Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
This ASSET PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of February 22, 2026 (the “Effective Date”), by and between [***] (“Buyer”), Cyprium Therapeutics, Inc., a Delaware corporation (“Seller”) and Fortress Biotech, Inc., a Delaware corporation (“Fortress”). Buyer, Seller and Fortress may hereinafter be referred to individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Seller is the holder of all right, title and interest in and to the Priority Review Voucher (as defined below);
WHEREAS, Seller, Fortress and Buyer each (i) desire that Buyer purchase from Seller, and Seller sell, transfer and assign to Buyer, the Purchased Assets (as defined below), all on the terms set forth herein (such transaction, the “Asset Purchase”) and (ii) in furtherance thereof, have duly authorized, approved and executed this Agreement and the other transactions contemplated by this Agreement in accordance with all applicable Legal Requirements (as defined below); and
WHEREAS, Seller, Fortress and Buyer desire to make certain representations, warranties, covenants and other agreements in connection with the Asset Purchase as set forth herein.
NOW, THEREFORE, in consideration of the foregoing and their mutual undertakings hereinafter set forth, and for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, intending to be legally bound, the Parties agree as follows:
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Other capitalized terms defined elsewhere in this Agreement and not defined in this Section 1.01 shall have the meanings assigned to such terms in this Agreement.
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Seller and Fortress each represents and warrants to Buyer, as of the Effective Date and the Closing Date, as follows:
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Section 4.16No Other Representations. Except for the representations and warranties contained in this Article IV, neither Seller nor Fortress nor any stockholder, director, officer, employee or agent of Seller or Fortress has made or makes any other express or implied representation or warranty, either written or oral, on behalf of Seller or Fortress.
Buyer represents and warrants to Seller, as of the Effective Date and the Closing Date, as follows:
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Section 8.05Exclusive Remedy. From and after the Closing, except in the case of Fraud and as otherwise provided in Section 11.09, the sole and exclusive remedy of any Indemnitee for any Damages that such Indemnitee may at any time suffer or incur, or become subject to, as a result of, or in connection with this Agreement, including any inaccuracy, violation or breach of any representation and warranty contained in this Agreement by any Party, or any failure by any Party to perform or comply with any covenant or agreement that, by its terms, was to have been performed, or complied with, under this Agreement, shall be indemnification in accordance with this Article VIII (subject to the applicable qualifications and limitations set forth in this Agreement).
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[***]
with a copy (which shall not constitute notice) to:
[***]
Fortress Biotech, Inc.
1111 Kane Concourse, Suite 301
Bay Harbor Islands, Florida 33154
Attention: David Jin, CFO
Email: [***]
with a copy (which shall not constitute notice) to:
Fortress Biotech, Inc.
1111 Kane Concourse, Suite 301
Bay Harbor Islands, Florida 33154
Attention: Legal Department
Email: [***]
and:
DLA Piper LLP (US)
Harbor East
650 S. Exeter Street, Suite 1100
Baltimore, Maryland 21202-4576
Email: [***]
Attention: [***]
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Arbitration. Each Party irrevocably agrees that any Proceeding arising out of or relating to this Agreement brought by such Party or its successors or assigns shall be finally resolved or settled exclusively through binding arbitration pursuant to this Section 11.11. [***] Arbitration shall be administered by the American Arbitration Association (“AAA”) in accordance with its Commercial Arbitration Rules then in effect. A panel of three arbitrators will conduct the arbitration. The demanding Party shall select one arbitrator and the responding Party shall select a second arbitrator within 15 days after giving or receiving the request for arbitration, whichever the case may be, and notify the other Party or Parties of such selection in writing. If there are more than two parties to such dispute, then all claimants shall jointly select one arbitrator and all respondents shall jointly select a second arbitrator within 15 days after giving or receiving the request for arbitration, whichever the case may be, and notify the other Party or Parties of such selection in writing. Such arbitrators shall be freely selected and the Parties shall not be limited in their selection to any prescribed list. The two selected arbitrators shall, in consultation with their respective appointing Parties, shall select a third arbitrator, who shall be the chairman of the arbitral tribunal (provided that such third arbitrator must be a legally-qualified lawyer, legal practitioner or judicial officer with at least ten (10) years of experience in commercial transactions or mergers and acquisitions), within 10 days of their appointment and notify both Parties of such selection in writing, but if they are unable or fail to agree upon the third arbitrator, the third arbitrator shall be selected in accordance with AAA’s Commercial Arbitration Rules. If any of the Parties does not appoint an arbitrator in accordance with this Agreement, such arbitrator shall be selected in accordance with AAA’s Commercial Arbitration Rules. The arbitration shall be conducted in English. The arbitral award shall be final and enforced in any court of competent jurisdiction by any Party. The arbitral tribunal may award legal costs and expenses as it deems fit. The Parties hereby
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acknowledge and agree that arbitrators may issue procedural orders and decide on interim measures or injunctions in the course of arbitration. The Parties agree that any one of them may request in aid of arbitration from any court of competent jurisdiction for injunctive relief, interim or other conservatory measures in connection with a Proceeding, to preserve property pending determination by the arbitrators, or to enforce judgement entered on an award of the arbitrators or to enforce. Confidential Information shall include, and the Parties shall keep confidential in accordance with Section 10.03, (a) the existence of any Proceeding arising out of or relating to this Agreement, (b) any notice delivered pursuant to this Section 11.11, (c) any information, document, memorials, briefs or other materials delivered, exchanged or produced in connection with any arbitration pursuant to this Section 11.11, (iv) any settlement or other resolution of such Proceeding, including any decision rendered by the arbitrators; provided that a Party may disclose such Confidential Information (or cause an Affiliate to disclose such Confidential Information) (x) as otherwise permitted by this Agreement, (y) as necessary to enforce the provisions of this Section 11.11 or any determination or award rendered by the arbitrators or to enforce other rights of a party to such Proceeding or (z) as required by applicable Law.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed as of the Effective Date.
