Aurigene

In July 2019, Exelixis entered into an exclusive collaboration, option and license agreement with Aurigene Discovery Technologies Limited (Aurigene) to discover and develop novel small molecule therapies for cancer. The agreement gives Exelixis the opportunity to in-license as many as six programs from Aurigene, which has developed a focused approach to drug discovery that targets differentiated first-in-class and best-in-class opportunities with unique mechanisms of action. Exelixis will contribute research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of Investigational New Drug acceptance. If Exelixis decides to exercise an option, it will assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Under the terms of the agreement, Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales, and retains limited development and commercial rights for India and Russia.

Bristol-Myers Squibb Company

In October 2010, Exelixis entered into a worldwide collaboration with BMS to discover, optimize and characterize ROR modulators that could be subsequently developed and commercialized by BMS. BMS continues to advance the program and in 2017, filed a Clinical Trial Authorization in Europe for the first in-human study of a RORt inverse agonist. Exelixis is eligible for development, regulatory and commercial milestone payments, as well as royalties on commercial net sales, depending on the advancement of the product candidate and eventual product.

In February 2017, Exelixis entered into a clinical collaboration agreement with BMS for the purpose of conducting clinical studies combining CABOMETYX® (cabozantinib) tablets with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab). As part of this collaboration, Exelixis and BMS initiated CheckMate 9ER, a phase 3 trial evaluating Opdivo in combination with CABOMETYX versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC), and CheckMate 040, a phase 1/2 trial evaluating the same combination and also CABOMETYX with both Opdivo and Yervoy versus sorafenib in patients with both previously treated and previously untreated advanced hepatocellular carcinoma (HCC).

Daiichi-Sankyo

In March 2006, Exelixis entered into a collaboration agreement with Daiichi Sankyo for the discovery, development and commercialization of novel therapies targeting the mineralocorticoid receptor. One of the compounds developed during this research collaboration is esaxerenone (CS-3150), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR), which Daiichi Sankyo subsequently took forward. In February 2018, based on the results of a phase 3 trial, Daiichi Sankyo submitted a regulatory application for esaxerenone as a treatment for patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency. Exelixis is eligible to receive development, regulatory and commercialization milestone payments, as well as royalties on any sales of products commercialized under the collaboration.

Genentech

In December 2006, Exelixis out-licensed cobimetinib, which it discovered internally, to Genentech via a worldwide collaboration agreement. Approved in 2015 for the treatment of a form of advanced melanoma and marketed as COTELLIC®, Exelixis and Genentech share in commercialization costs and ultimately profits/losses from COTELLIC in the United States, where Exelixis also has co-promotion rights. Outside the U.S., Exelixis is eligible to receive and is receiving royalties on COTELLIC sales. In addition, Genentech’s clinical development program currently includes three ongoing phase 3 pivotal trials for the compound, including IMBLAZE 370, evaluating cobimetinib in combination with atezolizumab in third-line colorectal carcinoma patients.

In addition to its cobimetinib partnership, Exelixis is also collaborating with Genentech’s parent company, Roche, on a phase 1b dose escalation study evaluating the safety and tolerability of Exelixis’ other lead compound, cabozantinib, in combination with atezolizumab, Roche’s anti-PD-L1 CPI, in patients with locally advanced or metastatic solid tumors. Enrollment for the trial began in mid-2017, and in early 2018, Exelixis amended the trial’s protocol to allow for four additional cohorts of patients.

Iconic Therapeutics

In May 2019, Exelixis entered into an exclusive option and licensing agreement with Iconic Therapeutics, Inc. (ICONIC) to advance an innovative next-generation antibody-drug conjugate (ADC) program for cancer. The agreement grants Exelixis an exclusive option to license ICON-2, Iconic’s lead oncology ADC, a potential best-in-class program targeting Tissue Factor in solid tumors. If Exelixis elects to exercise its option at the time of a potential investigational new drug filing, it will assume all further clinical development and commercialization activities, while Iconic will become eligible for future milestone payments and royalties on potential sales.

Invenra

In May 2018, Exelixis entered into a collaboration with Invenra to discover and develop novel biologics to treat cancer. The agreement grants Exelixis an exclusive, worldwide license to one preclinical asset, currently in lead selection against an undisclosed target, and forms a collaborative partnership enabling the two companies to pursue up to six additional discrete projects, in total directed to three discovery programs, through the use of Invenra’s B-Body^™ technology platform. Exelixis will lead investigational new drug (IND)-enabling studies, manufacturing, clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities. Invenra will be responsible for antibody lead discovery and generation and will be eligible to receive pre-clinical, clinical development, regulatory and commercialization milestones for any product containing a lead preclinical asset in the first indication as well as royalties on net sales.

Ipsen

In February 2016, Exelixis entered into an exclusive licensing agreement with Ipsen for the commercialization and further development of cabozantinib. Ipsen is now Exelixis’ global partner for cabozantinib in all geographies outside of the United States and Japan. Exelixis has received to date significant development and regulatory milestone payments from this collaboration, and is eligible to receive additional capital from commercial milestones and royalties on net sales of cabozantinib in Ipsen’s territories. Ipsen can opt in to funding additional cabozantinib clinical trials, thereby gaining access to the results to support potential future regulatory submissions in its territories.

Merck

In December 2011 Exelixis granted an exclusive worldwide license to its PI3k-delta program, including XL499 and other related compounds. Merck retains the sole responsibility to research, develop and commercialize compounds from this program, one of which is currently the subject of a phase 1 trial. Exelixis is eligible for payments associated with the successful achievement of development and regulatory milestones for multiple indications of compounds within the PI3k-δ program.

Sanofi

In May 2009, Exelixis entered into an out-license agreement with Sanofi for two internally discovered compounds, SAR24508 (XL765) and SAR24509 (XL765), both of which are inhibitors of phosphoinositide-3-kinase (PI3K) and are available to be taken orally. Both compounds have been evaluated by Sanofi as single agents and in combination regimens within a variety of cancer indications.

StemSynergy Therapeutics

In January 2018, Exelixis entered into an exclusive licensing agreement with StemSynergy for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key oncogenic processes. Exelixis will contribute research and development funding and be solely responsible for commercialization of any products resulting from the collaboration. StemSynergy will be eligible to receive development, regulatory and commercial milestones, as well as royalties on worldwide sales.

Takeda

In 2017, Exelixis and Takeda announced an exclusive licensing agreement for the commercialization and further development of cabozantinib in Japan. As part of this collaboration, Exelixis will receive development and regulatory milestone payments and is also eligible to receive additional capital from commercial milestones and royalties on net sales in Japan. In additional, Takeda is responsible for a portion of the costs associated with the global cabozantinib development plan, provided Takeda chooses to participate in such trials, as well as the entire cost of cabozantinib development activities that are exclusively for the benefit of Japan.