MANUFACTURING AND CHARACTERIZATION SERVICES FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASES   5

The purpose of this solicitation is to support a suite of services that encompasses the activities commonly associated with product construction, process development, manufacture, and characterization of vaccine and biologic products for infectious diseases. These services will include support of early research and development projects through the product development process and includes manufacture of Phase I/II clinical material of quality sufficient for inclusion in Investigational New Drug (INDs) applications and/or Biologic License Applications (BLAs). NIAID recognizes that to obtain the full spectrum of expertise of facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortium agreements, partnerships, subcontracts, and/or consultants. The Offeror shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.