BUYER:
[***]
By: s/ [***]
Name: [***]
Title: [***]
SELLER:
CYPRIUM THERAPEUTICS, INC.
By: /s/ Samuel Berry
Name: Samuel Berry
Title: Corporate Secretary
FORTRESS:
FORTRESS BIOTECH, INC.
By: /s/ David Jin
Title: David Jin
Name: Chief Financial Officer
EXHIBIT A
APPROVAL LETTER
[***]
EXHIBIT B
FORM OF BILL OF SALE
[***]
EXHIBIT C
LETTER FROM BUYER TO FDA CONFIRMING TRANSFER OF VOUCHER FROM SELLER TO BUYER
[***]
EXHIBIT D
LETTER FROM SELLER TO FDA CONFIRMING TRANSFER OF VOUCHER FROM SELLER TO BUYER
[***]
EXHIBIT E
LETTER FROM SELLER TO BUYER CONFIRMING TRANSFER OF VOUCHER
[***]
EXHIBIT F
LETTER FROM BUYER TO SELLER ACKNOWLEDGING TRANSFER OF VOUCHER FROM SELLER TO BUYER
[***]
EXHIBIT G
COVER LETTER FROM SENTYNL TO FDA
[***]
EXHIBIT H
PRESS RELEASE
Fortress Biotech’s Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
Miami, FL – February 23, 2026 – Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that Cyprium entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”) for gross proceeds of $205 million upon the closing of the transaction.
In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”) assumed full responsibility for the development and commercialization of ZYCUBO® (copper histidinate, formerly known as CUTX-101) from Cyprium. The PRV was issued upon approval of ZYCUBO by the U.S. Food and Drug Administration (“FDA”) on January 12, 2026. Pursuant to the transaction with Sentynl, the PRV was immediately transferred to Cyprium. Cyprium remains eligible to receive tiered royalties on net sales of ZYCUBO and up to $129 million in aggregate development and sales milestones from Sentynl. Cyprium is also obligated to pay 20% of the proceeds from a PRV sale to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health.
“The recent approval of ZYCUBO was a significant achievement for patients with Menkes disease and the sale of the PRV by Cyprium shows our continued execution in value-generating corporate transactions,” said Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer and Cyprium’s Chairman. “With the PRV sale and three FDA approvals received in the last 15 months for Emrosi™, UNLOXCYT™, and ZYCUBO, in addition to the recent sale of our former subsidiary Checkpoint Therapeutics to Sun Pharma, we believe that we are well positioned to continue to execute on our portfolio. We look forward to the potential achievement of upcoming milestones across our extensive pipeline of commercial and clinical-stage assets.”
“We are very pleased with the recent progress at Cyprium, which includes the approval of ZYCUBO for the treatment of Menkes disease along with the execution of this important agreement,” said Lung S. Yam, M.D., Ph.D., Cyprium’s President and Chief Executive Officer. “We are deeply grateful for everyone's support and look forward to advancing AAV-ATP7A Gene Therapy toward clinical development to provide additional therapeutic options for patients with Menkes disease.”
The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
About Cyprium Therapeutics
Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement with the Eunice Kennedy
Shriver National Institute of Child Health and Human Development (“NICHD”), part of the NIH, to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In 2023, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101 to Sentynl Therapeutics, Inc. ZYCUBO (formerly CUTX-101) was U.S. FDA-approved in 2026 for the treatment of Menkes disease in pediatric patients. Cyprium and NICHD also have an ongoing worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101; AAV-ATP7A gene therapy is currently in pre-clinical development and has received FDA Orphan Drug Designation. Cyprium was founded by, and is a majority-owned subsidiary of, Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.cypriumtx.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income. The company has eight marketed prescription pharmaceutical products and multiple programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital, Columbia University, Dana Farber Cancer Center and Sentynl Therapeutics. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: the possibility that the proposed transaction may not be completed in the time frame expected by Cyprium and/or Fortress, or at all; our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the
results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products or other marketable assets for which we receive regulatory approval; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Company Contact:
Jaclyn Jaffe
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com