Item 1.01
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Entry into a Material Definitive Agreement.
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Second Amended and Restated License Agreement
On June 15, 2017,
Cell Cure Neurosciences Ltd. (“Cell Cure”)
entered into a Second Amended and Restated License Agreement (the “License Agreement”) with Hadasit Medical Research Services and Development Ltd. (“Hadasit”), the commercial arm and a wholly-owned subsidiary of Hadassah Medical Organization. Pursuant to the License Agreement, Hadasit granted Cell Cure an exclusive, worldwide, royalty bearing license (with the right to grant sublicenses) in its intellectual property portfolio of materials and technology related to human stem cell derived photoreceptor cells and retinal pigment epithelial cells (the “Licensed IP”), to use, commercialize and exploit any part thereof, in any manner whatsoever in the fields of the development and exploitation of (i) human stem cell derived photoreceptor cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders, and (ii) human stem cell derived retinal pigment epithelial cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders.
As consideration for the Licensed IP, Cell Cure will pay
a one time lump sum payment, a royalty in the low single digits of net sales from sales of Licensed IP by any invoicing entity, and a low double digit percent of sublicensing receipts.
In addition, Cell Cure will pay Hadasit an annual minimal non-refundable royalty, which will become due and payable from the first January 1 falling after the completion of services to Cell Cure by the laboratory of Professor Reubinoff.
Cell Cure further agreed to pay Hadasit non-refundable milestone payments upon the recruitment of the first patient for the first Phase IIB clinical trial, upon the enrollment of the first patient in the first Phase III clinical trials, upon delivery of the report for the first Phase III clinical trials, upon the receipt of an NDA or marketing approval in the European Union, whichever is the first to occur, and
upon the first commercial sale in the United States or European Union, whichever is the first to occur.
The License Agreement terminates upon the expiration of Cell Cure’s obligation to pay royalties for all licensed products, unless earlier terminated. In addition, the License Agreement may be terminated by (i) Hadasit if, among other reasons, Cell Cure fails to continue the clinical development of the Licensed IP or fails to take actions to commercialize or sell the Licensed IP over any consecutive 12 month period, and (ii) by either party for (a) a material breach which remains uncured following a cure period, or (b) the granting of a winding-up order in respect of the other party, or upon an order being granted against the other party for the appointment of a receiver or a liquidator in respect of a substantial portion of such other party’s assets. The License Agreement also contains mutual confidentiality obligations of Cell Cure and Hadasit, and indemnification obligations of Cell Cure.
The foregoing description of the
License Agreement
does not purport to be complete and is qualified in its entirety by reference to the full text of the
License Agreement
, a copy of which will be filed as an exhibit to the Company’s (defined below) Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2017.
Debt and Note Purchase Agreement and Share Purchase and Transfer Agreement
On June 15, 2017, BioTime, Inc. (the “Company”) entered into a Debt and Note Purchase Agreement (the “Debt Purchase Agreement”) and
a Share Purchase and Transfer Agreement (the “HBL Purchase Agreement”)
with HBL-Hadasit Bio-Holdings Ltd. (“HBL”), pursuant to which the Company will purchase from HBL (i) the outstanding debt and promissory notes of, and issued by, Cell Cure (the “Cell Cure Debt”), and (ii) 96,025
ordinary shares of Cell Cure held by HBL (the “Cell Cure Shares”).
The Company agreed to purchase the Cell Cure Debt and the Cell Cure Shares from HBL with the issuance of 3,996,869 shares (the “Shares”) of the Company’s Common Stock, no par value per share (the “Common Stock”). In addition, the Company will cause Cell Cure to issue HBL a warrant equal to 5% of Cell Cure’s issued and outstanding share capital at a price per share of $40.5356.
Within 15 days after the date of the Debt Purchase Agreement, the Company is required to prepare and file with the Securities and Exchange Commission a Registration Statement on Form S-3 to enable the resale by HBL, from time to time on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”), of the Shares, and use its commercially reasonable efforts to cause such Registration Statement on Form S-3 to become effective.
The transactions are expected to close on or about June 27, 2017, subject to customary closing conditions. At the closing, both of the directors HBL previously appointed to Cell Cure will resign and HBL will have the right to appoint an observer to Cell Cure’s Board of Directors.
The foregoing descriptions of the Debt Purchase Agreement and HBL Purchase Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Debt Purchase Agreement and HBL Purchase Agreement, copies of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2017.