Item 1.01
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Entry into a Material Definitive Agreement.
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Entry into Exclusive License Agreement; Forfeiture by Intrexon of Series 1 Preferred Stock
On October 5, 2018, or the Effective Date, Precigen, Inc., or Precigen, a wholly owned subsidiary of Intrexon Corporation, or the Company, entered into an
exclusive license agreement, or the License Agreement, with Ziopharm Oncology, Inc., or Ziopharm. The Company is a party to certain provisions of the License Agreement, including with respect to exclusivity, release of claims, and the termination of
certain agreements. The terms of the License Agreement: (a) terminate, as of the Effective Date, and replace the terms of that certain Exclusive Channel Partner Agreement by and between the Company and Ziopharm, dated January 6, 2011, as
amended by the First Amendment to Exclusive Channel Partner Agreement effective September 13, 2011, the Second Amendment to the Exclusive Channel Partner Agreement effective March 27, 2015, and the Third Amendment to Exclusive Channel
Partner Agreement effective June 29, 2016, as assigned by the Company to Precigen; (b) (i) require Precigen to use good faith efforts to obtain consent to the transfer of Ziopharms right, title and interest under that certain License
and Collaboration Agreement effective March 27, 2015 between the Company, Ziopharm and Ares Trading S.A., a subsidiary of the biopharmaceutical business of Merck KGaA, as amended, or the Merck Agreement, and (ii) as between the parties,
assign certain rights and obligations under the Merck Agreement to Precigen; and (c) provide for the amendment of that certain License Agreement between the Company, Ziopharm and The University of Texas M.D. Anderson Cancer Center, or MD
Anderson, with an effective date of January 13, 2015, or the 2015 MDACC License, assigned by the Company and assumed by Precigen effective as of January 1, 2018, and that certain Research and Development Agreement between the Company,
Ziopharm and MD Anderson with an effective date of August 17, 2015, or the MDACC Research Agreement, and any amendments or statements of work thereto.
Pursuant to the terms of the License Agreement, Precigen has granted Ziopharm an exclusive, worldwide, royalty-bearing,
sub-licensable
license to research, develop and commercialize (i) products utilizing Precigens RheoSwitch
®
gene switch, or RTS to express
IL-12,
or the
IL-12
Products, for the treatment of cancer, (ii) chimeric antigen receptor, or CAR, products directed to (A) CD19 for the treatment of cancer,
referred to as CD19 Products, and (B) a second target, subject to the rights of Ares Trading, S.A. to pursue such target under the Merck Agreement, and
(iii) T-cell
receptor, or TCR, products, or TCR
Products, designed for neoantigens for the treatment of cancer or the treatment and prevention of human papilloma virus, or HPV, to the extent that the primary reason for such treatment or prevention is to prevent cancer, which is referred to as the
HPV Field. Precigen has also granted Ziopharm an exclusive, worldwide, royalty-bearing,
sub-licensable
license for certain patents relating to the
Sleeping Beauty
technology to research, develop and
commercialize TCR Products for both neoantigens and shared antigens for the treatment of cancer and in the HPV Field.
Ziopharm will be solely responsible
for all aspects of the research, development and commercialization of the exclusively licensed products for the treatment of cancer. Ziopharm is required to use commercially reasonable efforts to develop and commercialize
IL-12
Products and CD19 Products, and after a
two-year
period, the TCR Products.
Precigen has also granted Ziopharm an exclusive, worldwide, royalty-bearing,
sub-licensable
license to research,
develop and commercialize products utilizing an additional construct that expresses RTS
IL-12,
or Gorilla
IL-12
Products, for the treatment of cancer and in the HPV
Field.
Precigen will retain rights to research, develop and commercialize CAR products for all other targets, subject to the rights of Ares Trading, S.A.
to pursue such target under the Merck Agreement. In addition, Precigen may research, develop and commercialize products for the treatment of cancer, outside of the products exclusively licensed to Ziopharm.
In consideration of the licenses and other rights granted by Precigen, Ziopharm will pay Precigen an annual license fee of $100,000 and has agreed to
reimburse Precigen for certain historical costs of the licensed programs and up to $1.0 million, payable quarterly with respect to historical Gorilla
IL-12
Products.
Ziopharm will make milestone payments, payable upon the initiation of later stage clinical trials and upon the approval of exclusively licensed products in
various jurisdictions, totaling up to an additional $52.5 million for each of four exclusively licensed products, up to an aggregate of $210 million. In addition, Ziopharm will pay Precigen