Common use of CONTRACT TASKS Clause in Contracts

CONTRACT TASKS. The Contractor, as an independent organization and not as an agent of the Government, shall furnish all necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel as required to: 1) Deliver a quantity of FDP that includes 10 grams of active pharmaceutical ingredient to treat inhalational anthrax disease for independent comparative testing by the USG. 2) Manufacture between 10,000 and 100,000 therapeutic courses of treatment of a product to treat inhalational anthrax disease to be delivered to the SNS; 3) Perform accelerated, stress, and long-term storage stability testing to support the proposed product dating period of the Bulk Drug Substance (BDS) and FDP, and ongoing stability assessments to support extension of the product dating period (as necessary); 4) Conduct advanced development/pivotal studies, which include a) expanded human safety studies, b) animal efficacy studies if following the Animal Rule, or clinical studies required for Accelerated Approval and c) other studies as deemed necessary by FDA. 5) Obtain FDA approval/licensure for the therapeutic entity for the treatment of inhalational anthrax disease and provide necessary data to CDC to support CDC submission of a CDC-held IND protocol and/or an EUA to be utilized in the case of an anthrax public health emergency; 6) Perform quality control and quality assurance monitoring on product in the SNS, track/rotate inventory of the SNS stored product as needed while the product is under IND, and perform stability testing of product through the end of the contract; 7) Execute any product disposition directions provided by the USG; 8) Produce, release, maintain and monitor one (1) full scale lot of BDS per year for the life of the contract in order to maintain cGMP capacity to produce sufficient therapeutic courses of treatment of the product to replace expired FDP when ordered by the USG; 9) Initiate and complete all human and animal safety and efficacy studies to support licensure of biologics or approval of drugs for expanded indications for special populations, including pediatric and geriatric populations. Submit to FDA for review and potential inclusion in product labeling the results of special population studies; 10) Provide a security plan for development, manufacturing, storage, and distribution of the product; 11) Provide a security plan for information technology systems. The Contractor shall perform the work required to manufacture and to gain FDA approval or licensure of a safe and effective product for treatment of inhalational anthrax disease for delivery to the SNS in accordance with the requirements outlined below. The primary requirements are listed below with some containing subcategories of secondary activities. Requirements 1-11 below apply to all product type for treatment of inhalational anthrax disease. The Contractor shall incorporate these requirements into the work plan and timeline.