Annual report pursuant to Section 13 and 15(d)

License Agreements

v3.21.1
License Agreements
12 Months Ended
Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
License Agreements
5. License Agreements
Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc.
In June 2006, the Company entered into an exclusive worldwide, royalty-bearing license to seladelpar and certain other PPAR
d
compounds (the PPAR
d
Products) with Janssen Pharmaceutical NV (Janssen NV), with the right to grant sublicenses to third parties to make, use and sell such PPAR
d
Products. Under the terms of the agreement, the Company has full control and responsibility over the research, development and registration of any PPAR
d
Products and is required to use diligent efforts to conduct all such activities. Janssen NV has the sole responsibility for the preparation, filing, prosecution, maintenance of, and defense of the patents with respect to, the PPAR
d
Products. Janssen NV has a right of first negotiation under the agreement to license PPAR
d
Products from the Company in the event that the Company elects to seek a third-party corporate partner for the research, development, promotion, and/or commercialization of such PPAR
d
Products. Under the terms of the agreement Janssen NV is entitled to receive up to
 an
8.0
% royalty on net sales of PPAR
d
Products.
No
amounts were incurred or accrued for this agreement as of and for the years ended December 
31
,
2020
and
2019
.
In June 
2010
, the Company entered into two development and license agreements with Janssen Pharmaceuticals, Inc. (Janssen), a subsidiary of Johnson and Johnson, to further develop and discover undisclosed metabolic disease target agonists for the treatment of Type
2
diabetes and other disorders and received a
one-time
nonrefundable technology access fee related to the agreements. The Company received a termination notice from Janssen, effectively ending these development and licensing agreements in early
April 2015
. In
December 2015
, the Company exercised an option pursuant to the terms of one of the original agreements to continue work to research, develop and commercialize compounds with activity against an undisclosed metabolic disease target. Janssen granted the Company an exclusive, worldwide license (with rights to sublicense) under the Janssen
know-how
and patents to research, develop, make, have made, use, offer for sale and sell such compounds. The Company has full control and responsibility over the research, development and registration of any products developed and/or discovered from the metabolic disease target and is required to use diligent efforts to conduct all such activities.
DiaTex, Inc.
In June 1998, the Company ent
e
red into a license agreement with DiaTex, Inc. (DiaTex) relating to products containing halofenate, its enantiomers, derivatives, and analogs (the licensed products). The license agreement provides that DiaTex and the Company are joint owners of all of the patents and patent applications covering the licensed products and methods of producing or using such compounds, as well as certain other
know-how
(the covered IP). As part of the license agreement, the Company received an exclusive worldwide license, including as to DiaTex, to use the covered IP to develop and commercialize the licensed products. The Company also retained the right to
sub-license
the covered IP. The license agreement contains a $
2,000
per month license fee as well as a requirement to make additional payments for development achievements and royalty payments on any sales of licensed products. DiaTex is entitled to up to $
0.8
 million for the future development of arhalofenate, as well as royalty payments on commercial sales of products containing arhalofenate. In December 2016,
the
 
agreement was amended by the parties to change the timing of a specified development milestone. No 
development payments were made or due as of and for the years ended December 31, 2020 and 2019 and no royalties have been paid to date.