Provision Language
I. Scope of the Project Agreement
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I.5 Prototype Deliverables
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Manufacturing Development Plan. Janssen will, in the level of detail and format that Janssen solely elects (provided such format provides a reasonable and industry-standard level of detail), describe the manufacturing process for the vaccine product to ensure conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code (“U.S.C.“) §351 (a)(2)(B)), regarding GMP. This plan shall describe as such information becomes available to Janssen, but is not limited to, planned or completed drug substance studies; list of excipients and information to support the safety of excipients that, when appropriate, shall be cross-referenced; drug product and formulation development summary from initial concept through final design; physicochemical and biological properties; manufacturing process development and validation program documents; container closure system documents; microbiological attributes documents and plans; compatibility documents (e.g., precipitation); assay development and validation, stability plan; and any associated risks.
Quality Management Plan. Janssen will, in the level of detail and format that Janssen solely elects (provided such format provides a reasonable and industry-standard level of detail), provide a quality management plan which may include, but is not limited to, the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. The framework is normally divided into infrastructure, senior management responsibility, resource management, lifecycle management, and quality management system evaluation.
XIX. General Provisions
XIX.6 Regulatory Rights
a. The Parties understand and hereby acknowledge that BARDA OTA No. HHS0100201700018C (“BARDA OTA“) governs Janssen’s responsibilities and obligations with regards to IND activities regarding Janssen’s Ad26.COV2.S vaccine, specifically, Work Package 6.14, “Regulatory Support” of the BARDA OTA. Under the BARDA OTA, Janssen leads regulatory activities with the FDA. Janssen manages all regulatory communications, documentation, and submissions with health authorities. Janssen provides BARDA with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Investigational New Drug (“IND“) activities regarding Janssen’s Ad26.COV2.S vaccine and will invite the BARDA/JPEO–CBRND representatives to participate in any formal meetings between FDA and Janssen. Additionally, for this Project Agreement, Janssen will authorize BARDA to share information with the United States Department of Defense, JPEO-CBRND, as BARDA deems appropriate, in accordance with the Data Rights requirements of BARDA OTA No. HHS0100201700018C.
b. The Parties also understand that PL–115–92 allows the DoD to request, and FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life–threatening diseases or conditions facing American military personnel. Janssen recognizes that only the DoD is authorized to invoke PL–115–92. If Janssen, the DoD, and BARDA agree that the circumstances exist under the BARDA OTA to warrant DoD’s involvement, Janssen and BARDA may request DoD to utilize its authority under PL–115–92 to engage the FDA. If DoD, in its sole discretion, determines that it will engage with the FDA, the Parties agree that DoD will only invoke this authority in order to assist or facilitate Janssen in obtaining the necessary FDA approvals or authorizations. Notwithstanding any other provision in this Project Agreement, the BARDA OTA, or PL–115–92, the Parties agree that DoD shall not use its authority to become a “sponsor”, “co–sponsor”, or “applicant” as defined in the regulations cited in this Article. Further, the Parties hereby agree that any information provided to DoD by Janssen, to facilitate with the FDA under PL–115–92, will be provided with Limited Rights pursuant to the BARDA OTA.
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XIX.13 Compliance with Good Manufacturing Processes
The cGMP (21 CFR 210-211) will be the standard applied for manufacturing, processing and packing of any products to be administered to human subjects under this Project Agreement subject to any applicable guidance from, or enforcement discretion exercised by, the FDA in connection with COVID-19 subject to any applicable guidance from, or enforcement discretion exercised by, the FDA in connection with COVID-19.
If at any time during the life of this contract, the Recipient fails to comply with cGMP in the manufacturing, processing and packaging of the products subject to the exception noted above and such failure results in a material adverse effect on the safety, purity or potency of the products (a material failure) as identified by Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, the Recipient shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Recipient fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.
The Recipient agrees to comply with cGMP guidelines (21 CFR Parts 210-211,600) for manufacturing, processing and packing of drugs, chemicals, biological, and reagents subject to any applicable guidance from, or enforcement discretion exercised by, the FDA in connection with COVID-19.
The Recipient agrees to advise the AO and AOR promptly of any relocation of their prime manufacturing facility or the relocation of any sub consortium’s facility during the term or this Project Agreement. The Recipient also agrees to advise the AO and AOR immediately if at any time during the term of this Project Agreement, the items under this OTA fail to comply with cGMP guidelines and/or the facility receives a negative FDA Quality Assurance Evaluation (Form 483).