Geron expands licensing agreement with JnJ

[Fishermangents]

Form the 8-K filed by Geron:

1.01 Entry into a Material Definitive Agreement.

On September 15, 2016 (the “Execution Date”), Geron Corporation (“Geron” or the “Company”) and Janssen Pharmaceuticals, Inc. (“Janssen Pharmaceuticals”), entered into a license agreement (the “License Agreement”) granting Janssen Pharmaceuticals exclusive worldwide rights (the “Exclusive License”) under Geron’s proprietary patents and related know-how for the development and commercialization of products based on specialized oligonucleotide backbone chemistry, as well as novel amidates for ribonucleic acid interference, or RNAi, for the prevention, treatment and/or diagnosis of any and all human disorders, excluding cancers originating from the blood or bone marrow, and products whose predominant or primary mechanism of action is telomerase inhibition.

In addition to the Exclusive License, Geron has granted to Janssen Pharmaceuticals a non-exclusive, worldwide license (the “Non-Exclusive License”) under Geron patent rights covering the synthesis of monomers, which are the building blocks of oligonucleotides, necessary for the research, development and commercialization of the oligonucleotides. The patent rights under the Non-Exclusive License are also licensed exclusively to Janssen Biotech, Inc., or Janssen Biotech, under the Collaboration and License Agreement, or CLA, executed by Janssen Biotech and Geron on November 13, 2014 for the imetelstat program, and the License Agreement expressly excludes, and is subject to, the rights and licenses granted to Janssen Biotech under the CLA.

Janssen Pharmaceuticals is required to use reasonable efforts to perform research, development and commercialization activities to obtain at least one licensed product to be researched, developed and commercialized under the License Agreement, at Janssen Pharmaceutical’s sole cost.

Upon the execution of the License Agreement, Janssen Pharmaceuticals owes to Geron a non-refundable upfront payment of $5 million. In addition, Geron will be eligible to receive up to $75 million in development and regulatory milestone payments, as well as royalties in the low single digit percentage range on aggregate worldwide net sales of each licensed product. Earned royalties will be subject to royalty stacking in the event that Janssen Pharmaceuticals is obligated to make royalty payments to any third party having patent claims covering a licensed product as a composition of matter.

Under the terms of the License Agreement, Geron remains responsible for prosecution and maintenance of the patent rights under the Exclusive License, with reasonable input provided by Janssen Pharmaceuticals. The costs of prosecution and maintenance of patent rights under the Exclusive License will be shared 50/50 by the parties. Ownership of any intellectual property developed under the License Agreement will be determined in accordance with U.S. patent laws. Geron remains responsible for prosecuting and maintaining the patent rights under the Non-Exclusive License, as set forth in the CLA.

The License Agreement contains customary representations, warranties and covenants by Geron and Janssen Pharmaceuticals. Each of Geron and Janssen Pharmaceuticals is required to indemnify the other against all claims relating to the indemnifying party’s negligence or willful misconduct, failure to comply with its obligations under the License Agreement, breaches of warranties, or violations of law, except to the extent resulting from negligence or breach by the indemnified party. Janssen Pharmaceuticals is also responsible for indemnifying Geron against any claims arising from the development, commercialization or manufacture of any licensed product under the License Agreement, except to the extent resulting from negligence or breach by Geron.

The License Agreement will remain in effect until the expiration of the last-to-expire licensed patent right, unless terminated earlier. It may be terminated by either Geron or Janssen Pharmaceuticals in the event of uncured material breach or insolvency proceeding by the other party. Janssen Pharmaceuticals also may terminate the License Agreement at will upon prior written notice to Geron. In the event of early termination, all licenses to Janssen Pharmaceuticals would terminate.

The foregoing description of the License Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the License Agreement, which will be filed with the Securities and Exchange Commission (the “SEC”) as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2016.

[Fishermangents]

Nice article about JnJ - Geron partnership:

Janssen Builds On Partnership With Geron Corporation
By Andy Parker - September 21, 2016

Janssen Pharmaceuticals, a subsidiary of the giant manufacturing company, Johnson & Johnson (NYSE:JNJ) has expanded the current partnership with the long-beleaguered Geron Corporation (NASDAQ:GERN). The newly formed partnership is for the worldwide and exclusive rights to the biotech’s oligonucleotide backbone chemistry and the novel amides for ribonucleic acid interference or RNAi. The latter is used in the prevention, treatment, and diagnosis of any disease.

J&J And Geron Partnership

The Janssen Pharmaceuticals and Geron partnership specifically does not include any approach to bone marrow and blood originating cancers, including any product that works primarily via telomerase inhibition. These exclusions, however, have already been covered under a current deal between the two companies which was previously executed on November 2014.

In addition to this, Janssen has also been given a non-exclusive worldwide license to monomer synthesis technology. Monomers, known to be the building blocks of oligonucleotides, are stated to be used as part of the imetelstat program. Imetelstat is a modified short oligonucleotide. The particular imetelstat program was already licensed previously in a deal made back in 2014.

Aside from an upfront payment amounting to $5 million, Geron is eligible for development and regulatory milestones budget amounting to $75 million. This is in addition to existing low single digit royalties on the net sales of any resulting product marketed worldwide.

Janssen On Continuing To Advance With Telomerase Inhibitor Imetelstat

The motion to build a partnership with Geron comes ahead of a Janssen decision on continuing to advance with telomerase inhibitor imetelstat. Janssen is nominated to come up with a decision on whether to go on with the Phase III portion of a Phase II/III trial on the coming second quarter next year. If things go forward, patient enrollment in the Phase III portion is slated for mid-2017.

According to data, the two-armed and planned 200-patient Phase II portion of the imetelstat trial in the medication of intermediate-2 or high-risk myelofibrosis (MF) patients hasn’t been particularly promising. These patients are those who are refractory to or who have relapsed after treatment with a JAK inhibitor.

Link: http://marketexclusive.com/johnson-john ... ern/32602/