Provision Language
C.3 REQUIREMENTS
Independently, and not as an agent of the USG, in accordance with the Proposal submitted by Moderna US, Inc. in response to Solicitation Number W911QY20R0043, Titled, “Advanced Procurement of mRNA–1273 Vaccine for Prevention of SARS–CoV–2 Coronavirus (COVID–19)”), dated July 10, 2020 (and any subsequent USG–approved revisions thereto), the contractor shall provide all necessary services, qualified personnel, material, equipment and facilities (not otherwise provided by the USG under the terms of this contract) to perform the specific tasks set forth below.
C.3.1 Contract Line Item Number (CLIN) 0001 – Base Period: Large Scale Manufacturing of 100 Million Vaccine Doses
C.3.1.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million Final Drug Product (FDP) doses of a SARS–CoV–2 mRNA–1273 vaccine. This shall include, the following tasks and other activities reasonably contemplated by such task:
C.3.1.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of [***]. (Based on FDP stability data that supports a [***] shelf–life, subject to FDA confirmation of the assigned shelf–life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002, FDA Interactions and Inspections Documentation.
C.3.1.1.2 cGMP manufacturing of 100 million doses fully compliant with 21 CFR 210 and 211.
Supply Chain Resiliency Plan (Attachment 0001 to Contract Data Requirements)
The contractor shall provide a comprehensive Supply Chain Resiliency Plan that provides for identification and reporting of critical components associated with the secure supply of drug substance, drug product, and work–in–process through to finished goods.
1. A critical component is defined as any material that is essential to the product or the manufacturing process associated with that product. Included in the definition are consumables and disposables associated with manufacturing. NOT included in the definition are facility and capital equipment.
Consideration of critical components includes the evaluation and potential impact of raw materials, excipients, active ingredients, substances. pieces, parts, software, firmware, labeling, assembly, testing, analytical and environmental componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks, seed stocks, devices and key processing components and equipment. A clear example of a critical component is one where a sole supplier is utilized.
2. The contractor shall identify key equipment suppliers, their locations, local resources, and the associated control processes at the time of award. This document shall address planning and scheduling for active pharmaceutical ingredients, upstream, downstream, component assembly, finished drug product and delivery events as necessary for the delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or as necessary, as part of regular contractual communications.
b) For upstream and downstream processing, both single–use and re–usable in–place processing equipment, and manufacturing disposables also shall be addressed. For finished goods, the inspection, labeling, packaging, and associated machinery shall be addressed taking into account capacity capabilities.
c) The focus on the aspects of resiliency shall be on critical components and aspects of complying with the contractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreign sourced, both high and low volume, which would significantly affect throughput and adherence to the contractually agreed deliveries.
3. The contractor shall articulate in the plan, the methodology for inventory control, production planning, scheduling processes and ordering mechanisms, as part of those agreed deliveries.
a) Production rates and lead times shall be understood and communicated to the HHS/ASPR/BARDA Contracting Officer or the Contracting Officer’s Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by design, and communicated to contractual personnel. As necessary, communication should focus on identification, exploitation, elevation, and secondary constraints of throughput, as appropriate.
4. Reports for critical items should include the following information:
a) Critical Material
b) Primary vendor and secondary vendor, if applicable
c) Supplier, Manufacturing / Distribution Location
d) Supplier Lead Time
e) Shelf Life
f) Transportation / Shipping restrictions
g) Comparability studies, if applicable
h) Amount of material (dose equivalent) in inventory