H10 Ensuring Sufficient Supply of the Product
1.In recognition of the Government’s significant funding for the development and manufacturing of the product in this contract and the Government’s need to provide sufficient quantities of a COVlD-19 vaccine to protect the United States population, the Government shall have the remedy described in this section to ensure sufficient supply of the product to meet the needs of the public health or national security. This remedy is not available to the Government unless and until both of the following conditions ((a) and (b)) are met:
(a) Moderna gives written notice, required to be submitted to the Government no later than [***], of:
- (i) any formal management decision to terminate manufacturing of this product vaccine prior to delivery of any doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or serious technical or safety reasons; or
- (ii) any formal management decision to discontinue sale of this product vaccine to the Government prior to delivery of any doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or serious technical or safety reasons; or
- (iii) any filing that anticipates Federal bankruptcy protection; and
(b) Moderna has submitted an Emergency Use Authorization application under §564 of the FD&C Act or a biologics license application provisions of §351(a) of the Public Health Service Act (PHSA).
2. If both conditions listed in section 1 occur, Moderna, upon the request of the Government, shall provide the following items necessary for the Government to pursue manufacturing of this product vaccine with a third party for exclusive sale to the U.S. Government:
(a) a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royalty-free paid-up license to practice or have practiced for or on behalf of the U.S. Government any Moderna Background Patent, Copyright, other Moderna Intellectual Property, Moderna Know-How, Moderna Technical Data rights necessary to manufacture doses of the mRNA- 1273 vaccine;
(b) necessary FDA regulatory filings or authorizations owned or controlled by Moderna related to this product vaccine and any confirmatory instrument pertaining thereto; and
(c) any outstanding Deliverables contemplated or materials purchased under this contract.
3. This remedy will remain available until the end of the contract.
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