ADVERUM BIOTECHNOLOGIES, INC. (NASDAQ:ADVM) Files An 8-K Termination of a Material Definitive AgreementItem 1.02
On December 6, 2016, Adverum Biotechnologies, Inc. (the “Company”), the parent company of Annapurna Therapeutics SAS (“Annapurna”), delivered a notice to Cornell University (“Cornell”) to terminate the Amended and Restated Master Services Agreement, dated July 15, 2014, between Annapurna and Cornell (the “MSA”). Under the MSA, among other services, Cornell agreed to produce therapeutic materials for use in the Company’s clinical studies of ADVM-043, the Company’s product candidate for the treatment of alpha-1 antitrypsin (“A1AT”) deficiency. The Company is exercising its right to Section 8.02(i) of the MSA to terminate the MSA for breach as a result of Cornell’s failure to deliver therapeutic material suitable for use in human patients.
The termination will be effective on January 6, 2017 (the “Effective Date”), unless Cornell cures its breaches of the MSA prior to that date. The Company does not anticipate that Cornell will be able to cure such breaches by the Effective Date.
The material terms of the MSA were previously described in the Company’s definitive proxy statement filed by the Company with the U.S. Securities and Exchange Commission on April 7, 2016, and in the Company’s quarterly reports on Form 10-Q for the periods ended June 30, 2016 and September 30, 2016, which descriptions are incorporated herein by reference. In addition, the above description of the MSA is qualified in its entirety by reference to the text of the agreement, which was filed as an exhibit to the Company’s quarterly report on Form 10-Q for the period ended June 30, 2016.
Other Material Relationships between the Company or its affiliates and Cornell
Annapurna Therapeutics Limited, a subsidiary of Annapurna and the Company, is also party to three separate licensing agreements with Cornell to which Annapurna Therapeutics Limited holds, respectively, (i) an exclusive license to certain technology related to A1AT deficiency and rights to an Investigational New Drug application to initiate clinical studies of a gene therapy for A1AT, (ii) an exclusive license to certain technology related to hereditary angioedema (“HAE”) and a non-exclusive license to certain other intellectual property related to the HAE program and (iii) an exclusive license to certain patents related to allergens and a non-exclusive license to certain other technology related to allergens. Termination of the MSA will not result in the termination of any of these licenses, which will continue to remain in-effect after the Effective Date.
Dr. Ron Crystal, Chairman of Genetic Medicine, the Bruce Webster Professor of Internal Medicine and a Professor of Genetic Medicine and of Medicine at Cornell University’s Weill Cornell Medical College, has served as a consultant to Annapurna since inception and continues to provide services to the Company for annual compensation of up to $0.3 million. Dr. Crystal also owns common shares of the Company. Dr. Crystal does not have significant influence on the Company’s operations.
About ADVERUM BIOTECHNOLOGIES, INC. (NASDAQ:ADVM)
Adverum Biotechnologies, Inc., formerly Avalanche Biotechnologies, Inc., is a gene therapy company. The Company is engaged in discovering and developing medicines to patients suffering from chronic or debilitating disease. The Company operates and manages its business in the segment of developing and commercializing gene therapeutics. It focuses on diseases with unmet medical need, including ophthalmic diseases, such as wet age-related macular degeneration (AMD), as well as rare genetic diseases. The Company’s product candidates include AVA-101 and AVA-201 for treatment of Wet AMD; AVA-322 and AVA-323 for the treatment of Color Vision Deficiency, and AVA-311 for the treatment of Juvenile X-linked Retinoschisis. It has generated human proof-of-concept data for AVA-101 in a Phase I trial with over eight wet AMD subjects conducted at Lions Eye Institute (LEI) in Australia. It is developing AVA-322 and AVA-323 for the treatment of color vision deficiency (CVD). ADVERUM BIOTECHNOLOGIES, INC. (NASDAQ:ADVM) Recent Trading Information
ADVERUM BIOTECHNOLOGIES, INC. (NASDAQ:ADVM) closed its last trading session 00.00 at 3.20 with 203,250 shares trading hands.