Material Communication definition

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

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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.

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

• Seller shall fully comply with the U.S. Occupational Safety and Health Administration’s Hazardous Material Communication Standard and shall furnish Buyer with copies of Material Safety Data Sheets (“MSDS”) for all items Seller ships to Buyer five (5) days prior to the initial shipment and a MSDS copy shall accompany the initial shipment.

• 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.

• 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.

• 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 [**].

• 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.

• 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.

• Within [***] business days after receipt of any Material Communication from such Regulatory Authority with respect to such Licensed Product, Esperion will provide DSE with a brief written description of the principal issues raised in such Material Communication with such Regulatory Authority.

• Together with such assignment of such Regulatory Approvals, Esperion shall provide DSE with full registration dossiers of Licensed Product in the DSE Territory in eCTD format as well as complete electronic copies of all other necessary Regulatory Documentation available to Esperion, such as, but not limited to, Regulatory Approval application assessment reports and all Material Communication.

More Definitions of Material Communication

Material Communication means [***].

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.

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).