Material Communication definition

Material Communication means [***].
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Material Communication means any communication (including meetings) with Regulatory Authorities and Regulatory Authority questions or concerns regarding significant issues, including any of the following: key Product quality attributes (e.g., purity), significant safety findings, significant clinical or nonclinical findings affecting patient safety, or significant efficacy or lack of efficacy, in each case with respect to a Lead Product or a Collaboration Product, that could materially affect Anticalin proteins per se (e.g., serious adverse events, emerging safety signals).
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Material Communication means any communication which shows that there has been a material adverse change in the financial position of any member of the Group or that a Potential Event of Default has occurred or is about to occur.
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Examples of Material Communication in a sentence

  • Within [***] after receipt of any Material Communication from a Regulatory Authority with respect to any Collaboration Product, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication.

  • Upon Voyager’s reasonable request after receiving a notice from Genzyme in accordance with the immediately preceding sentence, Genzyme will provide to Voyager complete copies of such correspondence of any such Material Communication within a reasonable period of time following such request.

  • Upon the Noticed Party’s reasonable request after receiving a notice from the Noticing Party in accordance with the immediately preceding sentence, the Noticing Party will provide to the Noticed Party complete copies of correspondence of relating to such Material Communication in original language without translation within a reasonable period of time following such request.

  • Each Regulatory Lead Party will provide to the other Party for review and discussion a copy of each Material Communication with any Regulatory Authorities with respect to any Licensed Product for which such Party is the Regulatory Lead Party.

  • Any Material Communication to a Regulatory Authority with respect to any Licensed Product in the Profit-Share Territory must be consistent with the Profit-Share Regulatory Strategy for such Licensed Product approved by the JSC.

  • With respect to any Material Communication with the FDA or the EMA or a Regulatory Authority in [**] related to a Licensed Product, the Regulatory Lead Party will allow the other Party [**].

  • Ono will allow Repare a reasonable opportunity to review and comment on Ono’s proposed response to any Material Communications with PMDA with respect to any Licensed Product, and Ono will reasonably consider all comments timely provided by Repare in connection therewith; provided, that Ono may designate a reasonable time and date by which Repare must respond to a Material Communication by the PMDA in light of the requirements of the PMDA.

  • Notwithstanding the foregoing, Otsuka shall not be required to provide a brief written description or a translation of any Material Communication that is conveyed at any meeting, teleconference or videoconference that is attended by any Perception representative.

  • Upon Perception’s request after receiving such description from Otsuka, Otsuka shall translate such Material Communication, [***] as soon as practically possible and shall provide to Perception such translated Material Communication promptly after completion of such translation into English.

  • Each Party will provide the JSC for its review and discussion a brief description in English of the principal issues raised in each Material Communication with Regulatory Authorities in the EU/Japan with respect to the Distribution Product in the Field.


More Definitions of Material Communication

Material Communication has the meaning assigned to such term in Section 5.11(ao).
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Material Communication means material written, telephonic, or in person communications from or with any Regulatory Authority concerning any of the following: key product quality attributes (e.g., purity), safety findings affecting the platform (e.g., serious adverse events, emerging safety signals), clinical or non clinical findings affecting patient safety, lack of efficacy, receipt or denial of Regulatory Approval, the design of Clinical Trials, or the need for additional non clinical studies or IND-Enabling Studies (e.g., additional toxicology or carcinogenicity studies).
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Material Communication means communications regarding: key product quality attributes (e.g., purity), material safety findings (e.g., serious adverse events as identified by emerging safety signals), clinical or nonclinical findings affecting patient safety, or lack of efficacy.
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Material Communication means any written communications (other than any immaterial communications, such as e-mails without attachments or communications to schedule a meeting), telephonic communications or in-person communications from or with any Regulatory Authority concerning any of the following: key product quality attributes (e.g., purity) of Products; safety findings affecting a Product (e.g., Serious Adverse Events, emerging safety signals); clinical or non-clinical findings affecting patient safety, efficacy, or receipt or denial of Regulatory Approval; or the design of Clinical Studies of a Product or the need for additional Non-Clinical Studies (e.g., additional toxicology or carcinogenicity studies).
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Material Communication means all communication with the patient regarding the care of the patient, whether the communication was face-to-face or by telecommunication.
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Related to Material Communication

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

  • radio communication means communication by means of radio waves;

  • 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.

  • 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.

  • 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.

  • Collaborative law communication means a statement, whether oral or in a record, or verbal or nonverbal, to which both of the following apply:

  • 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;

  • 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.”

  • 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.

  • public communications network means an electronic communications network used wholly or mainly for the provision of electronic communications services available to the public which support the transfer of information between network termination points;

  • Electioneering communication means a communication that:

  • 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.

  • 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;

  • Written Communication has the meaning set forth in Rule 405 under the Securities Act.

  • Privileged Communications has the meaning specified in Section 12.17.

  • Permitted Section 5(d) Communication means the Section 5(d) Written Communication(s) and Marketing Materials listed on Schedule C attached hereto. All references in this Agreement to the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus and the Prospectus shall include the documents incorporated or deemed to be incorporated by reference therein. All references in this Agreement to financial statements and schedules and other information which are “contained,” “included” or “stated” in, or “part of” the Registration Statement, the Rule 462(b) Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus, and all other references of like import, shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in the Registration Statement, the Rule 462(b) Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus, as the case may be. All references in this Agreement to amendments or supplements to the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus shall be deemed to mean and include the filing of any document under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “Exchange Act”) that is or is deemed to be incorporated by reference in the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, or the Prospectus, as the case may be. All references in this Agreement to (i) the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus or the Prospectus, any amendments or supplements to any of the foregoing, or any free writing prospectus, shall include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“XXXXX”) and (ii) the Prospectus shall be deemed to include any “electronic Prospectus” provided for use in connection with the offering of the Offered Shares as contemplated by Section 3(n) of this Agreement. The Company hereby confirms its agreements with the Underwriters as follows:

  • Free Writing Communication means a written communication (as such term is defined in Rule 405) that constitutes an offer to sell or a solicitation of an offer to buy the Offered Securities and is made by means other than the Preliminary Offering Circular or the Final Offering Circular.

  • Communication is defined in Section 10.

  • 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.

  • Issuer Free Writing Communication means a Free Writing Communication prepared by or on behalf of the Issuers, used or referred to by the Issuers or containing a description of the final terms of the Offered Securities or of their offering, in the form retained in the Issuers’ records.

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

  • Private communication service means a telecommunication service that entitles the customer to exclusive or priority use of a communications channel or group of channels between or among termination points, regardless of the manner in which such channel or channels are connected, and includes switching capacity, extension lines, stations, and any other associated services that are provided in connection with the use of such channel or channels.

  • Correspondence between the Company, the Union, or any member of the Union arising out of this Agreement or incidental thereto, shall pass to and from the Company, the Union and member by verifiable means.

  • Testing-the-Waters Communication means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.

  • communication to the public of a performance means the transmission to the public by any medium, otherwise than by broadcasting, of an unfixed performance, or of a performance fixed in an audiovisual fixation. For the purposes of Article 11, “communication to the public” includes making a performance fixed in an audiovisual fixation audible or visible or audible and visible to the public.

  • Communications Facility means the set of equipment and network components, including wires, cables, antennas, and associated facilities, used by a communications service provider to provide communications service.