of Pharmos, by any manufacturer of Drug Substance), or which comes to either party's or its agent's attention, including, but not limited, to field actions, investigations or recalls of Drug Product or Placebo Product in the New Territories.
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Regulatory Communications means a Data Breach Team law firm communicating with a government agency to comply with Privacy Regulations, responding to a request for information or demand by a governmental agency alleging the violation of Privacy Regulations as a result of a Data Breach,
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Regulatory Communications has the meaning set forth in Section 11.2.
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Regulatory Communications means, collectively, whether existing before or after the Closing Date: (a) all written or electronic filings or submissions made with Regulatory Authorities in satisfaction of applicable regulatory and notification requirements with respect to Products in the Territory (including, without limitation, Annual Periodic Reports, Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports, and filings and submissions regarding recalls); (b) all written or electronic correspondence to or from the FDA 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 marked [***]. with respect to any of the foregoing; (c) minutes of any meeting between a party and the FDA regarding the Regulatory Approvals, or Manufacture or Commercialization of the Products in or for the Territory; and (d) written summaries of oral communications between a party and the FDA that would impact, or would reasonably be expected to be material to, the development, Manufacture or commercialization of the Products.
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Related to Regulatory Communications

  • Informal communications means any communication method other than written emails to the Point of Contact Person identified for this RFP.

  • campaign communication means “a written or oral communication relating to a campaign for nomination or election to public office or office of a political party or to a campaign on a measure.”

  • Mediation communication means a statement, whether oral, in a record, verbal or nonverbal, that occurs during a mediation or is made for purposes of considering, conducting, participating in, initiating, continuing, or reconvening a mediation or retaining a mediator.

  • Privileged Communications has the meaning specified in Section 12.17.

  • Ex parte communication ’ means an oral or written communication not on the pub- lic record with respect to which reasonable prior notice to all parties is not given, but it shall not include requests for status reports on any matter or proceeding covered by this sub- chapter.

  • Confidential communication means a communication not intended to be disclosed to third persons other than those to whom disclosure is in furtherance of the rendition of professional legal services to the client or those reasonably necessary for the transmission of the communication.

  • radio communication means communication by means of radio waves;

  • Remote communication means communication via electronic communication, conference telephone, videoconference, the internet, or such other means by which persons not physically present in the same location may communicate with each other on a substantially simultaneous basis.

  • Wire communication means any aural transfer made in whole or in part through the use of facilities for the transmission of communications by the aid of wire, cable, or other like connection between the point of origin and the point of reception (including the use of such connection in a switching station) furnished or operated by any person engaged in providing or operating such facilities for the transmission of interstate or foreign communications or communications affecting interstate or foreign commerce;

  • NOTICES AND COMMUNICATIONS All communications from you should be addressed to us at 0000 Xxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxxxxxxx, XX 00000. Any notice from us to you shall be deemed to have been duly given if mailed or telegraphed to you at the address set forth above. Each of us may change the address to which notices shall be sent by notice to the other in accordance with the terms hereof.

  • Regulatory Bodies means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

  • Privileged communication means a communication made to a psychiatrist or psychologist in connection with the examination, diagnosis, or treatment of a patient, or to another person while the other person is participating in the examination, diagnosis, or treatment or a communication made privileged under other applicable state or federal law.

  • Electioneering communication means a communication that:

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Communications Provider means a person who provides an Electronic Communications Network or an Electronic Communications Service;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Communications channel means a physical or virtual path of communications over which signals are transmitted between or among customer channel termination points.

  • Communication technology means an electronic device or process that:

  • Public Electronic Communications Network means an Electronic Communications Network provided wholly or mainly for the purpose of making Electronic Communications Services available to members of the public;

  • Oral communication means any oral communication uttered by a person exhibiting an expectation that such communication is not subject to interception under circumstances justifying such expectation, but such term does not include any electronic communication;

  • Catalogue of electronic communications means information that identifies each person with which a user has had an electronic communication, the time and date of the communication, and the electronic address of the person.

  • Communications Laws means the Communications Act of 1934, and any similar or successor federal statute, together with all published rules, regulations, policies, orders and decisions of the FCC promulgated thereunder.

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • means of distance communication refers to any means which, without the simultaneous physical presence of the payment service provider and the payment service user, may be used for the conclusion of a payment services contract;

  • Rating Agency Communication means, with respect to any action and any Securitization, any written communication intended for a Rating Agency, which shall be delivered at least ten (10) Business Days prior to completing such action, in electronic document format suitable for website posting to the 17g-5 information provider under the applicable Securitization Servicing Agreement.