MEI Pharma, Inc. (NASDAQ:MEIP) Files An 8-K Entry into a Material Definitive Agreement

MEI Pharma, Inc. (NASDAQ:MEIP) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.

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License Agreement

On September5, 2017, MEI Pharma, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with Presage Biosciences, Inc. (“Presage”). Under the terms of the Agreement, Presage grants to the Company exclusive worldwide rights to develop, manufacture and commercialize Voruciclib, a clinical-stage, oral and selective cyclin-dependent kinase (CDK) inhibitor, and related compounds. In exchange, the Company will pay Presage near-term payments of up to $2.9million and additional potential payments of up to $181million upon the achievement of certain development, regulatory and commercial milestones. With respect to the first indication, an incremental $2.0million payment, due upon dosing the first subject in the first registration trial will be owed to Presage, for total payments of $4.9million up to receipt of marketing approval of the first indication by the U.S., E.U. or Japan. The Company will also pay mid-single-digit tiered royalties on the net sales of any product successfully developed. As an alternative to milestone and royalty payments related to countries in which the Company sublicenses product rights, the Company will pay to Presage a tiered percent (which decreases as product development progresses) of amounts received from such sublicensees.

The Agreement has a term commencing on the effective date and continuing, on a country-by-country basis, until the later of the date (i)of expiration of patents licensed by Presage to the Company in such country, or (ii)of expiration of regulatory exclusivity in such country.

The Company will be solely responsible for the global commercialization of products and shall be solely responsible for the costs related thereto.

The Company has the right to terminate the Agreement upon 90 days’ prior written notice. If at any time following the second anniversary of the effective date, the Company has not taken certain actions towards the development of Voruciclib (other than for regulatory reasons or a need to manufacture clinical trial material) and there are no other related products or compounds for which material development activities are being undertaken, or with respect to which material commercialization activities are being undertaken, by the Company for a period of at least 18 months, Presage may terminate this Agreement upon written notice to the Company.

If either party materially breaches the Agreement, the non-breaching party may terminate the Agreement, if the breach is not cured within 60 days of receiving written notice of the breach.

If either party files or institutes bankruptcy, reorganization, liquidation or receivership proceedings, is the subject of involuntary bankruptcy proceedings, or assigns a substantial portion of the assets for the benefit of creditors, the other party may terminate the Agreement, if such proceeding is not dismissed within 60 days of the filing. Presage may also terminate the Agreement in the event that the Company challenges any of the licensed patents.

If the Agreement is terminated by the Company (other than as a result of an uncured material breach of the Agreement by Presage), the parties have an obligation, at Presage’s election, to negotiate in good faith an agreement by which the Company would grant an exclusive worldwide license to the patents and know how developed by the Company in connection with the development and commercialization of products and the Company shall transition the development of products to Presage and wind down any commercialization of products over a 12 month period. The Agreement also provides the Company with certain rights in connection with a termination of the Agreement resulting from the bankruptcy, reorganization, liquidation or receivership of Presage, including a right of first refusal in connection with the proposed sale of Presage’s rights and interest in products to a third party.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September30, 2017.

On September5, 2017, the Company issued a press release regarding the Agreement, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 1.01 Financial Statements and Exhibits.
Exhibit99.1 Press release of MEI Pharma, Inc. dated September5, 2017


MEI Pharma, Inc. Exhibit
EX-99.1 2 d395382dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 MEI Pharma Announces Exclusive License Agreement with Presage Biosciences for Voruciclib,…
To view the full exhibit click here

About MEI Pharma, Inc. (NASDAQ:MEIP)

MEI Pharma, Inc. is an oncology company. The Company is focused on the clinical development of drugs and therapies for treatment of cancer. The Company’s portfolio of clinical drug candidates includes Pracinostat, ME-344 and PWT143. Pracinostat is an orally available histone deacetylase (HDAC) inhibitor indicated for the treatment of advanced hematologic diseases, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). ME-344 is an isoflavone-based mitochondrial inhibitor targeting a mitochondrial component of the terminal respiratory chain complex in rapidly proliferating cells. PWT143 is an oral inhibitor of phosphatidylinositide 3-kinase (PI3K) delta, a molecular target that plays a critical role in the proliferation and survival of hematologic cancer cells. Pracinostat has been tested in multiple Phase I and Phase II clinical trials in advanced hematologic malignancies and solid tumor indications.

MEI Pharma, Inc. (NASDAQ:MEIP) Recent Trading Information

MEI Pharma, Inc. (NASDAQ:MEIP) closed its last trading session up +0.05 at 2.80 with 389,185 shares trading hands.

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