Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Sanofi, COVID-19 Vaccine Development Agreement

  • Business model | Regulatory strategy

<p><span style=”textdecoration: underline;”><strong>3.0 Requirementsstrong>span>p>
<p><b>3.1 Regulatory Planningb>p>
<p><span style=”fontweight: 400;”>The Contractor will target the FDA approval of an adjuvanted recombinant SARSCoV2 protein vaccine to be presented in multidose 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 COVID19 vaccine development program, the Contractor will initially pursue an indication in adults only with first approval in healthy adults &gt;18 years of age, including the elderly population, as well adults with predisposing comorbidities. 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 postlicensure.span>p>
<p><span style=”fontweight: 400;”>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 preIND interaction in May 2020 and received written answers on June 3rd. The Contractor will submit the prefinal protocol with the main design features except for the dose &amp; 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 <a href=”#kt“>INDa>. 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.span>p>
<p><span style=”fontweight: 400;”>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 nonclinical 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.span>p>
<p><span style=”fontweight: 400;”>The Contractor will requestFast Trackdesignation by CBER to allow the rolling submission of sections of the <a href=”#kt“>BLAa> as soon as they are completed with an Accelerated Approval, Priority Review or Breakthrough Therapy designation following the submission of the last BLA components. Postlicensure 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.span>p>
<p><span style=”textdecoration: underline;”><strong>7.0 Intellectual Property and Regulatory Rightsstrong>span>p>
<p><b>7.4 Regulatory Rightsb>p>
<p><span style=”fontweight: 400;”>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 premarket approval or clearance before commercial authorization. It is expected that this contract will result in the FDA authorization, clearance, and commercialization of Sanofi&#8217;s Adjuvanted Recombinant COVID19 Vaccine as a Vaccine for SARSCoV2 Coronavirus (the &#8220;<em><strong>Technologystrong>em>&#8220;). 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) premarket 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 &#8220;sponsor&#8221; andapplicantare 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.span>p>
<p><span style=”fontweight: 400;”>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 COVID19 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 followingspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>a. <span style=”textdecoration: underline;”>Communications.span> 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 FDAspan>p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>b. <span style=”textdecoration: underline;”>DoD Medical Product Priority.span> PL 11592 allows the DoD to request, and FDA to provide, assistance to expedite development of products to diagnose, treat, or prevent serious or lifethreatening diseases or conditions facing American military personnel. The Awardee recognizes that only the DoD can utilize PL 11592. 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 11592 Sponsor Authorization Letter that will be delivered to the designated OWS POC(s) within 30 days of awardspan>p>
<p style=”paddingleft: 25px;”>c. <span style=”textdecoration: underline;”>Rights of Referencespan><span style=”fontweight: 400;”><span style=”textdecoration: underline;”>.span> To the extent necessary or useful to exercise the Government&#8217;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 limitedright 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 COVID19 or other Material Threat (as defined at Section 319 of the Public Health Service Act) Purposes to Sanofi Pasteurs 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 Governments 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 crossreference 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].span>p>