Filing Data. S1 abstract - 2014 On December 19, 2013, we entered into a memorandum of understanding with Xxxx Biosciences, or the Xxxx MOU, to explore opportunities to collaborate in order to develop a XXXX clinical diagnostic tool, as well as a clinical diagnostic tool for patients receiving aramchol treatment. Xxxx performs lipidomic profiling analyses in order to generate molecular lipid quantification data. According to the Xxxx MOU, in connection with our planned Phase IIb clinical trial of aramchol, we will collect and provide to Xxxx liver tissue samples from biopsies and serum samples from the patients screened and enrolled in the Israeli-based centers in the trial and Xxxx will perform lipidomic profiling analysis based on such samples. Once Xxxx has performed its analysis, Xxxx is permitted to verify its results by comparing them to the results of the liver biopsies that will be taken from the trial participants and from their MRIs. We expect this to enable Xxxx to evaluate the performance of its lipidomic profiles and develop a XXXX disease clinical diagnostic tool and generate lipidomic profiles correlated with disease progression of patients. We also expect that this will enable Xxxx to develop a clinical diagnostic tool for patients receiving aramchol treatment, which would be intellectual property owned by us. We will not receive any financial payment from Xxxx. However, we will be obligated to pay to-be-agreed upon fees to Xxxx in respect of its lipidomic analysis activities, and if such activities generate patentable intellectual property for Xxxx, then we will receive a reimbursement of 40% of such fees. According to the Xxxx MOU, we will own all clinical data and Xxxx will own all lipidomic data, each as generated by our collaboration. We also agreed to xxxxx Xxxx a free license to use such clinical data only to develop biomarkers and related diagnostics in the field of XXXX. Xxxx will xxxxx to us a free license to use their lipidomic data generated by the clinical trial for developing a clinical diagnostic tool for patients receiving treatment with aramchol. Xxxx will also grant us a right of first discussion, exercisable upon completion of the Phase IIb clinical trial, to enter into a business transaction with Xxxx, separate from the transaction and relationship contemplated in the Xxxx MOU, regarding the commercial exploitation of its XXXX disease clinical diagnostic tool based upon the data generated during the collaboration. We agreed to enter i...
Filing Data. On July 1, 2013, we entered into a license agreement with Celgene, as amended on November 23, 2018, or the Celgene Agreement, pursuant to which we granted Celgene an exclusive, global license for the development, manufacture and commercialization of our proprietary CD47 binding domain, or the Celgene Licensed Intellectual Property. Per the terms of the Celgene Agreement, Celgene is operationally and financially responsible for the development, manufacturing and commercialization activities of Celgene Licensed Intellectual Property and any additional related antibodies covered by the Celgene Agreement. As payment for the license granted in the Celgene Agreement, we may be eligible to receive development and regulatory milestones of an aggregate of $934.1 million, assuming the achievement of all potential milestones in the Celgene Agreement, as well as percentage tiered royalties based on future worldwide sales, with rates ranging between the high single-digits and low teens, subject to potential reduction when and if comparable third party products attain certain levels of competitive market share (on a country-by-country basis) and, subject to certain limitations, payments to third parties for third-party intellectual property rights. We are obligated to pay 2% of future amounts received under the Celgene Agreement to advisors who assisted us with the negotiations and other matters in connection with the Celgene Agreement. LICENSE AGREEMENT This License Agreement (this “Agreement”) is made effective e as of July 1, 2013 (“Effective Date”) by and between INBRX 103, LLC, a limited liability company with an address at 00000 Xxxxx Xxxxxx Xxxxx Road, Suite 130, La Jolla, CA 92037 (“Inhibrx”), and Celgene Corporation a Delaware corporation with an address at 00 Xxxxxx Xxxxxx, Summit, NJ 07901 (“Licensee”). Inhibrx and Licensee each may be referred to herein individually as a “Party” and together as the “Parties.”
