Exhibit 10.1
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (“Agreement”) is made and entered into effective as of September 29, 2025 (“Effective Date”), by and between Serpin Pharma, Inc., a Delaware corporation (“Serpin”), and Dogwood Therapeutics, Inc., a Delaware corporation (“Dogwood”).
RECITALS
WHEREAS, Serpin has developed and owns certain intellectual property relating to SP16, a family of novel LRP1 agonists (collectively, “SP16”), and believes SP16, and in particular SP163M, a compound included in the SP16 family, should be developed further and commercialized; and
WHEREAS, Serpin desires to grant to Dogwood an exclusive license under such intellectual property in order to develop further and commercialize SP16, including SP163M, and Dogwood desires such license and to seek to develop further and commercialize SP16, including SP163M, in each case subject to the terms and conditions of this Agreement.
NOW, THEREFORE, intending to be legally bound and in consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
“Action” has the meaning set forth in Section 9.1(a).
“Affiliate” as to any Person, means any other Person that, directly or indirectly through one or more intermediaries, is in control of, is controlled by, or is under common control with, such Person. For purposes of this definition, “control” of a Person means the power, directly or indirectly, either to (a) vote 50% or more of the securities having ordinary voting power for the election of directors (or persons performing similar functions) of such Person or (b) direct or cause the direction of the management and policies of such Person, whether by contract or otherwise.
“Agent” has the meaning set forth in Section 12.14.
“Agreement” has the meaning set forth in Preamble.
“Bankruptcy Code” means Title 11 of the United States Code, as amended from time to time, or any similar federal or state law for the relief of debtors.
“Change in Control” of any Person means (a) a merger or consolidation of such Person, or (b) a transaction or series of related transactions in which any Person or group of persons within the meaning of § 13(d)(3) of the Securities Exchange Act of 1934, becomes the beneficial owner, directly or indirectly, of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Person.
“Confidential Information” means all non-public, confidential, or proprietary information of a party, or its Affiliates or Representatives, whether in oral, written, electronic or other form or media, whether or not such information is marked, designated or otherwise identified as “confidential” and includes the terms and existence of this Agreement and any information that, due to the nature of its subject matter or circumstances surrounding its disclosure, would reasonably be understood to be confidential or proprietary, including, without limitation, the Licensed Know-how.
Confidential Information does not include information that the Receiving Party can demonstrate by documentation (i) was already known to the Receiving Party without restriction on use or disclosure prior to the receipt of such information directly or indirectly from or on behalf of the Disclosing Party; (ii) was independently developed by the Receiving Party without use or reference to the Disclosing Party’s Confidential Information; (iii) is or becomes generally known to the public or otherwise becomes publicly available, other than through a breach of this Agreement by the Receiving Party; or (iv) is or was made available to the Receiving Party by a third party having the lawful right to do so without breaching any obligation of confidentiality to the Disclosing Party.
“Debarred” has the meaning set forth in Section 12.14.
“Debtor Relief Law” means the Bankruptcy Code and all other liquidation, bankruptcy, assignment for the benefit of creditors, conservatorship, moratorium, receivership, insolvency, rearrangement, reorganization or similar debtor relief laws of the US or other applicable jurisdictions in effect from time to time.
“Declaring Party” has the meaning set forth in Section 8.2(b).
“Disclosing Party” has the meaning set forth in Section 7.1.
“Dispute” has the meaning set forth in Section 8.2(a).
“Dogwood” has the meaning set forth in the Preamble.
“Effective Date” has the meaning set forth in the Preamble.
The terms “expiration” and “expire,” when referring to a pending or issued claim in a Licensed Patent, mean any expiration, revocation, invalidation, or other termination (by whatever proceeding, process, or event) of such pending or issued claim.
“Exploit” means to research, develop, seek regulatory approval for, make, import, export, use, promote, market, sell, offer for sale, commercialize, or otherwise utilize or exploit in any way, or to have any of the foregoing done by another Person (including, without limitation, to have made), by whatever means, now known or later developed.
“FDA” has the meaning set forth in the definition of Regulatory Authority.
“Field” means treatment for cancer-related pain, including the treatment of painful conditions resulting from a diagnosis of cancer itself, or resulting from therapy for said cancer,
whether due to surgical, chemotherapy, radiation, or immunotherapy treatments, whether the pain begins with, or is worsened by, a diagnosed malignancy or treatment thereof, or whether the pain is acute or chronic secondary to the underlying cancer diagnosis and/or treatment. For example, a partial list of malignancies that would be included in the Field are solid tumors, blood-borne malignancies, and metastatic tumors secondary to other primary malignancies, and the range of pain states would encompass acute fractures due to malignancy, chronic pain due to tissue infiltration with tumor cells, bony metastases, neuropathy due to therapy, as well as tissue damage due to cancer itself or the result of cancer-related therapy.
“GAAP” means generally accepted accounting principles in the United States of America as in effect from time to time.
