Development Lead. On a Product-by-Product basis, one Party will oversee development and regulatory activities for such Product in the Collaboration Scope (the “Development Lead”). The Development Lead for each Product is set forth in the Development/Commercial Lead Schedule. Absent agreement by the JSC to the contrary (as indicated in the applicable Development Plan), it is the expectation of the Parties that the Development Lead will have primary responsibility for day-to-day development activities relating to the relevant Product, including generating protocols, conducting clinical trials, and data collection, verification and analysis. Following the Effective Date, the Parties will promptly meet to coordinate the transition of development and regulatory activities from Amgen to Partner with respect to Products for which Partner is the designated Development Lead in a manner so as to not unduly delay or hamper the development of the relevant Products. The Parties will amend the applicable Development Budgets and Operations Budgets to reflect the reasonable costs to be incurred by each Party in connection with such transfer.
Development Lead. Amgen will oversee Development activities for all Products in the Collaboration Scope; provided that the Parties will collaborate on a local development strategy and plan in the Collaboration Territory and BeiGene will oversee the conduct of mutually-agreed-upon Development activities in or for the Collaboration Territory, in each case, in alignment with the Global Development Plan and Global Development Budget. In order to meet Amgen’s requirements for data security, integrity and compatibility, prior to the transition of Development activities for each of the Pipeline Products pursuant to Section 3.1.1, all Development activities of BeiGene which will contribute to the global database for a Product must be conducted using Amgen systems, processes and policies, including quality and compliance systems, standard operating procedures, processes and policies, unless otherwise mutually agreed. Each Party will use Commercially Reasonable Efforts to conduct the Development activities assigned to it pursuant to the foregoing.
Development Lead. 4.8 MedImmune shall take the lead in Developing the Licensed Products, with Innate performing such activities as may be allocated to it under the Development Plan. Each Party shall have primary responsibility for day-to-day activities and decisions relating to such Party’s allocated responsibilities, provided that such activities and decisions are consistent with the Development Plan and the authority granted to such Party thereunder.
Development Lead. The Development Lead is responsible for the day-to-day operations and success of the TDM for site plan development compliance and monitoring function. The Development Lead supports special exception development projects in the successful planning and implementation of their required TDM programs. The Development lead stays abreast of development cycles, approvals, and construction activities, as well as the state of the real estate marketplace, and tracks the schedules, documentation, and TDM needs associated with those processes. The Development Lead tracks and reports to the County the TDM monitoring and compliance activities, as well as the transportation performance of individual buildings through supervision of required performance monitoring research activities.
