3.1 Regulatory Planning
The Contractor will target the FDA approval of an adjuvanted recombinant SARS-CoV-2 protein vaccine to be presented in multi-dose vials. The Contractor will submit a new vaccine application to be developed for individuals 6 months of age and older. Owing to the accelerated timelines of a COVID-19 vaccine development program, the Contractor will initially pursue an indication in adults only with first approval in healthy adults >18 years of age, including the elderly population, as well adults with pre-disposing co-morbidities. The Contractor will initiate pediatric studies following the successful demonstration of vaccine efficacy in the adult pivotal Ph III efficacy trial and registration in the pediatric population will be proposed as the supplement to the initial approval. The Contractor will request CBER agreement to defer vaccine development in the pediatric population to post-licensure.
The Contractor already shared with the Center for Biologics Evaluation and Research (CBER) the Phase III concept protocol for the safety and efficacy study in adults as part of the pre-IND interaction in May 2020 and received written answers on June 3rd. The Contractor will submit the pre-final protocol with the main design features except for the dose & dosing schedule will be submitted to the FDA at least 60 days before the initiation of the Phase III trial in an amendment to the corresponding IND. The final protocol cannot be submitted 60 days in advance as the Contractor will not know the final dose or dosing schedule. The final approved protocol should have also been reviewed and approved by the regulatory authorities of the countries selected for this clinical trial before the initiation of the trial.
The Contractor will request expedited CBER review time to allow a seamless progression to Phase III following Phase I/II key data availability (Safety, Neutralizing antibodies, Cell mediated immunity) currently planned in December/January 2021 and the completion of non-clinical studies performed in parallel to the Phase I/II (Toxicology rabbit study, animal challenge models). The Contractor will negotiate the same accelerated approval of the clinical trial application with the other countries included in this Phase III study.
The Contractor will request “Fast Track” designation by CBER to allow the rolling submission of sections of the BLA as soon as they are completed with an Accelerated Approval, Priority Review or Breakthrough Therapy designation following the submission of the last BLA components. Post-licensure commitments will be required by the FDA for approval of the vaccine. The requirements will be definitized as directed by the FDA after BLA submission.
7.4 Regulatory Rights
This Project Agreement involves research with an investigational drug, biologic or medical device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial authorization. It is expected that this contract will result in the FDA authorization, clearance, and commercialization of Sanofi’s Adjuvanted Recombinant COVID-19 Vaccine as a Vaccine for SARS-CoV-2 Coronavirus (the “Technology”). The Contractor is the Sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this contract. As the Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.
The Parties agree that Contractor has invested significant time and resources in its platform and IP and is the best company situated to manage production of the Adjuvanted Recombinant COVID-19 Vaccine. At the same time, the Parties acknowledge that the Government has made significant investments in the prototype. Accordingly, the Contractor and the Government agree to the following:
a. Communications. Contractor will provide the Government with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that the Government representatives are invited to participate in any formal or informal Sponsor meetings with FDA;
b. DoD Medical Product Priority. PL 115-92 allows the DoD to request, and FDA to provide, assistance to expedite development of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. The Awardee recognizes that only the DoD can utilize PL 115-92. As such, the Awardee will work proactively with the Government to leverage this law to its maximum potential under this Project Agreement. The Awardee shall submit Public Law 115-92 Sponsor Authorization Letter that will be delivered to the designated OWS POC(s) within 30 days of award.
c. Rights of Reference. To the extent necessary or useful to exercise the Government’s rights under the license grants in Section 7 of this Project Agreement and subject to the restrictions set forth in that section, Sanofi Pasteur hereby grants to the Government and its permitted sublicensees a limited “right of reference or use” (as that term is defined in 21 C.F.R. § 314.3(b), as amended from time to time) strictly for COVID-19 or other Material Threat (as defined at Section 319 of the Public Health Service Act) Purposes to Sanofi Pasteur’s filings to the FDA in connection with the Regulatory Application (excluding such right of reference or use for [redacted content] and Sanofi Pasteur shall provide appropriate notification of the Government’s access and reference rights to the applicable regulatory authorities requested by the Government for the limited purposes described above. Sanofi Pasteur agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. This provision is in addition to any rights in technical data described earlier in this document, excluding with respect to [redacted content].