“Governmental Authority” means the government of any nation or any political subdivision thereof, whether at the national, state, territorial, provincial, municipal or any other level, and any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of, or pertaining to, government.
“Indemnitee” has the meaning set forth in Section 9.1(a).
“Infringement Notice” has the meaning set forth in Section 5.3(a).
“Law” means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, decree, other requirement or rule of law of any Governmental Authority or Regulatory Authority.
“Licensed Know-how” means all technical data, reports, information, procedures, techniques, regulatory filings and documentations, and other know-how or any trade secrets owned or controlled by Serpin or any of its Affiliates as of the Effective Date or during the Term that are necessary or reasonably useful to Exploit the System, including all items identified in Annex A attached hereto.
“Licensed Trademarks” means all trademarks, trade names, service marks, service names, brands, trade dress, logos, slogans and other indicia of source or origin (whether registered or unregistered), and all translations, adaptations, derivations and combinations of the foregoing, together with the goodwill associated with or symbolized by any of the foregoing, owned or controlled by Serpin from time to time that are used with or relevant to SP16.
“Licensed Patents” means any and all patents and patent applications (including, without limitation, any and all divisionals, continuations, continuations-in-part, extensions, reexaminations, and reissues) owned or controlled by Serpin or any of its Affiliates as of the Effective Date or during the Term that claim the System, or a method of making or using the System, or are otherwise necessary or reasonably useful to Exploit the System, including all patents and patent applications identified in Annex A attached hereto.
“Licensed Technology” means, collectively, the Licensed Patents and the Licensed Know-How.
“Losses” means all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs or expenses of whatever kind, including reasonable attorneys’ fees and the cost of enforcing any right to indemnification hereunder and the cost of pursuing any insurance providers.
“Notice” has the meaning set forth in Section 8.2(b).
“Order” means any order, decree, ruling, judgment, injunction, writ, determination, binding decision, verdict, judicial award, decision, directive, consent, award or other action that is or has been made, entered, rendered, or otherwise put into effect by or under the authority of any Governmental Authority.
“Patenting Costs” means any and all costs and expenses, including without limitation government fees and attorneys’ fees and costs, related to the preparing, filing, prosecuting, issuing and maintaining any of the Licensed Patents, including continuations, extensions, re-examinations, reissues and appeals.
“Person” means any individual, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, or other legal entity of any kind, foreign or domestic.
“Receiving Party” has the meaning set forth in Section 7.1.
“Regulatory Approval” means any approvals (including supplements, amendments, pre- and post-approvals and price approvals), licenses, registrations or authorizations, howsoever called, of any Regulatory Authority, which are necessary for the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a product in a regulatory jurisdiction.
“Regulatory Authority” means the United States Food and Drug Administration (“FDA”) or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council, ethics committee, review board or other entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a product.
“Regulatory Filings” means any filings, and all data contained therein, as may be required by the FDA or equivalent foreign Regulatory Authorities for the development, manufacture or commercialization of a product.
“Representatives” means a party’s employees, officers, directors, consultants and legal advisors.
“Reserved Interests” has the meaning set forth in Section 2.4(c).
The terms “sale”, “sold” and “sell” as used in this Agreement include without limitation sales, leases, licenses, rentals and other modes of distribution or transfer of a product or its beneficial use.
“Serpin” has the meaning set forth in the Preamble.
“Sublicense” shall mean an agreement in which Dogwood (a) sublicenses any of the rights licensed to Dogwood hereunder, (b) agrees not to assert such rights or to sue, prevent or seek a legal remedy for the practice of same, or (c) is under an obligation to grant, assign or transfer any such rights or non-assertion, or to forebear from granting or transferring such rights to any other entity. Agreements expressly considered Sublicenses include without limitation licenses, option agreements, “lock up” agreements, right of first refusal agreements, or similar agreements, to the extent that the rights granted therein relate to the rights licensed to Dogwood hereunder.
“Sublicensee” shall mean any Person to whom Dogwood has granted a Sublicense.
“System” means any SP16 compound, including SP163M, in an intravenous formulation, as covered by (a) one or more Valid Claims of the Licensed Patents, and/or (b) described in the Licensed Know-How.
“Term” has the meaning set forth in Section 6.1.
“Territory” means worldwide.
“Transfer” means the sale or other transfer to a Person of all or substantially all of the Licensed Technology and Licensed Trademarks.
“Valid Claim” means, on a country-by-country basis, any pending or issued claim of any Licensed Patent that has not been admitted by Serpin, or otherwise caused, to be invalid or unenforceable through reissue, disclaimer or otherwise, or held invalid or unenforceable by a Governmental Authority of competent jurisdiction from whose judgment no appeal is allowed or timely taken.
If a protective order or other remedy is not obtained, the Receiving Party shall, at the Disclosing Party’s expense, use reasonable efforts to obtain assurance that confidential treatment will be afforded the Confidential Information.
