Common use of Program Management Clause in Contracts

Program Management. Below are the individuals currently assigned to key roles on the project team. Regeneron reserves the right to make personnel changes which will be communicated accordingly. a. Regeneron will manage, integrate and coordinate all activities, including utilizing Regeneron’s state-of-the-art technical and administrative infrastructure to ensure efficient planning, initiation, implementation and direction of contracted activities. b. The [* * *], is responsible for guiding the project approach and scope of this Program. c. [* * *], will serve as Lead PI for this Program. The PI will be responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including any projects undertaken by subcontractors. d. A [* * *], will be responsible for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management for this Program. The contract deliverables list identifies all contract deliverables and reporting requirements for this contract. e. [* * *], will provide development of compliant subcontracts, consulting, and other legal agreements. f. [* * *], will be responsible for financial management and reporting on all activities conducted by Regeneron and any subcontractors. g. A [* * *], will be responsible for facilitating the development of integrated CMC plans and for monitoring and tracking the progress of the CMC milestones. h. A [* * *], will be responsible for management of batch disposition, oversight of discrepancy investigations, and to ensure all released product conforms to GMP standards. i. A [* * *], will be responsible for analytical method development, method transfer and specification development. j. A [* * *], will be responsible for ensuring Regeneron quality, preclinical, and clinical drug development programs are conducted in compliance with regulations governing pharmaceutical drug development, and with project specific regulatory commitments/requirements, and will serve as the liaison for communications with the US Food and Drug Administration. k. Regeneron shall provide Quarterly Progress Reports, which shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. l. Regeneron shall provide Annual Progress Reports, which shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. m. Regeneron shall provide Draft and Final Reports, which shall include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall describe the results achieved. n. Regeneron shall participate in regular meetings to coordinate and oversee the contract effort, as directed by a single point of contact established by the Government. Such meetings may include, but are not limited to, meetings of Regeneron and subcontractors to discuss clinical manufacturing progress, product development, scale-up manufacturing development, preclinical/clinical study designs and regulatory issues, meetings with individual contractors and other Health and Human Services (HHS) officials to discuss the technical, regulatory, and ethical aspects of the program, and meetings with technical consultants to discuss technical data provided by Regeneron. Regeneron shall also consult with the Government as required in connection with meetings and submissions to regulatory agencies, including the FDA. The Government will establish a single point of contact for regular meetings and coordinate all requests for information through such point of contact, such that Regeneron shall not be required to attend multiple meetings with different Government agencies for the same (or similar) subject matter, or respond to multiple requests for information or materials concerning the same (or similar) subject matter. o. Regeneron shall participate in teleconferences at an agreed upon frequency between Regeneron and the Government to review technical progress.

Program Management. Below are the individuals currently assigned to key roles on the project team. Regeneron reserves the right to make personnel changes which will be communicated accordingly. a. Regeneron will manage, integrate and coordinate all activities, including utilizing Regeneron’s state-of-the-art technical and administrative infrastructure to ensure efficient planning, initiation, implementation and direction of contracted activities. b. The [* * *], is responsible for guiding the project approach and scope of this Program. c. [* * *], will serve as Lead PI for this Program. The PI will be responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including any projects undertaken by subcontractors. d. A [* * *], will be responsible for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management for this Program. The contract deliverables list identifies all contract deliverables and reporting requirements for this contract. e. [* * ** ], will provide development of compliant subcontracts, consulting, and other legal agreements. f. [* * *], will be responsible for financial management and reporting on all activities conducted by Regeneron ▇▇▇▇▇▇▇▇▇ and any subcontractors. g. A [* * *], will be responsible for facilitating the development of integrated CMC plans and for monitoring and tracking the progress of the CMC milestones. h. A [* * *], will be responsible for management of batch disposition, oversight of discrepancy investigations, and to ensure all released product conforms to GMP standards. i. A [* * *], will be responsible for analytical method development, method transfer and specification development. j. A [* * *], will be responsible for ensuring Regeneron quality, preclinical, and clinical drug development programs are conducted in compliance with regulations governing pharmaceutical drug development, and with project specific regulatory commitments/commitments/ requirements, and will serve as the liaison for communications with the US Food and Drug Administration. k. Regeneron shall provide Quarterly Progress Reports, which shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. l. Regeneron shall provide Annual Progress Reports, which shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. m. Regeneron shall provide Draft and Final Reports, which shall include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall describe the results achieved. n. Regeneron shall participate in regular meetings to coordinate and oversee the contract effort, as directed by a single point of contact established by the Government. Such meetings may include, but are not limited to, meetings of Regeneron and subcontractors to discuss clinical manufacturing progress, product development, scale-up manufacturing development, preclinical/clinical study designs and regulatory issues, meetings with individual contractors and other Health and Human Services (HHS) officials to discuss the technical, regulatory, and ethical aspects of the program, and meetings with technical consultants to discuss technical data provided by Regeneron. Regeneron shall also consult with the Government as required in connection with meetings and submissions to regulatory agencies, including the FDA. The Government will establish a single point of contact for regular meetings and coordinate all requests for information through such point of contact, such that Regeneron shall not be required to attend multiple meetings with different Government agencies for the same (or similar) subject matter, or respond to multiple requests for information or materials concerning the same (or similar) subject matter. o. Regeneron shall participate in teleconferences at an agreed upon frequency between Regeneron and the Government to review technical progress.

