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Thursday, 12/13/2018 4:50:21 PM

Thursday, December 13, 2018 4:50:21 PM

Post# of 251603
ADXS / AMGN: termination of ADXS-NEO program

On December 10, 2018, Advaxis, Inc., a Delaware Corporation (the “Company”) received a written notice of termination from Amgen Inc. (“Amgen”) with respect to the License and Collaboration Agreement, dated as of August 1, 2016 (the “Amgen Agreement”) pertaining to the development and commercialization of the Company’s ADXS-NEO program, a novel, preclinical investigational immunotherapy, using the Company’s proprietary Listeria monocytogenes attenuated bacterial vector, which activates a patient’s immune system to respond against unique mutations, or neoepitopes, contained in and identified from an individual patient’s tumor. The termination is effective as of February 8, 2019. The Company’s ADXS-NEO study is currently enrolling patients and the Company will evaluate whether to re-partner the ADXS-NEO program.

Under the terms of the Amgen Agreement, Amgen received an exclusive worldwide license to develop and commercialize the ADXS-NEO program. Amgen previously made an upfront payment to the Company of $40 million, purchased $25 million of the Company’s common stock and reimbursed the Company for certain research and development costs in support of the ADXS-NEO program. Under the Amgen Agreement, the Company and Amgen collaborated through a joint steering committee for the development and commercialization of ADXS-NEO. The Company was eligible to receive future contingent payments based on development, regulatory and sales milestones as well as high single digit to double digit royalty payments based on worldwide sales of licensed products by Amgen. Pursuant to the terms of the Amgen Agreement, upon Amgen’s termination, the license to Amgen will terminate and the Company will regain worldwide rights for the development and commercialization of its ADXS-NEO program. In addition, Amgen will have certain obligations as set forth in the Amgen Agreement, including promptly deleting or destroying any materials related to the development or manufacturing of the ADXS-NEO program. During the fiscal years ended October 31, 2018 (unaudited) and 2017, the Company recorded reimbursements of approximately $5.8 million and $7.5 million, respectively, relating to the Amgen Agreement

source: https://www.sec.gov/Archives/edgar/data/1100397/000149315218017447/form8-k.htm

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