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.
c. Rights of Reference. In the event that all of the conditions described in Article 19, Section 7(1) are met, Janssen will grant the Government a right of reference to any regulatory application submitted to the FDA in support of this Project Agreement/Statement of Work. Separately, upon the DoD’s request, Janssen will grant the DoD a right of reference to any regulatory application submitted to the FDA in support of this Project Agreement/Statement of Work for the DoD’s regulatory filings involving (a) the use of a product to treat or prevent COVID-19 or (b) one of the material threats identified in Attachment 3, in each case for which the DoD is identified as the filing sponsor. DoD may request a WI 5QKN- 16-9-1002 P00081 Page 44 of 89 right of reference to additional material threats identified by the Government under Section 319F-2(c)(2)(A)(ii) of the Public Health Service Act, and Janssen may consent to provide such a right of reference with the agreement that its consent will not be unreasonably withheld. For clarity, the rights of reference identified in this paragraph will only authorize the FDA to cross-reference regulatory applications and will not provide the DoD or any other party with a right to access or review any such applications or information included in such applications.