Program Management. Below are the individuals currently assigned to key roles on the project team. Regeneron reserves the right to make personnel changes which will be communicated accordingly. a. Regeneron will manage, integrate and coordinate all activities, including utilizing Regeneron’s state-of-the-art technical and administrative infrastructure to ensure efficient planning, initiation, implementation and direction of contracted activities. b. The [* * *], ] is responsible for guiding the project approach and scope of this Program. c. [* * *], ] will serve as Lead PI for this Program. The PI will be responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including any projects undertaken by subcontractors. d. A [* * *], ] will be responsible for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management for this Program. The contract deliverables list identifies all contract deliverables and reporting requirements for this contract. e. [* * *], ] will provide development of compliant subcontracts, consulting, and other legal agreements. f. [* * *], ] will be responsible for financial management and reporting on all activities conducted by Regeneron ▇▇▇▇▇▇▇▇▇ and any subcontractors. g. A [* * *], ] will be responsible for facilitating the development of integrated CMC plans and for monitoring and tracking the progress of the CMC milestones. h. A [* * *], ] will be responsible for management of batch disposition, oversight of discrepancy investigations, and to ensure all released product conforms to GMP standards. i. A [* * *], ] will be responsible for analytical method development, method transfer and specification development. j. A [* * *], ] will be responsible for ensuring Regeneron quality, preclinical, and clinical drug development programs are conducted in compliance with regulations governing pharmaceutical drug development, and with project specific regulatory commitments/commitments/ requirements, and will serve as the liaison for communications with the US Food and Drug Administration. k. Regeneron shall provide Quarterly Progress Reports, which shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. l. Regeneron shall provide Annual Progress Reports, which shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. m. Regeneron shall provide Draft and Final Reports, which shall include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall describe the results achieved. n. Regeneron shall participate in regular meetings to coordinate and oversee the contract effort, as directed by a single point of contact established by the Government. Such meetings may include, but are not limited to, meetings of Regeneron and subcontractors to discuss clinical manufacturing progress, product development, scale-up manufacturing development, preclinical/clinical study designs and regulatory issues, meetings with individual contractors and other Health and Human Services (HHS) officials to discuss the technical, regulatory, and ethical aspects of the program, and meetings with technical consultants to discuss technical data provided by Regeneron. Regeneron shall also consult with the Government as required in connection with meetings and submissions to regulatory agencies, including the FDA. The Government will establish a single point of contact for regular meetings and coordinate all requests for information through such point of contact, such that Regeneron shall not be required to attend multiple meetings with different Government agencies for the same (or similar) subject matter, or respond to multiple requests for information or materials concerning the same (or similar) subject matter. o. Regeneron shall participate in teleconferences at an agreed upon frequency between Regeneron and the Government to review technical progress.