Filing Data. In December 2017, we entered into a Collaboration and License Agreement, or the Everest Agreement, with Everest regarding the development and commercialization of ralinepag and etrasimod in China, Taiwan, Hong Kong, Macau and South Korea, or the Everest Territories. In January 2019, we and Everest amended the Everest Agreement by entering into two separate agreements, one for each of ralinepag and etrasimod, with the terms for each program that are substantially the same as in the original Everest Agreement. Under the United Therapeutics Agreement, we assigned the separate Everest Agreement related to ralinepag to United Therapeutics.
Filing Data. 10K abstract - 2012 On April 14, 2010, we entered into a discovery and development collaboration and license agreement with Agios Pharmaceuticals, Inc., or Agios, which focuses on cancer metabolism targets and the discovery, development and commercialization of associated therapeutics. As part of the agreement, as amended, we paid Agios $121.2 million, which was recorded by us as research and development expense. We also made an
Filing Data. On February 5, 2019 (the “Effective Date”) Aegerion Pharmaceuticals, Inc. (the “Company”), a subsidiary of Novelion Therapeutics Inc. (“Novelion”), entered into a license agreement (the “License Agreement”) with Recordati Rare Diseases Inc. (“Recordati”) for the commercialization of JUXTAPID® (lomitapide) in Japan. Under the terms of the License Agreement, and subject to the conditions set forth therein, the Company granted to Recordati an exclusive license in Japan, with the right to grant sub-licenses, to manufacture and commercialize the Company’s current JUXTAPID product that contains lomitapide as the sole active ingredient (the “Product”), for the current marketed indication for homozygous familial hypercholesterolemia (HoFH). During the term of the License Agreement, Recordati also has an exclusive right of first negotiation to any new indications for the Product in Japan.
Filing Data. In October 2006, we entered into an exclusive license agreement with Duke University, or the Duke License, which we most recently amended in May 2017. Pursuant to the Duke License, Duke granted us an exclusive, worldwide license under certain patent rights owned or controlled by Duke, and a non-exclusive, worldwide license under certain know-how of Duke, to develop and commercialize any products covered by the Duke License, or Duke licensed products, relating to ELPs. Under the Duke License, we paid Duke an upfront fee of $37,000, additional fees in connection with amendments to the Duke License of $0.2 million and other additional licensing fees of $0.2 million. In consideration for license rights granted to us, we initially issued Duke 270,984 shares of our common stock. Until we reached a certain stipulated equity milestone, which we reached in October 2007, we were obligated to issue additional shares of common stock to Duke from time to time so that its aggregate ownership represented 7.5% of our issued and outstanding capital stock. We are also required to pay Duke: up to $2.2 million in regulatory and clinical milestone fees; up to $0.4 million in commercial milestone fees; low single-digit royalty percentages on net sales of Duke licensed products, with minimum aggregate royalty payments of $0.2 million payable following our achievement of certain commercial milestones; and up to the greater of $0.3 million or a low double-digit percentage of the fees we receive from a third party in consideration of forming a strategic alliance with respect to certain patent rights covered under the Duke License. We also must pay Duke the first $1.0 million of non-royalty payments we receive from a sublicensee, and thereafter a low double-digit percentage of any additional nonroyalty payments we receive. As of June 30, 2018, we have not paid any amounts under the Duke License. We are required to apply for, prosecute and maintain all U.S. and foreign patent rights under the Duke License. As of June 30, 2018, we have incurred $1.4 million in patent prosecution costs under the Duke License. LICENSE AGREEMENT THIS Agreement is entered into this eighteenth day of October, 2006 (“Effective Date”) between DUKE UNIVERSITY, a nonprofit educational and research institution organized under the laws of North Carolina (“DUKE”), having a place of business at Durham, North Carolina 27710, and Phase Bioscience, Inc., a corporation organized under the laws of Delaware (“Licensee”)...
