CERECOR INC. (NASDAQ:CERC) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.
CERECOR INC. (NASDAQ:CERC) Files An 8-K Entry into a Material Definitive Agreement
Cerecor Inc. (“Cerecor” or the “Company”) hereby reports that on May 28, 2020, Aevi Genomic Medicine, LLC, a wholly-owned subsidiary of Cerecor (“Aevi”), entered into an Amended and Restated Clinical Development and Option Agreement (the “New CDOA”) with Kyowa Kirin Co., Ltd., formerly known as Kyowa Hakko Kirin Co., Ltd (“KKC” and, collectively with Aevi, the “Parties”) relating to the development and potential commercialization of KKC’s first-in-class anti-LIGHT monoclonal antibody (the “Antibody”). The New CDOA replaces the Clinical Development and Option Agreement between the Parties effective June 6, 2016 (the “Prior CDOA”), which agreement was disclosed by Aevi in a Current Report on Form 8-K filed with the United States Securities and Exchange Commission (the “SEC”) on June 6, 2016 (the “June 6, 2016 8-K”) and redacted copy of which was filed on August 4, 2016 with Aevi’s Quarterly Report on Form 10-Q filed with the SEC for the fiscal quarter ending June 30, 2016.
The New CDOA retains all terms of the Prior CDOA, the summary of which contained in the June 6, 2016 8-K is incorporated by reference into this Current Report on Form 8-K, except that the Parties agreed to:
(1) eliminate certain rights of first negotiation and first refusal that would have been granted by KKC in favor of Aevi if Aevi exercised its option to obtain exclusive rights for the development, manufacture and commercialization of the Antibody”) in the treatment, prevention, and diagnosis of specified pediatric onset rare and orphan inflammatory diseases (including severe pediatric onset inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis and other specified pediatric onset rare and orphan auto-immune diseases (collectively, the “Original Field”) (such option, the “Original Option”); and
(2) extend a time-based termination right in favor of KKC.
In addition to retaining the terms of the Prior CDOA with the changes mentioned above, the New CDOA grants Aevi the right to conduct a signal finding study testing the Antibody in the treatment of COVID-19 acute respiratory distress syndrome (the “COVID Study”). The COVID Study will be conducted under a new investigational new drug application filed by Aevi. The New CDOA also grants Aevi an additional option separate from the Original Option to obtain exclusive rights for the development, manufacture and commercialization of the Antibody in the treatment, prevention, and diagnosis of acute lung injury and acute respiratory distress syndrome (collectively, the “ARDS/ALI Field”) (such option, the “New Option”).
If Aevi exercises the New Option, Aevi will have the exclusive right to develop, manufacture and commercialize the Licensed Products globally in the ARDS/ALI Field to a pre-agreed license agreement attached to the New CDOA. Aevi will be responsible for the manufacture of the Licensed Products for use in clinical trials as well as for commercialization in the ARDS/ALI Field.
Upon exercise of the New Option, Aevi will be required to pay KKC an initial license fee in the low single-digit millions of dollars. The Company may pay KKC up to an additional $14 million upon the achievement of certain regulatory milestones related to the Licensed Products in the ARDS/ALI Field. Aevi and KKC will split profits from the Company’s sales of Licensed Products in the ARDS/ALI Field with the Company being entitled to approximately 75% of such profits and KKC being entitled to approximately 25% of such profits. KKC will pay Aevi low double-digit royalties for sales of Licensed Products outside the ARDS/ALI Field. Aevi will be responsible for costs of development of Licensed Products in the ARDS/ALI Field. KKC will have the right to purchase the Licensed Products from Aevi for use outside the ARDS/ALI Field.
The New CDOA will expire if neither the Original Option nor the New Option are exercised during their applicable exercise period or if one of the options is exercised, then upon the expiration of the exercise period for the remaining option if such option is not exercised during such period. Upon any of the license agreements attached to the New CDOA becoming effective in connection with exercise of the relevant option, it will remain in effect so long as there are Licensed Products being commercialized by the Parties or until such license agreement is terminated to certain termination rights provided to each of the Parties. The New CDOA also contains early termination rights customary for this type of agreement.
The New CDOA (including the pre-agreed license agreements that become effective in connection with exercise of the Original Option and/or the New Option) will be attached as an exhibit to Cerecor’s Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2020 (the “Form 10-Q”). Cerecor intends to seek confidential treatment for certain terms of the New CDOA at the time of filing such agreements with the Form 10-Q.
The Company does not have any material relationship with KKC other than the New CDOA.
Item 8.01. Other Events.
On May 28, 2020, the Company issued a press release announcing that the Company has received clearance from the United States Food and Drug Administration to proceed with a clinical trial of CERC-002 in patients with COVID-19 induced Acute Respiratory Distress Syndrome (ARDS). On May 28, 2020, the Company also posted an updated investor presentation regarding this clearance and the clinical trial. Copies of the press release and investor presentation are attached hereto as Exhibit 99.1 and 99.2, respectively, and are incorporated herein in their entirety by reference.
Item 9.01. Financial Statements and Exhibits.
>(d) Exhibits.
Cerecor Inc. Exhibit
EX-99.1 2 ex-991pressreleasedatedmay.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Cerecor Announces FDA Clearance of IND for CERC-002 in COVID-19 Induced ARDSCompany to Initiate Multicenter,…
To view the full exhibit click
EX-99.1 2 ex-991pressreleasedatedmay.htm EXHIBIT 99.1 Exhibit Exhibit 99.1 Cerecor Announces FDA Clearance of IND for CERC-002 in COVID-19 Induced ARDSCompany to Initiate Multicenter,…
To view the full exhibit click
hereAbout CERECOR INC. (NASDAQ:CERC)
Cerecor, Inc. is a clinical stage biopharmaceutical company. The Company is engaged in developing drug candidates for patients with neurological and psychiatric disorders. The Company has a portfolio of clinical and preclinical compounds that it is developing for a range of indications, including CERC-301, which is an adjunctive treatment for major depressive disorder (MDD); CERC-501, which is for substance use disorders and adjunctive treatment of MDD, and CERC-406, which is for the treatment of cognitive impairment. The Company owns the rights to its COMTi platform. Catechol O methyltransferase (COMT) is an enzyme critical for the inactivation and metabolism of dopamine and its inhibition in the brain has applicability in treating subjects with neuropsychiatric conditions, including MDD, schizophrenia, Parkinson’s disease and pathological gambling. Its COMTi platform comprises COMT inhibitors with selectivity for membrane bound COMT, which is the dominant form of COMT.
