Material Communications definition

Material Communications means 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 Studies or the need for additional non-clinical studies (e.g., additional toxicology or carcinogenicity studies).

Material Communications means, with respect to any Contractual Obligation, any communication by the Borrower or any of its Subsidiaries with any Governmental Authority or any party to such Contractual Obligation regarding an event or circumstance that could reasonably be expected to result in a Material Adverse Effect.

Material Communications means contact in person, by telephone or by paper or electronic correspondence in furtherance of the business interests of the Company during the last twenty-four (24) months of Executive’s employment with the Company.

Examples of Material Communications in a sentence

• Executive agrees that during Executive’s employment with the Company and for a period of twenty-four (24) months after such employment ends, Executive will not, directly or indirectly, whether on Executive’s own behalf or on behalf of any other person or entity, solicit any sponsor bank or other vendor of the Company with whom Executive had Material Communications for the purpose of procuring products or services to support a Competing Business.

• Material Communications For the purpose of this Agreement, "Material Communications" shall be defined as those communications that are associated with material breach of this Agreement, termination or recapture of this Agreement, the resolution of disputes by arbitration, negotiation or court proceedings under this Agreement, a change in or loss of the Reinsurer's licensing or accreditation, and/or confidentiality and compliance provisions set forth in this Agreement.

• For the purpose of this Agreement, "Material Communications" shall be defined as those communications associated with material breach of this Agreement, termination or recapture of this Agreement, demand for arbitration or dispute resolution under this Agreement, a change in or loss of the Reinsurer's licensing or accreditation, and/ or confidentiality and compliance provisions set forth in this Agreement.

• Genzyme will allow Voyager a reasonable opportunity to review and comment on Genzyme’s proposed response to any Material Communications with the EMA with respect to any Split Territory Licensed Product or, if Genzyme has exercised the Co-Co Option, with the FDA with respect to any HD Licensed Product, in advance of the transmission of such response, and Genzyme will reasonably consider all comments timely provided by Voyager in connection therewith.

• Voyager will allow Genzyme a reasonable opportunity to review and comment on Voyager’s proposed response to any Material Communications with any Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product in advance of the transmission of such response, and Voyager will reasonably consider all comments timely provided by Genzyme in connection therewith.

More Definitions of Material Communications

Material Communications means any material communications with a Regulatory Authority, including clinical study protocols and amendments thereto, meeting requests and materials, request for information and responses thereto, clinical hold notices, investigator’s brochures, and supplemental NDA submissions.

Material Communications shall have the meaning set forth in Section 25.01. [REDACTED]

Material Communications means any letters, reports, or other documents received by, or sent to, any Governmental Authority that relates to a Product, a Facility, or such processes or procedures.

Material Communications has the meaning set forth in Section 5.1.2.

Material Communications means written, telephonic or in person communications from or with any Regulatory Authority concerning any of the following: product quality attributes (e.g., purity, toxicity, drug/drug interactions); significant or new safety findings (e.g., Serious Adverse Events, emerging safety signals); clinical or non-clinical findings affecting patient safety; lack of efficacy; potential pathways to Regulatory Approval; receipt or denial of Regulatory Approval; the design of Clinical Studies, or the need for additional Clinical Studies or Nonclinical Studies (e.g., additional toxicology or carcinogenicity studies).

Material Communications. MEANS WRITTEN, TELEPHONIC, OR IN‑PERSON COMMUNICATIONS FROM OR WITH ANY REGULATORY Authority concerning any of the following: [***].

Material Communications means written, telephonic, or in‑person communications from or with any Regulatory Authority concerning any of the following: [***].