SANA BIOTECHNOLOGY, INC. : conclusion of a major definitive agreement, disclosure of FD regulations, other events (form 8-K)

Item 1.01 Conclusion of a Material Definitive Agreement.

At January 7, 2022 (the “Effective Date”), Biotechnology Sana, Inc. (the “Company”) has entered into a patent license agreement (the “Agreement”) with the
US Department of Health and Human Services, represented by the National Cancer Institute, an institute of National Institutes of Health (the “NIH”), under which the NIH granted the Company an exclusive, worldwide commercial license under certain patent rights relating to certain fully human anti-CD22 binders and CD22 CAR constructs comprising such binders (the “Licensed Patent Rights”) for use in certain In vivo gene therapies and ex vivo allogeneic CAR T cell applications for malignant B cell tumors. Licensing is subject to customary legal requirements and rights reserved as required by federal law and NIH requirements. The Company has the right to sublicense under the licensed patent rights with the NIH prior consent.

Under the terms of the Agreement, the Company has undertaken to pay the NIH an upfront payment of $ 1.0 million. In addition, the Company will be required to pay the NIH (i) up to a total of $ 9.6 million in the specified regulatory, development and commercial milestone payments in respect of each product developed through the exploitation of the licensed patent rights (each, a “licensed product”) and (ii) a payment of $ 1,000,000 upon transfer of the Agreement to an affiliate upon a change of control of the Company. In addition, the Company is required to pay the NIH (i) a royalty on net sales of licensed products in digits below single digits, subject to reduction in certain circumstances and subject to certain minimum annual royalty payments, and (ii) a percentage, ranging from mid -figure mid-teenagers, income from sublicensing agreements. In addition, if the Company obtains a priority review voucher by the United States Food and Drug Administration in respect of a licensed product, the Company will be required to pay the NIH the greater of (i) $ 5,000,000 or (ii) a percentage in the average of the figures of any consideration received for the sale, transfer or rental of such priority review voucher. The Company is also required to pay the NIH a percentage in the lower digits of the consideration received by the Company for any assignment of the Agreement to a non-affiliate.

The Company is obligated to use commercially reasonable efforts to exploit and make publicly available the inventions developed by the exploitation of the licensed patent rights, including the licensed products.

Unless terminated earlier by either party, the Agreement will terminate upon the expiration of the last valid claim of licensed patent rights. the
NIH may terminate the Agreement with written notice in the event of a material breach of the Company if the Company fails to timely remedy such breach or during certain insolvency events involving the Company. In addition, the NIH may terminate or modify the Agreement, at its option, if the NIH determines that such termination or modification is necessary to meet public use requirements specified by federal regulations issued after the effective date of the Agreement, and that such requirements are not reasonably and in a timely manner met by the Society. The Company may terminate the Agreement or any license in any country or territory upon 60 days written notice.

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, of which the Company intends to file an attached copy of its annual report on Form 10-K for its closed exercise December 31, 2021.

Article 7.01 Regulation FD Disclosure.

The Company intends to present an updated corporate presentation (the “Corporate Presentation”) at the 40th JP Morgan Healthcare Conference to January 11, 2022. A copy of the Company Presentation is provided as Exhibit 99.1 of this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference herein.

By providing the information in this section 7.01 of this current report, including Exhibit 99.1, the Company makes no admission as to the materiality of this information. The information contained in this document is intended to be considered in the context of the Company’s filings with the United States Securities Commission (the “SEC”) and other public announcements the Company makes, by press release or otherwise, from time to time. The Company assumes no obligation or obligation to publicly update or revise the information contained in the Corporate Presentation, although it may do so from time to time as its management deems it appropriate. Such an update may be effected by filing other reports or documents with the SECOND, through press releases or other public disclosures.

In accordance with Policy Statement B.2 of Form 8-K, the information provided in item 7.01 of this current report and in Exhibit 99.1 of this current report will not be considered “filed” for the purposes of section 18 of the current report. the Securities Exchange Act of 1934., as amended (“Exchange Act”), or otherwise subject to the requirements of this section, nor will it be deemed to be incorporated by reference in any other filing under the Securities Act of 1933, as amended, or of the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 8.01 Other Events.



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At January 11, 2022, the Company issued a press release announcing the Agreement, described above in section 1.01 of this Current Report. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

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