Program Management. Below are the individuals currently assigned to key roles on the project team. Regeneron reserves the right to make personnel changes which will be communicated accordingly. a. Regeneron will manage, integrate and coordinate all activities, including utilizing Regeneron’s state-of-the-art technical and administrative infrastructure to ensure efficient planning, initiation, implementation and direction of contracted activities. b. The [* * *], is responsible for guiding the project approach and scope of this Program. c. [* * *], will serve as Lead PI for this Program. The PI will be responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including any projects undertaken by subcontractors. d. A [* * *], will be responsible for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management for this Program. The contract deliverables list identifies all contract deliverables and reporting requirements for this contract. e. [* * *], will provide development of compliant subcontracts, consulting, and other legal agreements. f. [* * *], will be responsible for financial management and reporting on all activities conducted by Regeneron and any subcontractors. g. A [* * *], will be responsible for facilitating the development of integrated CMC plans and for monitoring and tracking the progress of the CMC milestones. h. A [* * *], will be responsible for management of batch disposition, oversight of discrepancy investigations, and to ensure all released product conforms to GMP standards. i. A [* * *], will be responsible for analytical method development, method transfer and specification development. j. A [* * *], will be responsible for ensuring Regeneron quality, preclinical, and clinical drug development programs are conducted in compliance with regulations governing pharmaceutical drug development, and with project specific regulatory commitments/requirements, requirements ,and will serve as the liaison for communications with the US Food and Drug Administration. k. Regeneron shall provide Quarterly Progress Reports, which shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. l. Regeneron shall provide Annual Progress Reports, which shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. m. Regeneron shall provide Draft and Final Reports, which shall include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall describe the results achieved. n. Regeneron shall participate in regular meetings to coordinate and oversee the contract effort, as directed by a single point of contact established by the Government. Such meetings may include, but are not limited to, meetings of Regeneron and subcontractors to discuss clinical manufacturing progress, product development, scale-up manufacturing development, preclinical/clinical study designs and regulatory issues, meetings with individual contractors and other Health and Human Services (HHS) officials to discuss the technical, regulatory, and ethical aspects of the program, and meetings with technical consultants to discuss technical data provided by Regeneron. Regeneron shall also consult with the Government as required in connection with meetings and submissions to regulatory agencies, including the FDA. The Government will establish a single point of contact for regular meetings and coordinate all requests for information through such point of contact, such that Regeneron shall not be required to attend multiple meetings with different Government agencies for the same (or similar) subject matter, or respond to multiple requests for information or materials concerning the same (or similar) subject matter. o. Regeneron shall participate in teleconferences at an agreed upon frequency between Regeneron and the Government to review technical progress.

Program Management. Below are the individuals currently assigned to key roles on the project team. Regeneron reserves the right to make personnel changes which will be communicated accordingly. a. Regeneron will manage, integrate and coordinate all activities, including utilizing Regeneron’s 's state-of-the-art technical and administrative infrastructure to ensure efficient planning, initiation, implementation and direction of contracted activities. b. The [* * *], is responsible for guiding the project approach and scope of this Program. c. [* * *], will serve as Lead PI for this Program. The PI will be responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including any projects undertaken by subcontractors. d. A [* * *], will be responsible for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities, costs incurred, and program management for this Program. The contract deliverables list identifies all contract deliverables and reporting requirements for this contract. e. [* * *], will provide development of compliant subcontracts, consulting, and other legal agreements. f. [* * *], will be responsible for financial management and reporting on all activities conducted by Regeneron and any subcontractors. g. A [* * *], will be responsible for facilitating the development of integrated CMC plans and for monitoring and tracking the progress of the CMC milestones. h. A [* * *], will be responsible for management of batch disposition, oversight of discrepancy investigations, and to ensure all released product conforms to GMP standards. i. A [* * *], will be responsible for analytical method development, method transfer and specification development. j. A [* * *], will be responsible for ensuring Regeneron quality, preclinical, and clinical drug development programs are conducted in compliance with regulations governing pharmaceutical drug development, and with project specific regulatory commitments/requirements, requirements ,and will serve as the liaison for communications with the US Food and Drug Administration. k. Regeneron shall provide Quarterly Progress Reports, which shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. l. Regeneron shall provide Annual Progress Reports, which shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. m. Regeneron shall provide Draft and Final Reports, which shall include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall describe the results achieved. n. Regeneron shall participate in regular meetings to coordinate and oversee the contract effort, as directed by a single point of contact established by the Government. Such meetings may include, but are not limited to, meetings of Regeneron and subcontractors to discuss clinical manufacturing progress, product development, scale-up manufacturing development, preclinical/clinical study designs and regulatory issues, meetings with individual contractors and other Health and Human Services (HHS) officials to discuss the technical, regulatory, and ethical aspects of the program, and meetings with technical consultants to discuss technical data provided by Regeneron. Regeneron shall also consult with the Government as required in connection with meetings and submissions to regulatory agencies, including the FDA. The Government will establish a single point of contact for regular meetings and coordinate all requests for information through such point of contact, such that Regeneron shall not be required to attend multiple meetings with different Government agencies for the same (or similar) subject matter, or respond to multiple requests for information or materials concerning the same (or similar) subject matter. o. Regeneron shall participate in teleconferences at an agreed upon frequency between Regeneron and the Government to review technical progress.