Filing Data. In January 2017, we initiated a strategic collaboration with Novartis for the development and commercialization of AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. In February 2019, Novartis exercised its option to license AKCEA-APO(a)-LRx. Novartis initiated a Phase 3 study of AKCEA-APO(a)-LRx in patients with CVD and elevated levels of Lp(a). Novartis is now responsible for all future development and commercialization activities for AKCEA-APO(a)-LRx. We are eligible to receive tiered, double-digit royalties in the mid-teens to low twenty percent range on sales of AKCEA-APO(a)-LRx from Novartis and milestone payments if and when it meets the development, regulatory and sales milestones specified in our agreement. In connection with Novartis’ exercise of its option to exclusively license AKCEA-APO(a)-LRx, we and Novartis established a more definitive framework under which we may negotiate the co-commercialization of AKCEA-APO(a)-LRx between the two companies in selected markets. Included in this framework is an option by which Novartis could solely commercialize AKCEA-APO(a)-LRx in exchange for Novartis paying us increased commercial milestone payments based on sales of AKCEA-APO(a)-LRx. We will share any milestone payments and royalties equally with Ionis. In December 2019, Novartis made a strategic portfolio decision not to exercise its option and to terminate its rights to AKCEA-APOCIII-LRx and, consequently, we now retain the rights to AKCEA-APOCIII-LRx. In January 2020, we reported positive Phase 2 top line results from this program in the treatment of patients with hypertriglyceridemia who are at risk for, or have established, CVD. We and Ionis plan to initiate a Phase 3 program in FCS for this medicine in 2020 and we are evaluating development in additional rare and common diseases that are associated with high triglyceride levels. AKCEA-APOCIII-LRx also has the potential to favorably impact numerous other risk factors independently associated with CVD. Under our Novartis agreement, we received $75.0 million in an upfront option payment in February 2017, of which we retained $60.0 million and paid Ionis a $15.0 million sublicense fee, and Novartis purchased $100.0 million of Ionis' common stock at a premium. We also received a $150.0 million license fee when Novartis exercised its option to license AKCEA-APO(a)-LRx in February 2019, for which we issued 2,837,373 shares of our common stock to Ionis in March 2019, as payment for a $75.0 million sublicense fee....
Filing Data. Not available.
Filing Data. S1 abstract - 2015 In March 2012, we entered into a distribution agreement with Nipro that expires in August 2019, pursuant to which we granted Nipro the exclusive right to promote, sell, market and distribute our TVC Imaging System in Japan. Pursuant to the agreement, (1) Nipro paid us a one-time distribution franchise fee, which we are obligated to return to Nipro upon the occurrence of certain events specified in the agreement, including if we undergo a change of control that results in termination of the agreement, if we become insolvent, or if we withdraw our product from the Japanese market and (2) Nipro is obligated to purchase minimum volumes of our product at pre-determined prices, which are subject to renegotiation upon the occurrence of certain events specified in the agreement. Nipro is responsible for obtaining marketing authorization for the TVC System with Japan’s PMDA. Additionally, Nipro is responsible for all sales, marketing and promotion of the TVC System in Japan. The agreement automatically renews for subsequent one year periods, subject to agreement between us and Nipro as to the minimum volumes for the subsequent terms or, if Nipro desires to renew the agreement but we are unable to agree on minimum volumes, at minimum volumes calculated pursuant to a formula contained in the agreement. Pursuant to the agreement, we have also granted Nipro a right of first refusal to act as our Japanese distributor with respect to any new products that we may introduce in Japan based on the technology used in our current product. The agreement is terminable by us under a number of circumstances, including, but not limited to, in the event that Nipro fails to meet the minimum volume requirements, becomes insolvent, becomes disqualified from selling or importing our product, or upon a change of control of Nipro. The agreement is terminable by Nipro in the event that we undergo a change of control and is terminable by either party upon material breach of the terms of the agreement by the other party, with the termination rights contained in the agreement generally being subject to notice and/or opportunity to cure. Contemplated Amended and Restated Distribution Agreement with Nipro Corporation We have reached an agreement in principle with Nipro to amend and restate our 2012 distribution agreement, although there can be no assurance that we will enter into the contemplated amended and restated agreement with Nipro promptly or at all, or on the terms de...
Filing Data. Nothing in this Section 12.2 is intended to limit the obligations of Contractor under Section 12.1 of this Agreement with respect to the Confidential Information addressed in such Section.