The Parties further agree that upon commencement of a bankruptcy proceeding by or against a Party (the “Bankrupt Party”) under the Bankruptcy Code, the other Party (the “Non-Bankrupt Party”), all rights and licenses granted under or pursuant to this Agreement by a party to the other, including those set forth in Section 2 (License Granted), are and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code (the “Bankruptcy Code”), licenses of right to “intellectual property” as defined under Section 101 of the Bankruptcy Code. For the avoidance of doubt, the term “intellectual property” and “embodiments” includes, without limitation, all Licensed Technology, all patents, trade secrets, know-how, proprietary processes, software (including source code and object code), firmware, schematics, prototypes, technical documentation, data, and any other materials or information provided or made available under this Agreement. The Parties agree that the Parties and their respective sublicensees, as sublicensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the Bankruptcy Code and any foreign counterpart thereto.
Without limiting the foregoing, Dogwood may, in addition to any other remedies available to it by law or in equity, exercise the rights set forth below by written notice to Serpin, in the event Serpin shall have become insolvent or bankrupt, or shall have made a general assignment for the benefit of its creditors, or there shall have been appointed a trustee or receiver of Serpin or for all or a substantial part of its property, or any case or proceeding shall have been commenced or other action taken by or against Serpin in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, and any such event shall have continued for sixty (60) days undismissed, unbonded and undischarged.
The parties agree that Dogwood, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The parties further agree that any escrow agreements, maintenance agreements, or other agreements ancillary to or supplementing this Agreement shall be deemed “agreements supplementary to” this Agreement within the meaning of Section 365(n)(1)(B) of the Bankruptcy Code. The parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Serpin under the U.S. Bankruptcy Code, Dogwood shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and same, if not already in their possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless Serpin elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of Serpin upon written request therefor by Dogwood. Serpin also agrees that, in the event of a bankruptcy or insolvency, Serpin (and any trustee, debtor-in-possession or receiver) will not interfere with Dogwood’s rights to use and exploit the licensed intellectual property in accordance with this Agreement and Section 365(n).
The foregoing provisions are without prejudice to any rights the Non-Bankrupt Party may have arising under the Bankruptcy Code or other applicable Laws. Further, each Party agrees and acknowledges that all payments by Dogwood to Serpin hereunder do not constitute royalties within the meaning of Section 365(n) of the Bankruptcy Code.
If to Serpin: Cohava Gelber, CEO | If to Dogwood: Greg Duncan, CEO Dogwood Therapeutics, Inc. 44 Milton Ave Alpharetta, GA 30009 USA Email: Greg Duncan <greg@dwtx.com> |
Serpin Pharma, LLC Email: Cohava Gelber <cgelber@serpinpharma.com> |
Notices sent in accordance with this Section shall be deemed effectively given: (a) when received, if sent by a nationally or internationally recognized courier (receipt requested); or (b) on the date sent by e-mail, provided that the receipt of such e-mail is acknowledged by non-automated means (not to be unreasonably withheld, conditioned, or delayed).
Serpin shall provide notice to Dogwood of the same.
[SIGNATURE PAGE FOLLOWS]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed by their respective authorized representatives effective as of the Effective Date.
Serpin Pharma, Inc.
By__/s/ Cohava Gelber______________
Name_ Cohava Gelber, PhD, MBA ______
Title__CEO________________________
Date___September 27, 2025___________
Dogwood Therapeutics, Inc.
By_/s/ Greg Duncan_______________
NameGreg Duncan
TitleChief Executive Officer
DateSeptember 29, 2025
ANNEX A
LICENSED TECHNOLOGY
Licensed Patents:
Country Name | Status | Matter Type | Application # | Date Filed | Publication Number | Grant Date | Publication Date | Title | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PCT | Completed | Utility - ORG | PCT/US22/82669 | 12/30/2022 | WO2023/133078 | 07/13/2023 | | SERPIN PEPTIDES AND METHODS OF USING THE SAME | |||||||
United States | Issued | Utility - NSPCT | 15/755,693 | 08/26/2016 | US2019-0328852A1 | 10/31/2019 | | METHODS FOR TREATMENT OF DISEASES | |||||||
PCT | Completed | Utility - ORG | PCT/US16/48999 | 08/26/2016 | WO2017/040287 | | | METHODS FOR TREATMENT OF DISEASES |
Licensed Know-how:
(i) | Manufacturing Processes |
Proprietary methods for synthesizing and purifying SERPIN-based biologics.
(ii) | Analytical and Quality Control Techniques |
Annex A – Licensed Technology
Exclusive License AgreementA-1CONFIDENTIAL
(iii) | Preclinical and Clinical Data |
(iv) | Target Biology and Mechanism of Action |
(v) | Regulatory Strategy and Documentation |
Annex A – Licensed Technology
Exclusive License AgreementA-2CONFIDENTIAL