Material Communication definition

Material Communication has the meaning assigned to such term in Section 5.11(o).

Material Communication means [***].

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).

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 means all communication with the patient regarding the care of the patient, whether the communication was face-to-face or by telecommunication.

Material Communication means any communication which shows that there has been a material adverse change in the financial position of the Borrower or that an Event of Default has occurred

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).

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.

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).