Quarterly report pursuant to Section 13 or 15(d)

Collaboration and Licensing Agreements

v3.7.0.1
Collaboration and Licensing Agreements
9 Months Ended
Jul. 31, 2017
Business Combinations [Abstract]  
Collaboration and Licensing Agreements

9. COLLABORATION AND LICENSING AGREEMENTS

 

Amgen

 

On August 1, 2016, the Company entered into a global agreement (the “Amgen Agreement”) with Amgen for the development and commercialization of the Company’s ADXS-NEO, 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. Under the terms of the Amgen Agreement, Amgen receives an exclusive worldwide license to develop and commercialize ADXS-NEO. Advaxis and Amgen will collaborate through a joint steering committee for the development and commercialization of ADXS-NEO. Under the Amgen Agreement, Amgen will fund the clinical development and commercialization of ADXS-NEO and Advaxis will retain manufacturing responsibilities. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the clinical development payments to be received from Amgen. The Company determined the clinical development payments should be accounted for within the scope of collaboration arrangement accounting guidance. As a result, the Company will account for the clinical development payments as a reduction of Research and Development Expenses in the statement of operations. During the nine months ended July 31, 2017, the Company received clinical development payments from Amgen totaling $4,500,000. In addition, the Company recorded an expected clinical development payment of $1,500,000 as Other Receivables on the balance sheet. In August 2017, the Company received the $1,500,000 expected clinical development payment from Amgen.

 

Especificos Stendhal SA de CV

 

On February 3, 2016, the Company entered into a Co-Development and Commercialization Agreement (the “Stendhal Agreement”) with Especificos Stendhal SA de CV (“Stendhal”), for Advaxis’ lead Lm Technology™ immunotherapy, Axalimogene filolisbac , in HPV-associated cancers. Under the terms of the Stendhal Agreement, Stendhal will pay $10 million (“Support Payments”) towards the expense of AIM2CERV over the duration of the trial. Certain internal expenses of Stendhal up to $1 million shall be counted towards the $10 million in Support Payments. The Support Payments are contingent upon Advaxis achieving annual project milestones. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the Support Payments to be received from Stendhal. The Company determined the Stendhal Agreement should be accounted for within the scope of collaboration arrangement accounting guidance. Furthermore, the Company determined that Advaxis is the principal in the Stendhal Agreement. As a result, the Company will account for the Support Payments as a reduction of Research and Development Expenses in the statement of operations. During the nine months ended July 31, 2017, the Company reached the annual project milestones and received a $3,000,000 Support Payment from Stendhal.

 

Sellas Life Science Group

 

On February 27, 2017, the Company entered into a license agreement with Sellas Life Science Group (“Sellas”) to develop a novel cancer immunotherapy agent using Advaxis’ proprietary Lm-based antigen delivery product with SELLAS’ patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S)). Pursuant to the agreement, Advaxis will conduct all pre-clinical activities required for an IND filing and Sellas will be responsible for all clinical development and commercial activities. Advaxis will receive future payments of up to $358 million from SELLAS if certain development, regulatory, and commercial milestones are met. SELLAS has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net sales upon commercialization. If SELLAS sublicenses its rights, Advaxis will receive a percentage of applicable sublicense revenue paid.