For purposes of this Amendment, the CRS has been approved to carry out protocol VAC31518COV3001 [CoVPN 3003] (“Amendment 5 Protocol”) in emergency response to COVID-19 for CoVPN 3003/Janssen. This Amendment is subject to the applicable terms of Collaborative Agreement Between National Institute of Allergy and Infectious Diseases (“NIAID”) and Janssen Research & Development, LLC (“Company”) based on Protocol VAC31518COV3001 [CoVPN 3003] dated August 18, 2020 ("Amendment 5 CTA"), including Addendum II’s Subaward Flow Down Clauses, as shown in Appendix H. Amendment 5 CTA is confidential in accordance with this Agreement’s Article 15. Upon CRS request, UCLA shall provide a copy of Janssen’s: Home Healthcare Visit Program Site Guide, Talking Points for LTMs, and/or Governance and RACICOV3001 ph 3, each and all of which are confidential in accordance with this Agreement’s Article 15. Protocol is entitled “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.
|Effective start/end date||9/3/20 → 11/30/20|
- University of California at Los Angeles (CoVPN3003-Janssen//3UM1AI068636-14S2 REVISED)
- National Institute of Allergy and Infectious Diseases (CoVPN3003-Janssen//3UM1AI068636-14S2 REVISED)
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