Reports and Correspondence. The Company shall keep the Development Committee informed of its activities under the Development Plan through regular reports, as set forth in this Section 6.3. At each Scheduled Meeting of the Development Committee, or according to a schedule agreed to by the Development Committee, the Company shall, to the extent reasonably required by the Development Committee, provide a summary of the Company’s activities and developments with respect to the Programs for the period following the most recent preceding scheduled summary report. Such summary report shall include the following types of information in a format and frequency as determined by the Development Committee: (i) updates regarding (A) patient enrollment, adverse events or serious adverse events (to the extent the Company has been notified of such adverse events), any added or terminated clinical trial sites, any significant Protocol deviations, the results of any interim analyses, statistical reports, updated Investigator Brochures or final clinical study reports or any new Protocols, Protocol amendments or studies synopses being drafted, all to the extent relating to the Development Plan; and (B) CMC status, non-clinical program status, regulatory and quality program status, communications with regulatory agencies, results of meetings of the Company’s standing or ad hoc clinical advisors, safety monitoring boards or other similar oversight bodies (if and when formed) for a particular Program, and results of meetings with consultants for the Programs, all to the extent related to the Company Obligations; (ii) a copy of each standard clinical study progress report for the Programs received by the Company during the preceding period from any of the clinical research organizations engaged by the Company pursuant to any Subcontracting Agreements and a copy of any final preclinical study reports for such Programs; (iii) a financial report, in a format agreed upon by the Development Committee, itemizing actual spending under the Development Plan as well as any variation from planned spending; (iv) copies of all Subcontracting Agreements executed since the previous Development Committee Meeting; and (v) such other information as the Development Committee may reasonably request. The Company shall notify at least one (1) of the Development Committee Members designated by Holdings as soon as possible, but no later than within [ * ] ([ * ]) hours of the occurrence of any event that has, or could reasonably be expected to have, in the Company’s judgment in light of the circumstances existing at the time, a material effect on the Development Plan or the Development Budget and shall keep the Development Committee regularly updated and informed with respect to any such event. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Reports and Correspondence. (a) The Company shall keep the Development Committee informed of its activities under the Development Plan through regular reports, as set forth in this Section 6.3. At each Scheduled Meeting of the Development Committee, or according to a schedule agreed to by the Development Committee, the Company shall, to the extent reasonably required by the Development Committee, provide a summary of the Company’s activities and developments with respect to the Programs for the period following the most recent preceding scheduled summary report. Such summary report shall include the following types of information in a format and frequency as determined by the Development Committee: (i) updates regarding (A) patient enrollment, adverse events or serious adverse events (to the extent the Company has been notified of such adverse events), any added or terminated clinical trial sites, any significant Protocol deviations, the results of any interim analyses, statistical reports, updated Investigator Brochures or final clinical study reports or any new Protocols, Protocol amendments or studies synopses being drafted, all to the extent relating to the Development Plan; and (B) CMC status, non-clinical program status, regulatory and quality program status, communications with regulatory agencies, results of meetings of the Company’s standing or ad hoc clinical advisors, safety monitoring boards or other similar oversight bodies (if and when formed) for a particular Program, and results of meetings with consultants for the Programs, all to the extent related to the Company Obligations; (ii) a copy of each standard clinical study progress report for the Programs received by the Company during the preceding period from any of the clinical research organizations engaged by the Company pursuant to any Subcontracting Agreements and a copy of any final preclinical study reports for such Programs; (iii) a financial report, in a format agreed upon by the Development Committee, itemizing actual spending under the Development Plan as well as any variation from planned spending; (iv) copies of all Subcontracting Agreements executed since the previous Development Committee Meeting; and (v) such other information as the Development Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Committee may reasonably request. The Company shall notify at least one (1) of the Development Committee Members designated by Holdings as soon as possible, but no later than within [ * ] ([ * ]) hours of the occurrence of any event that has, or could reasonably be expected to have, in the Company’s judgment in light of the circumstances existing at the time, a material effect on the Development Plan or the Development Budget and shall keep the Development Committee regularly updated and informed with respect to any such event.
(b) The Symphony Collaboration Board member designated by the Company (the “Company Board Member”) and the Chairman of the Symphony Collaboration Board (the “Symphony Chairman”) shall from time to time agree on the strategic goals and general business terms (the “Parameters”) upon which third parties will be approached for the development or commercialization of any of the Programs (“Strategic Relationships”), including without limitation, material economic and business terms. Portions The Company shall be primarily responsible for negotiating (within the Parameters at the time) the Strategic Relationships. The Company Board Member shall notify the Symphony Chairman upon the commencement of this Exhibit were omitted any formal discussions with any third party concerning a potential Strategic Relationship with such third party. The Company Board Member shall report to and have been filed separately consult with the Secretary Symphony Chairman on any matters relating to such potential Strategic Relationship that may be reasonably requested by the Symphony Chairman and take the Symphony Chairman’s comments into account in negotiating such Strategic Relationships. For the avoidance of doubt, the Company can engage in business development activities not constituting Strategic Relationships, including disclosure of confidential information (subject to the terms of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 Confidentiality Agreement), without obtaining prior consent of the Securities Exchange Act of 1934, as amendedSymphony Collaboration.
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Reports and Correspondence. The Company Alexza shall keep the Development Committee informed of its activities under the Development Plan through regular reports, as set forth in this Section 6.3. At each Scheduled Meeting of the Development Committee, or according to a schedule agreed to by the Development Committee, the Company Alexza shall, to the extent reasonably required by the Development Committee, provide the Development Committee with a summary of the CompanyAlexza’s activities and developments with respect to the Programs for the period following the most recent preceding scheduled summary reportScheduled Meeting. Such summary report shall include the following types of information in a format and frequency as determined by the Development Committeeinclude: (i) updates regarding (A) patient enrollment, adverse events or serious any adverse events (to the extent the Company Alexza has been notified of such adverse events)) or serious adverse events, any added or terminated clinical trial sites, any significant Protocol deviationsdeviation, the results of any interim analyses, statistical reports, updated Investigator Brochures or final clinical study reports or any new Protocols, Protocol amendments or studies synopses being drafted, all to the extent relating to clinical trials under the Development Plan; and (B) CMC status, non-clinical program status, regulatory and quality program status, communications with regulatory agencies, results of meetings of the CompanyAlexza’s standing or ad hoc clinical advisors, safety monitoring boards or other similar oversight bodies (if and when formed) for a particular Program, and results of meetings with consultants for the Programs, all to the extent related to the Company Alexza Obligations; (ii) a copy of each standard clinical study progress report for the Programs received by the Company Alexza during the preceding period month from any of the clinical research organizations engaged by the Company Alexza pursuant to any Subcontracting Agreements and a copy of any final preclinical study reports for such Programs; (iii) a financial report, in a format agreed upon by the Development Committee, itemizing actual spending under the Development Plan as well as any variation from planned spending; (iv) copies if the portion of all Subcontracting Agreements executed since the previous Development Committee MeetingBudget related to a particular Program is altered to the extent that available funding for such Program no longer appears to be adequate to complete the Program, an updated budget forecast; and (v) such other information as the Development Committee may reasonably request. The Company Alexza shall notify at least one (1) of the Development Committee Members designated by Holdings as soon as possible, but no later than within [ * ] twenty-four ([ * ]24) hours of the occurrence of any event that has, or could reasonably be expected to have, in the Company’s judgment in light of the circumstances existing at the time, a material adverse effect on the Development Plan or the Development Budget and shall keep the Development Committee regularly updated and informed with respect to any such event. Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Sources: Research and Development Agreement (Alexza Pharmaceuticals Inc.)