TONIX PHARMACEUTICALS HOLDING CORP. (NASDAQ:TNXP) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01
On May 20, 2019, Tonix Pharmaceuticals Holding Corp. (the “Company”) and The Trustees of Columbia University in the City of New York (“Columbia”) entered into an exclusive License Agreement (the “License Agreement”) to which Columbia, for itself and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”) granted to the Company an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively, the “Technology”) related to a double-mutant cocaine esterase, and to develop and commercialize products thereunder (each, a “Product”). to the terms of the License Agreement, Columbia has reserved for itself and the Institutions the right to practice the Technology for academic research and educational purposes.
As consideration for entering into the License Agreement, the Company has agreed to pay a six-digit license fee to Columbia. The Company is obligated to use Commercially Reasonable Efforts, as defined in the License Agreement, to develop and commercialize the Product, and to achieve specified developmental milestones.
The Company has agreed to pay Columbia single-digit royalties on net sales of (i) Products sold by the Company or a sublicensee and (ii) any other products that involve material or technical information related to the Product and transferred to the Company to the License Agreement (“Other Products”) sold by the Company or a sublicensee. Royalties on each particular Product are payable on a country-by-country and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued patents covered by the License Agreement, (ii) a specified period of time after the first commercial sale of a Product in the country in question, or (iii) expiration of any market exclusivity period granted by a regulatory agency. Royalties on each particular Other Product are payable on a country-by-country and product-by-product basis until the later of (i) a specified period of time after the first commercial sale of such particular Other Product in such country or (ii) expiration of any market exclusivity period granted by a regulatory agency. Royalties payable on net sales of the Product and Other Products may be reduced by 50% of the royalties payable by the Company to any third party for intellectual property rights which are necessary for the practice of the rights licensed to the Company under the License Agreement, provided that the royalty payable on a Product or Other Product may not be reduced by more than 50%.
The Company is also obligated to make contingent milestone payments to Columbia totaling $3 million on a Product-by-Product basis upon the achievement of certain development, approval and sales milestones related to a Product. In addition, the Company shall pay Columbia 5% of consideration, other than royalty payments and certain other categories of consideration, payable to the Company by a sublicensee.
Dr. Donald Landry, a member of the faculty of Columbia and an inventor on key patents and patent applications being licensed to the License Agreement, resigned from the Board of Directors of the Company (the “Board”) on May 16, 2019. Under applicable Columbia policies, Dr. Landry has a pecuniary interest in certain proceeds that Columbia receives under the License Agreement. to the requirements of the Nevada Revised Statutes, the disinterested members of the Board approved the License Agreement with Columbia.
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2019. Certain terms of the License Agreement have been omitted from this Form 8-K and will be omitted from the version to be filed as an exhibit to the Form 10-Q.
A press release issued by the Company in connection with the License Agreement is included as Exhibit 99.1 hereto.
| 99.01 | Press Release dated May 23, 2019, issued by the Company | ||
Tonix Pharmaceuticals Holding Corp. Exhibit
EX-99.01 2 ex99-01.htm PRESS RELEASE Tonix Pharmaceuticals Holding Corp. 8-K Exhibit 99.01 Tonix Pharmaceuticals Expands Pipeline with Mid-stage Biologic Candidate TNX-1300 for Cocaine Intoxication Phase 2 Program Granted Breakthrough Therapy Designation by FDA Emergency Room Visits for Cocaine Abuse Total More than 500,…
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